Chemical analysis and in vitro toxicological evaluation of aerosol from a novel tobacco vapor product: A comparison with cigarette smoke

Regulatory Toxicology and Pharmacology

Volumn 92, Issue , 2018, Pages 94-103

  Takahashi, Yasunori ^a   Kanemaru, Yuki ^a   Fukushima, Toshiro ^a   Eguchi, Kentaro ^a   Yoshida, Shinya ^a   Miller Holt, Jacqueline ^b   Jones, Ian ^b  

^a JAPAN TOBACCO INC   (Japan)

^b JT International SA   (Switzerland)

Author keywords

Cigarette smoke; Cytotoxicity; Hoffmann analytes; In vitro genotoxicity; Mutagenicity; Tobacco vapor product

Indexed keywords

CIGARETTE SMOKE; NEUTRAL RED; NICOTINE; TOBACCO SMOKE; FLAVORING AGENT;

AEROSOL; ANALYTICAL PARAMETERS; ANIMAL CELL; ARTICLE; BACTERIAL MUTATION; CANADA; CHEMICAL ANALYSIS; COMBUSTION; CONTROLLED STUDY; CYTOTOXICITY ASSAY; FEMALE; GENOTOXICITY ASSAY; HOFFMANN ANALYTE; IN VITRO STUDY; LIQUID; MICRONUCLEUS; MUTAGENICITY; NONHUMAN; NOVEL TOBACCO VAPOR PRODUCT; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; REVERTANT; SMOKING CESSATION; TEMPERATURE; TOBACCO; TOXICOLOGY; UPTAKE ASSAY; ANALYSIS; ANIMAL; CELL LINE; CHEMISTRY; CHO CELL LINE; COMPARATIVE STUDY; CRICETULUS; ELECTRONIC CIGARETTE; PROCEDURES; SMOKE; SMOKING;

AEROSOLS; ANIMALS; CELL LINE; CHO CELLS; CRICETULUS; ELECTRONIC NICOTINE DELIVERY SYSTEMS; FLAVORING AGENTS; NEUTRAL RED; NICOTINE; SMOKE; SMOKING; TOBACCO; TOBACCO PRODUCTS;

EID: 85036584173     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2017.11.009     Document Type: Article

References (61)

