Purpose : This study was carried out to investigate the acute toxicity and safety of fermented Ssanghwa-tang extract. Methods : To evaluate their acute toxicity and safety, 0(control group), 1250, 2500 and 5000 mg/kg of Ssanghwa-tang and fermented Ssanghwa-tang extracts were orally administered to 20 male and 20 female ICR mice. After a single administration, we observed survival rates. general toxicity. changes of body weight, and autopsy. Results : Compared with the control group, we could not find any toxic alteration in any of the 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 for ICR mice.