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Annex V Entry 53 16/10/2010

Benzethonium Chloride

Benzenemethanaminium, N,N-dimethyl-N-[2-[2-[4-(1,1,3,3,-tetramethylbutyl)phenoxy]ethoxy]ethyl]-, chloride

Benzethonium Chloride appears in Annex V as a positive-list preservative entry for EU cosmetics. Maximum concentration in this record: 0.1%.

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Permitted preservative— Annex V, EU Regulation 1223/2009
Max conc.: 0.1%
Entry: 53

Chemical identity and properties

PubChem 2D chemical structure for CAS 121-54-0
CAS 121-54-0PubChem CID 8478

Benzethonium Chloride

Benzethonium chloride is a (synthetic) quaternary ammonium salt that is benzyldimethylamine in which the nitrogen is quaternised by a 2-{2-[p-(2,4,4-trimethylpentan-2-yl)phenoxy]ethoxy}ethyl group, with chloride as the counter-ion. An antiseptic and disinfectant, it is active against a broad spectrum of bacteria, fungi, moulds and viruses. It has a role as an antiviral agent, an antibacterial agent, an antifungal agent, an antiseptic drug and a disinfectant. It is a chloride salt, a quaternary ammonium salt and an aromatic ether. — ChEBI

IUPAC name
benzyl-dimethyl-[2-[2-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]ethoxy]ethyl]azanium chloride
Molecular formula
C27H42ClNO2
Molecular weight
448.1 g/mol
Exact mass
447.2904073 Da
Topological polar surface area
18.5 Ų
Hydrogen-bond donors
0
Hydrogen-bond acceptors
3
Covalent units
2
Defined stereocentres
0

Also known as

HyaminePhemeridePhemerol ChlorideBenzethoniumchlorideQuatrachlorDisilynInactisolKylacol
16 more reported names
PhemithynDiappHyamine 1622Chlorure de benzethoniumBenzetonium chlorideAntiseptolBanagermPhemerolSanizolAnti-germ 77Benzethonii chloridumNeostelin greenCloruro de benzetonioBenzetonio cloruroBenzethoni chloridumMicroklenz
Open full PubChem recordPubChem annotations3D structure image
External database identifiers

Evidence from additional scientific databases

NIH PubChem PUG-View
Exact identifier match8478

Attributed physical-property, hazard, environmental and use annotations.

