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Target Organs and Levels of Evidence for TR-598

TR-598 Toxicology and Carcinogenesis Studies of Perfluorooctanoic Acid (CASRN 335-67-1) Administered in Feed to Sprague Dawley (Hsd:Sprague Dawley SD) Rats

Chemical CASRN
(Study Title)
Peer Review Date Route/Exposure Levels Study Laboratory
Perfluorooctanoic acid
335-67-1
12/12/2019 Dosed-Feed MR: 0/0, 0/150, 0/300, 150/150, or 300/300; FR: 0/0, 0/300, 0/1000, 150/300, or 300/1000 ppm; 60/sex
Dosed-Feed MR: 0/0, 0/20, 0/40, 0/80, 300/0, 300/20, 300/40, or 300/80 ppm; 60/sex
Battelle Columbus Laboratory

Levels of Evidence

Male Rats: Clear Evidence
Type Organ/Tissue (Lesion)
Postweaning Perinatal + Postweaning
Neoplastic Lesions
  • Liver: hepatocellular adenoma (0/50, 0/50, 7/50, 11/50); hepatocellular carcinoma (0/50, 0/50, 0/50, 0/50); hepatocellular adenoma or carcinoma (0/50, 0/50, 7/50, 11/50)
  • Pancreas: acinar cell adenoma (3/50, 28/50, 26/50, 32/50); acinar cell adenocarcinoma (0/50, 3/50, 1/50, 3/50), acinar cell adenoma or adenocarcinoma (3/50, 29/50, 26/50, 32/50)
  • Liver: hepatocellular adenoma (0/50, 1/50, 5/50, 10/50); hepatocellular carcinoma (0/50, 0/50, 0/50, 4/50); hepatocellular adenoma or carcinoma (0/50, 1/50, 5/50, 12/50)
  • Pancreas: acinar cell adenoma (7/50, 18/50, 30/50, 30/50); acinar cell adenocarcinoma (0/50, 2/50, 1/50, 3/50), acinar cell adenoma or adenocarcinoma (7/50, 20/50, 30/50, 30/50)
Non-Neoplastic Lesions
  • Liver: hepatocyte, cytoplasmic alteration; hepatocyte, hypertrophy; hepatocyte, single cell death; necrosis; pigment
  • Pancreas: acinus, hyperplasia
  • Liver: hepatocyte, cytoplasmic alteration; hepatocyte, hypertrophy; hepatocyte, single cell death; necrosis; pigment
  • Pancreas: acinus, hyperplasia
Female Rats: Some Evidence
Type Organ/Tissue (Lesion)
Postweaning Perinatal + Postweaning
Neoplastic Lesions
  • Pancreas: acinar cell adenoma (0/50, 0/50, 1/49); acinar cell adenocarcinoma (0/50, 0/50, 1/49); acinar cell adenoma or adenocarcinoma (0/50, 0/50, 2/49) 
  • Pancreas: acinar cell adenoma (0/50, 0/50, 3/50); acinar cell adenocarcinoma (0/50, 0/50, 2/50); acinar cell adenoma or adenocarcinoma (0/50, 0/50, 5/50)
May Have Been Related
  • Liver: hepatocellular carcinoma (1/50, 1/50, 3/49)
  • Uterus: adenocarcinoma (1/50, 5/50, 8/50)
  • Liver: hepatocellular carcinoma (1/50, 0/50, 4/50)
  • Uterus: adenocarcinoma (1/50, 3/50, 5/50)
Non-Neoplastic Lesions
  • Liver: hepatocyte, cytoplasmic alteration; hepatocyte, hypertrophy; hepatocyte, single cell death; necrosis; pigment; bile duct hyperplasia; hepatocyte, increased mitoses
  • Kidney: papilla, urothelium, hyperplasia; papilla, necrosis; renal tubule, mineral
  • Forestomach: ulcer; epithelium, hyperplasia; submucosa, inflammation, chronic active
  • Thyroid gland: follicular cell, hypertrophy
  • Liver: hepatocyte, cytoplasmic alteration; hepatocyte, hypertrophy; hepatocyte, single cell death; necrosis; pigment; bile duct hyperplasia; hepatocyte, increased mitoses
  • Kidney: papilla, urothelium, hyperplasia; papilla, necrosis; renal tubule, mineral
  • Forestomach: ulcer; epithelium, hyperplasia; submucosa, inflammation, chronic active
  • Thyroid gland: follicular cell, hypertrophy