&EFA
            United States
            Environmental Protection
            Agency
            R«Marcft and Dvwloomcnt
Health Effects
Research Laboratory
Research Triangle Park
EPA/600/1-90/008

March 1989
                                  •
             Indoor Air —  Health

             Human Exposure
             and Dosimetry
             of Environmental
             Tobacco Smoke

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                                   EPA/600/1-90/008

                                   March 1989
      Indoor Air  —  Health

 Human Exposure  and  Dosimetry
of  Environmental Tobacco  Smoke
                      by
                  Joellen Lewtos
             Genetic Toxicology Division
          Health Effects Research Laboratory

              Contributing Authors
    Carl G. Hayes, George Goldstein, Judy Mumford,
          Randall Watts, Larry Claxton
         Health Effects Research  Laboratory

        Albert Collier, Frederick W. Henderson
    University of North Carolina, Dept of Pediatrics

                Goran Lofroth
       Distinguished Visiting Scientist to EPA
        from Nordic School of Public Health

             S. Katherine  Hammond
     University of Massachusetts Medical School

        John F. McCarthy, John D. Spengler
         Harvard School of Public Health

      David B. Coultas, Johnathan M. Samet
     University of New Mexico Medical Center
  U.S. EnYironmental Protection Agency
   Office of Research and Development
   Health Effects Research Laboratory
    Research Triangle Park, NC 27711

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         Human Exposure and Dosimetry of Environmental Tobacco Smoke


Abstract

     Environmental tobacco  smoke  (ETS)  is the largest  source  of indoor air
pollution and  is also  the major combustion source contributing to total human
exposure to nutagens and carcinogens.   This report provides specific data on
human exposure to ETS  using biochemical and mutagenesis bioassay measures as
well as physical/chemical markers of exposure.  Controlled laboratory chamber
studies were used to determine ETS emission factors for mutagenic activity
using three bioassays.  The emission factors for alkenes  (e.g., 1,3-butadiene)
and aldehydes  (e.g., formaldehyde),  which are either known or potential
carcinogens, are also  reported for the  first, time in  these papers.  Human
exposure concentrations and dosimetry are reported and compared under both
controlled chamber and actual indoor environmental conditions.  Nicotine
exposure and  its major metabolite, cotinine, have been found  to be useful
quantitative  and semiquantitative measures of human exposure  and dosimetry.
The relationship between nicotine exposure and urinary cotinine excretion has
been studied  in pre-school  children  exposed in their homes and in adults
exposed on commercial  airline flights.   Air monitoring studies in residences
and public indoor areas using both nicotine and mutagenic activity have
demonstrated  that separation of smokers into separate  areas does not achieve
an ETS-free or genuine nonsmoking area  unless there is both physical
separation and separate ventilation.

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                              TABLE OF CONTENTS
                                                                          Page

                                                                            1
Executive Summary
                                                                            2
Background and Rationale

Approach

     Emissions and Exposure Characterization
     Biological Markers of Exposure and Dose                                6

Results                                                                    10

     Characterization of ETS
     Assessment of Public Exposure to Environmental Tobacco
       Smoke Using a Mutagenicity Bioassay of Airborne
       Particulate Matter                                                  ''
     Evaluation of Urinary Cotinine as a Biomarker
       of ETS Exposure in Children                                         ''
     Variability of Measures of Exposure to Environmental
       Tobacco Smoke in the Home                                           12
     Application of the Nicotine/Cotinine Exposure/Dosimetry
       Method for Assessment of ETS on Airline Flights                     13
     Questionnaire Assessment of Lifetime and Recent Exposure
       to Environmental Tobacco Smoke Using Urinary Cotinine

Summary of Major Findings

     Exposure                                                              ' **

     Dosimetry                                                             '"

Disclaimer                                                                 '"

List of Publications Summarized                                            19
                                 ill

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EXECUTIVE SUMMARY








     Environmental tobacco smoke (ETS) is the largest source of indoor air




pollution and is also the major combustion source contributing to total human




exposure to mutagens and carcinogens.   This report provides specific data on




human exposure to ETS using biochemical and mutagenesis bioassay measures as




well as physical/chemical markers of exposure.   Controlled laboratory chamber




studies were used to determine ETS emission factors for mutagenic activity




using three bioassays.  The emission factors for alkenes (e.g., 1,3-butadiene)




and aldehydes (e.g., formaldehyde), which are either known or potential




carcinogens, are also reported for the first time in these papers.  Human




exposure concentrations and dosiraetry are reported and compared under both




controlled chamber and actual indoor environmental conditions.  Nicotine




exposure and its major metabolite, cotinine, have been found to be useful




quantitative and semiquantitative measures of human exposure and dosimetry.




The relationship between nicotine exposure and urinary cotinine excretion has




been studied in pre-school children exposed in their homes and in adults




exposed on commercial airline flights.  Air monitoring studies in residences




and public indoor areas using both nicotine and mutagenic activity have




demonstrated that separation of smokers into separate areas does not achieve




an ETS free or genuine nonsmoking area unless there is both physical




separation and separate ventilation.  This data provides information to




Congress as mandated by the Indoor Air Program and to OAR for information




needed in developing policy and guidance information which will be provided to




the public, local, state, and national governmental agencies and other




specific groups (e.g., ventilation engineers, etc.) on how to achieve indoor



air quality.
                                     1

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BACKGROUND AND RATIONALE








     The Environmental Tobacco Smoke  (ETS) Research Program it a part of EPA's



Indoor Air Research Program.  The overall goal of Che ETS research program is



to conduce the research necessary to  provide information to the public,



governmental agencies, the building industry, employers, and others in order



to allow them to make well informed choices regarding the control of exposure



to ETS.  In order  to accurately assess  the relationship between human exposure



and the resulting  risk from  that exposure, one of the goals of this program is



to determine the relationship between ETS exposure, uptake, and ultimate



tissue dose in order to assess the relationship between exposure and risk,








     Exposures to  ETS have been assessed by questionnaires, air monitoring,



modeling, and biological  markers.  The  simplest and yet the least precise and



reliable method of exposure  assessment  has been the use of simple



questionnaires (e.g., "If you are a nonsrooker, do you live with, work with, or



have regular contact with persons who are smokers?"),  Such questions have



been the basis for classifying individuals into broad categories of exposure,



however there are  serious difficulties  in developing uniform questions that



elicit unambiguous and correct replies, and even more difficult problems in



using  these replies  to make  quantitative estimates of exposure,



Questionnaires are particularly difficult to use to estimate an integrated



exposure over many years, yet this  is the primary method which has been used



to approximate such  long*term exposures.  The NAS Committee on ETS (1986)



recommended that future epidemlologic studies should Incorporate into their



design several different  exposure assessment methods in order to assess



exposure to ETS more accurately and to  estimate dose.

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     Personal exposure and doiimetry of ETS is dependent upon so many factors
that the optimal assessment should thaoratloally b« measured diractly through
tha usa of biological markara that accurately indicate uptake and/or doae in
physiological fluids, tiaauaa or calls.   Several chemicals found in body
fluids of active smokers have been evaluated as biological markers of exposure
to ETS.

     Nicotine and its metabolite, cotlnina, measured in saliva,  blood or urine
have been the most useful biological markers of recent ETS exposure since they
are derived virtually exclusively from tobacco products.   Urinary cotlnine
levels have been shown to increase in non-smokers with increasing number of
smokers in the home for all age groups (infants, children and adults).
Currently there is difficulty in interpreting the relative cotlnine levels In
nonsmokers compared to smokers because of the reported slower clearance of
cotlnine In nonsmokers and the lack of good uptake and clearance data for
nonsmokers of different ages, sax and genetic background.  The NAS Committee
on ETS (1986) recommended that absorption,  metabolism, and excretion of ETS
constituents, including nicotine or cotinine, be carefully studied in order to
evaluate whether there are differences between smokers and nonsmokers in these
factors,  Further epidemiologie studies using biological markers are needed to
quantify expoaure-dose relationships in nonsmokers.

     Several other potential biological markers which have been evaluated as
Indicators of ETS exposure Including thioeyanate, carboxyheraoglobln and
exhaled CO are not sufficiently sensitive to moderate or low levela of ETS
exposure to be generally useful,  Since there are several other sources of CO

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in the environment that equal or exceed the contribution made by ETS, this




marker is even less useful.  The use of nicotine and cotinine measurements in




urine and possibly saliva are recommended as the best methods now available




for quantifying human exposure to ETS, however, research is urgently needed to




improve the quantitation and interpretation of these markers.  Nicotine is not




an ideal marker for all constituents of ETS.  In ETS polluted environments,




nicotine is present in the vapor phase as a free base, thus its uptake by the




passive smoker may not be representative of the uptake of acidic and neutral




smoke components  from the vapor phase nor of any component in the particulate




phase.  Other suggested biological markers of exposure include N-




nitrosoproline, nitrosothioproline, and some of the aromatic amines  that are




present in high concentrations in side stream smoke as well as




3-vinylpyridine,  solanesol and other  tobacco specific constituents.  Thus,




future studies should be concerned with developing techniques to measure the




uptake by nonsmokers of various other types of tobacco-specific ETS  components




which would be representative of the particulate organic phase of ETS and the




volatile acidic and neutral phases.   Studies are needed to develop and apply




highly sensitive  methods  (e.g., immunoassays or postlabelling) for measuring




DNA  and protein adducts of  tobacco-specific chemicals.

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APPROACH








Emissions and Exposure Characterization








     Research is being conducted in chamber studies to determine the emission




factors and reactivities of specific ETS constituents.  The components




currently being measured in these studies include RSP (as well as the size




distribution of the aerosol), nicotine, particulate organic mass,




mutagenicity, semi-volatile organics, aldehydes,  alkenes (and other




hydrocarbons), CO and nitrogen oxides.  Future studies will expand the organic




analysis to include nitrosamines and other components being considered for




tracer compounds.  The results from these studies are critical to efforts to




model human exposure to ETS.  Effects of various factors such as room size,




temperature, humidity, air-exchange rate, numbers of cigarettes smoked and




surface materials will be determined.








     Exposure models developed as a part of EFAs indoor air research program




will be employed together with data from the emission factors determined in




the chamber studies to predict indoor air exposures.  These models and




emission factors will be evaluated in test home studies under realistic indoor




exposure conditions prior to field validation studies.








