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The EU Nickel Directive revisited-future steps towards better protection against nickel allergy
Abstract
In July 2001, the EU Nickel Directive came into full force to protect European citizens against nickel allergy and dermatitis. Prior to this intervention, Northern European governments had already begun to regulate consumer nickel exposure. According to part 2 of the EU Nickel Directive and the Danish nickel regulation, consumer items intended to be in direct and prolonged contact with the skin were not allowed to release more than 0.5 µg nickel/cm2/week. It was considered unlikely that nickel allergy would disappear altogether as a proportion of individuals reacted below the level defined by the EU Nickel Directive. Despite this, the EU Nickel Directive part 2 was expected to work as an operational limit that would sufficiently protect European consumers against nickel allergy and dermatitis. This review presents the accumulation of epidemiological studies that evaluated the possible effect of this major public health intervention. Also, it evaluates recent exposure assessment studies that have been performed using the dimethyl glyoxime test. It is concluded that the EU Nickel Directive has started to change the epidemiology of nickel allergy in Europe but it should be revisited to better protect consumers and workers since nickel allergy and dermatitis remain very frequent.
... 84 Conclusions regarding the effectiveness of the EU Nickel Directive are mixed: the contact allergy surveillance system identified heterogeneous trends in nickel allergy among the building trades (suggesting a partial failure of the nickel regulation), 85 while another study concluded that the regulation is starting to change the epidemiology of nickel allergy in the EU. 86 See Tables 5 and S2 for more information. ...
... We identified a range of studies illustrating that legislation and regulations are an effective tool for the primary prevention of contact dermatitis, [81][82][83]85,86 OA, 87,159,160,195 and occupational cancers due to exposure to asbestos, 112,114 silica, 115 and diesel exhaust. 113 However, the findings from the NIHL review suggest that their impact appears to be context-dependent and related to both the nature of the regulations and the degree of enforcement. ...
... 128 Medical surveillance and health screening were also identified as effective strategies for preventing OCD 29,91,107 and some forms of OA. 90,166,167 As illustrated in the contact dermatitis literature, an effective disease-reporting scheme, such as THOR (EPIDERM), is useful for evaluating the health impact of changes in OHS legislation and policy. 85,86 In two studies evaluating national-level surveillance systems (the ...
Background
Despite being largely preventable, many occupational diseases continue to be highly prevalent and extremely costly. Effective strategies are required to reduce their human, economic, and social impacts.
Methods
To better understand which approaches are most likely to lead to progress in preventing noise‐related hearing loss, occupational contact dermatitis, occupational cancers, and occupational asthma, we undertook a scoping review and consulted with a number of key informants.
Results
We examined a total of 404 articles and found that various types of interventions are reported to contribute to occupational disease prevention but each has its limitations and each is often insufficient on its own. Our principal findings included: legislation and regulations can be an effective means of primary prevention, but their impact depends on both the nature of the regulations and the degree of enforcement; measures across the hierarchy of controls can reduce the risk of some of these diseases and reduce exposures; monitoring, surveillance, and screening are effective prevention tools and for evaluating the impact of legislative/policy change; the effect of education and training is context‐dependent and influenced by the manner of delivery; and, multifaceted interventions are often more effective than ones consisting of a single activity.
Conclusions
This scoping review identifies occupational disease prevention strategies worthy of further exploration by decisionmakers and stakeholders and of future systematic evaluation by researchers. It also identified important gaps, including a lack of studies of precarious workers and the need for more studies that rigorously evaluate the effectiveness of interventions.
... ear rings). 66 We are not aware of legislation limiting nickel exposure in medical devices. In patients with confirmed nickel hypersensitivity, there is a 2.6-fold increase risk of adverse outcomes following insertion of a nickel containing endovascular device, but the presence of skin nickel HSR does not necessarily imply development of HSR to implants containing nickel. ...
Background: Hypersensitivity reactions (HSRs) to components of cardiac implantable electronic devices (CIEDs) are rare but difficult to differentiate from device infection. Data on best management strategies of HSRs to CIEDs are lacking. The aims of this systematic review are to summarise the available literature on the aetiology, diagnosis and management of HSR in CIED patients and to provide guidance on best management strategies for these patients. Methods and Results: A systematic search for publications on HSR to CIED in PubMed from January 1970 to November 2022 was conducted, resulting in 43 publications reporting on 57 individual cases. The quality of data was low. The mean age was 57 ± 21 years, and 48% of patients were women. The mean time from implant to diagnosis was 29 ± 59 months. Multiple allergens were identified in 11 patients (19%). In 14 cases (25%) no allergen was identified. Blood tests were mostly normal (55%), but eosinophilia (23%), raised inflammatory markers (18%) and raised immunoglobulin E (5%) were also encountered. Symptoms included local reactions, systemic reactions or both in 77%, 21% and 7% of patients, respectively. Explantation of CIED and reimplantation of another CIED coated with a non-allergenic material was usually successful. Use of topical or systemic steroids was associated with high failure rates. Conclusion: Based on the limited data available, the treatment of choice for HSRs to CIEDs is full CIED removal, reassessment of CIED indication and reimplantation of devices coated in non-allergenic materials. Steroids (topical/systemic) have limited efficiency and should not be used. There is an urgent need for further research in this field.
... This exposure may induce a nickel allergy at the site of contact with the nickel-releasing item, causing allergic contact dermatitis in the form of rashes, blisters, oedemas, or dry, scaly, and cracked skin [4,5]. As nickel allergies have been well documented, the REACH Directive for registration, evaluation, authorization, and restriction of chemicals used in European Union countries specifies the requirements of nickel release in products [6]. Metal alternatives for the whitening purposes of Au alloys, such as palladium, platinum, or titanium, increase the price of the alloy (noble metals) or increase the technological difficulty of production (as is the case with titanium). ...
In this paper, we present the idea and development of a new gold-copper-zinc-germanium (AuCuZnGe) alloy, which is related to the method of production and research of its key properties, so that the new Au alloy could be used for jewelry production and in dental technology. The research design was associated with the determination of appropriate chemical composition, manufacturing technology, and performing the characterization. Melting and casting technologies were used to cast the AuCuZnGe alloy while rolling was used to prepare the cylinders and cutting to make square plates with a = 10 mm and thickness of 1 mm. Such plates were provided for corrosion testing. Observation of the plate′s microstructure was performed with Scanning Electron Micros-copy (SEM) equipped by Energy-Dispersive X-ray spectrometry (EDS) and X-ray diffraction (XRD). Corrosion testing involved performing the following measurements: Polarization, the open circuit potentials, and linear polarization resistance. Based on the SEM, EDS, XRD, and results of corrosion testing it can be concluded that the new AuCuZnGe alloy possesses high corrosion stability and can be classified as a high noble alloy.
... По результатам патч-тестирования в течении последних трех десятилетий никель занимает 1-е место среди всех контактных аллергенов [5]. Распространенность сенсибилизации к данному металлу в общей популяции составляет приблизительно от 8 до 19% случаев среди взрослых и от 8 до 10% случаев среди детей и подростков [6][7][8]. ...
The article provides basic information about nickel-associated allergic contact dermatitis (NACD). Nickel is a common metal that is commonly used in alloys for jewelry, accessories and household items. Contact with this metal often leads to the development of allergic contact dermatitis in sensitized individuals. The prevalence of NACD among the population is high: up to 19% among adults and about 10% among children and adolescents. It is noted that in female’s sensitization to nickel is observed several times more often than in males. On the risk of developing an allergic reaction to nickel, the integrity of the skin barrier, the frequency of contacts with nickel-containing household items, the presence of piercings, high humidity and hyperhidrosis are of decisive importance. Nickel ions entering the body through the alimentary route are capable of both sensitizing the body and forming tolerance to it. The pathogenesis of NACD is based on the classic delayed-type hypersensitivity reaction. The main clinical forms of this allergic dermatosis, as well as the characteristic features of the course of the disease are presented. The features of the course of NACD in patients with atopic dermatitis (AD) are analyzed in detail. The presented data clearly demonstrate that contact allergy to nickel can not only maintain, but also significantly aggravate the course of AD. The main criteria for the differential diagnosis between simple contact and allergic contact dermatitis are shown schematically. The need for early identification and termination of contact with nickel-containing household items is noted as the initial stage of NACD treatment. The main treatment for NACD is local therapy with topical glucocorticosteroids.
... Ni is the most common skin sensitizer in the human population, especially among women. This might be due to the prevalence of Ni-containing material in the modern environment, including jewelry, buttons, clips, coins, and many alloys, although several measures have recently been instituted in many countries to lower the exposure (Thyssen et al., 2011b;Ahlström et al., 2019). Ni dermatitis is an allergic contact dermatitis (Section 4.5) with itchy, papular erythema that starts at the site of contact with Ni, but upon repeated exposure may occur on other parts of the body. ...
Our understanding of the effect of metals (including ions and their compounds) on the immune system continues to evolve. Observed effects include immunosuppression, immune stimulation, hypersensitivity, and autoimmunity. Many metals show a paradoxical dose-response pattern comprising stimulation of immune function at low doses and suppression at higher doses, but global immune function is often preserved due to the redundancy and the reserve capacity of the immune system, and clinically relevant effects are uncommon. Clinically relevant hypersensitivity reactions due to metals are dominated by T cell-mediated allergic contact dermatitis, particularly in response to exposure to beryllium, cobalt, chromium, gold, mercury, and nickel. Immediate (type I) hypersensitivity reactions dominated by airways symptoms occur infrequently, and then most often with platinum, but rarely with nickel or chromium. The induction of metal-induced autoimmunity, including the formation of immune-complex deposits, is well documented in humans, but the number of recognized cases is few. Studies in rodents using mercury and gold have increased our knowledge of the mechanisms of metal-induced autoimmunity. Of special importance is the unraveling of genetic factors that regulate susceptibility to mercury-induced autoimmunity, including the uptake and retention of mercury, as well as the threshold metal concentrations for eliciting autoimmunity. Recently mercury, lead, and cadmium have been shown to accelerate and/or exacerbate autoimmunity in autoimmune-prone animal models. The importance of metal exposure for inducing and/or accelerating autoimmunity in humans remains to be determined.
... Nickel is the chemical element with the atomic number 28 and is the fifth most common element in Earth [1]. Due to its versatility, nickel is considered as a crucial component for the modern world living. ...
Nickel is one of the most common contact allergens worldwide; it is used as the main component of the devices used for atrial septal defects (ASDs) and patent foramen ovale (PFO) closure. Developing nickel hypersensitivity after PFO/ASD occlusion is significantly rarer described in medical literature than typical nickel contact sensitization. The exact pathophysiological mechanism of this “device syndrome” remains unknown, and many question the real incidence or even the existence of this clinical entity. Nevertheless, it has been associated with a wide spectrum of symptoms, including chest pain, migraines, palpitation, and dyspnea. Skin patch tests are the first-line approach to diagnose nickel hypersensitivity. However, diagnostic criteria for the device syndrome have not been developed, and diagnosis in reported cases is established by a process of elimination. Management—drug therapy (corticosteroids, clopidogrel, etc.) or even surgical explantation in severe cases—of patients developing such clinical manifestations after percutaneous PFO/ASD occlusion is empirical. Undoubtedly, endocardiac device–related nickel hypersensitivity requires more focused research to discover the underlying mechanism as well as to develop reliable prognostic tests for detecting high-risk patients and preventing severe nickel hypersensitivity reactions.
