Appendix B: Toxicological Investigations Acute toxicity oral – Notified Chemical Similar to OECD TG 401 Acute Oral Toxicity Limit Test. – Species/Strain Rat/Sprague-Dawley Vehicle None Remarks Method No significant protocol deviations. – Group Number and Sex Dose Mortality of Animals mg/kg bw I 5 M 5000 0 II 5 F 5000 0 LD50 > 5000 mg/kg bw Signs of Toxicity There were no deaths or remarkable bodyweight changes. Clinical signs such as salivation, diarrhoea, decreased activity were observed in some of the animals in both groups. Decreased respiratory rate was observed in two female rats in the group. Effects in Organs There were no remarkable necropsy findings. Remarks - Results All animals showed expected body weight gains during the study. The notified chemical is of low toxicity via the oral route. Food and Drug Research (1985a) Acute toxicity dermal – Notified chemical Similar to OECD TG 402 Acute Dermal Toxicity Limit Test. – Species/Strain Rabbits/New Zealand White Vehicle None Type of dressing Occlusive Remarks - Method No significant protocol deviations. Group Number and Sex Dose Mortality of Animals mg/kg bw I 5 M 2000 0 II 5 F 2000 0 LD50 > 2000 mg/kg bw Signs of Toxicity - Local Test substance application site exhibited well defined erythema and slight Signs of Toxicity - Systemic oedema, at the time of removal of the test material from the skin. There were no deaths or remarkable bodyweight changes. Clinical signs such as soft stools, nasal discharge and anorexia were observed in some of the male rabbits. Effects in Organs There were no remarkable necropsy findings. Remarks - Results All animals showed expected body weight gains during the study. The notified chemical is of low toxicity via the dermal route. Food and Drug Research
Appendix B: Toxicological Investigations Acute toxicity – oral Notified Chemical Similar to OECD TG 401 Acute Oral Toxicity – Limit Test. Species/Strain Rat/Sprague-Dawley Vehicle None Remarks – Method No significant protocol deviations. Group Number and Sex of Animals Dose mg/kg bw Mortality I 5 M 5000 0 II 5 F 5000 0 LD50 > 5000 mg/kg bw Signs of Toxicity There were no deaths or remarkable bodyweight changes. Clinical signs such as salivation, diarrhoea, decreased activity were observed in some of the animals in both groups. Decreased respiratory rate was observed in two female rats in the group. Effects in Organs There were no remarkable necropsy findings. Remarks - Results All animals showed expected body weight gains during the study. The notified chemical is of low toxicity via the oral route. Food and Drug Research (1985a) Acute toxicity – dermal Notified chemical Similar to OECD TG 402 Acute Dermal Toxicity – Limit Test. Species/Strain Rabbits/New Zealand White Vehicle None Type of dressing Occlusive Remarks - Method No significant protocol deviations. Group Number and Sex of Animals Dose mg/kg bw Mortality I 5 M 2000 0 II 5 F 2000 0 LD50 > 2000 mg/kg bw Signs of Toxicity - Local Signs of Toxicity - Systemic Test substance application site exhibited well defined erythema and slight oedema, at the time of removal of the test material from the skin. There were no deaths or remarkable bodyweight changes. Clinical signs such as soft stools, nasal discharge and anorexia were observed in some of the male rabbits. Effects in Organs There were no remarkable necropsy findings. Remarks - Results All animals showed expected body weight gains during the study. The notified chemical is of low toxicity via the dermal route. Food and Drug Research
STD-1526-Final-FR.docx