Comparative risk assessment of tobacco smoke constituents using the margin of exposure approach: The neglected contribution of nicotine

Scientific Reports

Volumn 6, Issue , 2016, Pages

  Baumung, Claudia ^a,b   Rehm, Jürgen ^c,d,e,f   Franke, Heike ^a   Lachenmeier, Dirk W ^b,c  

^a UNIVERSITY OF LEIPZIG   (Germany)

^b Chemisches und Veterinaruntersuchungsamt CVUA Karlsruhe   (Germany)

^c DRESDEN UNIVERSITY OF TECHNOLOGY   (Germany)

^d CENTRE FOR ADDICTION AND MENTAL HEALTH   (Canada)

^e UNIVERSITY OF TORONTO   (Canada)

^f UNIVERSITY OF TORONTO   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

NICOTINE;

ADULT; ANIMAL; CHILD; CIGARETTE SMOKING; ENVIRONMENTAL EXPOSURE; HUMAN; LIVER DISEASE; MORTALITY; NEOPLASM; PASSIVE SMOKING; RAT; RISK ASSESSMENT; SURVIVAL ANALYSIS;

ADULT; ANIMALS; CHILD; CIGARETTE SMOKING; ENVIRONMENTAL EXPOSURE; HUMANS; LIVER DISEASES; NEOPLASMS; NICOTINE; RATS; RISK ASSESSMENT; SURVIVAL ANALYSIS; TOBACCO SMOKE POLLUTION;

EID: 84992126917     PISSN: None     EISSN: 20452322     Source Type: Journal    
DOI: 10.1038/srep35577     Document Type: Article

References (65)

