Triclosan: a safety profile.

Triclosan (2, 4, 4'-trichloro-2'-hydroxydiphenyl ether), an antimicrobial agent, has been used extensively for 20 years in consumer products, principally in deodorants, soaps and other dermatological preparations. Recently, the use of triclosan has been extended to oral health care products such as dentifrices. This paper reviews safety information, both pre-clinical and clinical studies, from the literature, data submitted to the Antimicrobial I OTC Review Panel and unpublished work from the Pharmacology and Toxicology Department of the Colgate-Palmolive Company. The data spans acute, subacute, subchronic and chronic toxicity; mutagenicity, carcinogenicity, reproduction/teratology and pharmacokinetics. Results of these studies show that triclosan is well tolerated by a variety of species including man. In clinical studies with triclosan in solutions and dentifrices, a steady state was reached by day 7 with blood levels in the parts per billion (ppb) range and urine as the main route of excretion. Based on these studies, triclosan can be considered safe for use in dentifrice and mouthrinse products.