Dioscin is the major active compound in many traditional Chinese medicines (TCMs), while safety evaluation of this
natural product has not yet been investigated. Therefore, the aim of this study was to evaluate the 90-day subchronic toxicity of
dioscin in rats. The rats were divided into four groups and
dioscin was administered orally at doses of 0, 75, 150 and 300 mg/kg/day, respectively. The toxicity of
dioscin was evaluated based on clinical observations, ophthalmic examination,
body weight, food and water consumption, urinalysis, hematology, clinical biochemistry and pathology. The results showed that
dioscin had no subchronic toxicity in female rats and had slight subchronic toxicity in male rats. However, male rats in the 300 mg/kg/day group showed slight gastro-intestinal tract distension during the treatment period and
hemolytic anemia in the hematology assessment. Compared with the control group,
body weight gain was significantly decreased in male rats. Other significant changes were not associated with
dioscin in the male and female groups. In conclusion, the no-observed-adverse-effect level (NOAEL) and the lowest-observed-adverse-effect level (LOAEL) of
dioscin are estimated to be 300 mg/kg/day for female and male rats, respectively. Our work provides useful data for further research and new
drug exploration of
dioscin.