Chronic toxicity/carcinogenicity studies of sulphamethazine in B6C3F1 mice.

A chronic feeding study was carried out in B6C3F1 mice with sulphamethazine (SMZ). The test substance was administered in the diet at dose levels of 0 (control), 300, 600, 1200, 2400 and 4800 ppm for 24 months. Mice were killed after 12, 18 and 24 months of continuous dosing. Body weights and food consumption were measured weekly, and mortality was recorded daily. All animals received a complete necropsy and histopathological examination, the results of which were analysed statistically. A slight decrease in body-weight gain was noted for mice of all dose groups with females showing the greater effect. Food consumption based on g food/g average body weight was relatively constant among the controls and various dose groups. The mortality rate for males and females of the control groups (8 and 8%, respectively) was higher than that for males and females of some of the higher dose groups. Neoplastic lesions associated with the ingestion of SMZ in the diet included follicular cell adenomas of the thyroid gland. At the 24-month necropsy, the incidence of this lesion for males and females of the 4800-ppm dose groups was 33 and 26%, respectively. Non-neoplastic dose-related lesions observed in both males and females included follicular cell hyperplasia (diffuse and focal) of the thyroid gland, haematopoietic cell proliferation of the spleen and pigmentation of the spleen. In females, pigmentation of the lymph nodes and hyperplasia of the mammary gland were also noted.