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Target Organs and Levels of Evidence for TR-425

Toxicology and Carcinogenesis Studies of Promethazine Hydrochloride (CASRN 58-33-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies)

Chemical (Study Title)
CASRN
Peer Review DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
Promethazine hydrochloride
58-33-3
AntihistaminicGavage
R: 0,3.7,300, M: 0,5,405 MG/10 PER GROUP
Litton Bionetics, Inc.

Levels of Evidence



Chemical (Study Title)
CASRN
Peer Review DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
Promethazine hydrochloride
58-33-3
12/01/1992AntihistaminicGavage
R: 0,8.3,16.6,33.3, FM: 0,3.75,7.5,15.0, MM: 0,11.25,22.5,45.0 MG/KG
T.S.I. Mason Laboratories, Inc.

Levels of Evidence

Male Rats: No Evidence
TypeOrgan/Tissue (Lesion)
Non-Neoplastic Lesions
  • LIVER: DIFFUSE FATTY CHANGE
Other Considerations
  • ADRENAL GLAND: PHEOCHROMOCYTOMA 14/50 11/50 8/50 2/51 OR MALIGNANT PHEOCHROMOCYTOMA 3/50 1/50 1/50 1/51 COMBINED 16/50 12/50 9/49 4/50
  • PITUITARY GLAND: ADENOMA 16/50 16/50 16/48 8/50
Female Rats: No Evidence
TypeOrgan/Tissue (Lesion)
Other Considerations
  • UTERUS/CERVIX: STROMAL POLYP 10/50 6/50 4/50 1/53
Male Mice: No Evidence
Female Mice: No Evidence