Behentrimonium Chloride
(in 3,074 products)

Potential Risk Index®:

ISCE InhaleISCE SwallowISCE ContactISCE Environment
PRI Legend

About:

Functions:
1. Antistatic Agent - Reduces or eliminates the build up of static electricity.
2. Emulsifier - Allows water and oils to remain mixed together to form an emulsion.
3. Preservative - Prevents and inhibits the growth of unwanted microorganisms which may be harmful
4. Surfactant - Reduces the surface tension to allow mixtures to be formed evenly. Emulsifier is a specific type of surfactant which allows two liquids to mix together evenly
Behentrimonium Chloride (BTC) is a quaternary ammonium derivative that may have the potential to be a skin irritant. It is commonly used as a preservative in cosmetic products. [1]
Recent Findings:
The European Union's Scientific Committee of Consumer Safety (EU SCCS) has stated that Behentrimonium Chloride does not pose a risk to consumer safety under the following concentration limits: for leave-on products, not exceeding 3.0% and for rinse-off products, not exceeding 5.0%.
In various studies conducted on the eyes of New Zealand white albino rabbits, 3.75% BTC is sufficient to cause eye irritation [2], 6.25% BTC is sufficient to cause conjunctival irritation for 15 days [3] and 10% BTC would cause irreversible ocular damage. [4]
In a skin-sensitization study conducted on Dunkin Hartley guinea pigs, 77-83% BTC is non-sensitizing under experimental conditions. [5]
An external independent study conducted on in vitro EpiDerm(R) skin also showed BTC to have "No evidence of allergic contact dermatitis or cumulative dermal irritation was noted under the exaggerated conditions of human occlusive patch tests [testing on EpiDerm skin]". [6] No reactions were also reported by adults or children who already suffer from pre-existing skin conditions such as "atopic, eczematous, and/or xerotic skin" over a 2- and 4-week period. [6] The study concluded that 1-5% BTC "will not cause dermal irritation or delayed contact sensitization when used in a whole-body, leave-on product". [6]
Despite BTC being a quaternary organic ammonium compound which triggered a "structural alert" that the compound is more susceptible to induce skin irritation/corrosion according to the in silico OECD QSAR Toolbox evaluation [7], studies conducted on both in vitro animal/human tissue has concluded BTC to have limited skin sensitization potential.
In environmental studies, BTC and behetrimonium compounds have found to be an emerging environmental contaminant, particularly in Jamaica Bay and Newton Creek, New York. [8] BTC appears to have potential for environmental persistence where doubling times of behetrimonium compounds is expected to be around 2.8-3.9 years. [8] The study implores that more research should be done on the environmental implications of behetrimonium compounds due to their rapid doubling times which exceed PCB/PBDE plastics (~5-10 years). [8]
EU CosIng Annex III Restriction Information:
Regulation:
(EU) No 866/2014
Annex/Ref#:
III/287
Product Type, body parts:
(a) Rinse-off hair products
(b) Leave-on hair products
(c) Leave-on face products
Maximum concentration in ready for use preparation:
(a) 5,0% for the individual concentration of behentrimonium chloride or the sum of the individual concentrations of cetrimonium chloride, steartrimonium chloride and behentrimonium chloride, while at the same time respecting the relevant maximum concentration for the sum of cetrimonium chloride and streartrimonium chloride set out in entry 286.
(b) 3,0% for the individual concentration of behentrimonium chloride or the sum of the individual concentrations of cetrimonium chloride, steartrimonium chloride and behentrimonium chloride, while at the same time respecting the relevant maximum concentration for the sum of cetrimonium chloride and streartrimonium chloride set out in entry 286.
(c) 3,0% for the individual concentration of behentrimonium chloride or the sum of the individual concentrations of cetrimonium chloride, steartrimonium chloride and behentrimonium chloride, while at the same time respecting the relevant maximum concentration for the sum of cetrimonium chloride and streartrimonium chloride set out in entry 286.
Other:
For purposes other than inhibiting the development of microorganisms in the product. The purpose has to be apparent from the presentation of the product.
Scientific References:
2. Griffon, B. (2001) Acute eye irritation in rabbits. Test substance: Behentrimonium chloride at a concentration of 3.75%. CIT, IFM Recherche, France. Unpublished Report No. 23039 dated 28.02.2002. (From EU SCCS Report)
3. Griffon, B. (2001) Acute eye irritation in rabbits. Test substance: Behentrimonium chloride at a concentration of 6.25%. CIT, IFM Recherche, France. Unpublished Report No. 23040 dated 28.02.2002. (From EU SCCS Report)
4. Griffon, B. (2001) Acute eye irritation in rabbits. Test substance: Behentrimonium chloride at a concentration of 10%. CIT, IFM Recherche, France. Unpublished Report No. 21880 dated 26.09.2001. (From EU SCCS Report)
5. Manciaux, X. (2001) Skin sensitisation test in Guinea pigs. Test substance: Behentrimonium chloride. CIT, IFM Recherche, France. Unpublished Report No. 20868 dated 17.07.2001. (From EU SCCS Report)
6. Confirmation of in vitro and clinical safety assessment of behentrimonium chloride-containing leave-on body lotions using post-marketing adverse event data. (Toxicol. In Vitro, 27(8), 2203–2212. doi:10.1016/j.tiv.2013.09.016)
7. Tier-based skin irritation testing of hair cleansing conditioners and their constituents. (Cutan. Ocul. Toxicol., 1–15. doi:10.1080/15569527.2018.1512610)
8. Occurrence of Alkyltrimethylammonium Compounds in Urban Estuarine Sediments: Behentrimonium As a New Emerging Contaminant. (Environ. Sci. Technol., 44(19), 7569–7575. doi:10.1021/es101169a)
Regulatory References:
1. South Korea - Ministry of Food and Drug Safety - Prohibited/Restricted Chemicals
- Ref: 463
2. EU CosIng Annex III, SUBSTANCES WITH RESTRICTIONS IN COSMETIC PRODUCTS [2018]
- Ref: III/287
4. EU CosIng Annex V, PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS [2017]
- Ref: V/44

Safety and Hazards (UN GHS):

1. Causes skin irritation (H315)
2. Causes serious eye irritation (H319)
3. Very toxic to aquatic life (H400)
4. Very toxic to aquatic life with long lasting effects (H410)

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