STUDY OF THE ACUTE TOXICITY OF A THICK EXTRACT FROM THE HERB OF RUSSELL’S LISIANTHUS

Abstract

Introduction. Determining the toxicity class is a key stage in the preclinical evaluation of potential medicinal products, as it allows for a comprehensive characterization of their safety profile and assessment of their suitability for further use. The obtained data serve as a foundation for subsequent pharmacodynamic and pharmacokinetic studies and provide a scientifically substantiated evidence base regarding the safety of a new medicinal compound before its transition to the clinical phase of trials. The aim of the study. To determine the acute toxicity of the thick extract obtained from the herb of Russell’s lisianthus. Materials and methods. The study of the acute toxicity of the thick extract from the herb of Russell’s lisianthus was carried out on 24 outbred white rats of both sexes weighing 180–210 g. Animals of the experimental groups received the investigated extract intragastrically twice within 24 hours at a dose of 5000 mg/kg. The solution was prepared by dissolving 1 g of the extract in 5 ml of water, which was administered to one animal. Control animals received drinking water in an equivalent dose. For 14 days, daily monitoring of the animals’ condition was performed with assessment of body weight, behavioral responses, level of motor activity, general condition, and registration of mortality. After completion of the observation period, the animals were withdrawn from the experiment under thiopental anesthesia. Macroscopic examination of the internal organs was subsequently performed, followed by determination of their relative organ weights. Results and discussion. The obtained results demonstrated the absence of toxic effects of the thick extract from the herb of Russell’s lisianthus in rats of both sexes after intragastric administration at a dose of 5000 mg/kg. Throughout the entire study period, no mortality was recorded, and no changes in behavioral responses or general condition of the animals were observed. The relative organ weights in male and female animals of the experimental groups did not statistically differ from those of the control animals. The overall findings allow the studied extract to be classified as a practically non-toxic substance. Conclusions. The obtained results indicate that the thick extract from the herb of Russell’s lisianthus can be classified as belonging to toxicity class IV, i.e., practically non-toxic substances.