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FORMOL
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Safety Data Sheet
According to REACH Regulation (1907/2006/EC) and Regulation (EU) 453/2010
Date of issue: 01-12-2010 Revision: 01
SECTION 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING
1.1. Product identifier
Name: Formol (Formaldehyde aqueous solution)
Index number under Regulation (EC) No 1272/2008 on classification, labelling and packaging: 605-001-00-5.
CAS Number: 50-00-0
REACH Registration number: 01-2119488953-20-0038
Methanol:
Index number under Regulation (EC) No 1272/2008 on classification, labelling and packaging: 603-001-00-X
CAS Number: 67-56-1
REACH Registration number: 01-2119433307-44-0061
1.2. Relevant identified uses of the substance or mixture and uses advised against
Identified uses:
Starting product for the Chemical Industry
Uses advised against:
There are no uses advised against providing that the instructions described in this Safety Data Sheet are observed.
1.3. Details of the supplier of the safety data sheet
Manufacturer, importer o distributor: Manufacturer.
Name: ERCROS S.A.
Group: ERCROS S.A. Full address: Avda. Diagonal 595
08014 Barcelona - Spain
Telephone number: +34 934 393 009 Fax:+34 934 308 073
e-mail address for the competent person responsible for the safety data sheet: [email protected]
1.4. Emergency telephone number
Manufacturing plants:
Tortosa: Tel: +34 977 454 022 Fax: +34 977 597 101
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Almussafes: Tel:+34 961 782 250 Fax +34 961 784 055
UK National Poisons Emergency number: 0870 600 6266
SECTION 2. HAZARDS IDENTIFICATION
2.1. Classification of the substance or mixture
Classification according to Regulation (EC) No 1272/2008 on classification, labeling and packaging:
Carcinogenicity: Category 2, H351.
Acute toxicity (oral): Category 3, H301.
Acute toxicity (dermal): Category 3, H311.
Acute toxicity (inhal.): Category 3, H331.
Skin corrosion: Category 1B, H314.
Sensitisation — Skin: Category 1, H317.
Specific target organ toxicity — Single exposure: Hazard Category 3, H335.
H351: Suspected of causing cancer.
H301: Toxic if swallowed.
H311: Toxic in contact with skin.
H331: Toxic if inhaled.
H314: Causes severe skin burns and eye damage.
H317: May cause an allergic skin reaction.
H335: May cause respiratory irritation.
Classification according to Directive 67/548/EEC or 1999/45/EC:
C; R34: Causes burns.
T; R23/24/25: Toxic by inhalation, in contact with skin and if swallowed.
Xi; R43: May cause sensitisation by skin contact.
Carc. Cat.3; R40: Limited evidence of a carcinogenic effect.
2.2. Label elements
DANGER
H351: Suspected of causing cancer.
H301: Toxic if swallowed.
H311: Toxic in contact with skin.
H331: Toxic if inhaled.
H314: Causes severe skin burns and eye damage.
H317: May cause an allergic skin reaction.
H335: May cause respiratory irritation.
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P271: Use only outdoors or in a well-ventilated area.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician.
P301 + P330 + P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting.
P303 + P361 + P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with
water/shower.
P304 + P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305 + P351 + P338: IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to
do. Continue rinsing.
P403+233 Store in a well-ventilated place. Keep container tightly closed.
2.3. Other hazards
The substance does not meet the criteria for PBT or vPvB (see section 12).
PHYSICOCHEMICAL HAZARDS:
For evaporation it can reach rapidly a harmful concentration in the air.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
3.1 Mixture
Name: Formaldehyde (aqueous solution)
CAS number: 50-00-0
EC number: 200-001-8
IUPAC name: Formaldehyde
Index number under Regulation (EC) No 1272/2008 on classification, labelling and packaging: 605-001-00-5.
Composition: Index
number
under
Regulation
(EC) No
1272/2008
EC No CAS No Name Concentration Classification
according to
Directive
67/548/EEC
Classification according to
Regulation (EC) No 1272/2008
Specific
concentration
limits
605-001-00-5 200-001-8 50-00-0 Formaldehyde 25-51%
Carc. Cat. 3;
R40 T; R23/24/25
C; R34
R43
Acute Tox.–oral: Cat. 3, H301.
Acute Tox.–dermal: Cat. 3, H311.
Acute Tox.–inhal.: Cat. 3, H331.
Skin Corr. 1B, H314. Skin Sens. 1, H317.
Carc. Cat. 2, H351.
Skin Corr. 1B;
H314: C ≥25 % Skin Irrit. 2; H315:
5 % ≤ C < 25 %
Eye Irrit. 2; H319: 5 % ≤ C < 25 %
STOT SE 3; H335:
C ≥ 5 % Skin Sens. 1; H317:
C ≥ 0,2 %
603-001-00-X 200-659-6 67-56-1 Methanol < 3% F; R11 T; R23/24/25-
39/23/24/25
Flam. Liq. 2, H225 Acute Tox. 3, H331
Acute Tox. 3, H311
Acute Tox. 3, H301 STOT SE 1, H370
STOT SE 1; H370: C ≥ 10 %
STOT SE 2; H371:
3 % ≤ C < 10 %
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SECTION 4. FIRST AID MEASURES
4.1. Description of first aid measures
4.1.1. General information:
Showers and safety eye washes, for use in the event of spraying.
4.1.2. In case of inhalation:
Transfer patient to fresh air. In severe cases apply oxygen if available. Seek medical advice.
4.1.3. After skin contact:
Wash repeatedly with plenty of water. If there is irritation, seek medical advice.
4.1.4. After eye contact:
Wash plenty of water for 10-15 minutes. Seek medical advice.
4.1.5. In case of ingestion:
If patient is conscious, give him plenty of water and induce vomiting. Seek medical advice.
4.1.6. Recommended personal protective equipment for first aid responders:
If there is no fire use the equipment recommended in section 8.2.2. If there is fire, follow the recommendations of section 5.3
4.2 Most important symptoms and effects, both acute and delayed Inhalation: May irritate the mucous membranes of the respiratory tracts, cough, bronchitis and mucosity.
Skin contact: Skin dermatitis is produced as a consequence of skin sensitivity to formaldehyde and subsequent irritant action at
low formaldehyde concentration.
Eye contact: Ocular exposure to formaldehyde vapors produces irritation and lacrimation.
Ingestion: Irritation to the mucus membranes of the digestive tract. Possible loss of consciousness.
4.3. Indication of any immediate medical attention and special treatment needed
Need of immediate medical attention.
SECTION 5. FIREFIGHTING MEASURES
5.1. Extinguishing media
Suitable extinguishing media:
Water, CO2, Foam or Dry Chemical Powder.
Use water spray to cool fire-exposed containers.
Unsuitable extinguishing media:
Not applicable.
5.2. Special hazards arising from the substance or mixture
Not applicable.
5.3. Advice for firefighters
Self-breathing equipment is recommended in case of important fire, due to the risk of combustion gases (carbon monoxide) and
formaldehyde vapors.
SECTION 6. ACCIDENTAL RELEASE MEASURES
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6.1. Personal precautions, protective equipment and emergency procedures
Wear protective equipment, goggles, gloves and masks with chemical filter. Avoid ignition sources.
6.2. Environmental precautions
Prevent spilled liquid from entering the sewer and closed areas. Advise the competent authorities, treatment plant operators and
other users of downstream waters that water may be contaminated.
6.3. Methods and material for containment and cleaning up
If possible, pump the spilled liquid to suitable containers. Alternatively, cover non-transferable product with a porous, inert
material (sand, sawdust, etc.) and transfer it to a closed container. If recycling is not possible, best disposal method is total
incineration.
6.4. Reference to other sections
See protection measures in section 8.
SECTION 7. HANDLING AND STORAGE
7.1. Precautions for safe handling
The relevant regulation on protection against risk of chemical agents in the working place must be taken into account. Do not eat,
drink or smoke during handling. Use in well ventilated places, and if it is possible with a located ventilation system.
Protection against fire and explosion: Take precautionary measures against static discharges. Vapours may form explosive
mixture with air. Keep away from sources of ignition - No smoking
Provide extinguishing media at hand, as well as eye and skin washing facilities. Staff handling the product should always use
protective garments as recommended in Section 8.
7.2. Conditions for safe storage, including any incompatibilities
Recommended materials: Stainless steel is the most suitable material for storage tanks. Epoxy-resin overlaid steel and
polyethyelene containers can also be used.
Incompatible materials: Metallic container.
Storage conditions: Well-closed containers, protected from the light and in well ventilated places.
Temperature and Humidity range/limit:
Formol %(w/w) Tª mín
30 25
37 35
45 50
50 55
Special conditions: Product must be kept away from heat, sparks, open flames or other sources of ignition.
Applicable regulations: The relevant regulation on chemicals products storage must be taken into account.
7.3. Specific end use(s)
Reacts with many substances like urea, phenol, melamine and polyacetals, to form synthetic polymerized resins.
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SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
8.1. Control parameters
Formaldehyde:
VLA-EC- 0.3 ppm , 0.37 mg / m3. (INSHT, Spain).
TLV-STEL 0.3 ppm , 0.37 mg / m3
. (ACGIH ).
MAK/2002 0.3 ppm , 0.37 mg / m3
Long term exposure limit (8 h): 2 ppm, 2.5 mg/ m3
WEL (UK)
Acute exposure limit (15 min.): 2 ppm, 2.5 mg/ m3 WEL (UK)
Human exposure:
For workers:
DNEL (Acute - local effects): 1 mg/m3 (inhalation)
DNEL (Long term - systemic effects): 240 mg/kg bw/day (dermal; repeated dose toxicity)
DNEL (Long term - systemic effects): 9 mg/m³ (inhalation; repeated dose toxicity)
DNEL (Long term - local effects): 37 µg/cm2 (dermal)
DNEL (Long term - local effects): 0.5 mg/m³ (inhalation)
For general population:
DNEL (Long term - systemic effects): 102 mg/kg bw/day (dermal; repeated dose toxicity)
DNEL (Long term - systemic effects): 3.2 mg/m³ (inhalation; repeated dose toxicity)
DNEL (Long term - systemic effects): 4.1 mg/kg bw/day (oral; repeated dose toxicity)
DNEL (Long term - local effects): 12 µg/cm2 (dermal)
DNEL (Long term - local effects): 0.1 mg/m³ (inhalation)
Environment:
PNEC (freshwater): 0.47 mg/L (based on statistical extrapolation and assessment factor 10).
PNEC (marine water): 0.47 mg/L (based on toxicity value 4.7 mg/L and assessment factor 10).
PNEC (water, intermittent releases): 4.7 mg/L (based on toxicity value 4.7 mg/L and assessment factor 1).
PNEC (sediment): 2.44 mg/kg dw (partition coefficient method)
PNEC (sediment, marine water): 2.44 mg/kg dw (partition coefficient method)
PNEC (soil): 0.21 mg/kg dw(partition coefficient method)
PNEC (sewage treatment plant): 0.19 mg/L (based on effect concentration EC50 (3 h): 19 mg/L and assessment factor 100).
Methanol:
VLA-ED (Valor Límite Ambiental-Exposición Diaria): 200 ppm, 266 mg / m3 (Spain)
TLV-STEL 250 ppm (ACGIH 2006).
WEL-Limit value - Eight hours: 200 ppm, 266 mg/m3 (UK)
WEL-Limit value - Short term: 250 ppm, 333 mg/m3 (UK)
For workers:
DNEL (Acute/Long term - systemic effects): 40 mg/kg bw/day (dermal; acute toxicity)
DNEL (Acute/Long term - systemic effects): 260 mg/m3 (inhalation; acute toxicity)
DNEL (Acute/Long term - local effects): 260 mg/m3 (inhalation; acute toxicity)
For general population:
DNEL (Acute/Long term - systemic effects): 8 mg/kg bw/day (dermal; acute toxicity)
DNEL (Acute/Long term - systemic effects): 50 mg/m3 (inhalation; acute toxicity)
DNEL (Acute/Long term - systemic effects): 8 mg/kg bw/day (oral; acute toxicity)
DNEL (Acute/Long term - local effects): 50 mg/m3 (inhalation; acute toxicity)
Environment:
PNEC (freshwater): 154 mg/L (based on the lowest aquatic toxicity value 96-h LC50 fish = 15400 mg/l and assessment factor
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100).
PNEC (marine water): 15.4 mg/L (based on the lowest aquatic toxicity value 96-h LC50 fish = 15400 mg/l and assessment factor
1000).
PNEC (water, intermittent releases): 1540 mg/L (based on the lowest aquatic toxicity value 96-h LC50 fish = 15400 mg/l and
assessment factor 10).
PNEC (sediment): 570.4 mg/kg dw (equilibrium partition method)
PNEC (soil): 23.5 mg/kg dw (equilibrium partition method)
PNEC (sewage treatment plant): 100 mg/L (based on the lowest effect concentration for micro-organisms toxicity IC50 > 1000
mg/L and assessment factor 10).
8.2. Exposure controls
8.2.1. Appropriate engineering controls
An assessment must be performed and organizational measures and collective and individual protective devices employed in order
to reduce exposure.
8.2.2. Individual protection measures, such as personal protective equipment
Respiratory protection:
Use protective mask provided with AB chemical filter (EN 143 et EN 14387).
Hand protection:
Use neoprene or rubber gloves (EN 374).
Eye protection:
Use safety goggles as airtight as possible (EN 166).
Skin proteciton:
Use full working clothing, EPI Category III (EN 340).
8.2.3. Environmental exposure controls
Take into account the regulations for the protection of the environment.
SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
9.1. Information on basic physical and chemical properties
Appearance (physical state and colour): Colourless liquid free from suspended matter
Odour: Characteristic pungent.
Odour threshold: No data available.
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pH: Aprox. 4
Melting point/freezing point: No data available.
Initial boiling point and boiling range: Between 96.7 and 101.1 ºC
Flash point: 50 ºC with 15% methanol
85 ºC with 0% methanol
Flammability (solid, gas): Not applicable for liquids.
Upper/lower flammability or explosive limits:
Formaldehyde:
Lower limit 7.0 vol%
Upper limit 73 vol%
Methanol:
Lower limit 7.3 vol%
Upper limit 36 vol%
Explosive properties: There are no chemical groups associated with explosive
properties present in the molecule
Oxidising properties: The substance is incapable of reacting exothermically with
combustible materials.
Vapour pressure: 1 at 1.3 mmHg at 20 ºC
Relative density: Aprox. 1.14 g/cm3 at 20 ºC
Solubility: Soluble in acetone, alcohol, benzene, chloroform and ether
at all rates.
Water solubility: Soluble in water.
Partition coefficient: n-octanol/water:
Formaldehyde:
0.35 at 25°C
Methanol:
- 0.77
Viscosity:
η(mPA·s)= 1.28+0.039F+0.05M-0.024T
F: Concentration Formol 25% to 50%
M: Concentration Methanol 0% to 13%
T: Temperature 25ºC to 40ºC
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Vapour density: 1.03 (air=1)
Evaporation rate: No data available.
Auto-ignition temperature:
Formaldehyde:
430 °C at 1013 hPa
Methanol:
455°C at 1013 hPa
Decomposition temperature: No data available.
9.2. Other information
Organic peroxide: Not classified (based on structure)
Self-heating: Based on the available data, the classification criteria are not met.
Pyrophoric liquid/solid: Based on the available data, the classification criteria are not met.
Corrosive to metals: No data available.
Substance which in contact with water emits flammable gases: Based on the available data, the classification criteria are not
met.
SECTION 10. STABILITY AND REACTIVITY
10.1. Reactivity
Reacts with strong oxidizing agents.
10.2. Chemical stability
At the above mentioned concentrations, formaldehyde is a stable substance. Its polimerization is not dangerous. It may polymerize
at low temperatures (T<20ºC).
10.3. Possibility of hazardous reactions
May react violently with oxidizing agents.
10.4. Conditions to avoid
Storage temperatures over 50ºC, sparks and flames.
Temperatures lower than 20ºC. It may polymerize.
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10.5. Incompatible materials
Sodium hydroxide and other alkalis, acids, amines, phenols, oxygen, hydrogen peroxide, and strong oxidant agents in general.
Also reacts with copper, iron and silver salts.
10.6. Hazardous decomposition products
Combustion: carbon monoxide.
Thermal descomposition: formaldehyde gas.
SECTION 11. TOXICOLOGICAL INFORMATION
11.1. Information on toxicological effects:
11.2. acute effects (acute toxicity, irritation and corrosivity):
11.2.1. LD50 oral (lethal dose, 50%)
Formaldehyde:
460 mg/kg bw (male rat)
(Equivalent or similar to OECD 401)
Methanol:
> 1187-2769 mg/kg bw (male and female rat)
Classification based on acute toxicity data in humans.
11.2.2. LD50 dermal (lethal dose, 50%)
Formaldehyde:
The study does not need to be conducted as formaldehyde
has corrosive properties.
Methanol:
17100 mg/kg bw (rabbit) (Rowe and McCollister, 1981). Classification based on acute toxicity data in humans.
11.2.3. LC50 inhalation (lethal dose, 50%)
Formaldehyde:
1000 mg/m³ (30 min) (rat)
(Equivalent or similar to OECD 403).
Methanol:
128.2 mg/L air; 4 hours (male and female rat)
Classification based on acute toxicity data in humans.
11.2.4. Skin corrosion /irritation
Formaldehyde:
Skin corrosion Category 1B: Causes severe skin burns and
eye damage.
Corrosive (rabbit)
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(Equivalent or similar to OECD 404)
Methanol:
Not irritating (rabbit).
11.2.5. Serious eye damage/irritation
Formaldehyde:
Eye damage: Category 1: Causes severe eye damage.
Methanol:
Not irritating (rabbit).
11.2.6 Specific target organ toxicity – single exposure
Formaldehyde: Concentration ≥ 5%: Category 3: May cause respiratory
irritation.
Methanol:
Category 1: It causes damage to the optic nerve and Central
Nervous System; oral, dermal exposure and inhalation.
11.3. Sensitisation:
Formaldehyde:
Respiratory sensitisation: Based on the available data, the classification criteria are not met.
Skin sensitisation: Skin sensitizing: Category 1: May cause an allergic skin reaction.
(Skin sensitization studies show positive results for mice and guinea pig tests)
Methanol:
Respiratory sensitisation: No data available.
Skin sensitisation: Not sensitizing (guinea pig) (Equivalent to similar to OECD 406).
11.4. Repeated dose toxicity:
Formaldehyde:
Specific target organ toxicity – repeated exposure: Based on the available data, the classification criteria are not met.
Oral exposure:
NOAEL: 82 mg/kg bw/day (male rat; Exposure up to 105 weeks; target organ: stomach)
NOAEL: 109 mg/kg bw/day (female rat; Exposure up to 105 weeks)
(Equivalent or similar to OECD 453)
Inhalation exposure:
NOAEC: 1.2 mg/m3
Methanol:
Specific target organ toxicity – repeated exposure: Chronic studies in monkeys clearly demonstrate the potential of the
substance to cause neurological and myocardium effects, with higher exposure times than the usual daily. It is therefore
conceivable that the effects observed in these cases were more serious compared with shorter daily exposures, because the
available biological dose of methanol was much higher
Although there is a clear potential of methanol to cause negative effects on primates health, experimental animal studies do not
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provide clear evidence for classification.
Oral exposure: LOAEL subacute: 2340 mg/kg bw/day (3 days; male monkey; target organs: neurological: eyes (retina, optic
nerve); lethal dose: 100% lethality after 3 days of exposure)
Inhalation exposure: NOEC: 0.013 mg/L air (monkey; 7-29 months of exposure; target organs: heart, brain, liver)
(Equivalent or similar to OECD 453)
11.5 CMR effects (carcinogenicity, mutagenicity and toxicity for reproduction):
Formaldehyde:
Carcinogenicity: Category 2: Suspected of causing cancer.
Inhalation exposure:
The substance presents carcinogen activity in laboratory animals. There is clear evidence obtained in chronic inhalation studies in
rats where the substance causes tumors of the nasal cavity.
Germ cell mutagenicity: Based on the available data, the classification criteria are not met.
Positive results in in vitro bacterial reverse mutation assays (equivalent or similar to OECD 471), mammalian cell gene mutation
assays (equivalent or similar to OECD 476) and mammalian chromosome aberration test (equivalent or similar to OECD 473).
Negative results in in vivo gene mutation studies (equivalent or similar to OECD 484) and chromosome aberration test (equivalent
or similar to OECD 474).
Toxicity for reproduction: Based on the available data, the classification criteria are not met.
Due to rapid metabolism of formic acid, the formaldehyde does not reach the reproductive organs.
It is not necessary to carry out a study if the substance is considered to be genotoxic and carcinogen and good risk management
measures are implemented.
Development effects have not been observed.
Inhalation exposure:
NOAEC (developmental toxicity): 10 ppm (rat) (highest dose tested)
NOAEC (maternal toxicity): 5 ppm (rat)
LOAEC (maternal toxicity): 10 ppm (rat) (decreased body weight and food consumption (highest dose tested))
(equivalent or similar to OECD 414)
Oral exposure:
LOAEL (maternal toxicity): 74 mg/kg bw/day (decrease in body weight gain)
NOAEL (developmental toxicity): 185 mg/kg bw/day (highest dose tested)
Reproductive toxicity, effects on or via lactation: No data available.
Methanol:
Carcinogenicity: Based on the available data, the classification criteria are not met.
Oral exposure: NOAEL: 466 — 529 mg/kg bw/day (104 weeks; male and female rat; global effects) LOAEL: 1872 — 2101 (104
weeks; male and female rat; global effects)
Inhalation exposure: There is no evidence of carcinogenic potential in rats and mice exposed to concentrations in air up to 1.3 mg/L. NOAEC: >= 1.3 mg/L air (24 months; male and female rat) (equivalent or similar to OECD 453)
Germ cell mutagenicity: Based on the available data, the classification criteria are not met.
Negative results in in vitro bacterial reverse mutation assays (OECD 471), mammalian cell gene mutation assays (equivalent or
similar to OECD 476) y and mammalian chromosome aberration test.
Negative results in in vivo studies: chromosome aberration (equivalent or similar to OECD 474).
Toxicity for reproduction: Based on the available data, the classification criteria are not met.
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Inhalation exposure:
NOAEC (P) = 1.3 mg/L air (male and female rat; reproductive parameter)
NOAEC (F1) = 0.13 mg/L air (male and female rat)
(equivalent or similar to OECD 416)
NOAEC (P): 2.39 mg/L air (female monkey; reproductive rate)
NOAEC (F1): 2.39 mg/L air (female monkey; offspring growth and physical development)
NOAEC = 1.33 mg/L (rat and mouse; developmental toxicity) (equivalent or similar to OECD 414)
Oral exposure: LOAEL = 5000 mg/kg bw (mice; developmental toxicity)
LOAEL = 1700 mg/kg bw (mice; maternal toxicity)
Reproductive toxicity, effects on or via lactation: Based on the available data, the classification criteria are not met.
11.6. Aspiration hazard:
There is no evidence for aspiration hazard.
SECTION 12. ECOLOGICAL INFORMATION
12.1. Toxicity
Acute toxicity to fish
LC50 (lethal concentration, 50%):
Formaldehyde:
Species: Morone saxatilis.
6.7 mg/L (96h; freshwater; static system)
(Wellborn, 1969)
Methanol:
Species: Lepomis macrochirus.
15400 mg/L (96 h; freshwater; flow-through system)
(EPA-660/3-75-009, 1975)
Chronic toxicity to fish
NOEC (no observed effect concentration):
Formaldehyde:
Species: Oryzias latipes
≥ 48 mg/L (28d ; freshwater; flow-through system; based on
mortality, target organ pathologies)
(Equivalent or similar to OECD Guideline 215)
Methanol:
Species: Oryzias latipes.
7900 - 15800 mg/L (200 h; freshwater; static system; based
on number of births)
(Gonzáles-Doncel, M. et al., 2008)
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Acute toxicity to crustaceans
EC50 (effect concentration, 50%):
Formaldehyde:
Species: Daphnia pulex.
5.8 mg/L (48 h; freshwater; static system)
(OECD 202)
Methanol:
Species: Daphnia magna.
>10000 mg/L (48 h; freshwater; static system; based on
mobility)
(DIN 38412 Teil 11)
Chronic toxicity to crustaceans
NOEC (no observed effect concentration):
Formaldehyde:
The formaldehyde is readily biodegradable so disappears
rapidly from the aquatic environment.
Methanol:
There are no studies available as they are not considered
necessary. Studies of chronic toxicity with substances
structurally related (2-Propanol and 1-Butanol) show no
reproductive effects up to 100 mg/l concentrations (NOEC
100 mg/l) and 18 mg/l respectively.
Acute toxicity to algae and other aquatic plants
EC50 (effect concentration, 50%):
Formaldehyde:
Species: Desmodesmus subspicatus
3.48 mg/L (72 h; freshwater; static system; based on
biomass)
4.89 mg/L (72 h; freshwater; static system; based on growth
rate)
(OECD 201)
Methanol:
Species: Selenastrum capricornutum (new name:
Pseudokirchnerella subcapitata)
22000 mg/L (96 h; freshwater; static system; based on
growth rate)
(OECD 201; EPA OPPTS 850.5400)
Toxicity data on soil micro- and macro-organisms and other environmentally relevant organisms, such as birds, bees and
plants
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Formaldehyde:
Species: Eisenia fetida (annelids)
LC50 (48 h; based on mortality): 1 — 10 µg/cm2
(Contact toxicity test. Roberts BL, Dorough HW, 1984)
Terrestrial plants: Lilium longiflorum.
LOEC (5 h): 440 µg/m3 (Effect parameters: pollen tube length).
EC100 (5 h): 1680 µg/m3 (Effect parameters: pollen tube length).
(Masaru N, Syozo F, Saburo K, 1976)
Methanol:
The substance has low adsorption potential, it is not bioaccumulative and it is readily biodegradable in both aerobic and anaerobic
environments. Further tests reveal that it has no harmful effects on the aquatic environment and suggest low toxicity to soil
organisms. Species: Eisenia fetida (annelids).
LC50 (48 h): > 1 mg/cm² (based on mortality).
(Equivalent or similar to OECD 207)
12.2. Persistence and degradability
Readily biodegradable
Formaldehyde:
Readily biodegradable in water: 90 % degradation after 28
days (OECD 301 C and D)
Methanol:
Readily biodegradable in water based on results from
standard studies showing a percentage of degradation of
71.5 - 95% after 5 to 20 days, respectively (Price et al. 1974;
Wagner 1976). In marine water degradation was 69 - 97 %
(Price et al. 1974).
Other relevant information
Formaldehyde:
No data available.
