Benzethonium chloride antimicrobial agent dermal toxicity, PK data sought by FDA.
This article was originally published in The Tan Sheet
Executive Summary
BENZETHONIUM CHLORIDE DERMAL TOXICITY, PHARMACOKINETIC STUDY NEEDED before FDA will consider the agent for Category I (generally recognized as safe and effective) status as an antimicrobial 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., and the firm's outside consultant, Toxicology/Regulatory Services President Gerald Schoenig, 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 a vehicle.
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Benzethonium Chloride Review Prior To Final Monograph Urged By Lonza
A safety review of benzethonium chloride as a Category I active ingredient in the healthcare antiseptic products monograph should be conducted by FDA before completing the rule, chemical ingredient supplier Lonza suggests.
Benzethonium Chloride Review Prior To Final Monograph Urged By Lonza
A safety review of benzethonium chloride as a Category I active ingredient in the healthcare antiseptic products monograph should be conducted by FDA before completing the rule, chemical ingredient supplier Lonza suggests.