CORESTA Congress, Quebec, 2014, Smoke Science/Product Technology Groups, ST 78

Predictability of in vitro toxicological assessments of cigarettes: analysis of seven years of regulatory submissions to Canadian authorities

(1) Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland; (2) Rothmans, Benson & Hedges Inc., Brampton, Ontario, Canada

Canadian authorities have required the annual submission of a wealth of by-brand information about cigarettes – including analytical data for cut filler and mainstream smoke constituents, for more than a decade. In 2005, the reporting requirements were extended to include results of three in vitro toxicity tests. These toxicity tests are to be performed on each brand annually, regardless of whether modifications to the brand were made. In the present study[1], information covering the period 2006-2012 submitted by Rothmans, Benson & Hedges – the Canadian affiliate of Philip Morris International – was analysed to investigate the possibility of establishing quantitative models for the in vitro toxicological endpoint responses to cigarette smoke. For the first time this dataset has allowed the confirmation of previously published results concerning the influence of such factors as cigarette blend, diameter and filter type on in vitro toxicity at the level of a representative range of products on a market. Taking these cigarette design features into account and adding a limited amount of quantitative mainstream smoke composition information, it was shown that, within the boundaries of the considered cigarette design parameters, the in vitro toxicological response could be effectively predicted. In vitro tests of tobacco products are an invaluable initial comparative product assessment tool. The present results reveal the limited value of data from repeated tests on products within the specified design ranges.

[1] Belushkin M.; Piadé J-J.; Chapman S.; Fazekas G.; Investigating predictability of in vitro toxicological assessments of cigarettes: Analysis of 7 years of regulatory submissions to Canadian regulatory authorities. Regulatory Toxicology and Pharmacology 2014, 68 (2), 222-230.