Comparative sensitizing potencies of fragrances, preservatives, and hair dyes.

The local lymph node assay (LLNA) is used for assessing sensitizing potential in hazard identification and risk assessment for regulatory purposes. Sensitizing potency on the basis of the LLNA is categorized into extreme (EC3 value of ≤0.2%), strong (>0.2% to ≤2%), and moderate (>2%). To compare the sensitizing potencies of fragrance substances, preservatives, and hair dye substances, which are skin sensitizers that frequently come into contact with the skin of consumers and workers, LLNA results and EC3 values for 72 fragrance substances, 25 preservatives and 107 hair dye substances were obtained from two published compilations of LLNA data and opinions by the Scientific Committee on Consumer Safety and its predecessors. The median EC3 values of fragrances (n = 61), preservatives (n = 19) and hair dyes (n = 59) were 5.9%, 0.9%, and 1.3%, respectively. The majority of sensitizing preservatives and hair dyes are thus strong or extreme sensitizers (EC3 value of ≤2%), and fragrances are mostly moderate sensitizers. Although fragrances are typically moderate sensitizers, they are among the most frequent causes of contact allergy. This indicates that factors other than potency need to be addressed more rigorously in risk assessment and risk management.

Methylisothiazolinone and benzisothiazolinone are widely used in paint: a multicentre study of paints from five European countries.

BACKGROUND: In view of the current epidemic of contact allergy to methylisothiazolinone (MI), it is important to clarify the extent of use of MI and related isothiazolinones in paints currently available for the consumer and worker in Europe. OBJECTIVES: To elucidate the use and concentrations of MI, methylchloroisothiazolinone (MCI) and benzisothiazolinone (BIT) in paints on the European retail market. METHODS: Wall paints (n = 71) were randomly purchased in retail outlets in five European countries. The paints were quantitatively analysed for their contents of MI, MCI and BIT by high-performance liquid chromatography coupled to tandem mass spectrometry. RESULTS: MI was found in 93.0% (n = 66) of the paints, with concentrations ranging from 0.7 to 180.9 ppm, MCI in 23.9% (n = 17), ranging from 0.26 to 11.4 ppm, and BIT in 95.8% (n = 68), ranging from 0.1 to 462.5 ppm. High concentrations of MI were found in paints from all five countries. Paints purchased in Denmark and Sweden contained especially high concentrations of BIT. CONCLUSION: The use of MI across European countries is extensive. In view of the ongoing epidemic of MI contact allergy, an evaluation of the safety of MI in paints is needed.

Readability of product ingredient labels can be improved by simple means: an experimental study.

BACKGROUND: Ingredient labels on products used by consumers and workers every day, such as food, cosmetics, and detergents, can be difficult to read and understand. OBJECTIVE: To assess whether typographical design and ordering of ingredients can improve the readability of product ingredient labels. METHODS: The study subjects (n = 16) had to search for two target ingredients in 30 cosmetic product labels and three alternative formats of each. Outcome measures were completion time (reading speed), recognition rate, eye movements, task load and subjective rating when the reading of ingredient labels was assessed by video recording, an eye tracking device, and questionnaires. RESULTS: The completion time was significantly lower (p < 0.001) when subjects were reading all alternative formats than when they were reading the original. The recognition rate was generally high, and improved slightly with the alternative formats. The eye movement measures confirmed that the alternative formats were easier to read than the original product labels. Mental and physical demand and effort were significantly lower (p < 0.036) and experience rating was higher (p < 0.042) for the alternative formats. There were also differences between the alternative formats. CONCLUSIONS: Simple adjustments in the design of product ingredient labels would significantly improve their readability, benefiting the many allergic individuals and others in their daily struggle to avoid harmful or unwanted exposure.

Coupled exposure to ingredients of cosmetic products: III. Ultraviolet filters.

BACKGROUND: The use of cosmetics exposes consumers to mixtures of ingredients, many of which are potential allergens. Ultraviolet (UV) filters are used not just in sunscreens, but also in other products. Many UV filters are known contact allergens and photoallergens. OBJECTIVE: To examine the pattern of co-exposure to UV filters in cosmetics. METHODS: A survey of products marketed in Germany, conducted in 2006-2009 by the Chemical and Veterinary Investigation Office in Karlsruhe, identified 4447 products (of all 5667 cosmetic products examined) (i) that were categorizable according to Annex I to the Cosmetics Directive, and (ii) with information on the presence of UV filters or zinc oxide. The occurrence and co-occurrence of UV filters were analysed and presented in tabular and graphical format. RESULTS: UV filters or zinc oxide were present in 22.5% of all 4447 products, ranging from almost 100% in sunscreens to a few per cent in, for example, some hair products; they were absent in two product categories. Frequently, several different UV filters were included in one product, for example in sunscreens (median 4) and in perfumes (median 3). The overall most frequent UV filters were butyl methoxydibenzoylmethane and titanium dioxide, combined mostly with octocrylene in sunscreens and with ethylhexyl methoxycinnamate in creams. CONCLUSIONS: The frequent co-occurrence of UV filters in cosmetic products possibly facilitates sensitization, and may explain why patients often react to chemically unrelated UV filters.

p-Phenylenediamine and other allergens in hair dye products in the United States: a consumer exposure study.