Methanol:
Degradation time in water: 1-7 days
Degradation time in sediment: 1-7 days
Degradation time in soil: 1-7 days
Degradation time in air: 17-18 days
12.3. Bioaccumulative potential
Bioconcentration factor (BCF): experimental data:
Formaldehyde:
BCF: 0.396 (estimated). Limited experimental data.
Methanol:
Species: Cyprinus carpio.
Aquatic bioaccumulation study performed during 72 hours,
in freshwater, static system:
Highest value: BCF: 4.5 (intestine)
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Partition coefficient: n-octanol/water (log Pow):
Formaldehyde:
0.35 at 20°C
Methanol:
- 0.77
12.4. Mobility in soil
Formaldehyde:
No data available.
Methanol:
Due to his low log Kow (-0,77) value and high water solubility, it has a high mobility in soil, with trend to quickly filter (mainly
on sandy beds) and reach underground aquifers. In clay fields or with organic matter content, it can be very slightly adsorbed (<
1%).
12.5. Results of PBT (persistent, bioaccumulative and toxic) and vPvB (very persistent and very bioaccumulative)
assessment
Formaldehyde:
Persistence assessment (P):
Due to its rapid degradation, the substance is not persistent P nor very persistent vP.
Bioaccumulation assessment (B):
The bioconcentration factor is always BCF: < 1 for studied aquatic species. Bioaccumulation in organisms is not expected.
Toxicity assessment (T):
The results of aquatic toxicity studies and those carried out in mammals indicate that the substance is not toxic.
The substance does not meet the criteria to be considered PBT or vPvB.
Methanol:
Persistence assessment (P):
Based on the available data on degradation, one can conclude that the substance is neither P nor vP.
Bioaccumulation assessment (B):
Based on the available data on bioaccumulation, one can conclude that the substance is neither P nor vP.
Toxicity assessment (T):
Based on the results of aquatic toxicity studies, and those carried out in mammals, the substance is not classified as toxic T.
Considering all available data in biotic and abiotic degradation, bioaccumulation and toxicity, it may be concluded that the
substance does not meet the PBT criteria nor vPvB.
12.6. Other adverse effects
No data available.
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SECTION 13. DISPOSAL CONSIDERATIONS
13.1. Waste treatment methods
Substance or preparation:
There are not uniform guidelines established by the European Union for the elimination of chemical residues which are of special
waste, left subject its treatment and disposal to the internal regulations of each country. Therefore, in each case, is appropriate to
contact with the competent authority, or with operators legally authorised for waste disposal.
European regulation:
- Council Decision 2001/573/EC of 23 July 2001 amending Decision 2000/532/EC as regards the list of wastes.
- Council Directive 91/156/CEE of 18 March 1991 amending Directive 75/442/EEC on waste.
- Commission Decision 2000/532/EC of 3 May 2000 replacing Decision 94/3/EC establishing a list of wastes.
Contaminated packaging:
Contaminated packaging of dangerous substances or preparations will have the same treatment to the contained products
themselves.
European regulation:
- European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste.
SECTION 14. TRANSPORT INFORMATION
14.1 ADR (road)/RID (rail)
14.1.1 UN number: 2209
14.1.2 UN proper shipping name: FORMALDEHYDE SOLUTION
14.1.3 Transport hazard Class : 8 Label: 8
14.1.4 Packing group: III
14.1.5. Environmental hazards: No.
14.2 IMDG (sea)
14.2.1 UN number: 2209
14.2.2 UN proper shipping name: FORMALDEHYDE SOLUTION
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14.2.3 Transport hazard Class : 8, Label: 8
14.2.4 Packing group: III
14.2.5. Environmental hazards: No.
14.3 ICAO / IATA (air)
14.3.1 UN number: 2209
14.3.2 UN proper shipping name: FORMALDEHYDE SOLUTION
14.3.3 Transport hazard Class : 8 Label:8
14.3.4 Packing group: III
14.3.5. Environmental hazards: No.
14.4. Special precautions for user
It is necessary to attend to the same information described in the previous epigraphs: ADR, RID, IMDG, ICAO / IATA.
14.5. Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code
Not applicable.
SECTION 15. REGULATORY INFORMATION
15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
- 96/82/CE Directive, on the control of major-accident hazards involving dangerous substances.
- 98/24/CE Council Directive, of 7 April 1998 concerning health protection for workers and safety from the risks related to
chemical agents at work.
15.2. Chemical safety assessment
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The supplier has carried out a chemical safety assessment for the substance.
SECTION 16. OTHER INFORMATION
Information sources used in the elaboration of this Safety Data Sheet:
- HANDBOOK OF REACTIVE CHEMICALS HAZARDS. BRETHERIC 4ª Ed. 1990
- DANGEROUS PROPERTIES INDUSTRIAL MATERIALS (TENTH EDITION) SAX
- HAZARDOUS CHEMICALS DATA BOOK (2nd EDITION) G.WEIS.
- IARC (International Agency for Research on Cancer).
- NIOSH (National Institute for Occupational Safety and Health).
- NTP (National Toxicology Program).
- ACGIH (American Conference of Governmental Industrial Hygienist).
- OSHA (Occupational Health and Safety Assessment)
- INSHT (Instituto Nacional de Seguridad e Higiene en el Trabajo).
Abbreviations:
N/A = not applicable
< SMALLER THAN > GREATER THAN
VLA-EC: Valor Límite Ambiental-Exposición de Corta Duración (Spain)
ED: Exposición diaria
TLV-STEL: Threshold Limit Value - Short term exposure limit
TWA: Time Weighted Average (Media ponderada en el tiempo)
WEL: workplace exposure limit (UK)
DNEL: derived no effect level
PNEC: predicted no effect concentration
Any chemical product can be handled safely if its physical and chemical properties are known, and appropriate safety measures
and clothing are employed.
The information contained in this brochure is a guide for the user and based on both reference texts and on our own experience. It
is intended to reflect the current state of the art, but shall under no circumstances compromise our liability. This information
cannot be used as a substitute for patented processes.
Users shall comply with the legal dispositions and regulations in force, particularly those relating to Health and Safety and the
Storage and Transport of Dangerous Goods.
We recommend that our clients perform the corresponding tests before using the product in new, insufficiently tested fields.
ERCROS S.A
Head office:
Avda Diagonal 595
08014 Barcelona
Tel:+34 934 393 009 –
Fax:+34 934 874 058
Factory:
Tortosa (Tarragona)
Polígono Industrial Baix Ebre
43500 Tortosa (Tarragona)
Tel: +34 977 454 022
Fax:+34 977 597 101
Factory:
Almusafes (VALENCIA)
C/Venta de Ferrer s/n
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Polígono Industrial Norte
46440 Almusafes (VALENCIA)
Teléf.: (+34) 961 782 250
Fax: (+34) 961 784 055
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APPENDIX I: Exposure scenarios for Formaldehyde
Section 1.- Title Manufacturing of Formaldehyde + aq. formaldehyde solutions and use as
intermediate
Systematic title based on use
descriptor
SU 3,8,9,10,12
PROC 1,2,3,4,5,6,8a,8b,9,14,15
ERC 1, 2, 3, 4, 6a, 6b, 6c, 6d, 7
Consortium use numbers covered:
1; production of formaldehyde (IU1)
8/9; use as intermediate including use as a monomer (IU2)
Section 2.- Operational conditions and risk management measures
Processes, tasks, activities covered
Use in closed process, no likelihood of exposure (PROC 1)
Use in closed, continuous process with occasional controlled exposure (PROC 2)
Use in closed batch process (synthesis / formulation) (PROC 3)
Use in batch or other process (synthesis) where opportunity for exposure arises (PROC 4)
Mixing or blending in batch processes (multistage and/or significant contact) (PROC 5)
Calendaring operations (PROC 6)
Transfer of substance or preparation (charging/discharging) from/to vessels/ large
containers at non dedicated facilities (PROC 8a)
Transfer of chemicals (charging/ discharging) from/to vessels/ large containers at dedicated
facilities (PROC 8b)
Transfer of substance or preparations into small containers (dedicated filling line including
weighing) (PROC 9)
Production of preparations or articles by tabletting, compression, extrusion, pelletisation
(PROC 14)
Use as laboratory reagent (PROC 15)
Environment characteristic
covered No environmental assessment is performed
Environmental Assessment
Method No environmental assessment is performed
Formaldehyde is not stable; therefore it is stored as formalin (30-60%). Formaldehyde has another vapour pressure than
formalin. The vapour pressure used in the exposure assessments is 100,000 Pa for pure formaldehyde. In production-transfer
activities formaldehyde is present as formalin with a vapour pressure of 1520 Pa at elevated temperature (49% formaldehyde
solution at 55 ºC) and 1400 Pa for formalin at room temperature (50 % formaldehyde solution (with 2 % of methanol)).
Number of sites using the substance (potentially required to demonstrate strictly controlled conditions of use to justify waiving of
information according to Annex XI of REACH)
2.1.- Control of workers exposure
Contributing exposure scenario 1 controlling worker exposure for PROC 1
Workers related free short title Manufacturing of formalin; general manufacture closed system
Use descriptor covered SU3, PROC 1
Processes, tasks, activities covered PROC 1: Use in closed process, no likelihood of exposure
Assessment Method Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Product characteristic
Vapour, Formaldehyde 100%. Pure formaldehyde is present within at least parts of the closed process equipment
Amounts used
Not relevant
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Frequency and duration of use/exposure
Daily, up to 480 minutes
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers exposure
Indoor, large industrial workrooms (300 m3)
Hot process (50-150 °C)
Technical conditions and measures at process level (source) to prevent release
High level of containment (99.9% reduction), consisting of:
• Sealed and enclosed system
• The enclosure is not opened during the activity
• The system is designed to minimize the surface area which can contact the material or pairs of valves with wash space
between them.
Technical conditions and measures to control dispersion from source towards the worker
General ventilation at least 3 air changes per hour
Organisational measures to prevent /limit releases, dispersion and exposure
No organizational measures required.
Conditions and measures related to personal protection, hygiene and health evaluation
Stringent use of protective gloves with specific worker training and management supervision to minimize exposure (reduction
factor 98%) at activities that may lead to contact with contaminated surfaces. Wear suitable eye protection if exposure to the eyes
may be possible, e.g. due to splashing, working overhead or when the face of the worker needs to be close to the source.
Contributing exposure scenario 2 controlling worker exposure for PROC 2
Workers related free short title Manufacturing of formalin; general manufacture closed system, continuous process.
Use descriptor covered SU3, PROC 2
Processes, tasks, activities covered
PROC 2: Use in closed, continuous process with occasional controlled exposure.
PROC 2 consists of closed process activities and dedicated transfer activities including
sampling. The contributing scenario consists of a combination of these two activities.
Assessment Method* Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Product characteristic
Closed process: Vapour, formaldehyde 100%. Pure formaldehyde is present within at least parts of the closed process equipment
Dedicated transfer: Liquid, formalin (30-60% formaldehyde in water). The finalized product (formalin) is transferred to storage or
further processing.
Amounts used
Closed process: Not relevant
Dedicated transfer: > 1000 L/min
Frequency and duration of use/exposure
Closed process: Daily, up to 360 minutes.
Dedicated transfer: Daily, up to 120 minutes.
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers exposure
Dedicated transfer and closed process:
Indoor, large industrial workrooms (300 m3)
Hot process activities (50-150 °C)
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Technical conditions and measures at process level (source) to prevent release
Dedicated transfer:
• Submerged loading
Dedicated transfer and closed process:
- Medium level of containment (99% reduction), consisting of:
• Physical containment or enclosure of the source of emission.
• The material transfer is enclosed with the receiving vessel being docked or sealed to the source vessel.
Examples include sealing heads, transfer containers and multiple o-rings. Inflatable packing head with continuous liner
ensures a seal is maintained during the transfer and the continuous plastic liner prevents direct contact with the product. The
correct type of tie off must be used.
Technical conditions and measures to control dispersion from source towards the worker
Dedicated transfer and closed process: general ventilation at least 3 air changes per hour
Dedicated transfer: transfer system is provided with a vapour recovery system (80% reduction)
Organisational measures to prevent /limit releases, dispersion and exposure
Ensure Dedicated transfer is limited to at most 120 minutes
Ensure Closed process activities are limited to at most 360 minutes
Conditions and measures related to personal protection, hygiene and health evaluation
Dedicated transfer and closed process:
Wear suitable eye protection if exposure to the eyes may be possible, e.g. due to splashing, working overhead or when the face of
the worker needs to be close to the source.
Closed process: Stringent use of protective gloves with specific worker training and management supervision to minimize
exposure (reduction factor 98%) at activities that may lead to contact with contaminated surfaces.
Dedicated transfer: Stringent use of protective gloves with specific worker training and management supervision to minimize
exposure (reduction factor 98%).
Dedicated transfer: Use of respiratory protective equipment (90% reduction).
Contributing exposure scenario 3 controlling worker exposure for PROC 3
Workers related free short title Manufacturing of formalin; general manufacture closed batch process
Use descriptor covered SU3, PROC 3
Processes, tasks, activities covered
PROC 3: Use in closed, continuous process with occasional controlled exposure.
PROC 3 consists of closed process activities and dedicated transfer activities including
sampling. The contributing scenario consists of a combination of these two activities.
Assessment Method Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Product characteristic
Closed process: Vapour, formaldehyde 100%. Pure formaldehyde is present within at least parts of the closed process equipment
Dedicated transfer: Liquid, formalin (30-60% formaldehyde in water). The finalized product (formalin) is transferred to storage or
further processing.
Amounts used
Closed process: Not relevant
Dedicated transfer: > 1000 L/min
Frequency and duration of use/exposure
Closed process: Daily, up to 360 minutes.
