Objective : This study was carried out to investigate the acute toxicity and safety of Insampaedok-san extract in ICR Mice. Methods : SPF ICR male and female mice were administered orally with Insampaedok-san extract of 0 (control group), 1250, 2500 and 5000 mg/kg. After single administration, we daily examined number of deaths, clinical signs, gross findings and changes of body weight for 14 days. Hematological parameters and isolated organ weights were determined after 14 days of administration. Results : No dead animal and no significant changes of body weights were found during experimental period. In addition, no differences were found between control and all of treated groups in clinical signs, organ weights and hematology, and other findings. Conclusions : Insampaedok-san extract did not show any toxic effects and oral LD50 values of the extracts was over 5000 mg/kg in ICR mice.