BACKGROUND: Hair dye products constitute an important source of allergen exposure, and contribute importantly to allergic contact dermatitis in consumers and hairdressers. OBJECTIVES: To evaluate the presence of potent contact sensitizers in oxidative hair dye products intended for home use on the US market. METHODS: Ingredient labels of 107 hair dyes from 10 major brands were examined and used to assess the prevalence of hair dye substances known to be potent contact sensitizers. RESULTS: One hundred and six of 107 (99%) products contained at least one potent sensitizer, and the average product contained six (range 0-11). p-Phenylenediamine (PPD) was found in 83 products (78%), but resorcinol (89%), m-aminophenol (75%), p-aminophenol (60%) and toluene-2,5-diamine (21%) were also frequently identified. CONCLUSIONS: Potent contact sensitizers were almost universally included in the hair dyes investigated in the United States. Although PPD is a common allergen, resorcinol and m-aminophenol were found more frequently. In total, 30 potent sensitizers were found. Clinicians should consider other allergens in addition to PPD when evaluating patients with suspected hair dye allergy.

Coupled exposure to ingredients of cosmetic products: II. Preservatives.

BACKGROUND: The use of cosmetics exposes consumers to mixtures of ingredients, many of which are potential allergens. Many cosmetics contain one or several preservatives, some being important contact allergens. OBJECTIVE: To examine the pattern of co-exposure to preservatives in different categories of cosmetics. METHODS: A survey of products marketed in Germany, conducted in 2006-2009 by the Chemical and Veterinary Investigation Office in Karlsruhe, identified 4680 products categorizable according to Annex I to the Cosmetics Directive with information on the presence of preservatives. The occurrence and co-occurrence of preservatives were analysed and presented in tabular and graphical format. RESULTS: Thirty per cent of all products were not declared to contain any preservatives; for 8%, no INCI labelling was present. For the remainder, the number of preservatives used tended to be higher in leave-on than in rinse-off products. Most often, combinations of (up to all five) parabens were used (39% of all products). Combinations with phenoxyethanol were also frequent. Formaldehyde releasers were found in 8% of products overall. CONCLUSIONS: The pattern of co-exposure to preservatives in important categories of cosmetic products illustrates the 'cocktail' of allergens that may facilitate sensitization, although, conversely, the combination of preservatives allows individual use levels to be kept lower, thereby possibly reducing sensitization risk.

Coupled exposure to ingredients of cosmetic products: I. Fragrances.

BACKGROUND: The use of cosmetics exposes consumers to mixtures of ingredients, many of which are contact allergens. Fragrances in particular are mostly used in combination; combinations of fragrances have been shown to enhance sensitization and elicitation. OBJECTIVE: To examine the pattern of co-exposure to fragrances in different categories of cosmetics, addressing the 26 fragrances that need to be identified on the label according to the Cosmetics Directive 76/768/EEC amended by 2003/15/EC. METHODS: A survey of products marketed in Germany, conducted in 2006-2009 by the Chemical and Veterinary Investigation Office in Karlsruhe, identified 4991 products with information on the presence of fragrances. The products were categorized according to Annex I to the Cosmetics Directive. The occurrence and co-occurrence of fragrances were analysed in tabular form and as social network diagrams. RESULTS: The median number of fragrances in products varied greatly between categories, ranging up to nine in perfumes. Limonene and linalool were the most commonly identified fragrances, often used together, but also with other fragrances. Thirty per cent of all products were not declared to contain any fragrances. CONCLUSIONS: For the first time, the pattern of co-exposure to fragrance ingredients in important categories of cosmetic products has been described. The observations illustrate and quantify the 'cocktail' of fragrance allergens that may facilitate sensitization.

p-Phenylenediamine and other hair dye sensitizers in Spain.

