电子烟产品的定量风险评估方法OA北大核心CSTPCD

As electronic cigarettes(e-cigarettes)continue to evolve and gain traction in the global markets,concerns regarding the potential health risks of vaping are growing.Compared to combustible cigarette smoke,the aerosol from e-cigarettes typically produces significantly lower levels of harmful and potentially harmful constituents(HPHCs).Quantitative risk assessment(QRA)is a scientific,evidence-based toxicological process that combines chemical and biological data to evaluate the risk of adverse health effects from exposure to health hazards.QRA has been widely used by Chinese and international regulatory agencies for decision-making of whether tobacco products meet regulatory requirements.The objective of this study was to establish a QRA framework,as part of a nonclinical weight of evidence approach,for evaluating relative health risks of e-cigarettes compared to combustible cigarettes to support product development and innovation.Aerosol samples from a closed,pod-based e-cigarette(a product sold exclusively overseas)were analyzed for HPHCs and target constituents its aerosol under both non-intense and intense puffing conditions and compared to HPHC emissions from the mainstream smoke of the Kentucky 1R6F reference cigarette.Toxicity reference values,i.e.reference concentration and inhalation unit risk,for HPHCs and target constituents obtained from regulatory and public health databases were used to determine their carcinogenic and non-carcinogenic health-based guidance values.Using exposure parameters unique to Chinese smokers as well as standard default exposure parameters for human health risk assessment,exposure concentrations were estimated for both"typical"and"heavy"consumer exposure scenarios.The potential health risks associated with the inhalation of machine-generated HPHC and target constituent emissions from e-cigarettes and combustible cigarettes for Chinese adult consumers were assessed and compared by integrating the exposure assessment and dose-response assessment into quantitative estimates of non-cancer health hazards and excess lifetime cancer risk.The estimated risks of vaping the closed-system e-cigarette for respiratory,cardiovascular,reproductive,developmental toxicity,and cancer were found to be at least 95.0%lower than those of cigarette smoking.These results were estimated using the QRA method described and therefore require further clinical and population studies to confirm.Although the results do not indicate absolute risk or represent epidemiologic data,the QRA approach provides an up-to-date,practical,and efficient tool for comparing the inhalation risks of e-cigarettes and combustible cigarettes,thus providing useful guidance to support responsible product research and innovation.