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Target Organs and Levels of Evidence for TR-439

Toxicology and Carcinogenesis Studies of Methylphenidate Hydrochloride (CASRN 298-59-9) in F344/N Rats and B6C3F1 Mice (Feed Studies)

Chemical (Study Title)
CASRN		 Peer Review Date Route/Exposure Levels Study Laboratory
Methylphenidate hydrochloride
298-59-9		 Dosed-Feed
0,125,2000 PPM/10 PER GROUP		 Hazleton Raltech, Inc.

Levels of Evidence: None



Chemical (Study Title)
CASRN		 Peer Review Date Route/Exposure Levels Study Laboratory
Methylphenidate hydrochloride
298-59-9		 06/22/1993 Dosed-Feed
R: 0, 100, 500, OR 1000 PPM M: 0, 50, 250, OR 500 PPM; 50 PER GROUP		 T.S.I. Mason Laboratories, Inc.

Levels of Evidence

Male Rats: No Evidence
Female Rats: No Evidence
Type Organ/Tissue (Lesion)
Other Considerations
  • MAMMARY GLAND: FIBROADENOMA 15/49 13/50 6/48 5/50
Male Mice: Some Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Liver: HEPATOCELLULAR ADENOMA 18/50 18/50 16/50 29/50 CARCINOMA 10/50 9/50 17/50 11/50 COMBINED 24/50 23/50 26/50 34/50; HEPATOBLASTOMA 0/50 1/50 1/50 5/50
Non-Neoplastic Lesions
  • LIVER: EOSINOPHILIC FOCI
Female Mice: Some Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Liver: HEPATOCELLULAR ADENOMA 6/49 10/48 10/49 28/50 CARCINOMA 5/49 3/48 2/49 6/50 COMBINED 9/49 11/48 11/49 30/50
Non-Neoplastic Lesions
  • LIVER: EOSINOPHILIC FOCI