Study of Aspir-35 toxicity

Abstract

Preclinical research on veterinary pharmaceuticals is crucial and required when creating new dosage forms. Preclinical research aims to ascertain the test substance's therapeutic efficacy, toxicity, future dose form, impact on the body's fundamental systems, and identification of potential side effects. The objective of this study was to assess the potential toxicity of Aspir-35 following short- and longer-term exposure in rats. The acute toxicity of the drug was studied on 30 white mice weighing 18–20.5 g and 15 white rats weighing 180–215 g. The animals were kept in a vivarium in accordance with sanitary rules and on a standard diet taken in the vivarium using compound feed. The drug “Aspir-35” was administered to rats and mice once in the morning on an empty stomach orally through a probe with a cannula in doses of 1250, 2500 and 5000 mg/kg of body weight. Animal feeding was started two hours after drug administration. The study of the toxicity of the drug “Aspir-35” during long-term subcutaneous administration was studied on rats with an initial body weight of 180–230 g divided according to the principle of analogues into two groups of 6 heads each. The animals were kept in similar conditions as in the study of the acute toxicity of the drug. The drug “Aspir-35” was administered to the rats of the experimental group subcutaneously daily for 18 days at a dose of 0.5 ml/kg of body weight. The drug “Aspir-35” did not cause the death of experimental rats and mice when administered once orally in doses of 1250, 2500 and 5000 mg/kg of body weight. On this basis, the drug “Aspir-35” can be attributed to the 4th class of danger according to the International Standard GOST 12.1.007-76, or to category 5 according to the International Global Classification of the Global Harmonized System, (GHS), since the LD50 of the drug “Aspir-35” when taken orally will exceed 5000 mg/kg of body weight. The drug “Aspir-35” in a dose of 0.5 ml/kg of body weight when administered subcutaneously for 18 days did not cause negative and harmful effects on the body of experimental rats, did not affect their growth and development, did not cause changes in the relative weight of internal organs and did not led to changes in hematological indicators in experimental animals. The analysis of the results of the conducted research indicates the relative harmlessness of the potential drug for veterinary medicine and allows us to predict that the drug “Aspir-35” can be classified as a low-risk substance, which justifies the feasibility of its further study and implementation in practice.