Safety assessment of saponins extract in Dolichos falcatus Klein: Subchronic study in Sprague-Dawley rats

Ethnopharmacological relevance: Dolichos falcatus Klein (DF), a Chinese Dai ethnic medicine popularly known as Tuoyeteng in Yunnan province of China, has been widely used in China to treat fracture, rheumatoid arthritis and soft tissue injuries for a long time. Our previous study showed that saponins in DF (DFS) ameliorated the gouty arthritis induced by MSU crystals in vivo and in vitro. The present study was carried out to evaluate the no-observed-adverse-effect level (NOAEL) of DFS. Materials and methods: Sprague-Dawley rats (10/sex/group) were gavaged with DFS at dose level of 0, 50, 100 and 200 mg/kg body weight /day for 90-days. Results: DFS administration did not result in mortality or show treatment-related changes in clinical signs of toxicity, body weights gain or feed consumption. Similarly, in addition to slightly hemolytic anemia and gastrointestinal tract lesion in males of high-dose treatment group, no toxicologically significant treatment-related changes in hematological, clinical chemistry, urine analysis parameters, organ weights, and macroscopic and microscopic abnormalities were noted during the testing period. Conclusion: The results of subchronic toxicity study support the NOAEL for DFS as 200 mg/kg/d in females and as 100 mg/kg/d in males. These results provide an important reference for further DFS-related clinical trials or new drug exploration. (c) 2015 Elsevier Ireland Ltd. All rights reserved.