TABLE 15. NUMBER OF RATS WITH SELECTED LESIONS OF THE EPIDIDYMIS, PREPUTIAL GLAND, 

 TESTIS, OR CLITORAL GLAND IN THE TWO-YEAR FEED STUDIES OF NITROFURANTOIN 



Site/Lesion Control 600 ppm 1,300 ppm 2,500 ppm 



MALE 



Number examined microscopically (a) 50 50 50 



12 



FEMALE 



Number examined microscopically 44 38 42 



Clitiiral Kland 



Adenoma 17 4 



Carcinoma 4 3 



(a) Unless otherwise specified 



(bl Forty-eight animals were examined. 



(cl Forty-seven animals were examined. 



TABLE 16. TESTICULAR INTERSTITIAL CELL ADENOMAS IN MALE RATS IN THE TWO-YEAR FEED 



STUDY OF NITROFURANTOIN (a) 



Control 1,300 ppm 2,500 ppm 



Overall Rates 47/50(94%) 45/50(90%! 21/50(42%) 



Adjusted Rates 100.0% 100.0% 61.8% 



Terminal Rates 24/24(100%) 27/27(100%) 14/26(54%) 



Day of First Observation 455 548 559 



Life Table TesU P<0.001N P = 0.162N P<0.001N 



Logistic Regression Tests P<0.001N P = 0.221N P<0.001N 



(a) Historical incidence of interstitial cell tumors at study laboratory (mean ± SO): 384/439(87% ± 8%); historical incidence 

 in NTP studies: 1,681/1,909(88% ± 7%) 



Nitrofurantoin, NTP TR 341 46 