Dedicated transfer: Daily, up to 120 minutes.
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers exposure
Dedicated transfer and closed process:
Indoor, large industrial workrooms (300 m3)
Hot process activities (50-150 °C)
Technical conditions and measures at process level (source) to prevent release
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Dedicated transfer:
• Submerged loading
Dedicated transfer and closed process:
- Medium level of containment (99% reduction), consisting of:
• Physical containment or enclosure of the source of emission.
• The material transfer is enclosed with the receiving vessel being docked or sealed to the source vessel.
Examples include sealing heads, transfer containers and multiple o-rings. Inflatable packing head with continuous liner
ensures a seal is maintained during the transfer and the continuous plastic liner prevents direct contact with the product. The
correct type of tie off must be used.
Technical conditions and measures to control dispersion from source towards the worker
Dedicated transfer and closed process: general ventilation at least 3 air changes per hour
Dedicated transfer: transfer system is provided with a vapour recovery system (80% reduction)
Organisational measures to prevent /limit releases, dispersion and exposure
Ensure Dedicated transfer is limited to at most 120 minutes
Ensure Closed process activities are limited to at most 360 minutes
Conditions and measures related to personal protection, hygiene and health evaluation
Dedicated transfer and closed process: Wear suitable eye protection if exposure to the eyes may be possible, e.g. due to splashing,
working overhead or when the face of the worker needs to be close to the source.
Closed process: Stringent use of protective gloves with specific worker training and management supervision to minimize
exposure (reduction factor 98%) at activities that may lead to contact with contaminated surfaces.
Dedicated transfer: Stringent use of protective gloves with specific worker training and management supervision to minimize
exposure (reduction factor 98%).
Dedicated transfer: Use of respiratory protective equipment (90% reduction).
Contributing exposure scenario 4 controlling worker exposure for PROC 4
Workers related free short title Manufacturing of formalin; batch and other processes.
Use descriptor covered SU3, PROC 4
Processes, tasks, activities covered
PROC 4: Use in batch and other processes (synthesis) with opportunity for exposure
PROC 4 consists of three types of activities:
• dedicated transfer activities
• closed process activities
• activities near open parts of the process
This contributing scenario consists of a combination of these three activities.
Assessment Method Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Product characteristic
Dedicated transfer: Liquid, formalin (30-60% formaldehyde in water). The finalized product (formalin) is transferred to storage or
further processing.
Closed process: Vapour, formaldehyde 100%. Pure formaldehyde is present within at least parts of the closed process equipment
Open parts of the process: Liquid, formalin (30-60% formaldehyde in water).
Amounts used
Dedicated transfer: > 1000 L/min
Closed process: Not relevant
Open parts of the process: Not relevant
Frequency and duration of use/exposure
Dedicated transfer and open parts of the process: Daily, up to 60 min.
Closed process: Daily, up to 360 min.
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers exposure
Dedicated transfer, closed process and open parts of the process:
Indoor, large industrial workrooms (300 m3)
Hot process activities (50-150 °C)
Technical conditions and measures at process level (source) to prevent release
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Dedicated transfer:
• Submerged loading
Dedicated transfer and closed process:
- Medium level of containment (99% reduction), consisting of:
• Physical containment or enclosure of the source of emission.
• The material transfer is enclosed with the receiving vessel being docked or sealed to the source vessel.
Examples include sealing heads, transfer containers and multiple o-rings. Inflatable packing head with continuous liner
ensures a seal is maintained during the transfer and the continuous plastic liner prevents direct contact with the product. The
correct type of tie off must be used.
Open parts of the process:
• Open surface < 0.1 m2
Technical conditions and measures to control dispersion from source towards the worker
Dedicated transfer, closed process and open parts of the process:
General ventilation at least 3 air changes per hour
Dedicated transfer: transfer system is provided with a vapour recovery system (reduction 80%)
Open parts of the process: Local exhaust ventilation (fixed capturing hoods, 90% reduction) at potential emission points.
Organisational measures to prevent /limit releases, dispersion and exposure
Ensure that the process activities dedicated transfer and open parts are limited to at most 60 minutes.
Ensure that the closed process activities are limited to at most 360 min.
Conditions and measures related to personal protection, hygiene and health evaluation
Dedicated transfer, closed process and open parts of the process:
Wear suitable eye protection if exposure to the eyes may be possible, e.g. due to splashing, working overhead or when the face of
the worker needs to be close to the source.
Process activities open parts of the process and dedicated transfer: Stringent use of protective gloves with specific worker training
and management supervision to minimize exposure (reduction factor 98%).
Closed process: Stringent use of protective gloves with specific worker training and management supervision to minimize
exposure (reduction factor 98%) at activities that may lead to contact with contaminated surfaces.
Open parts of the processs: Use of respiratory protective equipment (95% reduction).
Dedicated transfer: Use of respiratory protective equipment (90% reduction).
Contributing exposure scenario 5 controlling worker exposure for PROC 5
Workers related free short title Manufacturing of formalin; mixing and blending.
Use descriptor covered SU3, PROC 5
Processes, tasks, activities covered
PROC 5: Mixing or blending in batch processes for formulation of preparations and articles
(multistage and/or significant contact),
PROC 5 consists of three types of activities:
• dedicated transfer activities,
• closed process activities
• activities near open parts or the process
This contributing scenario consists of a combination of these three activities.
Assessment Method Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Product characteristic
Dedicated transfer: Liquid, formalin (30-60% formaldehyde in water). The finalized product (formalin) is transferred to storage or
further processing.
Closed process: Vapour, formaldehyde 100%. Pure formaldehyde is present within at least parts of the closed process equipment
Open parts of the process: Liquid, formalin (30-60% formaldehyde in water).
Amounts used
Dedicated transfer: > 1000 L/min
Closed process: Not relevant
Open parts of the process: Not relevant
Frequency and duration of use/exposure
Dedicated transfer and open parts of the process: Daily, up to 60 min.
Closed process: Daily, up to 360 min.
Human factors not influenced by risk management
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A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers exposure
Dedicated transfer, closed process and open parts of the process:
Indoor, large industrial workrooms (300 m3)
Hot process activities (50-150 °C)
Technical conditions and measures at process level (source) to prevent release
Dedicated transfer:
• Submerged loading
Dedicated transfer and closed process:
- Medium level of containment (99% reduction), consisting of:
• Physical containment or enclosure of the source of emission.
• The material transfer is enclosed with the receiving vessel being docked or sealed to the source vessel.
Examples include sealing heads, transfer containers and multiple o-rings. Inflatable packing head with continuous liner
ensures a seal is maintained during the transfer and the continuous plastic liner prevents direct contact with the product. The
correct type of tie off must be used.
Open parts of the process:
• Open surface < 0.1 m2
Technical conditions and measures to control dispersion from source towards the worker
Dedicated transfer, closed process and open parts of the process:
General ventilation at least 3 air changes per hour
Dedicated transfer: transfer system is provided with a vapour recovery system (reduction 80%)
Open parts of the process: Local exhaust ventilation (fixed capturing hoods, 90% reduction) at potential emission points.
Organisational measures to prevent /limit releases, dispersion and exposure
Ensure that the process activities dedicated transfer and open parts are limited to at most 60 minutes.
Ensure that the closed process activities are limited to at most 360 min.
Conditions and measures related to personal protection, hygiene and health evaluation
Dedicated transfer, closed process and open parts of the process:
Wear suitable eye protection if exposure to the eyes may be possible, e.g. due to splashing, working overhead or when the face of
the worker needs to be close to the source.
Process activities open parts of the process and dedicated transfer: Stringent use of protective gloves with specific worker training
and management supervision to minimize exposure (reduction factor 98%).
Closed process: Stringent use of protective gloves with specific worker training and management supervision to minimize
exposure (reduction factor 98%) at activities that may lead to contact with contaminated surfaces.
Open parts of the processs: Use of respiratory protective equipment (95% reduction).
Dedicated transfer: Use of respiratory protective equipment (90% reduction).
Contributing exposure scenario 6 controlling worker exposure for PROC 6
Workers related free short title Manufacture of formalin; use of formalin in calendaring operations
Use descriptor covered SU3, PROC 6
Processes, tasks, activities covered PROC 6: calendaring operations
Assessment Method* ECETOC TRA v2 (with modifications) is used for both inhalation and dermal exposure
because it is not possible to assess evaporation from solids by use of ART
Product characteristic
Liquid, formalin (30%-60% formaldehyde in water)
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 4 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers exposure
Industrial setting, indoor
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Technical conditions and measures at process level (source) to prevent release
Not relevant.
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation (90% efficacy).
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Stringent use of protective gloves with specific worker training and management supervision to minimize exposure (reduction
factor 98%). Use of respiratory protective equipment (90% reduction). Wear suitable eye protection if exposure to the eyes may be
possible, e.g. due to splashing, working overhead or when the face of the worker needs to be close to the source.
Contributing exposure scenario 7a controlling worker exposure for PROC 8a
Workers related free short title Manufacturing of formalin (30-60% formaldehyde); transfer into large containers
(non-dedicated filling).
Use descriptor covered SU3, PROC 8a
Processes, tasks, activities covered PROC 8a: Transfer of substance or preparation from /to vessels/large containers at non-
dedicated facilities.
Assessment Method* Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Product characteristic
Liquid, formalin (30%-60% formaldehyde in water)
Amounts used
100-1000 L/min.
Frequency and duration of use/exposure
Daily, up to 480 minutes.
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers exposure
Indoors, large industrial workrooms (300 m3)
Hot process (50-150 °C)
Outdoor use is safe once a vapour recovery system is available
Technical conditions and measures at process level (source) to prevent release
Submerged loading
Medium level of containment (99% reduction), consisting of:
• Physical containment or enclosure of the source of emission.
• The material transfer is enclosed with the receiving vessel being docked or sealed to the source vessel.
Examples include sealing heads, transfer containers and multiple o-rings. Inflatable packing head with continuous liner
ensures a seal is maintained during the transfer and the continuous plastic liner prevents direct contact with the product. The
correct type of tie off must be used.
Technical conditions and measures to control dispersion from source towards the worker
General ventilation at least 3 air changes per hour
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Stringent use of protective gloves with specific worker training and management supervision to minimize exposure (reduction
factor 98%).
Wear suitable eye protection if exposure to the eyes may be possible, e.g. due to splashing, working overhead or when the face of
the worker needs to be close to the source.
Use of respiratory protective equipment (90% reduction).
Contributing exposure scenario 7b controlling worker exposure for PROC 8a
Workers related free short title Manufacturing of formalin (5% formaldehyde); transfer into large containers (non-
dedicated filling).
Use descriptor covered SU3, PROC 8a
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Processes, tasks, activities covered PROC 8a: Transfer of substance or preparation from /to vessels/large containers at non-
dedicated facilities.
Assessment Method* Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Product characteristic
Liquid, formalin (5% formaldehyde in water)
Amounts used
100-1000 L/min.
Frequency and duration of use/exposure
Daily, up to 480 minutes.
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers exposure
Indoors, large industrial workrooms (300 m3)
Room temperature (15-25°C)
Outdoor use is safe once a vapour recovery system is available
Technical conditions and measures at process level (source) to prevent release
Submerged loading
Medium level of containment (99% reduction), consisting of:
• Physical containment or enclosure of the source of emission.
• The material transfer is enclosed with the receiving vessel being docked or sealed to the source vessel.
Examples include sealing heads, transfer containers and multiple o-rings. Inflatable packing head with continuous liner
ensures a seal is maintained during the transfer and the continuous plastic liner prevents direct contact with the product. The
correct type of tie off must be used.
Technical conditions and measures to control dispersion from source towards the worker
General ventilation at least 3 air changes per hour
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Stringent use of protective gloves with specific activity training (reduction factor 95%).
Wear suitable eye protection if exposure to the eyes may be possible, e.g. due to splashing, working overhead or when the face of
the worker needs to be close to the source.
Contributing exposure scenario 8c controlling worker exposure for PROC 8a
Workers related free short title Manufacturing of formalin (1.5% formaldehyde); transfer into large containers (non-
dedicated filling).
Use descriptor covered SU3, PROC 8a
Processes, tasks, activities covered PROC 8a: Transfer of substance or preparation from /to vessels/large containers at non-
dedicated facilities.
Assessment Method* Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Product characteristic
Liquid, formalin (1.5 % formaldehyde in water)
Amounts used
100-1000 L/min.
Frequency and duration of use/exposure
Daily, up to 480 minutes.
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers exposure
Indoors, large industrial workrooms (300 m3) only
Room temperature (15-25°C)
Outdoor use is safe once a vapour recovery system is available
Technical conditions and measures at process level (source) to prevent release
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Submerged loading
Medium level of containment (99% reduction), consisting of:
• Physical containment or enclosure of the source of emission.
• The material transfer is enclosed with the receiving vessel being docked or sealed to the source vessel.
Examples include sealing heads, transfer containers and multiple o-rings. Inflatable packing head with continuous liner
ensures a seal is maintained during the transfer and the continuous plastic liner prevents direct contact with the product. The
correct type of tie off must be used.
Technical conditions and measures to control dispersion from source towards the worker
General ventilation at least 3 air changes per hour
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Stringent use of protective gloves with specific activity training (reduction factor 95%).
Wear suitable eye protection if exposure to the eyes may be possible, e.g. due to splashing, working overhead or when the face of
the worker needs to be close to the source.
Contributing exposure scenario 9a controlling worker exposure for PROC 8b
Workers related free short title Manufacturing of formalin (30-60% formaldehyde); transfer into large containers
(dedicated filling).
