Testing Status of Milk thistle extract M990059

CASRN: 84604-20-6

Synonyms/Common Names

• Lady's thistle extract
• Silybum marianum extract

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 
  • 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