title: Genotoxicity and subchronic toxicity of Sophorae radix in rats: hepatotoxic and genotoxic potential.
abstract: Although Sophorae radix (SR) has been traditionally used as a treatment for various clinical symptoms, a comprehensive investigation of its safety has not yet been carried out. Therefore, we present an evaluation of the toxicity of the SR extract that was performed according to the Organization for Economic Cooperation and Development test guidelines for subchronic toxicity and genotoxicity. In an oral subchronic study for 13 weeks, the repeated treatment of rats with 429 or 1500 mg/kg of the SR extract induced a dose-related change in body weight. In particular, the SR extract was observed to exert a significant increase in liver weight along with an increase in serum alkaline phosphatase and alanine transaminase. A small but statistically significant reductions in red blood cell, hemoglobin, and hematocrit levels in the SR extract-treated rats suggest the possibility that anemia, accompanied by liver injury, was at least partially induced. These findings indicate the no-observed-adverse-effect-level for the SR extract was considered to be 10mg/kg/d. And, the data obtained from the chromosome aberration assay showed that SR extract might be considered to be a weak clastogen although no significant micronucleus induction was observed in vivo. Despite the benefits that SR extract can exhibit, this study indicates that SR extract may possess hepatotoxic and genotoxic potential.
authors: Department of Experimental Animal Research, Biomedical Research Institute, Seoul National University Hospital, Seoul, Republic of Korea; Biomedical Center for Animal Resource and Development, Bio-Max Institute, Seoul National University, Seoul, Republic of Korea.
authors: Jeong-Hwan
authors: JH
authors: Che
authors: Department of Experimental Animal Research, Biomedical Research Institute, Seoul National University Hospital, Seoul, Republic of Korea.
authors: Jun-Won
authors: JW
authors: Yun
authors: Department of Experimental Animal Research, Biomedical Research Institute, Seoul National University Hospital, Seoul, Republic of Korea.
authors: Yun-Soon
authors: YS
authors: Kim
authors: Department of Experimental Animal Research, Biomedical Research Institute, Seoul National University Hospital, Seoul, Republic of Korea.
authors: Seung-Hyun
authors: SH
authors: Kim
authors: Department of Experimental Animal Research, Biomedical Research Institute, Seoul National University Hospital, Seoul, Republic of Korea.
authors: Ji-Ran
authors: JR
authors: You
authors: Department of Pathology, Seoul National University College of Medicine, Seoul, Republic of Korea.
authors: Ja-June
authors: JJ
authors: Jang
authors: Department of Biomedical Engineering, College of Medicine and Institute of Medical and Biological Engineering, Medical Research Center, Seoul National University, Seoul, Republic of Korea.
authors: Hee Chan
authors: HC
authors: Kim
authors: Department of Urology, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: hhkim@snu.ac.kr.
authors: Hyeon Hoe
authors: HH
authors: Kim
authors: Department of Experimental Animal Research, Biomedical Research Institute, Seoul National University Hospital, Seoul, Republic of Korea; Biomedical Center for Animal Resource and Development, Bio-Max Institute, Seoul National University, Seoul, Republic of Korea; Graduate School of Translational Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; Designed Animal and Transplantation Research Institute, Seoul National University, Pyeongchang-gun, Gangwon-do, Republic of Korea. Electronic address: bckang@snu.ac.kr.
authors: Byeong-Cheol
authors: BC
authors: Kang
mesh_terms: D000284:Administration, Oral; D000740:Anemia / Q000097:blood / Q000139:chemically induced; D000818:Animals; D015415:Biomarkers / Q000097:blood; D001835:Body Weight / Q000187:drug effects; D056486:Chemical and Drug Induced Liver Injury / Q000097:blood / Q000175:diagnosis / Q000209:etiology*; D002869:Chromosome Aberrations / Q000139:chemically induced*; D004305:Dose-Response Relationship, Drug; D004435:Eating / Q000187:drug effects; D005260:Female; D008297:Male; D048629:Micronuclei, Chromosome-Defective / Q000139:chemically induced; D015162:Micronucleus Tests; D009152:Mutagenicity Tests / Q000379:methods; D019055:No-Observed-Adverse-Effect Level; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage / Q000633:toxicity*; D010946:Plants, Medicinal; D011916:Rats, Inbred F344; D018570:Risk Assessment; D029909:Sophora; D013997:Time Factors; D059550:Toxicity Tests, Subchronic
chemical_list: D015415:Biomarkers; D010936:Plant Extracts
keywords: Anemia; Genotoxicity; Hepatotoxicity; Liver; Sophorae radix; Subchronic