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Testing Status of Green Tea Extract M030008


Synonyms/Common Names

  • GTE

Short-Term Toxicity

  • 5 days (Gavage)  (C03008)  Data in Review 
    • 5 day
    • Rats: F344/NCrl (SAS FISCH)
    • Dose: Green Tea Extract; 0, 3, 30, 100, 300, or 1000 mg/kg; 6 males/group.
  • 13 weeks (Gavage)  (C20203)  Completed 
    • Rats: F344/NTac; Mice: B6C3F1/N
    • Dose: R&M: 0, 62.5, 125, 250, 500, or 1000 mg/kg; R: 20/sex/dose; M: 10/sex/dose.

Long-Term Carcinogenicity

  • 2 years (Gavage)  (C20203)  Completed 
    • TR-585 (NIH Number: 16-5927)  (Peer Review Approval 05/22/2014A )
      Toxicology Studies of Green Tea Extract in F344/NTac Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Green Tea Extract in Wistar Han [Crl:WI(Han)] Rats and B6C3F1/N Mice (Gavage Studies)
    • Rats: Wistar Han; Mice: B6C3F1/N
    • Dose: R: 0, 100, 300, or 1, 000 mg/kg; M: 0, 30, 100, or 300 mg/kg; 50/sex/species/dose.
    • Carcinogenesis Results
      • Male Rats No Evidence 
      • Female Rats No Evidence 
      • Male Mice No Evidence 
      • Female Mice No Evidence 

Genetic Toxicology

  • Micronucleus  (A70207)  Completed 
    • Mice: B6C3F1
    • Male Negative 
    • Female Negative 
  • 5 days Micronucleus (Gavage)  (G03008)  Completed 
    • Rats: F344/N Charles River
  • 24 hours Micronucleus (in-vitro) Selected (G03008C)  
    • Human (Cell Lines)
  • Salmonella  (A43286)  Completed 
    •  Positive 
  • Salmonella (in-vitro) Selected (G03008B)