Abstract
Introduction. At present, herbal medicinal products play a significant role in the prevention and treatment of various diseases, contributing to the maintenance and improvement of public health. Their pronounced therapeutic efficacy and preventive effects are обусловлены balanced composition of biologically active compounds present in medicinal plant raw materials. This highlights the need for in-depth investigation not only of their pharmacological activity but also of their safety. To evaluate the safety profile of an extract obtained from Saussurea alpina herb by studying its acute and chronic toxicity. Methods. The aerial parts of Saussurea alpina (L.) DC. were used in the study. The plant material was collected in August 2022 in the Turkestan region during the mass flowering period. The assessment of acute toxicity was carried out in an acute experiment using the generally accepted “Up-and-Down” procedure, as described in the OECD Guideline No. 425 for testing of chemicals (Acute Oral Toxicity). The study of acute toxicity was performed in two stages: a limit test (2000 mg/kg, oral administration) and a main test. Results. Prior to the experiment, the animals were placed in a quarantine facility for 14 days. The mice were observed for 14 days. The LD₅₀ value was calculated using the maximum likelihood method with the AOT425StatPgm Report (2002) software. Discussion. Based on the obtained results, it can be assumed that the tested extract does not produce significant toxic effects in laboratory animals during chronic administration (30 days). The obtained LD₅₀ value allows classification of the compound as toxicity class 5 according to the system of state standards for chemical substances. Conclusion. The results of the acute toxicity study showed that at LD₅₀ values up to 2000 mg/kg, no mortality was observed in animals, and no significant deviations in clinical signs were detected. In the chronic toxicity study, no significant changes were observed in the central nervous and cardiovascular systems of male and female rats. Keywords: Saussurea alpina (L.) DC., acute toxicity, chronic toxicity, medicinal plant raw material.