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Chemical Compounds as Trigger Factors of Immediate Contact Skin Reactions
Published in Ana M. Giménez-Arnau, Howard I. Maibach, Contact Urticaria Syndrome, 2014
In the case of free formaldehyde, for which bactericidal and fungicidal properties confer it a place of choice for preservation of cosmetics, its use has been reduced because of the bad press it has received as an irritant, sensitizer, and potential carcinogen.[27] Formaldehyde is known to be a strong, ubiquitous skin sensitizer, including from noncosmetic sources of contact. Because of this, exposure to formaldehyde in the European Union is subject to restrictions. Free formaldehyde may be used as a preservative in all cosmetic products (maximum authorized concentration 0.2%, except 0.1% in products for oral hygiene) except aerosol cosmetics. Annex VI of the Cosmetics Directive 76/768 EEC further stipulates that all finished products containing formaldehyde or substances that release formaldehyde must be labeled with the warning “contains formaldehyde” if the concentration of free formaldehyde in the finished product exceeds 0.05%.[28] As an alternative, chemical compounds that slowly release formaldehyde in the presence of water and under usage conditions, the so-called formaldehyde releasers, are commonly employed as preservatives in cosmetics (water-based preparations) instead of free formaldehyde. Examples are bronopol and imidazolidinyl urea. Unfortunately, many formaldehyde releasers used in cosmetics are also skin sensitizers because of released formaldehyde but also to reactive intermediates other than formaldehyde that could be involved in the formation of the hapten-protein antigenic complex, a key step of the sensitization process, and thus explaining their sensitizing potential per se.[29] Even if it is a strong sensitizer, reported immediate reactions to formaldehyde are mainly classified as NICoU because they seem not to be mediated by IgE.[30] However, there is still no consensus in the reports that have appeared as to whether the mechanism is immunological or nonimmunological.[31]
Combinative ex vivo studies and in silico models ProTox-II for investigating the toxicity of chemicals used mainly in cosmetic products
Published in Toxicology Mechanisms and Methods, 2022
Priyanka Banerjee, Ozge Cemiloglu Ulker
Formaldehyde is a preservative that is commonly used in water-based cosmetics to prevent microbial growth and nail and hair products. In general, preservatives in cosmetics must be declared in the list of ingredients. Moreover, products containing >500 ppm formaldehyde (equivalent to 0.05%) must be labeled with ‘contains formaldehyde’. Despite this, it is difficult for an allergic patient to completely avoid formaldehyde or formaldehyde-releasers, and previous studies have shown that hidden sources of formaldehyde in cosmetics can cause allergic contact dermatitis (Fasth et al. 2018). In 2015, formaldehyde was classified as a CMR-substance by the EU, i.e. a substance that is either carcinogenic, mutagenic or toxic for reproduction (European Chemicals Agency 2015). The European Commission has now finally decided to ban formaldehyde completely from use in cosmetics, nail products and toothpaste. On the other hand, the ban only applies to Formaldehyde, Paraformaldehyde, Methylene glycol and one of the formaldehyde releasers, Quternium-15, whereas all other formaldehyde releasers will still be allowed. Formaldehyde is highly soluble and reactive in lung tissues and hence had a very high uptake in the trachea (Nielsen et al. 2017). It was suggested that the implication that consumer use of terpenes, particularly limonene, is a significant source of formaldehyde formed through atmospheric chemistry (Wolkoff et al. 2008). In our study, the carcinogenic and mutagenic effects were also predicted by the computational method. Although the EU banned formaldehyde from being used in cosmetics in 2015, it is still allowed in the US. There should be a big concern about formaldehyde releasers in terms of immunotoxic and carcinogenic, mutagenic effects (Pferdehirt 2015).
Undeclared formaldehyde levels in patient consumer products: formaldehyde test kit utility
Published in Cutaneous and Ocular Toxicology, 2019
Jason E. Ham, Paul D. Siegel, Howard Maibach
Assessment of contact allergy that is potentially from formaldehyde-releasing agents poses multiple challenges with respect to clinical relevance, exposure assessment and analytical chemistry aspects. The common assumption is that the contact allergy elicited by formaldehyde-release agents is at least partially due to the formaldehyde1. There are multiple lines of evidence that support this assumption including the observation that multiple, non-structurally related formaldehyde releasers may produce allergic contact dermatitis in formaldehyde sensitized individuals. Aalto-Korte et al. (2008), in a study of occupational contact allergy to formaldehyde and formaldehyde releasers, reported that 79% of formaldehyde allergic patients reacted to formaldehyde releasers and that reactions to formaldehyde-releasers in the absence of formaldehyde allergy was rare4. They did, however, observe patch test reactions to one or more of the formaldehyde releasers included in their study in the absence of a formaldehyde (1%) patch test positive reaction. This may be attributable to either a false-negative formaldehyde patch test or to reaction to the parent compound or non-formaldehyde hydrolysis product. Commercially available formaldehyde releaser patch test reagents are supplied in either petrolatum or water. Emeis et al. (2010) reported that the formaldehyde-releaser petrolatum preparations did not have free formaldehyde, while those supplied in aqueous solutions had free formaldehyde ranging from 0.03 to 0.29% (w/w) with pH’s ranging from 4.0–9.510. Both the patch test vehicle and pH may potentially alter the rate of formaldehyde evolution and bioavailable for skin protein haptenation. This further confounds attempts to compare potency and prevalence of patch test reactivity between formaldehyde and the various releasing reagents.