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 6 4. PHYSICAL AND CHEMICAL PROPERTIES 6 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 10 6.3. Human Health Risk Characterisation 11 6.3.1. Occupational Health and Safety 11 6.3.2. Public Health 12 7. ENVIRONMENTAL IMPLICATIONS 12 7.1. Environmental Exposure & Fate Assessment 12 7.1.1. Environmental Exposure 12 7.1.2. Environmental Fate 12 7.1.3. Predicted Environmental Concentration (PEC) 13 7.2. Environmental Effects Assessment 13 7.2.1. Predicted No-Effect Concentration 14 7.3. Environmental Risk Assessment 14 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. Acute toxicity – inhalation 18 B.4. Irritation – skin (in vitro) 19 B.5. Irritation – skin (in vitro) 20 B.6. Irritation – eye (in vitro) 20 B.7. Irritation – eye 21 B.8. Skin sensitisation 22 B.9. Repeat dose toxicity 23 B.10. Genotoxicity – bacteria 25 B.11. Genotoxicity – in vitro 26 Appendix C: Environmental Fate and Ecotoxicological Investigations 28 C.1. Environmental Fate 28 C.1.1. Ready biodegradability 28 C.2. Ecotoxicological Investigations 28 C.2.1. Acute toxicity to fish 28 C.2.2. Acute toxicity to aquatic invertebrates 29 C.2.3. Algal growth inhibition test 30 C.2.4. Inhibition of microbial activity 30 BIBLIOGRAPHY 32
72-hour observations. Moderate conjunctival irritation was observed at the 1, 24 and 48-hour observations. At the 72-hour observation, moderate conjunctival irritation was observed in two treated eyes with minimal conjunctival irritation noted in one treated eye. At the 7-day observation, minimal conjunctival irritation was observed in all treated eyes. All effects disappeared at the 14-day observation. The body weight gain was normal for all animals. The notified chemical is irritating to the eye. Envigo Research Limited (2016b) Skin sensitisation Notified chemical OECD TG 406 Skin Sensitisation - Magnusson and Kligman method. EC Directive 96/54/EC B.6 Skin Sensitisation - Magnusson and Kligman method. Species/Strain Guinea pig/Dunkin-Hartley preliminary study Maximum Non-irritating Concentration: 100% intradermal: 10%, 20%, 50% and 100% topical: 10%, 20%, 50% and 100% main study 1 Number of Animals Test Group: 10 F Control Group: 5 F induction phase Induction Concentration: intradermal: 10% topical: 100% Signs of Irritation Dryness of the skin was observed in all animals in the test group after the second induction. challenge phase 1st challenge topical: 100% 2nd challenge topical: 100% main study 2 Number of Animals Test Group: 10 F Control Group: 5 F induction phase Induction Concentration: intradermal: 10% topical: 100% Signs of Irritation Discrete erythema was observed in 4 animals in the test group after the first induction. Dryness of the skin was observed in all animals in the test group and three animals in the control group after the second induction. challenge phase challenge topical: 100% Vehicle Olive oil for the intradermal injections and liquid paraffin for the topic applications Positive control Not conducted in parallel with the test substance, but had been conducted previously in the test laboratory using α-hexylcinnamaldehyde. Remarks - Method Minor deviations were not considered to affect the purpose or integrity of the study. As it appeared that the vehicle was having some impact on the results in the first test, a second test was conducted with 5 new control animals and 10 treated animals in the same experimental conditions except that no second challenge was conducted. Test 1 Animal Challenge Concentration Number of Animals Showing Skin Reactions after: