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Target Organs and Levels of Evidence for TR-535

Toxicology and Carcinogenesis Studies of 4-Methylimidazole (CASRN 822-36-6) in F344/N Rats and B6C3F1 Mice (Feed Studies)

Chemical (Study Title)
CASRN
Peer Review DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
4-Methylimidazole
822-36-6
09/28/2005Has been reported as one of several compounds resulting from interaction of reducing sugars with ammonia; major pharmaceutical intermediate; starting material for drug used for ulcer therapy & other drugs, antiseptic agents; photo developing solution. 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.Dosed-Feed
MR: 0, 625, 1250, OR 2500 PPM; FR: 0, 1250, 2500, OR 5000 PPM; M: 0, 312, 625, OR 1250 PPM; 50/SEX/SPECIES/GROUP
Southern Research Institute

Levels of Evidence

Male Rats: No Evidence
TypeOrgan/Tissue (Lesion)
Non-Neoplastic Lesions
  • LIVER: HISTIOCYTOSIS; CHRONIC INFLAMMATION; HEPATOCYTIC FOCAL FATTY CHANGE; EOSINOPHILIC FOCUS; MIXED CELL FOCUS
Female Rats: Equivocal Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Hematopoietic System: MONONUCLEAR CELL LEUKEMIA 9/50 7/50 16/50 20/50
Non-Neoplastic Lesions
  • LIVER: HISTIOCYTOSIS; CHRONIC INFLAMMATION; HEPATOCYTIC FOCAL FATTY CHANGE; EOSINOPHILIC FOCUS; MIXED CELL FOCUS
Male Mice: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Lung: ALVEOLAR/BRONCHIOLAR CARCINOMA 2/50 4/50 4/50 8/50 ALVEOLAR/BRONCHIOLAR ADENOMA OR CARCINOMA (COMBINED) 9/50 13/50 16/50 22/50
Female Mice: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Lung: ALVEOLAR/BRONCHIOLAR ADENOMA 0/50 8/50 16/50 8/50 ALVEOLAR/BRONCHIOLAR CARCINOMA 3/50 0/50 2/50 7/50 COMBINED 3/50 8/50 17/50 14/50
Non-Neoplastic Lesions
  • LUNG: ALVEOLAR EPITHELIAL HYPERPLASIA