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.
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). Industrial safety data is also available in the chemical safety database.
View industrial chemical safety profile for CAS 8001-54-5 →
Auto-generated CPSR Part A draft with source citations
Function
antimicrobial, preservative, surfactant
Safety Rating
MODERATE
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
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
no
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/1581/16
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% |
Additional Ingredient Properties
7 property records from structured ingredient metadata.
allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "surfactant", "cross_reactivity_group": "quaternary-ammonium-group", "patch_test_frequency_pct": "0.5", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "IVDK"}
deodorant
{"cas_number": "8001-54-5", "ingredient_class": "antimicrobial_deodorant", "mechanism_of_action": "bacterial_growth_inhibition", "antiperspirant_efficacy_sweat_reduction_pct": "0", "deodorant_efficacy_hours": "8-16", "odor_reduction_pct": "60-80", "bacteriostatic": "yes", "bactericidal": "yes", "target_bacteria": "broad_spectrum", "microbiome_impact": "broad", "axillary_microbiome_effect": "broad …
dermal_absorption
{"molecular_weight_da": "354.0", "log_p_value": "3.2", "skin_penetration_level": "epidermis", "penetration_depth": "epidermis/dermis", "absorption_pct": "15-25", "systemic_absorption": "yes", "penetration_enhancer": "no", "occlusion_effect": "no", "vehicle_dependent": "yes", "skin_barrier_effect": "weakens", "bioavailability_topical_pct": "10-20", "safety_margin_factor": "high", "source": "SCCS/15…
interactions
{"ingredient_2": "EDTA", "interaction_type": "synergistic", "severity": "beneficial", "effect": "EDTA chelates metals, enhances preservative efficacy", "recommendation": "Compatible; EDTA is preservative booster", "data_source": "Formulation science literature, dermatological research, cosmetic chemistry best practices", "last_updated": "2026-03-05"}
microbiome_impact
{"microbiome_effect": "negative", "prebiotic": "no", "probiotic_compatible": "no", "antimicrobial_spectrum": "broad", "preservative_effect_on_microbiome": "Quaternary ammonium compound; broad-spectrum disruption including beneficial flora", "skin_flora_disruption": "severe", "gut_microbiome_risk": "moderate", "microbiome_recovery_time": "14-21 days", "selective_antimicrobial": "no", "pathogen_inhi…
pediatric_safety
{"safe_for_newborn_0_6m": "caution", "safe_for_infant_6_12m": "yes", "safe_for_toddler_1_3y": "yes", "safe_for_child_3_12y": "yes", "safe_for_teen_12_18y": "yes", "pediatric_max_concentration_pct": "0.1", "adult_max_concentration_pct": "0.1", "pediatric_dermal_absorption_factor": "moderate", "immature_skin_barrier_risk": "low", "oral_ingestion_risk": "low", "eye_irritation_risk": "moderate", "diap…
preservative
{"preservative_class": "Quaternary ammonium", "antimicrobial_spectrum_bacteria_gp": "Excellent", "antimicrobial_spectrum_bacteria_gn": "Excellent", "antimicrobial_spectrum_yeast": "Yes", "antimicrobial_spectrum_mold": "Moderate", "mic_staph_aureus_ppm": "40", "mic_e_coli_ppm": "35", "mic_pseudomonas_ppm": "45", "mic_candida_albicans_ppm": "100", "mic_aspergillus_niger_ppm": "250", "challenge_test_…
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
Expert Verdict
Expert safety assessment and concern-level summary for Benzalkonium Chloride.
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
Frequently Asked Questions
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.
Compliance Tools
Check Benzalkonium Chloride compliance across multiple jurisdictions:
Ingredient Decoder
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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
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