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Target Organs and Levels of Evidence for TR-457

Toxicology and Carcinogenesis Studies of Salicylazosulfapyridine (CASRN 599-79-1) in F344 Rats and B6C3F1 Mice (Gavage Studies)

Chemical (Study Title)
CASRN
Peer Review DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
Salicylazosulfapyridine
599-79-1
Treatment of ulcerative colitis and Crohn's disease; psoriasis and rheumatoid arthritis; granulomatous colitis (veterinary medicine). Antibacterial.Gavage
R: 0, 84, 169, OR 337 M: 0, 675, 1350, OR 2700 MG/KG
T.S.I. Mason Laboratories, Inc.

Levels of Evidence



Chemical (Study Title)
CASRN
Peer Review DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
Salicylazosulfapyridine
599-79-1
06/20/1995Treatment of ulcerative colitis and Crohn's disease; psoriasis and rheumatoid arthritis; granulomatous colitis (veterinary medicine). Antibacterial.Gavage
R: 84, 168, OR 337.5 MG/KG; 70/GROUP M: 675, 1350, OR 2700 MG/KG; 60/GROUP
Southern Research Institute

Levels of Evidence

Male Rats: Some Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Urinary Bladder: (CORE STUDY) TRANSITIONAL CELL PAPILLOMA 0/50 0/49 2/50 6/50
Non-Neoplastic Lesions
  • URINARY BLADDER: (CORE STUDY) CONCRETION; DILATATION; (CORE AND STOP STUDY) TRANSITIONAL CELL HYPERPLASIA
  • KIDNEY: (CORE STUDY) CONCRETION; HYDRONEPHROSIS; (CORE AND STOP STUDY) TRANSITIONAL CELL HYPERPLASIA; MINERALIZATION; RENAL TUBULE DILATATION
  • SPLEEN: (CORE AND STOP STUDY) HEMOSIDEROSIS; HEMATOPOIETIC CELL PROLIFERATION
Other Considerations
  • VARIOUS ORGANS: MONONUCLEAR CELL LEUKEMIA 13/50 18/50 12/50 3/50
Female Rats: Some Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Kidney Transitional Cell: PAPILLOMA 0/50 0/50 0/50 2/50
  • Urinary Bladder: TRANSITIONAL CELL PAPILLOMA 0/49 0/50 2/50 0/50
Non-Neoplastic Lesions
  • URINARY BLADDER: HYPERPLASIA
  • KIDNEY: CONCRETION; TRANSITIONAL CELL HYPERPLASIA; HYDRONEPHROSIS; NEPHROPATHY
Other Considerations
  • VARIOUS ORGANS: MONONUCLEAR CELL LEUKEMIA 14/50 9/50 8/50 3/50
Male Mice: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Liver: ADENOMA 13/50 32/50 28/50 42/50 OR CARCINOMA 13/50 15/50 23/50 8/50 COMBINED 24/50 38/50 38/50 44/50
Non-Neoplastic Lesions
  • LIVER: EOSINOPHILIC FOCI
  • SPLEEN: HEMATOPOIETIC CELL PROLIFERATION; HEMOSIDEROSIS
Other Considerations
  • FORESTOMACH: HYPERPLASIA 18/50 11/50 11/49 10/50
Female Mice: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Liver: ADENOMA 12/50 28/50 25/50 28/49 OR CARCINOMA 2/50 10/50 10/50 9/49 COMBINED 14/50 32/50 28/50 29/49
Non-Neoplastic Lesions
  • LIVER: EOSINOPHILIC FOCI
  • SPLEEN: HEMATOPOIETIC CELL PROLIFERATION; HEMOSIDEROSIS
Other Considerations
  • FORESTOMACH: SQUAMOUS CELL PAPILLOMA 5/50 1/50 1/50 0/50; HYPERPLASIA 12/50 6/49 4/50 4/49


Chemical (Study Title)
CASRN
Peer Review DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
Salicylazosulfapyridine
599-79-1
06/20/1995Treatment of ulcerative colitis and Crohn's disease; psoriasis and rheumatoid arthritis; granulomatous colitis (veterinary medicine). Antibacterial.Gavage
Southern Research Institute

Levels of Evidence

Male Rats: Some Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Urinary Bladder: (CORE STUDY) TRANSITIONAL CELL PAPILLOMA 0/50 0/49 2/50 6/50
Non-Neoplastic Lesions
  • URINARY BLADDER: (CORE STUDY) CONCRETION; DILATATION; (CORE AND STOP STUDY) TRANSITIONAL CELL HYPERPLASIA
  • KIDNEY: (CORE STUDY) CONCRETION; HYDRONEPHROSIS; (CORE AND STOP STUDY) TRANSITIONAL CELL HYPERPLASIA; MINERALIZATION; RENAL TUBULE DILATATION
  • SPLEEN: (CORE AND STOP STUDY) HEMOSIDEROSIS; HEMATOPOIETIC CELL PROLIFERATION
Other Considerations
  • VARIOUS ORGANS: MONONUCLEAR CELL LEUKEMIA 13/50 18/50 12/50 3/50
Female Rats: Some Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Kidney Transitional Cell: PAPILLOMA 0/50 0/50 0/50 2/50
  • Urinary Bladder: TRANSITIONAL CELL PAPILLOMA 0/49 0/50 2/50 0/50
Non-Neoplastic Lesions
  • URINARY BLADDER: HYPERPLASIA
  • KIDNEY: CONCRETION; TRANSITIONAL CELL HYPERPLASIA; HYDRONEPHROSIS; NEPHROPATHY
Other Considerations
  • VARIOUS ORGANS: MONONUCLEAR CELL LEUKEMIA 14/50 9/50 8/50 3/50
Male Mice: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Liver: ADENOMA 13/50 32/50 28/50 42/50 OR CARCINOMA 13/50 15/50 23/50 8/50 COMBINED 24/50 38/50 38/50 44/50
Non-Neoplastic Lesions
  • LIVER: EOSINOPHILIC FOCI
  • SPLEEN: HEMATOPOIETIC CELL PROLIFERATION; HEMOSIDEROSIS
Other Considerations
  • FORESTOMACH: HYPERPLASIA 18/50 11/50 11/49 10/50
Female Mice: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Liver: ADENOMA 12/50 28/50 25/50 28/49 OR CARCINOMA 2/50 10/50 10/50 9/49 COMBINED 14/50 32/50 28/50 29/49
Non-Neoplastic Lesions
  • LIVER: EOSINOPHILIC FOCI
  • SPLEEN: HEMATOPOIETIC CELL PROLIFERATION; HEMOSIDEROSIS
Other Considerations
  • FORESTOMACH: SQUAMOUS CELL PAPILLOMA 5/50 1/50 1/50 0/50; HYPERPLASIA 12/50 6/49 4/50 4/49