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Supplemental material for Genotoxicity of oxidative hair dye precursors: A systematic review by Željka Babić, Sarah Hallmann, Martin S Havmose, Jeanne D Johansen, Swen M John, Cara Symanzik, Wolfgang Uter, Patricia Weinert, Henk F van der Molen, Sanja Kezic, Jelena Macan and Rajka Turk in Human & Experimental Toxicology

Introduction Hairdressers constitute a major subgroup in the service sector. They are exposed to various substances hazardous for skin, airways or systemically. Accordingly, skin and other occupational diseases are common. The present systematic review will compile and appraise evidence regarding skin, systemic and airways toxicity of an indicative set of specific, important product ingredients. Additionally, evidence concerning hand eczema morbidity among hairdressers will be reviewed. Methods and analysis Systematic searches will be performed in two electronic literature databases (Medline, Web of Science-Core Collection), the Cochrane register and two collections of toxicological dossiers (Scientific Committee on Consumer Safety of the European Commission and the MAK Commission of the German Research Council). Additional literature sources will be retrieved using hand search of reference lists of included studies and snowballing methods. We will include studies with all types of quantitative study designs, including results from in vitro and in vivo experiments, chemical analysis, epidemiological findings and clinical results. We will assess the risk of bias within studies amalgamating an abbreviated version of the Mixed Methods Appraisal Tool, basic Cochrane criteria and US Environmental Protection Agency assessment factors for scientific information. As we expect large heterogeneity in methods and outcomes, we will conduct a narrative synthesis of results instead of a meta-analysis, except where quantitative pooling is feasible. Ethics and dissemination Ethical approval and patient consent are not required as this is a systematic review based on published studies. The results of this study will be published in international peer-reviewed journals. PROSPERO registration number CRD42021238118

"Artículo escrito por un elevado número de autores, solo se referencian el que aparece en primer lugar, el nombre del grupo de colaboración, si le hubiere, y los autores pertenecientes a la UAM", Background: Clinical surveillance of the prevalence of contact allergy in consecutively patch tested patients is a proven instrument to continually assess the importance of contact allergens (haptens) assembled in a baseline series. Objectives: To present current results from the European Surveillance System on Contact Allergies, including 13 countries represented by 1 to 11 departments. Methods: Anonymized or pseudonymized patch test and clinical data from various data capture systems used locally or nationally as transferred to the Erlangen data centre were pooled and descriptively analysed after quality control. Results: In the 4 years (2015-2018), data from 51 914 patients patch tested with the European baseline series (EBS) of contact allergens were analysed. Contact allergy to nickel was most frequent (17.6% positive), followed by contact allergy to fragrance mix I (6.9%), methylisothiazolinone (MI; 6.2%), and Myroxylon pereirae resin (balsam of Peru; 5.8%). Conclusions: While the prevalence of MI contact allergy decreased substantially following regulatory intervention, the persistently high levels of allergy to metals, fragrances, other preservatives, and rubber chemicals point to problems needing further research and, potentially, preventive efforts. Results with national additions to the baseline series provide important information on substances possibly to be considered for inclusion in the EBS., Partial funding by EADV Grant PPRC-2018-8

Background: An increasing incidence of contact allergy to methylisothiazolinone (MI) has been seen, caused, in particular, by cosmetic products and paints. A study from 2015 showed that 93.0% of paints bought in five European countries contained MI. New regulations have been discussed for paints in the EU, which may have influenced this market. Objectives: To re-evaluate the use and concentrations of MI and four other isothiazolinones in water-based wall paints. Methods: Water-based white wall paints (n = 60) were purchased in retail stores in five European countries: Denmark, France, Germany, Sweden, and the United Kingdom. The paints were analysed for isothiazolione content by the use of high-performance liquid chromatography coupled to ultraviolet detection, and the results were confirmed with high-performance liquid chromatography–tandem mass spectrometry. Results: MI was identified in 55 (91.7%) of the paints, with concentrations ranging from 1.1 to 142.7 ppm. The other isothiazolinones were identified in 20.0% [methylchloroisothiazolinone (MCI)] to 88.3% [benzisothiazolinone (BIT)] of the paints. BIT concentrations varied significantly between countries, whereas MI and MCI concentrations did not. There were no statistically significant differences in MI, MCI and BIT concentrations between the current study and the 2015 study. Conclusions: MI and other isothiazolinones are widely used in paints available in Europe. Their use does not seem to be decreasing.

