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EC number: 309-665-4 | CAS number: 100683-96-3
The subject of this study was the Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test in the Rat according to OECD 422 and OECD guidance document 43. The guideline is designed for use with the rat, which is the preferred rodent species for reproduction toxicity testing. The purpose of this study is to obtain information on the possible toxic effects of the test item following repeated (daily) administration by oral gavage to Wistar rats at 3 dose levels. The study also included a 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 and parturition, and also on the development of the F1 offspring from conception to Day 4 post-partum.
The dose levels were 0, 150, 400 and 1000 mg/kg bw/d, and vehice use was water. There was no mortality during the study. There were no clinical signs related to treatment. There were no toxicologically significant changes in the animal behaviour, general physical condition or in the reactions to different type of stimuli in the control or treated groups. The results of the landing foot splay test, fore and hind limbgrip strengthevaluation and motor activity measurements were comparable with the control mean in all treated groups in males and females. There was no adverse effect on body weight or body weight gain. There was no effect of treatment on food consumption. There was no effect of treatment on haematology parameters, blood coagulation or urinalysis parameters.
For clinical chemistry parameters, slightly higher serum protein values were measured in both sexes, slightly increased creatinine in males at 1000 mg/kg bw/day and slightly increased cholesterol concentration in females at 400 and 1000 mg/kg bw/day. The changes were of low magnitude, values were within the normal historical range, were not consistent between sexes and not associated with any morphological changes, therefore were not considered to be adverse. There was no effect of treatment noted during evaluation of the reproductive parameters. There were no adverse effects on the F1 offspring viability, clinical signs or development. There were no treatment related macroscopic findings. There was no adverse effect of treatment on organ weights. Slightly higher liver weights (by 14% for body weight relative value) in males at 1000 mg/kg bw/day, without any structural or relevant clinical pathology changes were not considered to be adverse.
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