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.

Source: PubChem

US FDA substance register · UNII PH41D05744 · registered name Benzethonium Chloride · single chemical substance

Source: US FDA Unique Ingredient Identifier (UNII)

Benzethonium Chloride is the quaternary ammonium salt that conforms to the formula:

Restricted

Taiwan

Allowed preservative

Taiwan · United Kingdom

Source: Health Canada Cosmetic Ingredient Hotlist · MFDS (Korea) cosmetic regulatory information · ASEAN Cosmetic Directive · EU Cosmetics Regulation · Japan Standards for Cosmetics · Taiwan FDA cosmetic ingredients · UK cosmetics regulations (OPSS)

Argentina · Brazil

• Maximum concentration permitted at final product : 0.1%
• Other limitations and requirements : Prohibited in products not rinsed for oral hygiene.

ASEAN

• Maximum authorised concentration in the finished cosmetic product : 0.1%
• Other limitations and requirements : (a) Rinse-off products (b) Leave on products other than for oral care use.

Canada

• Conditions of Use by product type : (a) Not permitted in products to be applied to mucous membranes. (b) Leave-on products (c) Rinse-off products
• Maximum Concentration Permitted : b) 0.2% c) 0.3%

Japan

• Maximum amount per 100 g (Cosmetics not used for mucosa and to be washed away) : 0.50 g
• Maximum amount per 100 g (Cosmetics not used for mucosa and not to be washed away) : 0.20 g

China

• Maximum concentration : 0.1%

South Korea

• Maximum concentration : 0.10%

European Union

• Product Type, body parts : a) Rinse-off products b) Leave-on products other than oral products
• Maximum concentration in ready for use preparation : 0.1%

Not classified under Korea’s toxic-substance GHS list · existing chemical substance

Source: Korea toxic substances GHS register (NIER)

EU Cosmetics Regulation, Annex V (allowed preservatives), entry 53 · maximum concentration 0.1% · applies to a) Rinse-off products b) Leave-on products other than oral products

Source: EU allowed preservatives (Annex V)

Restriction V/53

Source: EU CosIng ingredient list

Reviewed by CIR: Annual Review of Cosmetic Ingredient Safety Assessments - 2004/2005

Source: US Cosmetic Ingredient Review (CIR)

Reviewed by CIR: Final Report on the Safety Assessment of Benzethonium Chloride and Methylbenzethonium Chloride

Source: US Cosmetic Ingredient Review (CIR)