Is Benzethonium Chloride safe in cosmetics?
Benzethonium Chloride has a safety rating of "MODERATE" in our database. EU status: restricted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Benzethonium Chloride
Also known as: Benzenemethanaminium, N,N-dimethyl-N-(2-(2-(4-(1,1 ,3,3-tetramethylbutyl)phenoxy)ethoxy)ethyl)-, chloride, Banagerm, Benzethoni chloridum, Benzethonium chloride 1622, Benzethoniumchloride (+15 more)
INCI: BENZETHONIUM CHLORIDE
Benzethonium Chloride (CAS 121-54-0) is a cosmetic cosmetic ingredient functioning as Antimicrobial Preservative, Cosmetic Biocide, Deodorant Agent, Surfactant. Reported NOAEL =0.014 mg/kg bw/day in rat (SCCNFP Opinion); EU Regulation 1223/2009 status: restricted, max 0.1%; GHS signal word DANGER. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
Cross-Vertical Regulatory Divergence
Benzethonium Chloride is classified GHS Danger (H301, H302, H314, H318, H400, H410, H315, H319) in the chemicals database but is restricted in EU cosmetics at max 0.1%.
Source: Cosmetics: ingredients.eu status/eu max; Chemicals: ghs classifications.signal word/hazard statement code
Function
Antimicrobial Preservative, Cosmetic Biocide, Deodorant Agent, Surfactant
Editorial assessment
MODERATE
Preliminary editorial note — not a computed safety verdict.
Chemistry & Identifiers
IUPAC Name
benzyl-dimethyl-[2-[2-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]ethoxy]ethyl]azanium chloride
InChIKey
UREZNYTWGJKWBI-UHFFFAOYSA-M
Regulatory Status
EU EU Status
restricted
EU Max Conc.
0.1%
US US Status
permitted
US Notes
Permitted as cosmetic preservative. Not GRAS for OTC antiseptic use (deferred by FDA 2016).
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Benzethonium Chloride.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Benzethonium 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 | =0.014 mg/kg bw/day | - | rat | dermal absorption | SCCNFP Opinion |
| NOAEL | =0.014 mg/kg bw/day | - | rat | dermal absorption | SCCNFP Opinion |
| NOAEL | =0.014 mg/kg bw/day | - | rat | dermal absorption | SCCNFP Opinion |
| NOAEL | =0.014 mg/kg bw/day | - | rat | dermal absorption | SCCNFP Opinion |
| NOAEL | =1 mg/kg bw/day | oral | rabbit | reproductive toxicity | SCCNFP Opinion |
| NOAEL | =1 mg/kg bw/day | oral | rabbit | reproductive toxicity | SCCNFP Opinion |
| NOAEL | =1 mg/kg bw/day | oral | rabbit | reproductive toxicity | SCCNFP Opinion |
| NOAEL | =1 mg/kg bw/day | oral | rabbit | reproductive toxicity | SCCNFP Opinion |
| NOAEL | =3.6 mg/kg bw/day | oral | rat | NOAEL study | SCCNFP Opinion |
| NOAEL | =3.6 mg/kg BW/day | - | - | NOAEL study | SCCNFP Opinion |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Signal Word
DANGER
Pictograms
Excl markWarnCorr
Hazard Statements
Harmful if swallowed Causes skin irritation Causes serious eye damage Toxic to aquatic life
Short-term Exposure Effects
The substance is corrosive to the eyes. The substance is irritating to the skin.
Long-term Exposure Effects
Repeated or prolonged contact with skin may cause dermatitis.
Routes of Exposure
The substance can be absorbed into the body through the skin and by ingestion.
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| NOEL | =0.06 mg/day | Mouse | dermal | chronic | ECOTOX |
| LD50 | =295 mg/kg | Rat | oral | - | ECHA |
| LEL | =6.3 mg/kg-day | Rat | dermal | short-term | EPA ToxRefDB |
| LEL | =6.3 mg/kg-day | Rat | dermal | short-term | EPA ToxRefDB |
| LEL | =6.3 mg/kg-day | Mouse | dermal | short-term | EPA ToxRefDB |
| LEL | =12.5 mg/kg-day | Mouse | dermal | short-term | EPA ToxRefDB |
| LEL | =1.56 mg/kg-day | Rat | dermal | subchronic | EPA ToxRefDB |
| LEL | =1.56 mg/kg-day | Rat | dermal | subchronic | EPA ToxRefDB |
| LEL | =1.56 mg/kg-day | Mouse | dermal | subchronic | EPA ToxRefDB |
| LEL | =1.56 mg/kg-day | Mouse | dermal | subchronic | EPA ToxRefDB |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10 - 100 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex V — Permitted Preservatives
Product type: a) Rinse-off products
b) Leave-on products other than oral products
Max: 0.1%
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.
KR Korea MFDS Annex 2 (Restricted)
Category: Preservative. Max: 0.1%. Mucous membrane products prohibited
SA Saudi SFDA (V - Preservatives)
Product type: a) Rinse-off products b) Leave-on products other than oral products. Max: 0.001.
