Target Organs and Levels of Evidence for TR-603

Toxicology and Carcinogenesis Studies of Black Cohosh Root Extract (CASRN 84776-26-1) Administered by Gavage to Sprague Dawley (Hsd:Sprague Dawley SD) Rats and Female B6C3F1/N Mice

(Study Title)
Peer Review Date Route/Exposure Levels Study Laboratory
Black Cohosh
01/01/2023 Gavage
Rats: 0, 75, 250, or 750 mg/kg/day; 50/sex/dose. Female mice: 0, 30, 100, 300, or 1000 mg/kg/day; 70/dose
Battelle Columbus Laboratory

Levels of Evidence

Male Rats: No Evidence (Perinatal Exposure Only)
Female Rats: Equivocal Evidence (Perinatal Exposure and Postweaning Dosing)
Type Organ/Tissue (Lesion)
May Have Been Related
  • Uterus: squamous cell papilloma (1/50, 1/50, 4/50, 0/49)
Non-Neoplastic Lesions
  • Uterus: squamous metaplasia; dilation; hemorrhage; thrombus; ulcers
  • Ovary: atrophy
Female Mice: No Evidence (Postweaning Dosing Only)
Type Organ/Tissue (Lesion)
Non-Neoplastic Lesions
  • Liver: necrosis
  • Thyroid gland: follicle, dilation