TABLE OF CONTENTS Full Public Report 3 SUMMARY 3 CONCLUSIONS AND REGULATORY OBLIGATIONS 3 Hazard classification 3 Human health risk assessment 3 Environmental risk assessment 3 Recommendations 3 Regulatory Obligations 4 1. APPLICANT AND NOTIFICATION DETAILS 5 2. IDENTITY OF CHEMICAL 5 3. 5 4. PHYSICAL AND CHEMICAL PROPERTIES 6 5. INTRODUCTION AND USE INFORMATION 6 6. HUMAN HEALTH IMPLICATIONS 8 6.1 Exposure assessment 8 6.1.1 Occupational exposure 8 6.1.2. Public exposure 8 6.2. Human health effects assessment 9 6.3. Human health risk characterisation 10 6.3.1. Occupational health and safety 10 6.3.2. Public health 10 7. ENVIRONMENTAL IMPLICATIONS 10 7.1. Environmental Exposure & Fate Assessment 10 7.1.1 Environmental Exposure 10 7.1.2 Environmental fate 11 7.1.3 Predicted Environmental Concentration (PEC) 11 7.2. Environmental effects assessment 11 7.2.1 Predicted No-Effect Concentration 11 7.3. Environmental risk assessment 11 Appendix A: Physical and Chemical Properties 12 Appendix B: Toxicological Investigations 14 B.1. Acute toxicity oral 14 – B.2. Acute toxicity dermal 14 – B.3. Irritation skin 15 – B.4. Irritation eye 15 – B.5. Skin sensitisation mouse local lymph node assay (LLNA) 16 – B.6. Repeat dose toxicity 16 B.7. Genotoxicity bacteria 18 – B.8. Genotoxicity in vitro 19 – B.9. Genotoxicity in vitro 20 – B.10. Developmental toxicity 21 Appendix C: Environmental Fate and Ecotoxicological Investigations 23 C.1. Environmental Fate 23 C.1.1. Ready biodegradability 23 C.1.2. Bioaccumulation 24 C.2. Ecotoxicological Investigations 24 C.2.1. Acute toxicity to fish 24 C.2.2. Acute toxicity to aquatic invertebrates 25 C.2.3. Algal growth inhibition test 25 C.2.4. Inhibition of microbial activity 26 Bibliography 28
TABLE OF CONTENTS Full Public Report 3 SUMMARY 3 CONCLUSIONS AND REGULATORY OBLIGATIONS 3 Hazard classification 3 Human health risk assessment 3 Environmental risk assessment 3 Recommendations 3 Regulatory Obligations 4 1. APPLICANT AND NOTIFICATION DETAILS 5 2. IDENTITY OF CHEMICAL 5 3. 5 4. PHYSICAL AND CHEMICAL PROPERTIES 6 5. INTRODUCTION AND USE INFORMATION 6 6. HUMAN HEALTH IMPLICATIONS 8 6.1 Exposure assessment 8 6.1.1 Occupational exposure 8 6.1.2. Public exposure 8 6.2. Human health effects assessment 9 6.3. Human health risk characterisation 10 6.3.1. Occupational health and safety 10 6.3.2. Public health 10 7. ENVIRONMENTAL IMPLICATIONS 10 7.1. Environmental Exposure & Fate Assessment 10 7.1.1 Environmental Exposure 10 7.1.2 Environmental fate 11 7.1.3 Predicted Environmental Concentration (PEC) 11 7.2. Environmental effects assessment 11 7.2.1 Predicted No-Effect Concentration 11 7.3. Environmental risk assessment 11 Appendix A: Physical and Chemical Properties 12 Appendix B: Toxicological Investigations 14 B.1. Acute toxicity – oral 14 B.2. Acute toxicity – dermal 14 B.3. Irritation – skin 15 B.4. Irritation – eye 15 B.5. Skin sensitisation – mouse local lymph node assay (LLNA) 16 B.6. Repeat dose toxicity 16 B.7. Genotoxicity – bacteria 18 B.8. Genotoxicity – in vitro 19 B.9. Genotoxicity – in vitro 20 B.10. Developmental toxicity 21 Appendix C: Environmental Fate and Ecotoxicological Investigations 23 C.1. Environmental Fate 23 C.1.1. Ready biodegradability 23 C.1.2. Bioaccumulation 24 C.2. Ecotoxicological Investigations 24 C.2.1. Acute toxicity to fish 24 C.2.2. Acute toxicity to aquatic invertebrates 25 C.2.3. Algal growth inhibition test 25 C.2.4. Inhibition of microbial activity 26 Bibliography 28
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