Appendix B: Toxicological Investigations Acute toxicity oral – Analogue 1 OECD TG 401 Acute Oral Toxicity Limit Test. – EC Directive 92/69/EEC B.1 Acute Toxicity (Oral) Limit Test. – Species/Strain Rat/Wistar Vehicle Peanut oil Remarks - Method No significant protocol deviations. Group Number and Sex Dose Mortality of Animals mg/kg bw 1 5 (M) 2000 0 2 5 (F) 2000 0 LD50 >2000 mg/kg bw of Toxicity The male animals did not show any signs of toxicity for the duration of the study (14 days). However, one female animal had slightly reddish coloured nose after 4-24 hours. No further symptoms were observed up to 14 days. Effects in Organs No special finding was noticed in male animals. In female animals, one animal had hydrometra, was not thought to be test-substance related. Remarks - Results All animals gained weight by the end of the study (Day 14). However, weight gain was more pronounced in male animals. The notified polymer is of low toxicity via the oral route. Institute for Toxicology (1989a) Acute toxicity dermal – Analogue 2 EC Directive 79/831/EEC B.3 Acute Toxicity (Dermal) Limit Test. – Species/Strain Rat/Sprague-Dawley Vehicle None Type of dressing occlusive Remarks - Method Only the summary of the test report was provided in English and details of any protocol deviations are not available. Five rats per sex were tested at one dose level. Number and Sex Dose Mortality of Animals mg/kg bw I 5 M / 5 F 2000 0 LD50 > 2000 mg/kg bw Signs of Toxicity - Local No signs of local toxicity were observed. Signs of Toxicity - Systemic No signs of systemic toxicity were observed. Effects in Organs No pathological findings. The test substance is of low toxicity via the dermal route.
Appendix B: Toxicological Investigations Acute toxicity – oral Analogue 1 OECD TG 401 Acute Oral Toxicity – Limit Test. EC Directive 92/69/EEC B.1 Acute Toxicity (Oral) – Limit Test. Species/Strain Rat/Wistar Vehicle Peanut oil Remarks - Method No significant protocol deviations. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5 (M) 2000 0 2 5 (F) 2000 0 LD50 >2000 mg/kg bw of Toxicity The male animals did not show any signs of toxicity for the duration of the study (14 days). However, one female animal had slightly reddish coloured nose after 4-24 hours. No further symptoms were observed up to 14 days. Effects in Organs No special finding was noticed in male animals. In female animals, one animal had hydrometra, was not thought to be test-substance related. Remarks - Results All animals gained weight by the end of the study (Day 14). However, weight gain was more pronounced in male animals. The notified polymer is of low toxicity via the oral route. Institute for Toxicology (1989a) Acute toxicity – dermal Analogue 2 EC Directive 79/831/EEC B.3 Acute Toxicity (Dermal) – Limit Test. Species/Strain Rat/Sprague-Dawley Vehicle None Type of dressing occlusive Remarks - Method Only the summary of the test report was provided in English and details of any protocol deviations are not available. Five rats per sex were tested at one dose level. Number and Sex of Animals Dose mg/kg bw Mortality I 5 M / 5 F 2000 0 LD50 > 2000 mg/kg bw Signs of Toxicity - Local No signs of local toxicity were observed. Signs of Toxicity - Systemic No signs of systemic toxicity were observed. Effects in Organs No pathological findings. The test substance is of low toxicity via the dermal route.
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