MODERATE Preservative SCCS/CIR Reviewed Sensitization Data Dermal Penetration

Benzalkonium Chloride

Also known as: ADBAC (C12 50%, C14 30%, C16 17%, C18 3%), BTC 2565, BTC 471, Quatramine 50, EC No.: 616-786-9 (+15 more)

INCI: BENZALKONIUM CHLORIDE

Benzalkonium Chloride (CAS 8001-54-5) is a cosmetic preservative functioning as antimicrobial, preservative, surfactant. NOAEL 1000 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted, max 0.1%; 1 safety opinion reviewed (CIR Safety Assessment). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in food safety data.

View industrial chemical safety profile for CAS 8001-54-5 →

CAS Number

8001-54-5

View industrial chemical safety profile →

Function

antimicrobial, preservative, surfactant

Editorial assessment

MODERATE

Preliminary editorial note — not a computed safety verdict.

Chemistry & Identifiers

EC Number

232-076-1

ChEBI: CHEBI:3020 UNII: 5R9MGR4CR5 Wikidata: Q72445001

Regulatory Status

EU EU Status permitted

EU Max Conc. 0.1%

US US Status restricted

US Notes 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.

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Benzalkonium Chloride.

Calculate MoS for your specific formulation with the MoS Calculator.

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

CIR Safety Assessment

Verdict: unknown

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for Benzalkonium Chloride across SCCS product categories, with measured dermal absorption where available.

Sensitization Profile

Contact sensitization data for Benzalkonium Chloride based on clinical patch test studies and IFRA standards.

Sensitization Rate

low

Allergen Class

surfactant

EU Allergen Listed

Patch Test Positive Rate

0.5%

Cross-reactivity Group

quaternary-ammonium-group

Reaction Type

contact-dermatitis

Source: IVDK

Dermal Penetration Profile

Skin absorption and penetration characteristics of Benzalkonium Chloride, relevant to systemic exposure and MoS calculations.

Absorption %

15-25%

Penetration Level

epidermis

Penetration Depth

epidermis/dermis

Molecular Weight

354.0 Da

Log P

3.2

Systemic Absorption

yes

Topical Bioavailability

10-20%

Safety Margin Factor

high

Vehicle Dependent

Yes — absorption varies by formulation

Source: SCCS Opinion

EPA ToxValDB — Toxicity Values

5 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).

Endpoint	Value	Species	Route	Duration	Source
LOEL	=10 % w/v	European Rabbit	environmental	acute	ECOTOX
LOEL	=2 %	Mouse	dermal	short-term	ECOTOX
NOEL	=1 %	Mouse	dermal	short-term	ECOTOX
NOEL	=5 %	Mouse	dermal	short-term	ECOTOX
LD50	=240 mg/kg	Rat	oral	-	ChemIDplus

Endocrine Disruptor Evidence (Expanded)

Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.

Cosmetic-Specific Mechanism

Category: preservative

Receptor targets: ERα (limited)

LOEC: 1 µM

EU status: restricted (max 0.1%)

weak modulator

Expanded Jurisdictional Detail

Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.

JPKR Japan/Korea Cosmetics

Japan (Positive (Preservative)): max 0.050

Korea (Restricted): max 0.1

Japan (Restricted): max Wash-away: No limit | Leave-on: 0.050% | Mucosa: 0.050%

Additional Jurisdictional Restrictions (9)

Jurisdiction	Status	Max %	Product Type
JP	restricted	Wash-away: No limit \| Leave-on: 0.050% \| Mucosa: 0.050%	Wash-away: No limit \| Leave-on: 0.050% \| Mucosa: 0.050%
CN	permitted_preservative	0.1	(a) Rinse-off (b) Leave-on
IN	permitted_preservative	0.1	all cosmetics
AU	restricted	3.0	rinse-off hair products
AU	restricted	0.1	preservatives (leave-on)
GCC	restricted	0.1	Rinse-off products
GCC	restricted	0.05	Leave-on products
BR	restricted	3 (hair rinse-off) / 0.1 (others)	a) Rinse-off hair treatments: 3%; b) Other products: 0.1% (as benzalkonium chloride); alifatic chain C≤14 not to exceed 0.1%

Function Categories & List Membership

Cosmetic/Chemical Function Categories

Anti-static agent Biocide Deodorizer Dispersing agent Pharmaceutical Preservative Surfactant (surface active agent)

Regulatory List Membership (2)

EU Regulated in Personal Care EU CosIng Cosmetics Ingredient Database

Editorial summary

Preliminary editorial summary for Benzalkonium Chloride — not a computed safety verdict. See the sourced toxicological data above.

