Mixture containing 30-70% Analogue 1 and < 70% Analogue 2 OECD TG 402 Dermal Toxicity Limit Test. – EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal) Limit Test. – Species/Strain Rat/ Sprague-Dawley CD (Crl:CD BR) Vehicle Test substance administered as supplied Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. GLP compliant. Group Number and Sex Dose Mortality of Animals mg/kg bw 1 5/Sex 2000 0/10 LD50 > 2000 mg/kg bw of Toxicity - Local There were no signs of skin irritation. Signs of Toxicity - Systemic There were no signs of systemic toxicity. All animals showed an expected gain in bodyweight during the study. Effects in Organs No abnormalities were noted at necroscopy. Remarks - Results There were no deaths during the study. The mixture containing 30-70% Analogue 1 and < 70% Analogue 2 is of low toxicity via the dermal route. Safepharm Laboratories (1998b) Acute toxicity dermal – Analogue 3 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 CD (Crl:CD BR) Vehicle Test substance administered as supplied Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. GLP compliant. 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 There were no signs of skin irritation. Signs of Toxicity - Systemic There were no signs of systemic toxicity. All animals showed an expected gain in bodyweight during the study. Effects in Organs No abnormalities were at necroscopy. Remarks - Results There were no deaths during the study. Analogue 3 is of low toxicity via the dermal route. Safepharm Laboratories (1999d) Acute toxicity dermal – Analogue 4
Mixture containing 30-70% Analogue 1 and < 70% Analogue 2 OECD TG 402 Dermal Toxicity – Limit Test. EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal) – Limit Test. Species/Strain Rat/ Sprague-Dawley CD (Crl:CD BR) Vehicle Test substance administered as supplied Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. GLP compliant. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5/Sex 2000 0/10 LD50 > 2000 mg/kg bw of Toxicity - Local There were no signs of skin irritation. Signs of Toxicity - Systemic There were no signs of systemic toxicity. All animals showed an expected gain in bodyweight during the study. Effects in Organs No abnormalities were noted at necroscopy. Remarks - Results There were no deaths during the study. The mixture containing 30-70% Analogue 1 and < 70% Analogue 2 is of low toxicity via the dermal route. Safepharm Laboratories (1998b) Acute toxicity – dermal Analogue 3 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 CD (Crl:CD BR) Vehicle Test substance administered as supplied Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. GLP compliant. 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 There were no signs of skin irritation. Signs of Toxicity - Systemic There were no signs of systemic toxicity. All animals showed an expected gain in bodyweight during the study. Effects in Organs No abnormalities were at necroscopy. Remarks - Results There were no deaths during the study. Analogue 3 is of low toxicity via the dermal route. Safepharm Laboratories (1999d) Acute toxicity – dermal Analogue 4
STD1235FR.docx