The dose–response relationship between the patch test and ROAT and the potential use for regulatory purposes

Fischer, Louise Arup; Voelund, Aage; Andersen, Klaus Ejner; Menné, Torkil; Johansen, Jeanne Duus

doi:10.1111/j.1600-0536.2009.01607.x

Cited by 46 publications

(47 citation statements)

References 47 publications

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“…When various usage tests including ROATs have been performed with fragrance sensitizers, positive reactions have been obtained in 0–100% of participants . Major reasons for the great variation are the concentration, the actual dose per cm 2 of the applied usage or ROAT preparation, and the length of the application period.…”

Section: Discussionmentioning

confidence: 99%

Validation of a questionnaire algorithm based on repeated open application testing with the constituents of fragrance mix I

et al. 2019

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Summary Background In a European study on contact allergy in the general population, it was hypothesized that the combination of contact allergy to a fragrance together with a history indicating dermatitis at exposure, and thereafter subsequent avoidance of scented products, implied a diagnosis of allergic contact dermatitis. Objectives The primary aim of this study was to validate this hypothesis and algorithm. The secondary aim was to investigate whether there was any association between the outcome of the repeated open application test (ROAT) and the patch test reactivity. Methods In total, 109 patients with and without contact allergy to fragrance mix (FM) I were recruited. Volunteers from six European dermatology clinics participated in the study including a patch test and a ROAT. Results Positive ROAT reactions were noted in 26 of the 44 volunteers with contact allergy to FM I. None of the volunteers reacted to the vehicle (P < 0·001). More individuals with a positive algorithm had positive ROATs than those with a negative algorithm. However, the difference was not statistically significant. The lower the patch test concentration eliciting a positive test reaction, the more likely a positive ROAT and the more likely that the positive ROAT appeared early during the investigative period. Conclusions The algorithm used in this study was not substantiated in this ROAT set‐up. The stronger the patch test reactivity the more likely was a positive ROAT and the more likely it was that the positive ROAT appeared early during the application period. What's already known about this topic? To the best of our knowledge, a scientifically designed and conducted repeated open application test (ROAT) has never been performed before to validate a diagnosis of allergic contact dermatitis partly based on a questionnaire. What does this study add? This is the largest controlled, randomized and blinded ROAT performed to date. Higher patch test reactivity to fragrance mix I indicated a greater likelihood of a positive ROAT. What are the clinical implications of this work? Further refinement of the questions is required in order to diagnose allergic contact dermatitis from fragrances based on a questionnaire.

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Section: Discussionmentioning

confidence: 99%

Validation of a questionnaire algorithm based on repeated open application testing with the constituents of fragrance mix I

et al. 2019

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“…The accumulated nickel skin dose (μg/cm 2 ) is recognized as the major factor that determines the risk of nickel allergy and allergic nickel dermatitis . The elicitation threshold for accumulated repeated nickel exposures corresponds to one higher single dose . Other essential factors are the type of exposure (on skin, penetrating, or systemic), the skin status (intact, irritated or damaged), the skin area, the bioavailability in the skin, the duration, previous dermatitis, and combined exposure with irritants.…”

Section: Thresholds For Nickel Allergymentioning

confidence: 99%

Nickel allergy and allergic contact dermatitis: A clinical review of immunology, epidemiology, exposure, and treatment

et al. 2019

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Nickel is the most frequent cause of contact allergy worldwide and has been studied extensively. This clinical review provides an updated overview of the epidemiology, exposure sources, methods for exposure quantification, skin deposition and penetration, immunology, diagnosis, thresholds for sensitization and elicitation, clinical pictures, prevention, and treatment. The implementation of a nickel regulation in Europe led to a decrease in the prevalence of nickel allergy, and changes in the clinical picture and disease severity. Nevertheless, the prevalences of nickel allergy in the European general population are approximately 8% to 19% in adults and 8% to 10% in children and adolescents, with a strong female predominance. Well‐known consumer items such as jewellery and metal in clothing are still the main causes of nickel allergy and dermatitis, although a wide range of items for both private and occupational use may cause dermatitis. Allergic nickel dermatitis may be localized to the nickel exposure site, be more widespread, or present as hand eczema. Today, efficient methods for exposure quantification exist, and new insights regarding associated risk factors and immunological mechanisms underlying the disease have been obtained. Nevertheless, questions remain in relation to the pathogenesis, the persistent high prevalence, and the treatment of severe cases.

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“…Alternatively, the repeated open application test (ROAT) [75] can be employed in which formulations with different concentrations of the sensitizer, as well as a control formulation without the sensitizer, are employed and a NOEL or BMD determined. There is good correlation between the results from the patch test and the ROAT [76]. As noted earlier, the induction and elicitation dose responses are not entirely independent, and there is not a clear demarcation between induction and elicitation.…”

Section: Clinical and Epidemiological Datamentioning

confidence: 74%

Immunotoxicology and Its Application in Risk Assessment

Rooney

Luebke

Selgrade

et al. 2012

Experientia Supplementum

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Immunotoxicology is the study of undesired modulation of the immune system by extrinsic factors. Toxicological assessments have demonstrated that the immune system is a target following exposure to a diverse group of xenobiotics including ultraviolet radiation, chemical pollutants, therapeutics, and recreational drugs. There is a well-established cause and effect relationship between suppression of the immune response and reduced resistance to infections and certain types of neoplasia. In humans, mild-to-moderate suppression of the immune response is linked to reduced resistance to common community-acquired infections, whereas opportunistic infections, which are very rare in the general population, are common in individuals with severe suppression. Xenobiotic exposure may also result in unintended stimulation of immune function. Although a cause and effect relationship between unintended stimulation of the immune response and adverse consequences has yet to be established, evidence does suggest that hypersensitivity, autoimmunity, and pathological inflammation may be exacerbated in susceptible populations exposed to certain xenobiotics. Xenobiotics can act as allergens and elicit hypersensitivity responses, or they can modulate hypersensitivity responses to other allergens such as pollen or dust mite by acting as adjuvants, enhancing the development or expression of hypersensitivity. Allergic contact dermatitis, allergic rhinitis, and asthma are the most commonly encountered types of hypersensitivity reactions resulting from chemical exposure. The immunologic effectors and mechanisms involved in autoimmune reactions are the same as those associated with responses to foreign antigens; however, the reactions are directed against the host's own cells. Thus, chemicals that induce immune suppression, nonspecific immunostimulation, or hypersensitivity may also impact autoimmunity. Risk assessment for immunotoxicity should be performed using the same approaches and principles for other noncancer effects. However, since xenobiotics may have effects on more than one aspect of immune function, immunotoxicity data should be evaluated separately for evidence of suppression, stimulation, hypersensitivity, and autoimmunity.

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The dose–response relationship between the patch test and ROAT and the potential use for regulatory purposes

Abstract: This equation may be used for non-volatile compounds other than nickel and MDBGN, after further validation. The relationship between the patch test and the ROAT can be used for prevention, to set safe levels of allergen exposure based on patch test data.

Cited by 46 publications

References 47 publications

Validation of a questionnaire algorithm based on repeated open application testing with the constituents of fragrance mix I

Validation of a questionnaire algorithm based on repeated open application testing with the constituents of fragrance mix I

Nickel allergy and allergic contact dermatitis: A clinical review of immunology, epidemiology, exposure, and treatment

Immunotoxicology and Its Application in Risk Assessment

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