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Target Organs and Levels of Evidence for TR-588

Toxicology and Carcinogenesis Studies of Glycidamide (CASRN 5694-00-8) in F344/N Nctr Rats and B6C3F1/Nctr  Mice (Dosed-Water Studies)

Chemical
CASRN
(Study Title)
Peer Review Date Primary Uses Route/Exposure Levels Study Laboratory
Glycidamide
5694-00-8
10/29/2013 Metabolite of acrylamide. 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-Water
R&M: 0, 0.0875, 0.175, 0.35, OR 0.70 MM
National Center for Toxicological Research

Levels of Evidence

Male Rats: Clear Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Epididymis: malignant mesothelioma 0/48 1/45 3/48 10/47 17/47
  • Testis: malignant mesothelioma 0/48 1/47 3/48 6/47 13/48
  • Epididymis or Testis: malignant mesothelioma 0/48 1/48 3/48 10/47 17/48
  • Heart: malignant schwannoma 2/48 3/48 3/48 7/47 8/48
  • Oral Cavity: Oral mucosa: squamous cell papilloma 1/48 1/48 0/48 2/47 3/48 squamous cell carcinoma 1/48 0/48 1/48 1/47 0/48
  • Oral Cavity: Tongue: squamous cell papilloma 0/48 1/48 0/48 1/47 4/48
  • Oral Cavity: Oral mucosa or tongue: squamous cell papilloma or carcinoma 2/48 2/48 2/48 3/47 7/48
  • Thyroid Gland Follicular Cell: adenoma 2/47 1/42 3/48 3/47 8/46 follicular cell carcinoma 0/47 2/42 3/48 1/47 5/46 follicular cell adenoma or carcinoma 2/47 3/42 6/48 4/47 13/46
May Have Been Related
  • Mononuclear Cell Leukemia: 21/48 26/48 27/48 27/47 31/48
Non-Neoplastic Lesions
  • Brain: gliosis
  • Epididymis: exfoliated germ cells
  • Liver: hepatocyte degeneration; necrosis
Female Rats: Clear Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Clitoral Gland: carcinoma 4/48 6/48 7/48 11/48 14/47
  • Mammary Gland: fibroadenoma 16/48 26/48 35/48 33/48 36/48
  • Oral Cavity: Oral mucosa: squamous cell papilloma 1/48 1/48 2/48 0/48 4/48 squamous cell carcinoma 0/48 0/48 0/48 1/48 2/48
  • Oral Cavity: Tongue: squamous cell papilloma 0/48 1/48 0/48 1/48 0/48 squamous cell carcinoma 0/48 0/48 0/48 0/48 1/48
  • Oral Cavity: Oral mucosa or tongue: squamous cell papilloma or carcinoma 1/48 2/48 2/48 2/48 7/48
  • Forestomach: squamous cell papilloma 0/48 1/48 0/48 0/47 3/46
  • Thyroid Gland Follicular Cell: adenoma 0/48 3/48 3/46 1/46 5/47 follicular cell carcinoma 0/48 0/48 2/46 3/46 3/47 follicular cell adenoma or carcinoma 0/48 3/48 5/46 4/46 8/47
  • Mononuclear Cell Leukemia: 14/48 11/48 21/48 19/48 27/48
Non-Neoplastic Lesions
  • Brain: gliosis
  • Bone marrow: hyperplasia
  • Spinal cord (lumbar): axonal degeneration
  • Uterus: endometrial hyperplasia
Male Mice: Clear Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Harderian Gland: adenoma 3/47 17/47 23/47 32/46 42/47
  • Lung: alveolar/bronchiolar adenoma 0/47 7/46 7/47 13/47 17/47
  • Skin: squamous cell papilloma 0/47 1/48 2/47 1/47 8/46 squamous cell carcinoma 0/47 0/48 0/47 0/47 2/46 squamous cell papilloma or carcinoma 0/47 1/48 2/47 1/47 9/46
  • Forestomach: squamous cell papilloma 0/47 2/45 3/48 2/45 10/41 squamous cell carcinoma 0/47 0/45 0/48 0/45 2/41 squamous cell papilloma or carcinoma 0/47 2/45 3/48 2/45 12/41
Non-Neoplastic Lesions
  • Eye: cataract; corneal inflammation
  • Preputial gland: degeneration; ductal dilatation; inflammation
  • Spleen: hematopoietic cell proliferation
  • Forestomach: epithelial hyperplasia
Female Mice: Clear Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Harderian Gland: adenoma 2/45 19/47 20/47 24/46 40/46
  • Lung: alveolar/bronchiolar adenoma 3/46 5/48 3/47 7/47 9/44
  • Mammary Gland: adenoacanthoma 0/45 0/48 0/47 1/47 8/45 adenocarcinoma 1/45 1/48 2/47 9/47 11/45 adenoacanthoma or adenocarcinoma 1/45 1/48 2/47 9/47 18/45
  • Skin: fibrosarcoma 0/45 1/48 2/47 2/47 9/45 sarcoma 0/45 0/48 1/47 3/47 3/45 fibrosarcoma or sarcoma 0/45 1/48 3/47 5/47 12/45
  • Forestomach: squamous cell papilloma 1/45 1/45 1/47 5/45 9/44
May Have Been Related
  • Ovary: granulosa cell tumor – benign or malignant 0/45 0/47 0/47 3/46 3/44
Non-Neoplastic Lesions
  • Eye: cataract; corneal inflammation
  • Liver: angiectasis; necrosis
  • Ovary: cyst
  • Spinal cord (cervical): axonal degeneration
  • Spleen: hematopoietic cell proliferation
  • Forestomach: epithelial hyperplasia