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Target Organs and Levels of Evidence for TR-450

Toxicology and Carcinogenesis Studies of Tetrafluoroethylene (CASRN 116-14-3) in F344 Rats and B6C3F1 Mice (Inhalation Studies)

Chemical (Study Title)
CASRN
Peer Review DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
Tetrafluoroethylene
116-14-3
Monomer for polytetrafluoroethylene polymers. Preparation of propellants for food product aerosols. Chemical intermediate. Inhalation
0,312,625,1250,2500,5000 PPM/010 PER GROUP
Battelle Northwest Laboratory

Levels of Evidence



Chemical (Study Title)
CASRN
Peer Review DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
Tetrafluoroethylene
116-14-3
12/05/1995Monomer for polytetrafluoroethylene polymers. Preparation of propellants for food product aerosols. Chemical intermediate. Inhalation
MICE & FR: 0, 312, 625, OR 1250 MR: 0, 156, 312, OR 625 PPM; 50/GROUP
Battelle Northwest Laboratory

Levels of Evidence

Male Rats: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Kidney Tubular Cell: SINGLE SECTIONS: ADENOMA 0/50 0/50 6/50 3/50 OR CARCINOMA 1/50 0/50 2/50 0/50 COMBINED 1/50 0/50 6/50 3/50; SINGLE AND STEP SECTIONS: ADENOMA 2/50 4/50 9/50 13/50 OR CARCINOMA 1/50 1/50 2/50 0/50 COMBINED 3/50 5/50 9/50 13/50
  • Liver: ADENOMA 3/50 6/50 8/50 5/50 OR CARCINOMA 1/50 1/50 10/50 3/50 COMBINED 4/50 7/50 15/50 8/50
May Have Been Related
  • Hematopoietic System: MONONUCLEAR CELL LEUKEMIA: 34/50 43/50 38/50 31/50
  • Testis: INTERSTITIAL CELL ADENOMA 39/50 40/50 48/50 47/50
Non-Neoplastic Lesions
  • KIDNEY: INCREASED SEVERITY OF NEPHROPATHY; TUBULE DEGENERATION; TUBULE HYPERPLASIA
Female Rats: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Kidney Tubular Cell: SINGLE SECTIONS: ADENOMA 0/50 3/50 1/50 3/50 OR CARCINOMA 0/50 0/50 0/50 2/50 COMBINED 0/50 3/50 1/50 5/50; SINGLE AND STEP SECTIONS: ADENOMA 0/50 3/50 3/50 8/50 OR CARCINOMA 0/50 0/50 0/50 3/50 COMBINED 0/50 3/50 3/50 10/50
  • Liver: ADENOMA 0/50 4/50 5/50 6/50 OR CARCINOMA 0/50 4/50 9/50 2/50 COMBINED 0/50 7/50 12/50 8/50
  • Hematopoietic System: MONONUCLEAR CELL LEUKEMIA: 16/50 31/50 23/50 36/50
  • Vascular System (Liver): HEMANGIOSARCOMA 0/50 0/50 5/50 1/50
Non-Neoplastic Lesions
  • KIDNEY: TUBULE DEGENERATION; TUBULE HYPERPLASIA
  • LIVER: ANGIECTASIS
  • EYE: CATARACTS
Male Mice: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Liver: ADENOMA 17/48 17/48 12/48 20/48 OR CARCINOMA 11/48 20/48 33/48 26/48 COMBINED 26/48 34/48 39/48 35/48
  • Hematopoietic System: HISTIOCYTIC SARCOMA 0/48 12/48 7/48 7/48
  • Vascular System (Liver): HEMANGIOMA 0/48 10/48 5/48 2/48 OR HEMANGIOSARCOMA 0/48 21/48 27/48 37/48 COMBINED 0/48 26/48 30/48 38/48
Non-Neoplastic Lesions
  • KIDNEY: TUBULE DILATATION; TUBULE KARYOMEGALY
  • LIVER: ANGIECTASIS
  • SPLEEN: HEMATOPOIETIC CELL PROLIFERATION
Female Mice: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Liver: ADENOMA 15/48 17/48 20/47 15/47 OR CARCINOMA 4/48 28/48 22/47 20/47 COMBINED 17/48 33/48 29/47 28/47
  • Hematopoietic System: HISTIOCYTIC SARCOMA 1/48 21/48 19/47 18/48
  • Vascular System (Liver): HEMANGIOMA 0/48 5/48 2/47 1/47 OR HEMANGIOSARCOMA 0/48 27/48 27/47 34/47 COMBINED 0/48 31/48 28/47 35/47
Non-Neoplastic Lesions
  • KIDNEY: TUBULE KARYOMEGALY
  • LIVER: ANGIECTASIS; HEMATOPOIETIC CELL PROLIFERATION
  • SPLEEN: HEMATOPOIETIC CELL PROLIFERATION