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Background  Although Ojeok-san (OJS), an oriental herbal formula, has been used in Asian countries including Korea, China and Japan to treat the common cold and illnesses including fatigue and gastrointestinal disorders, there is little information of its safety and toxicity  in vivo  and  in vitro .    Methods  In the present study, we investigated oral toxicity of OJS over 4 weeks through repeated administration to Crl:CD (SD) rats and its cytotoxicity against various cells as a part of safety evaluation. Animals were given a daily gavage treatment of OJS in daily dosages of 0, 500, 1000 or 2000 mg/kg for 4 weeks. Cytotoxicity assay was conducted at various concentrations in 23 different cell lines including neuroblastoma, glioblastoma, hepatocarcinoma, melanoma, leukemia, colon cancer, breast cancer, keratinocytes, phechromocytoma, prostate cancer, bronchial epithelial cells, and gastric adenocarcinoma.    Results  OJS did not induce significant changes in mortality, food consumption, organ weights, hematology, serum biochemistry, and urinalysis, except for decrease in number of white blood cells over 1000 mg/kg/day female group. Thus, the no observed adverse effect level (NOAEL) is more than 2000 mg/kg/day for male and 500 mg/kg/day for female rats. In addition, OJS had no cytotoxicity against all tested cells.    Conclusions  Collectively, our data indicate that OJS may be a safe drug although additional studies in the near future will be required before clinical trials can be taken.

Cytotoxicity and sub-acute toxicity in Crl:CD (SD) rats of traditional herbal formula Ojeok-san