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Objectives : Samchulgeonbi-tang (shenzhujianpi-tang) has been prescribed as one of traditional herbal medicine for treatment of stomach diseases since ancient time in Korea. Samchulgeonbi-tang extract was fermented by Lactobacillus spp. for improving the effect. However, the toxicity and safet y of fermented Samchulgeonbi-tang (FS) extract were not confirmed. Therefore, this study was performed to evaluate the acute toxicity and safety of FS extract.Methods : To evaluate the acute toxicity and safety of FS extract, several doses of FS extract, 0, 500, 1000 and 2000 ㎎/㎏, were orally administered to 20 male and 20 female ICR mice, respectively. After treatment with FS extract, we observed mortality, general toxicity, behavior and change of body weight for the 14 days. After 14 days of oral administration, all mice were sacrificed and hema tological parameters were analyzed from blood serum.Results : In present study, the toxic signs such as mortality or abnormal behaviors by FS extract were not observed. There are no significant differences between FS-treat ed group and control group in body weight, organ weights, and hematological parameters.Conclusions : The remarkable adverse effects by FS extract were not observed in ICR mice. Also, any death was not occurred at all treated FS doses, 500, 1000 and 2000 ㎎/㎏. T herefore, the approximate lethal dose (ALD) of FS extract may be more than 2000 ㎎/㎏.Key words : amchulgeonbi-tang (shenzhujianpi-tang), Fermented Samchulgeonbi-tang (FS), Acute toxicity, Safety, ALD

Single Oral Dose Toxicity Test of Fermented Samchulgeonbi-tang Extract in ICR mice