U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

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
Cytokine induction in human epidermal keratinocytes exposed to contact irritants and its relation to chemical-induced inflammation in mouse skin.
1994 Jun
[Contact sensitization to pharmaceutic aids in dermatologic cosmetic and external use preparations].
2004 May
Development of an in vitro dendritic cell-based test for skin sensitizer identification.
2013 Mar 18
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 17:45:09 GMT 2023
Edited
by admin
on Sat Dec 16 17:45:09 GMT 2023
Record UNII
F5UM2KM3W7
Record Status Validated (UNII)
Record Version
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Name Type Language
BENZALKONIUM CHLORIDE
EP   HSDB   II   INCI   INN   MART.   MI   USP-RS   VANDF   WHO-DD   WHO-IP  
INN   INCI  
Official Name English
BENZALKONIUM CHLORIDE [USP-RS]
Common Name English
HYAMINE 3500
Brand Name English
BENZALKONIUM CHLORIDE [JAN]
Common Name English
PENTONIUM
Brand Name English
ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C16)
Common Name English
BKC
Common Name English
ALKYLDIMETHYL(PHENYLMETHYL)AMMONIUM CHLORIDE
Common Name English
BENZALKONII CHLORIDUM [WHO-IP LATIN]
Common Name English
BENZALKONIUM CHLORIDE [MI]
Common Name English
BENZALKONIUM CHLORIDE [MART.]
Common Name English
AMMONIUM, ALKYLDIMETHYL(PHENYLMETHYL)-, CHLORIDE
Common Name English
ALKYL(C12-16)DIMETHYLBENZYLAMMONIUM CHLORIDE
Common Name English
ALPAGELLE
Brand Name English
Alkylbenzyldimethylammonium chloride
Common Name English
benzalkonium chloride [INN]
Common Name English
BENZALKONIUM CHLORIDE [VANDF]
Common Name English
BENZALKONIUM CHLORIDE [INCI]
Common Name English
ZEPHIRAN
Brand Name English
ROCCAL
Brand Name English
BENZALKONIUM CHLORIDE [HSDB]
Common Name English
BENZALKONIUM CHLORIDE [EP MONOGRAPH]
Common Name English
BENZALKONIUM CHLORIDE [II]
Common Name English
Benzalkonium chloride [WHO-DD]
Common Name English
ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE
Common Name English
BENZALKONIUM CHLORIDE [WHO-IP]
Common Name English
NSC-758480
Code English
Classification Tree Code System Code
NCI_THESAURUS C83486
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EPA PESTICIDE CODE 69106
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EPA PESTICIDE CODE 69194
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EPA PESTICIDE CODE 69161
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CFR 21 CFR 310.201
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EPA PESTICIDE CODE 69142
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EPA PESTICIDE CODE 69158
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EPA PESTICIDE CODE 69105
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EPA PESTICIDE CODE 69141
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EPA PESTICIDE CODE 69199
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EPA PESTICIDE CODE 69157
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EPA PESTICIDE CODE 169135
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EPA PESTICIDE CODE 69137
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EPA PESTICIDE CODE 169106
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EPA PESTICIDE CODE 69184
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Code System Code Type Description
SMS_ID
100000092079
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PRIMARY
RS_ITEM_NUM
1050993
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PRIMARY
CHEBI
3020
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PRIMARY
LACTMED
Benzalkonium Chloride
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PRIMARY
EVMPD
SUB00714MIG
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PRIMARY
CAS
8001-54-5
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PRIMARY
INN
1168
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PRIMARY
DRUG BANK
DBSALT001509
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PRIMARY
GRAS Notification (GRN No.)
723
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PRIMARY
FDA UNII
F5UM2KM3W7
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PRIMARY
GRAS Notification (GRN No.)
488
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PRIMARY
ALANWOOD
benzalkonium chloride
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PRIMARY
HSDB
234
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PRIMARY
CAS
68424-85-1
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ALTERNATIVE
WHO INTERNATIONAL PHARMACOPEIA
BENZALKONIUM CHLORIDE
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PRIMARY Description: A white or yellowish white powder, thick gel, or gelatinous pieces; odourless or a slight aromatic odour. Solubility: Very soluble in water and ethanol (~750 g/l) TS; freely soluble in acetone R; practically insoluble in ether R. Category: Antimicrobial preservative; surfactant. Storage: Benzalkonium chloride should be kept in a tightly closed container, protected from light. Additional information: Benzalkonium chloride is hygroscopic. Definition: Benzalkonium chloride is a mixture of alkylbenzyldimethylammonium chlorides, the alkyl groups having chain lengths of C8 to C18.
ChEMBL
CHEMBL1187417
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PRIMARY
NCI_THESAURUS
C82282
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PRIMARY
NSC
758480
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PRIMARY
RXCUI
1379
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PRIMARY RxNorm
DAILYMED
F5UM2KM3W7
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PRIMARY
EPA CompTox
DTXSID6028492
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PRIMARY
MERCK INDEX
m2331
Created by admin on Sat Dec 16 17:45:10 GMT 2023 , Edited by admin on Sat Dec 16 17:45:10 GMT 2023
PRIMARY Merck Index
WIKIPEDIA
BENZALKONIUM CHLORIDE
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PRIMARY
Related Record Type Details
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
Related Record Type Details
ACTIVE MOIETY
http://apps.who.int/phint/pdf/b/Jb.6.1.45.pdf
Definition References