Study of embryotoxic and teratogenic properties of Medicine No. 60 and evaluation of its effect on the reproductive function of rats.

Abstract

Intramuscular administration of medicine No. 60 at a dose of 1.281 mg/kg (30 times the estimated highest daily dose for humans) when diluted with 1:5 saline solution to pregnant rats from Day 1 to Day 19 of pregnancy does not affect the indicators of pre- and postimplantation death of baby rats. The body weight of the rats exposed to the medicine No. 60 during the prenatal period of development did not differ from the indicators in the control group. The development of offspring in the experimental group during the entire observation period took place without deviation from the terms characteristic of the normal physiological development of animals of this species. As a result of the studies conducted, it was found that intramuscular administration of drug No. 60 at a dose of 1.281 mg/kg in a 1:10 dilution with saline solution, which was 30 times the estimated maximum daily therapeutic dose for humans, did not affect the sexual activity of animals, reproductive indicators (number of live fetuses, body weight of embryos, their craniocaudal size, number of yellow bodies, implantation sites, resorption), or the neonatal development of baby rats. Thus, there was no effect of medicine No. 60 in the test dose of 1.281 mg/kg on the reproductive function of healthy mature rats and does not exhibit embryotoxic and teratogenic activity.