1. Adkison, S.E., et al. Electronic nicotine delivery systems: international tobacco control four-country survey. Am. J. Prev. Med. 44 (2013), 207–215 http://doi.org/10.1016/j.amepre.2012.10.018.
2. Baker, R.R., Smoke generation inside a burning cigarette: modifying combustion to develop cigarettes that may be less hazardous to health. Prog. Energy Combust. Sci. 32 (2006), 373–385 http://doi.org/10.1016/j.pecs.2006.01.001.
3. Baker, R.R., et al. An overview of the effects of tobacco ingredients on smoke chemistry and toxicity. Food Chem. Toxicol. 42 (2004), 53–83 http://doi.org/10.1016/j.fct.2004.01.001.
4. Bombick, B.R., et al. Chemical and biological studies of a newCigarette that primarily heats tobacco. Part 2. In vitro toxicology of mainstreamsmoke condensate. Food Chem. Toxicol. 36 (1998), 183–190 http://doi.org/10.1016/S0278-6915(97)00107-5.
5. Borgerding, M.F., et al. Chemical and biological studies of a new cigarette that primarily heats tobacco. Part 1. Chemical composition of mainstream smoke. Food Chem. Toxicol. 36 (1998), 169–182 http://doi.org/10.1016/S0278-6915(97)00108-7.
6. Breheny, D., et al. A novel hybrid tobacco product that delivers a tobacco flavour note with vapour aerosol (Part 2): in vitro biological assessment and comparison with different tobacco-heating products. Food Chem. Toxicol. 106 (2017), 533–546 http://doi.org/10.1016/j.fct.2017.05.023.
7. Cariello, N.F., Piegorsch, W.W., The Ames test: the two-fold rule revisited. Mutat. Res. 369 (1996), 23–31 http://doi.org/10.1016/S0165-1218(96)90044-0.
8. Counts, M., et al. Development of a commercial cigarette “market map” comparison methodology for evaluating new or non-conventional cigarettes. Regul. Toxicol. Pharmacol. 46 (2006), 225–242 http://doi.org/10.1016/j.yrtph.2006.07.002.
9. Counts, M., et al. Smoke composition and predicting relationships for international commercial cigarettes smoked with three machine-smoking conditions. Regul. Toxicol. Pharmacol. 41 (2005), 185–227 http://doi.org/10.1016/j.yrtph.2004.12.002.
10. Davis, D.L., Nielsen, M.T., Tobacco: Production, Chemistry and Technology. 1999, Blackwell Science Oxford, UK http://as.wiley.com/WileyCDA/WileyTitle/productCd-0632047917.html.
11. DeMarini, D.M., Mutation spectra of complex mixtures. Mutat. Research/Reviews Mutat. Res. 411 (1998), 11–18 http://doi.org/10.1016/S1383-5742(98)00009-X.
12. Eldridge, A., et al. Variation in tobacco and mainstream smoke toxicant yields from selected commercial cigarette products. Regul. Toxicol. Pharmacol. 71 (2015), 409–427 http://doi.org/10.1016/j.yrtph.2015.01.006.
13. European Chemicals Agency, Annex to a News Alert ECHA/NA/16/37. 2016 https://echa.europa.eu/documents/10162/22867731/annex_rac_seac_en.pdf/b18b01c2-7016-f0c8-fdf5-26584ed63f93.Last accessed 21 September 2017.
14. Fields, W.R., et al. Gene expression in normal human bronchial epithelial (NHBE) cells following in vitro exposure to cigarette smoke condensate. Toxicol. Sci. 86 (2005), 84–91 http://doi.org/10.1093/toxsci/kfi179.
15. Fiume, M.Z., Cosmetic Ingredients Review Expert, P, Final report on the safety assessment of triacetin. Int. J. Toxicol. 22:2 (2003), 1–10 http://doi.org/10.1080/10915810390204845.
16. Forey, B.A., et al. Systematic review with meta-analysis of the epidemiological evidence relating smoking to COPD, chronic bronchitis and emphysema. BMC Pulm. Med., 11(36), 2011 http://doi.org/10.1186/1471-2466-11-36.
17. Forster, M., et al. An experimental method to study emissions from heated tobacco between 100-200 degrees C. Chem. Cent. J., 9(20), 2015 http://doi.org/10.1186/s13065-015-0096-1.
18. Foulds, J., et al. Effect of smokeless tobacco (snus) on smoking and public health in Sweden. Tob. Control 12 (2003), 349–359 http://doi.org/10.1136/tc.12.4.349.
19. Foy, J., et al. A comparison of in vitro toxicities of cigarette smoke condensate from Eclipse cigarettes and four commercially available ultra low-“tar” cigarettes. Food Chem. Toxicol. 42 (2004), 237–243 http://doi.org/10.1016/j.fct.2003.08.020.
20. Go, A.S., et al. Heart disease and stroke statistics–2014 update: a report from the American Heart Association. Circulation 129 (2014), e28–e292 http://doi.org/10.1161/01.cir.0000441139.02102.80.
21. Gonzalez-Suarez, I., et al. In vitro systems toxicology assessment of a candidate modified risk tobacco product shows reduced toxicity compared to that of a conventional cigarette. Chem. Res. Toxicol. 29 (2016), 3–18 http://doi.org/10.1021/acs.chemrestox.5b00321.
