Gavage, 5 000 mg/kg (dose volume of 5.90 mL/kg) Method of administration: OECD TG 401 Test method: No signs of systemic toxicity Clinical observations: Nil Mortality: No abnormalities detected Morphological findings: > 5 000 mg/kg LD50: SOP was of very low acute oral toxicity in rats Result: 9.1.2.1 Dermal Toxicity (Safepharm Laboratories Limited, 1998c) SDP Test substance: Rat/Sprague Dawley Species/strain: 5/sex Number/sex of animals: 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 sites were observed for evidence of dermal irritation approximately 30 minutes after bandage removal and on Days 3, 7, 10 and 14 No signs of systemic toxicity Clinical observations: OECD TG 402 Test method: Nil Mortality: No abnormalities detected Morphological findings: No of skin irritation Dermal responses: > 2 000 mg/kg LD50: SDP was of low dermal toxicity in rats Result: 9.1.2.2 Dermal Toxicity (Safepharm Laboratories Limited, 1998p) SOP Test substance: Rat/Sprague Dawley Species/strain: 5/sex Number/sex of animals:
Method of administration: Gavage, 5 000 mg/kg (dose volume of 5.90 mL/kg) Test method: OECD TG 401 Clinical observations: No signs of systemic toxicity Mortality: Nil Morphological findings: No abnormalities detected LD50: > 5 000 mg/kg Result: SOP was of very low acute oral toxicity in rats 9.1.2.1 Dermal Toxicity (Safepharm Laboratories Limited, 1998c) Test substance: SDP Species/strain: Rat/Sprague Dawley Number/sex of animals: 5/sex 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 sites were observed for evidence of dermal irritation approximately 30 minutes after bandage removal and on Days 3, 7, 10 and 14 Clinical observations: No signs of systemic toxicity Test method: OECD TG 402 Mortality: Nil Morphological findings: No abnormalities detected Dermal responses: No of skin irritation LD50: > 2 000 mg/kg Result: SDP was of low dermal toxicity in rats 9.1.2.2 Dermal Toxicity (Safepharm Laboratories Limited, 1998p) Test substance: SOP Species/strain: Rat/Sprague Dawley Number/sex of animals: 5/sex