Benzalkonium Chloride
INCI: BENZALKONIUM CHLORIDE
Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
2 study endpoints found for Benzalkonium Chloride. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | 1000 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 5000 mg/kg bw/day | oral | rat | oral | REACH |
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
Sensitization Profile
Contact sensitization data for Benzalkonium Chloride based on clinical patch test studies and IFRA standards.
Source: IVDK
Dermal Penetration Profile
Skin absorption and penetration characteristics of Benzalkonium Chloride, relevant to systemic exposure and MoS calculations.
Source: SCCS/1581/16
Expert 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.
Regulatory Flags
Frequently Asked Questions
Is Benzalkonium Chloride safe in cosmetics?
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. The EU classifies Benzalkonium Chloride as "permitted". Safety rating: MODERATE. 2 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.
Is Benzalkonium Chloride allowed in the EU?
Benzalkonium Chloride EU regulatory status: permitted. Maximum allowed concentration: 0.1%. This is based on EU Regulation 1223/2009 and its amendments.
What does Benzalkonium Chloride do in cosmetics?
Benzalkonium Chloride functions as: antimicrobial, preservative, surfactant. It is classified as a Preservative in our database. CAS number: 8001-54-5.
What is the Margin of Safety for Benzalkonium Chloride?
not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.
What is the NOAEL for Benzalkonium Chloride?
The NOAEL (No Observed Adverse Effect Level) for Benzalkonium Chloride is 1000 mg/kg bw/day based on a oral study via oral route in rat. A total of 2 study endpoints are available. Source: REACH.
Compliance Tools
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Related Ingredients
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