Appendix B: Toxicological Investigations Toxicological investigations were conducted on notified chemical with a purity of >90%. Acute toxicity oral – Notified chemical OECD TG 423 Acute Oral Toxicity Acute Toxic Class Method. – EC Directive 92/69/EEC B.1tris Acute Oral Toxicity Acute Toxic Class – Method. Species/Strain Rat/Sprague-Dawley CD Vehicle Distilled water Remarks - Method No significant protocol deviations. Group Number and Sex Dose Mortality of Animals mg/kg bw 1 3 (F) 2000 0 2 3 (M) 2000 0 LD50 >2000 mg/kg bw Signs of Toxicity Clinical signs of toxicity noted were dark red-coloured diarrhoea and coloured staining of the urine and faeces. Animals recovered two or four days after dosing. There were no deaths. Effects in Organs No abnormalities were noted at necropsy. Remarks - Results All animals showed an expected gain in bodyweight during the study. The notified chemical is of low toxicity via the oral route. SafePharm Laboratories Ltd (2000f) Acute toxicity dermal – Notified chemical 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 Vehicle Test material was moistened with distilled water. Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. The animals were observed for fourteen days after the day of treatment and were then killed for gross pathological examination. Group Number and Sex Dose Mortality of Animals mg/kg bw 1 5 2000 0 2 5 2000 0 LD50 >2000 mg/kg bw Signs of Toxicity - Local No signs of dermal irritation were noted during the study. Pink-coloured staining was noted at the treatment sites of all animals one to three days after dosing. The staining prevented the accurate evaluation of erythema at the treatment sites of all animals one day after dosing.
Appendix B: Toxicological Investigations Toxicological investigations were conducted on notified chemical with a purity of >90%. Acute toxicity – oral Notified chemical OECD TG 423 Acute Oral Toxicity – Acute Toxic Class Method. EC Directive 92/69/EEC B.1tris Acute Oral Toxicity – Acute Toxic Class Method. Species/Strain Rat/Sprague-Dawley CD Vehicle Distilled water Remarks - Method No significant protocol deviations. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 3 (F) 2000 0 2 3 (M) 2000 0 LD50 >2000 mg/kg bw Signs of Toxicity Clinical signs of toxicity noted were dark red-coloured diarrhoea and staining of the urine and faeces. Animals recovered two or four days after dosing. There were no deaths. Effects in Organs No abnormalities were noted at necropsy. Remarks - Results All animals showed an expected gain in bodyweight during the study. The notified chemical is of low toxicity via the oral route. SafePharm Laboratories Ltd (2000f) Acute toxicity – dermal Notified chemical 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 Vehicle Test material was moistened with distilled water. Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. The animals were observed for fourteen days after the day of treatment and were then killed for gross pathological examination. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5 2000 0 2 5 2000 0 LD50 >2000 mg/kg bw Signs of Toxicity - Local No signs of dermal irritation were noted during the study. Pink-coloured staining was noted at the treatment sites of all animals one to three days after dosing. The staining prevented the accurate evaluation of erythema at the treatment sites of all animals one day after dosing. coloured