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3,3'-Dimethylbenzidine dihydrochloride (DMB) was evaluated for toxicity and carcinogenicity because of the potential for human exposure during production and use of bis-azobiphenyl dyes and because benzidine, a structurally related chemical, is a known human carcinogen. Two studies (9 and 15 months) were conducted by administering 0, 30, 70, or 150 ppm DMB (approx. 99% pure) in drinking water to F344/N rats. In the 15-month studies, 60 rats of each gender were used in the control group, 45 in the low-dose, 75 in the mid-dose, and 60 in the high-dose group. After exposure for 9 months, chemical-related neoplastic lesions were observed in the skin, Zymbal's gland, preputial gland, clitoral gland, liver, oral cavity, large and small intestines, and lung. Although designed for 24 months these studies were terminated after 15 months because significant numbers of treated rats were dying with tumors or were killed in moribund condition. Chemical-related nonneoplastic lesions included cystic degeneration and foci of alteration in the liver; exacerbation of nephropathy; hyperplasia of Zymbal's gland, preputial and clitoral glands, and alveolar epithelium. After exposure for 15 months, significantly increased incidences of neoplasms were observed at many organ sites: skin, Zymbal's gland, preputial and clitoral gland, liver, oral cavity epithelium, small and large intestines, mammary gland, lung, and mesothelium of treated rats. It is concluded that DMB is clearly carcinogenic for male and female F344/N rats.

Carcinogenicity of 3,3'-Dimethylbenzidine Dihydrochloride Given in Drinking Water to F344/N Rats