Benzalkonium Chloride
INCI: BENZALKONIUM CHLORIDE
CAS 8001-54-5 EC 264-151-6 / 269-919-4 / 270-325-2 / 287-089-1
Benzalkonium Chloride is a mixture of alkylbenzyldimethylammonium chlorides that conforms generally to the formula:
Limited Data
Insufficient safety data available. Consider enriching this ingredient.
Details
Description
Benzalkonium Chloride is a mixture of alkylbenzyldimethylammonium chlorides that conforms generally to the formula:
Purpose
Function
antimicrobial, preservative, surfactant
Profile
Properties
Silicone
Silicone free
Compliance
Regulatory Status
EU
Permitted
Safety
MODERATE
US
Restricted
EU Max Concentration0.1%
Absorptionmoderate
Sensitizationhigh
MoSnot established
NOAEL0.1 mg/kg
ConcernModerate
Flags
antimicrobialpreservativequathand-sanitizer-limited-efficacysensitization-riskfda-removed-sanitizereu_cosing_listed
Verdict
Quaternary ammonium antimicrobial with documented efficacy as a preservative in rinse-off and some leave-on cosmetics at low concentrations (0.1% max). FDA removed from OTC hand sanitizer monograph due to insufficient efficacy data. Less reliable activity against non-enveloped viruses. Notable sensitization and irritation concerns including ocular surface irritation, corneal epithelium effects, and conjunctival metaplasia with chronic exposure.
US Note
FDA removed from OTC hand sanitizer monograph (2016 final rule) due to insufficient efficacy data; currently not FDA-recognized as generally safe and effective for hand sanitizer use.
Assessment
Ratings
Reference