The study of acute and subchronic oral toxicity of medicinal drug «Enrocolitrim» on laboratory animals

Abstract

Relevance. The results of the study of the oral toxicity of the medicinal product for veterinary use «Enrocolitrim» on laboratory rodents are presented. Studies of acute toxicity in mice and rats with the determination of the hazard class are described, as well as data on the study of subchronic toxicity of the drug for 14 days in laboratory rats are presented.Methods. To determine the acute toxicity of the drug, 36 outbred rats and 50 outbred mice were used. «Enrocolytrim» was administered using an intragastric tube at doses that allow revealing a dose-dependent effect to assess LD50. Toxicity parameters were calculated according to the method of Kerber, Miller and Teintner, the nature and severity of signs of animal intoxication were visually assessed for 14 days. In a subchronic experiment, the study drug «Enrokolitrim» was studied on 40 outbred rats, of which 3 experimental and 1 control groups were formed. During the experiment, the rodents were weighed, signs of intoxication were recorded, and blood samples were taken for morphological and biochemical analyzes. Dead and euthanized animals were subjected to autopsy.Results. The obtained LD50 values with a single oral administration of the drug «Enrocolitrim» to rats and mice allowed it to be assigned the 4th hazard class – lowh–azard substances (GOST 12.1.007-76). In a subchronic 14-day experiment on rats, it was found that the dose of «Enrocolitrim» 1243 mg/kg with intragastric administration is toxic, and doses of 621.5 mg/kg and 248.6 mg/kg are inactive (safe).