Safety Assessment of the Ethanolic Seed Extract of Mucuna pruriens var. pruriens: Acute and Chronic Oral Toxicity Studies in Sprague–Dawley Rats

<b>Background/Objectives</b>: <i>Mucuna pruriens</i> (Linn.) DC. var. <i>pruriens</i> is a leguminous plant whose seeds have been used in traditional medicine, including for the enhancement of sexual function. However, scientific evidence regarding its toxicological safety remains limited. Accordingly, the present study aimed to investigate the acute and chronic oral toxicity of the ethanolic seed extract of <i>M. pruriens</i> var. <i>pruriens</i> in Sprague-Dawley rats. <b>Methods</b>: Acute oral toxicity was assessed in female rats following a single oral administration of the ethanolic seed extract of <i>M. pruriens</i> var. <i>pruriens</i> at a dose of 5000 mg/kg body weight, with animals monitored for general behavior, clinical signs, and mortality over a 14-day period. Chronic oral toxicity was evaluated in female and male rats administered the ethanolic seed extract of <i>M. pruriens</i> var. <i>pruriens</i> at doses of 100, 500, and 2500 mg/kg body weight daily for 270 days. Animals were monitored for general behavior, clinical signs, and health status throughout the study. Hematological, blood chemistry, gross pathological, and histopathological assessments were conducted at study termination. <b>Results</b>: In the acute oral toxicity study, no mortality or treatment-related behavioral abnormalities or clinical signs were observed in female rats receiving the ethanolic seed extract of <i>M. pruriens</i> var. <i>pruriens</i>, and findings were comparable to those of the control group. In the chronic oral toxicity study, no mortality occurred in any treatment group. Although statistically significant increases or decreases were observed in certain body weight, organ weight, hematological, and blood biochemical parameters compared with the control group, all values remained within established reference ranges. When considered together with the absence of abnormal behavioral changes, clinical signs, and gross pathological or histopathological alterations in major organs, these findings indicate that long-term oral administration of the ethanolic seed extract of <i>M. pruriens</i> var. <i>pruriens</i> did not result in chronic toxicity. <b>Conclusions</b>: The ethanolic seed extract of <i>M. pruriens</i> var. <i>pruriens</i> did not produce acute or chronic oral toxicity in Sprague-Dawley rats. Nevertheless, further clinical investigations are recommended to confirm its long-term safety for human use.