Appendix B: Toxicological Investigations Acute toxicity oral – Notified chemical (purity >87%) OECD TG 420 Oral Toxicity Fixed Dose Procedure. – EC Directive 92/69/EEC B.1 bis Acute toxicity (oral) fixed dose method. Species/Strain Rat/Wistar Vehicle Arachis oil BP Remarks - Method No significant protocol deviations Group Number and Sex Dose Mortality of Animals mg/kg bw I 1 F 300 0 II 1 F 2000 0 III 4 F 2000 0 LD50 >2000 mg/kg bw Signs of Toxicity There were no deaths and no sign of systemic toxicity. Effects in Organs No abnormalities were noted at necropsy. Remarks - Results All animals showed expected gains in bodyweight. Pale faeces were noted in one animal at the 4-hour, day 1 and day 2 observations. The notified chemical is of low toxicity via the oral route. Harlan Laboratories Ltd (2010e) Acute toxicity dermal – Notified chemical (purity >87%) OECD TG 402 Acute Dermal Toxicity Limit Test. – EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal) Limit Test. – Species/Strain Rat/Wistar Vehicle None Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations Group Number and Sex Dose Mortality of Animals mg/kg bw I 1 M 2000 0 II 1 F 2000 0 III 4 M 2000 0 IV 4 F 2000 0 LD50 >2000 mg/kg bw Signs of Toxicity - Local Increased respiratory rate and/or hunched posture were noted in two animals. Signs of Toxicity - Systemic There were no deaths and no signs of systemic toxicity were noted. Effects in Organs No abnormalities were in any animal at necropsy. Remarks - Results
Appendix B: Toxicological Investigations Acute toxicity – oral Notified chemical (purity >87%) OECD TG 420 Oral Toxicity – Fixed Dose Procedure. EC Directive 92/69/EEC B.1 bis Acute toxicity (oral) fixed dose method. Species/Strain Rat/Wistar Vehicle Arachis oil BP Remarks - Method No significant protocol deviations Group Number and Sex of Animals Dose mg/kg bw Mortality I 1 F 300 0 II 1 F 2000 0 III 4 F 2000 0 LD50 >2000 mg/kg bw Signs of Toxicity There were no deaths and no sign of systemic toxicity. Effects in Organs No abnormalities were noted at necropsy. Remarks - Results All animals showed expected gains in bodyweight. Pale faeces were noted in one animal at the 4-hour, day 1 and day 2 observations. The notified chemical is of low toxicity via the oral route. Harlan Laboratories Ltd (2010e) Acute toxicity – dermal Notified chemical (purity >87%) OECD TG 402 Acute Dermal Toxicity – Limit Test. EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal) – Limit Test. Species/Strain Rat/Wistar Vehicle None Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations Group Number and Sex of Animals Dose mg/kg bw Mortality I 1 M 2000 0 II 1 F 2000 0 III 4 M 2000 0 IV 4 F 2000 0 LD50 >2000 mg/kg bw Signs of Toxicity - Local Increased respiratory rate and/or hunched posture were noted in two animals. Signs of Toxicity - Systemic There were no deaths and no signs of systemic toxicity were noted. Effects in Organs No abnormalities were in any animal at necropsy. Remarks - Results
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