     Source receptor modeling procedures will be developed for apportioning




RSP, mutagens and specific organics to ETS in indoor exposure conditions using




the tracers nicotine, solenosol, C-32 (anteiso) HC and other candidate tracers




selected as described above.  RSP, mutagens and PAHs originating from other

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sources (e.g., kerosene heaters, wood & coal burning, etc) would be




apportioned using inorganic tracer methods previously developed as a part of




other EPA air pollution research programs.








Biological Markers of Exposure and Dose








     Although cotinine is  currently the best biological marker of human




exposure to ETS, research  is needed to improve the interpretation of cotinine




measurements  in body fluids.  Specifically, needed research is being conducted




to determine  the absorbtion, metabolism and excretion of nicotine and its




metabolites.  Specific studies either in progress or in planning stages




include:   (1) Determination of the dose of nicotine absorbed from ETS by




simultaneous  chamber exposure to ETS and infusion of dueterated-nicotine in




adults.   (2)  Continuation  of studies of adults, and children of various ages,




including  infants,  from homes where ETS is present to determine cotinine




clearance  rates and to compare exposure, uptake and dosimetry using nicotine




and  its metabolites.   (3)  Establish relationships between personal air




exposure  to RSP, mutagens  and nicotine to measured nicotine intake and




nicotine metabolites in body fluids for different exposure conditions and




population groups.








     A workshop was convened to evaluate the biological and analytical methods




for  cotinine  and the recommendations will be implemented in collaboration with




other  governmental  agencies using cotinine as a biological marker for ETS




exposure.  A  standard reference materials laboratory is being established to




provide reference chemicals and standardized reference body fluids applicable

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to all cotinlne assays.   Guidelines for a quality assurance program for




cotinine analysis have been recommended and an intercollaboratlve comparison




study designed and recommended specifically for quantitating cotinine at




levels appropriate to ETS exposures (rather than smoking exposures).   EPA will




collaborate with CDC, NCI, and the developer of a new monoclonal immunoassay




for cotinine (Langone, et al., 1986) to implement further improvements in this




assay and apply the assay in collaborative and comparative studies.








     Research will be conducted to evaluate candidate marker compounds for the




particulate phase of ETS and possibly the acidic or neutral gaseous phase.




Highest priority will be given to marker compounds which are preferably unique




to ETS and if possible,  genotoxic components which would form either protein




(e.g., hemoglobin) or DNA adducts.  Candidate compounds under consideration




are the tobacco-specific nitrosamines,  solanesol, polyphenols (e.g.,




chlorogenic acid, rutin) and other compounds for which DNA-adduct and/or




hemoglobin adduct methods are already available.








     Research to develop and evaluate ETS specific biological markers of




exposure and dose through the use of protein and DNA adducts is being




conducted.  Initially, postlabelling methods developed by Randerath,  et al.




(1986) and Gupta et. al. (1986) are being applied to blood cells, placental




tissue, buccal cells, and lung cells from smokers and ETS exposed individuals.




Although standard adducts [e.g.. B(a)P-DNA adducts and tobacco specific NNK-




DNA adducts] are used as reference standards, the postlabelling method allows




the detection and quantification of adducts formed in DNA after exposures to




complex mixtures such as ETS without knowledge of the specific adduct formed

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and without human exposures to radiolabelled materials.  These methods are now




able to detect 1 adduct in 1010 nucleotides, the sensitivity needed to detect




environmental exposures to indoor air pollutants such as ETS.








     In collaboration with the UNC-EPA clinical group, we have completed a




pilot study to determine  the relative adduct levels for human lavaged




macrophages isolated from smokers and nonsmokers.  DNA adducts were detected




in both groups, however,  heavy smokers were shown to have higher levels when




compared  to nonsmokers.   It is not  clear whether DNA isolated from light to




moderate  smokers has DNA  adduct levels above control nonsmokers.  Due to the




small number  of cells  isolated from nonsmokers, we are currently collecting




additional samples  to  establish a base line level for the control group.  We




plan to modify the  solvents used in the assay  to resolve any nonpolar adducts




that might otherwise go undetected  using the standard procedures described in




the  original  ^P-pos^Iabeiing method.








     Exposure-dosimetry  studies in  progress at the Frank Porter Graham Child




Development Center  on  40  pre-school children are designed to understand the




exposure-dose-effect relationships  in  infants  and children exposed in the home




to ETS.   Studies on school age children have been conducted in collaboration




with Harvard  and the Univ. of New Mexico to assess exposure to ETS using




biological markers  will be continued with  the  addition of improvements in




cotinine  and  cotinine  QA  methods.








     Studies  to evaluate  urinary mutagens  as markers of ETS exposure under




controlled exposure conditions have been completed.  Although the sensitivity
                                       8

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of the methods used have been improved more than tenfold,  the urinary concent-




rations are near the detection limits.  It appears that an ETS specific




mutagen or mutagenic fraction of the urine would have to be isolated and




quantitated to provide the sensitivity and specificity required in such a




biological marker.

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RESULTS









Characterization of Environmental Tobacco Smoke









     EPA conducted an ETS  characterization study  in both a human exposure




chamber and  an  indoor environment.  This study characterized both exposure




concentrations  and airborne yields  for particulate matter and its mutagenic




activity as  well as nicotine,  aldehydes and  alkenes.  Environmental  tobacco




smoke  (ETS)  was analyzed with  respect to several  components following  smoking




of  research  cigarettes in  the  chamber. Parameters analyzed and  their airborne




yield  per  cigarette  (shown in  parentheses) included: particulate matter  (10




mg)  and its  mutagenic activity in a Salmonella bioassay, carbon monoxide  (67




mg), nitrogen oxides  (2 mg). nicotine (0.8-3.3 mg), formaldehyde (2  mg),




acetaldehyde (2.4 mg), acrolein (0.56 mg), benzene  (0.5 mg) and several




unsaturated  aliphatic hydrocarbons  (e.g., 1,3-butadiene) of which isoprene




 (3.1 mg) had the highest yield.  ETS  from commercial cigarettes were likewise




analyzed  in  the experimental chamber  and at  a public location.  The  relative




component  composition for  ETS  is similar when generated from either  research




or  commercial cigarettes.   All components analyzed were present at




concentrations  above  the background concentrations.  Isoprene might  be




utilized  as  a tobacco smoke tracer  for unsaturated aliphatic hydrocarbons.




This study provided  documentation that the chamber ETS exposure was  comparable




to  that which people  would encounter  in indoor environments where tobacco is




being  smoked.   Additional  chemical  analyses  and subsequent studies were




conducted  to relate  the chamber ETS components to the analysis  of ETS  in  an




indoor environment.
                                       10

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Assessment of Public Exposure to Environmental Tobacco Smoke Using a




Mutaeenicitv Bloassay of Airborne Particulate Matter








     Airborne particulate matter has been collected by personal samplers in




public indoor areas and travel situations with environmental tobacco smoke




pollution.  Following extraction, the samples were assayed for mutagenicity in




the presence of S9 with a sensitive microsuspension test using Salmonella




TA98.  The mutagenic responses of indoor air from public areas were much




higher than those of ambient outdoor air.  Depending on the circumstances, the




mutagenic response varied in trains and airplanes but the results show that




physical separation of non-smoking sections from smoking sections is necessary




in order to achieve genuine non-smoking areas.  Chemical fractionation and




mutagenicity assay of the basic fraction show that Salmonella mutagenicity of




airborne particulate matter might be used as a tobacco smoke-specific




indicator, as the basic fraction of environmental tobacco smoke contains a




large part of the mutagenic activity.  This is not the case for outdoor




ambient airborne particulate matter and many other combustion emissions.








Evaluation of Urinary Cotinine as a Biomarker of ETS Exposure in Children








     The extent of correlation between urine cotinine and home air nicotine




levels was examined in 27 children who attended a research day care program




where they were not exposed to ETS during the daytime hours.  Average




concentrations of nicotine in home air were determined by active air sampling




during the evening and night hours on two consecutive days.  Urine samples for




cotinine and creatinine determinations were collected before, during, and




after the two sampling periods.  In addition, four sequential weekly urine
                                        11

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samples for cotinine were obtained from study children to determine the extent




to which single determinations of cotinine were representative for individual




children.  Fifteen children resided in homes with smokers and 12 in homes




without smokers.  Urine cotinine consistently distinguished most exposed and




unexposed children.  However, three exposed children had urine cotinines which




clustered routinely around the criterion (30 ng cotinine/mg creatinine) which




best distinguished exposed and unexposed children.  In children exposed to ETS




in the home, there was a significant correlation between average home air




nicotine levels and the average logarithm of urine cotinine the two mornings




following the home air monitoring periods (r - 0.67; p - 0.008).  In study




children, urine cotinines were remarkably stable over the one month




observation period.  Rank correlation coefficients for sequential weekly




determinations of cotinine were consistently greater than r - 0.88; p <




0.0001.








Variability of Measures of Exposure to Environmental Tobacco Smoke in the Home








     The variability of four markers of environmental tobacco smoke exposure




was assessed in 10 homes with 20 nonsmoking and 11 smoking household members.




The study included obtaining exposure questionnaires, saliva and urine for




cotinine, and air particle samples for respirable particles and nicotine on 10




sampling days:  every other day over 10 days, and then one day every other




week over 10 weeks.  The mean concentrations of respirable particles in the 10




homes  ranged from 32.4 ng/u? to 76.9 pg/nP and concentrations of nicotine




ranges from 0.59 pg/w? to 6.85 jig/m3.  A linear regression model that included




indicator variables for the number of smokers exposed to in the home and the




season, and the number of hours of exposure as a continuous variable explained
                                       12

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nine and 6% of the variability of the respirable particle and the nicotine




concentrations, respectively.   The individual mean cotinine levels




standardized to urinary creatinine concentration, ranged from 3.89 ng/mg Cr to




55.77 ng/mg Cr.  A linear regression model that included the number of smokers




exposed to in the home, the season, the age group,  and the number of hours of




exposure explained 8% of the variability of the urinary cotinine levels.




Because of the marked variability of these measures,  multiple measurements are




needed to establish a stable profile of exposure to environmental tobacco




smoke in a particular home or individual.   Furthermore, detailed questions to




quantitate exposure offered little additional information beyond whether the




subject was exposed or not.








Application of the Nicotine/Cotinine Exposure-Dosimetry Method for Assessment




of ETS on Airline Flights








     The National Cancer Institute and EPA jointly conducted a pilot research




study to measure environmental tobacco smoke exposure on typical commercial




flights at the request of The Surgeon General of the Public Health Service.




