TABLE OF CONTENTS SUMMARY 3 CONCLUSIONS AND REGULATORY OBLIGATIONS 3 ASSESSMENT DETAILS 5 1. APPLICANT AND NOTIFICATION DETAILS 5 2. IDENTITY OF CHEMICAL 5 3. IDENTITY OF ANALOGUES 6 4. COMPOSITION 7 5. PHYSICAL AND CHEMICAL PROPERTIES 8 6. INTRODUCTION AND USE INFORMATION 8 7. HUMAN HEALTH IMPLICATIONS 9 7.1. Exposure Assessment 9 7.1.1. Occupational Exposure 9 7.1.2. Public Exposure 9 7.2. Human Health Effects Assessment 10 7.3. Human Health Risk Characterisation 11 7.3.1. Occupational Health and Safety 11 7.3.2. Public Health 11 8. ENVIRONMENTAL IMPLICATIONS 12 8.1. Environmental Exposure & Fate Assessment 12 8.1.1. Environmental Exposure 12 8.1.2. Environmental Fate 12 8.1.3. Predicted Environmental Concentration (PEC) 13 8.2. Environmental Effects Assessment 13 8.2.1. Predicted No-Effect Concentration 14 8.3. Environmental Risk Assessment 14 Appendix A: Toxicological Investigations 15 A.1. Acute toxicity oral 15 – A.2. Acute toxicity dermal 15 – A.3. Irritation skin 16 – A.4. Irritation eye 16 – A.5. Skin sensitisation human volunteers (1) 16 – A.6. Skin sensitisation human volunteers (2) 17 – A.7. Repeat dose toxicity 17 A.8. Genotoxicity bacteria 19 – A.9. Genotoxicity 19 in vitro – A.10. Comedogenicity 20 Appendix C: Environmental Fate and Ecotoxicological Investigations 22 C.1. Environmental Fate 22 C.1.1. Ready biodegradability 22 C.2. Ecotoxicological Investigations 23 C.2.1. Acute toxicity to aquatic invertebrates 23 BIBLIOGRAPHY 24
TABLE OF CONTENTS SUMMARY 3 CONCLUSIONS AND REGULATORY OBLIGATIONS 3 ASSESSMENT DETAILS 5 1. APPLICANT AND NOTIFICATION DETAILS 5 2. IDENTITY OF CHEMICAL 5 3. IDENTITY OF ANALOGUES 6 4. COMPOSITION 7 5. PHYSICAL AND CHEMICAL PROPERTIES 8 6. INTRODUCTION AND USE INFORMATION 8 7. HUMAN HEALTH IMPLICATIONS 9 7.1. Exposure Assessment 9 7.1.1. Occupational Exposure 9 7.1.2. Public Exposure 9 7.2. Human Health Effects Assessment 10 7.3. Human Health Risk Characterisation 11 7.3.1. Occupational Health and Safety 11 7.3.2. Public Health 11 8. ENVIRONMENTAL IMPLICATIONS 12 8.1. Environmental Exposure & Fate Assessment 12 8.1.1. Environmental Exposure 12 8.1.2. Environmental Fate 12 8.1.3. Predicted Environmental Concentration (PEC) 13 8.2. Environmental Effects Assessment 13 8.2.1. Predicted No-Effect Concentration 14 8.3. Environmental Risk Assessment 14 Appendix A: Toxicological Investigations 15 A.1. Acute toxicity – oral 15 A.2. Acute toxicity – dermal 15 A.3. Irritation – skin 16 A.4. Irritation – eye 16 A.5. Skin sensitisation – human volunteers (1) 16 A.6. Skin sensitisation – human volunteers (2) 17 A.7. Repeat dose toxicity 17 A.8. Genotoxicity – bacteria 19 A.9. Genotoxicity – in vitro 19 A.10. Comedogenicity 20 Appendix C: Environmental Fate and Ecotoxicological Investigations 22 C.1. Environmental Fate 22 C.1.1. Ready biodegradability 22 C.2. Ecotoxicological Investigations 23 C.2.1. Acute toxicity to aquatic invertebrates 23 BIBLIOGRAPHY 24