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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)  Completed 
    • 5-Day Transcriptomic Dose-Response Studies
    • Citation: Gwinn WM, Auerbach SS, Parham F, Stout MD, Waidyanatha S, Mutlu E, Collins B, Paules RS, Merrick BA, Ferguson S, Ramaiahgari S, Bucher JR, Sparrow B, Toy H, Gorospe J, Machesky N, Shah RR, Balik-Meisner MR, Mav D, Phadke DP, Roberts G, DeVito MJ. Evaluation of 5-day In Vivo Rat Liver and Kidney With High-throughput Transcriptomics for Estimating Benchmark Doses of Apical Outcomes. Toxicol Sci. 2020 Aug 1;176(2):343-354. doi: https://doi.org/10.1093/toxsci/kfaa081.Pubmed Abstract
    • 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)  Completed 
    • Citation: Gwinn WM, Auerbach SS, Parham F, Stout MD, Waidyanatha S, Mutlu E, Collins B, Paules RS, Merrick BA, Ferguson S, Ramaiahgari S, Bucher JR, Sparrow B, Toy H, Gorospe J, Machesky N, Shah RR, Balik-Meisner MR, Mav D, Phadke DP, Roberts G, DeVito MJ. Evaluation of 5-day In Vivo Rat Liver and Kidney With High-throughput Transcriptomics for Estimating Benchmark Doses of Apical Outcomes. Toxicol Sci. 2020 Aug 1;176(2):343-354. doi: https://doi.org/10.1093/toxsci/kfaa081.Pubmed Abstract
    • Rats: Harlan Sprague-Dawley