... Ainsi, le Nitinol est un alliage adapté à l'application endodontique grâce à sa superélasticité mais présente des ruptures intempestives, difficilement prédictibles. De plus sa haute teneur en nickel, un élément réputé allergène (Thyssen 2011), en fait un alliage controversé dans l'utilisation médicale. ...
L’alliage NiTi (Nitinol) est à l’heure actuelle le seul alliage utilisé pour la fabrication de dispositifs médicaux qui nécessitent un effet mémoire de forme ou une superélasticité, comme les arcs orthodontiques, stents, cathéters et agrafes d’ostéosynthèse. La superélasticité est la capacité d’un alliage à se déformer de manière réversible bien plus qu’un alliage conventionnel. Elle est due à une transformation martensitique réversible entre deux phases cristallographiques, l’austénite et la martensite. Le NiTi entre dans la fabrication des limes endodontiques, un dispositif médical utilisé en dentisterie. Les limes endodontiques sont utilisées pour la mise en forme du système canalaire et la superélasticité de l’outil est nécessaire du fait que les canaux dentaires sont parfois très coudés. Cependant l’utilisation du NiTi souffre de quelques inconvénients, notamment de la toxicité reconnue du nickel mais aussi de sa rupture à caractère fragile et de sa difficulté de mise en forme.Certains alliages de titane du type β métastable présentent également des propriétés superélastiques. L’avantage est qu’ils peuvent être élaborés uniquement à partir d’éléments biocompatibles (i.e. Nb, Hf, Mo, Zr et Sn). Ils sont donc des candidats prometteurs pour le domaine médical.L’objectif de cette thèse est ainsi de déterminer l’intérêt potentiel des alliages de titane β métastable pour la réalisation de limes endodontiques.Dans ce travail de thèse, trois classes d’alliages ont été étudiées : le NiTi utilisé dans la fabrication des limes endodontiques actuelles, un alliage de titane β métastable disponible commercialement, le Beta III, de composition Ti-11,5Mo-6Zr-4,5Sn (% mass.) et des alliages de titane β métastable originaux élaborés en laboratoire, le Ti2448 et le Ti2334 de composition respectives Ti-24Nb-4Zr-8Sn (% mass.) et Ti-23Hf-3Mo-4Sn (% at.). Dans cette étude, l’influence de la composition et des traitements thermomécaniques sur les propriétés mécaniques et la transformation martensitique, responsable du comportement superélastique, a été étudiée. La transformation martensitique sous contrainte et son caractère réversible ont été plus profondément étudiés par une analyse in situ de diffraction des rayons X sous rayonnement synchrotron. Dans tous les dispositifs médicaux, il s’agit d’éviter la rupture intempestive pendant l’utilisation, aussi une résistance élevée à la rupture en chargement cyclique est nécessaire afin d’éviter les ruptures en fatigue dans le canal dentaire. Cette constatation a mené à étudier le comportement des alliages en fatigue et l’évolution de leur réponse mécanique et superélastique au cours des cycles. Enfin, le comportement des alliages une fois taillés en prototypes a été évalué avec l’équipement et les procédures de l’entreprise.
... Apart from the nickel content, the amount of free nickel ion release after device implantation may be of critical importance, because the systemic allergic response was initiated with the release of free nickel ions in the body. 20 In an in vitro study using human endothelial cells, inflammatory markers were significantly up-regulated after incubation with nitinol wires with a higher release of free nickel ions, but not when incubated with low-nickel-release wires. 21 Although there have been no studies on nickel release after aneurysm clipping or stenting, Ries et al. 22 studied serum nickel concentrations in 67 patients with atrial septal defects before and after implantation of a nitinol foramen ovale occluder containing 55% nickel. ...
... Several field studies have recently demonstrated that nickel release in concentrations that 21 result in sensitization and dermatitis remains common in Europe and the United States 22 (Thyssen and Menne 2010;Thyssen et al. 2011b). 23 ...
Prosthetic hip and knee implantations rank among the most common elective operations in the United States and Europe. These implants are compositionally complex and have undergone drastic evolutions over the past several decades. Hypersensitivity reactions to hip and knee implant components are well documented in the literature but remain uncommon. They range from localized dermatitis to implant loosening and subsequent failure. Currently, patch testing is the most useful method to evaluate for metal allergy. Preimplantation testing is not necessary unless patients have a significant history of skin rashes after metal contact or previously have experienced device failure. Postoperative complications such as aseptic loosening, chronic pain, or new, unexplained local or regional dermatitis may occasionally benefit from evaluation for metal allergy. Clinical next steps following implantation may be challenging. If the implant is symptomatic, topical or systemic corticosteroids may be tried, but ultimately, the surgeon and patient may need to decide whether replacement with a less allergenic alternative is feasible and safe. Whether pre- or postoperative, clinical decisions should be made by the collaborative efforts of dermatologists, allergists, and surgeons. Prospective trials in this field are still necessary to develop an evidence-based approach to the treatment of patients with allergic reactions to metal, as current clinicians are guided largely by expert opinion.
... However, European Union legislation that prohibited use or supply of cement containing >2 ppm of chromate led to a significant decline in the incidence of ACD attributed to chromate in the UK (79). Similarly, nickel, which is one of the most common causes of ACD, is not allowed to be released in concentrations greater than 0.5 lg nickel/cm 2 /week when used in consumer items (80). This guidance, published in 2011, has led to a reduction in nickel allergy in Denmark, Sweden, and Germany (80); however, a study in Spain found that the prevalence of nickel allergy was as high as 40.1% in females aged between 41 and 60 years, compared with 10.5% of males in the same age range (81). ...
Contact dermatitis (CD) is caused by environmental agents, irritants and allergens, that penetrate the epidermis and lead to inflammation. An intact skin barrier prevents penetration and is important in maintaining healthy skin. Classical diagnosis of CD is made using the patch test, and traditional treatment strategies for CD promote skin barrier integrity and resolve the inflammatory component of the condition. This can be achieved by using emollient-based therapy, which is most important for skin barrier repair, and in addition to topical glucocorticosteroids, which are used in severe cases of CD and are most effective in reducing inflammation. Preventative measures, such as irritant and allergen avoidance in the workplace, also play a pivotal role in effective CD management. Moreover, CD management necessitates a holistic approach that incorporates prevention, barrier repair and inflammatory resolution to ensure optimized efficacy. It is also important to consider potential barriers to optimal management when evaluating individuals with CD, such as limited patient education or poor access to care. Finally, key literature and our own clinical practice experience have highlighted the value of patient preference, as well as safety, efficacy and simplicity, in building the perfect emollient.
... In many countries, nickel is the most common cause of ACD, and it is considered to be a skin sensitization positive control by the ECETOC (43). Some studies have shown that the non-conserved histidines 456 and 458 of human toll-like receptor (TLR) 4 are required for DC activation by nickel, and these two residues are different in murine TLR4 (44). ...
Background:
Identification of the allergenic potency of chemicals is a key step in the safety assessment process. Predictive assays that require no or few animals are needed.
Objectives:
To develop an alternative in vitro mouse bone marrow-derived dendritic cell (BMDC) assay to determine the allergenic potential of chemicals.
Methods:
BMDCs were exposed to well-known allergens and to non-allergenic chemicals. Surface marker expression and cytokine release of BMDCs were analysed after treatment.
Results:
Eleven tested chemicals showed a significant stimulation index (SI) of >1.5 (accuracy, 75%; sensitivity, 69%). The four non-allergens all showed a SI of <1.5. Eight contact allergens tested showed a significant SI of >1.5 (accuracy, 92%; sensitivity, 89%), whereas only two respiratory allergens showed a significant SI of >1.5 (accuracy, 60%; sensitivity, 33%).
Conclusions:
The results indicate that the BMDC assay could become a reliable test for assessment of the allergenic potential of chemicals. The next step should include the testing of further chemicals, with the aim of integrating this assay into the toolbox of in vitro methods for the evaluation of the allergenic potential of chemicals.
... Several field studies have recently demonstrated that nickel release in concentrations that 21 result in sensitization and dermatitis remains common in Europe and the United States 22 (Thyssen and Menne 2010;Thyssen et al. 2011b). 23 ...
... There is, however, no strong evidence for the type of implants best to use in patients that have mild local skin reactions to nickel, cobalt, or chromium [25][26][27] . Guidelines and expert consensus studies do recommend that conventional implants be used in most patients with mild local cutaneous metal hypersensitivity reactions reported by patients or determined by patch testing 10,15,28,29) . Conversely, when there is a history of severe local cutaneous metal hypersensitivity reactions or generalised systemic reactions, it has been suggested that patients should be patch tested and appropriate "hypersensitivity-friendly" implants utilised 2,10,28,30) . ...
Purpose
To provide information on the type of “hypersensitivity-friendly” components available for primary total knee arthroplasty (TKA) in the current market.
Materials and Methods
Implant manufactures were identified using the 2013 National Joint Registries of the United Kingdom and Sweden and contacted to obtain information about the products they offer for patients with metal hypersensitivity.
Results
Information on 23 TKA systems was provided by 13 implant manufacturers. Of these, 15 systems had options suitable for metal hypersensitivity patients. Two types of “hypersensitivity-friendly” components were identified: 10 implants were cobalt chrome prostheses with a “hypersensitivity-friendly” outer coating and 5 implants were made entirely from non-cobalt chrome alloys.
Conclusions
The results of this study suggest that several hypersensitivity TKA options exist, some of which provide the same designs and surgical techniques as the conventional implants. The information in this study can guide TKA surgeons in making informed choices about implants and identifying implants that could be examined in future controlled studies comparing outcomes between “hypersensitivity-friendly” and conventional implants.
Contact dermatitis (CD) is a common skin condition that can also affect children. It occurs when the skin comes into direct contact with an irritant or an allergen, leading to an inflammatory reaction. The condition is characterized by redness, itching, and sometimes swelling or blistering of the affected area.It is estimated that 80% of contact dermatitis is Irritant Contact Cermatitis (ICD) and 20% of contact dermatitis is Allergic Contact (ACD). ICD develops because of a direct insult to the stratum corneum, causing alteration in pH or cellular lipids, leading to cell activation and a visible inflammatory reaction. The most common form of ICD in early infancy is diaper dermatitis or napkin dermatitis. ACD is an inflammatory skin disease which affects adults and children worldwide. ACD is an induced IV delayed-type hypersensitivity to a specific antigen, which occurs when a person’s skin surface comes in contact with it, resulting in an allergic reaction. Diagnosis of ACD comes from the combination of clinical data and patch testing. The distribution of dermatitis is of diagnostic importance, but its polymorphic morphology doesn’t usually help with the differential diagnosis among different allergens and between various types of CD. The association between AD and ACD has been studied and still presents controversial results: particularly, the relationship of atopic eczema to the predisposition of ACD has prompted much debate. AD children with ACD for more than one allergen and statistically more girls than boys. A significant difference in contact allergy frequency was demonstrated for those with hand or foot eczema compared to those without: for this reason, AD patients should always be patch tested to evaluate whether they have a relevant contact allergy and thus ACD. Differential diagnosis needs to consider in primis AD, seborrheic dermatitis, psoriasis, infections and infestations. The greater contact with an increasing number of environmental chemicals from jewelry, cosmetics, and personal hygiene products, to sporting gear and toys, made an increment in sensitization in pediatric population, which may be still on rise. They develop the condition from the usual offenders and even from exposure to diapers, baby wipes, sunscreens, clothing with snaps, dyes, etc. Acknowledge of a prevalence increase of this disease, have supported studies worldwide, to push on the patch test technique even at young age, for a quick diagnosis and a better treatment and prevention.
