Tooth whiteners are considered as cosmetic agents to be used for bleaching teeth. Since tooth whitener may be swallowed during the whitening procedure, studies were conducted to determine whether ingestion of tooth whitener containing carbamide peroxide resulted in toxic effects. Adult female rats were used, and vaginal smears were examined daily to determine whether the animals were ovulating. Following an overnight fast, a single bolus of a commercial tooth whitener (5 g of tooth whitener/kg fasting body weight) was administered by gavage. Control rats received de-ionized water. After 2 h, mean respirations per min of animals receiving the tooth whitener Quik Start (contains 35% carbamide peroxide) decreased from 169 to 55, and body temperature decreased from 38.4 to 34 degrees C. Other distress signs included: labored breathing, loss of righting reflex, partial eye closure, bloody urine, and incontinence. Three of 22 animals (3/22) died within 48 h, of gastric hemorrhaging. Eight/10 rats stopped ovulating. At necropsy 2 weeks post-dosing, 10/19 animals had grossly bloated stomachs, and mucosal necrosis was observed histologically in 3. Animals receiving White & Brite or Nu-Smile (containing 10 or 15% carbamide peroxide, respectively) exhibited similar but milder symptoms. The data indicate that ingestion of large doses of commercial preparations of tooth whiteners may be acutely toxic, sometimes fatal, to female laboratory rats.