Background: The current European baseline series consists of 30 allergens, and was last updated in 2015. Objectives: To use data from the European Surveillance System on Contact Allergies (ESSCA) to propose an extension to the European baseline series in response to changes in environmental exposures. Methods: Data from departmental and national extensions to the baseline series, together with some temporary additions from departments contributing to the ESSCA, were collated during 2013–2014. Results: In total, 31689 patients were patch tested in 46 European departments. Many departments and national groups already consider the current European baseline series to be a suboptimal screen, and use their own extensions to it. The haptens tested are heterogeneous, although there are some consistent themes. Potential haptens to include in an extension to the European baseline series comprise sodium metabisulfite, formaldehyde-releasing preservatives, additional markers of fragrance allergy, propolis, Compositae mix, and 2-hydroxyethyl methacrylate. Conclusion: In combination with other published work from the ESSCA, changes to the current European baseline series are proposed for discussion. As well as addition of the allergens listed above, it is suggested that primin and clioquinol should be deleted from the series, owing to reduced environmental exposure.

Fidget spinners, which are toys used by children of schoolage, became very popular in 2017. During normal use, they are in direct and prolonged contact with the skin on the hands. Fidget spinners may have metals parts, and therefore represent a potential source of metal contact allergy and thus allergic contact dermatitis. The aim of this study was to screen a random selection of fidget spinners on the Danish market for nickel and cobalt release.

Contact allergy is common, affecting 27% of the general population in Europe. Original publications, including case reports, published since 2016 (inclusive) were identified with the aim of collating a full review of current problems in the field. To this end, a literature search employing methods of systematic reviewing was performed in the Medline® and Web of Science™ databases on 28 January 2018, using the search terms (“contact sensitization” or “contact allergy”). Of 446 non-duplicate publications identified by above search, 147 were excluded based on scrutiny of title, abstract and key words. Of the remaining 299 examined in full text, 291 were deemed appropriate for inclusion, and main findings were summarised in topic sections. In conclusion, diverse sources of exposures to chemicals of widely-differing types and structures, continue to induce sensitisation in man and may result in allergic contact dermatitis. Many of the chemicals are “evergreen” but others are “newcomers”. Vigilance and proper investigation (patch testing) are required to detect and inform of the presence of these haptens to which our populations remain exposed.

Background. Lanolin has been tested as lanolin alcohols (30% pet.) in baseline patch test series since 1969, and this has shown clinically relevant allergic contact dermatitis cases. Objectives. To investigate the temporal development of lanolin allergy (i.e. positive reaction to lanolin alcohols and/or Amerchol (TM) L-101), and the association between contact allergy to lanolin and patient characteristics from the MOAHLFA index. Methods. A retrospective observational study of consecutively patch tested dermatitis patients (n=9577) between 1 January 2004 and 31 December 2015 with lanolin alcohols 30% pet. and Amerchol (TM) L-101 50% pet. was performed. Results. The prevalence of lanolin allergy increased from 0.45% in 2004 to 1.81% in 2015. In age-adjusted and sex-adjusted analyses, weak, significant associations were found between atopic dermatitis and lanolin and lanolin alcohols allergy, respectively, but no association with Amerchol (TM) L-101 allergy was found. Among 9286 dermatitis patients who were tested with both allergens, 108 had a positive test reaction to either lanolin alcohols or Amerchol (TM) L-101, whereas only 29 patients had positive test reactions to both markers. ConclusionsThe prevalence of lanolin contact allergy has increased over a 12-year period, and inclusion of Amerchol (TM) L-101 will increase the chance of detecting lanolin contact allergy. Patch testing with lanolin is helpful in atopics with dermatitis and suspected cosmetic allergy.

