Appendix B: Toxicological Investigations Acute toxicity oral (1) – SUBSTANCE Analogue A (87%) OECD TG 401 Acute Oral Toxicity Limit Test. – EC Directive 92/69/EEC B.1 Acute Toxicity (Oral) Limit Test. – Species/Strain Rat/Sprague-Dawley Vehicle None Remarks - Method No significant protocol deviations. RESULTS Dose Number and Sex Mortality mg/kg bw of Animals 2000 5 males 0 2000 5 females 0 LD50 >2000 mg/kg bw Remarks - Results There were no clinical signs of toxicity, any abnormal effects in organs at necropsy, or adverse bodyweight effects. The test substance is of low toxicity via the oral route. Centre International de Toxicologie (CIT) (1996a) Acute toxicity oral (2) – Analogue B (60%) OECD TG 423 Acute Oral Toxicity Acute Toxic Class Method. – EC Directive 92/69/EEC Acute Oral Toxicity Acute Toxic Class – Method. Species/Strain Rat/Sprague-Dawley Vehicle Purified water Remarks - Method No significant protocol deviations. Dose Number and Sex Mortality mg/kg bw of Animals 200 3 males 0 2000 3 males 0 2000 3 males 0 LD50 >2000 mg/kg bw of Toxicity No clinical signs were observed in the animals treated with 200 mg/kg. At the 2000 mg/kg dose-level, hypoactivity was observed in one male 4 hour after treatment, with no signs observed in the other animals. The body weight gain of females given 2000 mg/kg was reduced during the second week of the observation period compared to historical control animals. The body weight gain of other treated animals was not affected by treatment. Effects in Organs None
Appendix B: Toxicological Investigations Acute toxicity – oral (1) Analogue A (87%) OECD TG 401 Acute Oral Toxicity – Limit Test. EC Directive 92/69/EEC B.1 Acute Toxicity (Oral) – Limit Test. Species/Strain Rat/Sprague-Dawley Vehicle None Remarks - Method No significant protocol deviations. Dose mg/kg bw Number and Sex of Animals Mortality 2000 5 males 0 2000 5 females 0 LD50 >2000 mg/kg bw Remarks - Results There were no clinical signs of toxicity, any abnormal effects in organs at necropsy, or adverse bodyweight effects. The test substance is of low toxicity via the oral route. Centre International de Toxicologie (CIT) (1996a) Acute toxicity – oral (2) Analogue B (60%) OECD TG 423 Acute Oral Toxicity – Acute Toxic Class Method. EC Directive 92/69/EEC Acute Oral Toxicity – Acute Toxic Class Method. Species/Strain Rat/Sprague-Dawley Vehicle Purified water Remarks - Method No significant protocol deviations. Dose mg/kg bw Number and Sex of Animals Mortality 200 3 males 0 2000 3 males 0 2000 3 males 0 LD50 >2000 mg/kg bw of Toxicity No clinical signs were observed in the animals treated with 200 mg/kg. At the 2000 mg/kg dose-level, hypoactivity was observed in one male 4 hour after treatment, with no signs observed in the other animals. The body weight gain of females given 2000 mg/kg was reduced during the second week of the observation period compared to historical control animals. The body weight gain of other treated animals was not affected by treatment. Effects in Organs None SUBSTANCE RESULTS