Appendix B: Toxicological Investigations Acute toxicity oral – Notified chemical OECD TG 420 Acute Oral Toxicity Fixed Dose Method – Species/Strain Rat/Sprague-Dawley Vehicle Arachis oil BP Remarks - Method No significant protocol deviations Number and Sex Dose Mortality of Animals mg/kg bw 1 1 F 2000 0/1 4 4 F 2000 0/4 LD50 >2000 mg/kg bw Signs of Toxicity There were no signs of systemic toxicity. Effects in Organs There were no remarkable necropsy findings. Remarks - Results None The notified chemical is of low toxicity via the oral route. SafePharm Acute toxicity dermal – Acceptable analogue of notified chemical OECD TG 402 Acute Dermal Toxicity Limit Test. – Species/Strain Rat/Sprague-Dawley Vehicle Test substance administered as supplied. Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. Number and Sex Dose Mortality of Animals mg/kg bw 5 M 2000 0/5 5 F 2000 0/5 LD50 >2000 mg/kg bw Signs of Toxicity - Local None Signs of Toxicity - Systemic There were no treatment related clinical signs observed. Effects in Organs were no treatment related effects observed in organs. Remarks - Results None The notified chemical, based on its similarity to the analogue, may be expected to be of low toxicity via the dermal route. Safepharm (2006a)
Appendix B: Toxicological Investigations Acute toxicity – oral Notified chemical OECD TG 420 Acute Oral Toxicity – Fixed Dose Method Species/Strain Rat/Sprague-Dawley Vehicle Arachis oil BP Remarks - Method No significant protocol deviations Number and Sex of Animals Dose mg/kg bw Mortality 1 1 F 2000 0/1 4 4 F 2000 0/4 LD50 >2000 mg/kg bw Signs of Toxicity There were no signs of systemic toxicity. Effects in Organs There were no remarkable necropsy findings. Remarks - Results None The notified chemical is of low toxicity via the oral route. SafePharm Acute toxicity – dermal Acceptable analogue of notified chemical OECD TG 402 Acute Dermal Toxicity – Limit Test. Species/Strain Rat/Sprague-Dawley Vehicle Test substance administered as supplied. Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. Number and Sex of Animals Dose mg/kg bw Mortality 5 M 2000 0/5 5 F 2000 0/5 LD50 >2000 mg/kg bw Signs of Toxicity - Local None Signs of Toxicity - Systemic There were no treatment related clinical signs observed. Effects in Organs were no treatment related effects observed in organs. Remarks - Results None The notified chemical, based on its similarity to the analogue, may be expected to be of low toxicity via the dermal route. Safepharm (2006a)