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Benzethonium chloride antimicrobial agent dermal toxicity data sought by FDA.

This article was originally published in The Rose Sheet

Executive Summary

BENZETHONIUM CHLORIDE DERMAL TOXICITY, PHARMACOKINETIC STUDY NEEDED before FDA will consider the antimicrobial for Cate-gory I (generally recognized as safe and effective) status as a consumer hand or body wash ingredient, Division of Anti- Infective Drug Products Veterinary Medical Officer Terry Peters, DVM, said at an agency "feedback" meeting in Rockville, Md. April 1. Addressing representatives of the ingredient's supplier, Lonza, Inc., as well as the company's outside consultant, Gerald Schoenig, Toxicology/Regulatory Services agency toxicologist Peters also recommended the ingredient testing be done according to final product formulations, noting that according to data Lonza presented, absorption of the ingredient in ethanol, rather than water, is as high as 36%. Schoenig said he expected absorption rates would be lower if the tests were conducted in a finished product formulation with water as the vehicle.
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