Thomas Platzek

A medical-toxicological view of tattooing

Long perceived as a form of exotic self-expression in some social fringe groups, tattoos have left their maverick image behind and become mainstream, particularly for young people. Historically, tattoo-related health and safety regulations have focused on rules of hygiene and prevention of infections. Meanwhile, the increasing popularity of tattooing has led to the development of many new colours, allowing tattoos to be more spectacular than ever before. However, little is known about the toxicological risks of the ingredients used. For risk assessment, safe intradermal application of these pigments needs data for toxicity and biokinetics and increased knowledge about the removal of tattoos. Other concerns are the potential for phototoxicity, substance migration, and the possible metabolic conversion of tattoo ink ingredients into toxic substances. Similar considerations apply to cleavage products that are formed during laser-assisted tattoo removal. In this Review, we summarise the issues of concern, putting them into context, and provide perspectives for the assessment of the acute and chronic health effects associated with tattooing.

Risk assessment of nanomaterials in cosmetics: a European union perspective

In Europe, the data requirements for the hazard and exposure characterisation of chemicals are defined according to the REACH regulation and its guidance on information requirements and chemical safety assessment (Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), and its guidance documents; available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:396:0001:0849:EN:PDF; and at: http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm). This is the basis for any related risk assessment. The standard reference for the testing of cosmetic ingredients is the SCCP’s ‘Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation’ (The SCCP’s Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (2006); available at: http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_03j.pdf), which refers to the OECD guidelines for the testing of chemicals (The OECD Guidelines for the Testing of Chemicals as a collection of the most relevant internationally agreed testing methods used by government, industry and independent laboratories to assess the safety of chemical products; available at: http://www.oecd.org/topic/0,2686,en_2649_34377_1_1_1_1_37407,00.html). According to the cosmetics directive [76/768/EEC], compounds that are classified as mutagenic, carcinogenic or toxic to reproduction are banned for the use in cosmetic products. Since December 2010, the respective labelling is based on the rules of regulation (EC) No. 1272/2008 (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, Official Journal L 353, 31/12/2008, pages 1–1355; available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:en:PDF) on classification, labelling and packaging of substances and mixtures (CLP). There is no further impact from the CLP regulation on cosmetic products, because regulation (EC) No. 1223/2009 on cosmetic products defines its own labelling rules (Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products; available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF). Special notification procedures are mandatory for preservatives, colourants and UV-filters where a safety approval from the European ‘Scientific Committee on Consumer Safety’ (SCCS) is needed prior to marketing. The risk assessment of nanomaterials in consumer products still poses a significant challenge as highlighted by the example of UV-filters in sunscreens since nanomaterials cannot be classified as a homogenous group of chemicals but still need to be addressed in risk characterisation on a case by case basis.

Assessment of the sensitizing potential of textile disperse dyes and some of their metabolites by the loose-fit coculture-based sensitization assay (LCSA)

Certain textile disperse dyes are known to cause allergic reactions of the human skin. Here, we examined 8 disperse dyes and 7 products of azo-cleavage of these dyes in an in vitro assay. We used the loose-fit coculture-based sensitization assay (LCSA) of primary human keratinocytes and of allogenic dendritic cell-related cells for combined testing of the sensitizing and irritative properties of these substances. The obtained data were compared to data generated in a modified version of the local lymph node assay by our working group. Disperse Blue 1 (DB1), p-nitroaniline (pNA) and p-aminoacetanilide (AAA) showed no sensitizing potential under our experimental conditions. Disperse Blue 124 (DB124), Disperse Yellow 3 (DY3), Disperse Orange 37/76 (DO37), Disperse Blue 106 (DB106), Disperse Red 1 (DR1), 2-amino-p-cresol (ApC), Disperse Orange 3 (DO3) and 2,6-dichloro-4-nitroaniline (DCh) were categorized as extreme sensitizers. Para-phenylenediamine (pPD) was categorized as strong sensitizer, and 2-amino-5-nitrothiazole (ANT) and 2-(N-ethylanilino)-ethanol (EAE) as weak sensitizers. All dyes, except for DB1, and ApC turned out to be strong irritants. DB1, ANT and DCh showed only weak irritative potential. PPD, pNA, EAE and AAA did not show any irritative effect at the concentration range tested. These results correlate with data derived from the modified version of LLNA and human data. Therefore, the LCSA represents a suitable test system to simultaneously analyse two crucial properties of substances relevant for allergy induction.

Migration and penetration of a fluorescent textile dye into the skin –in vivo versus in vitro methods

Abstract:  The amount of textile dye migration from the textile and penetration into the skin is relevant when assessing the risk of textile dyes. In this paper, in vivo methods were developed using a harmless textile dye with a strong fluorescence and were then compared with in vitro methods. For the in vivo method, the textile was applied to the lower back of six volunteers wearing the textile 12 h and to the lower back of 12 volunteers during 30 min active sport. The maximum skin absorption of 55 ± 17 ng/cm2 was obtained in the group engaged in sports. The in vitro methods, which involved the application of the textile to the pig ear skin, was shown to yield similar results to the 12 h in vivo group (31.2 ± 9.6 ng/cm2 vs 27 ± 14 ng/cm2). The migration of the textiles into artificial sweat resulted in approximately 20 μg/cm2. The disadvantage of such textile extract applications on pig ear skin is discussed. It could be demonstrated that the absorption of the dye is strongly correlated to the amount of sweat, whereas the contact time was less important.

Opinion of the Scientific Committee on Consumer Safety (SCCS)--The safety of the use of formaldehyde in nail hardeners.

2015 Elsevier Inc. All rights reserved. The substance formaldehyde (CAS Number 50-00-0) is anticipated to be classified as a carcinogen category 1B under the CLP Regulation (EC) No. 1272/2008. However, such substances may be used in cosmetic products by way of exception where, subsequent to their classification as CMR substances of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No. 1272/2008, all of the conditions of Article 15.2 of the Cosmetics Regulation are fulfilled: (a) They comply with the food safety requirements as defined in Regulation (EC) No. 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matter of food safety; (b) there are no suitable alternative substances available, as documented in an analysis of alternatives; (c) the application is made for a particular use of the product category with a known exposure; and (d) they have been evaluated and found safe by the SCCS for use in cosmetic products, in particular in view of exposure to these products and taking into consideration the overall exposure from other sources, taking particular account of vulnerable population subgroups. Formaldehyde is used in nail hardeners for its specific crosslinking functionality with keratin. The use of formaldehyde in nail hardeners is currently restricted as specified in the Entry 13 of Annex III of Regulation (EC) No. 1223/2009 – i.e., a maximum concentration in the finished products of 5% (as formaldehyde); labelled as ‘contains formaldehyde’ when the finished cosmetic product contains formaldehyde in a concentration above 0.05% and with the warning ‘protect cuticles with grease or oil’. On 23 May 2013, the European Commission published a call for data on formaldehyde use in cosmetics and/or formaldehyde released by others substances used in cosmetics, seeking also information of the suitable alternatives. The Commission only received a full application from Cosmetics Europe which supports the use of formaldehyde in nail hardeners at the maximum level of 2.2% (as free formaldehyde). In view of the data that became available, the independent Scientific Committee on Consumer Safety (SCCS) was asked (i) to assess if condition d) of Article 15.2 is fulfilled, in order to confirm or not the safe use of formaldehyde in nail hardeners at the maximum level of 2.2% (as free formaldehyde) and (ii) to indicate if there are any further scientific concerns with regard to the use of formaldehyde in nail hardeners.