Remarks - Results All animals survived and showed the expected weight gain during the study. The notified chemical is of low toxicity via the oral route. Safepharm (1997b) Acute toxicity dermal – Notified chemical (approximately 30% concentration) OECD TG 402 Acute Dermal Toxicity Limit Test. – Commission Directive 92/69/EEC B.3 Toxicity (Dermal) Limit – Test. Species/Strain Rat/ Sprague-Dawley Vehicle Test substance administered as supplied Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. Group Number and Sex Dose Mortality of Animals Mg bw 1 5 per sex 2,000 0/10 LDdermal50 > 6,390 mg/kg bw. (equates to > 2,000 mg solids/kg bw) Signs of Toxicity - Local Slight straw-coloured staining was noted at the treatment sites of 8 animals. The staining did not affect evaluation of skin responses. Skin effects at the application site comprised erythema (up to 2), superficial epidermal cracking and desquamation were observed from day 1 up to day 8. All treated skin sites appeared normal on day 9. Signs of Toxicity - Systemic No signs of systemic toxicity were noted during the study. Effects in Organs No abnormalities were noted at necropsy. Remarks - Results All animals survived and showed the expected weight gain during the The notified chemical is of low toxicity via the dermal route. Safepharm Irritation skin – Notified chemical (approximately 93% concentration) OECD TG 404 Acute Dermal Irritation/Corrosion. Commission Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New White Number of Animals 3 Male Vehicle Test substance administered as supplied Observation Period 14 days Type of Dressing Semi-occlusive Remarks - Method No significant protocol deviations. Single 4-hour semi-occlusive application to intact skin. The rabbits were observed for deaths or overt signs of toxicity at 1, 24, 48 and 72 hours post-dosing. Additional observations were made on Days 7 and 14 to assess the reversibility of skin reactions.
Remarks - Results All animals survived and showed the expected weight gain during the study. The notified chemical is of low toxicity via the oral route. Safepharm (1997b) Acute toxicity – dermal Notified chemical (approximately 30% concentration) OECD TG 402 Acute Dermal Toxicity – Limit Test. Commission Directive 92/69/EEC B.3 Toxicity (Dermal) – Limit Test. Species/Strain Rat/ Sprague-Dawley Vehicle Test substance administered as supplied Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. Group Number and Sex of Animals Dose Mg bw Mortality 1 5 per sex 2,000 0/10 LDdermal50 > 6,390 mg/kg bw. (equates to > 2,000 mg solids/kg bw) Signs of Toxicity - Local Slight straw-coloured staining was noted at the treatment sites of 8 animals. The staining did not affect evaluation of skin responses. Skin effects at the application site comprised erythema (up to 2), superficial epidermal cracking and desquamation were observed from day 1 up to day 8. All treated skin sites appeared normal on day 9. Signs of Toxicity - Systemic No signs of systemic toxicity were noted during the study. Effects in Organs No abnormalities were noted at necropsy. Remarks - Results All animals survived and showed the expected weight gain during the The notified chemical is of low toxicity via the dermal route. Safepharm Irritation – skin Notified chemical (approximately 93% concentration) OECD TG 404 Acute Dermal Irritation/Corrosion. Commission Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New White Number of Animals 3 Male Vehicle Test substance administered as supplied Observation Period 14 days Type of Dressing Semi-occlusive Remarks - Method No significant protocol deviations. Single 4-hour semi-occlusive application to intact skin. The rabbits were observed for deaths or overt signs of toxicity at 1, 24, 48 and 72 hours post-dosing. Additional observations were made on Days 7 and 14 to assess the reversibility of skin reactions.
STD1498-FR-FINAL.DOCX