Reproductive: P07: Two-generation assessment of reproductive toxicity and teratogenicity of a niacin-bound chromium (III) complex

Abstract

This two-generation study was conducted to evaluate the effects of niacin-bound chromium (III) complex (NBC, commercially known as ChromeMate) on the reproductive systems of male and female rats, the postnatal maturation and reproductive capacity of their offspring. Across two generations, Sprague Dawley rats (30/sex/group) were maintained on feed containing NBC at dose levels of 0 (control), 4, 15, or 60 ppm for 10 weeks prior to mating, during gestation and during lactation. Clinical toxicity signs, body weight and feed consumption were recorded. For the parents (F0 and F1) and the offspring (F1 and F2a), reproductive parameters such as fertility, mating, gestation, parturition, litters, lactation, sexual maturity and development of offspring were assessed. At termination of the study, necropsy and histopathological examinations were performed. NBC supplementation to parental male and female rats of both (F0 and F1) generations during the premating and mating periods, for both sexes, and during gestation and lactation in case of female rats, did not reveal any remarkable frequency of mortality or abnormal clinical signs. NBC exposure did not affect feed consumption, body weight, or reproductive performance as evaluated by sexual maturity, fertility and mating, gestation, parturition, litter properties, lactation and development of the offspring. The parental as well as the offspring no-observed-adverse-effect level (NOAEL) for NBC was thus determined to be greater than 60 ppm in diet or equivalent to 7.80 and 8.31 mg/kg body weight/day in male and female rats, respectively. This study in conjunction with earlier studies reconfirmed the safety of NBC for human consumption.