a4template-online · web viewthis assessment report has been established as a result of the...

Regulation (EU) No 528/2012 as it applies in Great Britain (the

GB Biocidal Products Regulation (GB BPR))

Evaluation of active substances

Draft Risk Assessment Report

<active substance>

<product type>

Great Britain

<date>

1

<applicant> <active substance> <PT>

Guidance

For further guidance visit https://www.hse.gov.uk/biocides/active-substance-approval.htm.

Where there is no GB-specific guidance, reference is made to relevant technical guidance for the EU Biocidal Products Regulation (EU BPR), as the two sets of legislation are very similar.

Sections 1 and 2 are to be completed by the Competent Authority only.

Applicants should complete the summary on page 3 and all other sections from Section 3 onwards.

Explanatory notes and other text that should be deleted is marked as follows:

[Italics – green writing]

Examples and indications of the text that should be provided for some areas are marked as follows:

<Italics – purple writing>

2

https://www.hse.gov.uk/biocides/active-substance-approval.htm

https://www.hse.gov.uk/biocides/active-substance-approval.htm


Summary

Substance name

CAS number

EC number

Applicant

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Table of contents1. Statement of subject matter or purpose.......................................................112. Conclusion......................................................................................................12

2.1. Overall conclusion...................................................................................122.2. Draft opinion.............................................................................................122.3. Draft conclusions of the evaluation.......................................................122.4. Exclusion, substitution and POP criteria...............................................15

2.4.1. Exclusion and substitution criteria........................................................15

2.4.2. POP criteria..........................................................................................17

2.4.3. Public consultation for potential candidates for substitution.................17

2.5. Opinion on the application for approval of the active substance <active substance> in product type <PT>.......................................................172.6. Elements to be taken into account when authorising products..........182.7. Requirement for further information......................................................19

3. Assessment Report........................................................................................203.1. Summary presentation of the active substance....................................20

3.1.1. Identity of the active substance............................................................20

3.1.2. Intended uses and effectiveness..........................................................20

3.1.3. Classification and labelling...................................................................22

4. Summary of the human health risk assessment.........................................265. Summary of the environmental risk assessment........................................306. Assessment of exclusion, substitution criteria and POP...........................34Part A – Assessment of intrinsic properties and effects of the active substance...............................................................................................................351. General substance information.....................................................................35

1.1. Identification of the substance...............................................................351.2. Composition of the substance (reference specifications)...................361.3. Physical and chemical properties of the active substance..................371.4. Physical hazards and respective characteristics..................................401.5. Hazard identification for physico-chemical properties........................431.6. Analytical methods or detection and identification..............................43

2. Effects against target organisms..................................................................442.1. Function and field of use envisaged......................................................442.2. Intended uses...........................................................................................442.3. Summary on efficacy...............................................................................45

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2.3.1. Efficacy.................................................................................................46

2.3.2. Mode of action......................................................................................47

2.3.3. Resistance...........................................................................................47

2.4. Conclusion on efficacy............................................................................473. Assessment of effects on human health......................................................48

3.1. Toxicokinetics..........................................................................................483.1.1. Short summary of the toxicokinetic information...................................48

3.1.2. Values and conclusions used for the risk assessment.........................48

3.2. Acute toxicity............................................................................................503.2.1. Acute oral toxicity.................................................................................50

3.2.2. Acute dermal toxicity............................................................................51

3.2.3. Acute inhalation toxicity........................................................................53

3.2.4. Overall conclusion on acute toxicity.....................................................55

3.3. Irritation and corrosion............................................................................553.3.1. Skin corrosion and irritation..................................................................55

3.3.2. Eye irritation.........................................................................................58

3.3.3. Respiratory tract irritation.....................................................................60

3.3.4. Overall conclusion on corrosion and irritation......................................61

3.4. Sensitisation.............................................................................................623.4.1. Skin sensitisation.................................................................................62

3.4.2. Respiratory sensitisation......................................................................64

3.4.3. Overall conclusion on sensitisation......................................................65

3.5. Short-term repeated dose toxicity..........................................................653.5.1. Short-term oral toxicity.........................................................................66

3.5.2. Short-term dermal toxicity....................................................................67

3.5.3. Short-term inhalation toxicity................................................................69

3.5.4. Overall conclusion on short-term repeated dose toxicity.....................71

3.6. Sub-chronic repeated dose toxicity.......................................................723.6.1. Sub-chronic oral toxicity.......................................................................72

3.6.2. Sub chronic dermal toxicity..................................................................74

3.6.3. Sub-chronic inhalation toxicity..............................................................75

3.6.4. Overall conclusion on sub-chronic repeated dose toxicity...................77

3.7. Long-term repeated dose toxicity...........................................................78

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3.7.1. Long-term oral toxicity..........................................................................78

3.7.2. Long-term dermal toxicity.....................................................................80

3.7.3. Long-term inhalation toxicity................................................................81

3.7.4. Overall conclusion on long-term repeated dose toxicity.......................83

3.8. Genotoxicity..............................................................................................843.8.1. In vitro..................................................................................................84

3.8.2. In vivo...................................................................................................85

3.8.3. Overall conclusion on genotoxicity.......................................................87

3.9. Carcinogenicity........................................................................................873.10. Reproductive toxicity............................................................................89

3.10.1. Developmental toxicity......................................................................90

3.10.2. Fertility..............................................................................................91

3.10.3. Effects on or via lactation..................................................................93

3.10.4. Overall conclusion on reproductive toxicity.......................................95

3.11. Neurotoxicity.........................................................................................953.12. Immunotoxicity......................................................................................973.13. Disruption of the endocrine system....................................................993.14. Further human data............................................................................1013.15. Other data............................................................................................102

4. Environmental effects assessment.............................................................1044.1. Fate and distribution in the environment.............................................104

4.1.1. Degradation........................................................................................104

4.1.2. Distribution.........................................................................................123

4.1.3. Bioaccumulation.................................................................................126

4.1.4. Monitoring data..................................................................................131

4.2. Effects on environmental organisms...................................................1314.2.1. Atmosphere........................................................................................131

4.2.2. Sewage treatment plant (STP)...........................................................131

4.2.3. Aquatic compartment.........................................................................132

4.2.4. Terrestrial compartment.....................................................................145

4.2.5. Groundwater......................................................................................150

4.2.6. Birds and mammals...........................................................................151

4.2.7. Primary and secondary poisoning......................................................152

4.3. Endocrine disrupting properties...........................................................1544.4. Derivation of PNECs..............................................................................155

5. Assessment of exclusion criteria, substitution criteria and POP............1586


5.1. Exclusion criteria...................................................................................1585.1.1. Assessment of CMR properties.........................................................158

5.1.2. Assessment of endocrine disrupting properties.................................158

5.1.3. PBT Assessment (following Annex XIII to GB REACH).....................159

5.2. Substitution criteria...............................................................................1625.3. Assessment of long-range environmental transportation and impact on environmental compartments...................................................................163

Part B – Exposure assessment and effects of the active substance in the biocidal product(s)..............................................................................................1656. General product information.......................................................................165

6.1. Identification of the product..................................................................1656.2. Complete qualitative and quantitative composition of the biocidal product.............................................................................................................1656.3. Physical, chemical and technical properties.......................................1676.4. Hazard identification for physical and chemical properties..............1756.5. Analytical methods for detection and identification...........................176

7. Efficacy..........................................................................................................1817.1. Efficacy....................................................................................................1817.2. Mode of action........................................................................................1827.3. Resistance..............................................................................................1827.4. Conclusion on efficacy..........................................................................182

8. Human exposure assessment.....................................................................1838.1. Identification of main paths of human exposure towards the active substance from its use in the biocidal product............................................1838.2. List of scenarios.....................................................................................1838.3. Industrial user exposure........................................................................184

8.3.1. Scenario (n)........................................................................................184

8.3.2. Combined scenarios..........................................................................186

8.4. Professional user exposure..................................................................1868.4.1. Scenario (n)........................................................................................186


8.5. General public user exposure...............................................................1888.5.1. Scenario (n)........................................................................................188


8.6. Secondary exposure of the general public (bystanders) excluding dietary exposure..............................................................................................190

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8.6.1. Scenario (n)........................................................................................190


8.7. Dietary exposure....................................................................................1928.7.1. List of scenarios.................................................................................192

8.7.2. Information on non-biocidal use of the active substance...................192

8.7.3. Estimating livestock exposure to active substances used in biocidal products..........................................................................................................193

8.7.4. Estimating transfer of biocidal active substances into foods as a result of professional and / or industrial application(s).............................................194

8.8. Exposure associated with the production, formulation and disposal of the biocidal product........................................................................................194

8.8.1. Scenario (n)........................................................................................195


8.9. Combined residential scenarios...........................................................1969. Environmental exposure assessment........................................................197

9.1. Emission estimation..............................................................................1989.1.1. Scenario (n)........................................................................................198

9.2. Fate and distribution in exposed environmental compartments.......2009.3. Calculated PEC values...........................................................................2039.4. Primary and secondary poisoning.......................................................204

10. Assessment of effects on human health for the product......................20510.1. Product(s)............................................................................................20510.2. Dermal absorption..............................................................................20510.3. Acute toxicity.......................................................................................207

10.3.1. Overall conclusion on acute toxicity................................................208

10.4. Corrosion and irritation......................................................................20810.4.1. Skin corrosion and irritation............................................................209

10.4.2. Serious eye damage and eye irritation...........................................211

10.4.3. Respiratory tract irritation................................................................214

10.4.4. Overall conclusion on corrosion and irritation.................................216

10.5. Sensitisation........................................................................................21610.5.1. Skin sensitisation............................................................................217

10.5.2. Respiratory sensitisation.................................................................219

10.5.3. Overall conclusion on sensitisation.................................................220

10.6. Other.....................................................................................................22111. Environmental effects assessment for the product...............................222

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11.1. Atmosphere.........................................................................................22211.2. STP.......................................................................................................22211.3. Aquatic compartment.........................................................................22211.4. Terrestrial compartment.....................................................................22211.5. Primary and secondary poisoning....................................................222

Part C – Risk characterisation of the biocidal product(s)...............................22312. Risk characterisation for human health..................................................223

12.1. Critical endpoints................................................................................22312.1.1. Systemic effects..............................................................................223

12.1.2. Local effects....................................................................................223

12.1.3. Absorption.......................................................................................223

12.2. Reference values.................................................................................22412.2.1. Uncertainties and assessment factors............................................224

12.2.2. Reference values to be used in risk characterisation.....................226

12.2.3. Maximum residue limits or equivalent.............................................227

12.2.4. Specific reference value for groundwater.......................................227

12.3. Industrial uses.....................................................................................22712.3.1. Systemic effects..............................................................................227

12.3.2. Local effects....................................................................................228

12.3.3. Conclusion......................................................................................228

12.4. Professional uses...............................................................................22812.4.1. Systemic effects..............................................................................228

12.4.2. Local effects....................................................................................229

12.4.3. Conclusion......................................................................................229

12.5. General public uses............................................................................22912.5.1. Systemic effects..............................................................................229

12.5.2. Local effects....................................................................................230

12.5.3. Conclusion......................................................................................230

12.6. Secondary (indirect) exposure as a result of use............................23012.6.1. Systemic effects..............................................................................230

12.6.2. Local effects....................................................................................231

12.6.3. Conclusion......................................................................................231

12.7. Indirect exposure via food.................................................................23112.8. Production / formulation of active substance..................................231

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12.8.1. Systemic effects..............................................................................231

12.8.2. Local effects....................................................................................232

12.8.3. Conclusion......................................................................................232

12.9. Aggregated exposure.........................................................................23213. Risk characterisation for the environment..............................................233

13.1. Atmosphere.........................................................................................23313.2. Sewage treatment plant (STP)...........................................................23313.3. Aquatic compartment.........................................................................23313.4. Terrestrial compartment.....................................................................23313.5. Groundwater........................................................................................23413.6. Primary and secondary poisoning....................................................23413.7. Aggregated exposure (combined for relevant emission sources).235

14. Risk characterisation for the physico-chemical properties......................23714. Measures to protect man, animals and the environment......................237Part D – Appendices...........................................................................................238Appendix I: List of endpoints.............................................................................238

Chapter 1: Identity, physical and chemical properties, classification and labelling............................................................................................................238Chapter 2: Methods of analysis......................................................................241Chapter 3: Impact on human health...............................................................242Chapter 4: Fate and behaviour in the environment......................................247Chapter 5: Effects on non-target species......................................................250Chapter 6: Other end points...........................................................................252

Appendix II: Human exposure calculations......................................................253Appendix III: Environmental emission (and exposure) calculations..............254Appendix IV: List of terms and abbreviations..................................................255Appendix V: Overall reference list (including data owner and confidentiality claim)....................................................................................................................256Appendix VI: Confidential information..............................................................257

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1. Statement of subject matter or purpose

[To be completed by the Competent Authority only.]

This assessment report has been established as a result of the evaluation of the active substance <active substance> in product-type <PT and full name>, carried out in the context of Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (herein referred to as ‘GB BPR’), with a view to the possible approval of this substance.

Through agency agreements, the United Kingdom’s Health and Safety Executive (HSE) performs the functions of the GB biocidal competent authority, and hereafter is referred to as ‘the competent authority’ for the purposes of this document.

On <date> the competent authority received a dossier from the applicant. The competent authority accepted the dossier as complete for the purpose of the evaluation on <date>.

The aim of the assessment report is to provide a decision on the approval of <active substance> for product-type <PT>, and, should it be approved, to facilitate the authorisation of individual biocidal products. In the evaluation of applications for product authorisation, the provisions of GB BPR shall be applied, in particular the provisions of Chapter IV, as well as the common principles laid down in Annex VI.

For the implementation of the common principles of Annex VI, the content and conclusions of the assessment report shall be taken into account.

However, where conclusions of this assessment report are based on data protected under the provisions of GB BPR, such conclusions may not be used to the benefit of another applicant, unless access to these data for that purpose has been granted to that applicant.

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2. Conclusion

[Section 2 (and all subsections) to be completed by the Competent Authority. This section will require amendment for a PT21 active substance.]

2.1. Overall conclusion

The overall conclusion is that <active substance> in product type <PT> <may / may not> be approved. The detailed grounds for the overall conclusion are described in the assessment report.

