Contract for Testing the Acute and Chronic Toxicity of Denatonium Benzoate, an Acerbic Ingredient Proposed for Use in Bad-Tasting Paint to Prevent Paint Pica. Two year Oral Toxicity Study in Rats. Report Number 2F

摘要

The objective of this rat study was to determine the acute and chronic toxicity of denatonium benzoate, an acerbic ingredient proposed for use in bad - tasting paint to prevent paint pica. In a 2 - year study in Charles River CD rats, denatonium benzoate was administered by gavage at dosage levels of 1.6, 8, and 16 mg / kg / day. A total of 65 male and 65 female rats were initiated at each dosage level and also in a control group. The rats were observed daily for overt signs of toxicity and mortality, and detailed observations were recorded weekly. Individual body weights and sex group food consumption were measured daily for the first 5 weeks of study and weekly therafter. Hematological, biochemical, and urinalysis studies were conducted at 3, 6, 12, 18, and 24 months of study. Ophthalmoscopic examinations were performed for all rats during the control period and at 3, 6, 12, 18 and 24 months of study. No changes considered to be related to the compound were observed in general behavior and appearance, ophthalmoscopy, body weights, food consumption and efficiency, hematological, biochemical, and urinalysis studies or survival. No compound - related gross or microscopic pathologic lesions or variations in organ weights were observed in the experimental rats. Footnotes, 46 tables, and an appendix of results of ophthalmoscopic examinations are included. (Author abstract modified).