14 days. Observation period: Semi-occluded 24-hour application to intact skin; dose 2000 Method of administration: mg/kg. OECD TG 402 Test method: None. Mortality: No signs of toxicity. Erythema could not be evaluated due to Clinical observations: black staining of the skin one day after dosing and at 8 treatment sites 2 days after dosing. No evidence of skin irritation was noted for the remainder of the observation period. None. Morphological findings: > 2000 mg/kg. LD50: The notified chemical was of low dermal toxicity in rats. Result: 9.1.3 Inhalation Toxicity No data provided. 9.1.3 Skin Irritation (Safepharm Laboratories Ltd, 2000f) rabbit/New Zealand (NZW). Species/strain: 2 females/ 1 male. Number/sex of animals: 72 hours. Observation period: 0.5 g test substance under semi-occluded dressing for 4 Method of administration: hours. OECD TG 404 Test method: Grey coloured staining was observed in all animals at 1 hour Comment: and in one animal at 24 hours post-treatment but this did not affect scoring of irritative effects. No erythema or oedema was observed in any animal at any time point. The notified chemical was not irritating to the skin of Result: rabbits. 9.1.5 Eye Irritation (Safepharm Laboratories Ltd, 2000g) rabbit/NZW. Species/strain:
Observation period: 14 days. Method of administration: Semi-occluded 24-hour application to intact skin; dose 2000 mg/kg. Test method: OECD TG 402 Mortality: None. Clinical observations: No signs of toxicity. Erythema could not be evaluated due to black staining of the skin one day after dosing and at 8 treatment sites 2 days after dosing. No evidence of skin irritation was noted for the remainder of the observation period. Morphological findings: None. LD50: > 2000 mg/kg. Result: The notified chemical was of low dermal toxicity in rats. 9.1.3 Inhalation Toxicity No data provided. 9.1.3 Skin Irritation (Safepharm Laboratories Ltd, 2000f) Species/strain: rabbit/New Zealand (NZW). Number/sex of animals: 2 females/ 1 male. Observation period: 72 hours. Method of administration: 0.5 g test substance under semi-occluded dressing for 4 hours. Test method: OECD TG 404 Comment: Grey coloured staining was observed in all animals at 1 hour and in one animal at 24 hours post-treatment but this did not affect scoring of irritative effects. No erythema or oedema was observed in any animal at any time point. Result: The notified chemical was not irritating to the skin of rabbits. 9.1.5 Eye Irritation (Safepharm Laboratories Ltd, 2000g) Species/strain: rabbit/NZW.
NA930FR.docx