Rat, dermal LD50 >2000 mg/kg bw low toxicity Rabbit, skin irritation non-irritating Rabbit, eye irritation slightly irritating Guinea pig, skin sensitisation adjuvant test no evidence – Rat, repeat dose oral toxicity 28 days. NOEL 1000 mg/kg bw/day – Genotoxicity bacterial reverse mutation non mutagenic – Genotoxicity in vitro chromosome aberration test non genotoxic – 7.1. toxicity oral – Notified chemical OECD TG 401 Acute Oral Toxicity-Limit Test. Species/Strain Rat/Wistar (Winkelman strain) Vehicle 1% Carboxymethylcellulose Remarks - Method None. Group Number and Sex Dose Mortality of Animals mg/kg bw 1 5/sex 2000 0/10 2 5/sex 5000 0/10 LD50 >5000 mg/kg bw Signs of Toxicity No clinical symptoms of toxicity. Quieter behaviour was observed in high dose animals after dosing. This was considered to be due to the high dose volume (5 mL/100 g bw), and had regressed within 24 hours. Effects in Organs No anatomical or pathological changes were observed. Remarks - Results None The notified chemical is of low toxicity via the oral route. Pharmatox (1998a) 7.2. Acute toxicity dermal – Notified chemical OECD TG 402 Acute Dermal Toxicity. EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal). Species/Strain Rat/HanIbm: WIST (SPF) Vehicle Polyethylene glycol (PEG) 300 Type of dressing Semi-occlusive Remarks - Method None Group Number and Sex Dose Mortality of Animals mg/kg bw 1 5/sex 2000 0/10 LD50 >2000 mg/kg bw of Toxicity - Local No signs of toxicity Signs of Toxicity - Systemic No signs of toxicity
Rat, dermal LD50 >2000 mg/kg bw low toxicity Rabbit, skin irritation non-irritating Rabbit, eye irritation slightly irritating Guinea pig, skin sensitisation – adjuvant test no evidence Rat, repeat dose oral toxicity – 28 days. NOEL 1000 mg/kg bw/day Genotoxicity – bacterial reverse mutation non mutagenic Genotoxicity – in vitro chromosome aberration test non genotoxic 7.1. toxicity – oral Notified chemical OECD TG 401 Acute Oral Toxicity-Limit Test. Species/Strain Rat/Wistar (Winkelman strain) Vehicle 1% Carboxymethylcellulose Remarks - Method None. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5/sex 2000 0/10 2 5/sex 5000 0/10 LD50 >5000 mg/kg bw Signs of Toxicity No clinical symptoms of toxicity. Quieter behaviour was observed in high dose animals after dosing. This was considered to be due to the high dose volume (5 mL/100 g bw), and had regressed within 24 hours. Effects in Organs No anatomical or pathological changes were observed. Remarks - Results None The notified chemical is of low toxicity via the oral route. Pharmatox (1998a) 7.2. Acute toxicity – dermal Notified chemical OECD TG 402 Acute Dermal Toxicity. EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal). Species/Strain Rat/HanIbm: WIST (SPF) Vehicle Polyethylene glycol (PEG) 300 Type of dressing Semi-occlusive Remarks - Method None Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5/sex 2000 0/10 LD50 >2000 mg/kg bw of Toxicity - Local No signs of toxicity Signs of Toxicity - Systemic No signs of toxicity