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Epimedii Folium has been proven to possess efficacy on sexual dysfunction and osteoporosis.There are a lot of single prescription preparations and compound preparations which contain Epimedii Folium approved by China food and drug administration (CFDA) registration.However, a notification from CFDA reported some adverse effects on a traditional Chinese medicine compound which contain Epimedii Folium.A toxicity study was necessary to make clear whether Epimedii Folium contribte to those adverse effects.The effects of Epimedii Folium Extract were evaluated in a 90-day subchronic toxicity on Wistar rats.Four groups of 20 Wistar rats were gavaged with water, 238, 475 or 951 mg/kg/day Epimedii Folium extract for 90-day.Clinical observations, body weights, feed-intake, hematological and serum biochemical parameters, relative organ weights and gross and microscopic observations were conducted.No obvious toxic effects were observed in this study considered to be test material related.The no-observed-adverse-effect-level (NOAEL) of the rats study was determined to be 951 mg/kg BW Epimedii Folium Extract (contained 20% icariin).