Patch Test Data Research Articles

Safety Assessment of PEG-150 Pentaerythrityl Tetrastearate as Used in Cosmetics.

The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of polyethylene glycol (PEG)-150 pentaerythrityl tetrastearate, which functions as a viscosity-increasing agent-aqueous in cosmetic products and is being used at concentrations up to 5%. Given the chemical structure (large molecule), skin penetration is not likely. The available toxicity data and the low ingredient use concentrations suggest that systemic toxicity would not be likely even if percutaneous absorption were to occur. Additionally, the negative human repeated insult patch test data on the undiluted ingredient were deemed sufficient for evaluating skin irritation and sensitization potential. The Panel concluded that PEG-150 pentaerythrityl tetrastearate is safe in cosmetics in the present practices of use and concentration described in this safety assessment.

Contact allergy in Danish children: Current trends.

Contact allergy is common in children, but may be underdiagnosed. Importantly, the clinical relevance of specific allergies is subject to constant change, and it is therefore important to continuously monitor the trends and changes of contact allergies in the paediatric population. To identify possible changes in contact allergy and allergic contact dermatitis among Danish children referred for patch testing. A retrospective study was performed based on patch test data from the Danish National Database of Contact allergy. The current data were compared with previously published data on Danish children referred for patch testing. Between 2012 and 2016, 1573 children and adolescents were patch tested. Overall, 385 (24.5%) had at least 1 positive patch test reaction. The overall prevalence was similar in boys and girls, across age groups, and in patients with and without atopic dermatitis. Statistically significant increases in contact allergy to fragrances and isothiazoliones were seen, whereas a decrease in nickel allergy was found. Allergic contact dermatitis continues to be a common disease in children, and is even significantly increasing for some allergens.

Ten‐year trends in contact allergy to formaldehyde and formaldehyde‐releasers

Preservatives such as formaldehyde and formaldehyde-releasers are common causes of contact allergy. To examine trends in contact allergy to formaldehyde and formaldehyde-releasers in patch tested patients in Denmark over a 10-year period (2007-2016), and to investigate relevant sources of formaldehyde among the patients. A cross-sectional registry study on patch test data from patients tested with formaldehyde and formaldehyde-releasers (N = 8463) was performed. The presence of released formaldehyde in products from formaldehyde-allergic patients was identified with chemical analyses (chromotropic acid or acetylacetone test). The prevalence of contact allergy to formaldehyde 1% was 1.5%, and ranged between 0.97% and 2.3%, with a decreasing trend in this 10-year period. Contact allergy to formaldehyde 2% was found in 2.4%, and no significant trend was observed. Quaternium-15 was the formaldehyde-releaser most often positive (0.86%). Patients allergic to formaldehyde often had simultaneous positive patch test reactions to formaldehyde-releasers (36%). Almost 63% of the patients with formaldehyde allergy used products that released formaldehyde; cosmetics were the most common sources. Although contact allergy to formaldehyde 1% decreased in this 10-year time period, contact allergies to formaldehyde and formaldehyde-releasers overall remain frequent in patients. In most cases, formaldehyde-allergic patients are exposed to ≥1 products containing formaldehyde. Improved regulation on permitted amounts of free formaldehyde in cosmetics is still warranted, including direct labelling of formaldehyde when it is present in small but relevant amounts.

Carvone Contact Allergy in Southern Sweden: A 21-year Retrospective Study.

Carvone (l-carvone), a mint flavour in spearmint oil, is considered a mild skin sensitizer. Carvone-sensitization may be linked to oral/perioral signs and oral lichen planus, but studies are sparse. The prevalence of patch test reactions to carvone and relevant findings from the positive group were investigated. Records for patch-tested patients at the Malmö clinic, for the period 1996 to 2016, were studied. Carvone-positive and carvone-negative patients were compared regarding patch test data from baseline series and dental series. Dental series-tested carvone-positive patients were also compared with a matched group. A total of 147 out of 4,221 referred patients had a positive patch test to carvone. Sensitized patients had higher mean age and were primarily women; 73% had oral signs and 57% had oral lichen. Concomitant patch test reactions to gold, nickel and mercury were common. In the matched group-comparison carvone-positive patients had a higher frequency of oral lichen, but no difference was found in sensitization to gold and mercury.

Risks of Allergic Contact Dermatitis Elicited by Nickel, Chromium, and Organic Sensitizers: Quantitative Models Based on Clinical Patch Test Data.

