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EC number: 425-220-8 | CAS number: 5945-33-5
The potential maternal toxicity and developmental toxicity of CN-1985 were evaluated. The test article, CN-1985, in the vehicle, Mazola® corn oil, was administered to three groups of 25 bred Crl:CD®l(SD)BR rats once daily from gestation days 6 through
19. Dosage levels were 125, 500 and 1000 mg/kg/day administered at a dose volume of 5 ml/kg. A concurrent control group composed of 25 bred females received the vehicle, Mazola® corn oil, on a comparable regimen at 5 ml/kg. The route of administration was oral by gastric intubation. Clinical observations, body weights and food consumption were recorded. On gestation day 20, a laparohysterectomy was performed on all animals.
The uteri and ovaries were examined and the numbers of fetuses, early and late resorptions, total implantations and corpora lutea were recorded. Mean gravid uterine weights and net body weight changes were calculated for each group. The fetuses were weighed, sexed and examined for external, soft tissue and skeletal malformations and variations.
Al maternal animals survived to the scheduled necropsy on gestation day 20. Clinical signs observed in the 125, 500, and 1000 mg/kg/day groups included several changes in general appearance and behavior (animals rubbing their faces on the sides and
bottom of the cage, erratic pawing of the cage sides and bottom, clonic tremors of the forelimbs and/or excessive grooming) and salivation immediately following dose administration. However, al of these findings had subsided by one-hour post-dosing and
no dose relationship was apparent. Therefore, they were not considered to be signs of systemic toxicity, but perhaps an aversion to the taste of the test article or a local irritative effect. Body weight gains and food consumption were unaffected by test article
administration at all dose levels.
Intrauterine growth and survival were unaffected by test article administration at dose levels of 125, 500 and 1000 mg/kg/day. The fetal malformations observed in the treated groups were considered to be spontaneous in origin. The fetal developmental variations
noted in this study were observed infrequently or at a similar frequency in the control group.
Based on the results of this study, the NOAE (no-observed-adverse-effect level) for maternal toxicity and developmental toxicity was considered to be 1000 mg/kg/day.
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