Room air constituent concentrations from use of electronic nicotine delivery systems and cigarettes using different ventilation conditions

To assess potential exposure of non-users to exhaled constituents from pod and cartridge electronic nicotine delivery systems (ENDS) products, an environmental clinical study was conducted with (n = 43) healthy adult smokers. Room air concentrations of 34 selected constituents (nicotine, propylene glycol, glycerin, 15 carbonyls, 12 volatile organic compounds, and 4 trace metals) and particle number concentration (0.3 to 25 µm) were compared from use of two ENDS products and conventional cigarettes using room ventilations representative of a residential, an office or a hospitality setting over a 4-h. exposure period. Products used were JUUL ENDS, Virginia Tobacco flavor (Group I), VUSE Solo, Original flavor (Group II) (5.0 and 4.8% nicotine by weight, respectively) and subjects’ own conventional cigarettes (Group III). Cumulative 4-h room air sampling and particle counting were performed during prescribed (Groups I and II) and ad libitum product use (all Groups). Conventional cigarette use resulted in significantly more constituents detected and higher 4-h cumulative constituent concentrations compared to use of the ENDS products tested, except for the predominant ENDS ingredients, propylene glycol and glycerin. Use of conventional cigarettes also resulted in greater total particle number concentration than either prescribed or ad libitum use of either of the ENDS used in this study.

. Chemicals and validated analytical methods used for their detection in room air samples..... Table S4.Mean (±SD) cumulative (four-hour) baseline constituent concentrations (N=4) for each group and ventilation for any constituent detected above LOQ for at least one puffing regimen for any group.Statistically significant differences (p < 0.05) from one-way ANOVA found in baseline concentrations (N=4) between ventilation conditions are denoted with an asterisk. .with an Agilent Model 5975C Mass Selective Detector (Agilent Technologies, Santa Clara, CA, USA).Propylene Glycol and glycerin collected on the XAD-7 adsorbant tubes were also analyzed following ISO 16200-1 method 1 but used an Agilent Model 6890 GC with a Flame Ionization Detector.The selected carbonyls collected on DNPH-coated silica gel adsorbant tubes were analyzed following the ISO 16000-3 method 2 using an Agilent Model 1100 High Performance Liquid Chromatograph with a DAD-UV detector which was operated at 365nm (ISO 2011a).Selected VOCs collected on SVI thermal desorption tubes were analyzed following the ISO 16000-6 method 3 using an Agilent Model 6890 GC coupled to an Agilent Model 5973 Mass Selective Detector.The quartz filters were analyzed for the four trace metals using Inductively Coupled Plasma-Mass Spectrometry with a Perkin Elmer DRC-e ICP-MS in accordance with the EPA IO2.1 and 3.5 method 4,5 .ISO 16000-6 1.Not detected above limit of quantification for any group at any ventilation.Table S4.Mean (±SD) cumulative (four-hour) baseline constituent concentrations (N=4) for each group and ventilation for any constituent detected above LOQ for at least one puffing regimen for any group.Statistically significant differences (p < 0.05) from one-way ANOVA found in baseline concentrations (N=4) between ventilation conditions are denoted with an asterisk.

Figure S4 .
Figure S4.Mean background concentrations of Acetone measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the residential ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.............