22. Hatsukami, D.K., et al. Developing the science base for reducing tobacco harm. Nicotine Tob. Res. 9:4 (2007), S537–S553 http://doi.org/10.1080/14622200701679040.
23. Health Canada, Tobacco Reporting Regulations; SOR/200–273. 2000 http://laws-lois.justice.gc.ca/PDF/SOR-2000-273.pdf Last accessed 5 June 2017.
24. Health Canada, Health Canada Official Method T-501, Bacterial Reverse Mutation Assay for Mainstream Tobacco Smoke. 2004 http://www.hc-sc.gc.ca/hc-ps/tobac-tabac/legislation/reg/indust/method/tox-eng.php Last accessed 5 June 2017.
25. Health Canada, Health Canada Official Method T-503, in Vitro Micronucleus Assay for Mainstream Tobacco Smoke. 2004 http://www.hc-sc.gc.ca/hc-ps/tobac-tabac/legislation/reg/indust/method/tox-eng.php Last accessed 5 June 2017.
26. Health Canada, Health Canada Official Method T-502, Neutral Red Uptake Assay for Mainstream Tobacco Smoke. 2004 http://www.hc-sc.gc.ca/hc-ps/tobac-tabac/legislation/reg/indust/method/tox-eng.php Last accessed 5 June 2017.
27. Hoffmann, D., Hoffmann, I., Letters to the Editor-Tobacco smoke components. Beiträge zur Tabakforschung/Contributions Tob. Res. 18 (1998), 49–52 http://doi.org/10.2478/cttr-2013-0668.
28. Hoffmann, D., Wynder, E.L., Chemical Constituents and Bioactivity of Tobacco Smoke. 1986, IARC Sci. Publ., 145–165 http://publications.iarc.fr/Book-And-Report-Series/Iarc-Scientific-Publications/Tobacco-A-Major-International-Health-Hazard-1986.
29. Ishikawa, S., et al. Assessing the mutagenic activities of smoke from different cigarettes in direct exposure experiments using the modified Ames Salmonella assay. Mutat. Res. Genet. Toxicol. Environ. Mutagen 803–804 (2016), 13–21 http://doi.org/10.1016/j.mrgentox.2016.04.008.
30. Iskandar, A.R., et al. A systems toxicology approach for comparative assessment: biological impact of an aerosol from a candidate modified-risk tobacco product and cigarette smoke on human organotypic bronchial epithelial cultures. Toxicol. Vitro 39 (2017), 29–51 https://doi.org/10.1016/j.tiv.2016.11.009.
31. ISO, ISO 3402: Tobacco and Tobacco Products–Atmosphere for Conditioning and Testing. 1999 http://www.iso.org/standard/28324.html Last accessed 5 June 2017.
32. ISO, ISO 4387: Cigarettes - Determination of Total and Nicotine-free Dry Particulate Matter Using a Routine Analytical Smoking Machine. 2000 http://www.iso.org/standard/28323.html Last accessed 5 June 2017.
33. Johnson, M.D., et al. Evaluation of in vitro assays for assessing the toxicity of cigarette smoke and smokeless tobacco. Cancer Epidemiol. Prev. Biomarkers 18 (2009), 3263–3304 http://doi.org/10.1158/1055-9965.EPI-09-0965.
34. Kogel, U., et al. Biological impact of cigarette smoke compared to an aerosol produced from a prototypic modified risk tobacco product on normal human bronchial epithelial cells. Toxicol Vitro 29 (2015), 2102–2115 http://doi.org/10.1016/j.tiv.2015.08.004.
35. Kogel, U., et al. Evaluation of the Tobacco Heating System 2.2. Part 7: systems toxicological assessment of a mentholated version revealed reduced cellular and molecular exposure effects compared with mentholated and non-mentholated cigarette smoke. Regul. Toxicol. Pharmacol. 81 (2016), S123–S138 http://doi.org/10.1016/j.yrtph.2016.11.001.
36. Manabe, S., Wada, O., Carcinogenic tryptophan pyrolysis products in cigarette smoke condensate and cigarette smoke-polluted indoor air. Environ. Pollut. 64 (1990), 121–132 http://doi.org/10.1016/0269-7491(90)90109-P.
37. Matsushima, T., et al. Validation study of the in vitro micronucleus test in a Chinese hamster lung cell line (CHL/IU). Mutagenesis 14 (1999), 569–580 http://doi.org/10.1093/mutage/14.6.569.
38. OECD SIDS, SIDS Initial Assessment Report for 10th SIAM (Tokyo, 15–17 March 2000)., 2000, UNEP Publications http://www.inchem.org/documents/sids/sids/1854268.pdf Last accessed 21 September 2017.
39. Patrianakos, C., Hoffmann, D., Chemical studies on tobacco smoke LXIV. On the analysis of aromatic amines in cigarette smoke. J. Anal. Toxicol. 3 (1979), 150–154 http://doi.org/10.1093/jat/3.4.150.
40. Phillips, B., et al. Toxicity of the main electronic cigarette components, propylene glycol, glycerin, and nicotine, in Sprague-Dawley rats in a 90-day OECD inhalation study complemented by molecular endpoints. Food Chem. Toxicol. 109 (2017), 315–332 http://doi.org/10.1016/j.fct.2017.09.001.
41. Poussin, C., et al. Systems toxicology-based assessment of the candidate modified risk tobacco product THS2.2 for the adhesion of monocytic cells to human coronary arterial endothelial cells. Toxicology 339 (2016), 73–86 http://doi.org/10.1016/j.tox.2015.11.007.
