TABLE OF CONTENTS Full Public Report 4 1. APPLICANT AND NOTIFICATION DETAILS 4 2. IDENTITY OF CHEMICAL 4 3. COMPOSITION 4 4. PHYSICAL AND CHEMICAL PROPERTIES 5 5. INTRODUCTION AND USE INFORMATION 5 6. HUMAN HEALTH IMPLICATIONS 6 6.1 Exposure assessment 6 6.1.1 Occupational exposure 6 6.1.2. Public exposure 7 6.2. Human health effects assessment 8 6.3. Human health risk characterisation 9 6.3.1. Occupational health and safety 9 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 12 8. CONCLUSIONS AND REGULATORY OBLIGATIONS 12 Hazard classification 12 health risk assessment 12 Environmental risk assessment 12 Recommendations 13 Regulatory Obligations 13 Appendix A: Physical and Chemical Properties 15 Appendix B: Toxicological Investigations 17 B.1. Acute toxicity oral 17 – B.2. Acute toxicity dermal 17 – B.3. Irritation skin 18 – B.4. Irritation eye 18 – B.5. Skin sensitisation mouse local lymph node assay (LLNA) 19 – B.6. Repeat dose toxicity 20 B.7. Genotoxicity bacteria 21 – B.8. Genotoxicity in vitro 22 – Appendix C: Environmental Fate and Ecotoxicological Investigations 24 C.1. Environmental Fate 24 C.1.1. Ready biodegradability 24 C.2. Ecotoxicological Investigations 24 C.2.1. toxicity to fish 24 C.2.2. Acute toxicity to aquatic invertebrates 25 C.2.3. Chronic toxicity to aquatic invertebrates 27 C.2.4. Algal growth inhibition test 28 C.2.5. Inhibition of microbial activity 29 Bibliography 30
TABLE OF CONTENTS Full Public Report 4 1. APPLICANT AND NOTIFICATION DETAILS 4 2. IDENTITY OF CHEMICAL 4 3. COMPOSITION 4 4. PHYSICAL AND CHEMICAL PROPERTIES 5 5. INTRODUCTION AND USE INFORMATION 5 6. HUMAN HEALTH IMPLICATIONS 6 6.1 Exposure assessment 6 6.1.1 Occupational exposure 6 6.1.2. Public exposure 7 6.2. Human health effects assessment 8 6.3. Human health risk characterisation 9 6.3.1. Occupational health and safety 9 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 12 8. CONCLUSIONS AND REGULATORY OBLIGATIONS 12 Hazard classification 12 health risk assessment 12 Environmental risk assessment 12 Recommendations 13 Regulatory Obligations 13 Appendix A: Physical and Chemical Properties 15 Appendix B: Toxicological Investigations 17 B.1. Acute toxicity – oral 17 B.2. Acute toxicity – dermal 17 B.3. Irritation – skin 18 B.4. Irritation – eye 18 B.5. Skin sensitisation – mouse local lymph node assay (LLNA) 19 B.6. Repeat dose toxicity 20 B.7. Genotoxicity – bacteria 21 B.8. Genotoxicity – in vitro 22 Appendix C: Environmental Fate and Ecotoxicological Investigations 24 C.1. Environmental Fate 24 C.1.1. Ready biodegradability 24 C.2. Ecotoxicological Investigations 24 C.2.1. toxicity to fish 24 C.2.2. Acute toxicity to aquatic invertebrates 25 C.2.3. Chronic toxicity to aquatic invertebrates 27 C.2.4. Algal growth inhibition test 28 C.2.5. Inhibition of microbial activity 29 Bibliography 30