Well-known for their established reputation in restorative dentistry, gold alloys offer an excellent combination of strength, biocompatibility, and aesthetic appeal. Combined with other noble and base metals like palladium, silver, platinum, copper and zinc, these dental alloys exhibit enhanced mechanical properties while maintaining their inherent corrosion resistance and superior biocompatibility. Dental practitioners and patients benefit from these high quality materials, as they provide reliable tooth preparations and provide for durable long-lasting restorations. As research and development introduces cheaper contemporary materials, they are being compared to gold dental alloys, which have been highly suited for clinical use for decades. Gold dental alloys are preserving their high standard status in the dental community, especially for long-span bridges and for patients with bruxism. Their development has diminished in recent times due to their high prices, while conventional and redesigned gold dental alloys described in the chapter still represent a leading choice for patients susceptible to allergies, and for patients requiring or requesting the best for a lasting dental restoration with high aesthetics.
Allergic contact dermatitis is the classic delayed hypersensitivity reaction, developing in two phases – sensitization and elicitation. It can have profound effects on affected individuals and may result in sickness, absence from work and increased health expense. Its diagnosis requires consideration of many factors including the patient's history and a physical examination; knowledge of the skin's reaction to various chemicals is also desirable. Above all, it requires a high degree of suspicion on the part of the clinician and tenacity, skill and experience in the investigator. The diagnosis can only be confirmed by interpreting patch test results and the technique in itself has many pitfalls for the unwary. Any sensitization identified needs to be put into the context of a past or present dermatitis, and explanations for allergen avoidance or substitution need to be provided for the patient.
Objective:
Barrier creams (BCs) are marketed as locally-applied medical devices or cosmetic products to protect the skin from exposure to chemicals and irritants. Generally, the mechanism of action of such products is mainly due to the formation of a superficial thin film between the skin and the irritant or sensitizer, thus reducing or totally blocking the cutaneous penetration of such agents. Specifically, studies focusing on the effectiveness of commercial protective creams to prevent nickel cutaneous penetration are extremely scarce. The aim of the current work, therefore, is to evaluate the protective role of a commercially available barrier cream for nickel and compare the results with a simple moisturizing, following exposure to Ni powder.
Methods:
Marketed BCs were evaluated and tested. Human skin absorption of Ni was studied in vitro using static Franz diffusion cells.
Results:
Our results demonstrate that the application of both formulations caused a reduction of Ni inside the skin (8.00 ± 3.35 μg·cm-2 for the barrier cream and 22.6 ± 12.6 μg·cm-2 for the general moisturizing product), with the specialized barrier cream being statistically (p = 0.015) more efficient on forming a protective barrier, thus evidencing the importance of some ingredients of such formulations on the nickel dermal accumulation.
Conclusions:
The composition of the formulations based on film forming or chelating agents may play an imperative role to reduce the cutaneous penetration of Ni.
Allergic contact dermatitis (ACD) is not uncommon in children. Prevalence of ACD was previously thought to be low in children and
adolescents, but of late increased prevalence has been reported. Actual increase in the prevalence could be due to increased recognition of
the disease or due to other factors such as changes in lifestyle. Various factors such as age, gender, atopy, social and cultural practices, habits
of parents and caregivers, and geographical changes may influence the prevalence and pattern of ACD in children. It can significantly affect
the quality of life among children.
ACD can affect various sites, including hands, face, neck, axillae, trunk, anogenital region, thigh, feet, and others, depending on the site of
exposure to allergen. Common allergens implicated in childhood ACD include nickel, cobalt, potassium dichromate, mercury, aluminium,
skin care products, fragrances, neomycin, dyes, preservatives, rubber, and so on. Identification of the implicated allergen is vital as the patient
may experience recurrent episodes of dermatitis in the absence of avoidance of allergen. Patch testing is by far the commonly used method
of identification of the causative allergen. The only etiologic treatment is elimination of the contact allergen. The patients/parents should be
informed about the identity of the offending agent and the possible sources of the sensitizer.
Topical steroids used in the acute stage and topical calcineurin inhibitors along with oral H1-antihistamines to alleviate itching are the mainstay
of treatment. In widespread and severe cases, systemic corticosteroids may be indicated for a short period of time. The prognosis of ACD is
dependent on its cause and the feasibility of avoiding repeated or continued exposure to the causative allergen.
Coin materials and time of circulation affect their loss of the original appearance, color, and clear pits of their surfaces. This behavior mainly caused by human sweat that gradually destroys the coins surface. The corrosion behavior of the coins were investigated by many researchers. The wear test might also taking place on the coins before and after immersed in ASS. These coins were investigated in artificial sweat solution (ASS) by chemical and electrochemical techniques. The chemical technique used weight loss (WL) to the minted and sometimes the blanked coins. The electrochemical techniques that used are potentiodynamic polarization (PP) and electrochemical impedance spectroscopy (EIS) techniques to test the coins for different periods of time. The ASS analysis were taken periodically by atomic absorption spectroscopy to support the results of the corrosion methods. Also, it help to have a conceptual understanding of the corrosion process during their immersion in the artificial sweat solution. The ions that released from coins in artificial sweat solution were analyzed. The surface morphology was investigated for the coins before and after immersion in ASS by SEM and EDX. Moreover, the corrosion products on their surfaces after immersion in ASS were analyzed by XRD.
Allergic contact dermatitis (ACD) remains a globally prevalent disease for both children and adults. The silent ACD epidemic continues to be fueled by the introduction of novel allergens in industrial and household products and the continued presence of known allergens. In 1997, Allan Dillarstone noted a sinusoidal pattern to epidemics when allergenic preservatives were replaced by alternative chemicals within the market, which then similarly increased in allergenicity. A call for public health vigilance and prevention initiatives is needed to intervene in the ACD epidemic.
Background
Exposure to nickel releasing earpiercing jewelrymay explainthepersistently highprevalence of nickel allergy in Europe.While nickel release from earrings is regulated,fieldstudies show that the regulation is not always respected.Moreknowledge is neededregarding the risk of piercing exposure including suitable screening methods.
Objective
To examine the proportion of earringson the Danish market that release more nickel than allowed, and to validate the use of the dimethylglyoxime(DMG) testas a screening tool.
Methods
304 earrings were purchased and tested with the DMG test and X‐ray fluorescent (XRF) spectrometry.The level of nickel release was quantified in a selected subsample of 100 earrings by the European reference test EN 1811.The DMG spot test was validated against EN1811 at different thresholds.
Results
Excessive nickel release according to the European regulation was found in45(14.8%) of tested earrings. The sensitivity of the DMG test decreased with reduced levels of nickel release (sensitivity of 45.2% at ≥0.2 μg/cm²/week vs. 61.1%at >0.5 μg/cm²/week).
Conclusion
Excessive nickel release is commonin earrings on the Danish market. Due to low sensitivity, the DMG test has limited use in screening ofearrings for research butmay be still beusedclinically.
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Twenty substances among the most common allergens are reported. For each one of them, the general characteristics, sources of exposure, clinical presentation, and specific prevention rules are detailed. Special recommandations concerning the percentages of use and other useful data for patch tests are in addition discussed.
Background
The common contact allergens may change over time as the environmental exposure changes.
Objectives
To identify the prevalences and changing trends of contact allergens in Taiwan over a 40‐year period.
Materials & Methods
The patch testing results of a referral center from 1978 to 2018 were retrospectively reviewed. The study population was divided into four groups according to 10‐year intervals. The prevalences of contact sensitization to each agent and the clinical relevance were analyzed. For patients with positive reactions to relevant allergens, the occupations and sites of dermatitis were analyzed.
Results
From 1978 to 2018, a total of 4005 patients underwent patch testing. Successively increasing trends of positive reactions to cobalt, fragrance mix I, and paraphenylenediamine (PPD) were found. Methylchloroisothiazolinone/methylisothiazolinone (MCI/MI) was an emerging contact allergen. Hairdressers, cosmetologists, and aromatherapists became the occupations most commonly having positive reactions in the most recent 10 years. In the first two decades, the face and neck were the most commonly affected areas. Later, hands became the most commonly affected sites.
Conclusions
The prevalences of positive reactions to cobalt, fragrance mix I, and PPD increased successively MCI/MI was an emerging contact allergen of special concern.
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Patch testing is the gold standard for diagnosing allergic contact dermatitis. Causative allergens differ between children and adults, necessitating the development of pediatric-specific patch test series. The Pediatric Baseline Series was developed in 2018 through expert-consensus and includes relevant pediatric allergens of which dermatologists can use in practice. Obstacles in patch testing, such as the need for multiple office visits, length of patch application, and avoidance of sweat and water on the testing area, are particularly challenging for the pediatric population for which several strategies are proposed. Aside from formal patch testing, alternatives like the repeat open application test and empiric allergen avoidance can be helpful in children. The key to management of allergic contact dermatitis is allergen avoidance, emphasizing the need to properly identify causative allergens. Continued data collection through registries allows for a better understanding of the diagnosis and management of pediatric allergic contact dermatitis.
Background
Hairdressers are at high risk of contact dermatitis (CD) due to skin exposure to numerous irritants and haptens in hair products in combination with frequent wet work.
Objectives
To investigate the characteristics and incidence of CD among hairdressers in north‐eastern Italy.
Methods
324 hairdressers who had been examined and patch tested in north‐eastern Italy from 1996 to 2016 were retrospectively identified, and compared with 9669 matched controls. Sensitization to allergens of the hairdressing series was analysed among hairdressers attending occupational medicine clinic in Trieste, Italy. Incidence data were calculated from 1999 to 2016.
Results
Sensitization to p ‐phenylenediamine, thiuram mix, and N‐isopropyl‐N‐phenyl‐p ‐phenylenediamine was significantly associated with hairdressing and with hand/forearms dermatitis. Frequent sensitizers from hairdressing series were ammonium persulfate, toluene‐2,5‐diamine, and p ‐aminobenzene. The overall incidence of CD declined from 2003 (31.7 cases/10000 workers) to 2016 (20.8 cases/10000 workers).
Conclusions
Sensitization to several haptens were significantly associated with hairdressing. The incidence of CD among hairdressers in north‐eastern Italy has declined in recent years, but is still high. Preventive efforts are needed to reduce the burden of CD in this professional.group.
Background
Metalworkers are exposed to many sensitizing and irritant substances. There are no published data on contact allergy in this population in the Baltic countries.
Objective
To detect skin symptoms related to occupational exposure and to describe the reactivity pattern to the European baseline series in workers from two metal plants in Lithuania.
Methods
In this cross‐sectional study 185 metalworkers (154 production workers and 31 office staff) filled an interviewer‐administered questionnaire. Patch testing was performed in 135 metalworkers and office staff, as a control group.
