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Testing Status of Resveratrol M010090

 

CASRN: 501-36-0

Formula: C14-H12-O3

Synonyms/Common Names

  • 1,3-Benzenediol,5-(2-(4-hydroxyphenyl)ethenyl)-,(E)-
  • NSC 327430
  • 3,4',5-Stilbenetriol
  • 3,4',5-Trihydroxystilbene

Short-Term Toxicity

  • 2 weeks (Gavage)  (C20323)  Completed 
    • TOX-102 
      Toxicity Studies of Trans-resveratrol (CASRN 501-36-0) Administered by Gavage for Two Weeks or Three Months to F344/NTac Rats, Wistar Han [Crl:WI(Han)] Rats, and B6C3F1/N Mice
    • Rats: F344/NTac; Mice: B6C3F1
    • Dose: Rats and mice: 0, 78(R), 156, 312, 625, 1250, or 2500(M) mg/kg; 5/sex/species.
  • 13 weeks (Gavage)  (C20323)  Completed 
    • TOX-102 
      Toxicity Studies of Trans-resveratrol (CASRN 501-36-0) Administered by Gavage for Two Weeks or Three Months to F344/NTac Rats, Wistar Han [Crl:WI(Han)] Rats, and B6C3F1/N Mice
    • Rats: Wistar Han; Mice: B6C3F1
    • Dose: Rats: 0, 78, 156, 312.5, 625, or 1250 mg/kg; 10/sex/dose; Mice: 0, 156, 312, 625, 1250, or 2500 mg/kg; 10/sex/dose.

Long-Term Carcinogenicity

  • 2 years (Gavage)  (C20323)  Data in Review 
    • Rats: Harlan Sprague-Dawley; Mice: B6C3F1
    • Dose: Rats: 0, 312.5, 625, or 1250 mg/kg; 60/sex/dose @ 0 or 1250 mg/kg and 50/sex/dose @ 625 or 312.5; Mice: 0, 625, 1250, or 2500 mg/kg.

Modified One-Generation

  • 3 weeks Developmental Toxicity (Gavage)  (MOG01090)  Data in Review 
    • Developmental toxicity
    • Rats: Harlan Sprague-Dawley
    • Dose: 0, 312.5, 625, or 1250 mg/kg.
  • 8 weeks F0 Generation (Gavage)  (MOG01090)  Data in Review 
    • Rats: Harlan Sprague-Dawley
    • Dose: 0, 312.5, 625, or 1250 mg/kg.
  • 17 weeks Fertility Assessment (Gavage)  (MOG01090)  Data in Review 
    • Fertility assessment
    • Rats: Harlan Sprague-Dawley
    • Dose: 0, 312.5, 625, or 1250 mg/kg.

Special Studies

  • Toxicokinetic Study (Gavage)  (K01090B)  Completed 
    • Pilot study
    • Male and Female Rats: Wistar Han
    • Dose: Dose adult (13 ± 2 weeks) male and female Wistar-Han rats with resveratrol by gavage at 78 mg/kg or 1250 mg/kg body weight (7 per dose group). Rats will be fed NTP 2000 diet. Dose timed-mated pregnant female Wistar-Han rats on gestation day 11-18 with resveratrol by gavage at 78 mg/kg or 1250 mg/kg body weight (6 per dose group). Dose Wistar-Han dams starting at gd 18 through pnd 4 with resveratrol at 78 mg/kg or 1250 mg/kg body weight (8 dams per dose group) pups on postnatal day 4.Pilot study developed to generate plasma and tissue samples..
  • Toxicokinetic Study (Gavage; Intravenous; Gavage; Intravenous)  (K01090C)  Completed 
    • toxicokinetic studies of trans-resveratrol
    • Citation: Mutlu E, Gibbs ST, South N, Pierfelice J, Burback B, Germolec D, Waidyanatha S. Comparative toxicokinetics of Trans-resveratrol and its major metabolites in Harlan Sprague Dawley rats and B6C3F1/N mice following oral and intravenous administration. Toxicol Appl Pharmacol. 2020 May 1;394:114962. doi: https://doi.org/10.1016/j.taap.2020.114962. Epub 2020 Mar 20.Pubmed Abstract
    • Male and Female Rats: Harlan Sprague-Dawley; Male and Female Mice: B6C3F1/N
    • Dose: 0, 312.5, 625, and 1250 mg/kg. 10 mg/kg. 625, 1250, 2500 mg/kg.

Genetic Toxicology

  • Micronucleus  (G01090)  Completed 
    • Rats: Wistar Han
    • Male Negative 
    • Female Negative 
  • Micronucleus  (G01090B)  Completed 
    • Mice: B6C3F1
    • Male Negative 
    • Female Negative 
  • Salmonella  (A12955)  Completed 
    •  Negative 

Organ Systems Toxicity

  • 180 days Immunotoxicity (Gavage)  (I01090)  Data in Review 
    • Assessment of the Ability of trans-Resveratrol to Modulate Type 1 Diabetes in Female Non-Obese Diabetic Mice
    • Female Mice: NOD/MrKTac
    • Dose: 0, 125, 250, 500, 1000 or 2000 mg/kg/day.
  • 28 days Immunotoxicity (Gavage)  (IMM20704)  Data in Review 
    • Citation: Huang MC, White KL Jr, Elmore SA, Guo TL, Germolec D. Immunotoxicity studies of trans-resveratrol in male B6C3F1/N mice. J Immunotoxicol. 2020 Dec;17(1):194-201. doi: 10.1080/1547691X.2020.1833113.
    • Male Mice: B6C3F1
    • Dose: 0, 156, 312, 625, 1250, OR 2500 MG/KG/DAY.