Risks of allergic contact dermatitis (ACD) from consumer products intended for extended (nonpiercing) dermal contact are regulated by E.U. Directive EN 1811 that limits released Ni to a weekly equivalent dermal load of ≤0.5μg/cm2 . Similar approaches for thousands of known organic sensitizers are hampered by inability to quantify respective ACD-elicitation risk levels. To help address this gap, normalized values of cumulative risk for eliciting a positive ("≥+") clinical patch test response reported in 12 studies for a total of n = 625 Ni-sensitized patients were modeled in relation to observed ACD-eliciting Ni loads, yielding an approximate lognormal (LN) distribution with a geometric mean and standard deviation of GMNi = 15μg/cm2 and GSDNi = 8.0, respectively. Such data for five sensitizers (including formaldehyde and 2-hydroxyethyl methacrylate) were also ∼LN distributed, but with a common GSD value equal to GSDNi and with heterogeneous sensitizer-specific GM values each defining a respective ACD-eliciting potency GMNi /GM relative to Ni. Such potencies were also estimated for nine (meth)acrylates by applying this general LN ACD-elicitation risk model to respective sets of fewer data. ACD-elicitation risk patterns observed for Cr(VI) (n = 417) and Cr(III) (n = 78) were fit to mixed-LN models in which ∼30% and ∼40% of the most sensitive responders, respectively, were estimated to exhibit a LN response also governed by GSDNi . The observed common LN-response shape parameter GSDNi may reflect a common underlying ACD mechanism and suggests a common interim approach to quantitative ACD-elicitation risk assessment based on available clinical data.

Airborne allergic contact dermatitis caused by isothiazolinones in water-based paints: a retrospective study of 44 cases.

Airborne allergic contact dermatitis caused by paints containing isothiazolinones has been recognized as a health hazard. To collect epidemiological, clinical and patch test data on airborne allergic contact dermatitis caused by isothiazolinone-containing paints in France and Belgium. A descriptive, retrospective study was initiated by the Dermatology and Allergy Group of the French Society of Dermatology, including methylchloroisothiazolinone (MCI)/methylisothiazolinone (MI)- and/or MI-sensitized patients who developed airborne allergic contact dermatitis following exposure to isothiazolinone-containing paint. Forty-four cases were identified, with mostly non-occupational exposure (79.5%). Of the patients, 22.5% of also had mucosal symptoms. In several cases, the dermatitis required systemic corticosteroids (27.3%), hospitalization (9.1%), and/or sick leave (20.5%). A median delay of 5.5 weeks was necessary to enable patients to enter a freshly painted room without a flare-up of their dermatitis. Approximately one-fifth of the patients knew that they were allergic to MI and/or MCI/MI before the exposure to paints occurred. Our series confirms that airborne allergic contact dermatitis caused by paints containing isothiazolinones is not rare, and may be severe and long-lasting. Better regulation of isothiazolinone concentrations in paints, and their adequate labelling, is urgently needed.

Contact sensitization of children: a two-decade years history in Naples

Contact sensitization (CS) and allergic contact dermatitis (ACD) were once thought to be rare in children. The aim of our study was to assess CS and ACD in children affected by eczematous conditions referring to our contact and occupational dermatoses service, and to compare the obtained data to the results of a similar study performed in our Department in late Eighties. A retrospective analysis of Patch Test data from the Database of Contact Allergy of the Department of Dermatology, University Federico II of Naples, was performed. Moreover results were compared to previous data recorded and analyzed in our center. Of the 416 examined patients, tested during 2005-2010 with the pediatric series, 37.5% developed at least one positive reaction, 15.4% was diagnosed with ACD. The most common allergen was nickel sulphate (16.8%) and the most frequently involved body sites were head and neck (16.3%). Compared to the 1989 study data, our current results highlighted an increase of CS (P<0.001) and ACD diagnosis (P<0.01). ACD and CS are significantly increased during the last 20 years in our young patients population. The widespread chemical use and premature adult-like attitude may be responsible for earlier and extended exposure to sensitizers.

Metals Are Important Contact Sensitizers: An Experience from Lithuania.

