5/sex Number/sex of animals: 15 days Observation period: 5 000 mg/kg bodyweight, (dose volume of 5.29 mL/kg ) Method of administration: OECD TG 401 Test method: No signs of systemic toxicity noted Clinical observations: Nil Mortality: No abnormalities noted Morphological findings: > 5 000 mg/kg bodyweight LD50: OGA 499 was of very low acute oral toxicity in rats. Result: 9.1.2 Dermal Toxicity (Safepharm Laboratories Limited 1998b) Rat/Sprague Dawley CD Species/strain: 5/sex Number/sex of animals: 2 000 mg/kg (dose volume 2.12 mL/kg) held under semi Method of administration: occlusive dressing for 24 hours; after the treatment period, the dressing was removed and the treated site wiped clean with cotton wool moistened with liquid paraffin 14 days. Observation period: The treated sites were observed for evidence of dermal irritation approximately 30 minutes after dressing removal and on Days 3, 7, 10 and 14 No signs of toxicity noted Clinical observations: OECD TG 402 Test method: Nil Mortality: No abnormalities noted Morphological findings: Draize scores: Animal # males females Time 1 2 3 4 5 6 7 8 9 10 Treatment:
Number/sex of animals: 5/sex Observation period: 15 days Method of administration: 5 000 mg/kg bodyweight, (dose volume of 5.29 mL/kg ) Test method: OECD TG 401 Clinical observations: No signs of systemic toxicity noted Mortality: Nil Morphological findings: No abnormalities noted LD50: > 5 000 mg/kg bodyweight Result: OGA 499 was of very low acute oral toxicity in rats. 9.1.2 Dermal Toxicity (Safepharm Laboratories Limited 1998b) Species/strain: Rat/Sprague Dawley CD Number/sex of animals: 5/sex Method of administration: 2 000 mg/kg (dose volume 2.12 mL/kg) held under semi occlusive dressing for 24 hours; after the treatment period, the dressing was removed and the treated site wiped clean with cotton wool moistened with liquid paraffin Observation period: 14 days. The treated sites were observed for evidence of dermal irritation approximately 30 minutes after dressing removal and on Days 3, 7, 10 and 14 Clinical observations: No signs of toxicity noted Test method: OECD TG 402 Mortality: Nil Morphological findings: No abnormalities noted Draize scores: Time Treatment: Animal # males females 1 2 3 4 5 6 7 8 9 10