OF CONTENTS Full Public Report 3 1. APPLICANT AND NOTIFICATION DETAILS 3 2. IDENTITY OF CHEMICAL 3 3. COMPOSITION 3 4. PHYSICAL AND CHEMICAL PROPERTIES 4 5. INTRODUCTION AND USE INFORMATION 4 6. HUMAN HEALTH IMPLICATIONS 5 6.1 Exposure assessment 5 6.1.1 Occupational exposure 5 6.1.2. Public exposure 6 6.2. Human health effects assessment 6 6.3. health risk characterisation 7 6.3.1. Occupational health and safety 7 6.3.2. Public health 7 7. ENVIRONMENTAL IMPLICATIONS 7 7.1. Environmental Exposure & Fate Assessment 7 7.1.1 Environmental Exposure 7 7.1.2 Environmental fate 8 7.1.3 Predicted Environmental Concentration (PEC) 8 7.2. Environmental effects assessment 9 7.2.1 Predicted No-Effect Concentration 9 7.3. Environmental risk assessment 9 8. CONCLUSIONS AND REGULATORY OBLIGATIONS 9 Hazard classification 9 Human health risk assessment 10 Environmental risk assessment 10 Recommendations 10 Regulatory Obligations 10 Appendix A: Physical and Chemical Properties 12 Appendix B: Toxicological Investigations 15 B.1. Acute toxicity oral 15 – B.2. toxicity dermal 15 – B.3. Irritation skin 16 – B.4. Irritation eye 16 – B.5. Repeat dose toxicity 17 B.6. Genotoxicity bacteria 19 – B.7. Genotoxicity bacteria (Prival and Mitchell modification for Azo dyes) 20 – B.8. Genotoxicity in vitro 20 – B.9. Skin sensitisation mouse local lymph node assay (LLNA) 21 – Appendix C: Environmental Fate and Ecotoxicological Investigations 23 C.1. Environmental Fate 23 C.1.1. Ready biodegradability 23 C.2. Ecotoxicological Investigations 23 C.2.1. toxicity to fish 23 C.2.2. Acute toxicity to aquatic invertebrates 24 C.2.3. Algal growth inhibition test 25 Experiment A 26 Experiment B 26 inhibition test 27 C.2.4. Lemna growth C.2.5. Inhibition of microbial activity 27 Bibliography 29
OF CONTENTS Full Public Report 3 1. APPLICANT AND NOTIFICATION DETAILS 3 2. IDENTITY OF CHEMICAL 3 3. COMPOSITION 3 4. PHYSICAL AND CHEMICAL PROPERTIES 4 5. INTRODUCTION AND USE INFORMATION 4 6. HUMAN HEALTH IMPLICATIONS 5 6.1 Exposure assessment 5 6.1.1 Occupational exposure 5 6.1.2. Public exposure 6 6.2. Human health effects assessment 6 6.3. health risk characterisation 7 6.3.1. Occupational health and safety 7 6.3.2. Public health 7 7. ENVIRONMENTAL IMPLICATIONS 7 7.1. Environmental Exposure & Fate Assessment 7 7.1.1 Environmental Exposure 7 7.1.2 Environmental fate 8 7.1.3 Predicted Environmental Concentration (PEC) 8 7.2. Environmental effects assessment 9 7.2.1 Predicted No-Effect Concentration 9 7.3. Environmental risk assessment 9 8. CONCLUSIONS AND REGULATORY OBLIGATIONS 9 Hazard classification 9 Human health risk assessment 10 Environmental risk assessment 10 Recommendations 10 Regulatory Obligations 10 Appendix A: Physical and Chemical Properties 12 Appendix B: Toxicological Investigations 15 B.1. Acute toxicity – oral 15 B.2. toxicity – dermal 15 B.3. Irritation – skin 16 B.4. Irritation – eye 16 B.5. Repeat dose toxicity 17 B.6. Genotoxicity – bacteria 19 B.7. Genotoxicity – bacteria (Prival and Mitchell modification for Azo dyes) 20 B.8. Genotoxicity – in vitro 20 B.9. Skin sensitisation – mouse local lymph node assay (LLNA) 21 Appendix C: Environmental Fate and Ecotoxicological Investigations 23 C.1. Environmental Fate 23 C.1.1. Ready biodegradability 23 C.2. Ecotoxicological Investigations 23 C.2.1. toxicity to fish 23 C.2.2. Acute toxicity to aquatic invertebrates 24 C.2.3. Algal growth inhibition test 25 Experiment A 26 Experiment B 26 C.2.4. Lemna growth inhibition test 27 C.2.5. Inhibition of microbial activity 27 Bibliography 29
STD-1290-FR.docx