This study was undertaken (1) to measure nicotine levels in ambient air during




flights of approximately four hours' duration and urinary cotinine levels at




various points during the three days after the flights, and (2) to determine




if these exposure and excretion measurements correlate with each other and




with acute symptoms experienced during the flights.








     In-flight exposure to nicotine, urinary cotinine levels, and symptom




self-reports were assessed in a study of nine subjects (five passengers and




four attendants) on four routine commercial flights each of approximately four
                                        13

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hours' duration.  Urine samples were collected for 72 hours following each




flight.  Exposures to nicotine measured during the flights using personal




exposure monitors were found  to be variable, with some nonsmoking areas




attaining levels comparable to those in smoking sections.  Attendants assigned




to work in nonsmoking areas were not protected from smoke exposure.  The type




of aircraft ventilation was important  in  determining the levels of  in-flight




nicotine exposure.








      The levels of  ETS that occurred during the four-hour flights led to




increased levels of cotinine  in  the urine of both passengers  and attendants.




Subjects who  experienced  the  greatest  in-flight nicotine exposure generally




had  the highest levels of urinary cotinine and continued to excrete cotinine




for  72 hours  after  the flight.   The shape and time course of  the decay pattern




are  consistent with a  first-order pharmacokinetic decay process following an




initial exposure to nicotine.  The peak level of cotinine excreted  is related




to the dosage of nicotine received over the range of exposures encountered.








      Reports  on dose-response data under  conditions of exposure are sparse,




especially  for the  nicotine concentration range typically encountered by




nonsmokers  under free-living  conditions.   This analysis provides estimates of




the  response  to a bolus of ETS,  delivered over a four-hour period,  shown by a




subsequent  increase in urinary cotinine excretion over time synchronized




across subjects.  This study  expands upon previous studies employing single-




point estimates of  cotinine or self-reported smoke exposure levels  and




provides information on the shape of the  excretion curve, delay to  peak,




amplitude to  the peak, approximate functional form, and decay time  of cotinine




excretion after ETS  exposure.
                                        14

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     NCI measured changes in eye and nose symptoms between the beginning and




end of the flights.  These symptoms were significantly related both to




nicotine exposure during the flight and to the subsequent urinary excretion of




cotinine.  In addition,  subjects'  perceptions of annoyance and smokiness in




the airplane cabin were also related to in-flight nicotine exposure and




urinary excretion measures.








Questionnaire Assessment of Lifetime and Recent Exposure to Environmental




Tobacco Smoke Using Urinary Cotinine








     In a sample of 149 adult volunteers recruited in New Mexico in 1986, a




study was designed to assess the reliability of questions on lifetime exposure




to tobacco smoke in the home and also compared urinary cotinine level with




questionnaire report of environmental tobacco smoke exposure during the




previous 24 hours.  The agreement of responses obtained on two occasions




within six months was high for parental smoking during childhood:  94% for the




mother and 93% for the father.  For smoking by the spouse during adulthood,




agreement was 100%.  However, responses concerning amount smoked and hours




smoked in the home were less reliable.  For the amounts smoked by the mother




and father during the index subject's childhood, the agreement between the two




interviews was 52% and 39% respectively.  For hours smoked in the home, the




Spearman correlation coefficients also indicated only moderate reliability




(r- 0.18 for maternal smoking and r - 0.54 for paternal smoking).  For each




set of interviews, responses concerning recent tobacco smoke exposure and




urinary cotinine level were correlated to only a modest degree.  It was




concluded that adults can reliably report whether household members smoked




during their childhood, but information on quantitative aspects of smoking is



reported less reliably.






                                      15

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SUMMARY OF MAJOR FINDINGS








Exposure








     These studies confirm that ETS is a major source of indoor air pollution.




Methods were developed and applied to indoor environments to quantitate human




exposure to the following pollutants from ETS:




     • nicotine




     • mutagenicity




     • alkenes  (e.g., 1,3-butadiene)




     • aldehydes  (e.g.,  formaldehyde)




Exposure concentrations  of these pollutants, as well as emission rates, have




been determined for use  in assessment and guidance documents as well as future




exposure assessment and  modeling studies.








Dosimetry








     Urinary cotinine, a nicotine metabolite, was demonstrated to be a useful




biological marker of human exposure to nicotine from ETS.  The results of an




interagency workshop sponsored by EPA recommend steps that should be taken to




standardize and assure the quality of cotinine data.  Research in progress




will significantly improve our ability to determine nicotine dosimetry from




ETS exposure.








     Exposure-dosimetry  studies were conducted both in the normal indoor




exposure environments (day care and home) and controlled chamber environments
                                      16

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of preschool children.  A similar study was conducted on a commercial airline,




These studies show that urinary cotinine is a reliable and semi-quantitative




biological marker of ETS exposure in young children and adults.
                                     17

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DISCLAIMER

The information in this document has been funded wholly or in part by the
United States Environmental Protection Agency.  It has been subjected to the
Agency's peer and administrative review, and it has been approved for
publication as an EPA document.  Mention of trade names or commercial products
does not constitute endorsement or recommendation for use.
                                     18

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LIST OF PUBLICATIONS SUMMARIZED AND INCLUDED
1.   Human Exposure to Mutagens from Indoor Combustion Sources.   J.  Lewtas,




     L. Claxton, and J. L.  Mumford.   Indoor Air '87.  Vol.  1,  B.  Seifert, H.




     Esdorn, M. Fischer, H. Ruden,  J.  Wegner,  Eds,  Oraniendruck GmbH,  Berlin,




     pp. 473-477 (1987).








2.   A Genotoxic Assessment of Environmental Tobacco Smoke Using Bacterial




     Bioassays.  L.D. Claxton, R.S.  Morin,  T.J. Hughes, and J.  Lewtas.




     Mutation Research. 222:81-99 (1989).








3.   Characterization of Environmental Tobacco Smoke.  G.  Lofroth, R.  Burton,




     L. Forehand, K. Hammond, R. Seila, R.  Zweidinger and J.  Lewtas.




     Environmental Science and Technology.  23:610-614 (1989).








4.   Environmental Tobacco Smoke:  Mutagenic Emission Rates and Their




     Relationship to Other Emission Factors.  J. Lewtas, K. Williams,  G.




     Loforth, K. Hammond, B. Leaderer.  Indoor Air '87. Vol. 2, B. Seifert, H.




     Esdorn, M. Fischer, H. Ruden,  J. Wegner, Eds,  Oraniendruck GmbH,  Berlin,




     pp. 8-12  (1987).








5.   Mutagenic Determination of Passive Smoking.  P.I. Ling, G. Lofroth, and




     J. Lewtas.  Toxicology Letters. 15:147-151 (1987).
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6.   The Effect of Solvent and Extraction Methods on the Bacterial




     Mutagenicity of Sidestrearn Cigarette Smoke.  R.S. Morin, J.J. Tulis, L.D.




     Claxton.  Toxicology Letters. 18:279-290 (1987).








7.   Public Exposure to Environmental Tobacco Smoke.  6. Lofroth, F.I. Ling,




     and E. Agurell.  Mutation Research. 202:103-110 (1988).








8.   Variability of Measures of Exposure to Environmental Tobacco Smoke in the




     Home.  D.B. Coultas, J.M. Samet, J.F. McCarthy, and J.D. Spengler.




     Proceedings of the APCA Conference on Indoor Air, Niagra Falls, 1988.








9.   Questionnaire Assessment of  Lifetime and Recent Exposure to Environmental




     Tobacco  Smoke.  D.B. Coultas, G.T. Peake,  and J.M. Samet.  American




     Journal  of Epidemiology. 130:338-347 (1989).








10.  Cotinine Analytical Workshop Report:  Determination of  Cotinine in Human




     Body  Fluids as a Measure of  Passive Exposure to Tobacco Smoke.  R.R.




     Watts, J.J. Langone, G.J. Knight and J. Lewtas.  Environmental Health




     Perspectives. 84:173-182  (1990).








11.  Elimination of Urinary Cotinine in Children Exposed to  Known Levels of




     Side-Stream Cigarette Smoke.  George M. Goldstein, Albert Collier, Ruth




     Etzel, J. Lewtas, N. Haley.  Indoor Air '87. Vol. 2, B. Seifert, H.




     Esdorn,  M. Fischer, H. Ruden, J. Wegner, Eds, Oraniendruck GmbH, Berlin,




     pp. 61-67  (1987).
                                        20

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12.  Home Air Nicotine Levels and Urine Cotinine-Greatinine Ratios in




     Preschool Children.   F.W.  Henderson,  H.F.  Reid,  R.  Morris,  0-L.  Wang.,




     P.C. Hu, R.W.  Helms,  L.  Forehand,  J.  Mumford,  J.  Lewtas,  N.J. Haley,  and




     S.K. Hammond.   American Review of Respiratory Diseases.  140:197-201




     (1989).








13.  Passive  Smoking on Commercial Airline Flights.   H.H.  Mattson, G. Boyd, D.




     Byar, C. Brown, J.F.  Callahan, D.  Corle, J.W.  Cullen, J.  Greenblatt,  N.J.




     Haley, S.K.  Hammond,  J.  Lewtas,  and W.  Reeves.   Journal of the American




     Medical  Association.  261:867-872 (1989).
                                        21

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         HITMAN EXPOSURE TO MUTAGKNS FROM INDOOR COMBUSTION SOURCES

            Joelien Lewtas, Larry D. Claxton and Judy L. Mumford
              USEPA, Research Triangle Park, NC 27711, U.S.A.
                                  Abstract
     We have  measured human  exposure  to  rautagens,  using  indoor  medium-
volume samplers and personal  samplers,  in targeted field  studies of homes
in the U.S.  The  combustion sources included  in  these studies  were wood-
stoves, fireplaces, gas  appliances, cooking,  and tobacco  smoking.   These
studies demonstrate that the presence of  environmental tobacco smoke (ETS)
consistently results in human exposure to mutagens  which are significantly
higher than outdoor air or  non-smoking  indoor  spaces.  The mutagenic emis-
sion rates from the other  indoor combustion sources  (e.g.,  kerosene heat-
ers) as determined  in  chamber studies are  more  variable  than  ETS  and are
dependent on the  combustion source design  and operation.   Woodstoves  and
fireplaces result in higher concentrations  of  mutagens outdoors, which may
indirectly influence the concentration of mutagens indoors.
                                Introduction
     Combustion sources are  known to emit  carcinogenic chemicals  and ac-
count for most  of the mutagenicity  associated with particulate  matter in
the ambient outside air (3).   Apportionment studies of the mutagenicity for
these sources show  that  automotive  emissions  and residential  heating are
the major sources  of mutagens associated with ambient  outdoor particulate
matter (4).   Time-activity studies show that we  spend more than 80% of our
time indoors in primarily two types of indoor  environments, home and work.
In order to evaluate human exposure to mutagens,  it  is  necessary to evalu-
ate indoor as well as outdoor sources of  mutagens.  The sample mass requir-
ed for standard mutagenesis  bioassays exceeds that amount conveniently col-
lected in either indoor air  or personal exposure studies.  Recently the ap-
plication of mutagenesis microassay  methods has  facilitated the evaluation
of human exposure to  mutagens.   The  purpose of these studies  is to assess
the potential human exposure  to  mutagens from different  indoor combustion
sources.
                                  Methods .


