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Testing Status of Ginkgo biloba extract M990050

CASRN: 90045-36-6

Synonyms/Common Names

  • GBE
  • Maidenhair extract

Short-Term Toxicity

  • 5 days (Gavage)  (C99050)  Report in Preparation 
    • GBE 1 (020703)
    • 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
    • Citation: Yamashita H, Surapureddi S, Kovi RC, Bhusari S, Ton TV, Li JL, Shockley KR, Peddada SD, Gerrish KE, Rider CV, Hoenerhoff MJ, Sills RC, Pandiri AR. Unique microRNA alterations in hepatocellular carcinomas arising either spontaneously or due to chronic exposure to Ginkgo biloba extract (GBE) in B6C3F1/N mice. Arch Toxicol. 2020 Jul;94(7):2523-2541. doi: https://doi.org/10.1007/s00204-020-02749-8. Epub 2020 Apr 18.
    • 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
    •   (Peer Review Approval 02/08/2012A ) Citation: Yamashita H, Surapureddi S, Kovi RC, Bhusari S, Ton TV, Li JL, Shockley KR, Peddada SD, Gerrish KE, Rider CV, Hoenerhoff MJ, Sills RC, Pandiri AR. Unique microRNA alterations in hepatocellular carcinomas arising either spontaneously or due to chronic exposure to Ginkgo biloba extract (GBE) in B6C3F1/N mice. Arch Toxicol. 2020 Jul;94(7):2523-2541. doi: https://doi.org/10.1007/s00204-020-02749-8. Epub 2020 Apr 18.
    • 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
    • Dose: R: 0, 100, 300, OR 1000 MG/KG; M: 0, 200, 600, OR 2000 MG/KG; 50/SEX/SPECIES/DOSE.
    • Carcinogenesis Results
      • Male Rats Some Evidence 
      • Female Rats Some Evidence 
      • Male Mice Clear Evidence 
      • Female Mice Clear Evidence 

Special Studies

  • Absorption Distribution Metabolism Excretion (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
    • Human (Cell Lines) [HU]
    • Dose: (in-vitro) 0, 1, 10 um [HU].
  • Toxicokinetic Study (Gavage)  (K99050)  Completed 
    • GBE 1 (020703)
    • Citation: Waidyanatha S, Mutlu E, Gibbs S, Stiffler B, Andre J, Burback B, Rider CV. Systemic exposure to Ginkgo biloba extract in male F344/NCrl rats: Relevance to humans. Food Chem Toxicol. 2019 Sep;131:110586. doi: https://doi.org/10.1016/j.fct.2019.110586. Epub 2019 Jun 14.Pubmed Abstract
    • Male Rats [R]: F344/N Charles River
    • Dose: (gavage) 0, 30, 100, 300 mg/kg/day [R].

Genetic Toxicology

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