Fragrances Categorized According to Relative Human Skin Sensitization Potency

Abstract

BackgroundThe development of non-animal alternatives for skin sensitization potency prediction is dependent upon the availability of a sufficient dataset whose human potency is well characterized. Previously, establishment of basic categorization criteria for 6 defined potency categories, allowed 131 substances to be allocated into them entirely on the basis of human information.ObjectivesTo supplement the original dataset with an extended range of fragrance substances.MethodsA more fully described version of the original criteria was used to assess 89 fragrance chemicals, allowing their allocation into one of the 6 potency categories.ResultsNone of the fragrance substances were assigned to the most potent group, category 1, whereas 11 were category 2, 22 were category 3, 37 were category 4, and 19 were category 5. Although none were identified as non-sensitizing, note that substances in category 5 also do not pass the threshold for regulatory classification.ConclusionsThe combined datasets of >200 substances placed into potency categories solely on the basis of human data provides an essential resource for the elaboration and evaluation of predictive non-animal methods.

Computational approaches for skin sensitization prediction

“…For 57 substances, EC3 values were collected from more than one LLNA study and merged using a newly developed, median-like location parameter. Human data were collected from Basketter et al (2014) and Api et al (2017), whereas non-animal testing data were retrieved from, among others, Urbisch et al (2015) and Natsch et al (2013). The non-animal testing data not only comprise binary testing results but also several (partly quantitative) outcomes for each testing method.…”

Nickel: Intrinsic Skin Sensitization Potency and Relation to Prevalence of Contact Allergy

“…As a further point of reference, the human potency categories previously defined for skin sensitizers are used, suggesting nickel fits toward the middle of this grouping. 9 , 10 …”

“…That skin sensitizers do have widely differing intrinsic induction potency is well described in animal models, as well as in humans. 8 – 10 The central question addressed is where nickel fits into the potency spectrum; a secondary question considers thresholds. 11 , 12 Prompted by this discussion is the question of whether there is a relationship between the potency of an allergen and its elicitation threshold.…”

Contact Allergy to Fragrances: In Vitro Opportunities for Safety Assessment

“…Robust and reliable methods for the assessment of relative skin sensitizing potency is central for the classification of contact allergens for the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and for the development of accurate assessment of risk [10,[15][16][17]. Based on human data, 89 fragrances have been classified according to their human skin sensitization potency, which includes six categories, where category 1 (extreme) includes chemicals with human repeated insult patch test/human maximization test NOEL <25 µg/cm 2 and frequency > 3% in the diagnostic patch test, and category 6 are the non-sensitizer [18]. Of these, none of the fragrances were assigned to category 1, whereas 11 were category 2, 22 were category 3, 37 were category 4, and 19 were category 5.…”

“…Of these, none of the fragrances were assigned to category 1, whereas 11 were category 2, 22 were category 3, 37 were category 4, and 19 were category 5. Fragrances in category 2 include oakmoss, citronitrile, trans-2-hexenal, jasmalone, creosol, isoeugenol, pomarose, 6-methyl-3,5-heptadien-2-one, trans-damascone, tea leaf absolute, methyl heptine carbonate [18].…”