A To Z Tattooing Pdf Download
The continuous increase in the popularity of tattoos and permanent make-up (PMU) has led to substantial changes in their societal perception. Besides a better understanding of pathological conditions associated with the injection of highly diverse substances into subepidermal layers of the skin, their regulation has occupied regulatory bodies around the globe. In that sense, current regulatory progress in the European Union is an exemplary initiative for improving the safety of tattooing. On one hand, the compilation of market surveillance data has provided knowledge on hazardous substances present in tattoo inks. On the other hand, clinical data gathered from patients enabled correlation of adverse reactions with certain substances. Nevertheless, the assessment of risks remains a challenge due to knowledge gaps on the biokinetics of highly complex inks and their degradation products. This review article examines the strategies for regulating substances in tattoo inks and PMU in light of their potential future restriction in the frame of the REACH regulation. Substance categories are discussed in terms of their risk assessment and proposed concentration limits.
A To Z Tattooing Pdf Download
Tattoo inks are manufactured by mixing pigments with auxiliary compounds that control viscosity, drying properties, homogeneity in terms of particle sedimentation, and shelf life of the ink. The common components of tattoo inks are summarized in Scheme 1. Pigments are mostly manufactured for large-scale applications in the automotive, construction, or cosmetics industries (Laux et al. 2016) rather than specifically for tattooing. Therefore, the safety for their application in tattoo inks is not evaluated in particular. The injection of pigments into the human dermis as an ingredient of tattoo inks has actually neither considered nor even opposed by pigment manufacturers. A comprehensive evaluation of the safety of each product represents a great challenge for the rather minor sector of tattoo ink producers who are specialists for the formulation. Altogether, this underlines the urgent necessity for the regulation of tattoo ink constituents. The extent of pathological conditions directly related to the exposure to tattoo inks is generally difficult to estimate as only approximately 50% of those individuals that develop complications request medical advice (Renzoni et al. 2018). An additional reason for an inaccurate estimation of the prevalence of pathological conditions originates from the difficulty to connect certain systemic effects to the toxicity of tattoo ink ingredients or their degradation products. Although local reactions can undoubtedly be attributed to the site of the tattoo, the respective causative substances remain mostly undiscovered.
In a study which attempted to shed light on the systemic distribution of tattoo pigments, skin, lymph nodes, liver, spleen, kidney, and lung of tattooed mice have been analyzed (Sepehri et al. 2017). Mice tattooed with black and red inks were sacrificed after 1 year. In addition to skin and lymph nodes, pigments could be microscopically detected in Kupffer cells of the liver, hence suggesting their distribution via the bloodstream. In this study, no pigments could be localized in other organs though. However, there is further evidence that intradermal and subcutaneous injection of particulate matter may lead to deposition in organs such as liver, kidney, spleen, and hepatic lymph nodes (Gopee et al. 2007; Tang et al. 2009). Tattoo pigments are not eliminated from the site of injection via lymph and blood only. Until regeneration of the skin barrier has ended within about 1 month after tattooing, pigment particles are also eradicated by transepidermal elimination (Shah et al. 2018).