1. U.S. Department of Health and Human Services. The Health Consequences of Smoking-50 Years of Progress: A Report of the Surgeon General (Department of Health and Human Services. Centers for Disease Control and Prevention. National Center for Chronic Disease Prevention and Health Promotion. Office on Smoking and Health, Atlanta, GA, 2014).
2. IARC Working Group on the Evaluation of Carcinogenic Risks to Humans. Tobacco smoking. IARC Monogr. Eval. Carcinog. Risks Hum. 100E, 43-211 (2012).
3. WHO. Global Action Plan for the Prevention and Control of NCDs 2013-2020 (World Health Organization, Geneva, Switzerland, 2013).
4. Kontis, V. et al. Contribution of six risk factors to achieving the "25× 25" NCD mortality reduction target. Lancet 384, 427-437 (2014).
5. Talhout, R. et al. Hazardous compounds in tobacco smoke. Int. J. Environ. Res. Public Health 8, 613-628 (2011).
6. Fowles, J. & Dybing, E. Application of toxicological risk assessment principles to the chemical constituents of cigarette smoke. Tob. Control 12, 424-430 (2003).
7. Simms, L. Quantitative risk assessment vs. the whole story? In 66th Tobacco Science Research Conference: Quantitative Risk Assessment: a Path Forward (eds. Gerardi, A., Robertson, R. & Zaitlin, D.) pp. 33-63 (Tobacco Science Research Council, New York, NY, 2012).
8. Purkis, S. W. Issues, Paradigms and Paradoxes that Need to be Addressed by Both Manufacturers and Regulators in the Measurement and Interpretation of Cigarette Smoke Yields of Harmful and Potentially Harmful Constituents (HPHCs), In 67th Tobacco Science Research Conference: Quantitative Risk Assessment: a Path Forward, (eds. Gerardi, A., Steach, J. & Zaitlin, D.) pp. 3-58 (Tobacco Science Research Council, New York, NY, 2013).
9. Cunningham, F. H., Fiebelkorn, S., Johnson, M. & Meredith, C. A novel application of the Margin of Exposure approach: Segregation of tobacco smoke toxicants. Food Chem. Toxicol. 49, 2921-2933 (2011).
10. Yuen, S. T. et al. The effect of nicotine and its interaction with carbon tetrachloride in the rat liver. Pharmacol. Toxicol. 77, 225-230 (1995).
11. Rodgman, A. Problems with the Tobacco Products Scientific Advisory Committee (TPSAC) list of harmful or potentially harmful tobacco and/or tobacco smoke components. Beitr. Tabakforsch. Int. 24, 258-276 (2011).
12. West, K. A. et al. Rapid Akt activation by nicotine and a tobacco carcinogen modulates the phenotype of normal human airway epithelial cells. J. Clin. Invest. 111, 81-90 (2003).
13. WHO Study Group on Tobacco Product Regulation. Report on the Scientific Basis of Tobacco Product Regulation. WHO Technical Report Series, no. 951 (World Health Organization, Geneva, Switzerland, 2008).
14. Laviolette, S. R. & van der Kooy, D. The neurobiology of nicotine addiction: bridging the gap from molecules to behaviour. Nat. Rev. Neurosci. 5, 55-65 (2004).
15. Benowitz, N. L. Pharmacology of nicotine: addiction, smoking-induced disease, and therapeutics. Annu. Rev. Pharmacol. Toxocol. 49, 57-71 (2009).
16. Viarisio, V. Nicotine as a Health Risk. Facts on Smoking (German Cancer Research Center, Heidelberg, Germany, 2015).
17. Benowitz, N. L. Nicotine addiction. N. Engl. J. Med. 362, 2295-2303 (2010).
18. Govind, A. P., Vezina, P. & Green, W. N. Nicotine-induced upregulation of nicotinic receptors: underlying mechanisms and relevance to nicotine addiction. Biochem. Pharmacol. 78, 756-765 (2009).
19. Balfour, D. J., Wright, A. E., Benwell, M. E. & Birrell, C. E. The putative role of extra-synaptic mesolimbic dopamine in the neurobiology of nicotine dependence. Behav. Brain Res. 113, 73-83 (2000).
20. Nestler, E. J. Is there a common molecular pathway for addiction? Nat. Neurosci. 8, 1445-1449 (2005).
21. Wang, H. & Sun, X. Desensitized nicotinic receptors in brain. Brain Res. Brain Res. Rev. 48, 420-437 (2005).
22. Hukkanen, J., Jacob, P. & Benowitz, N. L. Metabolism and disposition kinetics of nicotine. Pharmacol. Rev. 57, 79-115 (2005).
23. Xie, J. et al. A probabilistic risk assessment approach used to prioritize chemical constituents in mainstream smoke of cigarettes sold in China. Regul. Toxicol. Pharmacol. 62, 355-362 (2012).
24. Lachenmeier, D. W. & Rehm, J. Comparative risk assessment of alcohol, tobacco, cannabis and other illicit drugs using the margin of exposure approach. Sci. Rep. 5, 8126 (2015).
25. Hahn, J. et al. Electronic cigarettes: overview of chemical composition and exposure estimation. Tob. Induc. Dis. 12, 23 (2014).
26. Lindgren, M., Molander, L., Verbaan, C., Lunell, E. & Rosen, I. Electroencephalographic effects of intravenous nicotine-a doseresponse study. Psychopharmacol. (Berl.) 145, 342-350 (1999).
27. O'Brien, I. A., O'Hare, P. & Corrall, R. J. Heart rate variability in healthy subjects: effect of age and the derivation of normal ranges for tests of autonomic function. Br. Heart J. 55, 348-354 (1986).
28. EFSA. Potential risks for public health due to the presence of nicotine in wild mushrooms. EFSA J. RN-286, 1-47 (2009).
29. Benowitz, N. L. & Henningfield, J. E. Establishing a nicotine threshold for addiction. The implications for tobacco regulation. N. Engl. J. Med. 331, 123-125 (1994).
30. Sanner, T. & Grimsrud, T. K. Nicotine: Carcinogenicity and Effects on Response to Cancer Treatment-A Review. Front. Oncol. 5, 196 (2015).
31. Room, R. Alcohol and drug disorders in the International Classification of Diseases: a shifting kaleidoscope. Drug Alcohol Rev. 17, 305-317 (1998).
