DETERMINATION OF THE IRRITANT EFFECT OF AN IRON-CONTAINING VETERINARY DRUG ON RABBITS: RESULTS OF PRECLINICAL STUDIES

Abstract

Preclinical studies were conducted to determine the irritant effect of the veterinary drug "Ferodev" when applied to the skin and mucous membrane of the eye of rabbits. One milliliter of the drug contains the active substance iron (in the form of iron (III) hydroxide dextran complex) – 100,0 mg and excipients – phenol, water for injection. The drug is used for the prevention and treatment of iron deficiency anemia in cattle (calves) and pigs (sows and piglets).

During the studies, it was established that the veterinary drug "Ferodev" (solution for injection), when applied to the skin of rabbits in doses from 750,0 to 3000,0 mg/kg of body weight, does not exhibit an irritant effect, and in terms of the degree of danger it can be attributed to class IV – low-hazard substances (LD₅₀>2500,0 mg/kg of body weight).

The drug "Ferodev" (solution for injection) does not cause an irritating (harmful) effect on the mucous membrane of the eye of rabbits, as evidenced by the absence of eyelid edema throughout the entire observation period, vascular injection and moderate discharge only during the first day after application.

The results of preclinical standard studies of the iron-containing drug "Ferodev" on safety pharmacology indicate the absence of a special danger to animals when using therapeutic doses.

Further studies will be the next stage of preclinical tests aimed at studying the embryofetotoxicity of the drug "Ferodev" in rabbits. The studies will include the study of pathological changes or death of embryos when dextran iron penetrates the body of pregnant females.