2.2. Draft opinion

<Enter draft opinion>

2.3. Draft conclusions of the evaluation

[This will include the section “Overall conclusions” of the assessment report following the structure below. This section shall be in the order of 6-8 pages containing a concise summary of the evaluation and conclusions of the risk assessment and which uses have been assessed.]

a) Presentation of the active substance including the classification and labelling of the active substance

This evaluation covers the use of <active substance> in product type <PT>. <active substance> acts by <short description of the mode of action; if possible refer to chemical class, for example pyrethroids or arylpyrroles.> <If relevant, click or tap here to enter description of isomeric composition: for example: The active substance is a reaction mass of stereoisomer a (x % w/w) and stereoisomer b (y % w/w).> Specifications for the reference source are established.

<Enter statement on physico-chemical properties e.g. “The physico-chemical properties of the active substance and biocidal product have been evaluated and are deemed acceptable for the appropriate use, storage and transportation of the active substance and biocidal product.”>

<Enter statement on analytical methods e.g. “ Validated analytical methods are available for the active substance as manufactured and for the relevant and significant impurities. Validated analytical methods are required and available for the relevant matrices x, y, z.”> < If relevant, indicate matrices for which validated analytical methods are missing and required at product authorisation and refer to the section 2.5>

< If relevant, enter a statement that the active substance has been assessed under another European Regulatory Framework(s), e.g. opinion adopted by an EFSA panel, EMA, SCCS etc>

<Click or tap here to enter the classification of the active substance. Indicate if a harmonised classification is available. If not, indicate status of CLH dossier. If available, indicate first the harmonised classification and second if a proposal is made to amend the harmonised classification. Indicate again the status of CLH dossier.>

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[Present only the classification and labelling according to GB CLP. Do not present the pictogram but only the pictogram codes. Do not include the precautionary statements. Use the table below to present the current and, where relevant, proposed classification.]

The (proposed) classification and labelling for <active substance> according to Regulation (EC) No 1272/2008 as it applies in Great Britain (GB) (GB Classification, Labelling and Packaging of substances and mixtures Regulation (GB CLP)) is:

(Proposed) Classification according to GB CLP

Hazard Class and Category Codes

Labelling

Pictogram codes

Signal Word

Hazard Statement Codes

Specific concentration limits, M-Factors<Enter M-Factor values and indicate if for acute, chronic or both.>

Justification for the proposal<Enter a concise justification for the proposed classification and labelling.>

b) Intended use, target species and effectiveness

<Enter a description of the uses: applied for, evaluated and if considered relevant possible other uses that may be applied for at product authorisation. Include a description of the users: industrial, professionals and / or general public.>

<Enter a description of the mode of action.>

<Enter a description of the effectiveness of the active substance and representative biocidal product, for example: “The data on the active substance and the representative biocidal product have demonstrated sufficient efficacy against the target species.” Include a concise statement on resistance.>

c) Overall conclusion of the evaluation including need for risk management measures

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Human health

<Enter a brief description of the key hazards / risks driving the risk assessment.>

The table below summarises the exposure scenarios assessed.

Scenario Primary or secondary exposure and description of scenario

Exposed group

Conclusion

<Indicate whether the exposure is acceptable or not acceptable and any PPE or other RMMs if required to be acceptable.>

[Add new rows as required.]

<Enter a description of the overall outcome of the evaluation focussing on the scenarios for which unacceptable risks were identified and the subsequent need for risk mitigation measures and indicate which risk mitigation measures are appropriate. This can be limited to several paragraphs. If possible, add a statement if a specific concern was identified with respect to the use of the active substance in treated articles or that no concerns were identified with respect to the use of the active substance in treated articles.>

Environment

<Enter a brief description of the key hazards / risks driving the risk assessment.>

The table below summarises the exposure scenarios assessed.

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Scenario Description of scenario including environmental compartments

Conclusion

<Indicate whether the exposure is acceptable or not acceptable and any PPE or other RMMs if required to be acceptable.>


<Enter a description of the overall outcome of the evaluation focussing on the scenarios for which unacceptable risks were identified and the subsequent need for risk mitigation measures and indicate which risk mitigation measures are appropriate. This can be limited to several paragraphs. If possible, add a statement if a specific concern was identified with respect to the use of the active substance in treated articles or that no concerns were identified with respect to the use of the active substance in treated articles.>

Overall conclusion

<Enter a description the overall outcome of the evaluation focussing on the acceptable uses.>

2.4. Exclusion, substitution and POP criteria2.4.1. Exclusion and substitution criteria

The tables below summarise the relevant information with respect to the assessment of exclusion and substitution criteria:

CMR properties

Property Conclusions

Carcinogenicity (C) <Indicate Cat 1A, 1B, 2 or no classification required>

Mutagenicity (M) <Indicate Cat 1A, 1B, 2 or no classification required>

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Toxic for reproduction (R) <Indicate Cat 1A, 1B, 2 or no classification required>

<Enter an overall conclusion on CMR properties e.g. The active substance does / does not fulfil criterion (a), (b) and (c) of Article 5 (1). If the active substance meets substitution due to the properties of metabolite(s) or impurity(ies), describe for which criteria the evaluation is based on the metabolite(s) or impurity(ies).>

PBT and vPvB properties


Persistent (P) or very Persistent (vP) <Indicate P, vP or not P or vP or potential P/vP>

Bioaccumulative (B) or very Bioaccumulative (vB)

<Indicate B, vB or not B or vB or potential B/vB>

Toxic (T) <Indicate T or not T or potential T>

<Enter an overall conclusion on PBT and vPvB properties e.g. The active substance does / does not fulfil criterion (e) of Article 5 (1) and does not fulfil criterion (d) of Article 10 (1). If the active substance meets substitution due to the properties of metabolite(s) or impurity(ies), describe for which criteria the evaluation is based on the metabolite(s) or impurity(ies).>

[Potential P/vP, B/vB or T refers to situations where there are indications that the active substance is meeting one or more of the criteria (for example if the screening criteria are met) but there is insufficient information to come to a definite conclusion. In such a case, additional information under section 2.5 has to be requested and normally discussion has to take place. If an active substance is regarded as “potential P/vP, B/vB or T” this does not imply that it shall be regarded as meeting the exclusion criteria according to Article 5(1) or as a candidate for substitution according to Article 10. This has to be reflected here.]

Endocrine disrupting properties

<Enter a statement according to (EU) 2017/2100 as it has effect in Great Britain (GB endocrine disrupting criteria) e.g. “The active substance is not considered to have endocrine disrupting properties” or “The active substance is considered to have endocrine disrupting properties”. Include a justification for the latter statement. If the active substance meets substitution due to the properties of metabolite(s) or

16


impurity(ies), describe this here.>

Respiratory sensitisation properties

<Indicate Cat 1, 1A, 1B or no classification required>

Concerns linked to critical effects

<Enter a statement whether the active substance fulfils this criterion. If the active substance meets substitution due to the properties of metabolite(s) or impurity(ies), describe this here.>

Proportion of non-active isomers or impurities

<Enter a statement whether the active substance fulfils this criterion. If the active substance meets substitution due to the properties of metabolite(s) or impurity(ies), describe this here.>

Overall conclusion

Consequently, the following is concluded:

<active substance> <does / does not> meet the exclusion criteria laid down in Article 5 of GB BPR.

<active substance> <does / does not meet the conditions laid down in Article 10 of GB BPR and is therefore / therefore not considered as a candidate for substitution. <Specify if any conditions are met, and in such a case also consider the results from public consultation.> The exclusion and substitution criteria were assessed in line with CA-March14-Doc.4.1 - Final - Principles for substance approval (https://circabc.europa.eu/sd/a/c41b4ad4-356c-4852-9512-62e72cc919df/CA-March14-Doc.4.1%20-%20Final%20-%20Principles%20for%20substance%20approval.doc) and in line with CA-Nov14-Doc.4.4 - Final - Further guidance on Art10(1) (https://circabc.europa.eu/sd/a/dbac71e3-cd70-4ed7-bd40-fc1cb92cfe1c/CA-Nov14-Doc.4.4%20-%20Final%20-%20Further%20guidance%20on%20Art10(1).doc). This implies that the assessment of the exclusion criteria is based on Article 5(1) and the assessment of substitution criteria is based on Article 10(1)(a, b, d, e and f).

2.4.2. POP criteria

<Enter a description of which of the POP criteria are met, as follows. The criteria for a substance being a persistent organic pollutant (POP) are P, B and having the potential for long range transport. In addition, high toxicity can breach the B criterion, in which case a substance will be a persistent organic pollutant if it is P, demonstrates the potential for long range transport, and is either B or T. The scientific and technical justification is not required as this is described in the AR.>

2.4.3. Public consultation for potential candidates for substitution

<Enter a description of the outcome of the public consultation and specify the type of information received, e.g. information on the availability of alternative active substances, information related to essentiality.>

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https://circabc.europa.eu/sd/a/dbac71e3-cd70-4ed7-bd40-fc1cb92cfe1c/CA-Nov14-Doc.4.4%20-%20Final%20-%20Further%20guidance%20on%20Art10(1).doc

https://circabc.europa.eu/sd/a/dbac71e3-cd70-4ed7-bd40-fc1cb92cfe1c/CA-Nov14-Doc.4.4%20-%20Final%20-%20Further%20guidance%20on%20Art10(1).doc

https://circabc.europa.eu/sd/a/c41b4ad4-356c-4852-9512-62e72cc919df/CA-March14-Doc.4.1%20-%20Final%20-%20Principles%20for%20substance%20approval.doc

https://circabc.europa.eu/sd/a/c41b4ad4-356c-4852-9512-62e72cc919df/CA-March14-Doc.4.1%20-%20Final%20-%20Principles%20for%20substance%20approval.doc


2.5. Opinion on the application for approval of the active substance <active substance> in product type <PT>

In view of the conclusions of the evaluation, it is proposed that <active substance> <shall not be approved / shall be approved and be included in the GB list of approved active substances, subject to the following specific conditions:>

[The text below should be deleted if non-approval is proposed.]

1. Specification: minimum purity of the active substance evaluated: <Enter minimum purity in % w/w. Where relevant, add characterisation of identity with respect to stereoisomers. If the approval covers a nanomaterial this shall be mentioned explicitly.>

<Where relevant, enter maximum content of relevant impurities.>

2. The authorisations of biocidal products are subject to the following condition(s):

a. The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the GB risk assessment of the active substance.

b. In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:

i. <Indicate the user category / population and / or the environmental compartment at risk, as well as the use related to this risk described in a general way.>

ii. <Indicate any additional requirements of the product assessment.>

c. <Indicate any specific restrictions (when no “unless clause” is feasible) or other conditions for product authorisation in accordance with CA-Sept15-Doc.5.4 (https://circabc.europa.eu/sd/a/6521f842-126d-4dbe-b4a3-63187d8b4514/CA-Sept15-Doc.5.4%20-%20Approval%20conditions.doc).>

d. <Indicate any additional conditions that are required if the active substance meets the substitution and/or exclusion criteria: see the document “Catalogue of standard phrases”.>

3. The placing on the market of treated articles is subject to the following condition(s):

[This section should be completed if: i) A specific use is fully restricted; ii) The substance meets the exclusion criteria, but is nevertheless approved; iii) The substance is a skin sensitizer category 1 or sub-category1A and/or respiratory sensitizer and/or vP or vB and/or and B and/or SVHC identified under Article 57 of EC 1907/2006 as it applies in Great Britain (GB REACH).]

a. The person responsible for the placing on the market of a treated article treated with or incorporating the active substance <active substance> shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of GB BPR.

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https://circabc.europa.eu/sd/a/6521f842-126d-4dbe-b4a3-63187d8b4514/CA-Sept15-Doc.5.4%20-%20Approval%20conditions.doc

https://circabc.europa.eu/sd/a/6521f842-126d-4dbe-b4a3-63187d8b4514/CA-Sept15-Doc.5.4%20-%20Approval%20conditions.doc


b. <Indicate any specific labelling requirements, when a specific use of a treated article is fully restricted.>

<Indicate either “The active substance fulfils the criteria according to Article 28 (1) to enable inclusion on the GB Simplified Active Substance List of GB BPR.” or “The active substance does not fulfil the criteria according to Article 28(2)(…) to enable inclusion on the GB Simplified Active Substance List of GB BPR.” Indicate on which grounds the active substance cannot be included.>

2.6. Elements to be taken into account when authorising products

[This section should be deleted if non-approval is proposed.]

1. [If applicable] The active substance <active substance> is considered as a candidate for substitution, and consequently GB shall perform a comparative assessment as part of the evaluation of an application for authorisation.

2. The following recommendations and risk mitigation measures have been identified for the uses assessed. The Competent Authority should consider these risk mitigation measures when authorising products, together with possible other risk mitigation measures, and decide whether these measures are applicable for the concerned product:

a. <Enter details of any elements that need to be taken into account at product authorisation. Elements need to be specific for the active substance under consideration, but not too prescriptive, leaving some flexibility at product authorisation. See also the document “Catalogue of standard phrases”. For example: i) If an unacceptable risk is identified for industrial and / or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.ii) An unacceptable risk for [describe the user / environmental compartment / area of use] is identified. If the risk can be mitigated then specify the risk mitigation measure recommended, and if not use the following standard phrase: “If the risk cannot be reduced to an acceptable level by appropriate risk mitigation measures or by other means, these uses should not be authorised.”>

2.7. Requirement for further information

Sufficient data have been provided to verify the conclusions on the active substance, permitting the proposal for the approval of <active substance>.

