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OECD SIDS BENZOYL PEROXIDE

UNEP PUBLICATIONS 1

FOREWORD INTRODUCTION

BENZOYL PEROXIDE

CAS N°: 94-36-0

SIDnitial Assessment Report

For

SIAM 15

1. Chemical Name:

2. CAS Number:

3. Sponsor Country:

4. Shared Partnership with:

5. Roles/Responsibilities of the Partners:

6. Sponsorship History

7. Review Process Prior to the SIAM:

8. Quality check process:

9. Date of Submission:

10. Date of last Update:

11. Comments:

SIDS INITIAL ASSESSMENT PROFILE

CAS No.

Chemical Name

Structural Formula

SUMMARY CONCLUSIONS OF THE SIAR

Human Health

in vitroin vivo

Environment

Selenastrum capricornutum)

Daphnia magna)Oryzias latipes

activated sludge)

Exposure

RECOMMENDATION

RATIONALE FOR THE RECOMMENDATION AND NATURE OF FURTHER WORK RECOMMENDED

SIDS Initial Assessment Report

1 IDENTITY

1.1 Identification of the Substance

1.2 Purity/Impurities/Additives

1.3 Physico-Chemical properties

Table 1

Property Value

Classification in member countries

2 GENERAL INFORMATION ON EXPOSURE

2.1 Production Volumes and Use Pattern

2.2 Environmental Exposure and Fate

2.2.1 Sources of Environmental Exposure

2.3 Human Exposure

2.3.1 Occupational Exposure

2.3.2 Consumer Exposure

3 HUMAN HEALTH HAZARDS

3.1 Effects on Human Health

3.1.1. Toxicokinetics, Metabolism and Distribution

Studies in Animals and Humans

In vitro and In vivo Studies

et alet al et al

et al in vivo

In vitro in vivo

et al, in vitro

3.1.2 Acute Toxicity

Inhalation

et al ,

et al

et al

et al

et al

Oral

et al ,

Conclusion

3.1.3 Irritation

Skin Irritation

Eye Irritation

et al ,

Conclusion

3.1.4 Sensitisation

Studies in Animals

et al et al

et al

et al

et al

et al

et al

Studies in Humans

et al, et al, et al, et al,

et al,

et al et al et al

et al

3.1.5 Repeated Dose Toxicity

et al

Conclusion

3.1.6 Mutagenicity

In vitro Studies

in vitro Salmonellatyphimurium Escherichia coli

et al et al et alin vitro

et al

In vivo Studies

in vivo

et al

Conclusionin vitro

in vivo

3.1.7 Carcinogenicity

Dermal

et al.,

et alin vivo

et al.,et al et al et al et al

in vivo

et al

et al et al

Oral

et al

in vivo

et al

Studies in Humans

in vitro

et al

et al

et al

Conclusion

3.1.8 Toxicity for Reproduction

et al

Conclusion

3.2 Initial Assessment for Human Health

in vitroin vivo

4 HAZARDS TO THE ENVIRONMENT

4.1 Aquatic Effects

Acute Toxicity Test Results

Selenastrum capricormutum

Pseudokirchneriella subcapitata

Selenastrum

capricornutum


Daphnia

Magna

Daphnia

Magna et al

Oryzias latipes

Poecilia reticulata

et al

activated sludge et al

Daphnia magna

Daphnia magnaet al

Poecilic reticulataet al

Oryzias latipes

Lepomis macrochirus Salmo gairdneri

Daphnia magna

Scenedesmus quadricauda

Conclusion

4.2 Terrestrial Effects

Eisenia foetidaEisenia foetida

et al

4.3 Other Environmental Effects

4.4 Initial Assessment for the Environment

Eisenia foetida

5 RECOMMENDATIONS

6 REFERENCES


Salmonella

Salmonella typhimurium

SIDS DOSSIER

Benzoyl peroxide

CAS No. : 94-36-0

Sponsor Country : Republic of Korea

1.01 SUBSTANCE INFORMATION

*A. CAS number : B. Name (Primary name)

:

*C. Name (OECD name)

:

†D. CAS Descriptor : E. EINECS-Number : F. Molecular Formula :

*G. Structural Formula

:

H. Substance Group : I. Substance Remark

J. Molecular Weight :

1.02 OECD INFORMATION

A. Sponsor Country :

B. Lead Organisation

:

:

:::::::

C. Name of responder

::

1.1 GENERAL SUBSTANCE INFORMATION

A. Type of Substance

:

B. Physical State :

C. Purity :

Source :

1.2 SYNONYMS

:

1.3 IMPURITIES

1.4 ADDITIVES

:::::