Background. Metals are very frequent sensitizers causing contact allergy and allergic contact dermatitis worldwide; up-to-date data based on patch test results has proved useful for the identification of a problem. Objectives. In this retrospective study prevalence of contact allergy to metals (nickel, chromium, palladium, gold, cobalt, and titanium) in Lithuania is analysed. Patients/Methods. Clinical and patch test data of 546 patients patch tested in 2014–2016, in Vilnius University Hospital Santariskiu Klinikos, was analysed and compared with previously published data. Results. Almost third of tested patients (29.56%) were sensitized to nickel. Younger women were more often sensitized to nickel than older ones (36% versus 22.8%, p = 0.0011). Women were significantly more often sensitized to nickel than men (33% versus 6.1%, p < 0.0001). Younger patients were more often sensitized to cobalt (11.6% versus 5.7%, p = 0.0183). Sensitization to cobalt was related to sensitization to nickel (p < 0.0001). Face dermatitis and oral discomfort were related to gold allergy (28% versus 6.9% dermatitis of other parts, p < 0.0001). Older patients were patch test positive to gold(I) sodium thiosulfate statistically significantly more often than younger ones (44.44% versus 21.21%, p = 0.0281). Conclusions. Nickel, gold, cobalt, and chromium are leading metal sensitizers in Lithuania. Cobalt sensitization is often accompanied by sensitization to nickel. Sensitivity rate to palladium and nickel indicates possible cross-reactivity. No sensitization to titanium was found.

Contact allergy trends in Singapore - a retrospective study of patch test data from 2009 to 2013.

Contact allergy trends in Singapore - a retrospective study of patch test data from 2009 to 2013.

Cement-Induced Chromate Occupational Allergic Contact Dermatitis.

Hexavalent chromium in cement is a common cause of occupational allergic contact dermatitis (OACD). Analysis of patch test data during 1999 to 2013 was done. Patients with cement-induced chromate OACD filled the Dermatology Life Quality Index, graded 1 to 5. Of 4846 consecutive patients who were patch tested, 146 (3%) were chromate-sensitive. Of 46 (31.5%) who presented with chromate OACD, 27 (59%) had cement-induced chromate OACD. The proportion of chromate-sensitive patients with clinically relevant cement exposure increased from 7.7% in 2002 to 2004 to 28.7% in 2011 to 2013 (P = 0.04). The median age of presentation was younger than for other chromate-sensitive patients (32 vs 42 years). Hand eczema (88.9%) was the most frequent clinical presentation. Of the 27 with cement-induced chromate OACD, 21 (77.8%) had ongoing dermatitis at the time of the review. Although 14/27 (51.9%) changed their occupation to avoid exposure to cement, symptoms persisted in 9/14 (64.3%). Prolonged exposure to cement before development of symptoms was associated with chronicity. All the symptomatic patients experienced at least a moderate effect on their quality of life (grade 3 or higher on the Dermatology Life Quality Index). We recommend the adoption of the European legislation in Israel, to reduce the prevalence of chromate OACD from cement.

Chromate Allergy in Northern Israel in Relation to Exposure to Cement and Detergents.

The prevalence of chromate allergy has declined worldwide in the last decades. The aim of the study was to assess tendencies in chromate allergy in northern Israel and its possible causes. Retrospective analysis of patch test data during 1999-2013 and a review of the medical records of patients with chromate allergy were conducted. A total of 4846 consecutive patients were patch tested, of whom 146 (3%) were found to be chromate sensitive. The prevalence of chromate allergy decreased significantly from 4.7% in 1999-2001 to 2.8% in 2002-2004 (P = 0.02). Since then, no significant fluctuations have occurred. A gradual and consistent decline in chromate allergy was recorded among women from 4.8% in 1999-2001 to 2.3% in 2008-2010. Cement (18.4%) was the most frequent source of exposure and was mainly observed in men. The frequency of clinically relevant cement exposure increased significantly from 7.7% in 2002-2004 to 28.7% in 2011-2013 (P = 0.04), whereas the frequency of relevant detergent exposure decreased significantly from 25% in 1999-2001 to 5.7% in 2011-2013 (P = 0.04). Hand (68.5%) was the most frequently involved anatomical site. The prevalence of chromate allergy in northern Israel is stable in the general population and gradually decreasing among women. These changes may be caused by reduced exposure to water-soluble hexavalent chromium in detergents but not in cement.

New Contact Allergens: 2008 to 2015.

Every year, new contact allergens, chemicals reported to have caused contact allergy/ACD for the first time, are described in literature. In the journals Contact Dermatitis and Dermatitis, 172 such compounds were identified in the period 2008-2015, 119 of which induced ACD. These are presented with the following data: name, synonyms, Chemical Abstracts Service (CAS) number, patch test data, function or class, causative product, number of patients, occupation (in case of occupational ACD), additional clinical data (if applicable), and references. Approximately one third of the new allergens were ingredients of cosmetics, followed by drugs causing occupational ACD (18%), chemicals in rubber, plastics, and paints (9%), drugs causing a drug eruption (9%), as well as chemicals used in laboratories inducing occupational ACD (8%). In 40%, the dermatitis was occupationally acquired. Fifty-three other chemicals causing contact allergy as indicated by positive patch test reactions only are shown without specifics.