42. Renne, R., et al. 2-Week and 13-week inhalation studies of aerosolized glycerol in rats. Inhal. Toxicol. 4 (1992), 95–111 http://doi.org/10.3109/08958379209145307.
43. Robertson, O., et al. Tests for the chronic toxicity of propylexe glycol and triethylene glycol on monkeys and rats by vapor inhalation and oral administration. J. Pharmacol. Exp. Ther. 91 (1947), 52–76 DOI not found.
44. Rodgman, A., Perfetti, T.A., The Chemical Components of Tobacco and Tobacco Smoke. 2013, CRC press https://www.crcpress.com/The-Chemical-Components-of-Tobacco-and-Tobacco-Smoke-Second-Edition/Rodgman-Perfetti/p/book/9781466515482.
45. Roemer, E., et al. Chemical composition, cytotoxicity and mutagenicity of smoke from US commercial and reference cigarettes smoked under two sets of machine smoking conditions. Toxicology 195 (2004), 31–52 https://doi.org/10.1016/j.tox.2003.08.006.
46. Roemer, E., et al. Evaluation of the potential effects of ingredients added to cigarettes. Part 3: in vitro genotoxicity and cytotoxicity. Food Chem. Toxicol. 40 (2002), 105–111 http://doi.org/10.1016/S0278-6915(01)00086-2.
47. Sakaguchi, C., et al. Exposure evaluation of adult male Japanese smokers switched to a heated cigarette in a controlled clinical setting. Regul. Toxicol. Pharmacol. 69 (2014), 338–347 http://doi.org/10.1016/j.yrtph.2014.04.016.
48. Schaller, J.-P., et al. Evaluation of the Tobacco Heating System 2.2. Part 2: chemical composition, genotoxicity, cytotoxicity, and physical properties of the aerosol. Regul. Toxicol. Pharmacol. 81 (2016), S27–S47 http://doi.org/10.1016/j.yrtph.2016.10.001.
49. Smith, M.R., et al. Evaluation of the tobacco heating system 2.2. Part 1: description of the system and the scientific assessment program. Regul. Toxicol. Pharmacol. 81:2 (2016), S17–S26 http://doi.org/10.1016/j.yrtph.2016.07.006.
50. Stabbert, R., et al. Toxicological evaluation of an electrically heated cigarette. Part 2: chemical composition of mainstream smoke. J. Appl. Toxicol. 23 (2003), 329–339 http://doi.org/10.1002/jat.924.
51. Suber, R.L., et al. Subchronic nose-only inhalation study of propylene glycol in Sprague-Dawley rats. Food Chem. Toxicol. 27 (1989), 573–583 http://doi.org/10.1016/0278-6915(89)90016-1.
52. Tewes, F., et al. Toxicological evaluation of an electrically heated cigarette. Part 3: genotoxicity and cytotoxicity of mainstream smoke. J. Appl. Toxicol. 23 (2003), 341–348 http://doi.org/10.1002/jat.925.
53. Torikai, K., et al. Effects of temperature, atmosphere and pH on the generation of smoke compounds during tobacco pyrolysis. Food Chem. Toxicol. 42 (2004), 1409–1417 http://doi.org/10.1016/j.fct.2004.04.002.
54. U.S. Food and Drug Administration, Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Established List. 2012 http://www.gpo.gov/fdsys/pkg/FR-2012-04-03/pdf/2012-7727.pdf Last accessed 5 June, 2017.
55. van der Toorn, M., et al. A prototypic modified risk tobacco product exhibits reduced effects on chemotaxis and transendothelial migration of monocytes compared with a reference cigarette. Food Chem. Toxicol. 80 (2015), 277–286 http://doi.org/10.1016/j.fct.2015.03.026.
56. Vineis, P., et al. Tobacco and cancer: recent epidemiological evidence. J. Natl. Cancer Inst. 96 (2004), 99–106 http://doi.org/10.1093/jnci/djh014.
57. Werley, M.S., et al. Toxicological assessment of a prototype e-cigaret device and three flavor formulations: a 90-day inhalation study in rats. Inhal. Toxicol. 28 (2016), 22–38 http://doi.org/10.3109/08958378.2015.1130758.
58. Werley, M.S., et al. Non-clinical safety and pharmacokinetic evaluations of propylene glycol aerosol in Sprague-Dawley rats and Beagle dogs. Toxicology 287 (2011), 76–90 http://doi.org/10.1016/j.tox.2011.05.015.
59. White, J., et al. Effect of pyrolysis temperature on the mutagenicity of tobacco smoke condensate. Food Chem. Toxicol. 39 (2001), 499–505 http://doi.org/10.1016/S0278-6915(00)00155-1.
60. World Health Organization, WHO Study Group on Tobacco Product Regulation Report on the Scientific Basis of Tobacco Product Regulation., 2008 WHO Technical Report Series, no. 951 http://www.who.int/entity/tobacco/global_interaction/tobreg/publications/9789241209519.pdf?ua=1 Last accessed 5 June, 2017.
61. Zenzen, V., et al. Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 2: smoke chemistry and in vitro toxicological evaluation using smoking regimens reflecting human puffing behavior. Regul. Toxicol. Pharmacol. 64 (2012), S11–S34 http://doi.org/10.1016/j.yrtph.2012.08.004.