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Target Organs and Levels of Evidence for TR-512

Toxicology and Carcinogenesis Studies of Elmiron® (CASRN 37319-17-8) in F344/N Rats and B6C3F1 Mice (Gavage Studies)

Chemical (Study Title)
CASRN		 Peer Review Date Route/Exposure Levels Study Laboratory
Elmiron (sodium pentosanpolysulfate)
37319-17-8		 09/05/2002 Gavage
MR: 0, 14, 42, OR 126 MG/KG FR: 0, 28, 84, OR 252 MG/KG MICE: 0, 56, 168, 504 MG/KG; 50/SEX/DOSE		 Battelle Columbus Laboratory

Levels of Evidence

Male Rats: No Evidence
Type Organ/Tissue (Lesion)
Non-Neoplastic Lesions
  • INTESTINES, RECTUM: MYXOMATOUS CHANGE; CELLULAR INFILTRATION, HISTIOCYTIC
  • LUNG: ALVEOLUS, INFLAMMATION, CHRONIC ACTIVE, FOCAL
  • LYMPH NODE, MESENTERIC: CELLULAR INFILTRATION, HISTIOCYTIC
  • SPLEEN: LYMPHOHISIOCYTIC; HYPERPLASIA
Female Rats: No Evidence
Type Organ/Tissue (Lesion)
Non-Neoplastic Lesions
  • INTESTINES, RECTUM: MYXOMATOUS CHANGE; CELLULAR INFILTRATION; HISTIOCYTIC
  • LUNG: ALVEOLUS, INFLAMMATION, CHRONIC ACTIVE, FOCAL
  • LYMPH NODE, MESENTERIC: CELLULAR INFILTRATION, HISTIOCYTIC
Male Mice: Some Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Liver: HEMANGIOSARCOMA 2/50 0/50 4/50 9/50
May Have Been Related
  • Liver: ADENOMA OR CARCINOMA 23/50 23/50 26/50 31/50
Non-Neoplastic Lesions
  • LIVER: CHRONIC INFLAMMATION
  • INTESTINES, RECTUM: CHRONIC ACTIVE INFLAMMATION; NECROSIS; SQUAMOUS METAPLASIA; CELLULAR INFILTRATION, HISTIOCYTIC; MYXOMATOUS CHANGE
  • LYMPH NODE, MESENTERIC: CELLULAR INFILTRATION, HISTIOCYTIC
  • SPLEEN: CELLULAR INFILTRATION, HISTIOCYTIC
Female Mice: Some Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Liver: HEMANGIOSARCOMA 1/50 1/49 1/50 4/49; ADENOMA 7/50 5/49 4/50 15/49; HEPATOCELLULAR ADENOMA OR CARCINOMA 10/50 8/49 9/50 18/49
May Have Been Related
  • Hematopoietic System: MALIGNANT LYMPHOMA (ALL ORGANS) 7/50 8/50 6/50 16/50
Non-Neoplastic Lesions
  • LIVER: CLEAR CELL FOCUS
  • INTESTINES, RECTUM: CHRONIC ACTIVE INFLAMMATION; NECROSIS; SQUAMOUS METAPLASIA; CELLULAR INFILTRATION, HISTIOCYTIC; MYXOMATOUS CHANGE
  • LYMPH NODE, MESENTERIC: CELLULAR INFILTRATION, HISTIOCYTIC
  • SPLEEN: CELLULAR INFILTRATION; HISTIOCYTIC