OCTOCRYLENE

Name / description

Octocrylene; 2-Cyano-3,3-diphenyl-2-propenoic Acid, 2-Ethylhexyl Ester

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Function(s) of this ingredient in cosmetic products

FRAGRANCE FUNCTIONAL

Functional ingredient (excipient) of perfume oils and / or flavours

LIGHT STABILIZER

Protecting the cosmetic product from deterioration effects of light

UV ABSORBER

Protects the cosmetic product from damage caused by UV light

UV FILTER

Protects skin or hair from harmful UV radiation

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Origin

synthetic

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Occurrence in cosmetics

As a UV filter in sunscreens and other cosmetics with UV protection (care products, decorative cosmetics)

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Background information on use in cosmetics

Octocrilene (INCI: OCTOCRYLENE) is a soluble organic UV-B filter. It absorbs UV-B radiation from approximately 280 to 320 nm. The maximum concentration of octocrilene is 10 %. UV filters minimise the undesired effects of UV radiation on the skin and are, therefore, an important component of sunscreens. By protecting the skin against the dangerous sun radiation, they contribute towards preventing premature light-caused skin ageing and skin cancer. In this connection a distinction is made between soluble organic UV filters and those based on mineral and / or organic pigments. Whereas soluble organic UV filters absorb the UV radiation, transform it into heat and form an invisible protection shield in the upper skin layer, UV filters on the basis of pigments reflect, scatter and absorb the sun radiation already on the skin surface. Organic UV filters absorb the energy of the ultraviolet part of the light in the range from approximately 280 to 400 nm. In this connection the energy of the absorbed photon must correspond to the energy which is necessary to elevate the electron in the molecule of the filter substance from a low to a higher orbit. When the electron falls back to its original orbit, the absorbed energy is either given off as heat or as radiation of a longer wavelength and hence rendered harmless. The organic UV filters are distinguished, amongst others, by the position of the absorption area, the photostability, the solubility and the penetration capacity. Depending on the wave range of the ultraviolet radiation which is absorbed by the UV filter, a distinction is made between UV-A, UV-B and broadband filters. Fragrances or mixtures of fragrances are often referred to in the cosmetics area as "perfuming agents" or "perfume oils" or "parfum oils". On the cosmetic products they are declared with the INCI name "PARFUM". These are undiluted individual substances or their mixtures which originate from natural raw materials or can be produced (semi-) synthetically. They are starting materials for the production of perfume, eau de parfum, eau de toilette, eau de cologne and other perfumed cosmetic products. The average content of fragrances amounts in perfume to 15-30 %, in eau de parfum to 10-14 %, in eau de toilette to 6-9 %, in eau de cologne to 3-5 % as well as in skin creams, shampoos, hair and deodorant sprays to approximately 0.2-1 % and approximately 1-3 in deodorant sticks. The perfume oils include essential oils, resinoids and absolutes. The sources are, amongst others, flowers, leaves and stems, fruits and fruit peels or roots of plants; woods, grasses or herbs, needles, resins and balsams. Moreover, only compounds isolated from natural products such as aldehydes, ketones, esters, alcohols etc. are used (geraniol, citronellal, citral, eugenol, menthol) as well as semi-synthetic (citronellol, geranyl acetate, jonone) and synthetic scents (eg phenylethyl alcohol and linalool) are used. Scents of animal origin such as musk and ambra are only rarely used.

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Information on safe use

In accordance with the EU Cosmetics Regulation [Regulation (EC) No. 1223/2009], which applies to the entire EU market, UV filters are defined as substances which are exclusively or mainly intended to protect the skin against certain UV radiation by absorbing, reflecting or scattering UV radiation. Annex VI of the Regulation defines the substances which may be used in cosmetic products as UV filters. In this so-called positive list of the UV filters maximum concentrations are prescribed for the use of these substances in cosmetic products and, if necessary, additional conditions for use are defined. Prior to their approval in Annex VI, UV filters are examined selectively for their toxicological safety and subjected to comprehensive tests. The manufacturers must prove the health safety in extensive scientific studies. Moreover, the approved filters are re-assessed, if necessary on the basis of new scientific findings and in the event of possible conspicuous findings in market observation and the list is updated accordingly.

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Links to scientific assessments

Opinion of the SCCS (2021) on the safety as cosmetic ingredient

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Why are we talking about it?

Octocrylene is accused of inducing skin allergies if there is simultaneous sunlight exposure (photosensitiser). It is also suspected of being an endocrine disruptor and of polluting coastal sea waters (near beaches). The facts: In the decade after year 2000, several cases of photoallergic contact dermatitis (skin allergy related to the application of a product on skin and simultaneous exposure to sunlight) triggered a discussion suggesting octocrylene of being a photosensitizer. Investigations revealed that these cases were associated with the use of anti-inflammatory gels (ketoprofen) on the skin, which are known to be photosensitising (1). Since the introduction of measures to inform health professionals and consumers, no case of photoallergy related to octocrylene has been reported. One single study suggests a moderate sensitising potential. In vitro studies (i. e. studies or manipulations carried out in an artificial laboratory environment, for instance in a test tube) indicated an effect on spermatozoa but the results of subsequently conducted in vivo studies (referring to studies or manipulations carried out on living organisms) were inconclusive. It has to be mentioned, that in vitro studies are particularly suitable to identify a mode of action. In view of the current lack of mature alternative methods, the relevance of such an identified mechanism of action for an entire organism requires confirmation by in vivo studies. European experts have not confirmed that octocrylene is considered a pollutant for coastal waters. In 2021, European experts concluded, based on the safety assessment and taking into account the concerns about its potential endocrine disrupting properties, that Octocrylene is safe as a UV filter at the concentrations authorised in cosmetic products (2). Key points to take away: The use of octorylene has been recognised as safe, especially as its skin penetration is negligible. The safety in use of octocrylene at the concentrations authorised in cosmetic products has been confirmed by the European Scientific Committee on Consumer Safety, SCCS (2). This most recent assessment did also consider an an alleged endocrine disrupting potential. In view of the health risks associated with sun exposure (photoaging, skin cancer), the use of sunscreen products and/or UV-protective clothing remains essential. Sources: (1) French National Agency for the Safety of Medicines and Health Products (ANSM / ex-AFSSAPS): 18/12/2009: “Suspension d’autorisation de mise sur le marché des gels contenant du kétoprofène” / Suspension of marketing authorisation for gels containing ketoprofen: https://archiveansm.integra.fr/S-informer/Communiques-Communiques-Points-presse/Suspension-d-autorisation-de-mise-sur-le-marche-des-gels-contenant-du-ketoprofene-communique (2) Scientific Committee on Consumer Safety: Opinion SCCS/1627/21

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Belongs to the following substance groups

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Regulating cosmetics

Cosmetics Ingredients are subject to regulation. Please note, different regulations may apply to cosmetic ingredients outside the EU.