Investigation of acute toxicity and local irritation of the vitamin-mineral preparation «Energolit»

Apply

Investigation of acute toxicity and local irritation of the vitamin-mineral preparation «Energolit»

Journal Title: Бюлетень "Ветеринарна біотехнологія" - Year 2018, Vol 33, Issue

Abstract

Introduction. Preclinical and clinical studies, especially toxicological trials on laboratory animals are obligatory requirement for the registration of a new medicinal product “Energolit” which includes vitamins B1, B2, B3, B5, B6, B12 and excipients such as glucose, sorbitol, sodium acetate, sodium chloride, potassium chloride, calcium chloride, magnesium chloride, Arginine, glutamic acid, lysine and methionine. The goal of the work was to determine acute toxicity and local irritation effects of the vitamin-mineral preparation “Energolit” in trials on laboratory animals. Materials and methods. The study of acute toxicity of the preparation “Energolit” was performed on 40 male and female white inbred rats weighing 190-220 g, kept under vivarium condition. They were divided into experimental and control groups. The preparation was administered intragastrically to rats at doses of 5.000-25.000 mg/kg body weight. Calculation of median lethal dose (LD50) and other indicators were determined by Litchfield and Wilcoxon method modified by Roth (1963) and the method described in the publication “Preclinical studies of veterinary preparations” (2006). Local irritation effect of the preparation was evaluated on 8 rabbits by applying of 2.0 mL/cm2 “Energolit” on the skin. Results of research and discussion. It has been experimentally determined that after intragastric administration of the preparation at doses: 5 000; 10 000; 15 000; 20 000 and 25 000 mg/kg, no signs of intoxication were observed in rats: the animals were clean, active, responded to sound and photic stimulus, had good appetite, normal urination and defecation, without any respiratory disturbances and convulsions. By the pathomorphological study, it was found that the rats of the experimental and control groups were well-fed, with bright, tidy coat that fit tightly to the body, with no alopecia and ulcers. It was found that the single application of “Energolit” on the bare skin areas did not cause lethal effects and changes in behavior or at the place of the drug application: erythema, edema, skin fold thickening and pain reaction were not observed. The skin reaction in the experimental animals was evaluated at 0 points. Conclusions and prospects for further research. According to the results of the experiment, a quantitative evaluation of acute toxicity with the median lethal dose (LD50) determination of intragastric administration of the preparation “Energolit” to rats was performed. The dose was higher than 5.000 mg/kg body weight. Study of local irritation showed that “Energolit” did not cause direct irritation on the skin in rabbits. The use of the preparation in investigated dilutions did not show local irritation effect on the conjunctiva. According to the requirements of the SOU 85.2-37-736: 2011 and GOST 12.1.007-76, the obtained results of the studies make it possible to classify the preparation “Energolit” in the ΙV class of hazard. Further researches will focus on the study of chronic toxicity, embryotoxic and teratogenic effects of the injectable “Energolit”.

Authors and Affiliations

Roman Sachuk

Keywords

vitamins minerals acute toxicity irritant effect laboratory animal Energolit

EP ID EP411591
DOI 10.31073/vet_biotech33-14
Views 109
Downloads 0