Abstract. Saussureae involucratae Flos is the primary component of the jiangu capsule, which also consists of 12 types of natural medicine. It is a traditional Chinese medicine used to treat a number of conditions including arthralgia, cold and sore muscles, stiff limbs, inconvenient flexion and activity limitation caused by different types of osteoarthritis. The present study was performed to assess the safety of the jiangu capsule following acute and chronic administration in mice and rats. In the acute study, mice were treated with the jiangu capsule orally at 16 g/kg/day, the highest dose, for 14 days. In the chronic oral toxicity study, rats were treated with 2, 4 and 8 g/kg/day of the jiangu capsule for 6 months. The general condition, body weight changes, food and water consumption, hematological and biochemical parameters, urinalysis, systematic anatomy and organ weights of the rats were monitored and histopathological examination was performed at the end of 3 and 6 months' daily administration, and following 14 days of withdrawal. There were no signs of toxicity in the general condition and body weight of the mice was not significantly affected by the treatment. Furthermore, necropsy findings for the animals in the acute and chronic toxicity studies demonstrated that no mortalities had occurred. The results of the current study indicate that treatment with the jiangu capsule did not induce mortality or any detectable abnormalities in mice and rats.