BACKGROUND: The use of methylisothiazolinone (MI) in cosmetic products has caused an unprecedented epidemic of MI contact allergy. Current data concerning exposures at a European level are required.OBJECTIVES: To describe demographics and MI exposures for European patients with MI contact allergy.METHODS: Eleven European dermatology departments from eight European countries prospectively collected data between 1 May and 31 October 2015 among consecutive patients who had positive patch test reactions to MI (2000 ppm aq.).RESULTS: A total of 6.0% (205/3434; range 2.6-13.0%) of patients had positive patch test reactions to MI. Dermatitis most frequently affected the hands (43.4%), face (32.7%), arms (14.6%), and eyelids (11.7%); 12.7% had widespread dermatitis. For 72.7% (149/205), MI contact allergy was currently relevant mainly because of exposure to cosmetic products (83.2%; 124/149). Of these 124 patients, 19.5% were exposed to leave-on and rinse-off cosmetic products, 24.8% only to leave-on cosmetic products and 38.9% only to rinse-off cosmetic products containing MI or methylchloroisothiazolinone/MI. The majority of these (79%) noted onset of their dermatitis between 2013 and 2015. Fifteen patients (7.3%) had previously experienced allergic reactions when they were in newly painted rooms.CONCLUSION: Clinically relevant MI contact allergy remains prevalent across European countries, mainly because of exposure to rinse-off and leave-on cosmetic products.

BACKGROUND: Hand eczema is the commonest occupational skin disease in Denmark, and hairdressing is a high-risk profession. In 2008-2010, a clinically controlled, prospective intervention study aimed at reducing the development of hand eczema was conducted at hairdressing schools in Denmark. The findings showed that significantly fewer apprentices in the intervention group developed hand eczema over a period of 18 months.OBJECTIVES: To investigate the long-term effect of the intervention.METHODS: Two hundred and eighty-four participants were identified from the original dataset, and were sent a questionnaire.RESULTS: No difference was seen between the intervention and control groups. This may partly be attributable to the two groups no longer being well matched, and improved work habits in the control group. Overall, there was an improvement in work habits. Participants had a 1-year prevalence of hand eczema of 22.4%. Reactions to hair dye were reported for 24.5%, and 35.5% had left the trade; 36.4% used gloves when shampooing, and 21.3% stated that they cut hair before colouring it.CONCLUSIONS: The effect of the intervention was not visible after 6 years, but an overall improvement in work habits was noted.

Summary Background Limonene and linalool are common fragrance terpenes. Both oxidized R-limonene and oxidized linalool have recently been patch tested in an international setting, showing contact allergy in 5.2% and 6.9% of dermatitis patients, respectively. Objective To investigate concomitant reactions between oxidized R-limonene and oxidized linalool in consecutive dermatitis patients. Methods Oxidized R-limonene 3.0% (containing limonene hydroperoxides 0.33%) and oxidized linalool 6% (linalool hydroperoxides 1%) in petrolatum were tested in 2900 consecutive dermatitis patients in Australia, Denmark, Singapore, Spain, Sweden, and the United Kingdom. Results A total of 281 patients reacted to either oxidized R-limonene or oxidized linalool. Of these, 25% had concomitant reactions to both compounds, whereas 29% reacted only to oxidized R-limonene and 46% only to oxidized linalool. Of the 152 patients reacting to oxidized R-limonene, 46% reacted to oxidized linalool, whereas 35% of the 200 patients reacting to oxidized linalool also reacted to oxidized R-limonene. Conclusions The majority of the patients (75%) reacted to only one of the oxidation mixtures, thus supporting the specificity of the reactions. The concomitant reactions to the two fragrance allergens suggest multiple sensitizations, which most likely reflect the exposure to the different fragrance materials in various types of consumer products. This is in accordance with what is generally seen for patch test reactions to fragrance materials.

