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https://ntp.niehs.nih.gov/go/38083

N,N-Dimethyl-p-toluidine: Target Organs and Levels of Evidence for TR-579

Toxicology and Carinogenesis Studies of N,N-Dimethyl-p-Toluidine (CASRN 99-97-8) in F344/N Rats and B6C3F1/N Mice (Gavage Studies)

Chemical (Study Title)
CASRN		Peer Review DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
N,N-Dimethyl-p-toluidine
99-97-8		02/08/2012Used as a polymerization accelerator for the manufacture of bone cements & dental materials. Found in industrial glues & artificial fingernail preps. Intermediate in dye & pesticide synthesis.Gavage
R&M: 0, 6, 20, OR 60 MG/KG; 50/SEX/SPECIES/DOSE		Battelle Columbus Laboratory

Levels of Evidence

Male Rats: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Liver: hepatocellular carcinoma 0/50, 0/50, 1/50, 6/50; hepatocellular adenoma or carcinoma 0/50, 0/50, 2/50, 6/50
  • Nasal Cavity: transitional epithelium, adenoma 0/50, 3/49, 2/50, 11/49; transitional epithelium, adenoma or carcinoma 0/50, 3/49, 2/50, 13/49
May Have Been Related
  • Thyroid Gland Follicular Cell: adenoma or carcinoma 1/50, 2/49, 2/50, 4/49
Non-Neoplastic Lesions
  • Liver: eosinophilic focus, mixed cell focus; bile duct, fibrosis; bile duct, hyperplasia; degeneration, cystic; hepatocyte, hypertrophy
  • Nasal Cavity: glands, olfactory epithelium, dilatation; glands, olfactory epithelium, hyperplasia; olfactory epithelium, metaplasia; glands, olfactory epithelium, necrosis; glands, respiratory epithelium, dilatation; glands, respiratory epithelium, hyperplasia; glands, respiratory epithelium, metaplasia, respiratory; glands, transitional epithelium, dilatation; glands, transitional epithelium, hyperplasia; inflammation; nerve, atrophy; olfactory epithelium, degeneration; olfactory epithelium, hyperplasia, basal cell; olfactory epithelium, metaplasia, respiratory; respiratory epithelium, hyperplasia; transitional epithelium, hyperplasia
  • Spleen: capsule, fibrosis; capsule, hypertrophy, mesothelium; congestion; hematopoietic cell proliferation; lymphoid follicle, atrophy; pigmentation
  • Kidney: severity of nephropathy; pigmentation
  • Forestomach: hyperplasia; inflammation; ulcer
  • Bone marrow: hyperplasia
  • Mesenteric lymph node: infiltration cellular, histiocyte
Female Rats: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Liver: hepatocellular carcinoma 0/50, 0/50, 0/50, 4/49; hepatocellular adenoma or carcinoma 0/50, 1/50, 1/50, 7/49
  • Nasal Cavity: transitional epithelium, adenoma 0/50, 1/49, 0/50, 2/49
Non-Neoplastic Lesions
  • Liver: clear cell focus; eosinophilic focus; mixed cell focus; bile duct, fibrosis; bile duct, hyperplasia; degeneration, cystic; hepatocyte, hypertrophy; hepatocyte, necrosis
  • Nasal Cavity: glands, olfactory epithelium, dilatation; glands, olfactory epithelium, hyperplasia; glands, olfactory epithelium, metaplasia; glands, olfactory epithelium, necrosis; glands, respiratory epithelium, dilatation; glands, respiratory epithelium, hyperplasia; glands, respiratory epithelium, metaplasia, respiratory; glands, transitional epithelium, dilatation; glands, transitional epithelium, hyperplasia; inflammation; nerve, atrophy; olfactory epithelium, degeneration; olfactory epithelium, hyperplasia, basal cell; olfactory epithelium, metaplasia, respiratory; respiratory epithelium, hyperplasia; transitional epithelium, hyperplasia
  • Spleen: capsule, fibrosis; capsule, hypertrophy, mesothelium; congestion; hematopoietic cell proliferation; lymphoid follicle, atrophy; pigmentation
  • Kidney: nephropathy; severity of nephropathy; pigmentation
  • Bone marrow: hyperplasia
Male Mice: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Liver: hepatocellular adenoma, multiple 17/50, 19/50, 27/50, 26/50; hepatocellular carcinoma 22/50, 25/50, 30/50, 36/50; hepatoblastoma 1/50, 5/50, 10/50, 8/50
Non-Neoplastic Lesions
  • Liver: eosinophilic focus; hepatocyte, hypertrophy
  • Nasal Cavity: glands, olfactory epithelium, dilatation; glands, olfactory epithelium, hyperplasia; glands, olfactory epithelium, metaplasia, respiratory; glands, respiratory epithelium, dilatation; glands, respiratory epithelium, metaplasia, respiratory; nerve, atrophy; olfactory epithelium, metaplasia, respiratory; olfactory epithelium, necrosis
  • Lung: alveolus, infiltration cellular, histiocyte
  • Olfactory lobe: atrophy
  • Forestomach: hyperplasia; inflammation; ulcer
Female Mice: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Liver: hepatocellular adenoma 17/50, 19/50, 37/50, 44/50; hepatocellular carcinoma 6/50, 13/50, 18/50, 31/50; hepatoblastoma 0/50, 1/50, 0/50, 4/50
  • Lung: alveolar/bronchiolar adenoma 2/50, 4/50, 8/50, 12/50; alveolar/bronchiolar adenoma or carcinoma 2/50, 5/50, 9/50, 13/50
  • Forestomach: squamous cell papilloma 1/50, 5/50, 6/50, 7/50; squamous cell papilloma or carcinoma 1/50, 6/50, 6/50, 7/50
Non-Neoplastic Lesions
  • Liver: eosinophilic focus; fatty change; hepatocyte, hypertrophy; necrosis
  • Lung: alveolar epithelium, hyperplasia; alveolus, infiltration cellular, histiocyte; bronchiole, epithelium, regeneration; bronchus, epithelium, regeneration; bronchus, necrosis
  • Forestomach: epithelium, hyperplasia; inflammation; ulcer
  • Nasal Cavity: glands, olfactory epithelium, dilatation; glands, olfactory epithelium, hyperplasia; glands, olfactory epithelium, metaplasia, respiratory; glands, respiratory epithelium, dilatation; glands, respiratory epithelium, hyperplasia; glands, respiratory epithelium, metaplasia, respiratory; inflammation; nasolacrimal duct, hyperplasia, regenerative; nerve, atrophy; olfactory epithelium, accumulation, hyaline droplet; olfactory epithelium, metaplasia, respiratory; olfactory epithelium, necrosis; respiratory epithelium, hyperplasia; respiratory epithelium, necrosis; vomeronasal organ, necrosis
  • Olfactory lobe: atrophy
  • Bone marrow: hyperplasia
  • Mesenteric lymph node: atrophy
  • Spleen: red pulp atrophy