TABLE OF CONTENTS SUMMARY 3 CONCLUSIONS AND REGULATORY OBLIGATIONS 3 ASSESSMENT DETAILS 6 1. APPLICANT AND NOTIFICATION DETAILS 6 2. IDENTITY OF CHEMICAL 6 3. COMPOSITION 7 4. PHYSICAL AND CHEMICAL PROPERTIES 7 5. INTRODUCTION AND USE INFORMATION 7 6. HUMAN HEALTH IMPLICATIONS 8 6.1. Exposure Assessment 8 6.1.1. Occupational Exposure 8 6.1.2. Public Exposure 9 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 11 7. ENVIRONMENTAL IMPLICATIONS 11 7.1. Environmental Exposure & Fate Assessment 11 7.1.1. Environmental Exposure 11 7.1.2. Environmental Fate 12 7.1.3. Predicted Environmental Concentration (PEC) 12 7.2. Environmental Effects Assessment 13 7.2.1. Predicted No-Effect Concentration 13 7.3. Environmental Risk Assessment 13 Appendix A: Physical and Chemical Properties 14 Appendix B: Toxicological Investigations 16 B.1. Acute toxicity oral 16 – B.2. Acute toxicity dermal 16 – B.3. Acute toxicity inhalation 17 – B.4. Irritation skin (in vitro) 17 – B.5. Irritation skin 18 – B.6. Irritation eye (in vitro) 18 – B.7. Irritation eye 19 – B.8. Skin sensitisation mouse local lymph node assay (LLNA) 19 – B.9. Skin sensitisation human volunteers 20 – B.10. Repeat dose toxicity 20 B.11. Genotoxicity bacteria 21 – B.12. 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. Acute toxicity to fish 24 C.2.2. Acute toxicity to aquatic invertebrates 25 C.2.3. Algal growth inhibition test 26 C.2.4. Inhibition of microbial activity 26 BIBLIOGRAPHY 28
TABLE OF CONTENTS SUMMARY 3 CONCLUSIONS AND REGULATORY OBLIGATIONS 3 ASSESSMENT DETAILS 6 1. APPLICANT AND NOTIFICATION DETAILS 6 2. IDENTITY OF CHEMICAL 6 3. COMPOSITION 7 4. PHYSICAL AND CHEMICAL PROPERTIES 7 5. INTRODUCTION AND USE INFORMATION 7 6. HUMAN HEALTH IMPLICATIONS 8 6.1. Exposure Assessment 8 6.1.1. Occupational Exposure 8 6.1.2. Public Exposure 9 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 11 7. ENVIRONMENTAL IMPLICATIONS 11 7.1. Environmental Exposure & Fate Assessment 11 7.1.1. Environmental Exposure 11 7.1.2. Environmental Fate 12 7.1.3. Predicted Environmental Concentration (PEC) 12 7.2. Environmental Effects Assessment 13 7.2.1. Predicted No-Effect Concentration 13 7.3. Environmental Risk Assessment 13 Appendix A: Physical and Chemical Properties 14 Appendix B: Toxicological Investigations 16 B.1. Acute toxicity – oral 16 B.2. Acute toxicity – dermal 16 B.3. Acute toxicity – inhalation 17 B.4. Irritation – skin (in vitro) 17 B.5. Irritation – skin 18 B.6. Irritation – eye (in vitro) 18 B.7. Irritation – eye 19 B.8. Skin sensitisation – mouse local lymph node assay (LLNA) 19 B.9. Skin sensitisation – human volunteers 20 B.10. Repeat dose toxicity 20 B.11. Genotoxicity – bacteria 21 B.12. 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. Acute toxicity to fish 24 C.2.2. Acute toxicity to aquatic invertebrates 25 C.2.3. Algal growth inhibition test 26 C.2.4. Inhibition of microbial activity 26 BIBLIOGRAPHY 28