< If appropriate, indicate whether further tests or studies shall be required and the dates at which these shall be submitted and to whom. With respect to the date of submission use the following standard phrasing: “… data must be provided as soon as possible but no later than 6 months before the date of approval to the Competent Authority”. It should be noted that a different phrase has to be used for new active substances; see document “Catalogue of standard phrases”.Data requirements for the biocidal product shall not be included in the opinion but in the Assessment Report.>

19


3. Assessment Report3.1. Summary presentation of the active substance3.1.1. Identity of the active substance

Main constituents

ISO name

IUPAC name

CAS number

EC number

Index number in Annex VI of GB CLP

Minimum purity / content

Structural formula

Relevant impurities and additives

IUPAC name or chemical name

Maximum concentration in % (w/w)

Index number in Annex VI of GB CLP


3.1.2. Intended uses and effectiveness

Use of the active substance

Product type

Intended use pattern(s)

20


Users

Effectiveness of the active substance

Function

Organisms to be controlled

Limitation of efficacy including resistance

Mode of action

21


3.1.3. Classification and labelling

3.1.3.1. Classification and labelling for the active substance

Physical hazards

Hazard class / property Proposed classification

Explosives

Flammable gases

Flammable aerosols

Oxidising gases

Gases under pressure

Flammable liquids

Flammable solids

Self-reactive substances

Pyrophoric liquids

Pyrophoric solids

Self-heating substances and mixtures

Substances that in contact with water emit flammable gases

Oxidising liquids

Oxidising solids

22



Organic peroxides

Corrosive to metals

Human health hazards


Acute toxicity via oral route

Acute toxicity via dermal route

Acute toxicity via inhalation route

Skin corrosion / irritation

Serious eye damage / eye irritation

Respiratory sensitisation

Skin sensitisation

Germ cell mutagenicity

Carcinogenicity

Reproductive toxicity

Specific target organ toxicity-single exposure

Specific target organ toxicity-repeated exposure

23



Aspiration hazard

Environmental hazards


Hazardous to the aquatic environment

Hazardous to the ozone layer

Current classification according to GB CLP

Hazard class and category Hazard statements

Current labelling according to GB CLP

Pictograms Signal word Hazard statements

Supplementary hazard statements

Proposed classification according to GB CLP [if deviating from current classification]


Proposed labelling according to GB CLP [if deviating from current labelling]



24


3.1.3.2. Classification and labelling for the representative product(s)

Proposed classification according to GB CLP


Proposed labelling according to GB CLP



Packaging of the biocidal product

Type of packaging

Size / volume of the packaging

Material of the packaging

Type and material of closure(s)

Intended user (e.g. professional, general public)

25


4. Summary of the human health risk assessmentSummary of the assessment of effects of human health

Endpoint Brief description

Toxicokinetics <Enter a very short description covering absorption, distribution, metabolism and excretion.>

Acute toxicity <Enter a very short description.>

Corrosion and irritation <Enter a very short description.>

Sensitisation <Enter a very short description.>

Repeated dose toxicity <Enter a very short description.>

Genotoxicity <Enter a very short description.>

Carcinogenicity <Enter a very short description.>

Reproductive toxicity <Enter a very short description.>

Neurotoxicity <Enter a very short description.>

Immunotoxicity <Enter a very short description.>

Disruption of the endocrine system <Enter a very short description.>

Other effects <Enter a very short description.>

26


Reference values

Reference value

Study NOAEL / LOAEL

Overall assessment factor

Value

AELshort-term

AELmedium-term

AELlong-term


Risk characterisation

[Sub-headings and tables that are not relevant can be deleted.]

Summary of scenarios

Scenario number

Scenario (e.g. mixing / loading)

Primary or secondary exposure and description of scenario

Exposed group (e.g. professionals, general public, bystanders)

1.

2.

Conclusion of risk characterisation for industrial user

Scenario, Tier, PPE

Relevant reference value

Estimated uptake (mg/kg bw/d)

Estimated uptake / reference value (%)

Acceptable (yes/no)

27


Scenario, Tier, PPE




Acceptable (yes/no)


[Please indicate which reference value is used (e.g. AELshort-term, AELmedium-term) and the value, plus include the results of local risk characterisation if relevant.]

Conclusion of risk characterisation for professional user

Scenario, Tier, PPE




Acceptable (yes / no)



Conclusion of risk characterisation for general public user

Scenario, Tier, PPE





28


Scenario, Tier, PPE







Conclusion of risk characterisation for indirect exposure

Scenario, Tier, PPE






29


5. Summary of the environmental risk assessmentFate and behaviour in the environment

[Please delete sub-headings and tables that are not relevant.]

Summary table on compartments exposed and assessed

Compartment Exposed (yes / no) Assessed (yes / no)


Summary table on relevant metabolites

Metabolite / transformation or reaction product

Compartment % active substance


Summary table on relevant physico-chemical and fate and behaviour parameters of the active substance

Parameter Value Unit Remarks

Molecular weight N/A

30


Parameter Value Unit Remarks

Log Octanol / eater partition coefficient

Log 10

Organic carbon/water partition coefficient (Koc)

l/kg

Henry’s Law Constant (20 °C)

Pa/m3/mol

Biodegradability N/A

DT50 for biodegradation in surface water

d or hr (at 12 ºC)

DT50 for hydrolysis in surface water

d or hr (at 12 ºC /pH)

DT50 for photolysis in surface water

d or hr

DT50 for degradation in soil

d or hr (at 12 ºC)

DT50 for degradation in air

d or hr

DT50 for degradation in sediment

d or hr


[Please include a similar table for relevant metabolites and/or degradation products.]

31


Effects assessmentSummary table on calculated PNEC values

Compartment PNEC



Exposure assessmentSummary table on calculated PEC values

Scenario number

PECSTP (mg/m3)

PECwater (mg/l)

PECsed (mg/kgwwt)

PECseawater (mg/l)

PECseased (mg/kgwwt)

PECsoil (mg/m3)

PECGW (μg/l) PECair (mg/m3)

1.

2.


[Insert / delete additional environmental compartments if relevant.]


32


Risk characterisationSummary table on calculated PEC / PNEC values

Scenario number

PEC / PNECSTP

PEC / PNECwater

PEC / PNECsed

PEC / PNECseawater

PEC / PNECseased

PEC / PNECsoil

PEC / PNECGW

PEC/PNECair

1.

2.


[Insert / delete additional environmental compartments if relevant.]


Conclusion<Enter a short summary on the conclusion of the risk assessment.>

33


6. Assessment of exclusion, substitution criteria and POP

Conclusion on exclusion criteria

Conclusion on CMR

Conclusion on ED assessment

Conclusion on PBT and vP/vB criteria

Conclusion on substitution criteria

Conclusion on LRTAP / POP assessment

34


Part A – Assessment of intrinsic properties and effects of the active substance1. General substance information1.1. Identification of the substanceSummary table on substance identity

Common name (ISO name, synonyms)

Chemical name (EC name, CA name, IUPAC name)

CAS number

EC number

Other CAS numbers (e.g. deleted, related, preferred, alternate)

Molecular formula

SMILES notation

Molar mass

Structural formula

Origin of the natural active substance or precursor(s) of the active substance

35


Method of manufacture

[Please include here a note if this information will be included in the confidential annex.]

1.2. Composition of the substance (reference specifications)

[Please include here a note if this information will be included in the confidential annex.]

Main constituent(s)

Constituent (chemical name)

Typical concentration (% w/w)

Concentration range (% w/w)

Remarks / Discussion

[Add rows as required.]

Impurities


Typical concentration (% w/w)



<Origin of impurity (e.g. manufacturing process, starting material)>


Additives


Function Typical concentration (% w/w)




36


1.3. Physical and chemical properties of the active substance

Property Result Test method applied or description in case of deviation

Remarks / Discussion References

Aggregate state at 20°C and 101.3 kPa

Physical state (appearance) at 20°C and 101.3 kPa

Colour at 20°C and 101.3 kPa

Odour at 20°C and 101.3 kPa

Melting / freezing point

Boiling point

Relative density

Granulometry

37




Vapour pressure

Henry’s law constant

Surface tension

Water solubility at 20 °C

Partition coefficient (n-octanol/water) and its pH dependency Surface tension at 20 °C

Thermal stability and identity of breakdown products

Reactivity towards container material

Dissociation constant

38




Granulometry

Viscosity

Solubility in organic solvents, including effect of temperature on solubility

Stability in organic solvents used in biocidal products and identity of relevant degradation products

39


1.4. Physical hazards and respective characteristics



Explosives

Flammable gases

Flammable aerosols

Oxidising gases


Flammable liquids

Flammable solids

Self-reactive substances and mixture

Pyrophoric liquids

40




Pyrophoric solids

Self-heating substances and mixtures

Substances and mixtures that in contact with water emit flammable gases

Oxidising liquids

Oxidising solids

Organic peroxide

Corrosive to metals

Auto-ignition temperature (liquids and gases)

41




Relative self-ignition temperature for solids

Dust explosion hazard

42


1.5. Hazard identification for physico-chemical properties

<Enter a summary on the hazard identification for physical-chemical properties.>

1.6. Analytical methods for detection and identificationAnalytical methods

Analyte (type of analyte e.g. active substance, metabolite etc)

Compartment Linearity Specificity Recovery rate (%): Fortification range / Number of measurements

Recovery rate (%): Mean

Recovery rate (%): RSD

Limit of quantification (LOQ), Maximum Residue Limits or other limits

Reference


43


2. Effects against target organisms2.1. Function and field of use envisaged

<Enter information on function and field of use.>

2.2. Intended usesSummary table of intended uses

Product Type

Product description

Target organisms (including development stage)

Description of use(s)

Mode of action

Objects to be protected

Concentration of product in the in-use formulation/product

44


Concentration of active substance in the in-use formulation/product

Application rate(s)

Frequency of application

Season/period for use (where relevant)

Field of use (indoors/outdoors)

Category(ies) of user(s)

Instruction for use

2.3. Summary on efficacy

45


2.3.1. Efficacy

Experimental data on the efficacy of the active substance against target organism(s)

Function Field of use envisaged

Test substance

Test organism(s)

Test method Test system / concentrations applied / exposure time

Test results: effects

Reference


46


Data waiving

Information requirement

Justification

[If not relevant, delete the table.]

2.3.2. Mode of action

<Enter any information on the mode of action.>

2.3.3. Resistance

<Enter any information on resistance.>

2.4. Conclusion on efficacy

<Enter a brief conclusion.>

47


3. Assessment of effects on human health3.1. ToxicokineticsSummary table of toxicokinetic studies

Method,Guideline,GLP status,Reliability

Species,Strain,Sex,No / Group

Test substance,Dose levels,Duration of exposure

Results Remarks (e.g. major deviations)

Reference

[Add / delete rows according to the number of studies. If not relevant, delete the table and include a statement that no data are available.]

3.1.1. Short summary of the toxicokinetic information

<Summarise the toxicokinetic information and the proposed metabolic pathway, if relevant.>

3.1.2. Values and conclusions used for the risk assessment

Value used in the risk assessment – Oral absorption

Value(s) <Include the concentration range(s) and type of formulation(s) the values are applicable for, if relevant.>

Justification

Value used in the risk assessment – Dermal absorption


Justification

[The dermal absorption value is applicable for the active substance and might not be usable in product authorisation.]

48


Value used in the risk assessment – Inhalatory absorption


Justification

Value used in the risk assessment – Distribution

Conclusion

Justification


Value used in the risk assessment – Metabolism

Conclusion

Justification


Value used in the risk assessment – Elimination

Conclusion

Justification


Data waiving


Justification


49


3.2. Acute toxicity3.2.1. Acute oral toxicity

Summary table of animal studies on acute oral toxicity



Test substance,Dose levels,Type of administration (gavage, in diet, other)

Signs of toxicity (nature, onset, duration, severity, reversibility)

ValueLD50

Remarks (e.g. major deviations)

Reference


Summary table of human data on acute oral toxicity

Type of data/ reportReliability

Test substance Relevant information about the study

Observations Reference

50


[Add / delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data are available.]

Value used in the risk assessment – Acute oral toxicity

Value

Justification

Data waiving


Justification


3.2.2. Acute dermal toxicity

Summary table of animal studies on acute dermal toxicity



Test substance,Vehicle,Dose levels,Surface area

ValueLD50


Reference

51




Test substance,Vehicle,Dose levels,Surface area

ValueLD50


Reference


Summary table of human data on acute dermal toxicity





Value used in the risk assessment – Acute dermal toxicity

Value

52


Justification

Data waiving


Justification


3.2.3. Acute inhalation toxicity

Summary table of animal studies on acute inhalation toxicity



Test substance, form (gas, vapour, dust, mist) and particle size (MMAD)Actual and nominal concentration,Type of administration (nose only / whole body/ head only)

ValueLC50


Reference

53



Summary table of human data on acute inhalation toxicity





Value used in the risk assessment – Acute inhalation toxicity

Value

Justification

Data waiving


54


Justification


3.2.4. Overall conclusion on acute toxicity

Value used in the risk assessment – Acute systemic toxicity

Value

Justification

Classification according to GB CLP

<Include the existing classification and / or a proposal if relevant.>

Value / conclusion used in the risk assessment – Acute local effects

Value / conclusion

Justification

3.3. Irritation and corrosion3.3.1. Skin corrosion and irritation

[If no data are available, delete all the tables and indicate only that no data are available.]

55


Summary table of in vitro studies on skin corrosion / irritation


Test substanceDoses

Relevant information about the study


Reference

[Add / delete rows according to the number of studies.]

Summary table of animal studies on skin corrosion / irritation



Test substance,Vehicle,Dose levels,Duration of exposure

ResultsAverage score (24, 48, 72 h), observations and time point of onset, reversibility, other adverse local/systemic effects, histopathological findings


Reference

56



Summary table of human data on skin corrosion / irritation





Conclusion used in the risk assessment – Skin irritation and corrosivity

Value / conclusion

Justification

Data waiving


Justification

57



3.3.2. Eye irritation


Summary table of in vitro studies on serious eye damage and eye irritation


Test substanceDoses



Reference


Summary table of animal studies on serious eye damage and eye irritation




ResultsAverage score (24, 48, 72 h), observations and time point of onset, reversibility


Reference

58





ResultsAverage score (24, 48, 72 h), observations and time point of onset, reversibility


Reference


Summary table of human data on serious eye damage and eye irritation





Conclusion used in the risk assessment – Eye irritation and corrosivity

Value / conclusion

59


Justification

Data waiving


Justification


3.3.3. Respiratory tract irritation


Summary table of animal studies on respiratory tract irritation




Resultsclinical signs, histopathology, reversibility


Reference


60


Summary table of human data on respiratory tract irritation





Conclusion used in the risk assessment – Respiratory tract irritation

Conclusion

Justification

3.3.4. Overall conclusion on corrosion and irritation

Conclusion used in the risk assessment – Corrosion and irritation

Value

Justification

61




3.4. Sensitisation3.4.1. Skin sensitisation


Summary table of animal studies on skin sensitisation



Test substance,Vehicle,Dose levels,Route of exposure (topical/intradermal, if relevant),Duration of exposure

Results(EC3-value or amount of sensitised animals at induction dose


Reference


62


Summary table of human data on skin sensitisation





Conclusion used in the risk assessment – Skin sensitisation

Value / conclusion

Justification

Data waiving


Justification


63


3.4.2. Respiratory sensitisation


Summary table of animal studies on respiratory sensitisation





Reference


Summary table of human data on respiratory sensitisation





64


Conclusion used in the risk assessment – Respiratory sensitisation

Value / conclusion

Justification

Data waiving


Justification


3.4.3. Overall conclusion on sensitisation

Conclusion used in the risk assessment – Sensitisation

Value

Justification



3.5. Short-term repeated dose toxicity

65


3.5.1. Short-term oral toxicity


Summary table of animal studies on short-term oral toxicity (usually 28-day studies)



Test substance,Dose levels,Route of exposure (gavage, in diet, other),Duration of exposure