Use descriptor covered SU3, PROC 8b
Processes, tasks, activities covered PROC 8b: Transfer of substance or preparation from /to vessels/large containers at
dedicated facilities.
Assessment Method* Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Product characteristic
Liquid, formalin (30%-60% formaldehyde in water)
Amounts used
>1000 L/min.
Frequency and duration of use/exposure
Daily, up to 480 minutes.
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers exposure
Indoors, large industrial workrooms (300 m3)
Hot process (50-150 °C)
Outdoor use is safe once a vapour recovery system is available
Technical conditions and measures at process level (source) to prevent release
Submerged loading
Medium level of containment (99% reduction), consisting of:
• Physical containment or enclosure of the source of emission.
• The material transfer is enclosed with the receiving vessel being docked or sealed to the source vessel.
Examples include sealing heads, transfer containers and multiple o-rings. Inflatable packing head with continuous liner
ensures a seal is maintained during the transfer and the continuous plastic liner prevents direct contact with the product. The
correct type of tie off must be used.
Technical conditions and measures to control dispersion from source towards the worker
General ventilation at least 3 air changes per hour
Transfer system is provided with a vapour recovery system (reduction 80%)
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Stringent use of protective gloves with specific worker training and management supervision to minimize exposure (reduction
factor 98%).
Wear suitable eye protection if exposure to the eyes may be possible, e.g. due to splashing, working overhead or when the face of
the worker needs to be close to the source.
Use of respiratory protective equipment (90% reduction).
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Contributing exposure scenario 8b controlling worker exposure for PROC 8b
Workers related free short title Manufacturing of formalin (5% formaldehyde); transfer into large containers
(dedicated filling).
Use descriptor covered SU3, PROC 8b
Processes, tasks, activities
covered
PROC 8b: Transfer of substance or preparation from /to vessels/large containers at
dedicated facilities.
Assessment Method Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Product characteristic
Liquid, formalin (5 % formaldehyde in water)
Amounts used
>1000 L/min.
Frequency and duration of use/exposure
Daily, up to 480 minutes.
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers exposure
Indoors, large industrial workrooms (300 m3)
Room temperature (15-25°C)
Outdoor use is safe once a vapour recovery system is available
Technical conditions and measures at process level (source) to prevent release
Submerged loading
Medium level of containment (99% reduction), consisting of:
• Physical containment or enclosure of the source of emission.
• The material transfer is enclosed with the receiving vessel being docked or sealed to the source vessel.
Examples include sealing heads, transfer containers and multiple o-rings. Inflatable packing head with continuous liner
ensures a seal is maintained during the transfer and the continuous plastic liner prevents direct contact with the product. The
correct type of tie off must be used.
Technical conditions and measures to control dispersion from source towards the worker
General ventilation at least 3 air changes per hour
Transfer system is provided with a vapour recovery system (reduction 80%)
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Stringent use of protective gloves with specific activity training (reduction factor 95%).
Wear suitable eye protection if exposure to the eyes may be possible, e.g. due to splashing, working overhead or when the face of
the worker needs to be close to the source.
Contributing exposure scenario 8c controlling worker exposure for PROC 8b
Workers related free short title Manufacturing of formalin (1.5% formaldehyde); transfer into large containers
(dedicated filling).
Use descriptor covered SU3, PROC 8b
Processes, tasks, activities
covered
PROC 8b: Transfer of substance or preparation from /to vessels/large containers at
dedicated facilities.
Assessment Method Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Product characteristic
Liquid, formalin (1.5 % formaldehyde in water)
Amounts used
>1000 L/min.
Frequency and duration of use/exposure
Daily, up to 480 minutes.
Human factors not influenced by risk management
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A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers exposure
Indoors, large industrial workrooms (300 m3)
Room temperature (15-25°C)
Outdoor use is safe once a vapour recovery system is available
Technical conditions and measures at process level (source) to prevent release
Submerged loading
Medium level of containment (99% reduction), consisting of:
• Physical containment or enclosure of the source of emission.
• The material transfer is enclosed with the receiving vessel being docked or sealed to the source vessel.
Examples include sealing heads, transfer containers and multiple o-rings. Inflatable packing head with continuous liner
ensures a seal is maintained during the transfer and the continuous plastic liner prevents direct contact with the product. The
correct type of tie off must be used.
Technical conditions and measures to control dispersion from source towards the worker
General ventilation at least 3 air changes per hour
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Stringent use of protective gloves with specific activity training (reduction factor 95%).
Wear suitable eye protection if exposure to the eyes may be possible, e.g. due to splashing, working overhead or when the face of
the worker needs to be close to the source.
Contributing exposure scenario 9a controlling worker exposure for PROC 9
Workers related free short title Manufacturing of formalin (30-60% formaldehyde); transfer into small containers
(dedicated filling).
Use descriptor covered SU3, PROC 9
Processes, tasks, activities
covered
PROC 9: Transfer of substance or preparation into small containers (dedicated filling line,
including weighing).
Assessment Method Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Product characteristic
Liquid, formalin (30%-60% formaldehyde in water)
Amounts used
10 - 100 L/min.
Frequency and duration of use/exposure
Daily, 480 minutes.
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers exposure
Indoors, large industrial workrooms (300 m3)
Hot process (50-150 °C).
Technical conditions and measures at process level (source) to prevent release
Submerged loading
Low level of containment (90% reduction), consisting of:
• Physical containment or enclosure of the source of emission.
• The air within the enclosure is not actively ventilated or extracted. The enclosure is not opened during the activity. The
process is contained with a loose lid or cover, which is not air tight. This includes tapping molten metal through covered
launders and placing a loose lid on a ladle. This class also includes bags or liners fitted around transfer points from source to
receiving vessel. These include Muller seals, Stott head and single bag, and associated clamps and closures.
Technical conditions and measures to control dispersion from source towards the worker
General ventilation at least 3 air changes per hour.
Local exhaust ventilation (fixed capturing hoods, 90% reduction) at potential emission points.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant.
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Conditions and measures related to personal protection, hygiene and health evaluation
Stringent use of protective gloves with specific worker training and management supervision to minimize exposure (reduction
factor 98%).
Wear suitable eye protection if exposure to the eyes may be possible, e.g. due to splashing, working overhead or when the face of
the worker needs to be close to the source.
Use of respiratory protective equipment (90% reduction).
Contributing exposure scenario 9b controlling worker exposure for PROC 9
Workers related free short title Manufacturing of formalin (5% formaldehyde); transfer into small containers
(dedicated filling).
Use descriptor covered SU3, PROC 9
Processes, tasks, activities
covered
PROC 9: Transfer of substance or preparation into small containers (dedicated filling line,
including weighing).
Assessment Method Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Product characteristic
Liquid, formalin (5% formaldehyde in water)
Amounts used
10 - 100 L/min.
Frequency and duration of use/exposure
Daily, 480 minutes.
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers exposure
Indoors, large industrial workrooms (300 m3)
Room temperature (15-25°C)
Technical conditions and measures at process level (source) to prevent release
Submerged loading
Low level of containment (90% reduction), consisting of:
• Physical containment or enclosure of the source of emission.
• The air within the enclosure is not actively ventilated or extracted. The enclosure is not opened during the activity. The
process is contained with a loose lid or cover, which is not air tight. This includes tapping molten metal through covered
launders and placing a loose lid on a ladle. This class also includes bags or liners fitted around transfer points from source to
receiving vessel. These include Muller seals, Stott head and single bag, and associated clamps and closures.
Technical conditions and measures to control dispersion from source towards the worker
General ventilation at least 3 air changes per hour.
Local exhaust ventilation (fixed capturing hoods, 90% reduction) at potential emission points.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant.
Conditions and measures related to personal protection, hygiene and health evaluation
Stringent use of protective gloves with specific activity training (reduction factor 95%).
Wear suitable eye protection if exposure to the eyes may be possible, e.g. due to splashing, working overhead or when the face of
the worker needs to be close to the source.
Contributing exposure scenario 9c controlling worker exposure for PROC 9
Workers related free short title Manufacturing of formalin (1.5% formaldehyde); transfer into small containers
(dedicated filling).
Use descriptor covered SU3, PROC 9
Processes, tasks, activities
covered
PROC 9: Transfer of substance or preparation into small containers (dedicated filling line,
including weighing).
Assessment Method Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Product characteristic
Liquid, formalin (1.5% formaldehyde in water)
Amounts used
10 - 100 L/min.
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Frequency and duration of use/exposure
Daily, 480 minutes.
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers exposure
Indoors, large industrial workrooms (300 m3)
Room temperature (15-25°C)
Technical conditions and measures at process level (source) to prevent release
Submerged loading
Low level of containment (90% reduction), consisting of:
• Physical containment or enclosure of the source of emission.
• The air within the enclosure is not actively ventilated or extracted. The enclosure is not opened during the activity. The
process is contained with a loose lid or cover, which is not air tight. This includes tapping molten metal through covered
launders and placing a loose lid on a ladle. This class also includes bags or liners fitted around transfer points from source to
receiving vessel. These include Muller seals, Stott head and single bag, and associated clamps and closures.
Technical conditions and measures to control dispersion from source towards the worker
General ventilation at least 3 air changes per hour.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant.
Conditions and measures related to personal protection, hygiene and health evaluation
Stringent use of protective gloves with specific activity training (reduction factor 95%).
Wear suitable eye protection if exposure to the eyes may be possible, e.g. due to splashing, working overhead or when the face of
the worker needs to be close to the source.
Contributing exposure scenario 10 controlling worker exposure for PROC 14
Workers related free short title Manufacture of formalin; use of formalin in the production of preparations or articles
Use descriptor covered SU3, PROC 14
Processes, tasks, activities
covered
PROC 14: Production of preparations or articles by tabletting, compression, extrusion,
pelletisation
Assessment Method ECETOC TRA v2 (with modifications) is used for both inhalation and dermal exposure
because it is not possible to assess evaporation from solids by use of ART
Product characteristic
Liquid, formalin (30%-60% formaldehyde in water)
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 4 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers exposure
Industrial setting, indoor
Technical conditions and measures at process level (source) to prevent release
Not relevant.
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation (90% efficacy).
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Stringent use of protective gloves with specific worker training and management supervision to minimize exposure (reduction
factor 98%). Use of respiratory protective equipment (90% reduction). Wear suitable eye protection if exposure to the eyes may be
possible, e.g. due to splashing, working overhead or when the face of the worker needs to be close to the source.
Contributing exposure scenario 11 controlling worker exposure for PROC 15
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Workers related free short title Use of formalin as a laboratory reagent up to 62%.
Use descriptor covered SU3, PROC 15
Processes, tasks, activities
covered PROC 15: Use as laboratory reagent
Assessment Method Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Product characteristic
Liquid, formalin (30%-60% formaldehyde in water)
Amounts used
<0.1 L/min
Frequency and duration of use/exposure
Daily, up to 480 minutes.
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers exposure
Indoor, small workrooms (100 m3)
Covers both industrial and professional laboratory settings
Technical conditions and measures at process level (source) to prevent release
Not relevant.
Technical conditions and measures to control dispersion from source towards the worker
General ventilation at least 10 air changes per hour.
Local exhaust ventilation (enclosing hood, fume cupboard, 99% reduction).
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Stringent use of protective gloves with specific worker training and management supervision to minimize exposure (reduction
factor 98%).
Wear suitable eye protection if exposure to the eyes may be possible, e.g. due to splashing, working overhead or when the face of
the worker needs to be close to the source.
Section 3.- Exposure estimation
See: http://www.ercros.es/eng/internas.asp?arxiu=sl_1
Section 4.- Guidance to DU to evaluate whether he works inside the boundaries set by the ES
The DU works inside the boundaries set by the ES if either the proposed risk management measures as described above are met or
the downstream user can demonstrate on his own that his operational conditions and implemented risk management measures are
adequate. This has to be done by showing that they limit the inhalation and dermal exposure to a level below the respective DNEL
(given that the processes and activities in question are covered by the PROCs listed above) as given below. If measured data are
not available, the DU may make use of an appropriate scaling tool such as
Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Important note: By demonstrating a safe use when comparing exposure estimates with the long-term DNEL, the acute DNEL is
therefore also covered (according to R.14 guidance, acute exposure levels can be derived by multiplying long-term exposure
estimates by a factor of 2).
