Cancer potencies and margin of exposure used for comparative risk assessment of heated tobacco products and electronic c
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GENOTOXICITY AND CARCINOGENICITY
Cancer potencies and margin of exposure used for comparative risk assessment of heated tobacco products and electronic cigarettes aerosols with cigarette smoke Gregory Rodrigo1 · Guy Jaccard1 · Donatien Tafin Djoko1 · Alexandra Korneliou1 · Marco Esposito1 · Maxim Belushkin1 Received: 20 February 2020 / Accepted: 29 September 2020 © The Author(s) 2020
Abstract Health risk associated with the use of combustible cigarettes is well characterized and numerous epidemiological studies have been published for many years. Since more than a decade, innovative non-combusted tobacco products have emerged like heated tobacco products (HTP) or electronic cigarettes (EC). Long-term effects of these new products on health remain, however, unknown and there is a need to characterize associated potential health risks. The time dedicated to epidemiological data generation (at least 20 to 40 years for cancer endpoint), though, is not compatible with innovative development. Surrogates need, therefore, to be developed. In this work, non-cancer and cancer risks were estimated in a range of HTP and commercial combustible cigarettes based upon their harmful and potentially harmful constituent yields in aerosols and smoke, respectively. It appears that mean lifetime cancer risk values were decreased by more than one order of magnitude when comparing HTPs and commercial cigarettes, and significantly higher margin of exposure for non-cancer risk was observed for HTPs when compared to commercial cigarettes. The same approach was applied to two commercial ECs. Similar results were also found for this category of products. Despite uncertainties related to the factors used for the calculations and methodological limitations, this approach is valuable to estimate health risks associated to the use of innovative products. Moreover, it acts as predictive tool in absence of long-term epidemiological data. Furthermore, both cancer and non-cancer risks estimated for HTPs and ECs highlight the potential of reduced risk for non-combusted products when compared to cigarette smoking. Keywords Margin of exposure approach · Cancer potency · Heated tobacco product · Risk assessment · Electronic cigarette
Introduction Electronic cigarettes (EC) and heated tobacco products (HTP) are becoming popular alternatives to cigarettes in a number of countries. For example, HTPs have partially replaced cigarettes in Japan since their introduction (Stoklosa et al. 2019), while the prevalence of ECs has risen in the United States (Berry et al. 2018; Soneji et al. 2018) and in a Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00204-020-02924-x) contains supplementary material, which is available to authorized users. * Guy Jaccard [email protected] 1
PMI R&D, Philip Morris Products S.A., Rue des Usines 56, 2000 Neuchâtel, Switzerland
number of other countries (Filippidis et al. 2017). EC aerosols are generated from the heating of liquids (Farsalinos and Polosa 2014), and HTP aer
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