Cosmetics and Skin Care Products* 30 Ian R
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30_493_506 05.11.2005 11:14 Uhr Seite 493 Chapter 30 Cosmetics and Skin Care Products* 30 Ian R. White, Anton C. de Groot * In this chapter, the nomenclature used is according to the International Nomenclature of Cosmetic Ingredients (INCI), as required for ingredient labeling in Europe. Contents 30.1 What Are Cosmetics? 30.1 What Are Cosmetics? . 493 30.2 Epidemiology of Side-Effects from Cosmetics 493 In European legislation, a “cosmetic product” is 30.2.1 The General Population . 493 any substance or preparation intended to be placed 30.2.2 Patients Seen by Dermatologists . 494 in contact with the various external parts of the human body (epidermis, hair system, nails, lips, and 30.3 Clinical Picture . 494 external genital organs) or with the teeth and the 30.4 The Products Causing Cosmetic Allergy . 495 mucous membranes of the oral cavity with a view ex- 30.5 The Allergens . 495 clusively or mainly to cleaning them, perfuming 30.5.1 Fragrances . 495 them, changing their appearance and/or correcting 30.5.2 Preservatives . 497 body odors and/or protecting them or keeping them 30.5.2.1 Methylchloroisothiazolinone in good condition (Cosmetics Directive 76/768/EEC; (and) Methylisothiazolinone . 497 article 1). 30.5.2.2 Methyldibromo Glutaronitrile . 497 Included within the definition of a cosmetic are 30.5.2.3 Formaldehyde . 497 the following: 30.5.2.4 Formaldehyde Donors . 498 30.5.3 Quaternium-15 . 498 30.5.4 Imidazolidinyl Urea . 498 í Soaps, shampoos, toothpastes, and cleansing 30.5.5 Diazolidinyl Urea . 498 and moisturizing creams for regular care 30.5.6 2-Bromo-2-Nitropropane-1,3-Diol (Bronopol) 498 í Color cosmetics, such as eye shadows, 30.5.7 DMDM Hydantoin . 498 lipsticks, and nail varnishes 30.5.7.1 Parabens . 499 í Hair colorants and styling agents 30.5.7.2 Iodopropynyl Butylcarbamate . 499 í Fragrance products, such as deodorants, 30.5.7.3 Miscellaneous Preservatives . 499 aftershaves, and perfumes 30.5.8 Tosylamide/Formaldehyde Resin . 499 í Ultraviolet light (UV light) screening p 30.5.9 -Phenylenediamine and Related Hair Dyes . 499 preparations 30.5.10 Cocamidopropyl Betaine . 500 30.5.11 UV Filters . 500 30.5.12 Lanolin and Derivatives . 500 30.5.13 Glyceryl Thioglycolate . 500 30.2 Epidemiology of Side-Effects 30.5.14 Propylene Glycol . 501 from Cosmetics 30.5.15 Antioxidants . 501 30.5.16 Miscellaneous Allergens . 501 30.2.1 The General Population 30.6 Diagnostic Procedures . 501 30.7 Ingredient Labeling in the European Union . 502 Everyone uses cosmetics and, given the enormous References . 503 volume of sales and the range of products available, there is remarkably little information on the inci- dence of adverse reactions to them. Most individuals who experience an adverse reaction to a cosmetic have a mild reaction and simply change to another product. Only rarely is an adverse reaction reported to a manufacturer, unless discomfort is marked or significant. In Europe, the industry is required to record adverse reactions reported to it and make the 30_493_506 05.11.2005 11:14 Uhr Seite 494 494 Ian R.White, Anton C. de Groot register available to the appropriate “competent au- Table 1. Frequency of reactions (mean from all centers and range) to cosmetic ingredients in the standard series thority.” Individuals are also unlikely to present to a n dermatologist for evaluation, unless an adverse reac- ( =20,791) [5] tion is severe, as in the case of contact allergy to a Substance Mean Range hair dye, or persistent. (%) (%) Several thousand substances are available to the cosmetic scientist for incorporation into cosmetics. Fragrance mix 7.0 6.4–9.4 Balsam of Peru (Myroxylon pereirae) 5.8 4.0–6.7 The European Commission publishes an indicative Colophony (colophonium) 3.4 1.7–4.7 but not exhaustive list of general ingredients and fra- p-Phenylenediamine 2.8 0.3–4.9 grance substances – known as the Inventory [1]. Wool wax alcohols (lanolin alcohol) 2.8 1.2–3.9 Many of these ingredients have had a long and estab- Formaldehyde 2.2 1.4–5.2 lished use, and are recognized as being safe or having Parabens 1.1 0.5–2.6 Quaternium-15 0.9 0.3–2.2 a low toxicological profile. Some substances, howev- er, pose a significant risk of causing adverse reac- tions, and, for these other substances, little is known about their safety. Regulatory aspects are discussed olidinyl urea, and diazolidinyl urea, and some in- in Chap. 45. clude iodopropynyl butylcarbamate and others. A In the general population, a questionnaire survey European study of the frequency of hypersensitivity 30 of 1,022 individuals in the United Kingdom found 85 to some of these agents in a patch-tested population people (8.3%) who claimed to have experienced an totaling 20,791 individuals showed the incidence of adverse reaction related to the use of a cosmetic [2]. reactions as listed in Table 1 [5]. Of dermatological Of these 85 individuals, 44 were patch tested and in 