Weight of Evidence Approach for Skin Sensitization Potency Categorization of Fragrance Ingredients.

Background: Reliable human potency data are necessary for conducting quantitative risk assessments, as well as development and validation of new nonanimal methods for skin sensitization assessments. Previously, human skin sensitization potency of fragrance materials was derived primarily from human data or the local lymph node assay.

Objectives: This study aimed to define skin sensitization potency of fragrance materials via weight of evidence approach, incorporating all available human, animal, in vitro, in chemico, and in silico data.

Methods: All available data on 106 fragrance materials were considered to assign each material into 1 of the 6 defined potency categories (extreme, strong, moderate, weak, very weak, and nonsensitizer).

Results: None of the 106 materials were considered an extreme sensitizer, whereas a total of 6, 23, 41, and 26 materials were categorized as strong, moderate, weak, and very weak sensitizers, respectively. Ten materials lacked evidence for the induction of skin sensitization.

Conclusions: Skin sensitization potency categorization of the 106 fragrance materials based on the described weight of evidence approach can serve as a useful resource in evaluation of nonanimal methods, as well as in risk assessment.