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Target Organs and Levels of Evidence for TR-563

Toxicology and Carcinogenesis Studies of Pulegone (CAS No. 89-82-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies)

Chemical (Study Title)
CASRN		 Peer Review Date Route/Exposure Levels Study Laboratory
Pulegone
89-82-7		 11/19/2009 Gavage
MALE RATS: 0, 18.75, 37.5, OR 75 MG/KG; FEMALE RATS AND MALE & FEMALE MICE: 0, 37.5, 75, OR 150 MG/KG		 Battelle Columbus Laboratory

Levels of Evidence

Male Rats: No Evidence
Type Organ/Tissue (Lesion)
Non-Neoplastic Lesions
  • Kidney: Hyaline glomerulopathy; severity of nephropathy; cyst
  • Liver: Hepatocyte, cellular alteration, diffuse; fatty change; bile duct cyst; hepatocyte, necrosis; oval cell, hyperplasia; bile duct, hyperplasia; portal fibrosis
  • Nasal Cavity: Olfactory epithelium, degeneration
  • Forestomach: Inflammation; perforation; ulcer; epithelium, hyperplasia
Female Rats: Some Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Urinary Bladder: Papilloma 0/50 0/49 1/50 3/47 papilloma or carcinoma 0/50 0/49 1/50 5/47
Non-Neoplastic Lesions
  • Kidney: Hyaline glomerulopathy; nephropathy; severity of nephropathy
  • Liver: Hepatocyte, cellular alteration, diffuse; fatty change; bile duct, cyst; hepatocyte, necrosis; oval cell, hyperplasia; bile duct, hyperplasia; portal fibrosis
  • Nasal Cavity: Olfactory epithelium, degeneration, metaplasia; respiratory inflammation
Male Mice: Clear Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Liver: Hepatocellular: Adenoma 22/50 31/50 35/50 28/50 adenoma, carcinoma, or hepatoblastoma 29/50 37/50 42/50 36/50
Non-Neoplastic Lesions
  • Kidney: Glomerulopathy, hyaline; glomerulus, congestion; severity of nephropathy
  • Liver: Clear cell focus; eosinophilic focus; mixed cell focus; fatty change, focal; centrilobular, hepatocyte, hypertrophy; vein, intravascular hepatocyte; necrosis; bile duct, cyst; bile duct, hyperplasia; oval cell hyperplasia
  • Nasal Cavity: Olfactory epithelium, degeneration; inflammation; nerve, atrophy; epithelium, metaplasia
  • Forestomach: Hyperplasia, squamous; inflammation; ulcer
Female Mice: Clear Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Liver: Hepatocellular: Adenoma 13/49 15/50 13/50 27/50 adenoma, carcinoma or hepatoblastoma 17/49 15/50 15/50 33/50
May Have Been Related
  • All Organs: Osteoma or osteosarcoma: 0/49 0/50 3/50 1/50
Non-Neoplastic Lesions
  • Kidney: Glomerulopathy, hyaline; mineralization; nephropathy; glomerulus, congestion
  • Liver: Clear cell focus; eosinophilic focus; mixed cell focus; fatty change, focal; centrilobular, hepatocyte, hypertrophy; vein, intravascular hepatocyte; necrosis; pigmentation; bile duct, cyst; bile duct, hyperplasia; oval cell hyperplasia
  • Nasal Cavity: Olfactory epithelium, degeneration; inflammation; nerve, atrophy; epithelium, metaplasia
  • Forestomach: Hyperplasia, squamous; inflammation