Category | Effects | Animal, dosage, in part frequency (Cases/Total number) |
---|---|---|
Non-neoplastic effects | (a) Slight reduction in number of erythrocytes and packed cell volume, liver mass, liver nodules, Leydig cell mass ↑; (b) number of white blood cells ↑ and AST, ALT, alkaline phosphatase, and creatine phosphokinase ↑; (c) breast tissue mass ↑ and tubular hyperplasia of the ovarian stroma; (d) kidney mass ↑ and changes in the liver (hepatomegalocytosis, necrosis, mononuclear cell infiltration, cystoid degeneration) | (a) Male rats, 300 mg/kg (b) Male rats, 30 mg/kg (c) Female rats, 30 mg/kg (d) Female rats, 300 mg/kg |
Carcinogenicity | (a) Incidences of testicular Leydig cell adenomas ↑ and (b) fibrocystic breast adenomas ↑ | (a) Male rats, 0 mg/kg (0/50), 30 mg/kg (2/50), 300 mg/kg (7/50) (b) Female rats, 0 mg/kg (10/46), 30 mg/kg (19/45), 300 mg/kg (21/44) |