:::::

:::::

1.5 QUANTITY

: :

:

1.6 LABELLING AND CLASSIFICATION

::::

:

:

:

1.7 USE PATTERN

A. General::

:

:

:

:

:

:

B. Uses in Consumer Products

::

1.8 OCCUPATIONAL EXPOSURE LIMIT VALUE

:::

:

::

:::

1.9 SOURCES OF EXPOSURE

::

:

1.10 ADDITIONAL REMARKS

2.1 MELTING POINT

Preferred Result::::

:::

:::

:::

:::

:::

:::

:::

::::

2.2 BOILING POINT


::::

2.3 DENSITY (RELATIVE DENSITY)

:::::

::::

:

2.4 VAPOUR PRESSURE

Preferred Result::::::

::::

2.5 PARTITION COEFFICIENT LOG10 POW

Preferred Result::::::

:::::

2.6 WATER SOLUBILITY


:::

:::

:::

:::

:::

2.7 FLASH POINT

:::

:::

2.8 AUTO FLAMMABILITY

::::

::::

::::

2.9 FLAMMABILITY

::::

:::

::::

::::

2.10 EXPLOSIVE PROPERTIES

:::

:

::

:::

:::

: �

::

:

::

:

::

:

::

: �

::

2.11 OXIDIZING PROPERTIES

:::

:::

:::

:::

2.12 OXIDATION: REDUCTION POTENTIAL

2.13 ADDITIONAL DATA

A. Partition co-efficient between soil/sediment and water (Kd)

::

::

et al

B. Henry’s Law Constant

::::

C. Volatilization from Soil/Water

:

:

::

::::

3.1 STABILITY

3.1.1 PHOTODEGRADATION

a) Preferred Result :

::

:::::

::::

::::

3.1.2 STABILITY IN WATER

(a) Preferred Result ::

:

::

::

::

3.1.3 STABILITY IN SOIL

3.2 MONITORING DATA (ENVIRONMENT)

3.3 TRANSPORT AND DISTRIBUTION BETWEEN ENVIRONMENTAL COMPARTMENTS INCLUDING ESTIMATED ENVIRONMENTAL CONCENTRATIONS AND DISTRIBUTION PATHWAYS

3.3.1 TRANSPORT

::::::

et al

3.3.2 THEORETICAL DISTRIBUTION (FUGACITY CALCULATION)

Preferred Result :::

Compartment

Release100 % to

air

Release100 % to

water

Release100 % to

soil

Allthree

Property Value

:::

::

:

:::

3.4 IDENTIFICATION OF MAIN MODE OF DEGRADABILITY IN ACTUAL USE

3.5 BIODEGRADATION

Preferred Result ::::::::

:

:

:::

::

::::::::

:::

:

::

3.6 BOD5, COD OR RATIO BOD5/COD

3.7 BIOACCUMULATION


::

::

et al


:

:

4.1 ACUTE/PROLONGED TOXICITY TO FISH

(a) Preferred Result :: Oryzias latipes ::::::::

:

::

:: Poecilia reticulata :::::::

:

:::

:: Oryzias latipes::

:::::::::

4.2 ACUTE TOXICITY TO AQUATIC INVERTEBRATES

A. Daphnia

:: Daphnia Magna::::

: Daphnia sp::

:

:

:

::

Daphnia

:: Daphnia Magna::::

::::

:

::

Daphnia magna

4.3 TOXICITY TO AQUATIC PLANTS

Algae

: Selenastrum capricornutum::::::

:::

:

::

: Pseudokirchneriella subcapitata ::::

::::::

:

::


4.4 TOXICITY TO MICROORGANISMS

:::::

:

:

:::

:::

4.5 CHRONIC TOXICITY TO AQUATIC ORGANISMS

4.5.1 CHRONIC TOXICITY TO FISH

4.5.2 CHRONIC TOXICITY TO AQUATIC INVERTEBRATES

4.6 TERRESTRIAL ORGANISMS

4.6.1 TOXICITY TO SOIL DWELLING ORGANISMS

:: Eisenia foetida::::

::::

:::

4.6.2 TOXICITY TO TERRESTRIAL PLANTS

4.6.3 TOXICITY TO OTHER NON MAMMALIAN TERRESTRIAL SPECIES (INCLUDING AVIAN)

:::::::::::

::

4.7 BIOLOGICAL EFFECTS MONITORING (INCLUDING BIOMAGNIFICATION)

4.8 BIOTRANSFORMATION AND KINETICS


:

Lepomis macrochirus Salmo gairdneri

Daphniamagna

Scenedesmusquadricauda

:

