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EC number: 947-656-2 | CAS number: -
A study was conducted to evaluate the repeated dose toxicity of the test substance when administered via the dermal route to B6C3F1 mice. The experiment was carried out in compliance with GLP. Groups of 10 male and 10 female mice were exposed to 0, 50, 100, 200, 400 or 800 mg/kg bw/day of the substance in ethanol by dermal application, 5 times per week, for 14 weeks. Mortality, clinical signs and bodyweight were recorded throughout the study. At the end of the study, samples were collected for sperm motility and vaginal cytology evaluations in the 0, 200, 400 and 800 mg/kg bw/day dose groups. At necropsy, a gross macroscopic examination was conducted. Selected organs were weighed and a complete histopathological evaluation was carried out for 0 and 800 mg/kg bw/day mice. All mice survived until the end of the study. The only treatment related clinical finding was irritation of the skin at the site of application in males and females administered 800 mg/kg bw/day. There were no effects on body weight. Weights of the liver and kidney of 800 mg/kg bw/day males and females, liver of 400 mg/kg bw/day females and lung of 800 mg/kg bw/day females were significantly increased compared to the controls. Epididymal spermatozoa concentration was significantly increased in 800 mg/kg bw/day males. Histopathologic lesions of the skin at the site of application included epidermal hyperplasia, sebaceous gland hyperplasia, chronic active inflammation, parakeratosis and ulcer. The incidences and severities of these skin lesions generally increased with increasing dose in males and females. Under the study conditions, the 14 week NOAEL in mice for systemic effects was considered to be 200 mg/kg bw/day and for the local effects 100 mg/kg bw/day (Irwin, 2001).
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