32. Rehm, J. et al. Defining substance use disorders: do we really need more than heavy use? Alcohol Alcohol. 48, 633-640 (2013).
33. Anderson, P. et al. The new governance of addictive substances and behaviours (Oxford University Press, Oxford, 2016).
34. Woolf, A., Burkhart, K., Caraccio, T. & Litovitz, T. Childhood poisoning involving transdermal nicotine patches. Pediatrics 99, E4 (1997).
35. Piade, J. J., Wajrock, S., Jaccard, G. & Janeke, G. Formation of mainstream cigarette smoke constituents prioritized by the World Health Organization-yield patterns observed in market surveys, clustering and inverse correlations. Food Chem. Toxicol. 55, 329-347 (2013).
36. Haussmann, H. J. Use of hazard indices for a theoretical evaluation of cigarette smoke composition. Chem. Res. Toxicol. 25, 794-810 (2012).
37. Pankow, J. F., Watanabe, K. H., Toccalino, P. L., Luo, W. & Austin, D. F. Calculated cancer risks for conventional and "potentially reduced exposure product" cigarettes. Cancer Epidemiol. Biomarkers Prev. 16, 584-592 (2007).
38. IARC Working Group on the Evaluation of Carcinogenic Risks to Humans. Alcohol consumption and ethyl carbamate. IARC Monogr. Eval. Carcinog. Risks Hum. 96, 1-1428 (2010).
39. Lachenmeier, D. W., Przybylski, M. C. & Rehm, J. Comparative risk assessment of carcinogens in alcoholic beverages using the margin of exposure approach. Int. J. Cancer 131, E995-E1003 (2012).
40. Bavarva, J. H., Tae, H., McIver, L. & Garner, H. R. Nicotine and oxidative stress induced exomic variations are concordant and overrepresented in cancer-associated genes. Oncotarget 5, 4788-4798 (2014).
41. Straif, K. et al. Future priorities for the IARC Monographs. The Lancet Oncology 15, 683-684 (2014).
42. Hatsukami, D. K. et al. Nicotine reduction revisited: science and future directions. Tob. Control 19, e1-10 (2010).
43. Kozlowski, L. T. Prospects for a nicotine-reduction strategy in the cigarette endgame: Alternative tobacco harm reduction scenarios. Int. J. Drug Policy 26, 543-547 (2015).
44. Benowitz, N. L. & Henningfield, J. E. Reducing the nicotine content to make cigarettes less addictive. Tob. Control 22 Suppl 1, i14-i17 (2013).
45. Donny, E. C. et al. Randomized Trial of Reduced-Nicotine Standards for Cigarettes. N. Engl. J. Med. 373, 1340-1349 (2015).
46. Benowitz, N. L. et al. Nicotine and carcinogen exposure with smoking of progressively reduced nicotine content cigarette. Cancer Epidemiol. Biomarkers Prev. 16, 2479-2485 (2007).
47. Land, T. et al. Recent increases in efficiency in cigarette nicotine delivery: Implications for tobacco control. Nicotine Tob. Res. 16, 753-758 (2014).
48. Ashton, H., Stepney, R. & Thompson, J. W. Self-titration by cigarette smokers. Br. Med. J. 2, 357-360 (1979).
49. Henningfield, J. E. Pharmacologic basis and treatment of cigarette smoking. J. Clin. Psychiatry 45, 24-34 (1984).
50. Revell, A. D. Smoking and performance-a puff-by-puff analysis. Psychopharmacol. (Berl.) 96, 563-565 (1988).
51. Woodward, M. & Tunstall-Pedoe, H. Self-titration of nicotine: evidence from the Scottish Heart Health Study. Addiction 88, 821-830 (1993).
52. Gable, R. S. Toward a comparative overview of dependence potential and acute toxicity of psychoactive substances used nonmedically. Am. J. Drug Alcohol Abuse 19, 263-281 (1993).
53. Frenk, H. & Dar, R. A critique of nicotine addiction, 2 ed. (Springer Science & Business Media, New York, 2000).
54. US FDA. FDA 101: Smoking Cessation Products. FDA Consumer Health Information (U.S. Food and Drug Administration, Silver Spring, MD, 2015).
55. US FDA. Nicotine Replacement Therapy Labels May Change. FDA Consumer Health Information (U.S. Food and Drug Administration, Silver Spring, MD, 2013).
56. Molyneux, A. Nicotine replacement therapy. BMJ 328, 454 (2004).
57. Bhatnagar, A. E-Cigarettes and Cardiovascular Disease Risk: Evaluation of Evidence, Policy Implications, and Recommendations. Curr. Cardiovasc. Risk Rep. 10, 1-10 (2016).
58. England, L. J., Bunnell, R. E., Pechacek, T. F., Tong, V. T. & McAfee, T. A. Nicotine and the Developing Human: A Neglected Element in the Electronic Cigarette Debate. Am. J. Prev. Med. 49, 286-293 (2015).
59. EFSA. Opinion of the Scientific Committee on a request from EFSA related to a harmonised approach for risk assessment of substances which are both genotoxic and carcinogenic. EFSA J. 282, 1-31 (2005).
60. US EPA. The use of the benchmark dose approach in health risk assessment. EPA/630/R-94/007 (Office of Research and Development. US Environmental Protection Agency, Washington, DC, 1995).
61. US EPA. Reregistration eligibility decision for nicotine (US Environmental Protection Agency, Washington, DC, 2008).
62. EFSA Scientific Committee. Guidance on selected default values to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data. EFSA J. 10, 2579 (2012).
63. Calafat, A. M. et al. Determination of tar, nicotine, and carbon monoxide yields in the mainstream smoke of selected international cigarettes. Tob. Control 13, 45-51 (2004).
64. Dourson, M. L., Hertzberg, R. C., Hartung, R. & Blackburn, K. Novel methods for the estimation of acceptable daily intake. Toxicol. Ind. Health 1, 23-33 (1985).
65. OECD. OECD.Stat Extracts. Non-Medical Determinants of Health. MetaData. Tobacco consumption. http://stats.oecd.org/index. aspx?queryid= 30127, 2014).