NOAELLOAEL


Reference


Summary table of human data on short-term oral toxicity




66



Value used in the risk assessment – Short-term oral toxicity

Value / conclusion

Justification

Data waiving


Justification


3.5.2. Short-term dermal toxicity


67


Summary table of animal studies on short-term dermal toxicity (usually 28-day studies)



Test substance,Dose levels,Surface areaDuration of exposure

NOAELLOAEL


Reference


Summary table of human data on short-term dermal toxicity





68


Value used in the risk assessment – Short-term dermal toxicity

Value / conclusion

Justification

Data waiving


Justification


3.5.3. Short-term inhalation toxicity


69


Summary table of animal studies on short-term inhalation toxicity (usually 28-day studies)



Test substance, form (gas, vapour, dust, mist) and particle size (MMAD),Actual and nominal concentration,Type of administration (nose only / whole body/ head only),Duration of exposure

NOAELLOAEL


Reference


Summary table of human data on short-term inhalation toxicity




70



Value used in the risk assessment – Short-term inhalation toxicity

Value / conclusion

Justification

Data waiving


Justification


3.5.4. Overall conclusion on short-term repeated dose toxicity

Value used in the risk assessment – Short-term repeated dose toxicity

Value

Justification



71


Value / conclusion used in the risk assessment – Short-term repeated dose local effects

Value / conclusion

Justification



3.6. Sub-chronic repeated dose toxicity3.6.1. Sub-chronic oral toxicity


Summary table of animal studies on sub-chronic oral toxicity (usually 90-day studies)




NOAELLOAEL


Reference

72



Summary table of human data on sub-chronic oral toxicity





Value used in the risk assessment – Sub-chronic oral toxicity

Value / conclusion

Justification

Data waiving


Justification

73



3.6.2. Sub chronic dermal toxicity


Summary table of animal studies on sub-chronic dermal toxicity (usually 90-day studies)




NOAELLOAEL


Reference


Summary table of human data on sub-chronic dermal toxicity




74






Value used in the risk assessment – Sub-chronic dermal toxicity

Value / conclusion

Justification

Data waiving


Justification


3.6.3. Sub-chronic inhalation toxicity


75


Summary table of animal studies on sub-chronic inhalation toxicity (usually 90-day studies)




NOAELLOAEL


Reference


Summary table of human data on sub-chronic inhalation toxicity




76



Value used in the risk assessment – Sub-chronic inhalation toxicity

Value / conclusion

Justification

Data waiving


Justification


3.6.4. Overall conclusion on sub-chronic repeated dose toxicity

Value used in the risk assessment – Sub-chronic repeated dose toxicity

Value

Justification



77


Value / conclusion used in the risk assessment – Sub-chronic repeated dose local effects

Value / conclusion

Justification



3.7. Long-term repeated dose toxicity3.7.1. Long-term oral toxicity


Summary table of animal studies on long-term oral toxicity




NOAELLOAEL


Reference

78



Summary table of human data on long-term oral toxicity





Value used in the risk assessment – Long-term oral toxicity

Value / conclusion

Justification

Data waiving


Justification

79



3.7.2. Long-term dermal toxicity


Summary table of animal studies on long-term dermal toxicity




NOAELLOAEL


Reference


Summary table of human data on long-term dermal toxicity




80






Value used in the risk assessment – Long-term dermal toxicity

Value / conclusion

Justification

Data waiving


Justification


3.7.3. Long-term inhalation toxicity


81


Summary table of animal studies on long-term inhalation toxicity




NOAELLOAEL


Reference


Summary table of human data on long-term inhalation toxicity




82



Value used in the risk assessment – Long-term inhalation toxicity

Value / conclusion

Justification

Data waiving


Justification


3.7.4. Overall conclusion on long-term repeated dose toxicity

Value used in the risk assessment – Long-term repeated dose systemic toxicity

Value

Justification



83


Value / conclusion used in the risk assessment – Long-term repeated dose local effects

Value / conclusion

Justification



3.8. Genotoxicity3.8.1. In vitro


Summary table of in vitro genotoxicity studies


Test substance,Doses

Relevant information about the study (e.g. cell type, strains)


Reference


84


Conclusion used in the risk assessment – Genotoxicity in vitro

Conclusion

Justification

Data waiving


Justification


3.8.2. In vivo


Summary table of in vivo genotoxicity studies



Relevant information about the study (e.g. species and strain, duration of exposure)

Observations Remarks (e.g. major deviations)

Reference

85




Relevant information about the study (e.g. species and strain, duration of exposure)

Observations Remarks (e.g. major deviations)

Reference


Summary table of human data on genotoxicity





Conclusion used in the risk assessment – Genotoxicity in vivo

Conclusion

86


Justification

Data waiving


Justification


3.8.3. Overall conclusion on genotoxicity

Conclusion used in the risk assessment – Genotoxicity

Conclusion

Justification



3.9. Carcinogenicity


87


Summary table of animal studies on carcinogenicity



Test substance,Dose levels,Route of exposure,Duration of exposure

NOAELLOAEL

Results (Please indicate any results that might suggest carcinogenic effects, as well as other toxic effects)


Reference


Summary table of human data on carcinogenicity





88


Conclusion used in the risk assessment – Carcinogenicity

Value / conclusion

Justification



Data waiving


Justification


3.10. Reproductive toxicity


89


3.10.1. Developmental toxicity

Summary table of animal studies on adverse effects on development




NOAELsLOAELs(also for maternal effects)


Reference


Summary table of human data on adverse effects on development





90


Conclusion used in the risk assessment –Effects on development

Value / conclusion

Justification

Data waiving


Justification


3.10.2. Fertility

Summary table of animal studies on adverse effects on fertility




NOAELsLOAELs


Reference

91





NOAELsLOAELs


Reference


Summary table of human data on adverse effects on fertility





Conclusion used in the risk assessment – Fertility

Value / conclusion

92


Justification

Data waiving


Justification


3.10.3. Effects on or via lactation

Summary table of animal studies on adverse effects on or via lactation




NOAELLOAEL


Reference


93


Summary table of human data on adverse effects on or via lactation





Conclusion used in the risk assessment – Effects on or via lactation

Value / conclusion

Justification

Data waiving


Justification


94


3.10.4. Overall conclusion on reproductive toxicity

Conclusion used in the risk assessment – Reproductive toxicity

Value

Justification



3.11. Neurotoxicity


Summary table of animal studies on neurotoxicity




NOAELLOAEL


Reference

95



Summary table of human data on neurotoxicity





Conclusion used in the risk assessment – Neurotoxicity

Value / conclusion

Justification

Data waiving


Justification

96



3.12. Immunotoxicity


Summary table of in vitro immunotoxicity studies




NOAELLOAEL


Reference


Summary table of animal studies on immunotoxicity




NOAELLOAEL


Reference

97



Summary table of human data on immunotoxicity





Conclusion used in the risk assessment – Immunotoxicity

Conclusion

Justification

Data waiving


Justification

98



3.13. Disruption of the endocrine system


Summary table of in vitro studies on endocrine disruption


Test substance,


Observations Results Remarks (e.g. major deviations)

Reference


Summary table of animal studies on endocrine disruption




NOAELLOAEL


Reference

99



Summary table of human data on endocrine disruption





Conclusion used in the risk assessment – Endocrine disruption

Conclusion

Justification

Data waiving


Justification

100



3.14. Further human data

[Include here only information that is not described elsewhere in sections 3.1 to 3.13. If no further data are available, delete the table and indicate only that no further data are available.]

Summary table of further human data





Conclusion used in the risk assessment – Further human data

Conclusion

Justification

3.15. Other data

[Include here only information that is not described elsewhere in sections 3.1 to 3.14, e.g. data on aspiration hazard if available. If no further data are available, delete the table and indicate only that no further data are available.]

101


Summary table of other data





Conclusion used in the risk assessment – Other data

Conclusion

Justification

102


4. Environmental effects assessment4.1. Fate and distribution in the environment4.1.1. Degradation

4.1.1.1. Abiotic degradation

HydrolysisSummary table – Hydrolysis


pH Temp (°C) Initial TS concentration, C0(mol/l)

Half-life, DT50(d)

Coefficient of correlation, r2

Remarks Reference

[Add / delete rows according to the number of studies. Please provide information (as free text) on breakdown products.]

Value used in the risk assessment – Hydrolysis

Value / conclusion

Justification

103


Data waiving


Justification


Phototransformation in waterSummary table – Photolysis in water


Initial molar TS concentration

Total recovery of test substance (% of appl. AS.)

Photolysis rate constant (kc

p)Direct photolysis sunlight rate constant (kpE)

Reaction quantum yield (φcE)

Half-life (t1/2E)

Remarks Reference

[Add / delete rows according to the number of studies. Please provide information (as free text) on breakdown products.]

Value used in the risk assessment – Photolysis in water

Value / conclusion

104


[Usually this endpoint is not used in the risk assessment; only relevant in very specific cases.]

Data waiving


Justification


Estimated photo-oxidation in airSummary table – Photo-oxidation in air

Model Light protection (yes/no)

Estimated daily (24h) OH concentration (OH/cm³)

Overall OH rate constant (cm³/molecule ec)

Half-life (hr) Reference


Value used in the risk assessment – Photo-oxidation in air

Value / conclusion

105


Justification

[Usually this endpoint is not used in the risk assessment; only relevant in very specific cases.]

Data waiving


Justification


4.1.1.2. Biotic degradation

4.1.1.2.1.Biodegradability (ready / inherent)Summary table – Biodegradation studies (ready / inherent)


Test typeaccording to OECD criteria

Test parameter

Inoculum: Type

Inoculum: Concentration

Inoculum: Adaptation

Additional substrate

Test substance conc.

Degradation: Incubation period

Degradation: Degree (%)

Remarks

Reference

106




Test parameter

Inoculum: Type







Remarks

Reference


Value used in the risk assessment – Biodegradation studies (ready / inherent)

Value / conclusion

Justification

Data waiving


Justification


107


4.1.1.3. Rate and route of degradation including identification of metabolites and degradation products

4.1.1.3.1.Biological sewage treatmentAerobic biodegradationSummary table – STP aerobic biodegradation



Test parameter

Inoculum: Type







Remarks

Reference


Value used in the risk assessment – STP aerobic biodegradation

Value / conclusion

Justification

108


Data waiving


Justification


Anaerobic biodegradationSummary table – STP anaerobic biodegradation



Test parameter

Inoculum: Type







Remarks

Reference


109


Value used in the risk assessment – STP anaerobic biodegradation

Value / conclusion

Justification

Data waiving


Justification


STP simulation testSummary table – STP simulation test


Test type(according to OECD criteria)

Test parameter

Inoculum: Type







Remarks

Reference

110




Test parameter

Inoculum: Type







Remarks

Reference


Value used in the risk assessment – STP simulation test

Value / conclusion

Justification

Data waiving


Justification


111


4.1.1.3.2.Biodegradation in freshwaterAerobic aquatic degradationSummary table – Freshwater aerobic biodegradation



Exposure Test substance conc.

Incubation period Degradation (DT50) Remarks Reference


Value used in the risk assessment – Freshwater aerobic biodegradation

Value / conclusion

Justification

Data waiving


112


Justification


Water / sediment degradation testSummary table – Freshwater / sediment degradation



Exposure Test system: Water

Test system: Sediment


Incubation period

Degradation (DT50)

Remarks Reference


Value used in the risk assessment – Freshwater / sediment degradation

Value / conclusion

Justification

113


Data waiving


Justification


4.1.1.3.3.Biodegradation in seawaterSeawater degradation studySummary table – Seawater aerobic biodegradation



Exposure Test substance conc.

Incubation period Degradation (DT50) Remarks Reference


114


Value used in the risk assessment – Seawater aerobic biodegradation

Value / conclusion

Justification

Data waiving


Justification


Seawater / sediment degradation studySummary table – Seawater / sediment degradation



Exposure Test system: Water

Test system: Sediment


Incubation period

Degradation (DT50)

Remarks Reference

115



Value used in the risk assessment – Seawater / sediment degradation

Value / conclusion

Justification

Data waiving


Justification


4.1.1.3.4.Higher tier degradation studies in water or sediment

[Since higher tier studies can have a very specific study design, no general template is provided. Please use the table provided under 4.1.1.3.3. and adapt it according to the respective study design.]

116


4.1.1.3.5.Biodegradation during manure storageSummary table – Biodegradation during manure storage



Test parameter

Inoculum: Type







Remarks

Reference


Value used in the risk assessment – Biodegradation during manure storage

Value / conclusion

Justification

Data waiving


117


Justification


4.1.1.3.6.Biotic degradation in soil4.1.1.3.6.1. Laboratory soil degradation studiesAerobic biodegradationSummary table – Aerobic biodegradation in soil – laboratory study



Exposure Test system: Soil origin

Test system: Soil type

Test system: pH

Test system: OC %


Incubation period

Degradation (DT50)

Remarks Reference


Value used in the risk assessment – Aerobic biodegradation in soil

Value / conclusion

118


Justification

Data waiving


Justification


Anaerobic biodegradationSummary table – Anaerobic biodegradation in soil – laboratory study



Exposure Test system: Soil origin

Test system: Soil type

Test system: pH

Test system: OC %


Incubation period

Degradation (DT50)

Remarks Reference


119


Value used in the risk assessment – Anaerobic biodegradation in soil

Value / conclusion

Justification

Data waiving


Justification


4.1.1.3.6.2. Higher tier degradation studies in soil

[Since higher tier degradation studies can have a very specific study design, in the following only a table for field dissipation studies is provided. In case of additional higher tier studies please use this table as basis and adapt it according to the respective study design.]

120


Field dissipation studies (field studies, two soil types)Summary table – Field dissipation



Site Application rate (g AS/ha)

Surface Soil type Soil texture

Test duration

Degradation (DT50)

Degradation (DT90)

Remarks Reference

<Soil 1>

<Soil 2>

<Soil 3>


Value used in the risk assessment – Field dissipation

Value / conclusion

Justification

121


Data waiving


Justification


4.1.2. Distribution

4.1.2.1. Adsorption onto / desorption from soils

Summary table – Adsorption / desorption


Soil Adsorbed AS (%)

Ka KaOC Kd

KdOC

Ka/Kd

Kf 1/n Remarks Reference

<Soil 1>

<Soil 2>

<Soil 3>

Ka = Adsorption coefficient

KaOC = Adsorption coefficient based on organic carbon content

122


Kd = Desorption coefficient

KdOC = Desorption coefficient based on organic carbon content

Ka/ Kd = Adsorption / Desorption distribution coefficient


Summary table – Adsorption / desorption metabolite / transformation or reaction product


Soil % of AS Ka KaOC Kf l/n Kd

KdOC

Ka/Kd

Remarks Reference

<Soil 1>

<Soil 2>

<Soil 3>

Ka = Adsorption coefficient

KaOC = Adsorption coefficient based on organic carbon content

Kd = Desorption coefficient

KdOC = Desorption coefficient based on organic carbon content

123


Ka/ Kd = Adsorption / Desorption distribution coefficient

[Please insert a table for each metabolite. If not relevant, delete the table.]