Sampling and Analysis

     Two medium volume indoor air samplers have been used in these studies.
The 0.22 m3/min  (8  CFM)  sampling  system used in the  Columbus, Ohio study
was equipped  with  a  filter  to  collect  total suspended  particulate (TSP)
followed by a polyurethane foam  (PUF) adsorbent  cartridge to collect semi-
volatile organic (SVO) matter.  The details of the  sampling system as used

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 in this  residential indoor air  study in Columbus, Ohio  are  reported else-
 where  (5).   The 0.11 nr/min  (4  CFM)  sampling system  used  in the woodstove
 study  in Raleigh,  NC has a PM-JO  size selective inlet (to exclude particles
 >10  um)  followed by a  filter and  an organic  adsorbant cartridge  usually
 containing  XAD-2 to collect  the  semi-volatile organics.   The details of the
 development of this sampling  system  are described  by Mumford  et  al.  (7).
 Studies  are in  progress  to  compare PUF and  XAD-2 as adsorbants for  semi-
 volatile mutagens   indoors.   The  filter  and PUF cartridge  samples  were
 Soxhlet  extracted  with methylene chloride  and  5%  ether/hexane respectively
 prior  to solvent  exchange  into dimethylsulfoxide  for  bioassay  analysis.

 Microsuspension Mutagenicity Assay

     The bioassays  used  in  these  studies  both  employed  microsuspension
 modifications  of established  bioassay protocols  in  Salmonella  typhimurium
 TA98 (6) and TM677 (9).  The TM677  forward mutation  assay  modification has
 been described  elsewhere  (5).   In  this  assay both  8-azaquanine  resistant
 (mutant) colonies  and  surviving colonies  are  counted and the  mutant  fre-
 quency (MF) is  the number of mutants  per  10^  surviving  cells.   The  TA98
 reverse  mutation assay is a microsuspension  assay described  by  Kado et al.
 (2).  This   assay  also utilizes  (8)  the  nitroreductase deficient  strains
 TA98NR and  TA98DNP6 which are diagnostic for nitroaromatics.

     The bioassays were  performed  with  or without the addition of  *roclor
 1254-induced male  Sprague-Dawley rat  liver S9 mixture prepared as described
 in  the above-referenced protocols.   All assays  were  performed at 3-5 doses
 and the  linear  slope of  the  dose-response curve  was  used  to determine the
•mutagenicity,  expressed as either  revertants per  m^ air,  or per ug organ-
 ic  mass.  In all assays both  solvent controls  (negative) and positive  con-
 trols  were  assayed simultaneously  as described  in the protocols (2,  6, 9).
                            Results and Discussion
      The use of microsuspension  bioassays  has made it possible  to measure
 the mutagenicity of indoor air as  shown  in Table  1.   In  the  absence of any
 combustion sources,  the  mutagenicity  associated  with   particulate-phase
 organic matter (PPOM)  was similar inside  and  outside the  homes.   Across all
 of these homes there were elevated concentrations  of semi-volatile organics
 (SVO) which were mutagenic, resulting  in mutagenic exposures indoors which
 were twice as high as outdoors.   Fireplaces in operation did not result in
 higher concentrations of  PPOM mutagenicity;  however, one  of these three
 homes had higher concentrations  of SVO mutagenicity.  The  concentration of
 PPOM mutagenicity per m^ was  greatest  in homes with  cigarette smoking and
 was highly correlated to the  number of cigarettes  smoked  as we have recent-
 ly reported (5).

      The SVO mass  and mutagenicity concentration  averaged  3.5 times higher
 indoors when compared to  outdoors.   Neither  the SVO  mass  nor mutagenicity
 were correlated with the number of cigarettes smoked and did not appear to
 be related to any of the major combustion  sources.  Although certain cook-
 ing activities (e.g.,  frying bacon)  significantly  increased  the  concentra-
 tion of PPOMs,  the kitchens  did not  show  substantially higher  concentra-
 tions of SVO when compared to other rooms in  the house.

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     The influence of outdoor PPOM  mutagen concentrations on indoor air  is
seen in Table  1.   The outdoor rautagenicity  of the two  electric homes was
significantly (14 times) less than outside the gas homes.  This may account
for the  10  times  lower  PPOM rautagenicity observed  in  these  two electric
homes.  Table 2  shows the  same  effect  in a neighborhood  where woodstove
emissions were  shown to  increase  the  outdoor  mutagenicity  at  least  10
times.  Under these  conditions  the concentration of  mutagens  indoors  also
increased but only  up to five  times.   Alfheim  and Ramdahl  (1)  have  also
shown that  woodstoves  and   fireplaces  result   in  increased  mutagenicity
outdoors.
Table 1:  Influence of  combustion  sources on indoor air  mutagenicity in a
          winter residential study in Columbus, Ohio
Major
No.
Particulate-Phase
Organics (PPOM)
Combustion Homes Ia
Source ( s )
Moned
Gas3
Gas /Fireplace'
Tobacco Smoke
Average
High*

2
2
3

5
1
(MF/m3)
.13
1.33
.68

5.64
26.70
0°
(MF/m3)
.18
2.53
2.84

2.13
2.73
I/O0

0.7
0.5
0.2

2.6
9.8
Semi-Volatile
Organics (SVO)
I
(MF/m3)
28.2
16.3
32.4

15.2
9.3
O
(MF/m3)
11.1
10.3
2.4

4.9
5.6
I/O

2.5
1.5
13.5

3.1
1.7
Total
I/O

2.3
0.8
1.3

2.7
8.4
Average
12
2.76
2.05   1.3
                                              21.9
6.2
3.5
1.9
alndoor sample; ^outdoor sample;  cratio  of indoor/outdoor mutant frequency
(mutants/10^ survivors)/m3; "all  electric homes; enatural  gas appliances,
both central heat and cooking; *fireplace was burning wood; ''kitchen sample
taken from 7:00 a.m. to 3:00 p.m.  in a home where 58 cigarettes were smoked
in a 24 hr. day.
Table 2:  Exposure to  PPOM mutagenicity in a  woodstove impacted neighbor-
          hood in Raleigh, NC
Date
2/27
2/26
2/13
2/14
2/20
2/21

Community Site
1.0
1.7
3.6
4.7
5.7
11.1
Relative Mutagenicity*
Outside Home
1.0
3.1
5.1
11.2
7.5
16.3

Inside Home
1.0
1.0
2.9
3.0
4.6
5.1
aMutant frequency  (MF)  per m3  for  each location was  divided by  the  MF/m3
 for 2/27.

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     Zn order to  examine the mutaganlc emission  rates from appliances,  we
have collaborated  on  studies  to  examine  the  organic pollutant  emissions
from kerosene heater*  (11) •   Table  3  summarize*  the mutagenicity  of  theee
emissions from initial studies of  two  heater  type*,  radiant and convective.
Kerosene heater*  have  previously  been reported  to  emit  highly  rmitagenic
nitrated polyeyelie  aromatic hydrocarbon*  (NC^-PAH*) and dinitropyrene*  in
particular  (10).
Table 3»  Mutaganicity of kerosene heater emi**ion*
Micro*u*pen* ion
Bioa«»ay	         89          Radiant               Maltuned Conveetive

TA98 (rev/ug)
TA«»8WR (rev/ug)
TA98/1,8DNP6 (rev/Mg)
TM677 (MF/Ug/ml) +
Erai**ion Rate*
TA98 (rev/hr)
TM677 (MF/hr)
Filter
5.1
2.4
0.8
1.9

2,500
930
XAD-2
0.33
neg
neg
neg

17,490
mm
Filter
0.«3
0.42
0.22

4,300
1,500
XAD-2
neg
neg
0.10

--
3,800
•Determined  from GRAV emi**ion  rate* given  in Traynor et al.,  1986  (11).
     The  84%  decreace  in mutagenicity  observed  in  TA98/1,8DMPg  *ugge*t*
that dinitropyrene*  may account for much of the PPOM mutagenicity  observed
in the  radiant  heater*'  emi**ion*.   The  decreased  activity  observed  in
TA98MR  *ugge*t*  that other  H02-PAH*  (e.g., 1-nitropyrene) are al*o  impor-
tant.   The  nitro-compounda,  including 1-nitropyrene,   3-nitrofluoranthene,
9-nitroanthracene, and  1-nitronapthalene, were detected from  theae heater*
(11).   We have al*o  found an increase  of  PPOM  mutagenicity in  aeveral home*
with kerocene heater*  (unpublished  data).

     Further studies are  needed to meaaure mutagenic  emi**ien  rate*  and
human exposure*  to  PPOM  and SVO mutagan*  emitted from indoor  combustion
sourcee and to  determine the  contribution of combustion  sources  vented
outdoors  on the  resulting Indoor air exposures.
                                  Disclaimer
     The  research described in this paper has  been reviewed by the  Health
Effects Research   Laboratory,   U.S.  Environmental   Protection   Agency  and
approved  for  publication.   Approval  does  not  signify that  the  contents
necessarily reflect  the views and policies of  the  Ageney nor does mention
of trade  names  or commercial products constitute endorsement or  recommenda-
tion for  use.

-------
                                 Raferencea
 1.   Alfheim I.,  and Ramdahl T.  Contribution of  wood combustion to indoor
     air pollution ae meaaurad by mutagenicity in Salmonella and polycyclic
     aromatic hydrocarbon concentration.   Environmental Mutaganeeia 6
     (1984), 121-130.