BACKGROUND: Oxidative hair dyes are important skin sensitizers, causing contact allergy and dermatitis in hairdressers and consumers. OBJECTIVES: To study the prevalence of hair dye substances, categorized as potent skin sensitizers, in consumer-available oxidative hair dye products on the market of a southern European country and to compare it with that in Sweden. METHODS: Ingredient labels of 105 oxidative hair dye products from 19 brands were studied, and the prevalence and use pattern of hair dye substances, categorized as potent skin sensitizers, was assessed. Network diagrams were used to display results. RESULTS: According to the labelling, all 105 products contained hair dye substances categorized as potent skin sensitizers. A total of 25 different hair dye substances categorized as potent skin sensitizers were identified. Eighty-seven per cent of the products contained at least four such substances. Either p-phenylenediamine, toluene-2,5-diamine or toluene-2,5-diamine sulfate was present in 103 products. CONCLUSIONS: Hair dye substances categorized as potent skin sensitizers were used in all studied hair dye products on the Spanish market. The prevalence of p-phenylenediamine was higher in the present study than in a similar study in Sweden. More than 20 potent sensitizers were identified in each country. Not only p-phenylenediamine should be used to diagnose allergy to hair dyes.

Preservatives and fragrances in selected consumer-available cosmetics and detergents.

BACKGROUND: Preservatives and fragrances are important and frequent skin sensitizers, found in a wide range of products intended for personal and occupational use. OBJECTIVES: To examine the use of preservatives and fragrances in certain cosmetics and detergents on the market. The product types studied were shampoos, hair conditioners, liquid soaps, wet tissues, washing-up liquids, and multi-purpose cleaners. MATERIALS/METHODS: Ingredient labels of 204 cosmetic products and ingredient data sheets of 97 detergents, available on company websites, were examined. RESULTS: The preservatives most frequently identified were phenoxyethanol, methylparaben, sodium benzoate, propylparaben, and methylchloroisothiazolinone/methylisothiazolinone. Parabens were found in 44% of cosmetics and 9% of detergents; formaldehyde-releasers in 25% of cosmetics and 8% of detergents; and isothiazolinones in 23% of cosmetics and 28% of detergents. The fragrances most frequently identified were linalool, limonene, hexyl cinnamal, butylphenyl methylpropional, and citronellol. Eighty-eight per cent of the products contained fragrances, and any of the 26 fragrances requiring labelling were found in half of the cosmetics and one-third of the detergents. CONCLUSIONS: Several preservatives and fragrances with well-known skin-sensitizing potential were common in the examined product types. Such products may be used several times a day by consumers and workers.

Nickel on the Swedish market: follow-up 10 years after entry into force of the EU Nickel Directive.

BACKGROUND: The EU Nickel Directive, aimed at primary and secondary prevention of nickel allergy by limitation of nickel release from certain items, came fully into force in July 2001. OBJECTIVES: To assess the prevalence on the market of items with nickel release and to compare the outcome with previous studies performed in Sweden in 1999 and 2002-2003. MATERIALS AND METHODS: Nickel release from 659 items covered by the EU Nickel Directive was assessed with the dimethylglyoxime (DMG) test. Special attention, as compared with the previous surveys, was given to cheap jewellery in street markets and sewing materials in haberdashery shops. RESULTS: Nickel release was shown for 9% of the tested items, all of which were intended for direct and prolonged contact with the skin. A high proportion of items bought at haberdashery shops and street markets, 34% and 61%, respectively, showed nickel release. CONCLUSIONS: The Swedish market for products intended for direct and prolonged contact with the skin has largely adapted to the Nickel Directive. It is suggested that authorities should monitor the market regularly and give attention to areas where compliance with the requirements is poor, for protection of public health.

Potent skin sensitizers in oxidative hair dye products on the Swedish market.

BACKGROUND: In recent years, the alarming increase in contact allergy to hair dyes has drawn much attention. It has been shown that many of the currently allowed hair dye substances are potent skin sensitizers. OBJECTIVES: To study the prevalence of hair dye substances, categorized as potent skin sensitizer, in oxidative hair dye products on the Swedish market. MATERIALS AND METHODS: Ingredient labels of 122 oxidative hair dye products from 20 brands were examined. All ingredients were recorded, and the prevalence of hair dye substances categorized as potent skin sensitizers was assessed. RESULTS: According to ingredient labelling, 120 out of 122 examined oxidative hair dye products contained hair dye substances categorized as potent skin sensitizers. More than 80% of the products contained at least four such substances; 37 hair dye substances categorized as potent skin sensitizers were identified, and 10 of these were more prevalent than p-phenylenediamine. CONCLUSIONS: Hair dye substances categorized as potent skin sensitizers are very common in oxidative hair dye products. A substantial number of potent skin sensitizers are more frequently used than p-phenylenediamine, while only a few are commercially available as patch test substances.