Abstrakt: |
3,3′-Dimethoxybenzidine dihydrochloride (DMOB) was evaluated for chronic toxicity and carcinogenicity because benzidine, a structurally related chemical, is a known human carcinogen, and because of potential human exposure during production of bisazobiphenyl dyes. Previous carcinogenicity studies of DMOB were considered to be inadequate. Toxicology and carcinogenesis studies were conducted by administering 0,80,170, or 330 ppm DMOB (>97.5% purity) in drinking water to groups of F344/N rats for 21 months. Seventy rats of each sex were used in the control group, 45 in the low-dose, 75 in the mid-dose, and 70 in the high-dose group. Ten rats of each sex in the control and 330 ppm dose groups were evaluated after 9 months. After exposure for 9 months, chemical-related neoplastic effects included liver foci, carcinoma of the preputial gland in one male, carcinoma of the clitoral gland in one female, and carcinoma of the Zymbal gland in two male rats. Although designed for 24 months, these studies were terminated at 21 months because significant numbers of exposed rats died with tumors or were sacrificed in moribund condition. Chemical-related nonneoplastic effects were hematopoietic cell proliferation in the spleen, and cystic and centrilobular degeneration and necrosis of the liver. 3,3′-Dimethoxybenzidine was clearly carcinogenic for male and female F344/N rats. After exposure for up to 21 months, significantly increased incidences of neoplasms were observed in multiple sites: skin, Zymbal gland, preputial and clitoral glands, oral cavity, small and large intestines, liver, brain, mesothelium, mammary gland, and uterus of treated rats. [ABSTRACT FROM PUBLISHER] |