Signs of Toxicity One male animal was found dead 5 days after dosing. Hunched posture with isolated incidents of ataxia. Effects in Organs No findings. Remarks - Results No necropsy was performed on the animal which was found dead. The notified chemical is of low toxicity via the oral route. Safepharm 7.2. toxicity - dermal Notified chemical. OECD TG 402 Acute Dermal Toxicity Limit Test. – EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal) Limit Test. – Species/Strain Rat/Sprague Dawley. Vehicle Distilled water. Type of dressing Semi-occlusive. Group Number and Sex Dose Mortality of Animals mg/kg bw 1 5/sex 2000 0/10 LD50 > 2000 mg/kg bw Signs of Toxicity - Local Desquamation at the treatment site in one female 3 to 5 days after dosing. Signs of Toxicity - Systemic None. Effects in Organs None. The notified chemical is of low toxicity via the dermal route. Safepharm (1983e). 7.3. Irritation skin – Notified chemical. OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 Vehicle Distilled water. Observation Period 7 days. Type of Dressing Semi-occlusive. Lesion Mean Score* Maximum Value Maximum Maximum Value at Animal No. Duration of Any End of Effect Observation Period 1 2 3 1.33 0.67 1.33 2 3 days 0 Erythema/Eschar 0.67 0 0.67 2 2 days 0 Oedema *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.
Signs of Toxicity One male animal was found dead 5 days after dosing. Hunched posture with isolated incidents of ataxia. Effects in Organs No findings. Remarks - Results No necropsy was performed on the animal which was found dead. The notified chemical is of low toxicity via the oral route. Safepharm 7.2. toxicity - dermal Notified chemical. OECD TG 402 Acute Dermal Toxicity – Limit Test. EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal) – Limit Test. Species/Strain Rat/Sprague Dawley. Vehicle Distilled water. Type of dressing Semi-occlusive. 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 - Local Desquamation at the treatment site in one female 3 to 5 days after dosing. Signs of Toxicity - Systemic None. Effects in Organs None. The notified chemical is of low toxicity via the dermal route. Safepharm (1983e). 7.3. Irritation – skin Notified chemical. OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 Vehicle Distilled water. Observation Period 7 days. Type of Dressing Semi-occlusive. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Erythema/Eschar 1.33 0.67 1.33 2 3 days 0 Oedema 0.67 0 0.67 2 2 days 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.