Publications : 2024

Burns AM, Ierardi AM. Risk evaluation of inhaled particulates during pressed powder makeup application. Abstract 3602, Society of Toxicology 63rd Annual Meeting, Salt Lake City, UT, March 2024.

Abstract

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Background and Purpose: Cosmetic makeup products typically contain various fillers, binding agents, colors, preservatives, and fragrance, with talc being one of many commonly used fillers. Typically, safety assessments of cosmetics are focused on dermal exposures. However, for powder products, the inhalation route of exposure is an important consideration. The European Association of the Cosmetic Industry (“Cosmetics Europe”) has proposed a framework for the safety evaluation of cosmetic powders, which was also referenced by the most recent 2021 Scientific Committee on Consumer Safety (SCCS) guidance. Under this proposed framework, compact or pressed powders require no further inhalation assessment due to the lack of significant airborne dust generation during typical use. To date, a number of studies have evaluated the potential airborne particulate exposures and consumer usage patterns associated with loose-matrix talc-containing cosmetic powder products. Yet, limited published data exists evaluating potential airborne exposures associated with consumer use of pressed powder formulations. Methods: Using previously published and validated fiber-to-dust conversion factors, we estimated potential airborne respirable dust exposures associated with consumer use of pressed powder products using recently published fiber air concentration data. We compared our estimated respirable dust air concentration data to measured respirable dust data associated with typical consumer use of loose-matrix products. Measured and estimated respirable dust data along with published consumer usage data were used to estimate eight-hour TWA values for comparison to the ACGIH TLV for talc of 2 mg/m3. Estimated pressed powder respirable dust air concentrations were also compared to Health Canada’s proposed adjusted NOAEC of 0.36 mg/m3 for talc based on non-cancer lung effects. Results: Overall, the results demonstrate that typical consumer use of both loose-matrix products and pressed powder products results in air concentrations well below the ACGIH TLV. Further, this comparison demonstrates that application of pressed powders results in potential exposures orders of magnitude below those associated with loosematrix powders; the margin of exposure calculated for consumer use of pressed powders compared to Health Canada’s proposed NOAEC is over 35,000, indicating low concern for a non-cancer inhalation health risk. Conclusions: The results of this exposure assessment support current safety assessment recommendations and demonstrate that particulate exposures associated with consumer use of pressed powder formulations are negligible and therefore are unlikely to pose a human health inhalation risk. Simulation studies specifically evaluating airborne respirable dust concentrations during typical consumer use of pressed powder products should be conducted to support the current model-derived conclusion.