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Phenacetin is a human carcinogen based on sufficient evidence of carcinogenicity studies in experimental animals. In an 18-month carcinogenicity study, dietary administration of 2.5% phenacetin induced renal cell carcinomas of the renal pelvis and transitional cell carcinomas of the urinary bladder in rats, the tumor incidence in males being greater than in females. In another long-term carcinogenicity study, dietary administration of 0.535% phenacetin for 117 weeks induced renal pelvic tumors in male rats. In B6C3F1 mice of each sex maintained on a diet containing 1.25% or 0.6% phenacetin for 96 weeks, a dose-related induction of renal tumors was observed in male mice, and urinary bladder proliferative lesions developed in mice of either sex fed 1.25% phenacetin.
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