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Testing Status of Ginkgo biloba extract M990050

 

CASRN: 90045-36-6

Synonyms/Common Names

  • GBE
  • Maidenhair extract

Known Uses

Herbal supplement

Chemical Properties

Toxicity Effects (HSDB)

Short-Term Toxicity

  • 5 days (Gavage)  (C99050)  Completed 
    • GBE 3 (D072/030/A14)
    • Rats: F344/NCrl (SAS FISCH)
    • Dose: Ginkgo Biloba Extract (Lot 1-5) 0, 3, 30, 100, 300, or 1000 mg/kg; 6 males/group.
  • 13 weeks (Gavage)  (C99031)  Completed 
    • Citation: Hoenerhoff et al., 2013, Hepatocellular Carcinomas in B6C3F1 Mice Treated with Ginkgo biloba Extract for Two Years Differ from Spontaneous Liver Tumors in Cancer Gene Mutations and Genomic Pathways, Tox Path, 41(6):826-841
    • Citation: Rider et al., 2013, Toxicity and Carcinogenicity Studies of Ginkgo biloba Extract in Rat and Mouse: Liver, Thyroid, and Nose Are Targets, Tox Path, 42(5): 830-843
    • Rats: F344/N; Mice: B6C3F1/N
    • Dose: R: 0, 62.5, 125, 250, 500 OR 1000 MG/KG; 20/SEX/DOSE; M: 0, 125, 250, 500, 1000 OR 2000 MG/KG; 10/SEX/DOSE.

Long-Term Carcinogenicity

  • 2 years (Gavage)  (C99031)  Completed 
    •   (Peer Review Approval 02/08/2012A ) Citation: Hoenerhoff et al., 2013, Hepatocellular Carcinomas in B6C3F1 Mice Treated with Ginkgo biloba Extract for Two Years Differ from Spontaneous Liver Tumors in Cancer Gene Mutations and Genomic Pathways, Tox Path, 41(6):826-841
    •   (Peer Review Approval 02/08/2012A ) Citation: Rider et al., 2013, Toxicity and Carcinogenicity Studies of Ginkgo biloba Extract in Rat and Mouse: Liver, Thyroid, and Nose Are Targets, Tox Path, 42(5): 830-843
    • TR-578 (NIH Number: 13-5920)  (Peer Review Approval 02/08/2012A )
      Toxicology and Carcinogenesis Studies of Ginkgo Biloba Extract (CASRN 90045-36-6) in F344/N Rats and B6C3F1/N Mice (Gavage Studies)
    • Rats: F344/N; Mice: B6C3F1/N
    • Carcinogenesis Results
      • Male Rats Some Evidence 
      • Female Rats Some Evidence 
      • Male Mice Clear Evidence 
      • Female Mice Clear Evidence 
    • Dose: R: 0, 100, 300, OR 1000 MG/KG; M: 0, 200, 600, OR 2000 MG/KG; 50/SEX/SPECIES/DOSE.

Special Studies

  • Absorption Disposition Metabolism Elimination (in-vitro)  (S0859)  Completed 
    • Citation: Etheridge AS, Black SR, Patel PR, So J, Mathews JM. An in vitro evaluation of cytochrome P450 inhibition and P-glycoprotein interaction with goldenseal, Ginkgo biloba, grape seed, milk thistle, and ginseng extracts and their constituents. Planta Med. 2007 Jul;73(8):731-41. Epub 2007 Jul 5. PubMed PMID: 17611934.Pubmed Abstract
    • Citation: Final Study Report Ginkgo Extract: Interaction with Cytochrome P450 Enzymes and P-glycoprotein.
    • Human (Cell Lines)
    • Dose: 0, 1, 10 µM..
  • Toxicokinetic Study (Gavage)  (K99050)  Report in Preparation 
    • GBE 1 (020703)
    • Male Rats: F344/N Charles River
    • Dose: 0, 30, 100, 300 mg/kg/day.

Genetic Toxicology

  • Micronucleus  (A97646)  Completed 
    • Mice: B6C3F1
    • Male Negative 
    • Female Equivocal 
  • Micronucleus (Gavage)  (G99050B)  On Test 
    • Ginkgo Biloba Extract Lot # 2
    • Rats: F344/N Charles River
  • Micronucleus (Gavage)  (G99050C)  On Test 
    • Ginkgo Biloba Extract Lot # 3
    • Rats: F344/N Charles River
  • Micronucleus (Gavage)  (G99050D)  On Test 
    • Ginkgo Biloba Extract Lot # 4
    • Rats: F344/N Charles River
  • Micronucleus (Gavage)  (G99050E)  On Test 
    • Ginkgo Biloba Extract Lot # 5
    • Rats: F344/N Charles River
  • Micronucleus (Gavage)  (G99050)  On Test 
    • Ginkgo Biloba Extract Lot # 1
    • Rats: F344/N Charles River
  • Salmonella  (A33386)  Completed 
    •  Positive 

Toxicogenomics

  • 5 days Microarray Analysis (Gavage)  (T99050)  On Test 
    • GBE 3 (D072/030/A14)
    • Rats: F344/N Charles River
    • Dose: Ginkgo Biloba Extract (Lot 1-5) 0, 3, 30, 100, or 1000 mg/kg; 6 males/group; Green Tea Extract; 0, 3, 30, 100, or 1000 mg/kg; 6 males/group; Golden Seal Extract; 0, 94, 188, 375, 750, or 1500 mg/kg; 6 males/group.