Value used in the risk assessment – Adsorption / desorption

Value / conclusion

Justification

Data waiving


Justification


4.1.2.2. Higher tier soil adsorption studies

[Since higher tier studies like column leaching studies, lysimeter studies or field leaching studies can have a very specific study design, no general template is provided. Please use the table provided under 4.1.2.1 and adapt it according to the respective study design.]

124


4.1.3. Bioaccumulation

Measured aquatic bioconcentrationSummary table – Measured aquatic bioconcentration


Exposure

Log Kow of AS

Initial concentration of AS

Steady state BCF

Uptake rate constant (K1)

Depur. rate constant (K2)

Depur. time (DT50)

Metabolites

Remarks

Reference


Value used in the risk assessment – Measured aquatic bioconcentration

Value / conclusion

Justification

125


Data waiving


Justification


Estimated aquatic bioconcentrationSummary table – Measured aquatic bioconcentration

Basis for estimation Log Kow (measured) Estimated BCF for fish (freshwater)

Estimated BCF for fish eating bird / predator

Remarks Reference


Value used in the risk assessment – Measured aquatic bioconcentration

Value / conclusion

126


Justification

Data waiving


Justification


Measured terrestrial bioconcentrationSummary table – Measured terrestrial bioconcentration


Exposure

Log Kow of AS

Initial concentration of AS

Steady state BCF

Uptake rate constant (K1)

Depur. rate constant (K2)

Depur. time (DT50)

Metabolites

Remarks

Reference


127


Value used in the risk assessment – Measured terrestrial bioconcentration

Value / conclusion

Justification

Data waiving


Justification


Estimated terrestrial bioconcentrationSummary table – Estimated terrestrial bioconcentration

Basis for estimation

Log Kow (measured)

Estimated BCF for terrestrial food chain I: Soil dwelling species

Estimated BCF for terrestrial food chain I: Predatory bird / vertebrate

Estimated BCF for terrestrial food chain II: Terrestrial plant

Estimated BCF for terrestrial food chain II: Grazing non-target organism

Remarks Reference

128


Basis for estimation

Log Kow (measured)

Estimated BCF for terrestrial food chain I: Soil dwelling species

Estimated BCF for terrestrial food chain I: Predatory bird / vertebrate

Estimated BCF for terrestrial food chain II: Terrestrial plant

Estimated BCF for terrestrial food chain II: Grazing non-target organism

Remarks Reference


Value used in the risk assessment – Estimated terrestrial bioconcentration

Value / conclusion

Justification

Data waiving


Justification


129


4.1.4. Monitoring data

<If monitoring data in any environmental compartment are available, please describe them here.>

4.2. Effects on environmental organisms4.2.1. Atmosphere

<Include text here if relevant.>

4.2.2. Sewage treatment plant (STP)

Inhibition of microbial activity (aquatic)Summary table – Inhibition of microbial activity


Species / Inoculum

Endpoint Exposure: Design

Exposure: Duration

Results: EC20

Results: EC50

Results: EC80 Remarks Reference


Value used in the risk assessment – Inhibition of microbial activity

Value / conclusion

130


Justification

Data waiving


Justification


4.2.3. Aquatic compartment

4.2.3.1. Freshwater compartment

Acute toxicity (freshwater)Summary table – Acute aquatic toxicity (freshwater) – Fish


Species Endpoint Exposure: Design

Exposure: Duration

Results: LC/EC0

Results: LC/EC50

Results: LC/EC100

Remarks Reference

131



Summary table – Acute aquatic toxicity (freshwater) – Invertebrates



Exposure: Duration

Results: LC/EC0

Results: LC/EC50

Results: LC/EC100

Remarks Reference


Summary table – Acute aquatic toxicity (freshwater) – Algae (growth inhibition)



Exposure: Duration

Results: NOErC

Results: ErC50 (calculated from the area under the growth curve)

Results: ErC50 (calculated from growth rate)

Remarks Reference

132




Exposure: Duration

Results: NOErC

Results: ErC50 (calculated from the area under the growth curve)

Results: ErC50 (calculated from growth rate)

Remarks Reference


Value used in the risk assessment – Acute aquatic toxicity (freshwater)

Value / conclusion

Justification

[May not be relevant if chronic data are available. Please indicate accordingly.]

Data waiving


Justification

133



Chronic toxicity (freshwater)Summary table – Chronic aquatic toxicity (freshwater) – Fish


Species Endpoint / Type of test

Exposure: Design

Exposure: Duration ResultsLOEC / NOEC / EC10

Remarks Reference


Summary table – Chronic aquatic toxicity (freshwater) – Invertebrates



Exposure: Design


Remarks Reference

134



Summary table – Chronic aquatic toxicity (freshwater) – Other aquatic plants



Exposure: Design


Remarks Reference


Value used in the risk assessment – Chronic aquatic toxicity (freshwater)

Value / conclusion

Justification

[If necessary, please include a discussion on pooling data (freshwater / seawater) or discussion on SSD here.]

Data waiving


135


Justification


4.2.3.2. Sediment compartment

Acute toxicity (freshwater sediment)Summary table – Acute toxicity to sediment dwelling organisms (freshwater)



Exposure: Duration

Results: LC/EC0

Results: LC/EC50

Results: LC/EC100

Remarks Reference


Value used in the risk assessment – Acute toxicity to sediment dwelling organisms (freshwater)

Value / conclusion

Justification

136



Data waiving


Justification


Chronic toxicity (freshwater sediment)Summary table – Chronic toxicity to sediment dwelling organisms (freshwater)



Exposure: Design


Remarks Reference


137


Value used in the risk assessment – Chronic toxicity to sediment dwelling organisms (freshwater)

Value / conclusion

Justification


Data waiving


Justification


138


4.2.3.3. Marine compartment

Acute toxicity (seawater)Summary table – Acute aquatic toxicity (seawater)



Exposure: Duration

Results: LC/EC0

Results: LC/EC50

Results: LC/EC100

Remarks Reference


Value used in the risk assessment – Acute aquatic toxicity (seawater)

Value / conclusion

Justification


139


Data waiving


Justification


Chronic aquatic toxicity (seawater)Summary table – Chronic aquatic toxicity (seawater)



Exposure: Design


Remarks Reference


Value used in the risk assessment – Chronic aquatic toxicity (seawater)

Value / conclusion

140


Justification


Data waiving


Justification


4.2.3.4. Sea sediment compartment

Acute toxicity (sea sediment)Summary table – Acute toxicity to sea sediment dwelling organisms



Exposure: Duration

Results: LC/EC0

Results: LC/EC50

Results: LC/EC100

Remarks Reference

141



Value used in the risk assessment – Acute toxicity to sediment dwelling organisms (freshwater)

Value / conclusion

Justification


Data waiving


Justification


142


Chronic toxicity (sea sediment)Summary table – Chronic toxicity to sea sediment dwelling organisms



Exposure: Design


Remarks Reference


Value used in the risk assessment – Chronic toxicity to sea sediment dwelling organisms

Value / conclusion

Justification


Data waiving


143


Justification


4.2.3.5. Higher tier studies on aquatic organisms

[Since higher tier studies like mesocosm studies can have a very specific study design, no general template is provided. Please use the table provided under 4.1.3.1 and adapt it according to the respective study design.]

4.2.4. Terrestrial compartment

Toxicity to terrestrial organisms, acute testsSummary table – Acute terrestrial toxicity – Earthworm / soil dwelling non-target invertebrates



Exposure: Design

Exposure: Duration

Organic matter (mg/Kg dw)

Results (in dry weight): LC/EC0



Remarks Reference


144


Summary table – Acute terrestrial toxicity – Soil microflora



Exposure: Design

Exposure: Duration





Remarks Reference


Summary table – Acute terrestrial toxicity – Non-target plants



Exposure: Design

Exposure: Duration





Remarks Reference

145



Summary table – Acute terrestrial toxicity – Bees and other (non-target) arthropods



Exposure: Design

Exposure: Duration





Remarks Reference


Value used in the risk assessment – Acute terrestrial toxicity

Value / conclusion

Justification


146


Data waiving


Justification


Toxicity to terrestrial organisms, chronic testsSummary table – Chronic terrestrial toxicity – Earthworm / soil dwelling non-target invertebrates reproduction


Species Endpoint / Type of test Exposure: Design Exposure: Duration ResultsLOEC / NOEC / EC10

Remarks Reference


147


Summary table – Chronic terrestrial toxicity – Non-target plants



Remarks Reference


Summary table – Chronic terrestrial toxicity – Bees and other (non-target) arthropods



Remarks Reference


148


Value used in the risk assessment – Chronic terrestrial toxicity

Value / conclusion

Justification

Data waiving


Justification


4.2.5. Groundwater

[Please include any tests or monitoring data in groundwater here.]

149


4.2.6. Birds and mammals

Summary table – Toxicity to birds and mammals



Exposure: Duration

Results (mg a.i./kg bw or feed): LD/LC0

Results (mg a.i./kg bw or feed): LOEL/LOEC

Results (mg a.i./kg bw or feed): NOEL/NOEC

Remarks Reference


Value used in the risk assessment – Toxicity to birds and mammals

Value / conclusion

Justification

Data waiving


150


Justification


4.2.7. Primary and secondary poisoning

Summary table – Primary poisoning



Duration Remarks Reference


Value used in the risk assessment – Primary poisoning

Value / conclusion

Justification

151


Data waiving


Justification


Summary table – Secondary poisoning



Duration Remarks Reference


Value used in the risk assessment – Secondary poisoning

Value / conclusion

152


Justification

Data waiving


Justification


<Waiving example: Substance is unlikely to bioaccumulate in aquatic or terrestrial environment according to the TGD: It has a low log Kow (x.xx), it is not highly adsorptive, it does not belong to a class of substances known to have a potential to accumulate in living organisms, its structural features does not indicate accumulation and it is readily biodegradable and has a short degradation half-life of 11 h in the water/sediment test. The low accumulation potential is supported by low BCF and BMF for fish and earthworms determined by EUSES 2.1.2. The bioconcentration factor for fish is x.xx l/kg and a default BMF of 1. The bioconcentration factor for earthworms is x.xx l/kg and a default BMF of 1. No further assessment of secondary exposure via the food chain is therefore considered necessary.>

4.3. Endocrine disrupting propertiesSummary table of ecotoxicological data on endocrine disruption (GB endocrine disrupting criteria)


Species,Strain,Sex,No / group



Reference

153






Reference

[Add / delete rows according to the number of studies. If not relevant, delete the table.]

Conclusion used in the risk assessment – Endocrine disruption

Conclusion

Justification

Data waiving


Justification


4.4. Derivation of PNECs

154


Compartment PNEC Remarks / Justification

<Freshwater> <PNECfreshwater: xx.x mg/L> Organism: <Fish (O. mykiss)>

Endpoint: LC50 (96 h): <0.52 mg/l>

Assessment factor: <1000>

Extrapolation method: <assessment factor (alternative: partitioning coefficient)>

Justification: <Since the three taxonomic groups (fish, invertebrates, algae) are covered but only short-term toxicity data are available for fish and invertebrates, an assessment factor of 1000 is applied.>

Organism:

Endpoint:

Assessment factor:

Extrapolation method:

Justification:

155


Compartment PNEC Remarks / Justification

Organism:

Endpoint:

Assessment factor:


Justification:

Organism:

Endpoint:

Assessment factor:


Justification:

[Include relevant environmental compartments or species for which PNECs have been derived.]

156


5. Assessment of exclusion criteria, substitution criteria and POP5.1. Exclusion criteria5.1.1. Assessment of CMR properties

Criteria (GB BPR Article 5 (1)) Assessment

Active substances that have been classified in accordance with GB CLP as, or that meet the criteria to be classified as, carcinogen category 1A or 1B

<Active substance is not classified and does not meet the criteria to be classified as Carc. Cat. 1A or 1B.>

Active substances that have been classified in accordance with GB CLP as, or that meet the criteria to be classified as, mutagen category 1A or 1B

<Active substance is not classified and does not meet the criteria to be classified as Muta. Cat. 1A or 1B.>

Active substances that have been classified in accordance with GB CLP as, or that meet the criteria to be classified as, toxic for reproduction category 1A or 1B

<Active substance is not classified and does not meet the criteria to be classified as Repr. Cat. 1A or 1B.>

Conclusion on CMR properties

<The exclusion criteria in BPR Article 5 (1) (a) – (c) are not met.>

5.1.2. Assessment of endocrine disrupting properties

Criteria Assessment

Active substances that, on the basis of GB endocrine disrupting criteria, are considered as having endocrine-disrupting properties that may cause adverse effects in humans and to the environment.

<The new criteria must be satisfied.>

157


Criteria Assessment

Active substances that are classified in accordance with GB CLP as, or meet the criteria to be classified as, carcinogen category 2 and toxic for reproduction category 2.(Such substances shall be considered as having endocrine disrupting properties.)

<Active substance is not classified and does not meet the criteria to be classified as Carc Cat. 2.

Active substance is not classified and does not meet the criteria to be classified as Repr. Cat. 2>.

Substances such as those that are classified in accordance with GB CLP as, or that meet the criteria to be classified as, toxic for reproduction category 2 and that have toxic effects on the endocrine organs.(Such substances may be considered as having endocrine disrupting properties.)

< Active substance is not classified and does not meet the criteria to be classified as Repr. Cat. 2.

Active substance has not been shown to have toxic effects on endocrine organs.>

Active substances that are identified in accordance with GB endocrine disrupting criteria as having endocrine disrupting properties.

<Active substance has not been identified as having endocrine disrupting properties.>

Conclusion on ED properties

<The exclusion criteria in BPR Article 5 (1) (d) are not met.>

5.1.3. PBT Assessment (following Annex XIII to GB REACH)

Assessment of persistenceScreening

[Include a persistence assessment based on the criteria for identification of persistent or very persistent substances based on GB REACH Annex XIII and summarised in the tables below.

In this context it is important to note that a substance may consist of more than one constituent or that it may form transformation or degradation products. If the substance contains one or more constituents with PBT / vPvB properties in individual amounts ≥ 0.1 % (w/w) or if transformation / degradation products with the respective properties in individual amounts ≥ 0.1 % are being generated, the substance must be treated like a PBT / vPvB.]