Characteristics of patients patch tested in the European Surveillance System on Contact Allergies (ESSCA) network, 2009-2012.

Patch test results often vary between departments, and also between countries. Such variation may be partly attributable to systematic effects introduced by patient characteristics, differing exposures, patient selection, or methodological differences. To examine the amount of variation of patient characteristics in terms of the MOAHLFA index and of the proportion of patients with at least one positive reaction to the (European) baseline series ('P' measure), and to examine potential reasons for the variation. A retrospective analysis was performed of patch test data from 63 530 consultations collected by 53 departments from 12 countries participating in the European Surveillance System on Contact Allergies (ESSCA) ( www.essca-dc.org) between 2009 and 2012. Considerable variation in the prevalence of the MOAHLFA factors between departments was found, caused, for example, by differing specializations (e.g. occupational dermatology) or patient characteristics. Notable variation concerning the 'P' measure was observed; however, larger national networks (contributing to the ESSCA) tend to have quite similar ranges of this measure. Data from one department per country give valuable insights into the spectrum of contact allergy prevalence rates in that country, but are not as representative as national data pooled from several departments.

Assessing the relationship between contact sensitization and eczema in adolescents and adults on the example of nickel and neomycin: preliminary results of a meta‐analysis of epidemiological data

Background Throughout literature, positive patch tests to nickel were found in 8.0–51.5% patients with eczema and in 5.9– 27.8% general population, the respective figures for neomycin being 0.0–40.0% and 0.0–2.9%, respectively. As these ranges for eczema patients and general population overlap, it is not clear how strong is the association between the disease and contact sensitization to respective haptens. The aim of the study was to analyze the putative relationship between contact sensitization to nickel or neomycin and eczema with the means of meta-analysis of available data for adolescents and adults. Method A systematic review of published data on the prevalence of sensitization to nickel and neomycin in adolescent and adult eczema patients and the general population. Patch test data from studies of respective populations that were comparable with regard to geographical location, year of study, demographics of the study group and patch test protocols were extracted and pooled to calculate estimated odds ratios (eOD) and estimated attributable risk ratios (eAR). Results

Risk of sensitization to fragrances estimated on the basis of patch test data and exposure, according to volume used and a sample of 5451 cosmetic products

AbstractThe risk of sensitization cannot be derived from the frequency of sensitization to allergens alone, as exposure also should be considered. The occurrence of 26 fragrances in 5451 products based on the labelling of the ingredients was documented. Use volumes were provided by the International Fragrance Association (IFRA). Frequency of sensitization to fragrances was analysed based on IVDK data from September 2007 to December 2009. As an estimate of sensitization risk, the sensitization exposure quotient (SEQ) was calculated as the quotient of the relative frequency of sensitization and the relative frequency of use/labelling. The SEQs (the risk) varied greatly, offering a ranking regarding risk of sensitization: oak moss, tree moss, farnesol, methyl 2‐octynoate (methyl heptine carbonate) and isoeugenol at the top of the list indicating a (very) high risk of sensitization, butylphenyl methylpropional (Lilial ®), hexyl cinnamal, citronellol, linalool and limonene at the bottom, indicating a (very) low risk of sensitization. Compounds with a high risk were found to be classified as potent allergens according to the LLNA. High frequencies of sensitization may be put into perspective by the frequent use of certain fragrances. Despite infrequent use, others (with higher potencies or too high use concentrations) may turn out to be associated with an increased risk. Hazard assessment should be supplemented by risk assessment. Copyright © 2015 John Wiley &amp; Sons, Ltd.

Contact allergy trends in Sweden - a retrospective comparison of patch test data from 1992, 2000, and 2009.

Contact allergy prevalence rates change over time as a result of variations in allergen exposure. Data from patch test clinics are often used as markers for allergy trends. The aim of the present retrospective study was to describe trends in rates of sensitization to allergens in the Swedish baseline series. Prevalence rates are described by comparing consecutive patch test data from 1992, 2000 and 2009 in Swedish patch test clinics. In total, 3680 patients were included in 1992, 3825 in 2000, and 3112 in 2009. Among test substances with a sensitization rate above 2% in 2009, significant decreases were noted for nickel sulfate, cobalt chloride, colophonium, and methylchloroisothiazolinone (MCI)/methylisothiazolinone (MI), and a significant increase for p-phenylenediamine, as compared with 1992. Potassium dichromate reactions had increased among younger women, whereas reactions to nickel and cobalt had decreased in this group. Sensitization to chromium, cobalt and fragrance mix I had decreased among older men, and sensitization to nickel had decreased among younger men. It is probable that these changes in 1992-2009 reflect both changes in regulations for nickel, lower levels of chromium in cement and of MCI/MI in cosmetics, and increasing use of hair dyes.

