Embryotoxicity and teratogenicity study with gamma-cyclodextrin in rats.

The embryotoxicity/teratogenicity of gamma-cyclodextrin (gamma-CD) was examined in Wistar Crl:(WI)WU BR rats. gamma-CD was fed at dietary concentrations of 0, 1.5, 5, 10, and 20% to groups of 25 pregnant female rats from day 0 to 21 of gestation. A comparison group received a diet with 20% lactose. The additions to the diet of gamma-CD and lactose were made at the expense of pregelatinized potato starch. Body weight and food and water intake were recorded during the treatment period. The rats were killed on day 21 and examined for standard parameters of reproductive performance. The fetuses were examined for signs of toxic and teratogenic effects. Generally, gamma-CD was well tolerated and no deaths occurred in any group. Weight gain and food consumption were similar in all groups during gestation, except for a slightly reduced food intake in the 20% gamma-CD group from day 0 to 16. Water intake was similar in all gamma-CD groups; in the lactose group, it was significantly higher than in the control group. Reproductive performance was not affected by the gamma-CD treatment. Examination of the fetuses for external, visceral, and skeletal alterations did not reveal any fetotoxic, embryotoxic, or teratogenic effects of gamma-CD. In conclusion, no adverse effects were observed at gamma-CD intakes of up to about 20% of the diet (approximately 11 g/kg body wt/day).