Safety profile of Colgate Platinum Professional Toothwhitening System

Abstract

Colgate Platinum, a professional tooth-whitening paste containing 10% urea peroxide as the active ingredient, was evaluated for potential acute oral toxicity, genotoxicity, and irritation to oral mucosa. Oral administration to rats of a single dose of 5 g/kg of Colgate Platinum did not induce any adverse effects. Colgate Platinum was not mutagenic in Ames/Salmonella Plate Incorporation assay and did not induce primary DNA damage in the bone marrow hematopoietic cells of rats that were given oral doses of up to 1 g/kg for 5 consecutive days. Results of the oral mucosa irritation study in rats indicated that Colgate Platinum did not induce damage to soft and hard tissues of oral cavity after repeated applications for 28 days. Collectively, the data from these studies document the safety of the product for the intended use.