The subcronic toxicity of BDR-29, a herbal preparation of Cassiae Semen, Prunellae Spica, Tribuli Fructus, and Uncariae Rhamulus et Uncus, was examined in male and female Sprague-Dawley rats. Rats were treated with the test substance at a dose 5 mg/kg, 50 mg/kg and 500 mg/kg intragastrically for 13 weeks. No death and abnormal clinical signs were observed throughout the administration period. There were not significantly different from control group in net body weight gain, food and water consumption, organ weight, gross pathological findings, and urine analysis among the groups rats treated with different doses of the BDR-29. Hematological findings and biochemical examination revealed no evidence of specific toxicity related to BDR-29. From these results, no observation effect level (NOEL) of BDR-29 is 500 mg/kg/day under the condition employed in this study.