Appendix B: Toxicological Investigations Acute toxicity oral – Notified chemical OECD TG 423 Acute Oral Toxicity Acute Toxic Class Method. – Species/Strain Rat/Albino Crl : CD (SD) Female Vehicle Corn oil Remarks - Method No significant protocol deviations. GLP compliant. Group Number and Sex Dose Mortality of Animals mg/kg bw I 3 Female 2000 0 II 3 Female 2000 0 LD50 > 2000 mg/kg bw Signs of Toxicity There were no deaths. Clinical findings consisted of abnormal excretion (feces smaller than normal and/or decreased defecation). No other abnormal physical signs were noted during the study. Effects in Organs There were no remarkable necropsy findings. Remarks - Results Body weight gains were as expected. The notified chemical is of low toxicity via the oral route. WIL (2008a) Acute toxicity dermal – Notified chemical OECD TG 402 Acute Dermal Toxicity Limit Test. – Species/Strain Rat/Sprague-Dawley CD (Crl : CD (SD) IGS BR) Vehicle Arachis oil was used to moisten the test substance. Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. GLP compliant. Group Number and Sex Dose Mortality of Animals mg/kg bw I 5 per sex 2000 0 LD50 > 2000 mg/kg bw Signs of Toxicity - Local There were no test substance-related dermal reactions. Signs of Toxicity - Systemic There were no deaths or test-substance related clinical signs. There were no signs of systemic toxicity. Effects in Organs No abnormalities were noted at necroscopy Remarks - Results Body weight gains were as expected. The notified chemical is of low toxicity via the dermal route. Safepharm (2008a)
Appendix B: Toxicological Investigations Acute toxicity – oral Notified chemical OECD TG 423 Acute Oral Toxicity – Acute Toxic Class Method. Species/Strain Rat/Albino Crl : CD (SD) Female Vehicle Corn oil Remarks - Method No significant protocol deviations. GLP compliant. Group Number and Sex of Animals Dose mg/kg bw Mortality I 3 Female 2000 0 II 3 Female 2000 0 LD50 > 2000 mg/kg bw Signs of Toxicity There were no deaths. Clinical findings consisted of abnormal excretion (feces smaller than normal and/or decreased defecation). No other abnormal physical signs were noted during the study. Effects in Organs There were no remarkable necropsy findings. Remarks - Results Body weight gains were as expected. The notified chemical is of low toxicity via the oral route. WIL (2008a) Acute toxicity – dermal Notified chemical OECD TG 402 Acute Dermal Toxicity – Limit Test. Species/Strain Rat/Sprague-Dawley CD (Crl : CD (SD) IGS BR) Vehicle Arachis oil was used to moisten the test substance. Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. GLP compliant. Group Number and Sex of Animals Dose mg/kg bw Mortality I 5 per sex 2000 0 LD50 > 2000 mg/kg bw Signs of Toxicity - Local There were no test substance-related dermal reactions. Signs of Toxicity - Systemic There were no deaths or test-substance related clinical signs. There were no signs of systemic toxicity. Effects in Organs No abnormalities were noted at necroscopy Remarks - Results Body weight gains were as expected. The notified chemical is of low toxicity via the dermal route. Safepharm (2008a)
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