11 patients patch tested for suspected allergic contact (1.1%), a significant reaction was obtained to a cos- dermatitis, about 10% are allergic to cosmetic ingre- metic ingredient. In Holland, a survey of 982 individ- dients [5]. uals attending beauticians found 254 (26%) who Women are more at risk of acquiring hypersensi- claimed to have experienced an adverse reaction to a tivity to cosmetic ingredients than men, due to their cosmetic [3]. Evaluation of 150 cases of this group by greater product use. Variability in the frequency of patch testing demonstrated 10 individuals, 1% of the reactions reported is partially attributable to differ- total, with an allergic reaction attributable to a cos- ent patient selection between centers. True temporal metic ingredient. These and other studies give an and geographical variations in the frequency of hy- idea of the proportion of the population who may persensitivity to cosmetic ingredients occur because have experienced an allergic contact reaction to a of differences in ingredient use. These differences in- cosmetic ingredient at some time.An estimated 1% is volve marketing strategies, local product preference, allergic to fragrances [4] and 2–3% are allergic to and preferred ingredient usage by manufacturers. substances that may be present in cosmetics and toi- Additionally, changes in legislation, recommenda- letries [5]. tions on ingredient use, and availability are further important factors. Dillarstone [6] has pointed out the phasic nature of the prevalence of contact allergy to 30.2.2 Patients Seen by Dermatologists preservatives that results from these latter factors. Detailed information is available regarding the prev- alence of contact allergy to some cosmetic ingre- 30.3 Clinical Picture dients amongst individuals who have been patch tested as an investigation for their dermatitis (of Sometimes, allergic contact dermatitis from cosmet- whatever type).The European standard series of con- ic products can easily be recognized. Examples in- tact allergens includes the following substances clude reactions to deodorant, eye shadow, perfume which may be used in cosmetics: fragrance mix, bal- dabbed behind the ears or on the wrist, and lipstick. sam of Peru (INCI name: Myroxylon pereirae; not In more than half of all cases, however, the diagnosis used as such in cosmetics, but included as an indica- of cosmetic allergy is not clinically suspected [7]. tor of fragrance sensitivity), formaldehyde, quaterni- The clinical picture of allergic cosmetic dermatitis um-15, methylchloroisothiazolinone (and) methylis- depends on the type of products used (and, conse- othiazolinone (MCI/MI), parabens, lanolin (wool al- quently, the sites of application), exposure, and the cohols), colophonium (colophony), and p-phenylen- patient’s sensitivity. Usually, a cosmetic contains only ediamine. Many centers also routinely test with the weak allergens or stronger ones present at low dilu- preservatives methyldibromo glutaronitrile, imidaz- tion, and the dermatitis resulting from cosmetic al- 30_493_506 05.11.2005 11:14 Uhr Seite 495 Cosmetics and Skin Care Products Chapter 30 495 lergy is mild: erythema, minimal edema, desquama- products specifically for children, may influence the tion, and papules.Weeping vesicular dermatitis rare- situation. ly occurs, although some products, especially the permanent hair dyes, may cause fierce reactions, not- ably on the face, ears, and scalp. Allergic reactions on 30.5 The Allergens the scalp may be seborrhö dermatitis-like with (tem- porary) hair loss. Although there are numerous publications on con- Contact allergy to fragrances may resemble an en- tact allergy to the ingredients of cosmetics, the dogenous eczema [8]. Lesions in the skin folds may systematic investigation of the allergens in such be mistaken for atopic dermatitis. Dermatitis due to products has been rare [7,15]. Fragrances and preser- perfumes or toilet water may be “streaky.”Allergy to vatives (and in recent years, the preservative methyl- tosylamide/formaldehyde resin in nail polish may af- dibromo glutaronitrile [18–20] has emerged as an fect the fingers [9], but most allergic reactions are lo- important cosmetic allergen) are the most common cated on the eyelids, in and behind the ears, on the causative ingredients in allergic cosmetic dermatitis. neck, and sometimes around the anus or vulva. Ecze- Other important allergens are the hair color p-phen- ma of the lips and the perioral region (cheilitis) [10] ylenediamine (and related permanent dyes), the nail may be caused by toothpastes [11], notably from the varnish resin tosylamide/formaldehyde resin [21], flavors contained therein [12]. and uncommonly to UV filters, lanolin and other The face itself is frequently involved,and often,the substances. dermatitis is limited to the face and/or eyelids. Other predilection sites for cosmetic dermatitis are the neck, arms, and hands. However, all parts of the body 30.5.1 Fragrances may be involved.