Results
Metalworkers younger than 40 years statistically significantly more often complained of skin symptoms especially on hands and face than older ones. Physician‐diagnosed skin diseases were reported in 1.7% of cases. Metalworkers, working <20 years in the factory, more often had skin symptoms. Contact with chemicals at the workplace was suspected as main factors provoking skin symptoms. Metalworkers were sensitized mainly to cobalt chloride, and nickel was the most prevalent allergen among the office staff.
Conclusion
Younger metalworkers more often had skin symptoms suspected of being work‐related compared to older ones. Sensitization to cobalt was more prevalent in the metalworkers than in controls.
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Introduction
Allergic contact dermatitis is an inflammatory skin disease which accounts for up to 20% of all childhood dermatitis. Childhood allergic contact dermatitis is more frequent than previously thought and today early diagnosis is considered very important. Patch testing represents the gold standard method used to confirm the diagnosis of allergic contact dermatitis. The knowledge of the most common allergens involved in allergic contact dermatitis in pediatric age is important considering that the first line management of allergic contact dermatitis in children is to avoid the involved allergens.
Areas covered
We reviewed the literature on PubMed® and SciVerse Scopus® medical database about allergic contact dermatitis and emerging contact allergens in children.
In this review, we summarize the clinical characteristics, differential diagnoses and epidemiology of allergic contact dermatitis in children, underlying the most recent evidences about the most frequent and emerging contact allergens.
Expert opinion
We believe that persistent, well localized and recurrent eczematous lesions in children should suggest an allergic contact dermatitis, inducing physicians to refer patients for patch testing. Physicians should be acquainted with the current trends and the emerging contact allergens in children, in order to provide not only the best treatment, but also the best management and prevention.
Nickel is a ubiquitous metal added to jewelry and metallic substances for its hardening properties and because it is inexpensive. Estimates suggest that at least 1.1 million children in the United States are sensitized to nickel. Nickel allergic contact dermatitis (Ni-ACD) is the most common cutaneous delayed-type hypersensitivity reaction worldwide. The incidence among children tested has almost quadrupled over the past 3 decades. The associated morbidities include itch, discomfort, school absence, and reduced quality of life. In adulthood, individuals with Ni-ACD may have severe disabling hand eczema. The increasing rate of Ni-ACD in children has been postulated to result from early and frequent exposure to metals with high amounts of nickel release (eg, as occurs with ear piercing or with products used daily in childhood such as toys, belt buckles, and electronics).
To reduce exposure to metal sources with high nickel release by prolonged and direct contact with human skin, Denmark and the European Union legislated a directive several decades ago with the goal of reducing high nickel release and the incidence of Ni-ACD. Since then, there has been a global reduction in incidence of Ni-ACD in population-based studies of adults and studies of children and young adults being tested for allergic contact dermatitis. These data point to nickel exposure as a trigger for elicitation of Ni-ACD and, further, provide evidence that legislation can have a favorable effect on the economic and medical health of a population.
This policy statement reviews the epidemiology, history, and appearances of Ni-ACD. Examples of sources of high nickel release are discussed to highlight how difficult it is to avoid this metal in modern daily lives. Treatments are outlined, and avoidance strategies are presented. Long-term epidemiological interventions are addressed. Advocacy for smarter nickel use is reviewed. The American Academy of Pediatrics supports US legislation that advances safety standards (as modeled by the European Union) that protect children from early and prolonged skin exposure to high–nickel-releasing items. Our final aim for this article is to aid the pediatric community in developing nickel-avoidance strategies on both individual and global levels.
In this chapter we aim to cover advances in total knee arthroplasty engineering. We discuss strategies such as techniques to reduce periprosthetic infection, novel implant designs to improve implant longevity include fixation modalities and bearing surfaces that are being developed. We also discuss the issue of metal hypersensitivity and the role it plays in implant outcome. We also highlight to the reader techniques and implants that are available for use in patients with implant hypersensitivity.
In the last decade, allergic contact dermatitis (ACD) has become an increasingly recognized diagnosis in children presenting with eczematous skin. Although the immunological pathway of a delayed hypersensitivity reaction is specifically distinct, it can be phenotypically difficult to distinguish from the clinical presentations of chronic irritant contact dermatitis (ICD) and atopic dermatitis (AD), even more so when they are concurrent. Furthermore, the barrier disruption inherent to AD appears to increase the risk for developing ACD. The gold standard diagnostic tool for ACD is the epicutaneous patch test. Confirmation of clinically relevant contact allergens is critical in order to direct avoidance and appropriately manage the disease. This chapter discusses the epidemiology, pathophysiology and clinical features of ACD in the context of the available evidence in the literature.
Highlights
• After the introduction of the EU regulatory interventions, nickel sensitization decreased significantly in the group of females aged ≤25 years.
• Women born between 1966 and 1975 presented the higheest prevalence of sensitization to nickel, then prevalence of sensitization gradually decreased with a minimum in more recent years.
• Nickel sensitization is higher in Italian patients compared to people living in other EU coutries.
• Additional interventions are needed to address nickel sensitization.
Les allergies représentent un problème majeur dans le domaine des maladies professionnelles et ont un impact sérieux sur la vie des travailleurs. Les allergies professionnelles sont principalement cutanées et respiratoires ; elles peuvent être causées par des produits chimiques de bas poids moléculaire. Dans le passé, les tests destinés à identifier les produits susceptibles d’entraîner des allergies étaient réalisés sur l’animal. Or, la législation européenne engage à limiter le recours à l’expérimentation animale pour évaluer le pouvoir sensibilisant des substances chimiques, incitant à développer des tests in vitro de substitution. C’est dans ce contexte que nous avons cherché à développer des modèles de cultures cellulaires destinés à identifier les substances sensibilisantes. Un premier modèle utilisant des cellules dendritiques dérivées de moelle osseuse (BMDC) de souris BALB/c a été développé et a donné des résultats prometteurs pour l’identification des produits sensibilisants et leur catégorisation selon leur puissance sensibilisante. De plus, la voie de signalisation Nrf2/Keap1 semble être impliquée dans la réponse de ce modèle cellulaire aux sensibilisants. Dans le but de compléter ce modèle et d’évaluer la capacité des BMDC à activer les lymphocytes T (LT), un modèle de coculture de BMDC et LT a été mis au point avec un sensibilisant de référence avant d’être testé sur un ensemble de produits de référence (sensibilisants cutanés et respiratoires, irritants et non sensibilisants). Les BMDC de notre modèle, exposées à des sensibilisants, se sont révélées capables d’activer les LT en coculture. Enfin, des essais préliminaires utilisant des cellules de souris de souche C57BL6/J dans notre modèle de coculture ont donné des résultats comparables à ceux obtenus avec des cellules issues de la souche BALB/c. Les modèles de cultures cellulaires BMDC et de coculture BMDC-LT sont prometteurs dans le cadre du développement de méthodes de substitution à l’expérimentation animale pour l’évaluation du pouvoir sensibilisant de substances chimiques
Background:
The epidemiology of nickel allergy in occupational settings is not well understood.
Objective:
The aim of the study was to characterize occupationally related nickel allergy (ORNA).
Methods:
This is a retrospective cross-sectional analysis of 44,378 patients patch tested by the North American Contact Dermatitis Group from 1998 to 2016. Characteristics of individuals with ORNA were compared with those with non-ORNA (NORNA).
Results:
A total of 7928 (18.2%) individuals were positive to nickel sulfate 2.5%. Two hundred sixty-eight (3.4%) had ORNA. As compared with NORNA, ORNA was statistically associated with the male sex (41.0% vs 12.9%, P < 0.001), a diagnosis of irritant contact dermatitis (22.4% vs 12.0%, P < 0.001), and no history of eczema (81.7% vs 75.7%, P = 0.0217). The most common sites of ORNA dermatitis were hand (39.9%) and arm (18.1%), which were significantly more common than in NORNA (P < 0.0001). Sixteen industry categories and 22 occupation categories were identified for ORNA; the most common industries were durable goods manufacturing (24.6%) and personal services (15.7%), and the most frequent occupations were hairdressers/cosmetologists/barbers (14.3%), machine operators (9.3%), and health care workers (7.1%). Overall 30% of ORNA occupations were in metalworking. Of 215 ORNA sources identified, instruments/phones/other equipment (16.3%), vehicles/machinery (15.8%), and tools (15.3%) were the most common.
Conclusions:
Occupational nickel allergy is distinct from nonoccupational nickel allergy.
Background:
Allergic contact dermatitis to metals is a significant clinical and public health problem. Little is known about the determinants of polysensitization to metals.
Objective:
The aim of the study was to determine the frequency and predictors of nickel co-reactions and metal polysensitization.
Methods:
This is a retrospective chart review of 686 adults (age ≥ 18 years) who were patch tested from 2014 to 2017.
Results:
Overall, 267 patients (38.9%) had 1 or more positive patch-test reactions to a metal allergen, most commonly nickel (17.4%), mercury (12.3%), and palladium (9.2%). Nickel reactions were inversely associated with age (logistic regression; adjusted odds ratio [95% confidence interval], 0.39 [0.29-0.78]). Among patients with positive reactions to nickel, 34.5%, 15.1%, and 5.0% had positive reactions to 1, 2, or 3 additional metals, respectively. The most common nickel co-reactors were palladium, mercury, and gold. Polysensitization to metals occurred in 11.8% of patients. Polysensitization to metal allergens was associated with female sex (6.67 [1.01-44.21]) and inversely associated with age (0.40 [0.18-0.88]).
Conclusions:
Nickel-sensitized patients have high rates of metal co-reactions. Polysensitization to metals is common in adults. These results may help guide future strategies for allergen avoidance.
Background
Knowledge about the skin deposition and penetration of nickel into the stratum corneum (SC) after short contact with metallic items is limited.
Objective
To quantify nickel skin deposition and penetration into the SC after short contact with metallic nickel.
Methods
Sixteen nickel‐allergic participants and 10 controls were exposed to 3 pure nickel discs and 1 aluminium disc on each volar forearm for 3 × 10 minutes. Before exposure, 1 forearm was irritated with 0.5% sodium lauryl sulfate under 24‐hour occlusion. Immediately, as well as 24 and 72 hours after metallic disc exposure, outer SC layers were removed with adhesive tapes and the nickel content was measured.
Results
Nickel deposition and SC penetration capable of eliciting allergic nickel dermatitis were found immediately and after 24 hours. Significantly higher nickel amounts were found on normal skin and in the SC of nickel‐allergic participants than in controls both immediately and after 24 hours, and on irritated skin immediately after exposure.
Conclusions
Nickel deposition and SC penetration is considerable after nickel skin exposure of 3 × 10 minutes. Combined with the allergic responses resulting from the same exposures reported previously, this study highlights that short skin exposure to nickel‐releasing items may cause allergic nickel dermatitis.
Allergic contact dermatitis (ACD) is a common disease in daily clinical practice, and its prevalence has increased in recent years. It is characterized clinically by varying degrees of erythema, vesiculation, flaking, and lichenification, though these signs can also be present in other eczematous diseases. Patch testing is the main diagnostic tool to confirm ACD, but its accurate interpretation requires correct correlation with the medical history (details of exposure) and physical examination. We provide a practical and instructive description of the most common clinical patters of ACD depending on the area affected. Knowledge of these patterns will not only help the clinician reach the diagnosis but will suggest possible allergens and forms of contact.
