Waalkens-Berendsen D H, Smits van Prooije A E, Bär A
TNO-Nutrition and Food Research Institute, Zeist, 3700 AJ, The Netherlands.
Regul Toxicol Pharmacol. 1998 Apr;27(2):172-7. doi: 10.1006/rtph.1998.1222.
In a standard embryotoxicity/teratogenicity study, gamma-cyclodextrin (gamma-CD) was administered to groups of 16, artificially inseminated New Zealand White rabbits at dietary concentrations of 0, 5, 10, or 20%. A comparison group received a diet containing 20% lactose. Treatment started on day 0 of gestation and ended on day 29 when the animals were killed. Except for the occurrence of transient diarrhea in 2 and 3 rabbits of the 10 and 20% gamma-CD groups, respectively, in the first few days, the treatment was well tolerated. A reduced food intake in the 20% gamma-CD group during the first week of treatment resulted in a reduced weight gain during this period. However, after week 1 there were no differences in weight gains between the groups, and at termination of the study body weights were similar in all groups. Even at the highest dose level, which corresponds to an intake of 5-7 g/kg body wt/day, no signs of maternal toxicity were observed. Reproductive performance was not affected by the treatment. Uterine weight, placental weight, fetal weight, number of fetuses, sex ratio, number of implantation sites, resorptions, and corpora lutea did not differ among the groups. Visceral and skeletal examinations of the fetuses did not reveal any malformations, anomalies, or variations that could be attributed to treatment. It was concluded that dietary gamma-CD is well tolerated by pregnant rabbits, has no adverse effect on reproductive performance, and is not embryotoxic, fetotoxic, or teratogenic at dietary concentrations of up to 20%.
在一项标准的胚胎毒性/致畸性研究中，将γ-环糊精（γ-CD）以0%、5%、10%或20%的饮食浓度给予16只经人工授精的新西兰白兔组。一个对照组接受含20%乳糖的饮食。治疗从妊娠第0天开始，在第29天动物被处死时结束。除了在最初几天，10%和20%γ-CD组分别有2只和3只兔子出现短暂腹泻外，该治疗耐受性良好。20%γ-CD组在治疗的第一周食物摄入量减少，导致在此期间体重增加减少。然而，在第1周后，各组之间体重增加没有差异，并且在研究结束时所有组的体重相似。即使在最高剂量水平，相当于摄入量为5 - 7克/千克体重/天，也未观察到母体毒性迹象。生殖性能未受治疗影响。各组之间子宫重量、胎盘重量、胎儿重量、胎儿数量、性别比例、着床部位数量、吸收情况和黄体数量均无差异。对胎儿的内脏和骨骼检查未发现任何可归因于治疗的畸形、异常或变异。得出的结论是，妊娠兔对饮食中的γ-CD耐受性良好，对生殖性能无不良影响，并且在饮食浓度高达20%时不具有胚胎毒性、胎儿毒性或致畸性。
