Updating exposure assessment for skin sensitization quantitative risk assessment for fragrance materials

Api, A.M.; Basketter, David A.; Bridges, James W.; Cadby, Peter A.; Ellis, Graham; Gilmour, Nicola; Greim, Helmut; Griem, Peter; Kern, Petra; Khaïat, Alain; O’Brien, John; Rustemeyer, Thomas; Ryan, Cindy A.; Safford, Bob; Smith, Benjamin; Vey, Matthias; White, Ian R.

doi:10.1016/j.yrtph.2020.104805

Cited by 89 publications

(44 citation statements)

References 58 publications

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“…25 Recently QRA1 has been refined, termed QRA2, which includes aggregate exposure to fragrances from multiple product use. 12 The design of the current study did not allow us to perform an aggregate exposure analysis for specific fragrance ingredients. However, we aimed to calculate an aggregate exposure to scented products by calculating the total sum of the frequency of exposure to the included scented products, thereby creating a continuous outcome as described in the methods.…”

Section: Associations Between Exposure To Scented Products and Fragrance Contact Allergymentioning

confidence: 99%

“…Longitudinal clinical studies to evaluate the efficacy of QRA2 as a tool for prevention of fragrance contact allergy are required. 12…”

Section: Associations Between Exposure To Scented Products and Fragrance Contact Allergymentioning

confidence: 99%

“…8 Multiple studies have evaluated the safety of chemicals in scented products and/or used quantitative risk assessment (QRA) to evaluate the induction of sensitization resulting from exposure to scented products. [9][10][11][12] These studies were carried out by calculating product use data using product information sheets or market information databases. Studies evaluating overall real life exposure to scented products are scarce.…”

Section: Introductionmentioning

confidence: 99%

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Skin exposure to scented products used in daily life and fragrance contact allergy in the European general population ‐ The EDEN Fragrance Study

et al. 2021

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Background: Fragrances are widely used in scented products used in daily life with the potential to induce skin sensitization.Objective: To evaluate exposure to scented products and to explore associations between exposure and fragrance contact allergy. Methods:A cross-sectional study on individuals from 18 to 74 years of age, who were randomly selected from the general population in five European countries. A random sample (N = 3119) was patch tested and interviewed on exposure to scented products.Results: Female participants were strongly associated with exposure to scented products relative to male participants. Participants age 40 years and older showed an inverse association with exposure to scented products. Compared to Sweden, The Netherlands followed by Germany showed the highest overall exposure to scented products. Sensitive skin was associated with exposure to scented products and with fragrance allergy. In univariable regression analysis, exposure to leave-on products and to specific scented product subgroups was significantly associated with fragrance allergy. Conclusion:Exposure to scented products depends primarily on sex and age. Female sex and sensitive skin are relevant indicators for developing fragrance allergy.Because aggregate exposure, especially to scented leave-on products, may enhance the prevalence of contact allergy to fragrances, further investigations into exposure amounts and frequencies is warranted.

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Section: Associations Between Exposure To Scented Products and Fragrance Contact Allergymentioning

confidence: 99%

“…Longitudinal clinical studies to evaluate the efficacy of QRA2 as a tool for prevention of fragrance contact allergy are required. 12…”

Section: Associations Between Exposure To Scented Products and Fragrance Contact Allergymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Skin exposure to scented products used in daily life and fragrance contact allergy in the European general population ‐ The EDEN Fragrance Study

et al. 2021

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“…The analysis carried out before the initiation of an HRIPT focuses on the definition of a NESIL. 17 , 25 However, to ensure that prediction is accurate, the human test is also performed, because there is evidence that albeit infrequently, the potency of a skin sensitizer differs between mice and humans. 26 Thus, this usage passes the essential criterion that it has scientific merit.…”

Section: Discussionmentioning

confidence: 99%

Fragrance Skin Sensitization Evaluation and Human Testing: 30-Year Experience

Na¹,

Ritacco²,

O’Brien³

et al. 2020

Dermatitis

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634

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Background The human repeated insult patch test (HRIPT) has a history of use in the fragrance industry as a component of safety evaluation, exclusively to confirm the absence of skin sensitization at a defined dose. Objective The aim of the study was to document the accumulated experience from more than 30 years of conducting HRIPTs. Methods A retrospective collation of HRIPT studies carried out to a consistent protocol was undertaken, with each study comprising a minimum of 100 volunteers. Conclusions The HRIPT outcomes from 154 studies on 134 substances using 16,512 volunteers were obtained. Most studies confirmed that at the selected induction/challenge dose, sensitization was not induced. In 0.12% of subjects (n = 20), there was induction of allergy. However, in the last 11 years, only 3 (0.03%) of 9854 subjects became sensitized, perhaps because of improved definition of a safe HRIPT dose from the local lymph node assay and other skin sensitization methodologies, as well as more rigorous application of the standard protocol after publication in 2008. This experience with HRIPTs demonstrates that de novo sensitization induction is rare and becoming rarer, but it plays an important role as an indicator that toxicological predictions from nonhuman test methods (in vivo and in vitro methods) can be imperfect.

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“…Therefore, for a human health risk assessment, it is important to evaluate the sensitization potential and consumer exposure levels to the chemical. To assess this risk, a quantitative risk assessment (QRA) approach has been developed by the International Fragrance Association (Api et al, 2020(Api et al, , 2008Basketter & Safford, 2016). The skin sensitization QRA approach is based upon determining the sensitization threshold, as such limits exist for the induction of DTH (Boukhman & Maibach, 2001).…”

Section: Introductionmentioning

confidence: 99%

Total dose defines the incidence of percutaneous IgE/IgG1 mediated immediate‐type hypersensitivity caused by papain

Yokozeki

Tobisawa

Ogasawara

et al. 2020

J of Applied Toxicology

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Assessment of human health risk requires an understanding of antigen dose metrics associated with toxicity. Whereas assessment of the human health risk for delayed‐type hypersensitivity is understood, the metrics remain unclear for percutaneous immediate‐type hypersensitivity (ITH) mediated by IgE/IgG1. In this work, we aimed to investigate the dose metric for percutaneous ITH mediated by IgE/IgG1 responses. Papain, which causes ITH via percutaneous sensitization in humans, was used to sensitize guinea pigs and mice. The total dose per animal or dose per unit area was adjusted to understand the drivers of sensitization. Passive cutaneous anaphylaxis (PCA) and enzyme‐linked immunosorbent assay (ELISA) for papain‐specific IgG1 enabled quantification of the response in guinea pigs. In mice, the number of antigen‐bearing B cells in the draining lymph nodes (DLN) was calculated using flow cytometry papain‐specific IgG1 and IgE levels were quantified by ELISA. PCA positive test rates and the amounts of antigen‐specific antibody corresponded with total dose per animal, not dose per unit area. Furthermore, the number of B cells taking up antigen within DLN also correlated with total dose. These findings indicate that the total antigen dose is the important metric for percutaneous IgE/IgG1‐mediated ITH.

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Updating exposure assessment for skin sensitization quantitative risk assessment for fragrance materials

Cited by 89 publications

References 58 publications

Skin exposure to scented products used in daily life and fragrance contact allergy in the European general population ‐ The EDEN Fragrance Study

Skin exposure to scented products used in daily life and fragrance contact allergy in the European general population ‐ The EDEN Fragrance Study

Fragrance Skin Sensitization Evaluation and Human Testing: 30-Year Experience

Total dose defines the incidence of percutaneous IgE/IgG1 mediated immediate‐type hypersensitivity caused by papain

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