Hand eczema can be caused or aggravated by metals, especially in occupational settings. In particular, metal-induced allergic contact dermatitis of the hands should be considered in individuals with metal allergy. The most important metal allergens are nickel, cobalt and chromium. The level and type of exposure to these metals have substantially changed over time and differ between countries. Thus, if a metal is suspected as a possible cause of hand eczema in sensitised individuals, a thorough investigation is required to assess the specific metal exposure and its relevance.
The use of work tools and their production has been of central importance to the development of humankind. In the modern manufacture of tools, nickel, chromium, and cobalt are often used because of their hardening properties and ability to inhibit corrosion, thereby improving quality. This chapter provides an overview of the current knowledge on metals in tools and the workplace, with regard to metal allergy.
Background:
Nickel and cobalt are important metal allergens, and more knowledge on the levels of exposure to these from everyday contacts is needed.
Objectives:
To report the results of a repeat routine surveillance scheme in the Federal Republic of Germany on the release of nickel and cobalt.
Methods:
Fifteen laboratories assessed earrings and piercing jewellery items from 12 of the states in 2014, complying with EN 1811:2011 + AC:2012 and using atomic absorption spectrometry, inductively coupled plasma mass spectrometry and inductively coupled plasma optical emission spectrometry for quantification. Kaplan-Meier analysis for left-censored data was employed to account for measurements below the limit of quantification.
Results:
Nickel release exceeded 0.35 µg/cm2 per week in 26 of 160 piercing posts (16.2%), and 0.88 µg/cm2 per week in 2.0-5.9% of other parts, that is, the current respective 'pass' thresholds, with no change from the previous 2008 survey. The level of cobalt release was lower than that of nickel release, and also significantly lower than in the previous survey.
Conclusions:
The finding of the highest level of nickel release from piercing posts, with their deliberately lower threshold of acceptability, is worrying, as is the largely unchanged overall level of nickel release. A regulation on cobalt release is currently lacking; risk assessment and management based on dose-elicitation data are needed.
High nitrogen nickel free stainless steel (HNNFSS) has begun to be used in clinic, which
possesses excellent mechanical properties, corrosion resistance and biocompatibility. Especially its
strength is two times more than that of the conventional 316L stainless steel, but this advantage is not fully
used in optimization of both the structure and the size of the implant devices. In this work, the effect of
thickness change of HNNFSS bone plate on the biomechanical behavior of bone plate was studied by
means of finite element analysis. The result showed that the resistances to bending, tension and compression
of HNNFSS plate are all better than those of 316L plate when its thickness is thinned less than
18%. The internal fixation of the lightweight HNNFSS plate was also studied by a 12 weeks rabbit femur
fracture model and the result showed that the HNNFSS plate with about 14% thickness thinning could
promote the healing and reconstruction of bone fracture of rabbit femur in comparison with 316L plate.
Background:
In spite of extensive regulation to limit exposure, nickel remains the main cause of contact allergy in the general population. More detailed knowledge on the skin uptake of haptens is required. So far, no method exists for the visualization of clinically relevant haptens and their distribution in the skin.
Objectives:
To show, in terms of a proof of concept, that imaging mass spectrometry [time of flight secondary ion mass spectrometry (ToF-SIMS)] can be applied for investigation of the penetration and distribution of nickel in human skin.
Method:
Full-thickness human skin obtained from breast reduction surgery was exposed to nickel sulfate (5% in deionized water) for 24 h in Franz-type diffusion cells. Biopsies were obtained from nickel-treated samples and control (deionized water). The tissue was sliced, and analysed with ToF-SIMS, generating high-resolution images of ion distribution in the epidermis and upper dermis.
Results:
The skin layers could be discerned from the ToF-SIMS data, particularly on the basis of the collagen signal. Nickel ions were localized to the stratum corneum and upper epidermis.
Conclusions:
This is the first time that ToF-SIMS has been applied to trace the distribution of a hapten in human skin. Proof of principle was shown for nickel, and the technique can, in the future, be expanded for investigation of the skin distribution of clinically relevant sensitizers in general.
Allergic contact dermatitis (ACD) is a common disease in daily clinical practice, and its prevalence has increased in recent years. It is characterized clinically by varying degrees of erythema, vesiculation, flaking, and lichenification, though these signs can also be present in other eczematous diseases. Patch testing is the main diagnostic tool to confirm ACD, but its accurate interpretation requires correct correlation with the medical history (details of exposure) and physical examination. We provide a practical and instructive description of the most common clinical patters of ACD depending on the area affected. Knowledge of these patterns will not only help the clinician reach the diagnosis but will suggest possible allergens and forms of contact.
Copyright © 2017 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.
Metal release from materials immersed in artificial sweat can function as a measure of potential skin exposure. Several artificial sweat models exist that, to various degree, mimic realistic conditions. Study objective was to evaluate metal release from previously examined and well characterized materials in two different artificial sweat solutions; a comprehensive sweat model intended for use within research, based on the composition of human sweat; and the artificial sweat, EN1811, intended for testing compliance with the nickel restriction in REACH. The aim was to better understand whether there are advantages using either of the sweat solutions in bio-elution testing of materials. Metal release in two different artificial sweat solutions was compared for discs of a white gold alloy and two hard metals, and a rock drilling insert of tungsten carbide at 1 h, 24 h, 1 week and 1 month. The released amount of metal was analysed by means of inductively coupled plasma mass spectrometry. Similar levels of released metals were measured from test materials in the two different artificial sweat solutions. For purposes in relation to legislations, it was concluded that a metal release test using a simple artificial sweat composition may provide results that sufficiently indicate the degree of metal release at skin contact.
Nickel is a unique, mysterious and troublesome chemical element. Its molecular structure (unfilled electron shell) determines the high-reactivity and multidirectional biological effects. Some authors classify nickel as trace element, although its biological role in animal and human metabolism remains unclear. Conversely, nickel possesses strong sensitizing potential: as many as 65 million Europeans may be allergic to nickel. In this article, we review chemical and biological properties of nickel, pathomechanism, clinical symptoms and diagnosis of contact allergy to nickel, epidemiology and risk factors. Finally, public health measures and legal regulations of the EU aimed at protecting the population from nickel allergy are discussed, with particular attention devoted to the 'Nickel Directive' 94/27/EC.
There is evidence that stimulants such as alcohol and tobacco have an effect on the immune system, but little is known about how these lifestyle factors affect the prevalence of contact sensitization. This study investigated whether smoking and alcohol consumption were associated with contact sensitization and nickel sensitization. A random sample of adults (n=3460) from the general population of Copenhagen was invited to participate in a general health examination including patch-testing. Alcohol consumption was not associated with nickel sensitization, whereas a significant trend (p<0.05) was identified between smoking status and nickel sensitization in an adjusted model; i.e. nickel sensitization was higher among both previous smokers (odds ratio (OR) = 1.19; confidence interval (CI) = 0.81-1.76), current light smokers (OR=1.50; CI=0.94-2.37) and current heavy smokers (OR=1.56; CI = 0.87-2.80) compared with never smokers. This study confirmed that smoking is associated with nickel sensitization, but rejected an association with alcohol consumption.
The use of nickel in certain consumer goods has been regulated in Denmark since 1990. The aim of this study was to reveal the clinical characteristics of nickel-allergic patients seen in seven private dermatology clinics and to identify current sources of nickel that may elicit nickel dermatitis. During 2006 to 2007, 634 patients with dermatitis aged 17-91 years were patch-tested and completed a questionnaire including a question about the occurrence of dermatitis following skin contact with ear-rings or ear-pins, watches, buttons or metal clasps (i.e. metal dermatitis). chi2 tests were applied to test for statistical significant differences. Analysis revealed a lower prevalence of nickel allergy among women in the youngest age group (17-22 years) in comparison with older age groups (23-34 years and 35-46 years) (p < 0.03). Most patients experienced metal dermatitis on the first occurrence be-tween 1975 and 1985. No new cases of metal dermatitis were identified after 1985. We conclude that nickel allergy has decreased among young females with dermatitis due to the nickel regulation.
In a two-year prospective study of cutaneous problems in orthopedic implant recipients, cutaneous eruptions of unknown cause that bore good temporal relationships with implant surgery occurred in 19 patients. Two clinical patterns were observed. A transient "exanthematic" dermatitis was seen in six patients; in two of them, it recurred after each surgical implant procedure. A persistent reaction was seen in 13 patients. Metal sensitivity was found in two patients and considered to be relevant. Allergic cutaneous complications of orthopedic implants are rare. However, in an implant recipient in whom a cutaneous problem develops, the likelihood of the cutaneous problem being allergic in nature is slightly greater if the implant is of the static type, if there is a history of metal sensitivity, if the cutaneous eruption shows a predilection for the anatomic zone of the implant, and if the eruption is eczematous and has developed late and persisted.
Background Nickel allergy is frequent and cause morbidity and increased health care costs.
Objective The aim of this study was to determine the proportion of inexpensive earrings randomly purchased from stores and street markets in two capitals that gave positive dimethylglyoxime (DMG) test reactions and to determine whether the degree of nickel release was related to shop category.
Methods Random inexpensive metallic earrings were purchased from stores and vendors in London and Warsaw. A qualitative investigation of nickel release by using the DMG test was performed.
Results DMG testing revealed that respectively 15.1% (n = 205) and 18.4% (n = 206) of earrings purchased in London and Warsaw released nickel as indicated by positive test outcomes. Stratification by store category showed that DMG test-positive jewellery were mainly purchased from street markets and from stores that were not part of national or international chains.
Conclusions Despite the EU Nickel Directive having resulted in decreasing prevalence of nickel allergy, a large proportion of inexpensive earrings still release nickel in concentrations that may result in nickel allergy and dermatitis. Authorities should prioritize information campaigns and random inspections as a legislation that is not followed is of limited value.
Background
In the early 1990s, the prevalence of nickel contact allergy was high—almost 20% on a population level, and some 40% in contact dermatitis patients. Around that time, nickel exposure was starting to be regulated.
Patients/Methods
Descriptive and bivariate analyses of patch test results of all patients tested with nickel sulfate (5% pet.) in the departments joining the Network of Departments of Dermatology (IVDK) 1992–2001 (n=82,991, women: 52,709; men: 30,282).The annual frequency of sensitization to nickel was analyzed in women and men in four age subgroups o (<31/31 to <44/44 to 58/>58).
Results
In young women less than 31 (n=13.909) the prevalence of contact allergy to nickel decreased significantly from 36.7% in 1992 to 25.8% in 2001. In young men in the same age group (n=7087), the prevalence dropped from 8.9% in 1992 to 5.2% in 2001.
Conclusions
The observed decline indicates that measures to limit the release of nickel from costume jewelry helped reduce the prevalence of nickel allergy. In general term, allergen elimination or reduction is an effective primary prevention strategy which does not depend on individual behavior modifications.
Nickel contact allergy is still frequent both in patch-tested patients and in the general population. Objectives. To explain this observation by relating clinical epidemiological data with recent chemical analyses of nickel release from costume jewellery.
