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Target Organs and Levels of Evidence for TR-422

Toxicology and Carcinogenesis Studies of Coumarin (CASRN 91-64-5) in F344/N Rats and B6C3F1 Mice (Gavage Studies)

Chemical (Study Title)
CASRN
Peer Review DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
Coumarin
91-64-5
Odor enhancing agent in perfumes. Pharmaceutic aid (flavor). Associated with tobacco: reported either as a natural component of tobacco, pyrolysis product (in tobacco smoke), or additive for one or more types of tobacco products.Gavage
R: 0,25,400, M: 0,30,150 MG/KG/5 PER GROUP
International Research & Development Corp.

Levels of Evidence



Chemical (Study Title)
CASRN
Peer Review DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
Coumarin
91-64-5
06/23/1992Odor enhancing agent in perfumes. Pharmaceutic aid (flavor). Associated with tobacco: reported either as a natural component of tobacco, pyrolysis product (in tobacco smoke), or additive for one or more types of tobacco products.Gavage
R: 0,25,50,100; M: 0,50,100,200 MG/KG/60 & 70 PER GROUP RESPECTIVELY
American Biogenics Corp (Bioassay Systems)

Levels of Evidence

Male Rats: Some Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Kidney Tubular Cell: ADENOMA 1/49 2/50 2/51 1/50, STEP SECTIONS 0/49 4/50 5/51 4/50
Non-Neoplastic Lesions
  • LIVER: CYTOLOGIC ALTERATIONS; FIBROSIS; NECROSIS; BILE DUCT HYPERPLASIA
  • FORESTOMACH: ULCER
  • PARATHYROID GLAND: HYPERPLASIA
  • KIDNEY: INCREASED SEVERITY OF NEPHROPATHY
Female Rats: Equivocal Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Kidney Tubular Cell: ADENOMA 0/49 0/50 0/50 2/49, STEP SECTIONS 0/49 0/50 1/50 1/49
Non-Neoplastic Lesions
  • LIVER: FIBROSIS; NECROSIS; DEGENERATION; BILE DUCT HYPERPLASIA
  • FORESTOMACH: ULCER
  • KIDNEY: INCREASED SEVERITY OF NEPHROPATHY
Male Mice: Some Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Lung: ALVEOLAR/BRONCHIOLAR ADENOMA 14/50 8/50 14/50 24/51 OR ALVEOLAR/BRONCHIOLAR CARCINOMA 1/50 1/50 2/50 1/51 COMBINED 14/50 9/50 15/50 25/51
May Have Been Related
  • Forestomach: SQUAMOUS CELL PAPILLOMA 2/50 8/50 2/50 0/51
Non-Neoplastic Lesions
  • LIVER: SYNCYTIAL ALTERATION; CENTRILOBULAR HYPERTROPHY; EOSINOPHILIC FOCUS
Female Mice: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Lung: ALVEOLAR/BRONCHIOLAR ADENOMA 2/51 5/49 7/49 20/51 OR ALVEOLAR/BRONCHIOLAR CARCINOMA 0/51 0/49 0/49 7/51 COMBINED 2/51 5/49 7/49 27/51
  • Liver: ADENOMA 8/50 26/49 29/51 12/50
May Have Been Related
  • Forestomach: SQUAMOUS CELL PAPILLOMA 1/52 5/50 2/51 2/51
Non-Neoplastic Lesions
  • LIVER: SYNCYTIAL ALTERATION; CENTRILOBULAR HYPERTROPHY; EOSINOPHILIC FOCUS