 2.   Kado,  K.Y.,  Langley, D., Eisenetadt, E.  A  simple modification of the
     Salmonella liquid incubation assayt   Xncreaeed sensitivity for detect-
     ing mutagena  in human  urine.   Mutation Reaearch  121  (1983),  25-32.

 3.   Lewtae, J.  Combuation emiaaionat  Characterization and comparlaon of
     their  mutagenic and carcinogenic activity.   In H.F. Stich (Ed.)/  Car-
     cinogens and  Mutagena  in the Environment,  Volume  V,  The  Workplace:
     Sourcea of  Carcinogens.   Vancouver!   CRC  Press,   (1985)  pp.  59-74.

 4.   Lewtas, J.,   and Williams, K.   A  retrospective  view  of the  value of
     short-term genetic  bioassays  in  predicting  the chronic  effects  of
     dieael, aoot.   In  W.  Zshinishi, A.  Koizumi,  R.O.  McClellan  and  W.
     fttober (Eds.),  Carcinogenicity   and Mutagenicity  of  Dieael  Engine
     Exhaust.   Amsterdam!   Elsevier,  (1986),  pp.  119*140.

 5.   Lewtas, J.,  Goto, I., Williams, K.,  Chuang,  J.C.,  Peteraen, B.A., and
     Wilson, N.K.  The mutagenicity  of  indoor air particles  in  a residen-
     tial pilot field studyi  Application and evaluation of new methodolo-
     gies.   Atmoapheric Environment 21  (1987),  443-449.

 6.   Maron,  D.M.,   and  Ames,  B.M.   Revised methods for  the  Salmonella
     mutagenicity teat.   Mutation Reaearch 113  (1983), 173-215.

 7.   Mumford,  J.L., Harris,  D.B.,  Williams, K., Chuang,  J.C., and Cooke, M.
     Development  of  a  medium-volume  sampler  for  indoor air sampling and
     mutagenicity studiea.   Environmental  Science  and  Technology, in preaa.

 8.   Rosenkranz,  H.8., and Mermelatein,  R.   Mutagenieity  and genotoxicity
     of nitroarenest   All   nitro-contalning   chemicala  were  not  created
     equal.  Mutation Reaearch 114 (1983), 217-267.

 9.   Skopek, T.R.,  Liber, H.L.,  Krolewski, J.J.,   and  Thilly,  w.G.  Quanti-
     tative forward mutation  aaaay in  Salmonella  typhimurium uaing fl-aza-
     guanine reaiatance aa  a genetic marker.  Proceedings  National Academy
     Science 75 (1974), 410-414.

10.   Tokiwa, T.,  Makagawa,  R.,  and Horikawa,  K.  Mutagenie/carcinogenlc
     agenta in indoor pollutantai   The  dinitropyrenes  generated by keroaene
     heaters and  fuel  gaa  and liquid petroleum gaa burners.   Mutation Re-
     aearch 157 (1985), 39-47.

11.   Traynor,   G.W.,  Apte,  M.O.,  Sokol,  H.A., Chuang,  J.C.,  and Mumford,
     J.L.  Selected  organic  pollutant  emlaaiona  from  unvented  keroaene
     heatera.   Proceedings  of the 79th Annual Meeting of the Air Pollution
     Control Association 52.5 (1986).

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Mutation Research. 222 (1989) 81-99
Elsevier
                                                                                               81
MTR 02102
            A genotoxic assessment of environmental tobacco smoke
                                 using bacterial bioassays-

    Larry D. Claxton \ Randall S. Morin2, Thomas J. Hughes 3  and Joellen Lewtas  '
        ' MD-68, Genetic Toxicology Division, Health Effects Research Laboratory, U.S. Environmental Protection Agency.
    Research Triangle Park, NC 27711 (U.S.A.), ' U.S. Army Health Services Command, Ft. Sam Houston, TX 78234 (U.S.A.),
                     and 3 Research Triangle Institute, Research Triangle Park, NC 27709 (U.S.A.)
                                       (Received 25 June 1987)
                                   (Revision received 12 October 1987)
                                      (Accepted 16 October 1987)
Keywords: Environmental tobacco smoke; Salmonella typhimurium; Indoor environments; Chemistry, Semi-volatiles; Monitoring

Summary

   Recently, the National Research Council in the U.S.A. stated that laboratory studies of environmental
tobacco smoke (ETS) should be important in identifying ETS carcinogens, their concentrations in typical
daily environments,  and in understanding how these compounds  contribute  to  ETS dose-response
relationships. This paper demonstrates that integrated  chemical and bacterial mutagenicity information
can be used to identify ETS genotoxicants, monitor human exposure, and make comparative assessments.
Approximately 1/3 of  the ETS constituents for which there is quantitative analytical chemistry informa-
tion also have associated genotoxicity information.  For example, 11 of the quantitated compounds are
animal carcinogens.  Work presented in  this paper demonstrates that both the nonparticle-bound semi-
volatile and the particulate-bound organic material contain bacterial mutagens. These ETS organics give
an equivalent of - 86000 revertants per cigarette. In addition, this article summarized efforts to estimate
ETS bacterial mutagenicity, to use bacterial tests for the monitoring of ETS-impacted indoor environ-
ments, and to use bacterial  assays for the direct monitoring of human exposure.
   Environmental tobacco smoke (ETS) is the total
tobacco smoke found in an environment and  in-
cludes both sides tream cigarette smoke and the
exhaled tobacco smoke of the smokers within the
environment. The first suggestion  that environ-
mental tobacco smoke (ETS) could have detrimen-
tal health effects  was  a medical case  report
published by Rosen and Levy in 1950. This report
Correspondence: Dr. L.D. Claxton, MD-68, Genetic Toxicol-
ogy Division, Health Effects Research Laboratory, U.S. En-
vironmental Protection Agency, Research Triangle Park, NC
27711 (U.S.A.).
concluded that an infant's severe astmatic symp-
toms were directly related to the mother's smoking
of tobacco products. It was not until 31 years later
that the results from  epidemiological studies of
passive smoking and lung cancer  were available.
Three  studies were published in 1981. Based on a
population  of 91 540  nonsmoking  Japanese
housewives, Hirayama (1981) reported  that the
wives of heavy  smokers (> 20 cigarettes/day) had
2.4 times the risk of developing lung cancer as the
nonsmoking wives of nonsmokers. Trichopoulos et
al.  (1981) reported a slightly  larger risk for non-
smoking Greek women whose husbands smoked
0165-1218/89/S03.50 
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82
more   than   20  cigarettes  per  day.   Although
Garfinkel (1981) found a small (10-30%) increase
in mortality associated with passive smoking,  his
study of 469000  nonsmokers  did not detect a
statistically significant increase in risk of develop-
ing lung cancer.  Since that time, a  number of
other epidemiologic studies  have emerged  (Na-
tional Research Council, 1986). The National Re-
search Council (1986) concluded that the summary
estimate of  increased risk  of lung cancer ranges
from  10% to 34%. They also concluded that  al-
though bias  may contribute to the results, the best
estimate at present for increased adjusted risk of
lung  cancer  to  nonsmokers due  to  passive  ex-
posure is approximately 25%. In identifying needed
scientific  information,   the  National  Research
Council (1986) stated: 'Laboratory studies should
be important in determining the carcinogenic con-
stituents of  ETS and their concentrations in typi-
cal daily environments  and in  facilitating under-
standing  of possible  dose-responsive relation-
ships.' The  purpose of this  paper is  to partially
fulfill  this  need  by  integrating chemical  and
bacterial genetic bioassay information concerning
sidestream and indoor air (IA) tobacco smoke.

Materials and methods

Integrating known  chemical and genotoxicity  infor-
mation for sidestream cigarette smoke
   Although  it is expected  that most of the com-
pounds found in mainstream tobacco smoke (MS)
would also be found in sidestream smoke (SS),  the
purpose of  this effort  was  to extract  from  the
literature compounds identified specifically  in SS
and to associate this information with presently
available genotoxicity information. As part  of an
earlier effort to identify airborne compounds and
genotoxicity  information (Graedel et  al.,  1986),
confirmed compounds  found in  tobacco smoke
and indoor air were cataloged. This summary pro-
vided the baseline information for this tabulation.
In addition, an on-line  Chemical Abstracts search
was used to locate relevant papers published since
January, 1983. The compounds identified in these
papers were summarized, and the MS, SS, and/or
indoor  air  (IA)  concentrations  were tabulated.
Where available, the bioassay summary informa-
tion as reported  by Graedel  et  al.  (1986) was
paired with the identified chemicals. All computer
literature  searches were kindly supplied  by the
Resource Information Center, U.S. Environmental
Protection Agency, Research Triangle Park, NC
(U.S.A.) via Ms. Libby Smith. Although the search
periods  covered a time period extending to De-
cember 1986, the information is not meant to be
exhaustive but representative of the available liter-
ature.

Methods for determining the Salmonella mutagenic-
ity  of organic  extracts from  sidestream  tobacco
smoke particles
   After being  lit, a generic U.S.  brand of filter
cigarettes  was allowed  to burn within  a  0.04-nr1
Plexiglass* chamber into which  filtered  air was
allowed to enter. The  generated SS was continu-
ously exhausted  at a  rate  of  0.03 m3/min and
collected on a 142-mm Teflon*-coated glass-fiber
filter. Sample preparation was done in the  manner
reported by  Morin et al. (1987). The  method can
be summarized as follows. All filter samples were
extracted  using 2 IS-min  sonications (Constant
Temperature, Sonicor** waterbath sonicator. Bay
Shore, NY) using either dichloromethane, metha-
nol, or acetone as the  solvent.  Extracted samples
were concentrated to  5-10  ml  using  rotatory
evaporation. Samples were  then  transferred into
15-ml volumetric tubes and concentrated to 1-2
ml  using  dry nitrogen. After  adding  15 ml of
dimethyl sulfoxide (DMSO), the remaining solvent
was removed  using  the nitrogen  purge method.
Negative  controls were prepared in  the  same
manner using filters not containing ETS particles.
The solvent-exchanged  samples were  tested using
the  Salmonella typhimurium plate incorporation
assay as previously described (Ames et al.,  1975;
Claxton et al., 1987).