(i) The trend of nickel allergy was analysed using data registered between January 1994 and December 2009 in the Information Network of Departments of Dermatology. (ii) In 2008, different parts of items of costume jewellery purchased at random on the German market (n = 609) were analysed for nickel release according to EN 1811:1998 + A1:2008 in five official German laboratories of food and non-food INVESTIGATION.
(i) Between 1994 and 2009, nickel allergy decreased in men (18-30 years) and in women (1-17 and 18-30 years); however, after 2000, there was no significant decrease in nickel allergy in the women aged 1-17 years. (ii) Of the post-assemblies, 28.0% exceeded the migration limit of ≥0.2 µg/cm(2) per week, and 5% released ≥26.8 µg/cm(2) per week. In articles with direct and prolonged contact with the skin, 12.8% of decorative parts and 17.1% of clasps exceeded the migration limit. If an adjustment factor was applied, according to the above norm, about half of the items otherwise rejected became acceptable.
Exposure to nickel-containing products exceeding the (unnecessarily relaxed) permitted limit may explain why nickel contact allergy remains a problem.
To cite this article: Czarnobilska E, Obtulowicz K, Dyga W, Spiewak R. The most important contact sensitizers in Polish children and adolescents with atopy and chronic recurrent eczema as detected with the extended European Baseline Series. Pediatr Allergy Immunol 2011; 22 :252–256.
Abstract
The differential diagnostic work‐up of children with chronic eczema should involve patch testing, also in cases with confirmed atopy. In our previous study, contact allergy was detected in every second child with chronic eczema. The aim of the present study was to identify the most important sensitizers in atopic children with eczema. During an allergy screening program, 103 consecutive children aged 7–8 and 93 adolescents aged 16–17 were enrolled. The inclusion criterion was chronic recurrent eczema as detected with the International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire and atopy, defined as positive skin prick test to one or more common airborne or food allergens. The children were patch‐tested with the newly extended European Baseline Series (EBS, 28 test substances) supplemented with propolis, thimerosal, benzalkonium chloride, and 2‐phenoxyethanol. In total, 67.0% children and 58.1% adolescents were found patch test positive. Among children, 35.9% reacted to nickel, 16.5% propolis, 11.7% thimerosal, 9.7% cobalt, each 6.8% fragrance mix (FM) I and chromium, and 5.8% to FM II. Among adolescents, 37.6% reacted to thimerosal, 19.4% to nickel, 6.5% to cobalt, and 5.4% to propolis. We demonstrate the advantage of using FM II – a new addition to the EBS that detects a relatively high proportion of contact hypersensitivity among children. An important sensitizer from outside EBS is propolis, which according to the frequency of sensitization occupies rank 2 in children and rank 4 in adolescents. These data show that propolis should be included into routine patch testing in children.
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.
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.
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.
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.
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.
Nickel allergy is prevalent as assessed by epidemiological studies.
In an attempt to further identify and characterize sources that may result in nickel allergy and dermatitis, we analysed items identified by nickel-allergic dermatitis patients as causative of nickel dermatitis by using the dimethylglyoxime (DMG) test.
Dermatitis patients with nickel allergy of current relevance were identified over a 2-year period in a tertiary referral patch test centre. When possible, their work tools and personal items were examined with the DMG test.
Among 95 nickel-allergic dermatitis patients, 70 (73.7%) had metallic items investigated for nickel release. A total of 151 items were investigated, and 66 (43.7%) gave positive DMG test reactions. Objects were nearly all purchased or acquired after the introduction of the EU Nickel Directive. Only one object had been inherited, and only two objects had been purchased outside of Denmark.
DMG testing is valuable as a screening test for nickel release and should be used to identify relevant exposures in nickel-allergic patients. Mainly consumer items, but also work tools used in an occupational setting, released nickel in dermatitis patients. This study confirmed 'risk items' from previous studies, including mobile phones.
Contact allergy epidemics to chromate and nickel were addressed in Denmark in 1983 and 1990 by regulatory interventions.
To evaluate whether regulatory interventions on nickel and chromate exposure have reduced the proportion of strong patch test reactions.
22 506 patients with dermatitis aged 4-99 years were patch tested with nickel sulfate, potassium dichromate, or cobalt chloride between 1977 and 2009.
The proportion of 3+ reactions to nickel sulfate was reduced and almost disappeared after the mid- and late 1980s (P-trend = 0.001). Today, 1+ and 2+ nickel reactions occur equally frequent. Cobalt chloride patch test reactivity reflected the nickel development to some degree. The proportion of 3+ reactions to potassium dichromate was reduced during the 1980s (P-trend = 0.13), whereas the proportion of 2+ reactions to potassium dichromate have increased in recent years.
The decrease in nickel sulfate and cobalt chloride 3+ patch test reactivity began long before the Danish nickel regulation came into effect. This could be because of research activity at the time as well as political attention in Northern Europe. The chromate content in cement regulation may have changed the epidemiology of patch test reactivity; however, in recent years, 2+ reactions to chromate have increased markedly, a development that should be carefully followed.
Before the introduction of the EU Nickel Directive, concern was raised that manufacturers of jewellery might turn from the use of nickel to cobalt following the regulatory intervention on nickel exposure.
The aim was to study 354 consumer items using the cobalt spot test. Cobalt release was assessed to obtain a risk estimate of cobalt allergy and dermatitis in consumers who would wear the jewellery.
The cobalt spot test was used to assess cobalt release from all items. Microstructural characterization was made using scanning electron microscope (SEM) and energy-dispersive spectroscopy (EDS).
Cobalt release was found in 4 (1.1%) of 354 items. All these had a dark appearance. SEM/EDS was performed on the four dark appearing items which showed tin-cobalt plating on these.
This study showed that only a minority of inexpensive jewellery purchased in Denmark released cobalt when analysed with the cobalt spot test. As fashion trends fluctuate and we found cobalt release from dark appearing jewellery, cobalt release from consumer items should be monitored in the future. Industries may not be fully aware of the potential cobalt allergy problem.
It is often difficult to establish clinical relevance of metal exposure in cobalt-allergic patients. Dermatologists and patients may incorrectly assume that many metallic items release cobalt at levels that may cause cobalt dermatitis. Cobalt-allergic patients may be unaware that they are exposed to cobalt from handling work items, causing hand dermatitis.
To present early findings with a newly developed cobalt spot test.
A cobalt spot test based on disodium-1-nitroso-2-naphthol-3,6-disulfonate was able to identify cobalt release at 8.3 ppm. The test may also be used as a gel test if combined with an agar preparation. We found no false-positive reactions when testing metals and alloys known not to contain cobalt. However, one cobalt-containing alloy, which elicited cobalt dermatitis in cobalt-allergic patients, was negative upon cobalt gel testing.
The cobalt test detects amounts of cobalt release that approximate the elicitation concentration seen in cobalt-allergic patients. It may serve as a useful tool in dermatology offices and workplaces.
The accuracy of the dimethylglyoxime (DMG) nickel spot test has been questioned because of false negative and positive test reactions. The EN 1811, a European standard reference method developed by the European Committee for Standardization (CEN), is fine-tuned to estimate nickel release around the limit value of the EU Nickel Directive from products intended to come into direct and prolonged skin contact. Because assessments according to EN 1811 are expensive to perform, time consuming, and may destruct the test item, it should be of great value to know the accuracy of the DMG screening test.
To evaluate the sensitivity and specificity of the DMG test.
DMG spot testing, chemical analysis according to the EN 1811 reference method, and X-ray fluorescence spectroscopy (XRF) were performed concomitantly on 96 metallic components from earrings recently purchased in San Francisco.
The sensitivity of the DMG test was 59.3% and the specificity was 97.5% based on DMG-test results and nickel release concentrations determined by the EN 1811 reference method.
The DMG test has a high specificity but a modest sensitivity. It may serve well for screening purposes. Past exposure studies may have underestimated nickel release from consumer items.
Exposure to nickel, cobalt and chromate are important causes of occupational contact dermatitis.
To estimate the prevalence of nickel, cobalt and chromate allergy in a population of consecutive patients and to investigate the possible association with individual and occupational risk factors.
A total of 14 464 patients (67.6% women and 32.4% men) with suspected allergic dermatitis underwent patch tests. The associations between patch test results and occupations were studied by multivariate logistic regression analysis.
About 24.6% of the patients reacted positively to nickel sulphate, 10.2% to cobalt chloride and 8.7% to potassium dichromate. Nickel sensitization was higher in women aged 26-35 years in comparison with the youngest group (15-25 years) and the older group (> 45 years). In women, the prevalence of positive reactions to nickel was positively associated with metal and mechanical work (OR 1.54; 95%, CI 1.16-2.05). Chromate sensitization was more prevalent in building trade workers for both women (OR 1.58; 95% CI 1.00-2.49) and men (OR 2.24; 95% CI 1.55-3.22). Cobalt sensitization was associated with textile and leather work in women (OR 1.52; 95% CI 1.09-2.12) and with cleaning work in men (OR 1.86; 95% CI 1.18-2.93).
Our study showed interesting associations between some occupations and nickel, chromate and cobalt allergy.
Hand eczema as well as nickel contact allergy is prevalent among hairdressers. Recently, two female hairdressers were diagnosed with nickel contact allergy-related hand eczema following prolonged skin contact with scissors and crochet hooks used during work.
To determine the proportion of hairdressers' scissors and crochet hooks that released an excessive amount of nickel and to determine the prevalence of nickel allergy among patch-tested female hairdressers.
Random hairdressers' stores in Copenhagen were visited. The dimethylglyoxime (DMG) test was used to assess excessive nickel release. The prevalence of nickel allergy among female hairdressers from the database at Gentofte Hospital was compared with the prevalence of nickel allergy among other consecutively patch-tested dermatitis patients.
DMG testing showed that 1 (0.5%; 95% CI = 0 - 2.0) of 200 pairs of scissors and 7 (53.8%; 95% CI = 26.0 - 82.0) of 13 crochet hooks released an excessive amount of nickel. The prevalence of nickel allergy was higher among middle-aged and older female hairdressers than among young female hairdressers.
The prevalence of nickel allergy was lower among young hairdressers in comparison to older hairdressers. This may possibly be a result of the European Union (EU) Nickel Directive or a consequence of a decreased use of nickel-releasing work tools in salons. When nickel allergic hairdressers present with hand eczema, their work tools should be investigated for nickel release.
An association between nickel contact allergy and hand eczema has previously been demonstrated. In 1990, Denmark regulated the extent of nickel release in the ear-piercing process as well as nickel release from consumer products.
This study aimed to evaluate the effect of the Danish nickel regulation by comparing the prevalence of concomitant nickel allergy and hand eczema observed in two repeated cross-sectional studies performed in the same general population in Copenhagen.
In 1990 and 2006, 3881 18-69 year olds completed a postal questionnaire and were patch tested with nickel. Data were analysed by logistic regression analyses and associations were expressed as odds ratios (ORs) with 95% confidence intervals (CIs).
The prevalence of concomitant nickel contact allergy and a history of hand eczema decreased among 18-35-year-old women from 9.0% in 1990 to 2.1% in 2006 (P < 0.01). The association between nickel contact allergy and a history of hand eczema decreased in this age group between 1990 (OR = 3.63; CI = 1.33-9.96) and 2006 (OR = 0.65; CI = 0.29-1.46). Among older women, no significant changes were observed in the association between nickel contact allergy and hand eczema. Conclusions: Regulatory control of nickel exposure may have reduced the effect of nickel on hand eczema in the young female population.
