Characterization of smoke and aerosol deliveries from combustible cigarettes, heated tobacco products and electronic nicotine delivery systems in the Vitrocell® Mammalian 6/48 exposure module

Toxicology Reports - Tập 9 - Trang 1985-1992 - 2022
Brian M. Keyser1, Robert Leverette1, Michael Hollings2, Adam Seymour2, Randy A. Weidman3, Carlton J. Bequette3, Kristen Jordan1
1RAI Services Company, Scientific & Regulatory Affairs, 401 North Main Street, Winston-Salem, NC 27101, USA
2Labcorp Early Development Laboratories Ltd., Harrogate, North Yorkshire, UK
3RJ Reynolds Tobacco Company, 950 Reynolds Blvd., Winston-Salem, NC 27106, USA

Tài liệu tham khảo

Adamson, 2014, An inter-machine comparison of tobacco smoke particle deposition in vitro from six independent smoke exposure systems, Toxicol. Vitr., 28, 1320, 10.1016/j.tiv.2014.06.012 Adamson, 2016, Application of dosimetry tools for the assessment of e-cigarette aerosol and cigarette smoke generated on two different in vitro exposure systems, Chem. Cent. J., 10, 74, 10.1186/s13065-016-0221-9 Aufderheide, 2007, A modified Ames assay reveals the mutagenicity of native cigarette mainstream smoke and its gas vapour phase, Exp. Toxicol. Pathol.: Off. J. Ges. fur Toxikol. Pathol., 58, 383, 10.1016/j.etp.2007.02.002 Behrsing, 2018, Characterization of a vitrocell VC1 using nicotine dosimetry: an essential component toward standardized in vitro aerosol exposure of tobacco and next generation nicotine delivery products, Appl. Vitr. Toxicol., 4, 159, 10.1089/aivt.2018.0001 R. Carvajal, D. Clissold, J.J.F. Shapiro, D. LJ, 2009. The family smoking prevention and tobacco control act: an overview. 64, 717. Cheng, 1988, Evaluation of a real-time aerosol monitor (RAM-S) for inhalation studies, Fundam. Appl. Toxicol., 10, 321, 10.1016/0272-0590(88)90317-X Crooks, 2013, The effect of long term storage on tobacco smoke particulate matter in in vitro genotoxicity and cytotoxicity assays, Regul. Toxicol. Pharm., 65, 196, 10.1016/j.yrtph.2012.11.012 Crooks, 2018, Evaluation of flavourings potentially used in a heated tobacco product: chemical analysis, in vitro mutagenicity, genotoxicity, cytotoxicity and in vitro tumour promoting activity, Food Chem. Toxicol., 118, 940, 10.1016/j.fct.2018.05.058 Dacunto, 2013, Real-time particle monitor calibration factors and PM2.5 emission factors for multiple indoor sources, Environ. Sci. Process Impacts, 15, 1511, 10.1039/c3em00209h Davis, 2019, Comparison of cytotoxicity of IQOS aerosols to smoke from Marlboro Red and 3R4F reference cigarettes, Toxicol. Vitr., 61, 10.1016/j.tiv.2019.104652 Ermala, 1956, On the burning temperatures of tobacco, Cancer Res., 16, 490 Fields, 2017, Development, qualification, validation and application of the neutral red uptake assay in Chinese Hamster Ovary (CHO) cells using a VITROCELL(R) VC10(R) smoke exposure system, Toxicol. Vitr., 40, 144, 10.1016/j.tiv.2017.01.001 Godec, 2019, In vitro mutagenicity of gas-vapour phase extracts from flavoured and unflavoured heated tobacco products, Toxicol. Rep., 6, 1155, 10.1016/j.toxrep.2019.10.007 ICCVAM, 2006. The Interagency Coordinating Committee on the Validation of AlternativeMethods (ICCVAM): ICCVAM test method evaluation report. In vitro cytotoxicity testmethods for estimating starting doses for acute oral systemic toxicity testing. ISO:3402, 1999. ISO 3402:1999 Tobacco and tobacco products — Atmosphere for conditioning and testing. ISO:20768, 2018. ISO 20768:2018 Vapour products — Routine analytical vaping machine — Definitions and standard conditions. Jaunky, 2018, Assessment of tobacco heating product THP1.0. Part 5: In vitro dosimetric and cytotoxic assessment, Regul. Toxicol. Pharm., 93, 52, 10.1016/j.yrtph.2017.09.016 Keyser, 2019, Development of a quantitative method for assessment of dose in in vitro evaluations using a VITROCELL(R) VC10(R) smoke exposure system, Toxicol. Vitr.: Int. J. Publ. Assoc. BIBRA, 56, 19, 10.1016/j.tiv.2018.12.010 Keyser, 2019, Investigation of multiple whole smoke dosimetry techniques using a VITROCELL(R)VC10(R) smoke exposure system, Toxicol. Rep., 6, 1281, 10.1016/j.toxrep.2019.10.011 Keyser, 2022, Characterization of