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Description
Curator's Comment: description was created based on several sources, including: https://en.wikipedia.org/wiki/Benzalkonium_chloride

Benzalkonium chloride, also known as BZK, BKC, BAC, alkyldimethylbenzylammonium chloride and ADBAC, is a type of cationic surfactant. It is an organic salt called a quaternary ammonium compound. In 2011, a large clinical trial designed to evaluate the efficacy of hand sanitizers based on different active ingredients in preventing virus transmission amongst schoolchildren was re-designed to exclude sanitizers based on benzalkonium chloride due to safety concerns. Benzalkonium chloride has been in common use as a pharmaceutical preservative and antimicrobial since the 1940s. While early studies confirmed the corrosive and irritant properties of benzalkonium chloride, investigations into the adverse effects of, and disease states linked to, benzalkonium chloride have only surfaced during the past 30 years. Benzalkonium chloride is classed as a Category III antiseptic active ingredient by the United States Food and Drug Administration. Ingredients are categorised as Category III when "available data are insufficient to classify as safe and effective, and further testing is required”. Benzalkonium chloride is excluded from the current United States Food and Drug Administration review of the safety and effectiveness of consumer antiseptics and topical antimicrobial over-the-counter drug products, meaning it will remain a Category III ingredient. The mechanism of bactericidal/microbicidal action is thought to be due to disruption of intermolecular interactions. This can cause dissociation of cellular membrane lipid bilayers, which compromises cellular permeability controls and induces leakage of cellular contents. Other biomolecular complexes within the bacterial cell can also undergo dissociation. Enzymes, which finely control a wide range of respiratory and metabolic cellular activities, are particularly susceptible to deactivation. Critical intermolecular interactions and tertiary structures in such highly specific biochemical systems can be readily disrupted by cationic surfactants. Benzalkonium chloride is a human skin and severe eye irritant. It is a suspected respiratory toxicant, immunotoxicant, gastrointestinal toxicant and neurotoxicant.

Approval Year

PubMed

PubMed

TitleDatePubMed
Human skin in organ culture and human skin cells (keratinocytes and fibroblasts) in monolayer culture for assessment of chemically induced skin damage.
2007 Aug
An in vitro test to screen skin sensitizers using a stable THP-1-derived IL-8 reporter cell line, THP-G8.
2011 Dec
Identification of cornifelin and early growth response-1 gene as novel biomarkers for in vitro eye irritation using a 3D reconstructed human cornea model MCTT HCE™.
2015 Sep
Patents

Sample Use Guides

Unknown
Route of Administration: Topical
In Vitro Use Guide
Curator's Comment: Cell exposure to 0.1% and 0.05% BAC induced cell lysis immediately after treatment. All cells (100%) treated with 0.01% BAC died in a delayed manner within 24 hours, with most of the characteristics of apoptosis (chromatin condensation and DNA fragmentation, reduction in cell volume, expression of the apoptotic marker Apo 2.7, and apoptotic changes in DNA content).
A continuous human conjunctival cell line (Wong-Kilbourne derivative of Chang conjunctiva) was exposed to benzalkonium chloride (BAC) solutions at various concentrations (0.1%-0.0001%) during a period of 10 minutes.
Substance Class Mixture
Created
by admin
on Sat Dec 16 19:52:10 GMT 2023
Edited
by admin
on Sat Dec 16 19:52:10 GMT 2023
Record UNII
5R9MGR4CR5
Record Status Validated (UNII)
Record Version
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Name Type Language
ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C14)
Common Name English
BTC 2125M Component N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C14)
Brand Name English
ALKYL(C12-14)DIMETHYLBENZYLAMMONIUM CHLORIDE
Common Name English
Code System Code Type Description
CAS
68424-85-1
Created by admin on Sat Dec 16 19:52:11 GMT 2023 , Edited by admin on Sat Dec 16 19:52:11 GMT 2023
ALTERNATIVE
FDA UNII
5R9MGR4CR5
Created by admin on Sat Dec 16 19:52:11 GMT 2023 , Edited by admin on Sat Dec 16 19:52:11 GMT 2023
PRIMARY
CAS
8001-54-5
Created by admin on Sat Dec 16 19:52:11 GMT 2023 , Edited by admin on Sat Dec 16 19:52:11 GMT 2023
PRIMARY
All of the following components must be present:
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ACTIVE MOIETY
http://apps.who.int/phint/pdf/b/Jb.6.1.45.pdf
Definition References