20
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Comparative and cumulative quantitative risk assessments on a novel heated tobacco product versus the 3R4F reference cigarette

      research-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Graphical abstract

          Highlights

          • Quantitative risk assessment comparing emissions from an HTP with 3R4F smoke.

          • Principles used by US regulatory bodies are applied for tobacco products.

          • in vitro and in vivo data for the HTP show reduced biological activity.

          • Clinical data for the HTP shows reduced biomarkers of potential harm and exposure.

          • Results suggest considerable (over 90 %) reduction in non-cancer and cancer risks.

          Abstract

          Novel tobacco products that heat rather than burn tobacco (heated tobacco products or HTPs) have been shown to produce lower levels of harmful and potentially harmful constituents than conventional combusted cigarettes. The present study uses a quantitative risk assessment approach to compare non-cancer and cancer risk estimates for emissions generated by an HTP with smoke from a reference cigarette (3R4F). Fifty-four analytes were evaluated from the HTP aerosol and the 3R4F cigarette smoke. Emissions were generated using the ISO and the Health Canada Intense smoking regimes. The measured values were extrapolated to define a conservative exposure assumption for per day use and lifetime use based on an estimated maximum usage level of 400 puffs per day i.e., approximately 8 HTP tobacco capsules or 40 combustible cigarettes. Non-cancer and cancer risk estimates were calculated using these exposure assumptions for individual and per health outcome domains based on toxicological reference values derived by regulatory and/or public health agencies. The results of this assessment showed a reduction of non-cancer and cancer risk estimates by more than 90 % for the HTP versus the 3R4F cigarette, regardless of the smoking regime.

          Related collections

          Most cited references59

          • Record: found
          • Abstract: not found
          • Article: not found

          Smoking and carcinoma of the lung; preliminary report.

            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Application of toxicological risk assessment principles to the chemical constituents of cigarette smoke.

            To provide a hazard prioritisation for reported chemical constituents of cigarette smoke using toxicological risk assessment principles and assumptions. The purpose is to inform prevention efforts using harm reduction. International Agency for Research on Cancer Monographs; California and US Environmental Protection Agency cancer potency factors (CPFs) and reference exposure levels; scientific journals and government reports from the USA, Canada, and New Zealand. This was an inclusive review of studies reporting yields of cigarette smoke constituents using standard ISO methods. Where possible, the midpoint of reported ranges of yields was used. Data on 158 compounds in cigarette smoke were found. Of these, 45 were known or suspected human carcinogens. Cancer potency factors were available for 40 of these compounds and reference exposure levels (RELs) for non-cancer effects were found for 17. A cancer risk index (CRI) was calculated by multiplying yield levels with CPFs. A non-cancer risk index (NCRI) was calculated by dividing yield levels with RELs. Gas phase constituents dominate both CRI and NCRI for cigarette smoke. The contribution of 1,3-butadiene (BDE) to CRI was more than twice that of the next highest contributing carcinogen (acrylonitrile) using potencies from the State of California EPA. Using those potencies from the USEPA, BDE ranked third behind arsenic and acetaldehyde. A comparison of CRI estimates with estimates of smoking related cancer deaths in the USA showed that the CRI underestimates the observed cancer rates by about fivefold using ISO yields in the exposure estimate. The application of toxicological risk assessment methods to cigarette smoke provides a plausible and objective framework for the prioritisation of carcinogens and other toxicant hazards in cigarette smoke. However, this framework does not enable the prediction of actual cancer risk for a number of reasons that are discussed. Further, the lack of toxicology data on cardiovascular end points for specific chemicals makes the use of this framework less useful for cardiovascular toxicity. The bases for these priorities need to be constantly re-evaluated as new toxicology information emerges.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: found
              Is Open Access

              Hazardous Compounds in Tobacco Smoke

              Tobacco smoke is a toxic and carcinogenic mixture of more than 5,000 chemicals. The present article provides a list of 98 hazardous smoke components, based on an extensive literature search for known smoke components and their human health inhalation risks. An electronic database of smoke components containing more than 2,200 entries was generated. Emission levels in mainstream smoke have been found for 542 of the components and a human inhalation risk value for 98 components. As components with potential carcinogenic, cardiovascular and respiratory effects have been included, the three major smoke-related causes of death are all covered by the list. Given that the currently used Hoffmann list of hazardous smoke components is based on data from the 1990s and only includes carcinogens, it is recommended that the current list of 98 hazardous components is used for regulatory purposes instead. To enable risk assessment of components not covered by this list, thresholds of toxicological concern (TTC) have been established from the inhalation risk values found: 0.0018 μg day−1 for all risks, and 1.2 μg day−1 for all risks excluding carcinogenicity, the latter being similar to previously reported inhalation TTCs.
                Bookmark

                Author and article information

                Contributors
                Journal
                Toxicol Rep
                Toxicol Rep
                Toxicology Reports
                Elsevier
                2214-7500
                02 November 2020
                2020
                02 November 2020
                : 7
                : 1502-1513
                Affiliations
                [0005]Scientific and Regulatory Affairs, JT International SA, Geneva, Switzerland
                Author notes
                [* ]Corresponding author at: Scientific and Regulatory Affairs, JT International SA, 8, rue Kazem Radjavi, 1202, Geneva, Switzerland. irene.abraham@ 123456jti.com
                [1]

                Authors contributed equally.

                [2]

                Present position: Senior Science Advisor/Senior Leader, Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Washington, D.C.

                Article
                S2214-7500(20)30427-3
                10.1016/j.toxrep.2020.10.019
                7658373
                f1e03329-e019-41ba-8c0e-a4d74f3cde26
                © 2020 The Author(s)

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 20 April 2020
                : 9 October 2020
                : 23 October 2020
                Categories
                Regular Article

                quantitative risk assessment,heated tobacco product,harmful and potentially harmful constituents

                Comments

                Comment on this article