Safety of a novel oxygen-coordinated niacin-bound chromium(III) complex (NBC): I. Two-generation reproduction toxicity study

The objective of this study was to evaluate the effects of a novel oxygen-coordinated niacin-bound chromium(III) complex (NBC) on the reproductive systems of male and female rats, the postnatal maturation and reproductive capacity of their offspring, and possible cumulative effects through multiple generations. Sprague-Dawley rats were maintained on feed containing NBC at dose levels of 0, 4, 15, or 60 ppm for 10 weeks prior to mating, during mating, and, for females through gestation and lactation, across two generations. For the parents (F₀ and F₁) and the offspring (F₁ and F_2a), reproductive parameters such as fertility and mating, gestation, parturition, litters, lactation, sexual maturity and development of offspring were assessed. Results from the current study indicated that dietary exposure of NBC to parental male and female rats of both (F₀ and F₁) the generations during the premating and mating periods, for both sexes, and during gestation and lactation in case of female rats, did not cause any significant incidence of mortality or abnormal clinical signs. Compared to respective controls, NBC exposure did not affect reproductive performance as evaluated by sexual maturity, fertility and mating, gestation, parturition, litter properties, lactation and development of the offspring. Based on the findings of this study, the parental as well as the offspring no-observed-adverse-effect level for NBC was 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.