Section 1.- Title Formulations of preparations (30-60%)
Free short title Formulations of preparations (30-60%)
Systematic title based on use
descriptor
SU 3, 10
PROC 1,2,3,4,5,6,8a,8b,9,14,15
ERC 2, 3
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Identified use covered:
Formulation (IU3)
Section 2.- Operational conditions and risk management measures
Processes, tasks, activities covered
Use in closed process, no likelihood of exposure (PROC 1)
Use in closed, continuous process with occasional controlled exposure (PROC 2)
Use in closed batch process (synthesis / formulation) (PROC 3)
Use in batch or other process (synthesis) where opportunity for exposure arises (PROC 4)
Mixing or blending in batch processes (multistage and/or significant contact) (PROC 5)
Calendering operations (PROC 6)
Transfer of substance or preparation (charging/discharging) from/to vessels/ large
containers at non dedicated facilities (PROC 8a)
Transfer of chemicals (charging/ discharging) from/to vessels/ large containers at
dedicated facilities (PROC 8b)
Transfer of substance or preparations into small containers (dedicated filling line including
weighing) (PROC 9)
Production of preparations or articles by tabletting, compression, extrusion, pelletisation
(PROC 14)
Use as laboratory reagent (PROC 15)
Environment characteristic
covered No environmental assessment is performed
Assessment Method See Exposure Scenario 1 for the description of the Exposure Scenarios and the
accompanying exposure assessments
Section 1.- Title Industrial use of preparations containing formaldehyde up to 60%
Free short title Industrial use of preparations containing formaldehyde up to 60%
Systematic title based on use
descriptor
SU: 3, 8
PROC: 1, 2
ERC: 5
Identified uses covered:
16; production of fertilizer granules (IU14)
Name of contributing
environmental scenario 1 and
corresponding ERC
No environmental assessment has been performed
Section 2.- Operational conditions and risk management measures
Name(s) of contributing worker
scenarios and corresponding
PROCs
Use in closed process, no likelihood of exposure (PROC 1),
Use in closed, continuous process with occasional controlled exposure (PROC 2)
Assessment Method See Exposure Scenario 1 for the description of the Exposure Scenarios and the
accompanying exposure assessments
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Section 1.- Title Industrial use of preparations containing formaldehyde up to 5%
Systematic title based on use
descriptor
SU: 2a, 3, 5, 8, 9, 10, 11, 12, 13, 14, 17, 19
PROC: 1, 2, 3, 4, 5, 6, 7, 8a, 8b, 9, 10, 13, 14, 16, 21, 22, 23, 24, 25
ERC: 2, 3, 5, 6d
Consortium use number covered:
Industrial use of formaldehyde products (IU4)
2; production of foams (IU15)
10; production of bonded particulates (IU8)
11; use of adhesives and coatings (IU9)
13; production of rubber (IU10)
14; production of firelighters (IU16)
15; production of leather (IU13)
Name of contributing environmental
scenario 1 and corresponding ERC No environmental assessment has been performed
Section 2.- Operational conditions and risk management measures
Name(s) of contributing worker
scenarios and corresponding PROCs
Use in closed process, no likelihood of exposure (PROC 1),
Use in closed, continuous process with occasional controlled exposure (PROC 2),
Use in closed batch process (synthesis or formulation) (PROC 3), Use in batch and other
process (synthesis) where opportunity for exposure arises (PROC 4),
Mixing or blending in batch processes (multistage and/or significant contact) (PROC 5),
Calendering operations (PROC 6),
Industrial spraying (PROC 7),
Transfer of chemicals from/to vessels/ large containers at non dedicated facilities (PROC
8a),
Transfer of chemicals from/to vessels/ large containers at dedicated facilities (PROC 8b),
Transfer of chemicals into small containers (dedicated filling line) (PROC 9),
Roller application or brushing (PROC 10),
Treatment of articles by dipping and pouring (PROC 13), Production of preparations or
articles by tabletting, compression, extrusion, pelletisation (PROC 14),
Using materials as fuel sources, limited exposure to unburned product to be expected
(PROC 16),
Low energy manipulation of substances bound in materials and/or articles (PROC 21),
Potentially closed processing operations with minerals/metals at elevated temperature
(PROC 22),
Open processing and transfer operations with minerals/metals at elevated temperature
(PROC 23),
High (mechanical) energy work-up of substances bound in materials and/or articles
(PROC 24),
Other hot work operations with metals (PROC 25),
Assessment Method All exposure assessments were done by use of ECETOC TRA, version 2 with
modifications (see beginning of chapter 9)
2.1 Control of workers exposure
Contributing exposure scenario 10 controlling worker exposure for PROC 1
Name of contributing exposure
scenario Use in closed process
Further specification Use in closed process, no likelihood of exposure
Product characteristic
Liquid, diluted substance, up to 5%
Amounts used
Not relevant
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Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 11 controlling worker exposure for PROC 2
Name of contributing exposure
scenario Use in closed, continuous process
Further specification Use in closed, continuous process with occasional controlled exposure
Product characteristic
Liquid, diluted substance, up to 5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
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Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 12 controlling worker exposure for PROC 3
Name of contributing exposure
scenario Use in closed batch process
Further specification Use in closed batch process (synthesis or formulation)
Product characteristic
Liquid, diluted substance, up to 5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 13 controlling worker exposure for PROC 4
Name of contributing exposure
scenario Use in batch and other process
Further specification Use in batch and other process (synthesis) where opportunity for exposure arises
Product characteristic
Liquid, diluted substance, up to 5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
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Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 14 controlling worker exposure for PROC 5
Name of contributing exposure
scenario Mixing or blending in batch processes
Further specification Mixing or blending in batch processes (multistage and/or significant contact)
Product characteristic
Liquid, diluted substance, up to 5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 15 controlling worker exposure for PROC 6
Name of contributing exposure
scenario Calendering operations
Further specification Calendering operations
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Product characteristic
Liquid, diluted substance, up to 5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 16 controlling worker exposure for PROC 7
Name of contributing exposure
scenario Industrial spraying
Further specification Industrial spraying
Product characteristic
Liquid, diluted substance, up to 5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 1 hour, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 95%.
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Organisational measures to prevent /limit releases, dispersion and exposure
Ensure operation is limited to at most 60 minutes
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 17 controlling worker exposure for PROC 8a
Name of contributing exposure
scenario Transfer of chemicals, non-dedicated
Further specification Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities
Product characteristic
Liquid, diluted substance, up to 5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Outdoor use is safe once a vapour recovery system is available
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 18 controlling worker exposure for PROC 8b
Name of contributing exposure
scenario Transfer of chemicals, dedicated
Further specification Transfer of chemicals from/to vessels/ large containers at dedicated facilities
Product characteristic
Liquid, diluted substance, up to 5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
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Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Outdoor use is safe once a vapour recovery system is available
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 97%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 19 controlling worker exposure for PROC 9
Name of contributing exposure
scenario Transfer of chemicals into small containers
Further specification Transfer of chemicals into small containers (dedicated filling line)
Product characteristic
Liquid, diluted substance, up to 5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
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Contributing exposure scenario 20 controlling worker exposure for PROC 10
Name of contributing exposure
scenario Roller application or brushing
Further specification Roller application or brushing
Product characteristic
Liquid, diluted substance, up to 5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 21 controlling worker exposure for PROC 13
Name of contributing exposure
scenario Treatment of articles
Further specification Treatment of articles by dipping and pouring
Product characteristic
Liquid, diluted substance, up to 5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
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Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 22 controlling worker exposure for PROC 14
Name of contributing exposure
scenario Production of preparations or articles
Further specification Production of preparations or articles by tabletting, compression, extrusion, pelletisation
Product characteristic
Liquid, diluted substance, up to 5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 23 controlling worker exposure for PROC 16
Name of contributing exposure
scenario Using materials as fuel sources
Further specification Using materials as fuel sources, limited exposure to unburned product to be expected
Product characteristic
Liquid, diluted substance, up to 5%
Amounts used
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Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 24 controlling worker exposure for PROC 21
Name of contributing exposure
scenario Low energy manipulation of substances
Further specification Low energy manipulation of substances bound in materials and/or articles
Product characteristic
Solid, bound substance in materials and/or articles, up to 5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
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Not relevant
Contributing exposure scenario 25 controlling worker exposure for PROC 22
Name of contributing exposure
scenario Potentially closed processing operations with minerals/metals
Further specification Potentially closed processing operations with minerals/metals at elevated temperature
Product characteristic
Solid, bound substance in materials and/or articles, up to 5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 26 controlling worker exposure for PROC 23
Name of contributing exposure
scenario Open processing and transfer operations with minerals/metals
Further specification Open processing and transfer operations with minerals/metals at elevated temperature
Product characteristic
Solid, bound substance in materials and/or articles, up to 5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
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Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 27 controlling worker exposure for PROC 24
Name of contributing exposure
scenario High (mechanical) energy work-up of substances
Further specification High (mechanical) energy work-up of substances bound in materials and/or articles
Product characteristic
Solid, bound substance in materials and/or articles, up to 5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 28 controlling worker exposure for PROC 25
Name of contributing exposure
scenario Other hot work operations with metals
Further specification Other hot work operations with metals
Product characteristic
Solid, bound substance in materials and/or articles, up to 5%
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Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Section 3.- Exposure estimation
See: http://www.ercros.es/eng/internas.asp?arxiu=sl_1
Section 4.- Guidance to DU to evaluate whether he works inside the boundaries set by the ES
The DU works inside the boundaries set by the ES if either the proposed risk management measures as described above are met or
the downstream user can demonstrate on his own that his operational conditions and implemented risk management measures are
adequate. This has to be done by showing that they limit the inhalation and dermal exposure to a level below the respective DNEL
(given that the processes and activities in question are covered by the PROCs listed above) as given below. If measured data are not
available, the DU may make use of an appropriate scaling tool such as
Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Important note: By demonstrating a safe use when comparing exposure estimates with the long-term DNEL, the acute DNEL is
therefore also covered (according to R.14 guidance, acute exposure levels can be derived by multiplying long-term exposure
estimates by a factor of 2).
Section 1.- Title Industrial use of preparations containing formaldehyde up to 2.5%
Systematic title based on use
descriptor
SU: 3, 5, 6a, 6b, 10, 11, 12, 13, 18, 19
PROC: 1, 2, 3, 4, 5, 6, 7, 8a, 8b, 9, 10, 13, 14, 16, 21, 22, 23, 24, 25
ERC: 2, 3, 5, 6d
Consortium use numbers covered:
Industrial use of formaldehyde products (IU4)
3; production of woodbased materials (IU5)
4; production of impregnated paper (IU6)
5; production of paper (IU12)
6; impregnation of textile (IU11)
7; production of bonded fibers or fiber mats (IU7)
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Name of contributing environmental
scenario 1 and corresponding ERC No environmental assessment has been performed
Section 2.- Operational conditions and risk management measures
Name(s) of contributing worker
scenarios and corresponding PROCs
Use in closed process, no likelihood of exposure (PROC 1),
Use in closed, continuous process with occasional controlled exposure (PROC 2),
Use in closed batch process (synthesis or formulation) (PROC 3), Use in batch and other
process (synthesis) where opportunity for exposure arises (PROC 4),
Mixing or blending in batch processes (multistage and/or significant contact) (PROC 5),
Calendering operations (PROC 6),
Industrial spraying (PROC 7),
Transfer of chemicals from/to vessels/ large containers at non dedicated facilities (PROC
8a),
Transfer of chemicals from/to vessels/ large containers at dedicated facilities (PROC 8b),
Transfer of chemicals into small containers (dedicated filling line) (PROC 9),
Roller application or brushing (PROC 10),
Treatment of articles by dipping and pouring (PROC 13), Production of preparations or
articles by tabletting, compression, extrusion, pelletisation (PROC 14),
Using materials as fuel sources, limited exposure to unburned product to be expected
(PROC 16),
Low energy manipulation of substances bound in materials and/or articles (PROC 21),
Potentially closed processing operations with minerals/metals at elevated temperature
(PROC 22),
Open processing and transfer operations with minerals/metals at elevated temperature
(PROC 23),
High (mechanical) energy work-up of substances bound in materials and/or articles
(PROC 24),
Other hot work operations with metals (PROC 25)
Assessment Method All exposure assessments were done by use of ECETOC TRA, version 2 with
modifications
2.1.-Control of workers exposure
Contributing exposure scenario 29 controlling worker exposure for PROC 1
Name of contributing exposure
scenario Use in closed process
Further specification Use in closed process, no likelihood of exposure
Product characteristic
Liquid, diluted substance, up to 2.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
FORMOL
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Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 30 controlling worker exposure for PROC 2
Name of contributing exposure
scenario Use in closed, continuous process
Further specification Use in closed, continuous process with occasional controlled exposure
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 31 controlling worker exposure for PROC 3
Name of contributing exposure
scenario Use in closed batch process
Further specification Use in closed batch process (synthesis or formulation)
Product characteristic
Liquid, diluted substance, up to 2.5%
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Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 32 controlling worker exposure for PROC 4
Name of contributing exposure
scenario Use in batch and other process
Further specification Use in batch and other process (synthesis) where opportunity for exposure arises
Product characteristic
Liquid, diluted substance, up to 2.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
FORMOL
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Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 33 controlling worker exposure for PROC 5
Name of contributing exposure
scenario Mixing or blending in batch processes
Further specification Mixing or blending in batch processes (multistage and/or significant contact)
Product characteristic
Liquid, diluted substance, up to 2.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 34 controlling worker exposure for PROC 6
Name of contributing exposure
scenario Calendering operations
Further specification Calendering operations
Product characteristic
Liquid, diluted substance, up to 2.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
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Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 35 controlling worker exposure for PROC 7
Name of contributing exposure
scenario Industrial spraying
Further specification Industrial spraying
Product characteristic
Liquid, diluted substance, up to 2.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 4 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 95%.
