P08: Developmental toxicity assessment of a niacin-bound chromium (III) complex

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The teratogenic potential of a niacin-bound chromium (III) complex (NBC, commercially known as ChromeMate) was investigated in a multi-generation reproduction toxicity model. Sprague-Dawley rat pups (∼30/sex/group) were selected randomly from the F2b generation and were grown to 10–12 weeks before mating to start the teratology study. NBC exposure was conducted through feed, while the weaning rats had exposure through lactation. The dietary exposure levels of NBC were 0 (control), 4, 15, or 60 ppm. Following mating at maturity, the pregnant rats were observed daily for clinical signs, body weight and feed consumption. On day 20th of the gestation, animals were subjected to necropsy and caesarean section to examine the uterus, ovaries and fetuses for assessment of different parameters of pregnancy and embryo-fetal defects which included death, structural anomalies and altered or retarded growth. A slight (10%) increase of maternal body weight gain during gestation period in the group receiving 60 ppm NBC was observed. However, there was no evidence of any adverse effects on the parameters evaluated for the maternal toxicity, gravid uteri, external abnormalities, soft tissue abnormalities, or skeletal abnormalities in the fetuses. Overall, NBC was found to be non-teratogenic in Sprague Dawley rats, at different dietary exposure levels up to 60 ppm, equivalent to 1240 mg/kg body weight/day, respectively. The present study demonstrates the broad spectrum safety of NBC.