JPKR Japan/Korea Cosmetics
Japan (Positive (Preservative)): max 0.20
Japan (Restricted): max Wash-away: 0.50% | Leave-on: 0.20% | Mucosa: Prohibited
Korea (Restricted): max 0.1%
BRIN Brazil/India Cosmetics
Brazil: Permitted Preservative · max 0,1%
India: Permitted Preservative · max 0.001
Additional Jurisdictional Restrictions (5)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| JP | restricted | Wash-away: 0.50% | Leave-on: 0.20% | Mucosa: Prohibited | Wash-away: 0.50% | Leave-on: 0.20% | Mucosa: Prohibited |
| IN | permitted_preservative | 0.1 | rinse-off products; leave-on products other than oral care |
| BR | permitted_preservative | 0.1 | Not in oral rinse-off products; not in leave-on products |
| CA | restricted | 0.2% (leave-on); 0.3% (rinse-off) | All products except mucous membrane products |
| ASEAN | permitted_preservative | 0.1% | Rinse-off products only |
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (2)
Carcinogen Classification
Benzethonium Chloride | TR-438: Toxicology and Carcinogenesis Studies of Benzethonium Chloride (CASRN 121-54-0) in F344/N Rats and B6C3F1 Mice (Dermal Studies) (1995 ) | 06/21/94 | No Evidence | No Evidence | No Evidence | No Evidence | Under the conditions of these 2-year dermal studies, there was no evidence of carcinogenic activity of benzethonium chloride in male or female F344/N…
Source: NTP Technical Reports
ICSC Safety Card
0387
Source: WHO/JECFA
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Biocide
Deodorizer
Preservative
Surfactant (surface active agent)
Regulatory List Membership (3)
EU Regulated in Personal Care
FDA Indirect Food Contact Additives
EU CosIng Cosmetics Ingredient Database
Editorial summary
Preliminary editorial summary for Benzethonium Chloride — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
Restricted
eu_cosing_listed
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Benzethonium Chloride by CAS number or substance name.
Studies
44
Lowest NOAEL
0.014
Highest NOAEL
80
Units vary across source rows: mg/kg bw/day, mg/kg bw
SCCNFP Opinion
Known Synonyms
Benzenemethanaminium, N,N-dimethyl-N-(2-(2-(4-(1,1 ,3,3-tetramethylbutyl)phenoxy)ethoxy)ethyl)-, chloride
Banagerm
Benzethoni chloridum
Benzethonium chloride 1622
Benzethoniumchloride
Benzyldimethyl-p-(1,1,3,3-tetramethylbutyl)phenoxyethoxy-ethylammonium chloride
Benzyldimethyl(2-(2-(p-(1,1,3,3-tetramethylbutyl)phenoxy)ethoxy)ethyl)ammonium chloride
Benzyldimethyl(2-(2-(4-(1,1,3,3-tetramethylbutyl)phenoxy)ethoxy)ethyl)ammonium chloride
BZT (VAN)
Caswell No. 614B
p-Diisobutyl phenoxyethoxyethyl dimethyl benzylammonium chloride
(2-(2-(4-Diisobutylphenoxy)ethoxy)ethyl)dimethylbenzylammonium chloride
N,N-Dimethyl-N-(2-(2-(4-(1,1,3,3-tetramethylbutyl)phenoxy)ethoxy)ethyl)-benzenemethanaminium chloride
Disilyn
EINECS 204-479-9
EPA Pesticide Chemical Code 069154
Formula 144
Inactisol
Kylacol
NCI-C61494
Chemical Function
Biocide
Surfactant (surface active agent)
Preservative
Deodorizer
Regulatory Lists
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
BENZETHONIUM CHLORIDE
ChEMBL ID
CHEMBL221753
Max Phase
2
Adverse Event Associations
347
Frequently Asked Questions
Is Benzethonium Chloride allowed in the EU?
Benzethonium Chloride EU regulatory status: restricted. Maximum allowed concentration: 0.1%. This is based on EU Regulation 1223/2009 and its amendments.
What does Benzethonium Chloride do in cosmetics?
Benzethonium Chloride functions as: Antimicrobial Preservative, Cosmetic Biocide, Deodorant Agent, Surfactant. It is classified as a cosmetic ingredient in our database. CAS number: 121-54-0.
What is the NOAEL for Benzethonium Chloride?
The NOAEL (No Observed Adverse Effect Level) for Benzethonium Chloride is =0.014 mg/kg bw/day based on a dermal absorption study via oral route in rat. A total of 10 study endpoints are available. Source: SCCNFP Opinion.
Is Benzethonium Chloride classified as hazardous under GHS?
Benzethonium Chloride carries a GHS signal word of "DANGER". Hazard statements: Harmful if swallowed Causes skin irritation Causes serious eye damage Toxic to aquatic life. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance — at cosmetic use concentrations, hazard thresholds may not be met.
Is Benzethonium Chloride used outside cosmetics?
Benzethonium Chloride also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Benzethonium Chloride have different safety status in cosmetics vs industrial chemicals?
Benzethonium Chloride is classified GHS Danger (H301, H302, H314, H318, H400, H410, H315, H319) in the chemicals database but is restricted in EU cosmetics at max 0.1%.
Compliance Tools
Check Benzethonium Chloride compliance across multiple jurisdictions:
Ingredient Decoder
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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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