Organisational measures to prevent /limit releases, dispersion and exposure
Ensure operation is limited to at most 240 minutes
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 36 controlling worker exposure for PROC 8a
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Name of contributing exposure
scenario Transfer of chemicals, non-dedicated
Further specification Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities
Product characteristic
Liquid, diluted substance, up to 2.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Outdoor use is safe once a vapour recovery system is available
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 37 controlling worker exposure for PROC 8b
Name of contributing exposure
scenario Transfer of chemicals, dedicated
Further specification Transfer of chemicals from/to vessels/ large containers at dedicated facilities
Product characteristic
Liquid, diluted substance, up to 2.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Outdoor use is safe once a vapour recovery system is available
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
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Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 97%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 38 controlling worker exposure for PROC 9
Name of contributing exposure
scenario Transfer of chemicals into small containers
Further specification Transfer of chemicals into small containers (dedicated filling line)
Product characteristic
Liquid, diluted substance, up to 2.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 39 controlling worker exposure for PROC 10
Name of contributing exposure
scenario Roller application or brushing
Further specification Roller application or brushing
Product characteristic
Liquid, diluted substance, up to 2.5%
Amounts used
Not relevant
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Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 40 controlling worker exposure for PROC 13
Name of contributing exposure
scenario Treatment of articles
Further specification Treatment of articles by dipping and pouring
Product characteristic
Liquid, diluted substance, up to 2.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
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Not relevant
Contributing exposure scenario 41 controlling worker exposure for PROC 14
Name of contributing exposure
scenario Production of preparations or articles
Further specification Production of preparations or articles by tabletting, compression, extrusion, pelletisation
Product characteristic
Liquid, diluted substance, up to 2.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 42 controlling worker exposure for PROC 16
Name of contributing exposure
scenario Using materials as fuel sources
Further specification Using materials as fuel sources, limited exposure to unburned product to be expected
Product characteristic
Liquid, diluted substance, up to 2.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
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Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 43 controlling worker exposure for PROC 21
Name of contributing exposure
scenario Low energy manipulation of substances
Further specification Low energy manipulation of substances bound in materials and/or articles
Product characteristic
Solid, bound substance in materials and/or articles, up to 2.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 44 controlling worker exposure for PROC 22
Name of contributing exposure
scenario Potentially closed processing operations with minerals/metals
Further specification Potentially closed processing operations with minerals/metals at elevated temperature
Product characteristic
Solid, bound substance in materials and/or articles, up to 2.5%
Amounts used
Not relevant
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Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 45 controlling worker exposure for PROC 23
Name of contributing exposure
scenario Open processing and transfer operations with minerals/metals
Further specification Open processing and transfer operations with minerals/metals at elevated temperature
Product characteristic
Solid, bound substance in materials and/or articles, up to 2.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
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Not relevant
Contributing exposure scenario 46 controlling worker exposure for PROC 24
Name of contributing exposure
scenario High (mechanical) energy work-up of substances
Further specification High (mechanical) energy work-up of substances bound in materials and/or articles
Product characteristic
Solid, bound substance in materials and/or articles, up to 2.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 47 controlling worker exposure for PROC 25
Name of contributing exposure
scenario Other hot work operations with metals
Further specification Other hot work operations with metals
Product characteristic
Solid, bound substance in materials and/or articles, up to 2.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
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Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Section 3.- Exposure estimation
See: http://www.ercros.es/eng/internas.asp?arxiu=sl_1
Section 4.- Guidance to DU to evaluate whether he works inside the boundaries set by the ES
The DU works inside the boundaries set by the ES if either the proposed risk management measures as described above are met or
the downstream user can demonstrate on his own that his operational conditions and implemented risk management measures are
adequate. This has to be done by showing that they limit the inhalation and dermal exposure to a level below the respective DNEL
(given that the processes and activities in question are covered by the PROCs listed above) as given below. If measured data are not
available, the DU may make use of an appropriate scaling tool such as
Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Important note: By demonstrating a safe use when comparing exposure estimates with the long-term DNEL, the acute DNEL is
therefore also covered (according to R.14 guidance, acute exposure levels can be derived by multiplying long-term exposure
estimates by a factor of 2).
Section 1.- Title Industrial use of preparations containing formaldehyde up to 1.5%
Systematic title based on use
descriptor
SU: 2a, 3, 5, 8, 9, 10, 11, 12, 13, 14, 17, 19
PROC: 1, 2, 3, 4, 5, 6, 7, 8a, 8b, 9, 10, 13, 14, 16, 21, 22, 23, 24, 25
ERC: 2, 3, 5, 6d
Consortium use number covered:
Industrial use of formaldehyde products (IU4)
2; production of foams (IU15)
10; production of bonded particulates (IU8)
11; use of adhesives and coatings (IU9)
13; production of rubber (IU10)
14; production of firelighters (IU16)
15; production of leather (IU13)
Name of contributing environmental
scenario 1 and corresponding ERC No environmental assessment has been performed
Section 2.- Operational conditions and risk management measures
Name(s) of contributing worker
scenarios and corresponding PROCs
Use in closed process, no likelihood of exposure (PROC 1),
Use in closed, continuous process with occasional controlled exposure (PROC 2),
Use in closed batch process (synthesis or formulation) (PROC 3), Use in batch and other
process (synthesis) where opportunity for exposure arises (PROC 4),
Mixing or blending in batch processes (multistage and/or significant contact) (PROC 5),
Calendering operations (PROC 6),
Industrial spraying (PROC 7),
Transfer of chemicals from/to vessels/ large containers at non dedicated facilities (PROC
8a),
Transfer of chemicals from/to vessels/ large containers at dedicated facilities (PROC 8b),
Transfer of chemicals into small containers (dedicated filling line) (PROC 9),
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Roller application or brushing (PROC 10),
Treatment of articles by dipping and pouring (PROC 13), Production of preparations or
articles by tabletting, compression, extrusion, pelletisation (PROC 14),
Using materials as fuel sources, limited exposure to unburned product to be expected
(PROC 16),
Low energy manipulation of substances bound in materials and/or articles (PROC 21),
Potentially closed processing operations with minerals/metals at elevated temperature
(PROC 22),
Open processing and transfer operations with minerals/metals at elevated temperature
(PROC 23),
High (mechanical) energy work-up of substances bound in materials and/or articles
(PROC 24),
Other hot work operations with metals (PROC 25),
Assessment Method All exposure assessments were done by use of ECETOC TRA, version 2 with
modifications (see beginning of chapter 9)
2.1.-Control of workers exposure
Contributing exposure scenario 48 controlling worker exposure for PROC 1
Name of contributing exposure
scenario Use in closed process
Further specification Use in closed process, no likelihood of exposure
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 49 controlling worker exposure for PROC 2
Name of contributing exposure
scenario Use in closed, continuous process
Further specification Use in closed, continuous process with occasional controlled exposure
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Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 50 controlling worker exposure for PROC 3
Name of contributing exposure
scenario Use in closed batch process
Further specification Use in closed batch process (synthesis or formulation)
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
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Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 51 controlling worker exposure for PROC 4
Name of contributing exposure
scenario Use in batch and other process
Further specification Use in batch and other process (synthesis) where opportunity for exposure arises
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 52 controlling worker exposure for PROC 5
Name of contributing exposure
scenario Mixing or blending in batch processes
Further specification Mixing or blending in batch processes (multistage and/or significant contact)
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
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A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 53 controlling worker exposure for PROC 6
Name of contributing exposure
scenario Calendering operations
Further specification Calendering operations
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
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Contributing exposure scenario 54 controlling worker exposure for PROC 7
Name of contributing exposure
scenario Industrial spraying
Further specification Industrial spraying
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 95%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 55 controlling worker exposure for PROC 8a
Name of contributing exposure
scenario Transfer of chemicals, non-dedicated
Further specification Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Outdoor use is safe once a vapour recovery system is available
Technical conditions and measures at process level (source) to prevent release
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Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 56 controlling worker exposure for PROC 8b
Name of contributing exposure
scenario Transfer of chemicals, dedicated
Further specification Transfer of chemicals from/to vessels/ large containers at dedicated facilities
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Outdoor use is safe once a vapour recovery system is available
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 97%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 57 controlling worker exposure for PROC 9
Name of contributing exposure
scenario Transfer of chemicals into small containers
Further specification Transfer of chemicals into small containers (dedicated filling line)
Product characteristic
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Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 58 controlling worker exposure for PROC 10
Name of contributing exposure
scenario Roller application or brushing
Further specification Roller application or brushing
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
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Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 59 controlling worker exposure for PROC 13
Name of contributing exposure
scenario Treatment of articles
Further specification Treatment of articles by dipping and pouring
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 60 controlling worker exposure for PROC 14
Name of contributing exposure
scenario Production of preparations or articles
Further specification Production of preparations or articles by tabletting, compression, extrusion, pelletisation
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
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Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 61 controlling worker exposure for PROC 16
Name of contributing exposure
scenario Using materials as fuel sources
Further specification Using materials as fuel sources, limited exposure to unburned product to be expected
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 62 controlling worker exposure for PROC 21
Name of contributing exposure
scenario Low energy manipulation of substances
Further specification Low energy manipulation of substances bound in materials and/or articles
Product characteristic
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Solid, bound substance in materials and/or articles, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 63 controlling worker exposure for PROC 22
Name of contributing exposure
scenario Potentially closed processing operations with minerals/metals
Further specification Potentially closed processing operations with minerals/metals at elevated temperature
Product characteristic
Solid, bound substance in materials and/or articles, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
FORMOL
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Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 64 controlling worker exposure for PROC 23
Name of contributing exposure
scenario Open processing and transfer operations with minerals/metals
Further specification Open processing and transfer operations with minerals/metals at elevated temperature
Product characteristic
Solid, bound substance in materials and/or articles, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 65 controlling worker exposure for PROC 24
Name of contributing exposure
scenario High (mechanical) energy work-up of substances
Further specification High (mechanical) energy work-up of substances bound in materials and/or articles
Product characteristic
Solid, bound substance in materials and/or articles, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
FORMOL
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Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 66 controlling worker exposure for PROC 25
Name of contributing exposure
scenario Other hot work operations with metals
Further specification Other hot work operations with metals
Product characteristic
Solid, bound substance in materials and/or articles, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Section 3.- Exposure estimation
See: http://www.ercros.es/eng/internas.asp?arxiu=sl_1
Section 4.- Guidance to DU to evaluate whether he works inside the boundaries set by the ES
FORMOL
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The DU works inside the boundaries set by the ES if either the proposed risk management measures as described above are met or
the downstream user can demonstrate on his own that his operational conditions and implemented risk management measures are
adequate. This has to be done by showing that they limit the inhalation and dermal exposure to a level below the respective DNEL
(given that the processes and activities in question are covered by the PROCs listed above) as given below. If measured data are not
available, the DU may make use of an appropriate scaling tool such as
Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Important note: By demonstrating a safe use when comparing exposure estimates with the long-term DNEL, the acute DNEL is
therefore also covered (according to R.14 guidance, acute exposure levels can be derived by multiplying long-term exposure
estimates by a factor of 2).
Section 1.- Title Industrial use of preparations containing formaldehyde up to 1%
Systematic title based on use
descriptor
SU: 3, 5, 6a, 6b, 10, 11, 12, 13, 18, 19
PROC: 1, 2, 5, 6, 7, 8a, 8b, 9, 10, 13, 14, 24
ERC: 2, 3 5, 6d
Consortium use numbers covered:
Industrial use of formaldehyde products (IU4)
3; production of woodbased materials (IU5)
4; production of impregnated paper (IU6)
5; production of paper (IU12)
6; impregnation of textile (IU11)
7; production of bonded fibers or fiber mats (IU7)
Name of contributing
environmental scenario 1 and
corresponding ERC
No environmental assessment has been performed
Section 2.- Operational conditions and risk management measures
Name(s) of contributing worker
scenarios and corresponding
PROCs
Use in closed process, no likelihood of exposure (PROC 1),
Use in closed, continuous process with occasional controlled exposure (PROC 2),
Mixing or blending in batch processes (multistage and/or significant contact) (PROC 5),
Calendering operations (PROC 6),
Industrial spraying (PROC 7),
Transfer of chemicals from/to vessels/ large containers at non dedicated facilities (PROC
8a),
Transfer of chemicals from/to vessels/ large containers at dedicated facilities (PROC 8b),
Transfer of chemicals into small containers (dedicated filling line) (PROC 9),
Roller application or brushing (PROC 10),
Treatment of articles by dipping and pouring (PROC 13), Production of preparations or
articles by tabletting, compression, extrusion, pelletisation (PROC 14),
High (mechanical) energy work-up of substances bound in materials and/or articles (PROC
24)
Assessment Method All exposure assessments were done by use of ECETOC TRA, version 2 with
modifications (see beginning of chapter 9)
2.1.-Control of workers exposure
Contributing exposure scenario 67 controlling worker exposure for PROC 1
Name of contributing exposure
scenario Use in closed process
Further specification Use in closed process, no likelihood of exposure
Product characteristic
Liquid, diluted substance, up to 1%
Amounts used
Not relevant
Frequency and duration of use/exposure
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Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 68 controlling worker exposure for PROC 2
Name of contributing exposure
scenario Use in closed, continuous process
Further specification Use in closed, continuous process with occasional controlled exposure
Product characteristic
Liquid, diluted substance, up to 1%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
FORMOL
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Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 69 controlling worker exposure for PROC 5
Name of contributing exposure
scenario Mixing or blending in batch processes
Further specification Mixing or blending in batch processes (multistage and/or significant contact)
Product characteristic
Liquid, diluted substance, up to 1%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 70 controlling worker exposure for PROC 6
Name of contributing exposure
scenario Calendering operations
Further specification Calendering operations
Product characteristic
Liquid, diluted substance, up to 1%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
FORMOL
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Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 71 controlling worker exposure for PROC 7
Name of contributing exposure
scenario Industrial spraying
Further specification Industrial spraying
Product characteristic
Liquid, diluted substance, up to 1%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 95%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 72 controlling worker exposure for PROC 8a
Name of contributing exposure
scenario Transfer of chemicals, non-dedicated
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Further specification Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities
Product characteristic
Liquid, diluted substance, up to 1%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Outdoor use is safe once a vapour recovery system is available
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 73 controlling worker exposure for PROC 8b
Name of contributing exposure
scenario Transfer of chemicals, dedicated
Further specification Transfer of chemicals from/to vessels/ large containers at dedicated facilities
Product characteristic
Liquid, diluted substance, up to 1%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Outdoor use is safe once a vapour recovery system is available
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
FORMOL
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Local exhaust ventilation with an efficacy of 97%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 8 controlling worker exposure for PROC 9
Name of contributing exposure
scenario Transfer of chemicals into small containers
Further specification Transfer of chemicals into small containers (dedicated filling line)
Product characteristic
Liquid, diluted substance, up to 1%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 9 controlling worker exposure for PROC 10
Name of contributing exposure
scenario Roller application or brushing
Further specification Roller application or brushing
Product characteristic
Liquid, diluted substance, up to 1%
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Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 10 controlling worker exposure for PROC 13
Name of contributing exposure
scenario Treatment of articles
Further specification Treatment of articles by dipping and pouring
Product characteristic
Liquid, diluted substance, up to 1%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
FORMOL
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Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 11 controlling worker exposure for PROC 14
Name of contributing exposure
scenario Production of preparations or articles
Further specification Production of preparations or articles by tabletting, compression, extrusion, pelletisation
Product characteristic
Liquid, diluted substance, up to 1%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 12 controlling worker exposure for PROC 24
Name of contributing exposure
scenario High (mechanical) energy work-up of substances
Further specification High (mechanical) energy work-up of substances bound in materials and/or articles
Product characteristic
Solid, bound substance in materials and/or articles, up to 1%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
FORMOL
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Indoor, industrial setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Section 3.- Exposure estimation
http://www.ercros.es/eng/internas.asp?arxiu=sl_1
Section 4.- Guidance to DU to evaluate whether he works inside the boundaries set by the ES
The DU works inside the boundaries set by the ES if either the proposed risk management measures as described above are met or
the downstream user can demonstrate on his own that his operational conditions and implemented risk management measures are
adequate. This has to be done by showing that they limit the inhalation and dermal exposure to a level below the respective DNEL
(given that the processes and activities in question are covered by the PROCs listed above) as given below. If measured data are
not available, the DU may make use of an appropriate scaling tool such as
Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Important note: By demonstrating a safe use when comparing exposure estimates with the long-term DNEL, the acute DNEL is
therefore also covered (according to R.14 guidance, acute exposure levels can be derived by multiplying long-term exposure
estimates by a factor of 2).