Occupational contact allergy in nurses: results from the Information Network of Departments of Dermatology 2003-2012.

Healthcare workers are occupationally exposed to various allergens in protective gloves, surface or instrument disinfectants, drugs, and skin care products. An increased prevalence of sensitization to thiurams, glutaraldehyde, formaldehyde and glyoxal in nurses with occupational contact dermatitis (OCD) has been known since the 1990s. To update the range of occupational allergens in healthcare professionals. We retrospectively analysed patch test data from the Information Network of Departments of Dermatology (IVDK), 2003-2012. Patch test results from 2248 nurses with OCD were compared with those of 2138 nurses without OCD. Significantly increased sensitization rates were found for thiuram mix (6.7%), potassium dichromate (5.7%), methylchloroisothiazolinone/methylisothiazolinone (4.4%), colophonium (3.4%), 2-bromo-2-nitropropane-1,3-diol (1.7%), and zinc diethyldithiocarbamate (1.7%). Patch testing with products from the patients' workplaces gave additional clues to further allergens, for example tetrazepam. The known range of contact sensitization in nurses with OCD has been confirmed. Formaldehyde allergy seems to be less important today. Drugs such as tetrazepam are occupational sensitizers in nurses. The increase in chromium sensitization remains unexplained.

Allergic contact dermatitis to para-phenylenediamine.

Exposure to hair dye is the most frequent route of sensitisation to para-phenylenediamine (PPD), a common contact allergen. International studies have examined the profile of PPD, but Australian-sourced information is lacking. Patients are often dissatisfied with advice to stop dyeing their hair. This study examines patients' characteristics, patch test results and outcomes of PPD allergy from a single Australian centre, through a retrospective analysis of patch test data from 2006 to 2013 at the Liverpool Hospital Dermatology Department. It reviews the science of hair dye allergy, examines alternative hair dyes and investigates strategies for hair dyeing. Of 584 patients, 11 were allergic to PPD. Our PPD allergy prevalence rate of 2% is at the lower end of international reported rates. About half these patients also react to para-toluenediamine (PTD). Affected patients experience a significant lifestyle disturbance. In all, 78% tried alternative hair dyes after the patch test diagnosis and more than half continued to dye their hair. Alternative non-PPD hair dyes are available but the marketplace can be confusing. Although some patients are able to tolerate alternative hair dyes, caution is needed as the risk of developing an allergy to other hair dye ingredients, especially PTD, is high.

The first Australian Baseline Series: Recommendations for patch testing in suspected contact dermatitis.

Patch testing is a standard diagnostic tool used in the identification of causative allergens in allergic contact dermatitis. Ongoing surveillance of rates of allergen positivity is vitally important to detect trends and allow comparisons between countries. The objective of this study was to propose the first evidence-based Australian baseline series, based on retrospective review of our patch test data. We aimed to identify the most important and most relevant allergens in our population. We conducted a 10-year (2001-2010) retrospective review of data from the contact dermatitis clinic and the occupational dermatitis clinic from our institution. We patch tested 5281 patients in all. The top 20 allergens with the highest number of relevant positive patch test reactions were: fragrance mix 1: nickel, potassium dichromate, Myroxylon pereirae, formaldehyde, p-phenylenediamine (PPD), thiuram mix, colophony (rosin), dermatophagoides mix, ammonium persulfate, quaternium-15, cobalt chloride, methylchloroisothiazolinone or methylisothiazolinone, diazolidinylurea, epoxy resin, 1,3-dimethylol-5,5-dimethyl hydantoin, Compositae mix, toluenesulfonamide formaldehyde resin, basic red 46 and imidazolidinyl urea. We have elucidated the most frequent and relevant contact allergens in our patient population and used this information to construct the first Australian baseline series.

Occupational contact dermatitis in blue-collar workers: results from a multicentre study from the Danish Contact Dermatitis Group (2003-2012).

Blue-collar workers have a high risk of occupational contact dermatitis, but epidemiological studies are scarce. To investigate allergic contact dermatitis in blue-collar workers with dermatitis registered by the Danish Contact Dermatitis Group. 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. 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. 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.