Toxicological Study Of Albendazole

Genotoxicity: In vitro trials such as Ames test, Escherichia coli test and CHO-K1 mutation test, no mutation was found in this product. In human lymphocyte chromosome aberration and rat micronucleus test, also did not see this product is inducing fission effect.

Reproductive toxicity: A study of the effects of this product on fertility has not yet been carried out, but the long-term dose of this product is greater than or equal to 1mg/kg/day (its plasma Cssmax and AUC0-24h are 19 times times and 9 times times higher than those in postmenopausal health), and ovarian hypertrophy and follicular cysts are visible. In addition, the female canine long-term dose of this product is greater than or equal to 1mg/kg/day (its plasma Cssmax and AUC0-24h respectively than the postmenopausal healthy people at the recommended dose of 22 times times and 16 times times higher than the), visible uterine hyperplasia. It is unclear whether the effects of animal reproductive organs are related to the damage of human fertility.

Pregnant women taking this product can lead to embryo toxicity. The rat and rabbits were given 0.1 mg/kg (by body surface area) at the mouth of the product, which was about 3/4 and 1.5 times times the recommended dose, respectively, found that this product could penetrate the placenta barrier. The rats and rabbits were given this product in the organ formation period, and the dosage was greater than or equal to 0.1 and 0.02 mg/kg/Day (translated by body surface area), when approximately 3/4 and 1/3 of the recommended doses are equivalent to the clinic, the rate of pregnancy loss is increased (the increase in loss of implant and after implantation, increased absorption of the fetus, decreased living number), and dose dependence on the rats ' effects. The weight of placenta increased significantly when the dosage of 0.1 was mg/kg/day or above in rats. The rat dose reached 1 mg/kg/days (its plasma Cssmax and AUC0-24h were 19 times times and 9 times times higher than the recommended dose in postmenopausal healthy persons), and the embryo toxicity was observed. Including the delayed embryo development (eg: incomplete ossification and growth of fetal body weight), the rat in the dosage of the drug did not appear teratogenic. Rabbits give this product dose greater than or equal to 1.0 mg/kg/Day (translated by body surface area, approximately 16 times times the equivalent of clinical recommended dose), can lead to pregnancy failure. The rabbit dose reached 0.2mg/kg/day (translated by body surface area, approximately 3 times times the equivalent of clinical recommended dose), no teratogenic was found. There is no adequate and strictly controlled study of the medication of pregnant women, if the use of this product during pregnancy or during the use of this product pregnancy, the patient should be informed of the potential of the drug to the fetus and the potential risk of abortion.

This product is not clear in human milk excretion, because many drugs can be excreted in human milk, breast-feeding women should be cautious with this product.

Carcinogenicity: There are no long-term drug-induced carcinogenic research data on animals.