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Target Organs and Levels of Evidence for TR-416

Toxicology and Carcinogenesis Studies of o-Nitroanisole (CASRN 91-23-6) in F344 Rats and B6C3F1 Mice (Feed Studies)

Chemical (Study Title)
CASRN
Peer Review DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
o-Nitroanisole
91-23-6
11/21/1991Used as an intermediate for the preparation of o-anisidine and in the manufacture of azo dyesDosed-Feed
(CORE STUDY) R: 0, 222, 666, 2000 PPM M: 0, 666, 2000, 6000 PPM (STOP STUDY) R: 0, 6000, 18000 PPM; 50/GROUP
Southern Research Institute

Levels of Evidence

Male Rats: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Hematopoietic System: MONONUCLEAR CELL LEUKEMIA 26/50 25/50 42/50 34/50
  • Urinary Bladder: (STOP STUDY) TRANSITIONAL CELL PAPILLOMA 0/59 9/59 1/60, TRANSITIONAL CELL CARCINOMA 0/59 27/59 50/60, SQUAMOUS CELL PAPILLOMA 0/59 0/59 4/60, SQUAMOUS CELL CARCINOMA 0/59 0/59 6/60, SARCOMA 0/59 2/59 9/60
  • Intestines: (STOP STUDY) ADENOMATOUS POLYP 0/60 26/60 30/60, CARCINOMA 0/60 0/60 5/60
  • Kidney Transitional Cell: PAPILLOMA (STOP STUDY) 0/60 0/60 4/60 OR CARCINOMA 0/60 1/60 8/60
May Have Been Related
  • Kidney Tubular Cell: ADENOMA 0/49 1/50 1/50 1/49 OR CARCINOMA 0/49 0/50 0/50 2/49
  • Forestomach: SQUAMOUS CELL PAPILLOMA O/50 0/50 1/50 1/50; SQUAMOUS CELL CARCINOMA 0/50 0/50 1/50 1/50
Non-Neoplastic Lesions
  • FORESTOMACH: FOCAL HYPERPLASIA; ULCERS
  • KIDNEY: TUBULAR FOCAL HYPERPLASIA; NEPHROPATHY; (STOP STUDY) TRANSITIONAL CELL HYPERPLASIA
  • URINARY BLADDER: (STOP STUDY) TRANSITIONAL CELL HYPERPLASIA
Female Rats: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Hematopoietic System: MONONUCLEAR CELL LEUKEMIA 14/50 11/50 14/50 26/50
  • Urinary Bladder: (STOP STUDY) TRANSITIONAL CELL PAPILLOMA 0/58 2/59 1/60, TRANSITIONAL CELL CARCINOMA 0/58 28/59 48/60
  • Intestines: (STOP STUDY) ADENOMATOUS POLYP 0/60 8/60 18/60, CARCINOMA 0/60 0/60 2/60
  • Kidney Transitional Cell: (STOP STUDY) PAPILLOMA 0/60 0/60 1/60 OR CARCINOMA 0/60 0/60 1/60
May Have Been Related
  • Forestomach: SQUAMOUS CELL PAPILLOMA 0/50 1/50 0/50 1/50
Non-Neoplastic Lesions
  • URINARY BLADDER: (STOP STUDY) TRANSITIONAL CELL HYPERPLASIA
  • FORESTOMACH: FOCAL HYPERPLASIA
  • KIDNEY: (STOP STUDY) TRANSITIONAL CELL HYPERPLASIA
Male Mice: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Liver: ADENOMA 14/50 26/50 41/50 29/50; CARCINOMA 7/50 12/50 11/50 7/50; HEPATOBLASTOMA 0/50 3/50 17/50 9/50
Female Mice: Some Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Liver: ADENOMA 14/50 2/50 36/50 18/50