Direct comparisons of  mainstream and sidestream
tobacco smoke bacterial mutagenicity
   In order to compare the total genotoxic poten-
tial of MS and SS it was necessary to bioassay the
particle-bound, semi-volatile,  and volatile com-
pounds emitted. In order to accomplish this, sep-
arate trapping  trains  for MS  and SS  were used.
Each train consisted of an ethanol  bubbler solvent
trap, a sand trap, and  a liquid-nitrogen cold trap
in sequence (Monteith et al., 1986). Cigarette sam-

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                                                                                               83
pies were generated using a smoking machine. The
standard conditions were 1  puff/min for each of
the 30  cigarettes (1R3  Kentucky  Reference), a
puff duration of 2 s, and a puff volume of 35 ml.
Mainstream smoke  was pulled directly  into the
MS trapping train. In  order to collect the SS, the
cigarette smoking machine was enclosed within a
Tedlar* bag which had a total volume of 0.12 m3.
Air from the bag was continuously drawn into the
SS trapping trains. The ethanol bubbler  collected
primarily semi-volatile compounds, the sand trap
collected primarily particulate matter, and the cold
trap collected any remaining organic compounds.
The sand trap and semi-volatile concentrates were
bioassayed  in sealed dram vials using a  modified
version of the preincubation protocol of Yahagi et
al. (1975). Preincubation was for 15 min at 37 °C
while  vials  were shaken by  a rotary shaker at 60
rpm. Tests  were done using 500 /xI/plate of 5%
Aroclor-1254-induced  male Syrian hamster liver
homogenate. Volatiles from the cold trap were
transferred  as  a gas to  Tedlar* bags containing
standard bioassay plates. All other aspects of the
test were conducted as described by  Ames et al.
(1975).

Results and discussion

   When one evaluates the hazard of a complex
organic  emission such as ETS, there are multiple
and varied approaches that one may use. As stated
in the introduction, several researchers  have as-
sessed  ETS   through  epidemiological  efforts
(Hirayama,  1981;  Trichopoulos et  al.,   1981;
Garfinkel,  1981;  National  Research  Council,
1986). Although such studies can demonstrate the
statistical likelihood of  increased risk associated
with  ETS,  these studies were not designed to
answer  more specific  questions  concerning ETS
and human health. For example, these studies do
not identify which constituents within ETS emis-
sions  are carcinogens, mutagens, and other types
of toxicants. Epidemiology, therefore, is unlikely
to determine whether  or not changes in tobacco
type used, cigarette design,  tar values, room ven-
tilation  rates, etc. will produce major changes in
the health impact of ETS. When human epidemio-
logical data are unavailable  and unlikely to be
available to answer such relevant issues, one can
sometimes  use  whole animal  studies (Stara  and
Kello, 1979). However, since whole animal studies
for carcinogenesis and heritable mutations are ex-
pensive, lengthy processes, they too are unlikely to
be useful for answering many relevant questions.
Short-term  test data, especially  when associated
with quantitative data on analytical chemistry, can
be used to make comparative assessments, to iden-
tify  genotoxicants,  and  to  monitor  human ex-
posure.
   After identification  and quantification of the
individual constituents of the mixture, the known
lexicological properties of each constituent can be
related to the source, for example ETS.  The total
potential impact of a source can then be  estimated
by summing the activity of the known constituents
or by using some form of lexicological  modeling
or scaling.
   Approximately  10%  of the more than  3800
compounds found in MS have been identified in
ETS. Table 1 lists over 100 constituents found in
ETS and in MS and  IA samples for which there is
quantitative analytical information. The  relative
concentrations  of the constituents  vary  according
to whether they are measured as MS, SS. or IA
components. The reasons (e.g., combustion tem-
perature, oxygen levels, etc.) for  differences in
concentrations  of organic components in MS and
SS have been discussed previously (Sakuma et al..
1983, 1984; Baker, 1981. 1982;  KJus and Kutin.
1982; IARC,  1968;  National Research Council.
1986).
   Table 2 lists  the   genotoxicity  information
(Graedel et al., 1986; Nesnow et al., 1987) for the
compounds in Table 1. Approximately 1/3 of the
compounds in Table 1 have associated genotoxic-
ity information. Eleven  of these compounds are
animal  carcinogens (Nesnow et  al., 1987). Nine-
teen of the compounds are positive in  at least  1
bioassay, and  10 are  positive in  the Salmonella
bioassay (Graedel et al.,  1986). This type of infor-
mation  provides a qualitative evaluation of poten-
tial human health impacts.  For  comparative risk
analysis methods (Lewtas, 1985).  the amount of
each constituent can be associated with  the bioas-
say activity of each constituent in order  to provide
a crude means of comparison between  sources or
components of interest.  For example, using  con-
centrations of constituents in SS and  their known

-------
84
TABLE 1

CONCENTRATIONS OF COMPOUNDS ASSOCIATED WITH MAINSTREAM AND SIDESTREAM TOBACCO SMOKE
AND INDOOR AIR POLLUTED WITH TOBACCO SMOKE "
Compound
Acetamidc
Acetamide
Acetic acid
Acetic acid
Acetic acid
Acetic acid
Acrolein
Acrolein
Acrolein
Acrolein
Acrolein
Acrolein (gas only + people)
Acrolein (people absent)
Acrolein (people present)
Acrolein control air
Aldehydes (gas only + people)
Aldehydes (generic)
Aldehydes (people absent)
Aldehydes (people present)
Alkoxyl radicals
Alkoxyl radicals
Ammonia
Ammonia
Ammonia (cigars)
Ammonia (cigars)
Ammonia
Ammonia
Ammonia (cigars)
Ammonia (cigars)
Anatabine
Anatabine
Anthanthrene
Anthanthrene
Anthanthrene
Anthanthrene
Anthracene
Anthracene
Anthracene
Anthracene
Anthracene
Benz{a]anthracene
Ben2(fl]anthracene
Benz(a]anihracene
Benz|a]anthracene
Benz(o]anthracene
Sample
type
MS
SS
MS
MS
SS
SS
IA
IA
IA
IA
SS
IA
IA
IA
IA
IA
IA
IA
IA
MS
SS
MS
MS
MS
MS
SS
SS
SS
SS
MS
SS
IA
IA
MS
SS
IA
MS, P
MS, V
SS, P
SS. V
IA
MS, P
MS. V
SS, P
SS. V
Concentration
Low
70.00
86.00
333.00
272.00
1241.00
695.00
0.90
0.02
6.00
0.01
50.00
130.00
119.00
10.00
0.00
1290.00
0.39
1100.00
391.00
8.00 X1015
6.00x10"
79.40
95.30
30.50
148.00
5.14
6.11
6.98
9.34
2.40
0.00

3.00
22.00
39.00

23.60
0.10
670.00
40.00

13.30
0.09
201.00
2.50
range
High
111.00
156.00
809.00
475.00
2187.00
1 148.00
1.30
0.12
10.00
0.19
70.00
190.00
133.00
48.00
5.00
1 350.00
1.37
1 370.00
622.00
spins/c
spins/c
131.00
163.00
322.00
288.00
5.77
7.18
106.00
20.50
20.10
2.40















Units
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
ppm
mg/m3
ppm
mg/m3
ppm
Mg/m3
Mg/m3
Mg/m3
ppm
Mg/m3
mg/m3
Mg/m3
Mg/m3


Mg/cig
Mg/g smoked
Mg/g smoked
/ig/product
mg/cig.
mg/g smoked
mg/cig
mg/g smoked
Mg/cig
Mg/cig
Qua! (ng/m3)
ng/m3
ng/cig
ng/cig
Qual (ng/m3)
ng/cig
ng/cig
ng/cig
ng/cig
Qual (ng/m3)
ng/cig
ng/cig
ng/cig
ng/cig
Ref. h
25
25
23
25
23
25
2
3
12
19
2
19
19
19
12
19
19
19
19
22
22
9
9
9
9
9
9
9
9
24
24
1
15
14
14
1
16
16
16
16
1
16
16
16
16

-------
                                                                                                       85
TABLE 1 (continued)
Compound
Benz( e Jacenaphthylene
Benzene
Benzene (breath, non-smokers)
Benzene (breath, smokers)
Benzene (homes, non-smokers)
Benzene (homes, smokers)
Benzo[ a jfluorene
Benzo[ a jfluorene
Benzo[ a Jfluorene
Benzol a ]fluorene
Benzo[ a jpyrene
Benzol a Ipyrene
Benzo[ a jpyrene
Benzo[a]pyrene
Benzol a Jpyrene
Benzo[ a Jpyrene
Benzo[a]pyrene
Benzo[a]pyrene
Benzo[ a Ipyrene
Benzol a Jpyrene
Benzo[a]pyrene control
Benzo[ b ]naphtho(2.1 -djthiophene
Benzo{ b Jnaph tho[2,l -d]thiophene
Benzo[ 6]naphtho(2,l-d]thiophene
Benzo{ b ]naphtho[2,l-d]thiophene
Benzo[ 2>/c]fluorene
Benzo[ 6/c]fluorene
Benzo( b/j/k ]fluoran thene
Benzo[ b/j/k jfluoranthene
Benza[ b/j/k ]fluoranthene
Benzo{ ejfluorene
Benzo(e Ipyrene
Benzo[ ejpyrene
Benzo[ « Ipyrene
Benzo[? Jpyrene
Benzo[ e ]pyrene
Benzo[e Ipyrene
Benzo[e Ipyrene
Benzo(e Ipyrene
Benzo[ e Jpyrene
Benzo( e Ipyrene control
Benzo( 8hi jfluoranthene
Benzo[ £Ai]perylene
Benzo[ g/i/Jperylene
Benzo[g/»']perylene
Benzo[g/i/]perylene
Benzo[ £*' Iperylene
Benzol ggi'lperylene
Benzo( £/»' Iperylene
Benzol g>i/]perylene
Sample
type
[A
IA
IA
IA
IA
IA
IA
IA
MS
SS
IA
IA
IA
IA
MS
MS. P
MS, V
SS
SS, P
SS, V
IA
MS, P
MS. V
SS, P
SS, V
MS
SS
IA
MS
SS
IA
IA
1A
IA
MS
MS, P
MS. V
SS
SS, P
SS.V
IA
IA
IA
IA
MS
MS. P
MS,V
SS
SS, P
SS, V
Concentration range
Low High

0.05 0.15
2.50
16.00
4.40 9.20
4.80 16.00

39.00
184.00
751.00

7.10 21.70
6.20 144.00
22.00
44.00
10.90
0.08
199.00
103.00
0.48
0.00 0.69
2.80
0.21
50.00
1.10
69.00
251.00
35.00
49.00
260.00


