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Testing Status of Milk thistle extract M990059

 

CASRN: 84604-20-6

Formula: N/A

Synonyms/Common Names

  • Lady's thistle extract
  • Silybum marianum extract

Known Uses

Used as an herbal supplement and medicinally as an hepatoprotectant and for treatment of chronic inflammatory liver disorders.

Chemical Properties

Toxicity Effects (HSDB)

Short-Term Toxicity

  • 5 days (Gavage)  (C99059)  On Test 
    • 5-Day Transcriptomic Dose-Response Studies
    • Rats: Harlan Sprague-Dawley
    • Dose: Male rats: 0, 39.1, 78.125, 156.25, 312.5, 625, 937.5, 1250, or 1750 mg/kg; N=4.
  • 13 weeks (Dosed-Feed)  (C20008)  Completed 
    • Rats: F344/N; Mice: B6C3F1/N
    • Dose: R&M: 0, 3125, 6250, 12500, 25000, OR 50000 PPM; 10/SEX/SPECIES.

Long-Term Carcinogenicity

  • 2 years (Dosed-Feed)  (C20008)  Completed 
    • TR-565 (NIH Number: 10-5907)  (Peer Review Approval 11/19/2009A )
      Toxicology and Carcinogenesis Studies of Milk Thistle Extract (CASRN 84604-20-6) in F344/N Rats and B6C3F1 Mice (Feed studies)
    • Rats: F344/N; Mice: B6C3F1/N
    • Carcinogenesis Results
      • Male Rats No Evidence 
      • Female Rats No Evidence 
      • Male Mice No Evidence 
      • Female Mice No Evidence 
    • Dose: R&M: 0, 12500, 25000, OR 50000 PPM; 50/SEX/SPECIES.

Special Studies

  • Absorption Disposition Metabolism Elimination (in-vitro)  (S0857)  Completed 
    • Citation: Final Study Report. Milk Thistle Extract: Interaction of Extracts with Cytochrome P450 Enzymes and P-glycoprotein. Studies of Chemical Disposition in Mammals. 10/14/2002 - 02/28/2006.
    • Human (Cell Lines)
    • Dose: 0, 1, 10, 100 uM..

Genetic Toxicology

  • Micronucleus  (A73501)  Completed 
    • Mice: B6C3F1
    • Male Negative 
    • Female Negative 
  • Salmonella  (A21904)  Completed 
    •  Positive 
  • Salmonella  (A41673)  Completed 
    •  Negative 
  • Salmonella  (A42260)  Completed 
    •  Negative 
  • Salmonella  (A44499)  Completed 
    •  Negative 
  • Salmonella  (A78884)  Completed 
    •  Positive 
  • Salmonella  (G99059)  Completed 
    •  Positive 

Toxicogenomics

  • 5-day Transcriptome Sequencing (Gavage)  (T99059)  On Test 
    • Rats: Harlan Sprague-Dawley