Oral Acute Toxicity Study of Aqueous Extract of Chaihu Shugan Tang Modified with Adenosma Bracteosum

Background: The aqueous extract of Chaihu Shugan Tang combined with Adenosma bracteosum (CAE) has been suggested to exhibit low hepatotoxic potential with enzyme modulation and may support the treatment of hepatobiliary diseases. However, data on its acute toxicity remain limited. Objectives: To determine the acute toxicity of the CAE aqueous extract in mice. Materials and methods: Mice were divided into seven groups: one control group and six experimental groups receiving increasing doses of the extract (8–64 g/kg body weight). Acute toxicity was assessed using the Litchfield–Wilcoxon method by monitoring mortality and adverse reactions. Hematological and biochemical parameters, as well as histopathological examinations of the liver, kidneys, and spleen, were compared between the experimental and control groups. Results: At the highest tested dose (64 g/kg body weight), no mortality was observed. Body weight, hematological parameters, and renal biochemical indices showed no significant abnormalities (p > 0.05). However, liver biochemical indices in groups receiving 30.4–64 g/ kg differed significantly from the control group (p < 0.05). Histopathological examination revealed no signs of damage or pathological changes in the liver, kidneys, or spleen. Conclusions: The CAE aqueous extract did not cause acute toxicity in mice at doses up to 64 g/kg body weight. Further subchronic and chronic toxicity studies are required to comprehensively assess its long-term safety.