18.00
3.30 23.40
25.00
6.70
0.13
135.00
75.00
0.74
3.00 5.10


17.00
39.00
7.10
0.09
98.00
41.00
0.62

Units
Qual(ng/m3)
mg/m3
Hg/m3
Mg/m3
Mg/cm3
Mg/m3
Qual(ng/m3)
ng/m3
ng/cig
ng/cig
Qual(ng/m3)
ng/m3
ng/m3
ng/m3
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
ng/m3
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
ng/m3
ng/cig
ng/cig
Qual(ng/m3)
Qual(ng/m3)
ng/m3
ng/m3
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
ng/m3
QuaUng/m;1)
Qual(ng/m3)
ng/m3
ng/cig
ng/cig
ng/ciiz
Of *O
ng/cig
ng/cig
Of O
ng/cig
Ref. h
1
3
30
30
30
30
1
15
14
14
1
11
13
15
14
16
16
14
16
16
11
16
16
16
16
14
14
15
14
14
1
1
15
20
14
16
16
14
16
16
20
I
1
15
14
16
16
14
16
16

-------
86
TABLE 1 (continued)
Compound
BenzoCluoramhenes (b + j + k)
Benzofluoranthenes (b + j + k)
Benzofluoranthenes (b+j •+• k)
Benzofluoranthenes (b+j + k)
Benzoic acid
Benzoic acid
Benzoic acid, m-hydroxy-
Benzoic acid, /n-hydroxy-
Benzonitrile
Benzonitrile
Bipyridyl. 2. 3'-
Bipyridyl. 2, 3'-
Bipyridyl. 5-methyl-2. 3'-
Bipyridyl. 5-methyl-2. 3'-
Butyrolactone, gamma-
Butyrolactone. gamma-
Carbon monoxide
Carbon monoxide
Carbon monoxide (gas only •+• people)
Carbon monoxide (people absent)
Carbon monoxide (people present)
Carbon monoxide (people present)
Carbon monoxide control
Carbon monoxide control
Carbon monoxide (artificial cond.)
Carbon monoxide (natural conditions)
Carbon, total
Carbon, elemental
Carbon, organic
Carboxyhemoglobin (blood, passive)
Carhoxyhemoglobin (blood, smoker)
Carboxyhemoglobin
(blood, no smoking)
Catechol
Catechol
Catechol. 2-methyl-
Catechol, 2-methyl-
Catechol, 3-methyl-
Catechol. 3-methyl-
Catechol. 4-ethyl-
Catechol. 4-ethyl-
Catechol, 4-methyl-
Catechol. 4-methyl-
Catechol. 4-vinyl-
Catechol, 4-vinyl-
Catechols (all catechols)
Catechols (all catechols)
Coronene
Coronene control
Sample
type
MS, P
MS. V
SS. P
SS. V
MS
SS
MS
SS
MS
SS
MS
SS
MS
SS
SS
MS
1A
IA
1A
IA
IA
IA
IA
IA
IA
IA
IA
IA
IA
IA
IA

IA
MS
SS
MS
SS
MS
SS
MS
SS
SS
MS
MS
SS
MS
SS
IA
IA
Concentration range
Low
20.50
0.22
196.00
1.38
14.00
12.00
8.00
3.00
5.00
33.00
9.90
20.00
6.60
6.00
40.00
11.00
2.00
0.00
23.00
21.00
18.00
3.70
0.00
0.00
8.00
9.00
207.00
11.90
195.00
0.55
3.38

0.57
148.00
138.00
6.00
8.00
31.00
24.00
27.00
19.00
25.00
29.00
23.00
7.00
25.00
88.00
0.50
1.00
High




28.00
23.00
64.00
15.00
6.00
57.00
27.40
73.00
14.70
14.00
103.00
22.00
23.00
1.20
26.00
25.00
22.00
4.20
15.00
0.50
16.00








362.00
292.00
13.00
21.00
62.00
47.00
102.00
68.00
55.00
80.00
113.00
40.00
328.00
212.00
1.20
2.80
Units
ng/cig
ng/cig
ng/cig
ng/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
Mg/m3
Mg/rn3
Mg/m3
%
%

%
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/m3
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
ng/m3
ng/m3
Ref. "
16
16
16
16
23
23
23
23
25
25
24
24
24
24
25
25
3
31
19
19
19
28
3
31
29
29
27
27
27
28
28

28
23
23
23
23
23
23
23
23
23
23
23
23
4
4
20
20

-------
TABLE 1 (continued)
                                                                                                       87
Compound
Cotinine (plasma, non-smoker)
Cotinine (plasma, passive smoker)
Cotinine (plasma, smoker)
Cresoi, m-
Cresol, m-
Cresol, m-
Cresol, m-
Cresol, o-
Cresol, o-
Cresol. p-
Cresol, p-
Cresol, p-
Cresol, p-
Cyclopentenone, 2, 3-dimethyl-2-
Cyclopentenone, 2, 3-dimethyl-2-
Cyclopentenone, 2-
Cyclopentenone, 2-
Cyclopentenone, 2-O//-3-methyl-2-
Cyclopentenone, 2-0/f-3-methyl-2-
Cyclopentenone, 2-methyl-2-
Cyclopentenone, 2-methyl-2-
Dibenzfa, y]anthracene
Dibenz[a, y'Janthracene
Dibenz(
-------
88
TABLE 1 (continued)
Compound
Furoic acid. 2-
Furoic acid. 2-
Glutaric acid
Glutaric acid
Glycolic acid
Glycolic acid
Guaiacol. 4-vinyl-
Guaiacol, 4-vinyl-
Guaiacol, 4-vinyl-
Guaiacol. 4-vinyl-
HCN
HCN (gas only + people)
HCN (people absent)
HCN (people present)
Hydrazine
Hydrazine
Hydroquinone
Hydroquinone
Hydroquinone, methyl-
Hydroqumonc. methyl-
Hydroxypropionic acid, 3-
Hydroxypropionic acid, 3-
Indenofl, 2, 3-«/]pyrene
Indenofl. 2, 3-o/]pyrene
Indeno(l, 2. 3-o/]pyrene
Indenofl, 2. 3-«/]pyrene
Indeno[l, 2. 3-o/]pyrene
Isoquinoline
Isoquinoline
Lactic acid
Lactic acid
Levulinic acid
Levulinic acid
Limonene
Limonene
Lutidine, 2, 4-
Lutidine, 2, 6-
Lutidine, 2, 6-
Lutidine, 3, 5-
Lutidine, 3, 5-
Sample
type
MS
SS
MS
SS
MS
SS
SS
MS
MS
SS
IA
IA
IA
IA
MS
SS
MS
SS
MS
SS
MS
SS
IA
MS, V
SS. P
SS.V
MS, P
MS
SS
MS
SS
MS
SS
MS
SS
SS
MS
SS
MS
SS
Concentration
Low
44.00
25.00
10.00
6.00
37.00
35.00
24.00
23.00
16.00
15.00
0.01
82.00
50.00
10.00
31.50
94.20
114.00
91.00
23.00
21.00
2.00
1.00

0.17
51.00
0.36
8.10
1.60
5.00
63.00
45.00
29.00
25.00
15.00
63.00
35.00
1.40
1.40
0.00
22.00
range
High
107.00
60.00
58.00
18.00
126.00
77.00
32.00
36.00
30.00
37.00
0.08
86.00

14.00


300.00
285.00
39.00
41.00
31.00
29.00





2.00
8.00
174.00
123.00
56.00
49.00
49.00
397.00
315.00
33.00
33.00
17.00
251.00

Units
Mg/cig
MgAig
Mg/cig
Mg/cig
Mg/cig
Mg/c'g
MgA'g
Mg/cig
Mg/cig
Mg/cig
mg/m3
Mg/m3
jig/m3
Mg/m3
ng/cig
ng/cig
Mg/cig
Mg/cig
Mg/cig
MgAig
Mg/cig
Mg/cig
Qual (ng/m3)
ng/cig
ng/cig
ng/cig
ng/cig
Mg/cig
MgAig
Mg/cig
Mg/cig
Mg/cig
Mg/c'g
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Ref."
23
23
23
23
23
23
23
23
25
25
19
19
19
19
21
21
23
23
23
23
23
23
1
16
16
16
16
24
24
23
23
23
23
25
25
6
6
6
6
6
 Methylenephenanthrene, 4, 5-
IA
Qual (ng/m3)
Methylnaphthalene, 1-
Methylnaphthalene, 1-
Methylnaphthalene, 2-
Methylnaphthalene, 2-
SS
MS
MS
SS
30.00
1.02
1.21
31.60
Mg/cig
Mg/cig
MgAig
Mg/cig
26
26
26
26

-------
                                                                                                       89
TABLE 1 (continued)
Compound
Methylnitrosoamino-pyridyl-butanone
Methylnitrosoamino-pyridyl-butanone
Methylphenanthrene. 1-
Methylphenanthrene, 2-
Methylphenanthrene, 3-
Methylphenanthrene. 4/9-
Myosmine
Myosmine
Naphthalene
Naphthalene
Neophytadiene
Neophytadiene
Nicotine
Nicotine
Nicotine
Nicotine
Nicotine
Nicotine
Nicotine
Nicotine
Nicotine (gas only + people)
Nicotine (people absent)
Nicotine (people present)
Nicotine, office buildings
Nicotyrine
Nicotyrine
Nicotyrine
Nicotyrine
Nitrogen dioxide
Nitrogen dioxide
Nitrogen dioxide (gas only + people)
Nitrogen dioxide (people absent)
Nitrogen dioxide (people present)
Nitrogen dioxide control
Nitrogen oxide
Nitrogen oxide
Nitrogen oxide (gas only + people)
Nitrogen oxide (people absent)
Nitrogen oxide (people present)
Nitrogen oxide control
Nitrogen oxides (combined)
Nitrosoamine, methylethyl-
Nitrosoamine, methylethyl-
Nitrosoamine, methylethyl-
Nitrosoamine, methylethyl-
Nitrosoanabasine, N'-
Nitrosoanatidine, N'-
Nitrosoanatidine, N'-
Sample
type
MS
SS
IA
1A
IA
IA
MS
SS
MS
SS
MS
SS
IA
IA
IA
IA
MS
MS
SS
SS
IA
IA
IA
IA
MS
MS
SS
SS
IA
IA
IA
IA
IA
IA
IA
IA
IA
IA
IA
IA
IA
MS
MS
SS
SS
SS
MS
SS
Concentration
Low
46.00
201.00




