CORESTA Meeting, Smoke Science/Product Technology, 2019, Hamburg, STPOST 33

Quantitative risk assessment (QRA) indicates reduced risk potential for carcinogenic and non-carcinogenic effects of the aerosol of the next generation products (NGPs) compared to reference cigarettes

AYALA-FIERRO F.(1); CZEKALA L.(2); SIMMS L.(2); RUDD K.(2); CAVA G.(2); STEVENSON M.(2)
(1) ITG Brands LLC, Greensboro, NC, U.S.A.; (2) Imperial Brands PLC, Bristol, U.K.

In order to understand the potential relative health risks of NGPs compared to cigarettes, we compared the relative risks of aerosols from tobacco-containing and tobacco-free NGPs to the smoke generated from a reference cigarette. Quantitative Risk Assessment (QRA) is a scientific, evidence-based analytical process that combines chemical and biological data to quantify the probability and potential impact of defined risks. This work will present a comparison of reduced exposure and corresponding potential risks for the myblu™ e-cigarette and heated tobacco (HT) in comparison to the reference cigarette. QRA was used to estimate the potential carcinogenic and non-carcinogenic effects of myblu™ e-cigarette and Pulze HT aerosols and these were compared to smoke from a reference cigarette (3R4F).

Selective harmful and potentially harmful constituents (HPHCs) were measured in myblu™ e-cigarette aerosol and converted to µg/L. For the HT and reference cigarette, the analytes were measured on a per unit basis (i.e. µg per cigarette). Exposure concentrations (EC) were estimated assuming a lifetime continuous exposure using the equation EC = AC × CPD (SPD) × ED × EF / DIR × AT for the HT stick and cigarette or EC = AC × (PC × PV) × ED × EF / DIR × AT for the e-cig, where EC: exposure concentration, AC: analyte concentration, CPD (SPD): cigarettes/HT sticks per day, ED: exposure duration (64.4 years), EF: exposure frequency (356 days), DIR: daily inhalation rate (20 m3/day), AT: averaging time (23506 days), PC: puff count (worst-case 400 puffs), and PV: puff volume (0.055 L).

Non-cancer risks were quantified using the hazard quotient (HQ) approach and cancer risks were estimated by calculating the incremental lifetime cancer risk (ILCR), utilizing non-cancer and cancer toxicity values issued by government agencies or published in the peer-review literature.

As may be expected, the modelling of exposure to HPHCs in both e-cigarette and HT aerosols lead to a marked reduction when compared to the smoke from reference cigarettes, indicating the potential for reduced non-cancer and cancer health hazard risks. Exposure to some analytes was found to be below LOD or LOQ for the test method.