158


Assessment

P Criteria Assessment

T1/2 > 60 days in seawater; or

T1/2 > 40 days in fresh or estuarine water; or

T1/2 > 180 days in seawater sediment; or

T1/2 > 120 days in freshwater or estuarine sediment; or

T1/2 <= 120 days in soil.

P Criteria Assessment

T1/2 > 60 days in sea, fresh or estuarine water; or

T1/2 > 180 days in sea, freshwater or estuarine sediment; or

T1/2 > 180 days in soil.

Conclusion on P / vP properties

<The criteria for P / vP are not met.>

159


Assessment of bioaccumulationScreening[Include assessment of screening information provided in GB REACH Annex XIII:

Octanol-water partitioning coefficient experimentally determined or estimated by (Q)SAR models

Other information provided that its suitability and reliability can be reasonably demonstrated.]

Assessment

B Criteria Assessment

BCF > 2000

vB Criteria Assessment

BCF > 5000

Conclusion on B / vB properties

<The criteria for B / vB are not met.>

Assessment of toxicityScreening[Include assessment of screening information provided in GB REACH Annex XIII:

Short-term aquatic toxicity in accordance with Section 9.1 of Annex VII and Section 9.1.3 of Annex VIII;

Other information provided that its suitability and reliability can be reasonably demonstrated.]

Assessment

T Criteria Assessment

NOEC/EC10 (long-term) < 0.01 mg/L for freshwater or seawater organisms; or

160


T Criteria Assessment

substance meets the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to GB CLP; or

there is other evidence of chronic toxicity, as identified by the substance meeting the criteria for classification as specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to GB CLP.

Conclusion on T properties

<The criteria for T are not met.>

Summary and overall conclusions on PBT or vPvB propertiesOverall conclusion:

<Based on the assessment described in the subsections above the submission substance is not a PBT / vPvB substance.>

5.2. Substitution criteria

[Include an assessment if the active substance meets any of the following conditions:]

Substitution criteria (GB BPR, Article 10)

Assessment

One of the exclusion criteria listed in Article 5 (1) is met but AS may be approved in accordance with Article 5 (2).

The criteria to be classified, in accordance with GB CLP, as a respiratory sensitiser is met.

161


Substitution criteria (GB BPR, Article 10)

Assessment

The acceptable daily intake, acute reference dose or acceptable operator exposure level, as appropriate, is significantly lower than those of the majority of approved active substances for the same product-type and use scenario.

Two of the criteria for being PBT in accordance with Annex XIII to GB REACH are met.

There are reasons for concern linked to the nature of the critical effects that, in combination with the use patterns, amount to use that could still cause concern, such as high potential of risk to groundwater, even with very restrictive risk management measures.

The AS contains a significant proportion of non-active isomers or impurities.

Conclusion on substitution criteria

<The substitution criteria in GB BPR Article 10 (1) (a) – (f) are not met.>

5.3. Assessment of long-range environmental transportation and impact on environmental compartments

Assessment

The active substance or a degradation product is a persistent organic pollutant (POP) listed in Annex I of EC 850/2004 as it applies in Great Britain (GB POP).

162


Assessment

Assessment of long-range transport potential (LRTAP):

Vapour pressure <1000 Pa

and

half-life in air > 2 days; or

Monitoring data in remote area showing that the substance is found in remote regions; or

Result of multi-media modelling.

The active substance or a degradation product is vP/vB or T.

Conclusion on LRTAP / POP assessment

163


Part B – Exposure assessment and effects of the active substance in the biocidal product(s)6. General product information6.1. Identification of the productName(s) of the product

Trade name(s) or proposed trade name(s)

Manufacturer’s development code and number of the product

Formulation type

6.2. Complete qualitative and quantitative composition of the biocidal product

Active substance(s)

ISO or trivial name

IUPAC name or other accepted chemical name

CAS number

EC number Composition / all constituents (upper and lower concentration limit in % w/w/)

Concentration in the product in % w/w)

[Add / delete rows as required.]

[Include here a note if this information will be included in the confidential annex.]

164


Other components / ingredients of the product

ISO or trivial name

IUPAC name or other accepted chemical name

CAS number

EC number Concentration in the product in % w/w)

Function


[Include here a note if this information will be included in the confidential annex.]

165


6.3. Physical, chemical and technical propertiesGeneral properties


Remarks / Discussion / Justification for waiving

References

Physical state at 20°C and 101.3 kPa

Colour at 20°C and 101.3 kPa

Odour at 20°C and 101.3 kPa

Acidity / alkalinity

Relative density

166


Storage stability, stability and shelf-life



References

Accelerated storage

Long term storage at ambient temperature

Low temperature stability (liquids)

Effects on content of the active substance



References

Light

Temperature and humidity

167




References

Reactivity towards container material

Technical characteristics



References

Wettability

Suspensibility, spontaneity and dispersion stability

Wet sieve analysis and dry sieve test

Emulsifiability, re-emulsifiability and emulsion stability

168




References

Disintegration time

Particle size distribution, content of dust / fines, attrition, friability

Persistent foaming

Flowability, pourability, dustability

Burning rate – smoke generators

Burning completeness – smoke generators

Composition of smoke – smoke generators

169




References

Spraying pattern - aerosols

Other technical characteristics

Physical and chemical compatibility with other products including other biocidal products with which its use is to be authorised



References

Physical compatibility

Chemical compatibility

Degree of dissolution and dilution stability

Surface tension

170




References

Viscosity

Physical hazards and characteristics



References

Explosives

Flammable gases

Flammable aerosols

Oxidising gases


Flammable liquids

171




References

Flammable solids

Self-reactive substances and mixtures

Pyrophoric liquids

Pyrophoric solids

Substances and mixtures that in contact with water emit flammable gases

Oxidising liquids

Oxidising solids

172




References

Organic peroxides

Corrosive metals

Auto-ignition temperature of products (liquid and gas)

Relative self-ignition temperature of solids

Dust explosion hazard

173


6.4. Hazard identification for physical and chemical properties

<Please include a summary on the hazard identification for physical-chemical properties.>

174


6.5. Analytical methods for detection and identification

<Description of analytical methods used for the analysis of the active substance as manufactured including impurities and additives.>

Analytical methods for the analysis of the product as such, including the active substance, impurities and residues

Analyte (type of analyte e.g. active substance)

Analytical method

Fortification range / Number of measurements

Linearity Specificity Recovery rate (%): Range



Limit of quantification (LOQ) or other limits

Reference

[Add /delete rows as required.]

175


Analytical methods for monitoring


Analytical method






Reference


Analytical methods for soil


Analytical method






Reference

176



Analytical method






Reference


Analytical methods for air


Analytical method






Reference

177



Analytical methods for water


Analytical method






Reference


178


Analytical methods for monitoring of active substances and residues in food and feeding stuffs


Analytical method






Reference


179


7. Efficacy7.1. EfficacyExperimental data on the efficacy of the biocidal product against target organism(s)

Function Field of use envisaged

Test substance Test organism(s)

Test method Test system / concentrations applied / exposure time

Test results: effects

Reference


Data waiving


Justification


180


7.2. Mode of action

<Please include any information on the mode of action.>

7.3. Resistance

<Please include any information on resistance.>

7.4. Conclusion on efficacy

<Please include a brief conclusion.>

181


8. Human exposure assessment8.1. Identification of main paths of human exposure towards the active

substance from its use in the biocidal productSummary table – Relevant paths of human exposure – Primary (direct) exposure

Exposure path Industrial use Professional use General public use

Inhalation

Dermal

Oral

[Please indicate the main paths of human exposure by stating “yes”,“no” or “n.a.” (not applicable) for each cell.]

Summary table – Relevant paths of human exposure – Secondary (indirect) exposure

Exposure path

Industrial use Professional use

General public bystanders

Via food

Inhalation

Dermal

Oral

[Please indicate the main paths of human exposure by stating “yes”,“no” or “n.a.” (not applicable) for each cell.]

8.2. List of scenarios

[This list should contain all scenarios for industrial, professional, general public use and secondary exposure, but exclude dietary exposure that is covered in Chapter 8.7.]

182


Summary table – Exposure scenarios

Scenario number

Scenario (e.g. mixing / loading)

Primary or secondary exposureDescription of scenario

Exposed group (e.g. professionals, general public users, bystanders)

1.

2.

[Add / delete rows as required. Include all scenarios in this table and then refer to them by their running number given in column 1. If exposure may take place to one person performing different tasks, please include a separate scenario for each type of (sub)task. If the same people may be exposed in several scenarios, there may be the need to evaluate the combined exposure occurring when performing these tasks.]

8.3. Industrial user exposure8.3.1. Scenario (n)

[Industrial users use biocides in the course of their job or business and they have received suitable information, instruction and training in their use. Industrial users are involved in manufacturing, handling and / or packaging of actives or products in industry and in producing end-products containing biocidal products.

Please include a section for each scenario where primary or secondary industrial exposure is foreseen. If no industrial exposure is foreseen, then only indicate this and delete the tables and text.]

Description of Scenario (n)

<Please give detailed information on the scenario and tasks, exposed worker, application method, indoor and / or outdoor use; frequency and (route specific) duration of exposure; concentration of active substance in product; absorption values (or equivalent) and any other variables and assumptions used in the calculations. Indicate the model / tool / software / database used.>

Tier Parameters Value

Tier 1

Tier 2

Tier 3

183



Reverse reference scenario

[Add / delete rows as required. Output tables from exposure assessment tools may also be included to replace or to complement the table.]

[Include generic parameters (e.g. respiration rates, exposed skin areas, exposure times) and protection / penetration rates for PPE. Use footnotes for references and justifications.]

[For each Tier, only include the parameters changed with respect to the previous Tier.]

Calculations for Scenario (n)

[Please include any relevant calculations here or in Appendix II. If not relevant, delete the title.]

Summary table – Systemic exposure from industrial uses

Exposure scenario

Tier / PPE Estimated inhalation uptake

Estimated dermal uptake

Estimated total uptake

Scenario (n)

Scenario (n)

[Add / delete rows as required. Output tables from exposure assessment tools may be included to complement the table.]

Further information and consideration on Scenario (n)

[Please include relevant information and considerations not covered above, e.g. information relevant for risk characterisation for local effects. If not relevant, delete the title.]

184


8.3.2. Combined scenarios

Summary table – Combined systemic exposure from industrial uses

Scenarios combined

Estimated inhalation uptake



Scenarios (n….)

Scenarios (n…..)


[Please include the Tier where relevant.]

8.4. Professional user exposure8.4.1. Scenario (n)

[Professional users use biocides in the course of their job or business and they have received suitable information, instruction and training in their use. Professional users use end-products outside industry.

Please include a section for each scenario where primary or secondary professional exposure is foreseen. If no professional exposure is foreseen, then only indicate this and delete the tables and text.]




Tier 1

Tier 2

Tier 3

185





[Include generic parameters (e.g. generic parameters and protection / penetration rates for PPE.) Use footnotes for references and justifications.]




Summary table – Systemic exposure from professional uses

Exposure scenario




Scenario (n)

Scenario (n)




186



Summary table – Combined systemic exposure from professional uses

Scenarios combined




Scenarios (n….)

Scenarios (n…..)



8.5. General public user exposure8.5.1. Scenario (n)

[General public users use biocides in their own homes / for personal use. They have not received specific instruction and training in their use.

Please include a section for each scenario where primary or secondary general public user exposure is foreseen. If no general public user exposure is foreseen, then only indicate this and delete the tables and text.]


<Please give detailed information on the scenario and tasks, exposed general public user, application method, indoor and / or outdoor use; frequency and (route specific) duration of exposure; concentration of active substance in product; absorption values (or equivalent) and any other variables and assumptions used in the calculations. Indicate the model / tool / software / database used.>


Tier 1

Tier 2

Tier 3

187





[Include generic parameters (e.g. generic parameters and protection / penetration rates for PPE if relevant.) Use footnotes for references and justifications.]




Summary table – Systemic exposure from general public uses

Exposure scenario




Scenario (n)

Scenario (n)




188



Summary table – Combined systemic exposure from general public uses

Scenarios combined




Scenarios (n….)

Scenarios (n…..)



8.6. Secondary exposure of the general public (bystanders) excluding dietary exposure

8.6.1. Scenario (n)

[Secondary exposure to the general public as bystanders may occur from use by any user group.

Please include a section for each scenario where secondary general public bystander exposure is foreseen. If no general public bystander exposure is foreseen, then only indicate this and delete the tables and text.]


<Please give detailed information on the scenario and tasks, exposed general public bystanders, application method, indoor and / or outdoor use; frequency and (route specific) duration of exposure; concentration of active substance in product; absorption values (or equivalent) and any other variables and assumptions used in the calculations. Indicate the model / tool / software / database used.>


Tier 1

Tier 2

Tier 3

189





[Include generic parameters (e.g. generic parameters and protection / penetration rates for PPE if relevant.) Use footnotes for references and justifications.]




Summary table – Systemic secondary exposure of general public bystanders

Exposure scenario



Estimated oral uptake


Scenario (n)

Scenario (n)




190



Summary table – Combined systemic secondary exposure of general public bystanders

Scenarios combined





Scenarios (n….)

Scenarios (n…..)



8.7. Dietary exposure

[Please include a section for each scenario where food, drinking water or livestock exposure is foreseen. If no exposure is foreseen, then only indicate this and delete the tables and text.]

8.7.1. List of scenarios

Summary table of main representative dietary exposure scenarios

Scenario number

Type of use (e.g. animal husbandry, food industry, professional use, residential use)

Description of scenario

Subject of exposure (e.g. chicken, milk, beer)

1.

2.

[Add / delete rows as required. Include all scenarios in this table and then refer to them by their running number given in column 1. Do not use the same numbers already used in Chapter 8.2 List of scenarios.]

8.7.2. Information on non-biocidal use of the active substance

[Please include a section for each area of other (non-biocidal) use of the active substance. Add / delete rows as required.]

191


Summary table of other (non-biocidal uses)

Use number Sector of use (e.g. plant protection products, veterinary use food or feed additives)

Intended use Reference value(s) (e.g. MRLs – use footnotes for references))

1.

2.

8.7.3. Estimating livestock exposure to active substances used in biocidal products

8.7.3.1. Scenario (n)

[Please include a section for each relevant scenario. If not relevant, then only indicate this and delete the tables and text.]


<Please give detailed information on the scenario; concentration of active substance in product and any other variables and assumptions used in the calculations.>


Tier 1

Tier 2

Tier 3



[Include generic parameters Use footnotes for references and justifications.]