The present guideline summarizes all aspects of patch testing for the diagnosis of contact allergy in patients suspected of suffering, or having been suffering, from allergic contact dermatitis or other delayed-type hypersensitivity skin and mucosal conditions. Sections with brief descriptions and discussions of different pertinent topics are followed by a highlighted short practical recommendation. Topics comprise, after an introduction with important definitions, materials, technique, modifications of epicutaneous testing, individual factors influencing the patch test outcome or necessitating special considerations, children, patients with occupational contact dermatitis and drug eruptions as special groups, patch testing of materials brought in by the patient, adverse effects of patch testing, and the final evaluation and patient counselling based on this judgement. Finally, short reference is made to aspects of (continuing) medical education and to electronic collection of data for epidemiological surveillance.

BACKGROUND: Blue-collar workers have a high risk of occupational contact dermatitis, but epidemiological studies are scarce.OBJECTIVES: To investigate allergic contact dermatitis in blue-collar workers with dermatitis registered by the Danish Contact Dermatitis Group.METHODS: A retrospective analysis of patch test data from 1471 blue-collar workers and 1471 matched controls tested between 2003 and 2012 was performed. A logistic regression was used to test for associations.RESULTS: The blue-collar workers often had occupational hand dermatitis (p < 0.001). Atopic dermatitis was less commonly observed among blue-collar workers (19.6%) than among controls (23.9%) (p = 0.005). Allergens with a statistically significant association with the occupational group of blue-collar workers were epoxy resins, methyldibromo glutaronitrile, 2-bromo-2-nitro-1,3-propanediol, potassium dichromate, and methylchloroisothiazolinone (MCI)/methylisothiazolinone (MI). The following occupations were additionally identified as risk factors for contact sensitization to MCI/MI and MI, epoxy resins, and potassium dichromate, respectively: painting, construction work, and tile setting/terrazzo work.CONCLUSION: Contact allergy is a major problem among blue-collar workers. The data indicate a healthy worker effect among blue-collar workers diagnosed with dermatitis, as blue-collar workers were diagnosed significantly less often with atopic dermatitis than were controls.

BACKGROUND: The pathogenesis of total joint replacement failure is multifactorial. One hypothesis suggests that corrosion and wear of alloys result in metal ion release, which may then cause sensitization and even implant failure, owing to the acquired immune reactivity.OBJECTIVES: To assess cobalt, nickel and chromium(VI) release from, and the metal composition of, failed metal-on-ethylene total hip replacements.MATERIALS/METHODS: Implant components from 52 revision cases were evaluated with spot tests for free nickel, cobalt, and chromium (VI) ions. Implant composition was determined with X-ray fluorescence spectroscopy, and information on the reason for revision and complications in relation to surgery was collected from the medical charts when possible (72%). For 10 implants, corrosion was further characterized with scanning electron microscopy.RESULTS: We detected cobalt release from three of 38 removed femoral heads and from one of 24 femoral stems. Nickel release was detected from one of 24 femoral stems. No chromium(VI) release was detected.CONCLUSIONS: We found that cobalt and nickel were released from some failed total hip arthroplasties, and corrosion was frequently observed. Metal ions and particles corroded from metal-on-polyethylene may play a role in the complex aetiopathology of implant failure.

BACKGROUND: R-Limonene is a common fragrance terpene found in domestic and industrial products. R-Limonene autoxidizes on air exposure, and the oxidation products can cause contact allergy. In a recent multicentre study, 5.2% (range 2.3-12.1%) of 2900 patients showed a positive patch test reaction to oxidized R-limonene.OBJECTIVE: To study the exposure to limonene among consecutive dermatitis patients reacting to oxidized R-limonene in an international setting, and to assess the relevance of the exposure for the patients' dermatitis.METHODS: Oxidized R-limonene 3.0% (containing limonene hydroperoxides at 0.33%) in petrolatum was tested in 2900 consecutive dermatitis patients in Australia, Denmark, the United Kingdom, Singapore, Spain, and Sweden. A questionnaire assessing exposure to limonene-containing products was completed.RESULTS: Overall, exposure to products containing limonene was found and assessed as being probably relevant for the patients' dermatitis in 36% of the limonene-allergic patients. In Barcelona and Copenhagen, > 70% of the patients were judged to have had an exposure to limonene assessed as relevant.CONCLUSIONS: Oxidized R-limonene is a common fragrance allergen, and limonene was frequently found in the labelling on the patients' products, and assessed as relevant for the patients' dermatitis. A large number of domestic and occupational sources for contact with R-limonene were identified.

