Acute and Subchronic Toxicity Study of Sampilnorov Wurile

Abstract

Introduction: Sampilnorov Wurile (SW) is a traditional medicinal preparation containing 29 plant-, mineral-, and animal-derived components. It is used for cerebrovascular ischemia, retinal disorders, cardiovascular diseases, and neurological conditions. This study aimed to evaluate the acute and subchronic toxicities of SW. Methods: Acute toxicity was assessed in C57BL/6 mice based on OECD-423 guidelines, with oral doses ranging from 500 to 6,000 mg/kg body weight. Subchronic toxicity was evaluated in Wistar rats following OECD-407 guidelines, with daily oral doses of 300 and 600 mg/kg of SW daily for 4 weeks. Clinical signs, mortality, body weight, and physical condition were monitored. Hematological, biochemical, and histopathological analyses were conducted on day 29. Results: No mortality or significant clinical signs of toxicity were observed at doses up to 6,000 mg/kg, suggesting an oral median lethal dose exceeding this level. Subchronic toxicity assessment revealed no clinical signs of toxicity or mortality. SW at 300 and 600 mg/kg had no significant effects on serum biochemical parameters or vital organ histology compared to controls. Conclusion: SW exhibited no acute toxicity at doses up to 6,000 mg/kg and showed no adverse effects in a 28-d subchronic toxicity study. These findings support its safety at tested doses.