Triclosan safety study
This article was originally published in The Rose Sheet
Executive Summary
Will be conducted to support Category I status for the ingredient in the FDA OTC drug monograph for antimicrobial body washes, according to the Triclosan Industry Alliance. The study, a 13-week dermal sub-chronic toxicity study of rats, is expected to begin by year end. Under the protocol, rats will receive 91 daily applications of .3 mg, 1 mg, 3 mg or 5 mg triclosan and be assessed for various endpoints. Members of the alliance include Colgate- Palmolive (Softsoap), Dial (Dial), Procter & Gamble (Safeguard) and Unilever (Lever 2000). The protocol was submitted by Colgate. FDA's NDAC is meeting July 29 to discuss testing requirements for the antimicrobial monograph but is not expected to consider the triclosan protocol...