aerosol deliveries from combustible cigarettes, heated tobacco products, and electronic nicotine delivery systems using the vitrocell Ames 48, Appl. Vitr. Toxicol., 8, 39, 10.1089/aivt.2022.0001 Kobashi, 1960, Combustion temperatures of some unblended cigarettes and the transfer of nicotine into cigarette smoke, Bull. Agric. Chem. Soc. Jpn., 24, 274, 10.1080/03758397.1960.10857658 Lucci, 2018, Characterization and modeling of aerosol deposition in Vitrocell® exposure systems - exposure well chamber deposition efficiency, J. Aerosol Sci., 123, 141, 10.1016/j.jaerosci.2018.06.015 Nicol, 2020, Comprehensive chemical characterization of the aerosol emissions of a vaping product based on a new technology, Chem. Res. Toxicol., 33, 789, 10.1021/acs.chemrestox.9b00442 OECD, 2010. Test No. 129: Guidance document on using cytotoxicity tests to estimate starting doses for acute oral systemic toxicity tests. OECD 2018. Guidance Document on Good In Vitro Method Practices (GIVIMP). Oldham, 2020, Deposition efficiency and uniformity of monodisperse solid particle deposition in the Vitrocell® 24/48 air–liquid-interface in vitro exposure system, Aerosol Sci. Technol., 54, 52, 10.1080/02786826.2019.1676877 Paszkiewicz, 2008, Spectrofluorometric method for measuring tobacco smoke particulate matter on cigarette filters and Cambridge pads, Tob. Control, 17, i53, 10.1136/tc.2007.024109 Raynor, 2012, Assessing potential nanoparticle release during nanocomposite shredding using direct-reading instruments, J. Occup. Environ. Hyg., 9, 1, 10.1080/15459624.2012.633061 Rodgman, 2013 Roemer, 2012, Mainstream Smoke Chemistry and in Vitro and In Vivo Toxicity of the Reference Cigarettes 3R4F and 2R4F, Beitrage Zur. Tab. Int. Contrib. Tob. Res., 25, 316 Schaller, 2016, Evaluation of the tobacco heating system 2.2. Part 2: chemical composition, genotoxicity, cytotoxicity, and physical properties of the aerosol, Regul. Toxicol. Pharmacol., 81, S27, 10.1016/j.yrtph.2016.10.001 Scott, 2013, The resolving power of in vitro genotoxicity assays for cigarette smoke particulate matter, Toxicol. Vitr.: Int. J. Publ. Assoc. BIBRA, 27, 10.1016/j.tiv.2013.02.015 Smith, 2016, Evaluation of the tobacco heating system 2.2. Part 1: description of the system and the scientific assessment program, Regul. Toxicol. Pharmacol., 81, S17, 10.1016/j.yrtph.2016.07.006 Stabbert, 2017, Studies on the contributions of smoke constituents, individually and in mixtures, in a range of in vitro bioactivity assays, Toxicol. Vitr., 42, 222, 10.1016/j.tiv.2017.04.003 T-115, H.C.O.M , 1999. Determination of Tar, Nicotine and Carbon Monoxide in Mainstream Tobacco Smoke. Prepared by the Department of Health. Taylor, 2018, Assessment of novel tobacco heating product THP1.0. Part 6: a comparative in vitro study using contemporary screening approaches, Regul. Toxicol. Pharmacol., 93, 62, 10.1016/j.yrtph.2017.08.016 Thorne, D., Adamson, J., Sticken, E.T., Wieczorek, R., Behrsing, H., Steiner, S., Majeed, S., Frentzel, S., Ishikawa, S., Ito, S., et al., 2021a. An interlaboratory in vitro aerosol exposure system reference study. 5, 2397847321992752. Thorne, 2018, Assessment of novel tobacco heating product THP1.0. Part 7: comparative in vitro toxicological evaluation, Regul. Toxicol. Pharmacol., 93, 71, 10.1016/j.yrtph.2017.08.017 Thorne, 2015, A comparative assessment of cigarette smoke aerosols using an in vitro air-liquid interface cytotoxicity test, Inhal. Toxicol., 27, 1, 10.3109/08958378.2015.1080773 Thorne, 2013, Characterisation of a Vitrocell® VC 10 in vitrosmoke exposure system using dose tools and biological analysis, Chem. Cent. J., 7, 146, 10.1186/1752-153X-7-146 Thorne, 2014, Development of a BALB/c 3T3 neutral red uptake cytotoxicity test using a mainstream cigarette smoke exposure system, BMC Res. Notes, 7, 367, 10.1186/1756-0500-7-367 Thorne, 2021, A survey of aerosol exposure systems relative to the analysis of cytotoxicity: a cooperation centre for scientific research relative to tobacco (CORESTA) perspective, Toxicol. Res. Appl., 5 Thorpe, 2013, Direct-reading inhalable dust monitoring--an assessment of current measurement methods, Ann. Occup. Hyg., 57, 824