Appendix The robust summaries of the (eco)toxicological studies analysed for the assessment of Fluorosurfactant FC-4430 as a new chemical are reproduced here without modification. A.1. HEALTH TOXICITY STUDIES A.1.1 Acute toxicity oral – Test Substance T-7329 Method OECD TG 423 Acute Oral Toxicity Acute Toxic Class Method. EC – Directive 92/69/EEC B.1tris Acute Oral Toxicity Acute Toxic Class – Method. Species/Strain Rat/Wistar Vehicle 1% aqueous carboxymethyl cellulose. Remarks - Method GLP & QA Results Group Number and Sex Dose Mortality of Animals mg/kg bw 1 3/sex 2000 0 LD50 >2000 mg/kg bw Signs of Toxicity On day 1, 5 animals had lethargy, and one female had uncoordinated movements and piloerection. Effects in Organs None. Remarks - Results None. Conclusion The notified polymer is of low toxicity via the oral route. Test Facility NOTOX (2001a). A.1.2 Acute toxicity dermal – Test Substance T-7329 Method OECD TG 402 Acute Dermal Toxicity Limit Test. – EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal) Limit Test. – Species/Strain Rat/Wistar. Vehicle None. Type of dressing Occlusive. Remarks - Method GLP & QA. Results Group Number and Sex Dose Mortality of Animals mg/kg bw 1 5/sex 2000 0
Appendix The robust summaries of the (eco)toxicological studies analysed for the assessment of Fluorosurfactant FC-4430 as a new chemical are reproduced here without modification. A.1. HEALTH TOXICITY STUDIES A.1.1 Acute toxicity – oral Test Substance T-7329 Method OECD TG 423 Acute Oral Toxicity – Acute Toxic Class Method. EC Directive 92/69/EEC B.1tris Acute Oral Toxicity – Acute Toxic Class Method. Species/Strain Rat/Wistar Vehicle 1% aqueous carboxymethyl cellulose. Remarks - Method GLP & QA Results Group Number and Sex of Animals Dose mg/kg bw Mortality 1 3/sex 2000 0 LD50 >2000 mg/kg bw Signs of Toxicity On day 1, 5 animals had lethargy, and one female had uncoordinated movements and piloerection. Effects in Organs None. Remarks - Results None. Conclusion The notified polymer is of low toxicity via the oral route. Test Facility NOTOX (2001a). A.1.2 Acute toxicity – dermal Test Substance T-7329 Method OECD TG 402 Acute Dermal Toxicity – Limit Test. EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal) – Limit Test. Species/Strain Rat/Wistar. Vehicle None. Type of dressing Occlusive. Remarks - Method GLP & QA. Results Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5/sex 2000 0
Fluorosurfactant-FC-4430-secondary-notification-assessment.docx