Acute toxicity of carbamide peroxide and a commercially available tooth-bleaching agent in rats.

Previous studies have indicated that tooth-bleaching agents contain potentially hazardous chemicals. The present study evaluates the acute toxicity of a commercially available tooth-bleaching agent and carbamide peroxide, which is the active bleaching ingredient. Rats were dosed by stomach gavage, i.e., via a stomach tube, with 5, 15, and 50 mg carbamide peroxide/kg body weight and 150 and 500 mg tooth-bleaching agent/kg body weight, corresponding to 15 and 50 mg carbamide peroxide/kg body weight. Animals were killed after either one or 24 h. Autopsies were performed, and the distal part of the esophagus and the stomach were removed and processed for light microscopy investigation. Liver and kidney were evaluated histologically in animals killed after 24 h. Carbamide peroxide gave dose-dependent ulcerations of the gastric mucosa, with the 15 mg/kg body weight as the lowest observed effect level. The lesions were clearly visible after one h and seemed to be healing after 24 h. The ulcerations of the gastric mucosa were more pronounced after exposure to the tooth-bleaching agent than those observed after a comparable dose of carbamide peroxide. This may be attributed to the hydrophobic gel and the content of a carbopol (which increases the tissue adherence and retards the release of oxygen) in the bleaching agent. No apparent injury was observed in livers and kidneys. An exposure limit based on the lowest observed effect level (15 mg carbamide peroxide/kg body weight) and a safety factor of 100 were established and utilized in a risk assessment which indicated that daily human exposure during a bleaching procedure may come close to or even exceed this limit.