In terms of potential risk to human health, impurities of tattoo inks might be most relevant. These may comprise genotoxins such as certain PAAs, PAHs, nitrosamines, and formaldehyde. Furthermore, heavy metals such as nickel, chromium, and lead have been reported (Forte et al. 2009; Regensburger et al. 2010). Preservatives, a substance group with specific functional properties, may pose human health risks, as well. Adverse effects appearing directly after tattooing or years later have been monitored in dermatological clinics and are comprehensively summarized by Kluger (2019) and Serup et al. (2016). In summary, acute contact dermatitis, inflammatory reactions, and infectious complications account for common acute effects. And yet instant or delayed allergic reactions remain to be the most predominant adverse effect (Laux et al. 2016). Individual cases of patients who developed systemic anaphylaxis shortly after receiving a tattoo have been also reported (Jungmann et al. 2016). The analytical assessment of the applied ink revealed the presence of formaldehyde, parabens, isothiazolinones, and metals such as nickel, cobalt, manganese, cadmium, and antimony. Red inks were often reported for inducing an allergic reaction, although the identification of the specific allergen or the hapten is not necessarily straightforward (Serup et al. 2016; van der Bent et al. 2019; Wenzel et al. 2013). In fact, patients who developed an allergic reaction to a red tattoo did not react to the respective pigment in a patch test (Gaudron et al. 2015; Greve et al. 2003). This might be due to the necessity of the presence of other compounds or metabolites of the original pigment to promote cross activation. Also, the poor penetration of the test substance into the skin may lead to a false-negative readout (Steinbrecher et al. 2004). Recently, the analysis of skin biopsies of patients with allergic reactions against tattoos allowed the identification of organic pigments as well as metal ions with most frequent abundance (Serup et al. 2019). Among the organic pigments, azo class pigments were found in most of the biopsies analyzed. In particular, Pigment Red 22 (C.I number 12315) was found in 35% of the biopsies. The majority of the analyzed samples contained elevated levels of Fe and Cu, but also of Cr, Ti, Mn, Ni, and Cd. Hence, there is evidence of photo-degradation of pigments in human skin and cross reactivity between emerging metabolites and their parent compounds.
The report of the Joint Research Center (JRC) of the European Commission (EC), compiled by expert stakeholders from research and risk assessment, intended to set a legislative framework for assuring consumer safety. The reports of the four work packages represent the results of collaborative efforts of member states to monitor trends in tattooing, their prevalence, as well as adverse effects linked to their application and removal (JRC 2015a, b, 2016a, b). The main finding of the report was the presence of tattoo inks on the European market which do not comply with the limits set by the recommendations of the Council of Europe [ResAP(2003)2 or ResAP(2008)1]. Moreover, both the absence of suitable analytical methods and the insufficiency of clinical data on systemic or local complications were underlined. Interestingly, along with the reported adverse health reactions, bacterial infections at a rate of 5% were traced back to non-sterile inks or tattoo practice. Different from cosmetic products, tattoo inks are injected directly into the dermis and thus come into direct contact with immune cells, blood, and lymphatic fluid. For that reason, data obtained by the conventional dermal toxicity assays are unlikely to fully predict the toxicity of these substances when injected into human skin.
Although restricted substances may have a threshold under the CLP regulation, their total ban in tattoo inks is justified by the absence of supporting experimental data for their intradermal application. This is of particular relevance for skin sensitizers. Under the assumption that substances administered intradermally have a stronger sensitization effect when compared to conventional exposure routes, no DN(M)EL [Derived No (Minimal) Effect Level] can be derived. Recent literature and the RAC opinion underline that the simultaneous presence of irritants and the damage induced to the skin during tattooing may enhance the sensitization potential of certain substances (Frankild et al. 2000; McFadden and Basketter 2000; RAC 2018; Schwitulla et al. 2014).
Complications related to tattoos can be caused not only by hazardous substances but also by their wrong application resulting in pigment overload or excessive needle traumata (JRC 2016a; Sepehri et al. 2016; Serup et al. 2016). The regulation of tattoo ink ingredients as chemicals with no direct consideration of hygienic aspects based on existing clinical evidence is insufficient to provide comprehensive safety of the consumers. The newly developed European standard for safe and hygienic practice is an evidence-based document which provides guidelines for protecting the consumers and tattoo artists from infections (DIN EN 2017). This norm is foreseen to be officially adopted and published by the European Committee for Standardization (CEN). Although legally non-binding, it covers vital aspects of tattooing practice and communication with health authorities.
The efforts of regulatory authorities to ensure a safe practice of tattooing have led to enormous progress in the understanding of the life cycle of substances injected underneath the epidermal layer of the skin. Along with that knowledge, many questions remain unresolved, in particular regarding degradation products and their systemic bioavailability. It seems obvious that only a stand-alone legislation of tattoo inks may encompass the diverse aspects of tattooing such as their ingredients, sterility, labeling requirements, and appropriate training of tattoo artists. Such a restriction should be based on thoroughly evaluated target substances. The scope of the dossier prepared by ECHA represents a common European initiative and certainly provides an important step towards a legislative framework for the restriction of non-intentionally added compounds, i.e., impurities. Its implementation and effectiveness should be carefully monitored and further developed.