Appendix B: Toxicological Investigations Acute toxicity oral – Analogue 1 (identity in Exempt Information) OECD TG 401 Acute Oral Toxicity Limit Test. – Species/Strain Rat/Sprague-Dawley Vehicle None Remarks - Method No significant protocol deviations Number and Sex Dose Mortality of Animals mg/kg bw 1 5F 5004 0/5 2 5M 5004 0/5 LD50 > 5004 mg/kg bw Signs of Toxicity No abnormal clinical signs were noted. Effects in Organs No treatment-related macroscopic findings were noted at necropsy. Remarks - Results All animals showed expected body weight changes. The test substance is of low toxicity via the oral route. Pharmakon Acute toxicity dermal – Analogue 1 (identity in Exempt Information) OECD TG 402 Acute Dermal Toxicity Limit Test. – Species/Strain Rat/ Sprague-Dawley Vehicle None Type of dressing Semi-occlusive Remarks - Method No significant protocol deviations Number and Sex Dose Mortality of Animals mg/kg bw 1 5F 2006 0/5 2 5M 2006 0/5 LD50 > 2006 mg/kg bw Signs of Toxicity - Local No erythema or oedema was Signs of Toxicity - Systemic No abnormal clinical signs were noted. Effects in Organs No treatment-related macroscopic findings were noted at necropsy. Remarks - Results There were no treatment-related effects on body weight. The test substance is of low toxicity via the dermal route. Pharmakon (1997b) Irritation skin – Analogue 1 (identity in Exempt Information) OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New Zealand
Appendix B: Toxicological Investigations Acute toxicity – oral Analogue 1 (identity in Exempt Information) OECD TG 401 Acute Oral Toxicity – Limit Test. Species/Strain Rat/Sprague-Dawley Vehicle None Remarks - Method No significant protocol deviations Number and Sex of Animals Dose mg/kg bw Mortality 1 5F 5004 0/5 2 5M 5004 0/5 LD50 > 5004 mg/kg bw Signs of Toxicity No abnormal clinical signs were noted. Effects in Organs No treatment-related macroscopic findings were noted at necropsy. Remarks - Results All animals showed expected body weight changes. The test substance is of low toxicity via the oral route. Pharmakon Acute toxicity – dermal Analogue 1 (identity in Exempt Information) OECD TG 402 Acute Dermal Toxicity – Limit Test. Species/Strain Rat/ Sprague-Dawley Vehicle None Type of dressing Semi-occlusive Remarks - Method No significant protocol deviations Number and Sex of Animals Dose mg/kg bw Mortality 1 5F 2006 0/5 2 5M 2006 0/5 LD50 > 2006 mg/kg bw Signs of Toxicity - Local No erythema or oedema was Signs of Toxicity - Systemic No abnormal clinical signs were noted. Effects in Organs No treatment-related macroscopic findings were noted at necropsy. Remarks - Results There were no treatment-related effects on body weight. The test substance is of low toxicity via the dermal route. Pharmakon (1997b) Irritation – skin Analogue 1 (identity in Exempt Information) OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New Zealand
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