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目的依据《GB 15670-1995农药登记毒理学试验方法》,旨在通过经口染毒大鼠,检测妊娠动物接触虱螨脲原药后引起致畸的可能性,初步评价虱螨脲原药致畸危害程度。方法选用的大鼠按雌雄2∶1比例同笼交配,次日清晨阴道涂片检查雌鼠,发现精子即确定为受孕第0天。剂量设计高剂量为500 mg/kg,中剂量为100 mg/kg,低剂量为20mg/kg,阳性对照为维生素A。在雌鼠受孕第6～15天灌胃给予受试物,连续共10 d,在妊娠第20天,腹腔注射麻醉后剖腹检查胎鼠是否畸形。结果高剂量组:胎鼠骨骼畸形例数明显增多,差异有统计学意义(P<0.01)。中剂量组:大鼠吸收胎率升高(P<0.01),胎鼠骨骼畸形例数明显增多,差异有统计学意义(P<0.01)。低剂量组:未观察到明显的孕鼠、胎鼠毒性,未发现致畸作用。结论虱螨脲原药大鼠致畸试验未观察到有害作用剂量(NOAEL)为20 mg/kg。
Purpose Based on the “GB 15670-1995 pesticide registration toxicology test method”, intended to be tested by oral exposure to rats, pregnant animals exposed to the original drug lutropine teratogenic potential after the initial assessment of Luibufen original drug induced Teratogenic harm. Methods The rats were mated with the male and female 2: 1 ratio, the female rats were examined by vaginal smear the next morning, and the sperm was found to be on the 0th day of conception. Dose Design High dose of 500 mg / kg, the medium dose of 100 mg / kg, low dose of 20 mg / kg, the positive control for vitamin A. On the 6th to 15th day after fertilization, female rats were given gavage for 10 days. On the 20th day of gestation, intraperitoneal injection of anesthesia was performed to check if the fetus was abnormal. Results In the high-dose group, the number of skeletal malformations in fetal rats increased significantly with a significant difference (P <0.01). In the middle dose group, the uptake rate of the fetus in rats increased (P <0.01), and the number of skeletal malformations in fetal rats increased significantly with a significant difference (P <0.01). Low-dose group: no obvious pregnant rats, fetal rat toxicity, no teratogenic effects were observed. Conclusion No teratogenic effect (NOAEL) of 20 mg / kg was observed in teratogenic rats.