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Target Organs and Levels of Evidence for TR-465

Toxicology and Carcinogenesis Studies of Phenolphthalein (CASRN 77-09-8) in F344 Rats and B6C3F1 Mice (Feed Studies)

Chemical (Study Title)
CASRN		 Peer Review Date Route/Exposure Levels Study Laboratory
Phenolphthalein
77-09-8		 Dosed-Feed
0,.3,5 %/5 PER GROUP		 BioReliance, Inc

Levels of Evidence: None



Chemical (Study Title)
CASRN		 Peer Review Date Route/Exposure Levels Study Laboratory
Phenolphthalein
77-09-8		 12/05/1995 Dosed-Feed
R: 0, 1.2, 2.5, OR 5%; M: 0, 0.3, 0.6, OR 1.2% IN FEED (50/SEX/SPECIES/GROUP)		 T.S.I. Mason Laboratories, Inc.

Levels of Evidence

Male Rats: Clear Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Adrenal Gland Medulla: PHEOCHROMOCYTOMA 17/50 34/50 34/50 34/50
  • Kidney Tubular Cell: (SINGLE SECTIONS) ADENOMA 0/50 4/50 2/50 6/50 OR CARCINOMA 0/50 1/50 1/50 2/50 COMBINED 0/50 5/50 3/50 7/50; (SINGLE AND STEP SECTIONS) ADENOMA 1/50 10/50 15/50 15/50 OR CARCINOMA 0/50 1/50 2/50 2/50 COMBINED 1/50 10/50 16/50 16/50
Non-Neoplastic Lesions
  • ADRENAL GLAND: MEDULLA, FOCAL HYPERPLASIA
  • KIDNEY: INCREASED SEVERITY OF NEPHROPATHY
Female Rats: Some Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Adrenal Gland Medulla: PHEOCHROMOCYTOMA 3/50 11/50 9/50 2/49 OR MALIGNANT PHEOCHROMOCYTOMA 0/50 1/50 1/50 0/50 COMBINED 3/50 12/50 10/50 2/49
Non-Neoplastic Lesions
  • KIDNEY: INCREASED INCIDENCE AND SEVERITY OF NEPHROPATHY
Male Mice: Clear Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Hematopoietic System: HISTIOCYTIC SARCOMA 1/50 3/50 11/50 12/49; LYMPHOMA (THYMIC ORIGIN) 0/50 4/50 7/50 2/49
Non-Neoplastic Lesions
  • THYMUS: ATYPICAL HYPERPLASIA
  • TESTIS: GERMINAL EPITHELIAL DEGENERATION
Other Considerations
  • LIVER: ADENOMA 22/50 12/50 8/50 10/49 OR CARCINOMA 8/50 10/50 5/50 9/49 COMBINED 27/50 20/50 11/50 16/49; CLEAR CELL FOCUS 24/50 6/50 1/50 0/49; EOSINOPHILIC FOCUS 22/50 6/50 1/50 1/49; MIXED CELL FOCUS 6/50 2/50 1/50 0/49
Female Mice: Clear Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Hematopoietic System: HISTIOCYTIC SARCOMA 0/50 2/50 7/50 7/50; LYMPHOMA 15/50 28/50 33/5 25/50; LYMPHOMA (THYMIC ORIGIN) 1/50 9/50 10/50 7/50
  • Ovary: BENIGN SEX-CORD STROMAL TUMOR 0/50 7/49 6/50 5/50
Non-Neoplastic Lesions
  • THYMUS: ATYPICAL HYPERPLASIA
  • OVARY: HYPERPLASIA
Other Considerations
  • LIVER: ADENOMA 17/50 2/50 6/50 1/50 OR CARCINOMA 6/50 1/50 0/50 1/50 COMBINED 21/50 3/50 6/50 2/50; EOSINOPHILIC FOCUS 20/50 4/50 2/50 1/50