Continual surveillance based on patch test results has proved useful for the identification of contact allergy.
To provide a current view on the spectrum of contact allergy to important sensitizers across Europe.
Clinical and patch test data of 19 793 patients patch tested in 2005/2006 in the 31 participating departments from 10 European countries (the European Surveillance System on Contact Allergies' (ESSCA) www.essca-dc.org) were descriptively analysed, aggregated to four European regions.
Nickel sulfate remains the most common allergen with standardized prevalences ranging from 19.7% (central Europe) to 24.4% (southern Europe). While a number of allergens shows limited variation across the four regions, such as Myroxylon pereirae (5.3-6.8%), cobalt chloride (6.2-8.8%) or thiuram mix (1.7-2.4%), the differences observed with other allergens may hint on underlying differences in exposures, for example: dichromate 2.4% in the UK (west) versus 4.5-5.9% in the remaining EU regions, methylchloroisothiazolinone/methylisothiazolinone 4.1% in the South versus 2.1-2.7% in the remaining regions.
Notwithstanding residual methodological variation (affecting at least some 'difficult' allergens) tackled by ongoing efforts for standardization, a comparative analysis as presented provides (i) a broad overview on contact allergy frequencies and (ii) interesting starting points for further, in-depth investigation.
An increased prevalence of nickel allergy prompted the Danish government to prohibit excessive nickel release (ie, >0.5 microg nickel/cm(2)/wk) from consumer products in 1990. Concomitant allergy to nickel and cobalt is often observed among patients with dermatitis, probably as a result of cosensitization.
The study investigated the development of nickel and cobalt allergy among Danish female patients with dermatitis tested between 1985 and 2007. This was done to examine whether Danish nickel regulation has reduced the prevalence of nickel allergy and to examine whether the prevalence of cobalt allergy has increased as a result of the nickel regulation.
A retrospective analysis of all patch test data from our database was performed (n = 10,335). Comparisons were made using a chi-square test for trend. Logistic regression analyses were used to test for associations.
The prevalence of nickel allergy decreased significantly among those aged 5 to 30 years from 27.6% in 1985 to 16.8% in 2007 (P(trend) < .002) but increased among those aged 31 to 49 years from 21.3% to 33.8% in the same period (P(trend) < .001). The median age was significantly higher among patients with isolated cobalt allergy than among patients with nickel allergy (P < .001).
No information on causative exposures was available.
Nickel allergy decreased among young female patients with dermatitis between 1985 and 2007 whereas it increased among older patients, probably as a result of a cohort effect. The prevalence of cobalt allergy remained relatively unchanged.
Nickel allergic subjects are at risk factor of acquiring hand eczema. In 1990 and 1994, respectively, Denmark and member states in the EU regulated nickel release from selected consumer products. The intention was that the nickel epidemic could be controlled and prevented if the general population was protected from high cutaneous nickel concentrations. Despite a decrease, the prevalence of nickel allergy remains high as nearly 10% of young women are nickel allergic.
This study aimed to perform dimethylglyoxime (DMG) testing of inexpensive jewelry and hair clasps purchased from random stores in Copenhagen, Denmark to detect the proportion of items that may result in nickel allergy.
Inexpensive jewelry and hair clasps were purchased from 36 stores and street vendors in Copenhagen and were later tested for nickel release using the DMG test.
The study showed that 19.3% hair clasps, 14.8% earrings, and 12.9% necklaces intended for adult women released an excessive amount of nickel. Of 25 stores visited, 36.0% sold DMG positive jewelry. For items designed for children, excessive nickel release was identified in hair clasps (79.4%) and in finger rings (20%). Four (50.0%) of 8 children clothing stores sold jewelry that released too much nickel.
Excessive nickel release has been regulated since 1990 in Denmark. However, 1/5 of purchased items released nickel in concentrations that may lead to nickel allergy. Especially hair clasps intended for children released an excessive amount of nickel.
Wolfgang Uter, Werner Aberer, José Carlos Armario-Hita, José M. Fernandez-Vozmediano, Fabio Ayala, Anna Balato, Andrea Bauer, Barbara Ballmer-Weber, Aiste Beliauskiene, Anna Belloni Fortina, Andreas Bircher, Jochen Brasch, Mahbub M. U. Chowdhury, Pieter-Jan Coenraads, Marie-Louise Schuttelaar, Sue Cooper, Magda Czarnecka-Operacz, Maria Zmudzinska, Peter Elsner, John S. C. English, Peter J. Frosch, Thomas Fuchs, Juan García-Gavín, Virginia Fernández-Redondo, David J. Gawkrodger, Ana Giménez-Arnau, Cathy M. Green, Helen L. Horne, Jeanne Duus Johansen, Riitta Jolanki, Maria Pesonen, Clodagh M. King, Beata Krêcisz, Dorota Chomiczewska, Marta Kiec-Swierczynska, Francesca Larese, Vera Mahler, Anthony D. Ormerod, Andrea Peserico, Tapio Rantanen, Thomas Rustemeyer, Javier Sánchez-Pérez, Jane E. Sansom, Juan Fco. Silvestre, Dagmar Simon, Radoslaw Spiewak, Barry N. Statham, Natalie Stone, Mark Wilkinson, Axel Schnuch. (2012) Current patch test results with the European baseline series and extensions to it from the ‘European Surveillance System on Contact Allergy’ network, 2007-2008. Contact Dermatitis 67:10.1111/cod.2012.67.issue-1, 9-19
CrossRef
Patch testing is an essential procedure in the investigation of eczema in children.
To analyse the frequency of contact hypersensitivity and allergic contact dermatitis among Polish children with eczema.
During an allergy screening programme involving 9320 children aged 7 and 16 years, 12.6% reported symptoms of chronic/recurrent eczema. From this group, a representative sample of 229 eczema children underwent patch testing: 96 children aged 7 years and 133 teenagers aged 16 years. Patch testing was with 10 allergens: methylchloroisothiazolinone/methylisothiazolinone (MCI/MI), nickel sulfate, mercury ammonium chloride, thimerosal, cobalt chloride, potassium dichromate, lanolin, fragrance mix I, Myroxylon pereirae (balsam of Peru), and colophonium.
49.4% tested children were found patch test (PT) positive. 43.8% of 7 year olds with eczema were PT positive, with sensitization to nickel sulfate (30.2%), thimerosal (10.4%), cobalt chloride (8.3%), fragrance mix I (7.3%), MCI/MI (6.3%), potassium dichromate (6.3%), M. pereirae (3.1%), mercury ammonium chloride (2.3%), and colophonium (1.0%). 52.6% teenagers were PT positive, with sensitization to nickel sulfate (23.3%), thimerosal (27.8%), cobalt chloride (10.5%), potassium dichromate (6.0%), mercury ammonium chloride (2.3%), M. pereirae (1.5%), and MCI/MI (0.8%). The final diagnosis of allergic contact dermatitis was confirmed in 36% of 7 year olds and 26% of 16 year olds.
Every second child with eczema is PT positive, whereas every third child is finally diagnosed with allergic contact dermatitis.
A case of sarcoidal-type allergic contact granuloma due to palladium is presented. The patient developed papulonodular lesions at the right earlobe after ear piercing, which after 3 to 4 years became more granulomatous and very resistant to treatment. Repeated intralesional injections with corticosteroids produced only a temporary regression of the lesions. Patch testing revealed a strong positive reaction to palladium (and nickel). Biopsy specimens taken from the persistent granulomatous lesion in the nodule at the earlobe, as well as from the site of the positive test reaction to palladium several weeks after patch testing, indicated epithelioid granulomas with some multinucleate histiocytes surrounded by a lymphocytic-histiocytic infiltrate. Similar cases (also with other metals) have been reported in the literature.
11 widely used nickel alloys were investigated with respect to corrosion stability and reactivity in nickel-sensitive individuals. Alloys with a nickel release in synthetic sweat exceeding 1 microgram/cm2/week gave a strong patch test reaction in nickel-sensitive persons; those with a release below 0.5 microgram/cm2/week showed weak reactivity with one exception. Nickel allergy is a health problem. It may be minimized by using nickel alloys with a corrosion level below 0.5 microgram/cm2/week. Action should be taken by dermatologists, industry and authorities to solve this neglected problem.
• In a two-year prospective study of cutaneous problems in orthopedic implant recipients, cutaneous eruptions of unknown cause that bore good temporal relationships with implant surgery occurred in 19 patients. Two clinical patterns were observed. A transient "exanthematic" dermatitis was seen in six patients; in two of them, it recurred after each surgical implant procedure. A persistent reaction was seen in 13 patients. Metal sensitivity was found in two patients and considered to be relevant. Allergic cutaneous complications of orthopedic implants are rare. However, in an implant recipient in whom a cutaneous problem develops, the likelihood of the cutaneous problem being allergic in nature is slightly greater if the implant is of the static type, if there is a history of metal sensitivity, if the cutaneous eruption shows a predilection for the anatomic zone of the implant, and if the eruption is eczematous and has developed late and persisted.
(Arch Dermatol 1981;117:554-560)
The Nickel Directive will become law in the countries of the European Union in 1996. This directive states that the concentration of nickel in post assemblies (used after ear piercing) may not exceed 0.05%, that products which come into direct and prolonged contact with the skin, e.g. earrings, watchstraps or zippers, may not release greater than 0.5 microgram/cm2/week, and that nickel release from coated products will not exceed this level after 2 years of normal use. The data relating to the threshold for reacting to nickel and the levels of nickel release from nickel-containing objects, are considered in this review. Although the level of 0.5 microgram/cm2/week is one below which a minority of nickel-allergic subjects will react, it is not safe in every nickel-sensitive individual. This level of nickel release is currently exceeded by many nickel-containing alloys and jewelery items that are made from high-sulfur stainless steel, and manufacturers are going to have to change the composition of jewelery to comply with the directive.
Nickel allergy in women has been thoroughly studied: its prevalence, the most important sources of sensitization, and risk factors for elicitation of dermatitis. Preventive measures have also been introduced. Nickel allergy in men has not, however, been equally focused on. Based on clinical experience, some publications indicating that tools may be a risk factor for nickel allergy and hand eczema in men, and the fact that large occupational groups regularly use tools, we decided to carry out a study, of the prevalence on the market of tools that release nickel. 27% of 565 hand-held tools with metal parts that come into contact with the skin were found to be dimethylglyoxime (DMG) test positive. Release of nickel and other metals into artificial sweat and composition of metals on the surface and in the base alloy were also studied. It is suggested that tool producers should consider nickel allergy and avoid nickel-releasing materials, and that analytical methods, relevant for nickel release from tools, should be further developed.
