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Evaluate the Effect of Mouth Level Exposure and Biomarkers of Exposure Estimates of Cigarette Smoke Exposure Following A Forced Switch to a Lower ISO ‘Tar’ Yield Cigarette; Regul. Toxicol. Pharmacol. 61 (2011) S13-S24. 4. Morin, A., C.J. Shepperd, A.C. Eldridge, N. Poirier, and R. Voisine: Estimation and Correlation of Cigarette Smoke Exposure in Canadian Smokers as Determined by Filter Analysis and Biomarkers of Exposure; Regul. Toxicol. Pharmacol. 61 (2011) S3-S12. 5. St Charles, F.K., M. Ashley, C.J. Shepperd, P. Clayton, and G. Errington: A Robust Method for

.D. Tavakoli, L. Zhang, D.L. Ashley, and C.H. Watson: Estimating Smokers’ Mouth Level Exposures to Select Mainstream Smoke Constituents from Discarded Cigarette Filter Butts; Nicotine Tob. Res. 11 (2009) 868-874. DOI: 10.1093/ntr/ntp080. 28. Hyodo, T., K. Minagawa, T. Inoue, J. Fujimoto, N. Minami, and A. Mikita: Estimation of Mouth Level Exposure to Smoke Constituents of Cigarettes with Different Tar Levels Using Filter Analysis; Regul. Toxicol. Pharmacol. 67 (2013) 486-498. DOI: 10.1016/j.yrtph.2013.09.009. 29. Ding, Y.S., T. Chou, S. Abdul-Salaam, B. Hearn, and C

ABBREVIATIONS APCI Atmospheric Pressure Chemical Ionization CL Confidence Limit CRM CORESTA Recommended Method EHCSS Electrically Heated Cigarette Smoking System FAS Full Analysis Set FID Flame Ionization Detection HCI Health Canada Intense HPHC Harmful and Potentially Harmful Constituents HS Human-Smoked HST Human Smoking Topography IRQ Interquartile Range ISO International Standard Organization LLOQ Lower Limit Of Quantification LOD Limit Of Detection LR-3 Specific Smoking Regimen MEK Methyl Ethyl Ketone MLE Mouth Level Exposure MLR Multiple Linear Regression

Abstract

Filter analysis methodology can be used to estimate smokers’ mouth level exposure (MLE) to ‘tar’ and nicotine from spent cigarette filters. Variation in smoking behaviour and cigarette design are known to have an impact on the range of ‘tar’ and nicotine MLE. Most ‘King Size’ (KS) cigarettes have a circumference of about 25 mm and are 83-84 mm long, with filters 20-27 mm in length. Recently, a slimmer format, described as a ‘King Size Superslim’ (KSSS), with a circumference of 17 mm, has become popular in several countries. Although several studies have estimated the MLE to ‘tar’ and nicotine of smokers of KS cigarettes, there have been no studies of KSSS smokers reported to date. KSSS cigarettes from Romania were chosen for this study with a single product to represent each 1, 4 and 7 mg machine-smoked ISO ‘tar’ yields. Since these products have filters containing activated carbon, comparisons were made with a single product at each ISO ‘tar’ level of KS cigarettes with both activated carbon filters (King Size Carbon - KSC), to assess the effect of format on MLE, and cellulose acetate filters (King Size Non-carbon - KSNC) to assess the effect of filter carbon on MLE. A target population of 50 to 70 male and female smokers (subjects) aged 21 to 50 years of each product were recruited in Romania, with self-reported consumption of 15-25 cigarettes per day. The subjects gave written informed consent before commencing the study. Mean MLE to ‘tar’ and nicotine obtained by the smokers of all products were greater than ISO pack ‘tar’ and nicotine as reported in numerous studies. Regarding MLE to ‘tar’, there were no significant differences between the KSC, KSNC and KSSS smokers within each of the 1, 4 and 7 mg machine-smoked ISO ‘tar’ yield groups, but there were significant differences between the ISO pack ‘tar’ groups: 1 mg < 4 mg < 7 mg. Regarding MLE to nicotine, KSC and KSSS smokers obtained similar yields within an ISO pack ‘tar’ group. KSNC smokers obtained lower MLE nicotine yields than the KSC and KSSS smokers at both 4 mg and 7 mg ISO pack ‘tar’, corresponding to lower blend nicotine levels. No gender differences were observed.

. Clayton, and G. Errington: A Robust Method for Estimating Human Smoked Cigarette Yields from Filter Analysis Data; Beitr. Tabakforsch. Int. 23 (2009) 232-243. 7. Mariner, D.C., M. Ashley, C.J. Shepperd, G. Mullard, and M. Dixon: Mouth Level Exposure Using Analysis of Filters from Smoked Cigarettes: A Study of Eight Countries; Regul. Toxicol. Pharmacol. 61, Suppl. 3 (2011) S39-S50. 8. St. Charles, F.K., A.A. Kabbani, and M.F. Borgerding: Estimating “Tar” and Nicotine Exposure: Human Smoking Versus Machine Smoking; Regul. Toxicol. Pharmacol. 56 (2010) 100-110. 9. Nelson

-2013-0863 14. Hyodo, T., K. Minagawa, T. Inoue, J. Fujimoto, N. Minami, R. Bito, and A. Mikita: Estimation of Mouth Level Exposure to Smoke Constituents of Cigarettes With Different Tar Levels Using Filter Analysis; Regul. Toxicol. Pharmacol. 67 (2013) 486–498. DOI: 10.1016/j.yrtph.2013.09.009 15. Nelson, P.R., P. Chen, M. Dixon, and T. Steichen: A Survey of Mouth Level Exposure to Cigarette Smoke in the United States; Regul. Toxicol. Pharmacol. 61 (2011) S25–38. DOI: 10.1016/j.yrtph.2010.10.001 16. Ashley, M., M. Dixon, A. Sisodiya, and K. Prasad: Lack of Effect of

Research Conference, Winston-Salem, NC, Program Booklet and Abstracts Vol. 58, Poster No. 8, 2004, p 25. 7. Nelson, P.R., P. Chen, M. Dixon, and T. Steichen: A Survey of Mouth Level Exposure to Cigarette Smoke in the Unites States; Regul. Toxicol. Pharmacol. 61 (2011) S25-S38. 8. Heck, J.D.: Smokers of Menthol and Non-Menthol Cigarettes Exhibit Similar Levels of Biomarkers of Smoke Exposure; Cancer Epidemiol. Biomarkers Prev. 18 (2009) 622-629. 9. Caraballo, R.S., D.B. Holiday, S.D. Stellman, P.D. Mowery, G.A. Giovino, J.E. Muscat, M.P. Eriksen, J.T. Bernert, P

. Ringberger, and I. Wahlberg: Swedish Snus and the GothiaTek® Standard; Harm Reduct. J. 8 (2011) 11. 21. Nelson, P.R., P. Chen, M. Dixon, and T. Steichen: A Survey of Mouth Level Exposure to Cigarette Smoke in the United States; Regul. Toxicol. Pharmacol. 61 (2011) Suppl. 3, S25-S38. 22. St Charles, F.K., M. Ashley, C.J. Shepperd, P. Clayton, and G. Errington: A Robust Method for Estimating Human Smoked Cigarette Yields From Filter Analysis Data; Beitr. Tabakforsch. Int. 23 (2009) 232-243. 23. Caraway, J.C. and P.X. Chen: Assessment of Mouth- Level Exposure to Tobacco