title: Genotoxicity evaluation of Guibi-Tang extract using an in vitro bacterial reverse mutation assay, chromosome aberration assay, and in vivo micronucleus test.
abstract: BACKGROUND
  Guibi-Tang is a traditional herbal prescription made from 12 different herbs that is used in the treatment of amnesia and poor memory.
  
  
  METHODS
  In the present study, we evaluated the acute oral toxicity and genotoxic potential of Guibi-Tang water extract (GBT) at doses up to 2000 μg/plate an using a bacterial reverse mutation test (Ames test) with Salmonella typhimurium strains TA100, TA1535, TA98, and TA1537, and Escherichia coli strain WP2uvrA. Acute toxicity and genotoxic potential were measured in the presence and absence of an exogenous source of metabolic activation, in an in vitro chromosome aberration assay with Chinese hamster lung (CHL) cells, and in an in vivo micronucleus test using ICR mice bone marrow as recommended by the Korean Food and Drug Administration. An acute oral toxicity test of GBT was performed in Sprague Dawley rats. The Ames test showed that GBT did not induce gene mutations in S. typhimurium or in E. coli in the presence or absence of S9 activation.
  
  
  RESULTS
  GBT did not significantly increase the number of structural aberrations in CHL cells with or without S9 activation. The oral administration of GBT at a dose of up to 2000 mg/kg caused no significant increase in the number of micronucleated polychromatic erythrocytes or in the mean ratio of polychromatic to total erythrocytes.
  
  
  CONCLUSIONS
  However, as we did not identify the components of GBT responsible for these effects, other assays are needed to confirm its genotoxicity.
authors.forename: Mee-Young
authors.initials: MY
authors.lastname: Lee
authors.forename: Chang-Seob
authors.initials: CS
authors.lastname: Seo
authors.forename: Ji-Young
authors.initials: JY
authors.lastname: Kim
authors.affiliation: Herbal Medicine Formulation Research Group, Korea Institute of Oriental Medicine, 483 Expo-ro, Daejeon 305-811, Yusung-gu, Republic of Korea. hkshin@kiom.re.kr.
authors.forename: Hyeun-Kyoo
authors.initials: HK
authors.lastname: Shin
mesh_terms: D000818:Animals; D001419:Bacteria / Q000187:drug effects / Q000235:genetics; D002460:Cell Line; D002869:Chromosome Aberrations / Q000139:chemically induced*; D006224:Cricetinae; D003412:Cricetulus; D004249:DNA Damage; D004365:Drugs, Chinese Herbal / Q000633:toxicity*; D004912:Erythrocytes / Q000187:drug effects; D005260:Female; D008297:Male; D051379:Mice; D008813:Mice, Inbred ICR; D009152:Mutagenicity Tests / Q000379:methods; D009154:Mutation; D051381:Rats; D017207:Rats, Sprague-Dawley
chemical_list: D004365:Drugs, Chinese Herbal