BACKGROUND: Metal-on-metal (MOM) total hip arthroplasties were reintroduced because of the problems with osteolysis and aseptic loosening related to polyethylene wear of early metal-on-polyethylene (MOP) arthroplasties. The volumetric wear rate has been greatly reduced with MOM arthroplasties; however, because of nano-size wear particles, the absolute number has been greatly increased. Thus, a source of metal ion exposure with the potential to sensitize patients is present. We hypothesized that higher amounts of wear particles result in increased release of metal ions and ultimately lead to an increased incidence of metal allergy.METHODS: 52 hips in 52 patients (median age 60 (51-64) years, 30 women) were randomized to either a MOM hip resurfacing system (ReCap) or a standard MOP total hip arthoplasty (Mallory Head/Exeter). Spot urine samples were collected preoperatively, postoperatively, after 3 months, and after 1, 2, and 5 years and tested with inductively coupled plasma-sector field mass spectrometry. After 5 years, hypersensitivity to metals was evaluated by patch testing and lymphocyte transformation assay. In addition, the patients answered a questionnaire about hypersensitivity.RESULTS: A statistically significant 10- to 20-fold increase in urinary levels of cobalt and chromium was observed throughout the entire follow-up in the MOM group. The prevalence of metal allergy was similar between groups.INTERPRETATION: While we observed significantly increased levels of metal ions in the urine during the entire follow-up period, no difference in prevalence of metal allergy was observed in the MOM group. However, the effect of long-term metal exposure remains uncertain.

BACKGROUND: Blue-collar workers have a high risk of occupational contact dermatitis, but epidemiological studies are scarce.OBJECTIVES: To investigate allergic contact dermatitis in blue-collar workers with dermatitis registered by the Danish Contact Dermatitis Group.METHODS: A retrospective analysis of patch test data from 1471 blue-collar workers and 1471 matched controls tested between 2003 and 2012 was performed. A logistic regression was used to test for associations.RESULTS: The blue-collar workers often had occupational hand dermatitis (p CONCLUSION: Contact allergy is a major problem among blue-collar workers. The data indicate a healthy worker effect among blue-collar workers diagnosed with dermatitis, as blue-collar workers were diagnosed significantly less often with atopic dermatitis than were controls.

BACKGROUND: In recent years, the prevalence of contact allergy to isothiazolinones has reached epidemic levels. Few studies have presented data on occupations at risk of developing contact allergy to isothiazolinones.OBJECTIVES: To present demographics and examine risk factors for sensitization to methylisothiazolinone (MI), methylchloroisothiazolinone (MCI) in combination with MI and benzisothiazolinone (BIT) in Danish dermatitis patients.MATERIALS AND METHODS: A retrospective epidemiological analysis of data from three Danish hospitals departments was conducted. All patients consecutively patch tested with MI, MCI/MI and BIT between 2009 and 2013 were included.RESULTS: MI contact allergy showed a significantly increased trend in prevalence from 1.8% in 2009 to 4.2% in 2012 (p 40 years, and the occupational groups of tile setters/terrazzo workers, machine operators, and painters. MCI/MI contact allergy was significantly associated with the following high-risk occupations: painting, welding (blacksmiths), machine operating, and cosmetology. The occupational group of painting was frequent in the group of patients with BIT contact allergy.CONCLUSION: Several high-risk occupations for sensitization to isothiazolinones exist. Regulation on the allowed concentration of isothiazolinones, and especially MI, in both consumer products and industrial products is needed.