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
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.