A single, 24-hour semi occluded, dermal application to Method of administration: intact skin at 2 000 mg/kg (dose volume 2.36 mL/kg) 14 days. Observation period: Treated were observed for evidence of dermal irritation approximately 30 minutes after bandage removal and on Days 3, 7, 10 and 14 No of systemic toxicity Clinical observations: OECD TG 402 Test method: Nil Mortality: No abnormalities detected Morphological findings: No signs of skin irritation Dermal responses: > 2 000 mg/kg LD50: SOP was of low dermal toxicity in rats Result: 9.1.3 Inhalation Toxicity Study not conducted. Not considered to be a relevant route of exposure. 9.1.4.1 Skin Irritation (Safepharm Laboratories Limited, 1998b) SDP Test substance: Rabbit/New Zealand White Species/strain: 6 males Number/sex of animals: 1, 24, 48,72 and 96 hours post exposure Observation period: A single 4-hour semi occluded application of 0.5 mL of neat Method of administration: test substance to intact rabbit skin; OECD TG 404 Test method: Draize scores: Time after Animal # treatment 1 2 3 4 5 6 Erythema/Eschar Formation 30 minutes a2 2 2 2 2 2 24 hours 2 1 1 2 2* 2
Method of administration: A single, 24-hour semi occluded, dermal application to intact skin at 2 000 mg/kg (dose volume 2.36 mL/kg) Observation period: 14 days. Treated were observed for evidence of dermal irritation approximately 30 minutes after bandage removal and on Days 3, 7, 10 and 14 Clinical observations: No of systemic toxicity Test method: OECD TG 402 Mortality: Nil Morphological findings: No abnormalities detected Dermal responses: No signs of skin irritation LD50: > 2 000 mg/kg Result: SOP was of low dermal toxicity in rats 9.1.3 Inhalation Toxicity Study not conducted. Not considered to be a relevant route of exposure. 9.1.4.1 Skin Irritation (Safepharm Laboratories Limited, 1998b) Test substance: SDP Species/strain: Rabbit/New Zealand White Number/sex of animals: 6 males Observation period: 1, 24, 48,72 and 96 hours post exposure Method of administration: A single 4-hour semi occluded application of 0.5 mL of neat test substance to intact rabbit skin; Test method: OECD TG 404 Draize scores: Time after Animal # treatment 1 2 3 4 5 6 Erythema/Eschar Formation 30 minutes a2 2 2 2 2 2 24 hours 2 1 1 2 2* 2
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