TOXICOLOGICAL INVESTIGATIONS Endpoint and Result Assessment Conclusion Rat, acute oral LD50 2000 mg/kg bw low toxicity Rat, acute oral LD50 >5000 mg/kg bw low toxicity Rat, acute dermal LD50 2000 mg/kg bw low toxicity Rat, inhalation not conducted Rabbit, skin irritation slightly irritating Rabbit, eye irritation slightly irritating Guinea pig, skin sensitisation non-adjuvant test. limited evidence of sensitisation. – Rat, repeat dose oral toxicity 28 days. NOEL <160 mg/kg bw/day – Genotoxicity bacterial reverse mutation non mutagenic – Genotoxicity in vitro chromosomal aberration test non genotoxic – Acute toxicity oral – toxicity oral Initial Test – – TEST SUBSTANCE Notified chemical METHOD EC Directive 92/69/EEC B.1 Toxicity (Oral) Limit Test. – Species/Strain Rat/Sprague-Dawley (CD) Vehicle None Remarks - Method No significant protocol deviations. A preliminary study was carried out on a female rat dosed at 500 or 2000 mg/kg bw, and as a result, 2000 mg/kg bw was chosen as the dose level for the main study. RESULTS Group Number and Sex mg/kg bw Dose of Animals Mortality 1 5/sex 2000 0/10 LD50 2000 mg/kg bw Signs of Toxicity Piloerection in all animals were observed almost immediately after dosing and was accompanied by hunched posture on Day 1. All animals recovered by Day 4. Effects in Organs Macroscopic examination of all animals at termination kill revealed no abnormalities. Remarks - Results Two male animals had slightly low body weight gain on Day 8 and Day 15. All other animals had normal body weight gains through out the study. CONCLUSION The notified chemical is of low toxicity via the oral route. TEST FACILITY Huntingdon Life Sciences Ltd (1996b) Acute toxicity oral Repeat Test – – TEST SUBSTANCE Notified chemical METHOD OECD TG 401 Acute Oral Toxicity Limit Test. – EC Directive 92/69/EEC B.1 Acute Toxicity (Oral) Limit Test. – Toxic Substances Control Act (TSCA) Health Effects Test Guidelines (40 CFR 798.1175).
TOXICOLOGICAL INVESTIGATIONS Endpoint and Result Assessment Conclusion Rat, acute oral LD50 2000 mg/kg bw low toxicity Rat, acute oral LD50 >5000 mg/kg bw low toxicity Rat, acute dermal LD50 2000 mg/kg bw low toxicity Rat, inhalation not conducted Rabbit, skin irritation slightly irritating Rabbit, eye irritation slightly irritating Guinea pig, skin sensitisation – non-adjuvant test. limited evidence of sensitisation. Rat, repeat dose oral toxicity – 28 days. NOEL <160 mg/kg bw/day Genotoxicity – bacterial reverse mutation non mutagenic Genotoxicity – in vitro chromosomal aberration test non genotoxic Acute toxicity – oral toxicity – oral – Initial Test TEST SUBSTANCE Notified chemical METHOD EC Directive 92/69/EEC B.1 Toxicity (Oral) – Limit Test. Species/Strain Rat/Sprague-Dawley (CD) Vehicle None Remarks - Method No significant protocol deviations. A preliminary study was carried out on a female rat dosed at 500 or 2000 mg/kg bw, and as a result, 2000 mg/kg bw was chosen as the dose level for the main study. RESULTS Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5/sex 2000 0/10 LD50 2000 mg/kg bw Signs of Toxicity Piloerection in all animals were observed almost immediately after dosing and was accompanied by hunched posture on Day 1. All animals recovered by Day 4. Effects in Organs Macroscopic examination of all animals at termination kill revealed no abnormalities. Remarks - Results Two male animals had slightly low body weight gain on Day 8 and Day 15. All other animals had normal body weight gains through out the study. CONCLUSION The notified chemical is of low toxicity via the oral route. TEST FACILITY Huntingdon Life Sciences Ltd (1996b) Acute toxicity – oral – Repeat Test TEST SUBSTANCE Notified chemical METHOD OECD TG 401 Acute Oral Toxicity – Limit Test. EC Directive 92/69/EEC B.1 Acute Toxicity (Oral) – Limit Test. Toxic Substances Control Act (TSCA) Health Effects Test Guidelines (40 CFR 798.1175).