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EC number: 249-828-6 | CAS number: 29761-21-5
The study was performed according to an equivalent of OECD guideline 414, but the treatment period was shorter than required (GD6 -19 in stead of the entire gestation period). 25 female rats/group were treated with 0, 300, 1000 or 3000 mg/kg bw/day. Mortality, clinical signs and body weight of the dams were recorded, uterine examinations were performed to reveal effects on the development of fetuses.
One gravid dam died on GD17 due to hemorrhage in the stomach and was attributed to a gavage error. Some clinical signs were noted but these were not considered of toxicological relevance. No effect on body weight was observed. Necropsy revealed some effects, but these were not considered to be related to treatment. An increase in external malformations was noted for the mid dose group and an increase in visceral malformations for the low dose group, but no dose-related response was observed. Skeletal malformations were observed in the low and high dose group. The effects were not considered to be toxicologically relevant as these were also observed in historical controls.
Under the conditions of this study, no significant or toxicologically relevant adverse effects were noted in the dams and fetuses. A NOAEL of 3000 mg/kg bw/day was established for both maternal and developmental toxicity.
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