Section 1.- Title Professional use of preparations containing formaldehyde up to 1.5%
Systematic title based on use
descriptor
SU: 22
PROC: 5, 8a, 8b, 10, 11, 13, 15, 16, 19, 21, 22, 23, 24, 25
ERC: 2, 3, 5, 8a, 8b, 8c, 8d, 8f
PC: 8, 9a, 13, 31, 35, 39
Consortium use numbers covered:
Professional use of formaldehyde products (IU17)
2p; production of foams (IU21)
11p; application of adhesives and coatings (IU19)
14p; use of firelighters (IU20)
21p; cleaning agents (IU22)
Remark: PROC 22 can not be assessed within the professional domain and is therefore not
included in this ES. It is assumed that the other PROC describe the situation at the
workplace accurately.
Name of contributing
environmental scenario 1 and
corresponding ERC
No environmental assessment has been performed
Section 2.- Operational conditions and risk management measures
2.1.-Control of workers exposure
FORMOL
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Name(s) of contributing worker
scenarios and corresponding
PROCs
Mixing or blending in batch processes (multistage and/or significant contact) (PROC 5),
Transfer of chemicals from/to vessels/ large containers at non dedicated facilities (PROC
8a),
Transfer of chemicals from/to vessels/ large containers at dedicated facilities (PROC 8b),
Roller application or brushing (PROC 10),
Non industrial spraying (PROC 11),
Treatment of articles by dipping and pouring (PROC 13),
Use of laboratory reagents in small scale laboratories (PROC 15), Using materials as fuel
sources, limited exposure to unburned product to be expected (PROC 16),
Hand-mixing with intimate contact and only PPE available (PROC 19),
Name(s) of contributing worker
scenarios and corresponding
PROCs
Low energy manipulation of substances bound in materials and/or articles (PROC 21),
Open processing and transfer operations with minerals/metals at elevated temperature
(PROC 23),
High (mechanical) energy work-up of substances bound in materials and/or articles (PROC
24),
Other hot work operations with metals (PROC 25)
Assessment Method All exposure assessments were done by use of ECETOC TRA, version 2 with
modifications (see beginning of chapter 9)
Contributing exposure scenario 74 controlling worker exposure for PROC 5
Name of contributing exposure
scenario Mixing or blending in batch processes
Further specification Mixing or blending in batch processes (multistage and/or significant contact)
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, professional setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%). Wear a respirator with Type A
filter or better (efficacy 90%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
FORMOL
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Contributing exposure scenario 75 controlling worker exposure for PROC 8a
Name of contributing exposure
scenario Transfer of chemicals, non-dedicated
Further specification Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 4 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, professional setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%). Wear a respirator with Type A
filter or better (efficacy 90%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 76 controlling worker exposure for PROC 8b
Name of contributing exposure
scenario Transfer of chemicals, dedicated
Further specification Transfer of chemicals from/to vessels/ large containers at dedicated facilities
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, professional setting
Conditions and measures at level of article production to prevent release during service life
FORMOL
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Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 77 controlling worker exposure for PROC 10
Name of contributing exposure
scenario Roller application or brushing
Further specification Roller application or brushing
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 4 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, professional setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%). Wear a respirator with Type A
filter or better (efficacy 90%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
FORMOL
Date15/05/2011; Revision 01 SDS: 2-111 page 86 of 95
Contributing exposure scenario 78 controlling worker exposure for PROC 11
Name of contributing exposure
scenario Non industrial spraying
Further specification Non industrial spraying
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 4 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, professional setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%). Wear a respirator with Type A
filter or better (efficacy 90%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 79 controlling worker exposure for PROC 13
Name of contributing exposure
scenario Treatment of articles
Further specification Treatment of articles by dipping and pouring
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 4 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, professional setting
FORMOL
Date15/05/2011; Revision 01 SDS: 2-111 page 87 of 95
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%). Wear a respirator with Type A
filter or better (efficacy 90%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 80 controlling worker exposure for PROC 15
Name of contributing exposure
scenario Use of laboratory reagents
Further specification Use of laboratory reagents in small scale laboratories
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, professional setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 81 controlling worker exposure for PROC 16
Name of contributing exposure
scenario Using materials as fuel sources
Further specification Using materials as fuel sources, limited exposure to unburned product to be expected
FORMOL
Date15/05/2011; Revision 01 SDS: 2-111 page 88 of 95
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, professional setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 82 controlling worker exposure for PROC 19
Name of contributing exposure
scenario Hand-mixing with intimate contact
Further specification Hand-mixing with intimate contact and only PPE available
Product characteristic
Liquid, diluted substance, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 4 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, professional setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
FORMOL
Date15/05/2011; Revision 01 SDS: 2-111 page 89 of 95
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%). Wear a respirator with Type A
filter or better (efficacy 90%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 83 controlling worker exposure for PROC 21
Name of contributing exposure
scenario Low energy manipulation of substances
Further specification Low energy manipulation of substances bound in materials and/or articles
Product characteristic
Solid, substance bound in materials and/or articles, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, professional setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 84 controlling worker exposure for PROC 23
Name of contributing exposure
scenario Open processing and transfer operations with minerals/metals
Further specification Open processing and transfer operations with minerals/metals at elevated temperature
Product characteristic
Solid, substance bound in materials and/or articles, up to 1.5%
Amounts used
Not relevant
FORMOL
Date15/05/2011; Revision 01 SDS: 2-111 page 90 of 95
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, professional setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 85 controlling worker exposure for PROC 24
Name of contributing exposure
scenario High (mechanical) energy work-up of substances
Further specification High (mechanical) energy work-up of substances bound in materials and/or articles
Product characteristic
Solid, substance bound in materials and/or articles, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, professional setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
FORMOL
Date15/05/2011; Revision 01 SDS: 2-111 page 91 of 95
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 86 controlling worker exposure for PROC 25
Name of contributing exposure
scenario Other hot work operations with metals
Further specification Other hot work operations with metals
Product characteristic
Solid, substance bound in materials and/or articles, up to 1.5%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, professional setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Section 3.- Exposure estimation
See: http://www.ercros.es/eng/internas.asp?arxiu=sl_1
Section 4.- Guidance to DU to evaluate whether he works inside the boundaries set by the ES
The DU works inside the boundaries set by the ES if either the proposed risk management measures as described above are met or
the downstream user can demonstrate on his own that his operational conditions and implemented risk management measures are
adequate. This has to be done by showing that they limit the inhalation and dermal exposure to a level below the respective DNEL
(given that the processes and activities in question are covered by the PROCs listed above) as given below. If measured data are
not available, the DU may make use of an appropriate scaling tool such as
Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Important note: By demonstrating a safe use when comparing exposure estimates with the long-term DNEL, the acute DNEL is
therefore also covered (according to R.14 guidance, acute exposure levels can be derived by multiplying long-term exposure
estimates by a factor of 2).
FORMOL
Date15/05/2011; Revision 01 SDS: 2-111 page 92 of 95
Section 1.- Title Professional use of preparations containing formaldehyde up to 1%
Systematic title based on use
descriptor
SU: 22
PROC: 5, 8a, 8b, 10, 15
ERC: 2,3,8c, 8f
PC: 1
Consortium use number covered:
Professional use of formaldehyde products (IU17)
3p; professional use of resins in wood applications (e.g. glues) (IU18)
Name of contributing
environmental scenario 1 and
corresponding ERC
No environmental assessment has been performed
Section 2.- Operational conditions and risk management measures
2.1.-Control of workers exposure
Name(s) of contributing worker
scenarios and corresponding
PROCs
Mixing or blending in batch processes (multistage and/or significant contact) (PROC 5),
Transfer of chemicals from/to vessels/ large containers at non dedicated facilities (PROC
8a),
Transfer of chemicals from/to vessels/ large containers at dedicated facilities (PROC 8b),
Roller application or brushing (PROC 10),
Use of laboratory reagents in small scale laboratories (PROC 15)
Assessment Method All exposure assessments were done by use of ECETOC TRA, version 2 with
modifications (see beginning of chapter 9)
Contributing exposure scenario 87 controlling worker exposure for PROC 5
Name of contributing exposure
scenario Mixing or blending in batch processes
Further specification Mixing or blending in batch processes (multistage and/or significant contact)
Product characteristic
Liquid, diluted substance, up to 1%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, professional setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 80%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
FORMOL
Date15/05/2011; Revision 01 SDS: 2-111 page 93 of 95
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 88 controlling worker exposure for PROC 8a
Name of contributing exposure
scenario Transfer of chemicals, non-dedicated
Further specification Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities
Product characteristic
Liquid, diluted substance, up to 1%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, professional setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 80%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 89 controlling worker exposure for PROC 8b
Name of contributing exposure
scenario Transfer of chemicals, dedicated
Further specification Transfer of chemicals from/to vessels/ large containers at dedicated facilities
Product characteristic
Liquid, diluted substance, up to 1%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
FORMOL
Date15/05/2011; Revision 01 SDS: 2-111 page 94 of 95
Other given operational conditions affecting workers/consumers exposure
Indoor, professional setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 90%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Contributing exposure scenario 90 controlling worker exposure for PROC 10
Name of contributing exposure
scenario Roller application or brushing
Further specification Roller application or brushing
Product characteristic
Liquid, diluted substance, up to 1%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, professional setting
Conditions and measures at level of article production to prevent release during service life
Not relevant
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Local exhaust ventilation with an efficacy of 80%.
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
FORMOL
Date15/05/2011; Revision 01 SDS: 2-111 page 95 of 95
Not relevant
Contributing exposure scenario 91 controlling worker exposure for PROC 15
Name of contributing exposure
scenario Use of laboratory reagents
Further specification Use of laboratory reagents in small scale laboratories
Product characteristic
Liquid, diluted substance, up to 1%
Amounts used
Not relevant
Frequency and duration of use/exposure
Up to 8 hours, daily exposure
Human factors not influenced by risk management
A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body
weight for workers.
Other given operational conditions affecting workers/consumers exposure
Indoor, professional setting
Technical conditions and measures at process level (source) to prevent release
Not relevant
Technical conditions and measures to control dispersion from source towards the worker
Not relevant
Organisational measures to prevent /limit releases, dispersion and exposure
Not relevant
Conditions and measures related to information and behavioural advice to consumers
Not relevant
Conditions and measures related to personal protection, hygiene and health evaluation
Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).
Additional good practice advice (for environment) beyond the REACH CSA
Not relevant
Section 3.- Exposure estimation
See: http://www.ercros.es/eng/internas.asp?arxiu=sl_1
Section 4.- Guidance to DU to evaluate whether he works inside the boundaries set by the ES
The DU works inside the boundaries set by the ES if either the proposed risk management measures as described above are met or
the downstream user can demonstrate on his own that his operational conditions and implemented risk management measures are
adequate. This has to be done by showing that they limit the inhalation and dermal exposure to a level below the respective DNEL
(given that the processes and activities in question are covered by the PROCs listed above) as given below. If measured data are
not available, the DU may make use of an appropriate scaling tool such as
Dermal exposure: ECETOC TRA v2 (with modifications)
Inhalation exposure: ART
Important note: By demonstrating a safe use when comparing exposure estimates with the long-term DNEL, the acute DNEL is
therefore also covered (according to R.14 guidance, acute exposure levels can be derived by multiplying long-term exposure
estimates by a factor of 2).