5.1 ACUTE TOXICITY

5.1.1 ACUTE ORAL TOXICITY

(a) Preferred Result ::::::::::::

:

:

::

:::::::::

:

:

:

:

::

:

:::::::::

:

::

:::

::::

:

:::

:::::

5.1.2 ACUTE INHALATION TOXICITY

:::::::

::

:

:

ad libitum

:

:

:

5.1.3. ACUTE DERMAL TOXICITY

5.1.4 ACUTE TOXICITY, OTHER ROUTES OF ADMINISTRATION

:::::

::

::

::

:::::

::::

::

:::::::::::

5.2 CORROSIVENESS/IRRITATION

5.2.1 SKIN IRRITATION

: in vivo::::::

:

:

:

:

:

: in vivo::: et al

::

::

ID50 (irritant dose 50)

IT50 (irritant time 50)

:

:

:

::

::::::

:

:

::::

:

:

Free bezoyl peroxide Entrapped benzoyl peroxide

::

::::::

::

5.2.2 EYE IRRITATION/CORROSION

: in vivo ::::::

:

:

::

: in vivo ::

:::

:

:

:

:

:

:::::

:

5.3 SKIN SENSITIZATION

::::::

:

in vivo

:

- stimulation index(SI)

:

:

:

:::

::::::

::

::::::

:

::

:::::::

::

5.4 REPEATED DOSE TOXICITY

(a) Preferred Result ::::

::

:::

:::

:

:AgeNo. of animals

VehicleSatellite groups

Clinical observations performed and frequency

Organs examined at necropsy

::

: Body weight

Food/water consumption

- Description, severity, time of onset and duration of clinical signs

- Hematological and biochemical findings incidence and severity

Histopathology incidence and severity

- Mortality and time to death

- Ophthalmologic findings - Organ weight changes

- Histopathology incidence and severity

Treatment (mg/kg/day) 0 250 500 1,000 C (+)

:

::

:::::

::::::::

:

:

Infective F1 F2 F3 FC B1 B2 BC

::

:

5. 5 GENETIC TOXICITY IN VITRO

A. BACTERIAL TEST

(a) Preferred Result :: Salmonella typhimurium

Escherichia coli:::::

:::

:

:

:

:

:

:

: Salmonella typhimurium ::::

::

:::::


:: Salmonella typhimurium::

::::::::

Salmonellatyphimurium

::

Salmonella

:: Salmonella typhimurium:

:::

::: et al::

::

:Salmonella

B. NON-BACTERIAL TEST

: in vitro:::::

:

:

: In vitro

:

:

:

:

in vitro

:

5. 6 GENETIC TOXICITY IN VIVO

(a) Preferred Result : in vivo:::::::::::

::

- Organs examined at necropsy not examined:

Dose (mg/kg) Group mean

(PCE/PCE+NCE)

Group mean frequency of MNPCE

(per 1000)

:

: in vivo

:

:

::::::

::

:::

::

5. 7 CARCINOGENICITY

(a) Preferred Result::::::::::::::

::

::::

:

ad libitum

:

:

::

::::::::::::

::

:

:::

:

::

::::::

:

:

:

:

::

::

::::::::

::::

::

::::::::

::

:

:::

::::::::

::::

::

::::::::

::::

::

::::::::

::::

::

::::::::

:

:

::

::

:::::

:::

:

:::

::

::::::::

::

::

::

:::::

::

:

:::

:

::

:::::

::

:

:

::

::

5.8 TOXICITY TO REPRODUCTION

:::

:::

::

:::

:

:::

Treatment (mg/kg/day) 0 250 500 1000 Cyclophosphamide

:

:

:

5.9 DEVELOPMENTAL TOXICITY/TERATOGENICITY

:::

:

::::

:::

::

::

::

5.10 OTHER RELEVANT INFORMATION

A. Specific toxicities

B. Toxicodynamics, toxicokinetics

::

in vitroin vivo In vitro

In vivo

:

J. Am.

:

:

in vivoIn vitro

In vivo

:

::

:

::

in vitro in vivoin vitro

:

5.11 EXPERIENCE WITH HUMAN EXPOSURE

::

:

::

:

:

::

:

:

::

:

::

:

::

:

::

:

::

:

::

:

::

:

:

::

:

:

:::

::

::

:

::

:::

::

:::

::

:::

No. of subjects giving response

Treatment +2 +1 ± 0 +2 +1 ± 0 Tota

l

::

:::

::

6. REFERENCES


Salmonella

Environ. Res

et al

Daphnia

Daphnia magna

Salmonella

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