  • Substance: Benzethonium Chloride Source: NTP Technical Reports
  • NTP Technical Report: TR-438: Toxicology and Carcinogenesis Studies of Benzethonium Chloride (CASRN 121-54-0) in F344/N Rats and B6C3F1 Mice (Dermal Studies) (1995 ) Source: NTP Technical Reports
  • Peer Review Date: 06/21/94 Source: NTP Technical Reports
  • Conclusion for Male Rat: No Evidence Source: NTP Technical Reports
  • Conclusion for Female Rat: No Evidence Source: NTP Technical Reports
  • Conclusion for Male Mice: No Evidence Source: NTP Technical Reports
  • Conclusion for Female Mice: No Evidence Source: NTP Technical Reports
  • Summary: 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 rats receiving 0.15, 0.5, or 1.5 mg/kg. There was no evidence of carcinogenic activity in male or female B6C3F1 mice receiving 0.15, 0.5, or 1.5 mg/kg.; Exposure of rats and mice to benzethonium chloride by dermal application in ethanol for 2 years resulted in epithelial hyperplasia in male and female rats and mice and sebaceous gland hyperplasia and ulcers in female rats at the site of application. Source: NTP Technical Reports
  • First Aid: EYES: First check the victim for contact lenses and remove if present. Flush victim's eyes with water or normal saline solution for 20 to 30 minutes while simultaneously calling a hospital or poison control center. Do not put any ointments, oils, or medication in the victim's eyes without specific instructions from a physician. IMMEDIATELY transport the victim after flushing eyes to a hospital even if no symptoms (such as redness or irritation) develop.; SKIN: IMMEDIATELY flood affected skin with water while removing and isolating all contaminated clothing. Gently wash all affected skin areas thoroughly with soap and water. IMMEDIATELY call a hospital or poison control center even if no symptoms (such as redness or irritation) develop. IMMEDIATELY transport the victim to a hospital for treatment after washing the affected areas.; INHALATION: IMMEDIATELY leave the contaminated area; take deep breaths of fresh air. If symptoms (such as wheezing, coughing, shortness of breath, or burning in the mouth, throat, or chest) develop, call a physician and be prepared to transport the victim to a hospital. Provide proper respiratory protection to rescuers entering an unknown atmosphere. Whene Source: CAMEO Chemicals
  • Note: This chemical does not meet GHS hazard criteria for 1.3% (5 of 394) of reports. Source: European Chemicals Agency (ECHA)
  • Signal: Danger Source: European Chemicals Agency (ECHA)
  • GHS Hazard Statements: H301 (81%): Toxic if swallowed [Danger Acute toxicity, oral]; H302 (17.5%): Harmful if swallowed [Warning Acute toxicity, oral]; H314 (95.2%): Causes severe skin burns and eye damage [Danger Skin corrosion/irritation]; H318 (47.5%): Causes serious eye damage [Danger Serious eye damage/eye irritation]; H400 (94.4%): Very toxic to aquatic life [Warning Hazardous to the aquatic environment, acute hazard]; H410 (84%): Very toxic to aquatic life with long lasting effects [Warning Hazardous to the aquatic environment, long-term hazard] Source: European Chemicals Agency (ECHA)
  • Precautionary Statement Codes: P260, P264, P264+P265, P270, P273, P280, P301+P316, P301+P317, P301+P330+P331, P302+P361+P354, P304+P340, P305+P354+P338, P316, P317, P321, P330, P363, P391, P405, and P501 (click each P-code to see the statement) Source: European Chemicals Agency (ECHA)
  • ECHA C&L Notifications Summary: Aggregated GHS information provided per 394 reports by companies from 25 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.; Reported as not meeting GHS hazard criteria per 5 of 394 reports by companies.; There are 24 notifications provided by 389 of 394 reports by companies with hazard statement code(s).; Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown. For more detailed information, please visit ECHA C&L website. Source: European Chemicals Agency (ECHA)
  • Signal: Warning Source: NITE-CMC
  • GHS Hazard Statements: H302: Harmful if swallowed [Warning Acute toxicity, oral]; H315: Causes skin irritation [Warning Skin corrosion/irritation]; H319: Causes serious eye irritation [Warning Serious eye damage/eye irritation] Source: NITE-CMC
  • Precautionary Statement Codes: P264, P264+P265, P270, P280, P301+P317, P302+P352, P305+P351+P338, P321, P330, P332+P317, P337+P317, P362+P364, and P501 (click each P-code to see the statement) Source: NITE-CMC
  • Signal: Warning Source: Hazardous Chemical Information System (HCIS), Safe Work Australia
  • GHS Hazard Statements: H302: Harmful if swallowed [Warning Acute toxicity, oral]; H315: Causes skin irritation [Warning Skin corrosion/irritation]; H319: Causes serious eye irritation [Warning Serious eye damage/eye irritation] Source: Hazardous Chemical Information System (HCIS), Safe Work Australia
  • Precautionary Statement Codes: P264, P264+P265, P270, P280, P301+P317, P302+P352, P305+P351+P338, P321, P330, P332+P317, P337+P317, P362+P364, and P501 (click each P-code to see the statement) Source: Hazardous Chemical Information System (HCIS), Safe Work Australia
  • Cosmetic Ingredient Review Conclusion: On the basis of the available animal and clinical data, the Expert Panel concludes that Benzethonium Chloride and Methylbenzethonium Chloride are safe at concentrations of 0.5 percent in cosmetics applied to the skin. A maximum concentration of 0.02 percent is safe for cosmetics used in the eye area. Note: FDA has prohibited the use of Methylene Chloride in cosmetic products, action which supercedes this CIR conclusion (21CFR700.19). Source: Cosmetic Ingredient Review (CIR)
  • Cosmetic Ingredient Review Finding(s): Safe for use in cosmetics, with qualifications Source: Cosmetic Ingredient Review (CIR)

