The aim of the study was carried out to investigate a single oral toxicity of a 50% ethanol extract derived from fruiting body of Poria cocus (PCE) using male and female SD rats. Groups consisted of five male and female rats were treated with a single dose of the test substance intragastrically at 0, 5, 50, 300 and 2,000 mg/kg, respectively. Animals were monitored for the mortality and changes in the body weight, clinical signs and gross observation during the 14 days after dosing, upon necropsy. As the results, we could not find any mortality. Compared with the control group, significant weight change was not observed in the experimental group. Also there was no difference in water and food consumption or gross pathological findings at terminal sacrifice among the groups of rat treated with different doses of the test substance. The results suggested that the approximate lethal dose of ACM in both female and male rats were considered as over 5000 mg/kg.