TABLE OF CONTENTS FULL PUBLIC REPORT 3 1. APPLICANT AND NOTIFICATION DETAILS 3 2. IDENTITY OF CHEMICAL 4 3. COMPOSITION 4 4. INTRODUCTION AND USE INFORMATION 4 5. PROCESS AND RELEASE INFORMATION 4 5.1. Distribution, transport and storage 5 5.2. Operation description 5 5.3. Occupational exposure 5 5.4. Release 6 5.5. Disposal 7 5.6. Public exposure 7 6. PHYSICAL AND CHEMICAL PROPERTIES 7 7. TOXICOLOGICAL INVESTIGATIONS 9 7.1. Acute toxicity – oral 10 7.2. Irritation – skin 11 7.3. Irritation – eye 11 7.4. Skin sensitisation 12 8. ENVIRONMENT 13 8.1. Environmental fate 13 8.1.2. Bioaccumulation 13 8.2. Ecotoxicological investigations 13 8.2.1(a). toxicity to fish 13 8.2.1(b). Acute toxicity to fish 14 8.2.2. Acute toxicity to aquatic invertebrates 14 9. RISK ASSESSMENT 15 9.1. Environment 15 9.1.1. Environment – exposure assessment 15 9.1.2. Environment – effects assessment 16 9.1.3. Environment – risk characterisation 17 9.2. health 17 9.2.1. Occupational health and safety – exposure assessment 17 9.2.2. Public health – exposure assessment 17 9.2.3. health – effects assessment 17 9.2.4. Occupational health and safety – risk characterisation 18 9.2.5. Public health – risk characterisation 18 10. CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND HUMANS 18 10.1. Hazard classification 18 10.2. Environmental risk assessment 18 10.3. Human health risk assessment 18 10.3.1. Occupational health and safety 18 10.3.2. Public health 18 11. MATERIAL SAFETY DATA SHEET 18 11.1. Material Safety Data 18 11.2. Label 19 12. RECOMMENDATIONS 19 12.1. Secondary notification 20 13. BIBLIOGRAPHY 20
Conjunctiva: redness 0.3 1 < 96 h 0 Conjunctiva: chemosis 0 0 0 0 Conjunctiva: discharge 0 1 < 24 h 0 Corneal opacity 0 0 0 0 Iridial inflammation 0 0 0 0 *Calculated on the of the scores at 24, 48, and 72 hours for ALL animals. Remarks - Results Slight conjunctival inflammation was observed in all six test animals one hour after instillation. Slight conjunctival discharge was observed in two of the animals one hour after instillation, but this had resolved 24 hours after instillation. The number of animals affected decreased over the test period, with no animals affected 96 hours after instillation. The notified polymer is slightly irritating to the eye. Hoechst-Roussel 7.4. Skin sensitisation Notified polymer (~90% purity) In house method. Species/Strain Guinea pig/Hartley-derived albino preliminary study Maximum Non-irritating Concentration: topical: 100% main study Number of Animals Test Group: 5M, 5F Control Group: 5M, 5F induction Induction Concentration: topical: 100% of Irritation Slight, patchy erythema (score of ) was observed in 7 of the 10 animals. challenge phase 1st challenge topical: 100% Remarks - Method The only significant protocol deviations from OECD TG 406 Skin Sensitisation – Buehler were: The number of animals in the test group was only half the number required by OECD TG 406 (20 animals required). The dermal grading system included an additional rating of , (score of 0.5) for slight, patchy erythema. Animal Challenge Concentration Number of Animals Showing Skin Reactions after: 1st challenge 2nd challenge 24 h 48 h 24 h 48 h Test Group 100% 2/10 0/10 Control 100% 3/10 1/10 Remarks - Results The only signs of dermal irritation observed were slight, patchy erythema (a dermal grading score of ). This was observed after 24 hours in 2 of the 10 test animals and 3 of the 10 control animals. Therefore, there was no significant difference between test and control animals. A rechallenge was not performed. The positive control confirmed the sensitivity of the test. There was no evidence of reactions indicative of skin sensitisation to the notified polymer under the conditions of the test.