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Two-Year Toxicity Study of Doxylamine Succinate in B6C3F1 Mice

Doxylamine succinate, a commonly used antihistamine, was administered as an admixture in the feed to groups of male and female B6C3F1 mice at dosage levels of 0,190,375, and 750 parts per million (ppm) (based on free amine) for 65 weeks (12 per group) or 2 years (48 per group). Survival to terminal sacrifice in the 2-year groups was 85–98% with no significant differences between groups of the same sex. Final body weights of the highest dose group were 3.4% and 8.7% less than controls in males and females, respectively. Doxylamine produced liver lesions in male mice including hepatocellular hypertrophy, atypical hepatocytes, clear cell and mixed cell foci, and necrosis. In females, doxylamine produced liver fatty change, hepatocellular hypertrophy, and necrosis. Doxylamine produced a significant increase in hepatocellular adenomas in the mid- and high-dosage groups of males and in the high-dosage group of females. Thyroid follicular cell hyperplasia and thyroid follicular cell adenomas also were increased in treated mice of both sexes. A treatment-related increase in cytoplasmic alteration of the parotid salivary gland in males and an increased incidence in hyperplasia of the pituitary gland in females were observed.