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EC number: 233-634-3
CAS number: 10287-53-3
The potential for the test material to cause developmental toxicity via the oral route in the rat was investigated in a study conducted in accordance with the standardised guideline OECD 414 under GLP conditions.
The test material was administered by gavage to pregnant Wistar rats from gestation days (GD) 6 to 19 at daily doses of 40, 200, and 1000 mg/Kg. The control rats in group 1 were treated with the vehicle Miglyol 812 neutral oil. The foetuses were delivered by caesarean section on GD 20 and were examined for macroscopic malformations. Half of them were examined for skeletal malformations and half for organ malformations. The terminal body weights of the dams were recorded.
Rooting in the bedding material was seen in all rats in the mid and high dose groups. alivation was seen in half the animals of the mid and in most animals of the high dose group. None of the animals died. Twenty one to 24 rats out of 25 per group proved to be pregnant.
The body weight gain in the mid dose group was very slightly and in the high dose group clearly reduced. The food consumption was reduced in the high dose group. The water consumption in the mid and high dose groups was dose dependently increased. The terminal body weight and the uterus weight were decreased in the high dose group. The numbers of corpora lutea, implantations and live foetuses were not affected. The number of dead foetuses, complete, early and late resorptions were not increased. The sex distribution was not affected in any of the groups. The foetuses in the mid dose group were slightly and in the high dose group clearly lighter than those of the controls.
Despite a trend towards retarded ossification in the mid dose group and a clearly retarded ossification in the high dose group, corresponding to the low foetus weights, the skeletal examinations gave no indication of malformations attributable to the treatment with the test material. The frequency of all malformations was in a usual range.
In conclusion, the dose of 40 mg/kg of test material was systemically tolerated by the rats. The dose of 200 mg/kg led to slight maternotoxic effects, such as rooting in the bedding material, salivation, slightly reduced body weight gain and higher water consumption. The foetuses were slightly lighter and there was a trend towards lower ossification. The dose of 1000 mg/kg led to clear maternotoxic effects, expressed by salivation and rooting in the bedding material, reduced body weight gain and reduced food consumption. The foetuses were clearly lighter and the ossification was retarded at 1000 mg/kg/day.
Under the conditions of this study, the no observed adverse effect level (NOAEL) for maternal toxicity and for developmental toxicity was 200 mg/kg/day. At 1000 mg/kg/day, a lower maternal bodyweight was associated to the lower foetuses bodyweight and retarded skeletal ossification. No teratogenic effect was found in this study.
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