Fragrances Categorized According to Relative Human Skin Sensitization Potency.

BACKGROUND

The 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.

OBJECTIVES

To supplement the original dataset with an extended range of fragrance substances.

METHODS

A 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.

RESULTS

None 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.

CONCLUSIONS

The 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.