Figure S1 .
Figure S1.Mean (N=4) background concentrations of 2,5 Dimethylbenzaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the residential ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S2 .
Figure S2.Mean (N=4) background concentrations of 2-Butanone measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the residential ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S3.Mean (N=4) background concentrations of Acetaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the residential ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S4 .
Figure S4.Mean (N=4) background concentrations of Acetone measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the residential ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S5.Mean (N=4) background concentrations of Acrolein measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the residential ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S6 .
Figure S6.Mean (N=4) background concentrations of Benzaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the residential ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S7.Mean (N=4) background concentrations of Butyraldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the residential ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S8 .
Figure S8.Mean (N=4) background concentrations of Crotonaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the residential ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S9.Mean (N=4) background concentrations of Formaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the residential ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S10 .
Figure S10.Mean (N=4) background concentrations of Hexaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the residential ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S11 .
Figure S11.Mean background concentrations of Isovaleraldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the residential ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S12 .
Figure S12.Mean (N=4) background concentrations of Propionaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the residential ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S13.Mean (N=4)background concentrations of Valeraldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the residential ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S14 .
Figure S14.Mean (N=4) background concentrations of m&p-Tolualdehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the residential ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S15.Mean (N=4) background concentrations of Tolualdehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the residential ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S16 .
Figure S16.Mean (N=4) background concentrations of 2,5 Dimethylbenzaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the office ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S17.Mean (N=4) background concentrations of 2-Butanone measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the office ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S18 .
Figure S18.Mean (N=4) background concentrations of Acetaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the office ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S19.Mean (N=4) background concentrations of Acetone measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the office ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S20 .
Figure S20.Mean (N=4) background concentrations of Acrolein measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the office ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S21.Mean (N=4) background concentrations of Benzaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the office ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S22 .
Figure S22.Mean (N=4) background concentrations of Butyraldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the office ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S23.Mean (N=4) background concentrations of Crotonaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the office ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S24 .
Figure S24.Mean (N=4) background concentrations of Formaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the office ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S25.Mean (N=4) background concentrations of Hexaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the office ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S26 .
Figure S26.Mean (N=4) background concentrations of Isovaleraldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the office ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S27.Mean (N=4) background concentrations of Propionaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the office ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S28 .
Figure S28.Mean (N=4) background concentrations of Valeraldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the office ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S29.Mean (N=4) background concentrations of m&p-Tolualdehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the office ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S30 .
Figure S30.Mean (N=4) background concentrations of Tolualdehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the office ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S31.Mean (N=4) background concentrations of 2,5 Dimethylbenzaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the hospitality ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S32 .
Figure S32.Mean (N=4) background concentrations of 2-Butanone measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the hospitality ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S33.Mean (N=4) background concentrations of Acetaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the hospitality ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S34 .
Figure S34.Mean (N=4) background concentrations of Acetone measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the hospitality ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S35.Mean (N=4) background concentrations of Acrolein measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the hospitality ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S36 .
Figure S36.Mean (N=4) background concentrations of Benzaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the hospitality ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S37.Mean (N=4) background concentrations of Butyraldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the hospitality ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S38 .
Figure S38.Mean (N=4) background concentrations of Crotonaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the hospitality ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S39.Mean (N=4) background concentrations of Formaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the hospitality ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S40 .
Figure S40.Mean (N=4) background concentrations of Hexaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the hospitality ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S41.Mean (N=4) background concentrations of Isovaleraldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the hospitality ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S42 .
Figure S42.Mean (N=4) background concentrations of Propionaldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the hospitality ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S43.Mean (N=4) background concentrations of Valeraldehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the hospitality ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure S44 .
Figure S44.Mean (N=4) background concentrations of m&p-Tolualdehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the hospitality ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Figure
Figure S45.Mean (N=4) background concentrations of Tolualdehyde measured prior to and after Group I (solid circles), Group II (solid squares), and Group III (solid triangles) product use at the hospitality ventilation condition.Error bars represent the standard deviation and maybe obscured by the data point.The 90% Confidence intervals are shown by the dashed lines with the Limit of Detection shown in red and the Limit of Quantification shown in blue.

Table S1 .
Participant Inclusion Criteria: Subjects satisfied the following criteria before being tentatively enrolled into the study Item Criteria 1Informed of the nature of the study and had agreed to and were able to read, review, and sign the informed consent document (in English) prior to the first study procedure.Therefore, the volunteer must have had the ability to read and communicate in English in order to participate in the study 2 Subjects screened as a part of an IRB-approved General Screening Protocol at the CRO site may have been included in this study without additional Screening procedures provided all the required screening procedures were completed within 60 days prior to Clinic Visit 1.
5Judged by the Investigator to be in good general health as documented by the medical history, physical examination (including but may not have been limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, electrocardiogram (ECG), clinical laboratory assessments, and by general observations.Any abnormalities or deviations outside the normal ranges for any clinical testing (laboratory tests, ECG, vital signs) could have been repeated at the discretion of the Investigator and judged to be not clinically significant for study participation.6Agreed to abide by the study restrictions and return for the required assessments.7Hada self-reported daily conventional(combustible)cigarette consumption rate of a minimum of10 cigarettes per day for a minimum of 3 months prior to Screening Visit.

Table S2 .
Participant Exclusion Criteria: Subjects who met any of the following exclusion criteria were not tentatively enrolled in the study.
Reported use of prescription or over-the-counter bronchodilator medication (e.g., inhaled or oral β-agonists) within 6 months of Screening (Screening Visit).Breast-feeding or pregnant female subjects (confirmed by a positive pregnancy test).Female subjects, who were considered women of child bearing potential (WOCBP) and sexually active, were willing and able to use an acceptable method of contraception from Screening (Screening Visit) through the end of the study.Allergic to propylene glycol or vegetable glycerin.Were or had a first-degree relative (i.e., parent, sibling or child) who was a current employee of the CRO, Sponsor, or Site.

Table S3 .
Chemicals and validated analytical methods used for their detection in room air samples.