Carcinogenicity of Captafol in F344/DuCrj Rats

Captafol was administered at dietary levels of 0 (control), 750 and 1,500 parts per million (ppm) to groups of 50 male and 50 female F344/DuCrj rats for 104 weeks, and then all animals were maintained without captafol for a further 8 weeks, and killed in week 113. Renal cell carcinoma was found in eight of 50 male rats treated with 1,500 ppm and in one of 50 male rats treated with 750 ppm of captafol. The incidences of renal adenomas, including micro‐adenomas, and basophilic altered cell tubules were significantly higher in both sexes treated with captafol than in controls, and the increases were apparently dose‐dependent except that of adenomas in females. The incidences of neoplastic and preneoplastic lesions of the kidney in captafol‐treated animals were higher in males than in females. Captafol also induced hepatocellular carcinomas in four of 50 female rats in the 1,500 ppm group. The incidences of hyperplastic (neoplastic) nodules and foci of cellular alterations in the liver were also significantly increased in both sexes treated with captafol, the increases being dose‐dependent. In conclusion, captafol induced renal cell carcinomas in male rats and hepatocellular carcinomas in female rats.