Aggregate Exposure Assessment for Skin Sensitizing Fragrances: Using an Aggregate Exposure Model to Assign Maximum Concentration Levels.

摘要

Consumers are routinely exposed to fragrance materials in personal care products and cosmetics, which can potentially give rise to allergenic reactions and skin sensitization. Determining a safe level of a fragrance in personal care products and cosmetics requires consideration of a number of different factors, for which detailed data is often required in order to avoid worst case assumptions. In a population of consumers, different application sites are exposed to different combinations of products, which in turn are used in different amounts with varying levels of fragrances in the products themselves. Accurately accounting for this variability is necessary to accurately determine exposure, requiring probabilistic modelling and large data sets of consumer habits and practices. At the same time, a practically applicable method is needed that be used to set a maximum concentration of a fragrance material in a range of products when the No Expected Sensitisation Induction Level (NESIL) is known, along with the appropriate Safety Assessment Factors (SAFs) for different combinations of products and application sites (amongst others). The Creme RIFM aggregate exposure model is now routinely used for the safety assessment of fragrance materials currently on the market, and is capable of assessing dermal exposure to fragrance materials in consumer populations for all major product application sites. This model has recently be applied in the Quantitative Risk Assessment (QRA) of fragrance materials to derive a set of adjustment factors that can be used to set safe concentrations of fragrance materials in cosmetics and personal care products which take aggregate exposure into account. This presents a convenient and robust methodology for setting maximum allowable concentrations of fragrances in products that can be easily applied, includes consideration of aggregate exposure, and is protective of consumer risk to skin sensitization.