Regulatory Flags

antimicrobial preservative quat hand-sanitizer-limited-efficacy sensitization-risk fda-removed-sanitizer eu_cosing_listed

Known Synonyms

ADBAC (C12 50%, C14 30%, C16 17%, C18 3%) BTC 2565 BTC 471 Quatramine 50 EC No.: 616-786-9 ADBAC Alkyl* dimethyl benzyl ammonium chloride *(50%C12, 30%C14, 17%C16, 3%C18) Alkyl dimethylbenzyl ammonium chloride Alkyldimethyl(phenylmethyl)quaternary ammonium chlorides Ammonyx Arquad B 100 Arquad dmmcb-75 Barquat MB-50 Barquat MB-80 Bayclean Benirol Benzalkonium A Bio-quat 50-24 Bio-quat 50-25 Bio-quat 50-30

Chemical Function

Surfactant (surface active agent) Biocide Preservative Pharmaceutical

Regulatory Lists

active_ingredient; Europe; Pesticides Cleaning products and household care - dishwasher and dishes - automatic dishwashing detergent; Europe active_ingredient; Europe; Pesticides pharmaceutical active_ingredient; animal_products; Europe; pharmaceutical; residue Europe; Specialty occupational products inert_ingredient; non_food_use; Pesticides Europe; Personal care

Australian Status

AICIS status: listed

Cross-Vertical Safety Context

Same-CAS public records found in food safety data.

SOURCE EFSA / FDA GRAS fda_gras_enriched

Food Safety Data

Same-CAS food additive or FDA GRAS records from the core public database.

Food Name

Benzalkonium chloride

FDA GRAS

At the notifier's request, FDA ceased to evaluate this notice

GRN

488

As a processing aid for lettuce and carrot products

View full food safety profile →

Frequently Asked Questions

Is Benzalkonium Chloride safe in cosmetics?

Benzalkonium Chloride has a safety rating of "MODERATE" in our database. EU status: permitted. US status: restricted. This ingredient has been reviewed by CIR Safety Assessment.

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.

Is Benzalkonium Chloride used outside cosmetics?

Benzalkonium Chloride also appears in food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Compliance Tools

Check Benzalkonium Chloride compliance across multiple jurisdictions:

Ingredient Decoder

Paste a full ingredient list for instant analysis

82 Allergen Checker

Check for EU declarable fragrance allergens

Substance Compliance

Check compliance across multiple jurisdictions

MoS Calculator

Calculate Margin of Safety using SCCS methodology

Heavy Metal Limits

Compare limits across jurisdictions

Related Ingredients

4-Hydroxybenzoic Acid

EXCELLENT Same category

Preservative, pH Balancer

Caprylhydroxamic Acid

EXCELLENT Same category

preservative booster, chelating agent

Glyceryl Caprylate

EXCELLENT Same category

Antimicrobial agent; emollient; prese...

Levulinic Acid

EXCELLENT Same category

Preservative (combination systems); a...

Potassium Sorbate

EXCELLENT Same category

preservative

Sodium Benzoate

EXCELLENT Same category

preservative

(20S)-Protopanaxadiol

MODERATE Similar safety

(Cnidium Officinale/Coptis Chinensis/Glycyrrhiza Uralensis) Root Extract

MODERATE Similar safety

Skin conditioning

(Cryptomeria Japonica/Chamaecyparis Obtusa) Stem Ferment Extract

MODERATE Similar safety

Antimicrobial, antioxidant, humectant

(Eclipta Prostrata/Houttuynia Cordata) Leaf Extract

MODERATE Similar safety

Skin conditioning

(Lepidium Meyenii/Sarcodon Aspratus) Root Water

MODERATE Similar safety

Skin conditioning

(Licorice/Reynoutria Japonica) Root/Stem Extract

MODERATE Similar safety

Skin conditioning, antioxidant

ALOE BARBADENSIS LEAF

GOOD Chemical family

Fragrance

Acacia Catechu Leaf/Wood Powder

MODERATE Chemical family

Skin conditioning

Acacia Catechu Seed Extract

MODERATE Chemical family

Skin conditioning

Browse all 30,000+ ingredients A-Z →

Is Benzalkonium Chloride in Your Products?

Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free →

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Benzalkonium Chloride in your formulation.

Ingredient Decoder MoS Calculator