Metal contact allergy is a common problem in the general population. Diagnostic and therapeutic medical-surgical procedures in which metals can be responsible for eczema are diverse. Endovascular aortic surgery is still an experimental but less invasive technique. A generalized eczematous dermatitis elicited by metal of an endovascular prosthesis is presented. An abdominal aortic aneurysm was diagnosed in a 79-year-old woman. Endoluminal repair with a straight Vanguard endograft was successful. 3 weeks later, she suffered a severe episode of erythema and eczema on the legs. Since then, she complained of continuous pruritus with eczema and excoriated papules. The dermatitis and also the patch test pathology showed eczema. Patch testing was positive to nickel sulfate and cobalt chloride. An endograft semi-quantitative metal analysis was performed with plasma-induction joint mass-spectrometry. The self-expanding metal stent was mainly composed of nickel (approximately 55%) and titanium (21%) with reinforcing thread of platinum. Antimony was detected only in the polyester textile. These results are consistent with Nitinol composition. The need for preoperative patch testing for metals is controversial. Enquiry about metal allergy is recommended before endoluminal surgical procedures. In the near future, the design of endografts must take into account the possibility of this sort of reaction.
Nickel allergy is by far the most frequent contact allergy, affecting 10-15% of women in the general population, and causing dermatitis and hand eczema. The EU Nickel Directive, aimed at the prevention of nickel allergy, comes fully into force by July 2001. The Directive covers piercing materials, items in contact with the skin, and requirements on resistance to wear. We carried out a study of the prevalence on the market, before the Nickel Directive, of items that release nickel and of nickel in piercing posts. Nickel release, as shown by a positive dimethylglyoxime (DMG) test, was detected in 25% of 725 items intended for direct and prolonged contact with the skin. Of 15 posts intended for use during epithelialization after piercing, 60% contained more than 0.05% nickel. These products do not comply with the requirements of the EU Nickel Directive. It is suggested that experts in contact dermatitis participate in the prevention of nickel allergy by explaining its effects: the r le of skin exposure and which parts of an item are in contact with the skin, and the crucial question of nickel release versus nickel content.
Nickel allergy is the most frequent contact allergy and is also one of the major background factors for hand eczema. The clinical significance of nickel release from coins was discussed when the composition of euro coins was decided. Current European coinage is dominated by cupro-nickel coins (Cu 75; Ni 25); other nickel-containing and non-nickel alloys are also used. Nickel release from used coinage from the UK, Sweden and France was determined. It was shown that nickel ions are readily available on the surface of used coins. After 2 min in artificial sweat, approximately 2 microg of nickel per coin was extracted from cupro-nickel coins. Less nickel was extracted from non-nickel coins. Nickel on the surface was mainly present as chloride. After 1 week in artificial sweat approximately 30 microg/cm2 was released from cupro-nickel coins: less nickel was released from coins made of other nickel alloys. Theoretically, several microg of nickel salts may be transferred daily onto hands by intense handling of high-nickel-releasing coins.
In the early 1990s, the prevalence of nickel contact allergy was high-almost 20% on a population level, and some 40% in contact dermatitis patients. Around that time, nickel exposure was starting to be regulated.
Descriptive and bivariate analyses of patch test results of all patients tested with nickel sulfate (5% pet.) in the departments joining the Network of Departments of Dermatology (IVDK) 1992-2001 (n=82,991, women: 52,709; men: 30,282). The annual frequency of sensitization to nickel was analyzed in women and men in four age subgroups (<31/31 to <44/44 to 58= or >58).
In young women less than 31 (n=13.909) the prevalence of contact allergy to nickel decreased significantly from 36.7% in 1992 to 25.8% in 2001. In young men in the same age group (n=7087), the prevalence dropped from 8.9% in 1992 to 5.2% in 2001.
The observed decline indicates that measures to limit the release of nickel from costume jewelry helped reduce the prevalence of nickel allergy. In general term, allergen elimination or reduction is an effective primary prevention strategy which does not depend on individual behavior modifications.
The Nickel Directive aims at the prevention of sensitization and elicitation of nickel dermatitis. It limits nickel release from, and nickel content in, certain items. The Directive came into full force by July 2001. The aim of this study was to investigate the frequency on the market of items that release nickel and of nickel content in piercing posts, 2 years after coming into force of the Directive. Of special interest was to study changes compared to the situation in 1999, when a baseline study had been carried out. Nickel release from 786 items covered by the Nickel Directive was tested with the dimethylglyoxime (DMG) test, and nickel content in 18 piercing posts was analysed. Nickel release was shown from 8% of items intended for direct and prolonged contact with the skin, and 17% of the piercing posts contained too much nickel, a decrease compared to 1999. There has been significant adaptation to the requirements of the Nickel Directive. The DMG test is useful for screening for nickel release and for monitoring the market. Provided there is further adaptation to the requirements, the risk of sensitization and elicitation of nickel dermatitis will be significantly reduced.
Nickel (Ni) is the most frequent cause of contact allergy among the female population. This makes it interesting to examine thresholds for elicitation under different conditions. Even though Ni exposure may be open, occluded, penetrating or oral, most dose-response studies in the literature concern single occluded application. The aims of this study were to assess thresholds of response by making a statistical analysis of available dose-response studies with single occluded exposure and comparing the results to thresholds from other modes of exposure. 8 occluded Ni dose-response studies were selected based on statistical considerations. The statistical analysis showed that 5% of a sensitized population react to 0.44 microg Ni/cm2 and 10% react to 1.04 microg Ni/cm2. In another study with a single open application, 7.8% of sensitized persons responded to a dose x6 higher than the dose to which 10% reacted in occluded exposure. When combining the exposure to Ni with an irritant, divagating results were found, although the literature shows evidence of an augmented response when combining exposure to an allergen and an irritant. The thresholds of penetrating exposure were found to be lower than the thresholds of single occluded exposure. Comparisons of different kind of exposures across studies are difficult, because of differences in the studies, although a comparison could be made by a study that compares the different exposures within the same individuals at the same time.
Nickel-elicited systemic contact dermatitis is a well-known entity, although it is far less common than allergic contact dermatitis. In most of the cases, the main way of nickel administration is oral. Clinical manifestations are miscellaneous including pompholyx, diffuse exanthema, flexural dermatitis or baboon syndrome. Systemic nickel dermatitis induced by venous catheters is very uncommon, but it is probably underdiagnosed. We report here 2 patients with diffuse recurrent maculopapular rash corresponding to nickel-elicited systemic contact dermatitis. They were both perfused during the last episode with the assistance of a peripheral polyurethane venous catheter during or just before the cutaneous eruption. At the base of the catheter, there was a small metallic eyelet on which dimethylglyoxime test was positive, indicating a release of nickel. Then, we measured nickel release in normal use conditions and found high nickel levels, although the manufacturer denied that nickel could be released. This diagnosis is important to know because such exanthema often occurred during postoperative or postpartum period. Its frequency is probably underestimated because it is often considered as a cutaneous drug reaction. To our knowledge, only 2 cases have been reported in the literature.
Allergic contact dermatitis is recognized as a public health problem and some major allergens have been subject to intervention aiming at lowering skin exposure. There is an obvious interest in evaluating the effect of such interventions. Population studies are difficult to perform and epidemiological studies based on clinical data from testing patients with contact dermatitis are common surrogates. Our objective was to gather Swedish clinical standard series test data on two occasions in order to monitor trends in sensitization rates. Consecutive patch test results from the Swedish standard series were collected from 9 centres from 1991 to 1993 and from 1999 to 2001. In total, 3680 and 3790 patients, respectively, were included. Crude, age-adjusted and age-stratified prevalence are given separately for women and men. Our top 10 allergens are much in line with newly published European test data. Significant changes among those allergens are increasing sensitization rates for Myroxylon pereirae and decreasing rates for colophony, 5-chloro-2-methyl-4-iso-thi-azo-lin-3-one, Amerchol L 101 and thiuram mix. Nickel allergy is decreasing among young women. Among less common allergens, a noteworthy increase of sensitization to 4-phenyl-en-diamine is found. In conclusion, significant trends in sensitization rates of important allergen, reflecting changes in exposure, have been found.
The capability of alloys used in cheap jewellery to release metal ions on contact with the skin causing allergic contact dermatitis (ACD) is generally acknowledged. To reduce the diffusion of the Ni-induced ACD the Council Directive 94/27/EC [Council Directive 94/27/EC of 30 June 1994. Official Journal L 188, 22/07/1994, 1.] limited the total Ni content in alloys and its release rate in artificial sweat. In this work, three different aspects were explored: i) the frequency of skin sensitization to Ni-containing earrings in patients before and after the introduction of the Directive's limit; ii) metal composition of alloys by X-ray analysis; iii) metal leaching in artificial sweat followed by Sector Field Inductively Coupled Plasma Mass Spectrometry (SF-ICP-MS) quantification. Well-known allergenic metals, as Ni, Cr and Co, and possible emergent allergens, as Al, Ag, Au, Cd, Cu, Fe, Ir, Mn, Pb, Pd, Pt, Rh, Sn, V and Zn, were studied.
Nickel sensitization is frequent among US patients with dermatitis and in the general population. In Europe, decreasing prevalences of nickel sensitization are observed as a result of the European Union Nickel Directive. However, no directive exists in the United States.
We sought to examine nickel release from inexpensive earrings and discuss possible methods of reducing nickel exposure among consumers.
A total of 34 different stores and artists were visited. A total of 277 earrings were purchased and examined with the dimethylglyoxime (DMG) test.
DMG-positive earrings were identified from local artists (69%) and tourist stores (42.9%) but also chain stores targeting young (24.1%) and mature (1.7%) women. No correlation between price and outcome of DMG testing was identified.
Our study does not reflect buying trends in the United States. Pretreatment of earrings with artificial sweat was not performed and the DMG may lead to both false-positive and false-negative results.
Nickel exposure from inexpensive earrings is frequent in the United States. A regulatory governmental intervention may be warranted.
Nickel, chromium, and cobalt are important skin sensitizers. Better knowledge about skin exposure is needed for more efficient prevention. We have previously developed acid wipe sampling for assessment of skin exposure to metals.
To apply the acid wipe sampling technique in some occupations where intense contact with metallic items occurs and to gather experience for the design of future workplace studies.
18 volunteers (carpenters, locksmiths, cashiers, and secretaries as controls) participated. They performed their normal tasks during a job session for exposure. Samples were taken from fingers and palms by acid wipe sampling, and analysis of metals was performed by inductively coupled plasma mass spectrometer.
The metals were detected in all samples, and the amount of nickel was larger than that of chromium and cobalt. Fingers were more exposed than palms. 8-h exposure to nickel was calculated and was highest in locksmiths (mean 3.784 mug/cm(2), range 1.846-5.028 mug/cm(2)) followed by carpenters, cashiers, and secretaries.
The acid wipe sampling technique is suitable for studies of skin exposure to nickel, chromium, and cobalt in the workplace. The sampling efficiency of acid wipe sampling is high. The amounts of nickel deposited on skin in carpenters, locksmiths, and cashiers are judged capable of eliciting allergic contact dermatitis.
The European baseline series in 10 European Countries
- W Uter
- C Ramsch
- W Aberer
21 Uter W, Ramsch C, Aberer W et al. The
European baseline series in 10 European
Countries, 2005/2006 – results of the
European Surveillance System on Contact
Allergies (ESSCA). Contact Dermatitis
2009: 61: 31–38.
Social and demographic aspects of nickel contact allergy In: Nickel and the Skin: Immunology and Toxicology
- B Edman
- L Janzon
28 Edman B, Janzon L. Social and
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