National Toxicology Program

National Toxicology Program
http://ntp.niehs.nih.gov/go/ts-m990059

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)

Nomination Background

Short-Term Toxicity

  • 5 days (Gavage)  (C99059)  Assigned 
    • 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)  Report Complete 
    • 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) Selected (T99059)  
    • Rats: Harlan Sprague-Dawley
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.