192




Summary table – Internal dose received by the animal and WCCE*

<Indicate the model / calculations / database used.>

Exposure scenario

Parameters Inhalation exposure

Dermal exposure

Oral exposure

WCCE

Scenario (n)

Scenario (n)

*Worst case consumer exposure: combined estimate of the internal dose with the standard food basket (300 g muscle, 100 g liver, 50 g fat, 50 g kidney, plus 1500 g milk, 100 g eggs and 20 g honey).


[Describe the parameters used to derive the WCCE. Use footnotes for references and justifications.]


[Please include relevant information and considerations not covered above. If not relevant, delete the title.]

Conclusion

<Please give a brief conclusion on the acceptability of the scenario.>

8.7.4. Estimating transfer of biocidal active substances into foods as a result of professional and / or industrial application(s)

8.7.4.1. Scenario (n)

<Please include for each intended representative use scenario a description of scenario; assumptions, parameters and data used for exposure estimation, including refinements if applicable; calculations and result.>

Conclusion

<Please give a brief conclusion on the acceptability of the scenario.>

8.8. Exposure associated with the production, formulation and disposal of 193


the biocidal product8.8.1. Scenario (n)

[Please include a section for each relevant scenario. If not relevant, delete the title.]




Tier 1

Tier 2

Tier 3



[Include generic parameters (e.g. respiration rates, exposed skin areas, exposure times) and protection/penetration rates for PPE.) Use footnotes for references and justifications.]




194


Summary table – Systemic exposure associated with production, formulation and disposal

Exposure scenario





Scenario (n)

Scenario (n)





Summary table – Combined systemic exposure associated with production, formulation and disposal

Scenarios combined





Scenarios (n….)

Scenarios (n…..)



8.9. Combined residential scenarios

[Please include any combined residential uses, e.g. general public dietary exposure in combination with other general public user exposure or secondary exposure. Please delete this chapter if not used.]

195


9. Environmental exposure assessment

[If several PTs are considered, please repeat the following chapters per PT accordingly.]

General information

Assessed PT <PT 2>

Assessed scenarios

<Scenario 1: Disinfection of rooms, furniture and objects>

<Scenario 2: Disinfection of instruments>

ESD(s) used <Emission Scenario Document for Product Type 2: Private and public health area disinfectants and other biocidal products (sanitary and medical sector), March 2001>

Approach [Please indicate per scenario if the approach is tonnage based, average consumption based or, if both are not applicable, describe the approach chosen.]

<Scenario 1: Average consumption>

<Scenario 2: Average consumption>

Distribution in the environment

<Calculated based on TGD 2003 (alternative: based on measured data>)

Groundwater simulation

[Please indicate per scenario if any simulation for leaching to groundwater using a higher tier model like e.g. one of the FOCUS models was performed.]

Confidential annexes

<NO / YES: In the confidential Annex VI to Part B the tonnage based scenarios 2 and 3 are provided>

Life-cycle steps assessed

Scenario n:

Production: <Yes/No>

Formulation: <Yes/No>

Use: <Yes/No>

Service life: <Yes/No>

196


Remarks

Biocidal product specific data

<Please include here additional product specific data that may influence the fate, distribution or the toxicity of the active substance (e.g. results of leaching tests).>

9.1. Emission estimation9.1.1. Scenario (n)

[Please include a section for each scenario per PT per life cycle step.]

[Please note only the values that have been included as “Set values” in the emission scenario, default values that are under discussion or when it is possible to choose between different default values should be stated in the table.]

Input parameters for calculating the local emission – Scenario: <Disinfection of rooms, furniture and objects>

Input Value Unit Remarks

Application rate of biocidal product(alternative: annual tonnage in GB)

l/m²

Concentration of active substance in the product

g/l

[Add / delete rows according to the number of relevant set values or other necessary input parameters depending on the scenario chosen.]


[Please include any relevant calculations here or in Appendix [III.] . If not relevant, delete the title.]

197


Resulting local emission to relevant environmental compartments

Compartment Local emission (Elocalcompartment) (kg/d)

Remarks

Freshwater

Sediment

Seawater

Seawater sediment

STP

Air

Soil

Groundwater

[Add / delete additional compartments if relevant.]

198


9.2. Fate and distribution in exposed environmental compartmentsIdentification of relevant receiving compartments based on the exposure pathway

Scenario Freshwater Sediment Seawater Seawater sediment STP Air Soil Groundwater Other

Scenario 1

Scenario n

[Please indicate relevant environmental compartments by stating “yes”,“no” or “not relevant” for each cell. Add / delete rows for the number of scenarios.]

Input parameters (only set values) for calculating the fate and distribution in the environment


Molecular weight g/mol

Melting point °C

Boiling point °C

Vapour pressure (at X °C) Pa

199



Water solubility (at X °C) mg/l

Log10 Octanol/water partition coefficient ---

Organic carbon/water partition coefficient (Koc) l/kg

Henry’s Law Constant (at X °C)[if measured data available.] Pa/m3/mol

Biodegradability <Ready biodegradable>

Rate constant for STP[if measured data available] h-1

DT50 for biodegradation in surface water d or hr (at 12 ºC)

DT50 for hydrolysis in surface water d or hr (at 12 ºC / pH)

DT50 for photolysis in surface water d or hr

200



DT50 for degradation in soil d or hr (at 12 ºC)

DT50 for degradation in air d or hr

[Add / delete rows according to the number of relevant input parameters.]

Calculated fate and distribution in the STP (if STP is a relevant compartment)

Compartment Percentage (%) Scenario 1 Percentage (%) Scenario n Remarks

Air

Water

201


Compartment Percentage (%) Scenario 1 Percentage (%) Scenario n Remarks

Sludge

Degraded in STP

9.3. Calculated PEC valuesSummary table on calculated PEC values

Scenario PECSTP (mg/m3) PECwater (mg/l) PECsed

(mg/kgwwt)PECseawater

(mg/l)PECseased

(mg/kgwwt)PECsoil (mg/m3) PECGW (μ/l) PECair (mg/m3)

Scenario 1

Scenario n

[If the PECGW was calculated by using a simulation tool (e.g. one of the FOCUS models), please provide the results for the different simulated scenarios in a separate table.

[Please insert / delete additional environmental compartments if relevant. Add / delete rows according to the number of scenarios. Please include a similar table for relevant metabolites and/or degradation products.]

202


9.4. Primary and secondary poisoningPrimary poisoning

<If applicable, please describe how the exposure through primary poisoning was assessed and report the outcome.>

Secondary poisoningSummary table on estimated theoretical exposition (ETE)

Scenario ETE (mg/kg*d-1) ETE (mg/kg*d-1)

Scenario 1

Scenario n

[Add / delete additional columns according to the number of species for which ETE was calculated. Add / delete rows according to the number of scenarios.]

<Waiving example if not relevant: Substance is unlikely to bioaccumulate in aquatic or terrestrial environment according to the TGD. It has a low log Kow (x.xx), it is not highly adsorptive, it does not belong to a class of substances known to have a potential to accumulate in living organisms, its structural features does not indicate accumulation and it is readily biodegradable and has a short degradation half-life of 11 h in the water/sediment test. The low accumulation potential is supported by low BCF and BMF for fish and earthworms determined by EUSES 2.1.2. The bioconcentration factor for fish is x.xx l/kg and a default BMF of 1. The bioconcentration factor for earthworms is x.xx l/kg and a default BMF of 1. No further assessment of secondary exposure via the food chain is therefore considered necessary.>

203


10. Assessment of effects on human health for the product10.1. Product(s)

<Please give details of the product(s), the formulation, the in-use concentration(s), and substance(s) of concern, if relevant.>

10.2. Dermal absorption

[Please only include additional studies not covered in Part A. If a relevant study performed with the product is included in Part A, please only refer to the respective study. If no data are available, delete the tables and indicate only that no data are available.]

Summary table of in vitro studies on dermal absorption




Absorption data for each compartment and final absorption value


Reference

204


Summary table of animal studies on dermal absorption



Concentration of test substance / LabelDuration of exposure

Signs of toxicity Absorption data for each compartment and final absorption value


Reference

[Add / delete rows according to the number of studies. If not relevant, delete the table.]

Value(s) used in the risk assessment – Dermal absorption

Value(s)

Justification

[Please include the concentration range(s) the values are applicable for, if relevant.]

Data waiving


205


Justification


10.3. Acute toxicity


Summary table of acute toxicity studies performed with the product

Route Method,Guideline,GLP status,Reliability


Test substance,Dose levels

Signs of toxicity (nature, onset, duration, severity, reversibility)

ValueLD50/LC50


Reference


206


10.3.1. Overall conclusion on acute toxicity

Value(s) used in the risk assessment – Acute toxicity

Value(s)

Justification

Classification for the product according to GB CLP

<Please include a proposal if relevant.>

[Please include the concentration range(s) the values are applicable for, if relevant.]

Data waiving


Justification


10.4. Corrosion and irritation


207


10.4.1. Skin corrosion and irritation

[If no data are available, delete the tables and indicate only that no data are available.]

Summary table of in vitro studies on skin corrosion / irritation





Reference


Summary table of animal studies on skin corrosion / irritation




ResultsAverage score (24, 48, 72h), observations and time point of onset, reversibility, other adverse local/systemic effects, histopathological findings


Reference

208





ResultsAverage score (24, 48, 72h), observations and time point of onset, reversibility, other adverse local/systemic effects, histopathological findings


Reference


Summary table of human data on skin irritation

Type of data/ report, Reliability




Conclusion used in the risk assessment – Skin corrosion / irritation

Value / conclusion

209


Justification



Data waiving


Justification


10.4.2. Serious eye damage and eye irritation


Summary table of in vitro studies on serious eye damage and eye irritation





Reference

210






Reference


Summary table of animal studies on serious eye damage and eye irritation




ResultsAverage score (24, 48, 72h), observations and time point of onset, reversibility


Reference


211


Summary table of human data on serious eye damage and eye irritation





Conclusion used in the risk assessment – Serious eye damage and eye irritation

Value / conclusion

Justification



Data waiving


212


Justification


10.4.3. Respiratory tract irritation


Summary table of animal studies on respiratory tract irritation




ResultsClinical signs, histopathology, reversibility


Reference


213


Summary table of human data on respiratory tract irritation





Conclusion used in the risk assessment – Respiratory tract irritation

Conclusion

Justification



Data waiving


214


Justification


10.4.4. Overall conclusion on corrosion and irritation

Conclusion used in the risk assessment – Corrosion and irritation

Value(s) / Conclusion(s)

Justification



Data waiving


Justification


10.5. Sensitisation


215


10.5.1. Skin sensitisation


Summary table of animal studies on skin sensitisation



Test substance,Vehicle,Dose levels,Duration of exposureRoute of exposure (topical/intradermal, if relevant)

Results (EC value or amount of sensitised animals at induction dose)Evidence for local or systemic toxicity (time course of onset)


Reference


Summary table of human data on skin sensitisation




216






Conclusion used in the risk assessment – Skin sensitisation

Value / conclusion

Justification



Data waiving


Justification


217


10.5.2. Respiratory sensitisation


Summary table of animal studies on respiratory sensitisation





Reference


Summary table of human data on respiratory sensitisation





218


Conclusion used in the risk assessment – Respiratory sensitisation

Value / conclusion

Justification



Data waiving


Justification


10.5.3. Overall conclusion on sensitisation

Conclusion used in the risk assessment – Sensitisation

Value(s) / Conclusion(s)

Justification

219




Data waiving


Justification


10.6. Other

[Please include any relevant information and considerations not covered above e.g. synergistic or cumulative effects. If not relevant, delete the title.]

220


11. Environmental effects assessment for the product11.1. Atmosphere

[To be provided in line with section 4.2 if there are any compounds in the product that adversely affect the conclusions of the risk assessment for the active substance in the product.]

<Waiving example if not relevant: The ecotoxicological properties of the product may be derived from the properties of the active substance and other components of the product. Information on the ecotoxicity of the active substance is presented in Part A, Section 4.2. There are no compounds of concern in the formulated products that adversely affect the conclusions of the risk assessment for the active substance in the product , therefore no further assessment is needed.>

11.2. STP


11.3. Aquatic compartment


11.4. Terrestrial compartment


11.5. Primary and secondary poisoning


<Waiving example if not relevant: Substance is unlikely to bioaccumulate in aquatic or terrestrial environment according to the TGD. It has a low log Kow (x.xx), it is not highly adsorptive, it does not belong to a class of substances known to have a potential to accumulate in living organisms, its structural features does not indicate accumulation and it is readily biodegradable and has a short degradation half-life of 11 h in the water/sediment test. The low accumulation potential is supported by low BCF and BMF for fish and earthworms determined by EUSES 2.1.2. The bioconcentration factor for fish is x.xx l/kg and a default BMF of 1. The bioconcentration factor for earthworms is x.xx l/kg and a default BMF of 1. No further assessment of secondary exposure via the food chain is therefore considered necessary.>

221


Part C – Risk characterisation of the biocidal product(s)12. Risk characterisation for human health12.1. Critical endpoints12.1.1. Systemic effects

Duration Study Route Relevant effects

NOAEL / LOAEL

References

Acute

Medium-term

Long-term


12.1.2. Local effects

Route Effect Study Classification Hazard category

Dermal

Respiratory


[Please provide the hazard category according to the guidance “Risk characterisation for local effects including sensitisation”.]

12.1.3. Absorption

Route Study Test substance

Concentration of test substance

Applicability (concentration ranges)

Value

Oral

222


Route Study Test substance

Concentration of test substance

Applicability (concentration ranges)

Value

Dermal

Inhalation

[Add / delete rows as required. If relevant, indicate “n.a.” in the table and use footnotes for references and justifications.]

12.2. Reference values12.2.1. Uncertainties and assessment factors

[Tables have been included below for the three AEL values that should be always derived. Please include tables for any further reference values to be derived.]

AELshort-term

Uncertainty AF Justification

Interspecies variability

Intraspecies variability

Route to route extrapolation

Time duration extrapolation

NOAEL to LOAEL extrapolation

Dose response

Severity of key health effects

Overall AF (n.a.)

223



AELmedium-term







Dose response


Overall AF (n.a.)


AELlong-term






224




Dose response


Overall AF (n.a.)


12.2.2. Reference values to be used in risk characterisation

Reference Study NOAEL (LOAEL)

AF Correction for oral absorption

Value

AELshort-term

AELmedium-term

AELlong-term

ARfD

ADI

[Add / delete rows for additional reference values if necessary e.g. for local effects.]

