Appendix B: Toxicological Investigations Acute toxicity oral – Notified chemical OECD TG 425 Acute Oral Toxicity: Up-and-Down Procedure. Species/Strain Rat/Wistar Vehicle None Remarks - Method No significant protocol deviations. LD50 >2000 mg/kg bw Remarks - Results No mortality, signs of toxicity, or adverse effects in organs were observed at the dose level of 2000 mg/kg bw. The notified chemical is of low toxicity via the oral route. RCC Acute toxicity dermal – Notified chemical OECD TG 402 Acute Dermal Toxicity. Species/Strain Rat/Wistar Vehicle None Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. LD50 >2000 mg/kg bw Remarks - Results No mortality, signs of toxicity, or adverse effects in organs were observed at the dose level of 2000 mg/kg bw. On test day 5, one animal displayed slight local erythema. The same animal also had slight scaling from day 5 to day 8. The notified chemical is of low toxicity via the dermal route. RCC (2007f) Irritation skin – Notified chemical OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New Zealand Number of Animals 1 male, 2 females Vehicle None Observation Period 10 days Type of Dressing Semi-occlusive. Remarks - Method No significant protocol deviations
Appendix B: Toxicological Investigations Acute toxicity – oral Notified chemical OECD TG 425 Acute Oral Toxicity: Up-and-Down Procedure. Species/Strain Rat/Wistar Vehicle None Remarks - Method No significant protocol deviations. LD50 >2000 mg/kg bw Remarks - Results No mortality, signs of toxicity, or adverse effects in organs were observed at the dose level of 2000 mg/kg bw. The notified chemical is of low toxicity via the oral route. RCC Acute toxicity – dermal Notified chemical OECD TG 402 Acute Dermal Toxicity. Species/Strain Rat/Wistar Vehicle None Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. LD50 >2000 mg/kg bw Remarks - Results No mortality, signs of toxicity, or adverse effects in organs were observed at the dose level of 2000 mg/kg bw. On test day 5, one animal displayed slight local erythema. The same animal also had slight scaling from day 5 to day 8. The notified chemical is of low toxicity via the dermal route. RCC (2007f) Irritation – skin Notified chemical OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New Zealand Number of Animals 1 male, 2 females Vehicle None Observation Period 10 days Type of Dressing Semi-occlusive. Remarks - Method No significant protocol deviations
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