Mapped by: Existing checksum-valid CAS to unique PubChem CID match. Retrieved: 2026-08-31. Open source record

Scientific classifications and hazard annotations provide context and do not replace the market-specific regulatory decision shown above.

Additional source coverage and match status
SourceResultChecked
NIH PubChem PUG-ViewExact match2026-08-31

A recorded no-match is useful evidence that the source was checked; it is not a claim that the substance does not exist elsewhere.

Retrieved from NIH PubChem on 2026-08-31 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.

Record details

Maximum concentration

0.1%

Product type

Rinse-off products Leave-on products other than oral products

INCI glossary name

Benzethonium Chloride

Chemical name

Benzenemethanaminium, N,N-dimethyl-N-[2-[2-[4-(1,1,3,3,-tetramethylbutyl)phenoxy]ethoxy]ethyl]-, chloride

Regulatory information

Regulation

(EC) 2009/1223

See every entry this act set

SCCS opinions

Identified ingredients

Key data

CAS
121-54-0
EC
204-479-9
Annex
V
Entry number
53

Inventory links for Benzethonium Chloride

Annex III 100
Shared product type

TRICLOCARBAN

CAS: 101-20-2
EC: 202-924-1
Annex III 257
Shared product type

LAURETH-9

CAS: 3055-99-0
EC: 221-284-4

What Annex V means for Benzethonium Chloride

Benzethonium Chloride is an approved preservative listed in Annex V of EU Cosmetics Regulation 1223/2009. Only substances on this positive list may be used as cosmetic preservatives in the EU.

Each preservative entry specifies maximum permitted concentrations and applicable product scope. Concentrations must not exceed the listed maximum. Some preservatives require warning statements on the product label.

This record is linked to 1 CosIng inventory ingredient for name and identifier cross-reference. The page also surfaces 12 related annex records with overlapping identifiers, annex logic or naming patterns.

Compliance checklist

  • Use concentration must not exceed: 0.1%
  • Verify the preservative is effective at the permitted concentration for your matrix.

Frequently asked questions

Yes. Benzethonium Chloride is listed in Annex V of EU Cosmetics Regulation 1223/2009 as a permitted preservative. It may be used in cosmetics up to the maximum concentration specified above, within the permitted product scope.

CAS 121-54-0 is the unique numerical identifier assigned to Benzethonium Chloride by the Chemical Abstracts Service. In cosmetic compliance work, the CAS number is used to cross-reference the substance across regulatory databases, raw material specifications and safety assessment reports. Multiple EU annex entries may share the same CAS number if the same substance appears under different conditions or in different annexes.

The maximum concentration of 0.1% applies to the concentration of the substance in the ready-to-use cosmetic product. When the substance is supplied as part of a blend or mixture, the calculation must account for the contribution of all sources in the formulation. The combined concentration must not exceed the stated limit.

Use the INCI Checker tool on this site to paste your full ingredient list (INCI) and scan it against all Annex II–VI entries. The tool highlights any ingredients that match restricted, prohibited or allergen-flagged records. This is useful for rapid compliance screening of finished product formulas or raw material declarations.
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Source note for Annex V record Benzethonium Chloride

This page summarizes one Annex V record for Benzethonium Chloride from public European Commission cosmetic materials and adds linked inventory or identifier matches when available.

Use this record page to review Annex V conditions for Benzethonium Chloride, but confirm any final regulatory decision against the current official annex wording and source files.

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