Exposing Ingredient Exposure: It's Better Than We Thought


A new paper published in Regulatory Toxicology and Pharmacology provides an update on a test model that can estimate aggregated user exposures to ingredients in personal care products. This model is the result of a joint project between the Research Institute for Fragrance Materials (RIFM) and Creme Global Ltd. Interestingly, the results suggest consumers are less exposed to certain ingredients than previously thought.

In part one of the study, the Creme RIFM model is described whereby some 36,446 subjects across European countries and the United States were surveyed for daily cosmetic and personal care product use over several days by differing demographics and the amounts used per application. This enabled the calculation of aggregate exposures to cosmetic and personal care products in a representative population.

From there, Monte Carlo simulations of product amount per use and body measurements, in conjunction with statistical analyses of habits and practices, showed the data could be used to estimate consumer ingredient exposure. This, in turn, could could assist in determining ingredient safety.

In part two, researchers continue the study, adding data on habits and practices, which enables the model to estimate consumer exposure from dermal, oral and inhalation routes for 25 product types. Furthermore, concentration data has been obtained to model the levels of fragrance in these product types. The present paper shows results of simulated systemic exposure (in μg/kg bw/day) for each fragrance ingredient in each product type, along with simulated aggregate exposure.

Interestingly, these results indicate the highest fragrance exposure occurred from body lotions, body sprays and hydroalcoholic products. However, for the fragrances investigated, aggregate exposure calculated was 11.5–25 fold lower than that calculated using deterministic methodology—suggesting lower exposure levels than previously anticipated.

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