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EC number: 201-615-9 | CAS number: 85-56-3
A study was conducted to determine repeated dose toxicity of the test substance when administered to Crl:WI Wistar rats according to OECD Guideline 422, in compliance with GLP. The reproductive/developmental toxicity-screening test intended to provide initial information on possible effects on male and female reproductive performance such as gonadal function, mating behaviour, conception, pregnancy, parturition and development of the F1 offspring from conception to post-partum Day (PPD) 4. The details on systemic effects are summarised in section RDT: oral. Male and female Wistar rats were treated for 2 weeks pre-mating and then during the mating/post-mating periods. This was 28 days in total for males. Females were treated throughout gestation and up to and including post-partum/lactation Day (PPD) 4. The test substance, formulated in methyl cellulose, was administered by oral gavage to test animals. One control group and three treated groups were tested (30 mg/kg bw, 100 mg/kg bw and 300 mg/kg bw), each consisting of 12 males and 12 females. The reproductive performance, pregnancy, parturition and post-partum/lactation period were monitored in the adult animals, and viability, clinical signs and development were evaluated in their F1 offspring until post-natal Day (PND) 4. No test substance related changes were noted in the reproductive parameters during mating and gestation, delivery and post-partum/lactation period in any dose groups when compared to control. There were no effects on the F1 offspring viability, clinical signs, development or at macroscopic observations in any dose groups. Under the study conditions, the NOAEL for the test substance was considered to be 100 mg/kg bw/day for parental/adult generation for systemic effects, and 300 mg/kg bw/day for reproduction effects and for the F1/pups generation (Hargitai, 2017).
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