Evaluation of Acute Oral Toxicity Induced by Tablets Based on Ethanolic Extract of Salvia dumetorum Leaves in Experimental Rats

Abstract

The aim of this study was to assess the acute oral toxicity of a solid dosage form based on Salvia dumetorum Andrz. ex Besser leaf extract (SDT5) in experimental rats. Acute toxicity was evaluated over a 14-day observation period following a single oral administration at three dose levels (500 mg/kg, 1000 mg/kg, and 2000 mg/kg), prepared in 0.5 mL of distilled water. Animals were weighed during group formation, prior to administration, and every 24 h thereafter. Daily monitoring included food and water intake as well as behavioral observations. After euthanasia, liver, heart, and spleen tissues were collected for histopathological analysis, with a focus on vascular, inflammatory, and necrotic changes. Additional histological evaluation of vital organs was also performed. The results showed that no mortality occurred, and no statistically significant differences (p > 0.05) were observed between treated and control groups in body weight, organ histology, hematological parameters, or structural abnormalities. These findings suggest that SDT5 does not exhibit detectable acute oral toxicity under the tested conditions and may be considered a promising candidate for further preclinical and clinical investigations.