Objectives : This study was carried out to investigate the acute toxicity and safety of Ssanghwa-tang extract fermented with Paecilomyces japonica. Methods : To evaluate the acute toxity and safety, 0(control group), 1250, 2500 and 5000 mg/kg of Ssanghwa-tang and fermented Ssanghwa-tang extracts were orally administered to 35 male and 35 female ICR mice. After single administration, we observed number of death, general toxicity, changes of body weight, and autopsy. Results : Compared with the control group, we could not find any toxic alteration in all treated groups (1250, 2500 and 5000 mg/kg). Conclusions : $LD_{50}$ of Ssanghwa-tang and fermented Ssanghwa-tang extracts might be over 5000 mg/kg and it is very safe to ICR mice.