Appendix B: Toxicological Investigations Acute toxicity oral – Notified chemical OECD TG 423 Acute Oral Toxicity Acute Toxic Class Method. – Species/Strain Rat/Wistar Vehicle Propylene glycol Remarks - Method No significant protocol deviations were noted. The test substance contains > 10% impurity and no correction was made for the purity. The substance was mixed with the vehicle, heated in a water bath at a maximum temperature of 96 C for 1 h to obtain homogeneity and dosed at 40 C. ≤ Group Number and Sex Dose Mortality of Animals mg/kg bw 1 3F 2000 0/3 2 3F 2000 0/3 LD50 > 2000 mg/kg bw Signs of Toxicity Clinical signs including lethargy, hunched posture and/or piloerection were noted for all animals on Days 1 and/or 2. Effects in Organs No abnormalities were noted at macroscopic post mortem examination. Remarks - Results All animals showed expected body weight development. The notified chemical is of low toxicity via the oral route. WIL (2015a) Acute toxicity dermal – Notified chemical OECD TG 402 Acute Dermal Toxicity Limit Test. – Species/Strain Rat/Wistar Vehicle Propylene glycol Type of dressing Occlusive Remarks - Method No significant protocol deviations were noted. The test substance contains > 10% impurities and no correction was made for the purity. The substance was mixed with the vehicle, heated to a maximum of 93 C for 1 h to obtain visual homogeneity and dosed at < 40 C. Group Number and Sex Dose Mortality of Animals mg/kg bw 1 5M 2000 0/5 2 5F 2000 0/5 LD50 > 2000 mg/kg bw Signs of Toxicity - Local Erythema, fissuring, scales and/or scabs were noted on the treated skin area and/or left flank of all animals. In addition, necrosis of the treated skin area and/or left flank was noted on Days 4-8 for all female animals, with one of them having a wound on the left flank on Days 7 and 8 and scar formation on Days 14 and 15. Signs of Toxicity - Systemic None reported Effects in Organs No abnormalities were noted at macroscopic post mortem examination. Remarks - Results All animals showed expected body weight development.
Appendix B: Toxicological Investigations Acute toxicity – oral Notified chemical OECD TG 423 Acute Oral Toxicity – Acute Toxic Class Method. Species/Strain Rat/Wistar Vehicle Propylene glycol Remarks - Method No significant protocol deviations were noted. The test substance contains > 10% impurity and no correction was made for the purity. The substance was mixed with the vehicle, heated in a water bath at a maximum temperature of 96 C for 1 h to obtain homogeneity and dosed at ≤ 40 C. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 3F 2000 0/3 2 3F 2000 0/3 LD50 > 2000 mg/kg bw Signs of Toxicity Clinical signs including lethargy, hunched posture and/or piloerection were noted for all animals on Days 1 and/or 2. Effects in Organs No abnormalities were noted at macroscopic post mortem examination. Remarks - Results All animals showed expected body weight development. The notified chemical is of low toxicity via the oral route. WIL (2015a) Acute toxicity – dermal Notified chemical OECD TG 402 Acute Dermal Toxicity – Limit Test. Species/Strain Rat/Wistar Vehicle Propylene glycol Type of dressing Occlusive Remarks - Method No significant protocol deviations were noted. The test substance contains > 10% impurities and no correction was made for the purity. The substance was mixed with the vehicle, heated to a maximum of 93 C for 1 h to obtain visual homogeneity and dosed at < 40 C. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5M 2000 0/5 2 5F 2000 0/5 LD50 > 2000 mg/kg bw Signs of Toxicity - Local Erythema, fissuring, scales and/or scabs were noted on the treated skin area and/or left flank of all animals. In addition, necrosis of the treated skin area and/or left flank was noted on Days 4-8 for all female animals, with one of them having a wound on the left flank on Days 7 and 8 and scar formation on Days 14 and 15. Signs of Toxicity - Systemic None reported Effects in Organs No abnormalities were noted at macroscopic post mortem examination. Remarks - Results All animals showed expected body weight development.
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