225


12.2.3. Maximum residue limits or equivalent

MRLs or other relevant reference values

Reference Relevant commodities

Value


12.2.4. Specific reference value for groundwater

[If it is proposed to derive a value according to GB BPR Annex VI point 68, other than the maximum permissible concentration laid down by UK Water Supply (Water Quality) Regulations, please include the argumentation and the calculations here. Otherwise, please delete this chapter.]

12.3. Industrial uses12.3.1. Systemic effects

Task / Scenario

Tier Systemic NOAEL (mg/kg bw/d)

AEL (mg/kg bw/d)


Estimated uptake / AEL (%)

Acceptable

(yes/no)

[Please include a row for each task / scenario where industrial exposure is foreseen. If no exposure is foreseen and / or no systemic effect is observed, then only indicate this and delete the table.]

226


Combined scenarios

Scenarios combined


AEL (mg/kg bw/d)



Acceptable

(yes/no)

[Please include a row for each combination of scenarios assessed. If no combined exposure is foreseen, then only indicate this and delete the table.]


[Please include an appropriate table for the assessment; please use the guidance document “Risk Characterisation for local effects and sensitisation“. If no exposure is foreseen and/or there is no need to consider local effects separately, then only indicate this.]

12.3.3. Conclusion

<Please give a brief conclusion on the acceptability of the scenarios.>

12.4. Professional uses12.4.1. Systemic effects

Task / Scenario


AEL (mg/kg bw/d)



Acceptable

(yes/no)

[Please include a row for each task / scenario where professional exposure is foreseen. If no exposure is foreseen and / or no systemic effect is observed, then only indicate

227


this and delete the table.]

Combined scenarios

Scenarios combined


AEL (mg/kg bw/d)



Acceptable

(yes/no)



[Please include an appropriate table for the assessment; please see Guidance for Human Health Risk Assessment Volume III, Part B. If no exposure is foreseen and/or there is no need to consider local effects separately, then only indicate this.]

12.4.3. Conclusion


12.5. General public uses12.5.1. Systemic effects

Task / Scenario


AEL (mg/kg bw/d)



Acceptable

(yes/no)

[Please include a row for each task / scenario where general public exposure is

228


foreseen. If no exposure is foreseen and / or no systemic effect is observed, then only indicate this and delete the table.]

Combined scenarios

Scenarios combined


AEL (mg/kg bw/d)



Acceptable

(yes/no)




12.5.3. Conclusion


12.6. Secondary (indirect) exposure as a result of use12.6.1. Systemic effects

Task / Scenario


AEL (mg/kg bw/d)



Acceptable

(yes/no)

229


[Please include a row for each representative scenario where secondary (indirect) exposure of general public bystanders is foreseen. If no exposure is foreseen and / or no systemic effect is observed, then only indicate this and delete the table.]

Combined scenarios

Scenarios combined


AEL (mg/kg bw/d)



Acceptable

(yes/no)




12.6.3. Conclusion


12.7. Indirect exposure via food

[Template structure to be further developed once the guidance is finalised.]

12.8. Production / formulation of active substance12.8.1. Systemic effects

Task / Scenario


AEL (mg/kg bw/d)



Acceptable

(yes/no)

230


Task / Scenario


AEL (mg/kg bw/d)



Acceptable

(yes/no)

[Please include a row for each scenario where exposure from production / formulation of the active substance is foreseen. If no exposure is foreseen and / or no systemic effect is observed, then only indicate this and delete the table.]

Combined scenarios

Scenarios combined


AEL (mg/kg bw/d)



Acceptable

(yes/no)




12.8.3. Conclusion


12.9. Aggregated exposure

[Template structure to be further developed once the guidance is finalised.]

231


13. Risk characterisation for the environment13.1. AtmosphereConclusion

<Please include a short conclusion on the assessment of the air compartment.>

13.2. Sewage treatment plant (STP)Summary table on calculated PEC / PNEC values

Scenario PEC / PNECSTP

Scenario 1

Scenario n


Conclusion

<Please include a short text summarising the conclusion on the risk assessment.>

13.3. Aquatic compartmentSummary table on calculated PEC / PNEC values

Scenario PEC / PNECwater PEC / PNECsed PEC / PNECseawater PEC / PNECseased

Scenario 1

Scenario n


Conclusion


13.4. Terrestrial compartment

232


Summary table on calculated PEC / PNEC values

Scenario PEC / PNECsoil

Scenario 1

Scenario n


Conclusion


13.5. Groundwater

[Please assess according to GB BPR Annex VI point 68 if the foreseeable concentration (PEC) of the active substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products in groundwater, exceeds the lower of the following concentrations:

the maximum permissible concentration laid down by UK Water Supply (Water Quality) Regulations, or

the maximum concentration as laid down following the procedure for approving the active substance under this Regulation, on the basis of appropriate data, in particular toxicological (please refer to section 14.2.4), unless it is scientifically demonstrated that under relevant field conditions the lower concentration is not exceeded.]

13.6. Primary and secondary poisoningPrimary poisoning

<Where relevant please summarise here the outcome of the primary poisoning assessment.>

Secondary poisoningSummary table on secondary poisoning

Scenario Concentration PECoral predator PEC / PNECbirds

PEC / PNECmammals

PEC / PNECfish

Scenario 1

233


Scenario Concentration PECoral predator PEC / PNECbirds

PEC / PNECmammals

PEC / PNECfish

Scenario n


Conclusion

<Please include a short text summarising the conclusion on primary and secondary poisoning.>

13.7. Aggregated exposure (combined for relevant emission sources)

[Please include an assessment if aggregated exposure is relevant based on the decision scheme developed by UBA (see Figure 1) and an overview on the results in the table below, if an aggregated exposure was conducted.]

Annual tonnage of a.s. for

biocide use

Same a.s./b.p. indifferent PTs

yes

Aggregatedexposure estimationrequired for a.s./b.p.*

no

Decision tree on need for estimation of aggregated exposure

Biocide use of a.s. < 10%

of total?

no/unknown

no

no

yes

Uses of a.s./b.p. within 1 PT Different user

categories

Wide dispersiveuse

Multiple b.p.for same purpose

Other a.s. affected

Overlapin time and

space?

No aggregated exposure estimation required for a.s./b.p.

No aggregated exposure

estimation for a.s./b.p.required

Otherregulatory

areas

or

or

or

Biocidalspecific emission

pattern

yes

yes

* a) aggregate only compartments and consider only PTs where overlap in time and space existsb) if production or formulation is within Europe, add a qualitative description of the respective environmental exposure e.g. in CAR

Different use/service life/waste

scenarios

Part 1§ Part 3

Part 2

a.s. is relevant metabolite

of other a.s., and vice versa

Main constituent of a.s. is part of

other a.s.

or

Uses of a.s./b.p. within >1 PTs

§ Part 1 has to be checked for all PTs affected

Different a.s. form the same

relevant metabolite

or

Figure 1: Decision tree on the need for estimation of aggregated exposure

234


Summary table on calculated PEC / PNEC values

Sources combined

PEC / PNECSTP

PEC / PNECwater

PEC / PNECsed

PEC / PNECseawater

PEC / PNECseased

PEC / PNECsoil

PEC / PNECGW

PEC / PNECair

[Add / delete rows / columns as required.]

Conclusion

<Please include a short text summarising the conclusion on the risk assessment based on aggregated exposure.>

[N.B.: This part of the template will be further elaborated as soon as the guidance on aggregated exposure is available.]

235


14. Risk characterisation for the physico-chemical properties

<Please include a conclusion on the risk characterisation.>

14. Measures to protect man, animals and the environment

<Please include a summary on relevant measures.>

236


Part D – AppendicesAppendix I: List of endpointsChapter 1: Identity, physical and chemical properties, classification and labelling

Active substance (ISO name)

Product type

Identity

Chemical name (IUPAC)

Chemical name (CA)

CAS No

EC No

Other substance No.

Minimum purity of the active substance as manufactured (g/kg or g/l)

Identity of relevant impurities and additives (substances of concern) in the active substance as manufactured (g/kg)

Molecular formula

Molecular mass

Structural formula

237


Physical and chemical properties

Melting point (state purity)

Boiling point (state purity)

Thermal stability / Temperature of decomposition

Appearance (state purity)

Relative density (state purity)

Surface tension (state temperature and concentration of the test solution)

Vapour pressure (in Pa, state temperature)

Henry’s law constant (Pa m3 mol -1)

Solubility in water (g/l or mg/l, state temperature)

pH 5 at <X> C:⁰

pH 9 at <X> C:⁰

pH <X> at <X> C:⁰

Solubility in organic solvents (in g/l or mg/l, state temperature)

Stability in organic solvents used in biocidal products including relevant breakdown products

Partition coefficient (log POW) (state temperature)

pH 5 at <X> C:⁰

pH 9 at <X> C:⁰

pH <X> at <X> C:⁰

238


Dissociation constant

UV/VIS absorption (max.) (if absorption > 290 nm state at wavelength)

Flammability or flash point

Explosive properties

Oxidising properties

Auto-ignition or relative self-ignition temperature

Classification and proposed labelling

with regard to physical hazards

with regard to human health hazards

with regard to environmental hazards

239


Chapter 2: Methods of analysisAnalytical methods for the active substance

Technical active substance (principle of method)

Impurities in technical active substance (principle of method)

Analytical methods for residues

Soil (principle of method and LOQ)

Air (principle of method and LOQ)

Water (principle of method and LOQ)

Body fluids and tissues (principle of method and LOQ)

Food/feed of plant origin (principle of method and LOQ for methods for monitoring purposes)

Food/feed of animal origin (principle of method and LOQ for methods for monitoring purposes)

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Chapter 3: Impact on human healthAbsorption, distribution, metabolism and excretion in mammals

Rate and extent of oral absorption:

Rate and extent of dermal absorption*:

Distribution:

Potential for accumulation:

Rate and extent of excretion:

Toxicologically significant metabolite(s)

*The dermal absorption value is applicable for the active substance and might not be usable in product authorisation.

Acute toxicity

Rat LD50 oral

Rat LD50 dermal

Rat LC50 inhalation



Eye irritation

Eye irritation

Respiratory tract irritation

Respiratory tract irritation

241


Skin sensitisation

Skin sensitisation (test method used and result)

Respiratory sensitisation

Respiratory sensitisation (test method used and result)

Repeated dose toxicityShort-term

Species / target / critical effect

Relevant oral NOAEL / LOAEL

Relevant dermal NOAEL / LOAEL

Relevant inhalation NOAEL / LOAEL

Sub-chronic





Long-term




242



Genotoxicity

Genotoxicity

Carcinogenicity

Species / type of tumour

Relevant NOAEL / LOAEL

Reproductive toxicityDevelopmental toxicity

Species/ Developmental target / critical effect

Relevant maternal NOAEL

Relevant developmental NOAEL

Fertility

Species / critical effect

Relevant parental NOAEL

Relevant offspring NOAEL

Relevant fertility NOAEL

Neurotoxicity


243


Developmental neurotoxicity


Immunotoxicity


Developmental immunotoxicity


Other toxicological studies

Medical data

Summary

Value Study Safety factor

AELlong-term

AELmedium-term

AELshort-term

ADI (if residues in food or feed)

ARfD

MRLs

Relevant commodities

244


Reference value for groundwater

According to GB BPR Annex VI, point 68

Dermal absorption

Study (in vitro / vivo), species tested

Formulation (formulation type and including concentration(s) tested, vehicle)

Dermal absorption values used in risk assessment

Acceptable exposure scenarios (including method of calculation)

Formulation of biocidal product

Intended uses

Industrial users

Professional users

General public users

General public bystanders

Exposure via residue in food

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Chapter 4: Fate and behaviour in the environmentRoute and rate of degradation in water

Hydrolysis of active substance and relevant metabolites (DT50) (state pH and temperature)

pH 5

pH 9

Other pH: <indicate the value>

Photolytic / photo-oxidative degradation of active substance and resulting relevant metabolites

Readily biodegradable (yes / no)

Inherent biodegradable (yes / no)

Biodegradation in freshwater

Biodegradation in seawater

Non-extractable residues

Distribution in water / sediment systems (active substance)

Distribution in water / sediment systems (metabolites)

Route and rate of degradation in soil

Mineralisation (aerobic)

246


Laboratory studies (range or median, with number of measurements, with regression coefficient)

DT50lab (20C, aerobic):



DT50lab (20C, anaerobic):

Degradation in the saturated zone:

Field studies (state location, range or median with number of measurements)

DT50f:

DT90f:

Anaerobic degradation

Soil photolysis

Non-extractable residues

Relevant metabolites – name and / or code, % of applied a.i. (range and maximum)

Soil accumulation and plateau concentration

247


Adsorption / desorption

Ka , KdKaoc , Kdoc

pH dependence (yes / no) (if yes, type of dependence)

Fate and behaviour in air

Direct photolysis in air

Quantum yield of direct photolysis

Photo-oxidative degradation in air Latitude:Season:DT50:

Volatilization

Reference value for groundwater

According to GB BPR Annex VI, point 68

Monitoring data, if available

Soil (indicate location and type of study)

Surface water (indicate location and type of study)

Ground water (indicate location and type of study)

Air (indicate location and type of study)

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Chapter 5: Effects on non-target speciesToxicity data for aquatic species (most sensitive species of each group)Fish

Species Timescale Endpoint Toxicity

Invertebrates


Algae


Micro-organisms


Effects on earthworms or other soil non-target organisms

Acute toxicity to <non-target organism>

Reproductive toxicity to <non-target organism>

Effects on soil micro-organisms

Nitrogen mineralisation

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Carbon mineralisation

Effects on terrestrial vertebrates

Acute toxicity to mammals

Acute toxicity to birds

Dietary toxicity to birds

Reproductive toxicity to birds

Effects on honeybees

Acute oral toxicity

Acute contact toxicity

Effects on other beneficial arthropods

Acute oral toxicity

Acute contact toxicity

Acute toxicity to <arthropod>

Bioconcentration

Bioconcentration factor (BCF)

Degradation time (DT50)

Degradation time (DT90)

Level of metabolites (%) in organisms accounting for > 10 % of residues

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Chapter 6: Other end points

251


Appendix II: Human exposure calculations

252


Appendix III: Environmental emission (and exposure) calculations

253


Appendix IV: List of terms and abbreviations

254


Appendix V: Overall reference list (including data owner and confidentiality claim)

Section No. / Reference No.

Author(s) Year Title, Source (where different from company), Company, Report No., GLP (where relevant) / (Un)Published

Vertebrate study(Yes / No)

Data protection claimed(Yes / No)

Data protection expiry date

Owner

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Appendix VI: Confidential information

256

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