13.10
73.00
2.76
45.50
66.00
70.00
25.00
0.70
1.00
1.70
1720.00
1483.00
3210.00
2987.00

130.00
102.00
1.70
4.20
17.00
49.00
93.00
0.00
58.00
0.01
0.00
0.00
27.00
0.30
0.00
0.31
0.48
0.30
5.00
59.00
0.10
0.00
9.00
0.00
15.00
82.00
61.00
range
High
240.00
540.00




33.00
224.00


232.00
421.00
1010.00
3.10
10.30
180.00
3330.00
3149.00
5830.00
6588.00



180.00
20.20
41.00
211.00
263.00
0.03

0.03



0.60
9.00
0.40
0.59
0.60

218.00
9.10
1.80
75.00
27.00
40.00
167.00
220.00

Units
ng/cig
ng/cig
Qual(ng/mJ)
Qual(ng/rrr')
Qual(ng/nr )
Qual(ng/mJ)
Mg/cig
Mg/cig
Mg/eig
Mg/cig
Mg/cig
Mg/cig
Mg/mJ
Mg/m3
Mg/nv
pg/m2 min
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Traces only
Mg/m3
Mg/m3
pg/m2 min
Mg/cig
Mg/cig
Mg/cig
Mg/cig
ppm
ppb
Ppm
ppm
ppm
ppb
ppm
ppb
ppm
ppm
ppm
ppb
ppb
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
Ref. h
8
8
1
1
1
1
24
24
26
26
25
25
3
17
18
32
24
25
24
25
19
19
19
32
24
25
24
25
19
31
19
19
19
31
19
31
19
19
19
31
12
5
7
5
7
8
8
8

-------
90
TABLE 1 (continued)
Compound
Nitrosodiethylamine
Nilrosodiethylamine
Nitrosodiethylamine, N-
Nitrosodiethylamine, N-
Nitrosodiethylamine (artificial)
Nitrosodiethylamine (natural cond.)
Nitrosodimethylamine
N itrosodimethylamine
Nitrosodimethylamine
Nitrosodimethylamine
N i trosodi meihylamine
Nitrosodimethylamine. N-
Nitrosodimethylamine. N-
Nitrosodimethylamine (artificial)
Nitrosodimethylamine (natural cond.)
NUrosoethylmethylamine, A/-
Nitrosoethylmethylamine, N-
Nitrosonomicotine
Nitrosonomicotine
Nitrosopyrrolidine
N i irosopy rrolidi ne
N i t rosopy rrolidine
Nitrosopyrrolidine
Nitrosopyrrolidine
Nitrosopyrrolidine, N-
Nitrosopyrrolidine, N-
Octane (breath smokers)
Octane (breath, non-smokers)
Octane (homes, non-smokers)
Octane (homes, smokers)
Parvoline
Parvoline
Pentadien-4-olide, 2, 4-
Pentadien-4-olide, 2, 4-
Perylene
Perylene
Perylene
Perylene
Perylene
Perylene control
Phenanthrene
Phenamhrene
Phenanthrene
Phenanthrene
Phenanthrene
Phenol
Phenol
Phenol
Phenol
Sample
type
MS
SS
MS
SS
IA
IA
MS
MS
SS
SS
SS
MS
SS
IA
IA
MS
SS
MS
SS
MS
MS
SS
SS
SS
MS
SS
IA
IA
IA
IA
MS
SS
MS
SS
IA
IA
IA
MS
SS
IA
IA
MS, P
MS,V
SS, P
SS, V
MS
MS
SS
SS
Concentration range
Low
0.00
8.00
1.80
8.20
0.00
0.00
1.70
0.00
680.00
143.00
460.00
1.70
680.00
0.02
0.00
0.00
9.40
81.00
110.00
2.60
1.50
204.00
28.00
80.00
2.60
204.00
1.10
0.10
1.70
1.50
0.00
10.00
8.00
71.00

11.00
0.70
9.00
39.00
2.80

74.80
2.10
2149.00
248.00
79.00
77.00
69.00
157.00
High
4.80
73.00
4.80
73.00
0.01
0.20
97.00
27.00
1 770.00
415.00
1 880.00
97.00
1040.00
0.15
0.70
9.10
30.00
390.00
390.00
52.00
29.00
612.00
143.00
500.00
51.70
387.00


3.10
4.70
4.30
145.00
41.00
256.00


1.30


1.70





136.00
139.00
241.00
289.00
Units
ng/cig
ng/cig
ng/cig
ng/cig
ng/1
ng/l
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
"8/1
ng/I
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
ng/ciq
/ig/m3
Mg/m3
Mg/m3
/ig/m3
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Qual (ng/m3)
ng/m3
ng/m3
ng/cig
ng/cig
ng/m3
Qual (ng/m3)
ng/cig
ng/cig
ng/cig
ng/cig
MgA'g
Mg/cig
Mg/cig
Mg/cig
Ref. h
5
5
10
10
29
29
5
7
5
7
8
10
10
29
29
10
10
8
8
5
7
5
7
8
10
10
30
30
30
30
6
6
25
25
1
15
20
14
14
20
1
16
16
16
16
23
25
23
25

-------
                                                                                                        91
TABLE 1 (continued)
Compound
Phenol. 4-vinyI-
Phenol, 4-vinyl-
Phenols
Phenylacetic acid
Phenylacetic acid
Picoline, 3-
Picoline. 3-
Picoline, alpha-
Picoline, alpha-
Pyran-4-one, 5, 6-diOH-3, 5-diOH-2-ME
Pyran-4-one, 5. 6-diOH-3, 5-diOH-2-ME
Pyrazine, 2, 3-dimethyl-
Pyrazine, 2-methyl
Pyrazine, 2-methyl-
Pyrene
Pyrene
Pyrene
Pyrene
Pyrene
Pyrene
Pyrene
Pyrene
Pyrene
Pyrene control
Pyrene, 1-methyl-
Pyrene, 2-raethyl-
Pyrene, 4-methyI-
Pyridine
Pyridine
Pyridine
Pyridine
Pyridine, 2-(3-pentyl)-
Pyridine, 2-(3-pentyl)-
Pyridine, 2-ethyl-
Pyridine, 2-ethyl-
Pyridine, 3-acetyl-
Pyridine, 3-acetyl-
Pyridine, 3-cyano-
Pyridine, 3-cyanc-
Pyridine, 3-ethyl-
Pyridine, 3-ethyl-
Pyridine, 3-ethyl-
Pyridine, 3-etbyl-4-methyl-
Pyridine, 3-ethyl-4-methyl-
Pyridine, 3-hydroxy-
Pyridine, 3-hydroxy-
Pyridine, 3-hydroxy-
Pyridine, 3-hydroxy-
Pyridine, 4-ethyl-
Pyridine, 4-r-butyl-
Pyridine, 4-r-butyl-
Pyridine, methylvinyl-
Pyridine, methylvinyl-
Sample
type
MS
SS
IA
MS
SS
MS
SS
MS
SS
MS
SS
SS
MS
SS
IA
IA
IA
MS
MS, P
MS,V
SS
SS. P
SS, V
IA
IA
IA
IA
MS
MS
SS
SS
MS
SS
MS
SS
MS
SS
SS
MS
MS
SS
SS
SS
MS
MS
MS
SS
SS
SS
MS
SS
MS
SS
Concentration
Low
18.00
25.00
7.40
18.00
11.00
12.00
90.00
12.30
128.00
13.00
0.00
0.00
0.00
0.00

66.00
4.10
270.00
43.00
1.90
1011.00
466.00
10.30
2.80



32.40
16.00
336.00
187.00
0.00
0.00
2.60
2.60
3.80
9.00
24.00
2.40
4.00
71.00
21.00
6.40
0.00
125.10
90.00
152.00
157.00
27.00
0.00
17.00
2.20
12.00
range
High
45.00
57.00
11.50
38.00
30.00
22.00
166.00
189.00
1 090.00
153.00
143.00
50.00
8.60
8.60


9.40






7.00



648.00
20.00
3420.00
262.00
1.50
143.00
35.00
35.00
6.40
11.00
64.00
4.20
6.00
960.00
36.00
34.00
1.50
211.40
119.00
167.00
191.00
379.00
4.50
287.00
4.10
19.00

Units
Mg/cig
Mg/cig
Mg/m2
Mg/cig
Mg/cig
MS/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Qual(ng/mJ)
ng/mj
ng/m3
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
ng/cig
ng/nr1
Qual (ng/m3)
Qual (ng/m3)
Qua! (ng/m3)
Mg/cig
1" Of ™*O
Mg/cig
Mg/cig
• Of O
Mg/cig
Mg/cig
ue/cie
f~o/ *e
US./ CIS.
~o/ O
ue/cie
f^Of "6
ue/ciz
I^Of "O
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Ref. h
25
25
20
23
23
25
25
6
6
25
25
6
6
6
1
15
20
14
16
16
14
16
16
20
1
1
1
6
25
6
25
6
6
5
6
24
24
24
24
25
6
25
6
6
24
25
24
25
6
6
26
24
23

-------
92
TABLE 1 (continued)
Compound
Pyrrole
Pyrrole
Styrene (breath, non-smokers)
Styrene (breath, smokers)
Styrene (homes, non-smokers)
Styrene (homes, smokers)
Succmic acid
Succinic acid
Succmic acid, metnyl-
Succimc acid, methyl-
Tar radical sol in r-butylbenzene
Tar radical sol in f-butylbenzene
Thiocyanate (plasma, non-smoker)
Thiocyanate (plasma, passive smoker)
Thiocyanate (plasma, smoker)
Thioethers (urine, non-smoker)
Thioethers (urine, passive)
Thioethers (urine, smoker)
Sample
type
MS
SS
IA
IA
IA
IA
MS
SS
MS
SS
MS
SS
IA
IA
IA
IA
IA
IA
Concentration
Low
16.00
140.00
0.30
1.10
0.80
1.10
112.00
65.00
4.00
1.00


70.80
71.80
70.70
6.00
6.40
6.30
range
High
23.00
272.00
1.10
2.20
163.00
70.00
31.00
13.00









Unit*
Mg/cig
Mg/cig
Mg/m3
Mg/m3
fig/Hi3
Mg/m3
Mg/c»g
Mg/cig
Mg/cig
Mg/cig
Qualitative
Qualitative
Mmol/l
Mmol/l
Mmol/l
mmol/ml
mmol/ml
mmol/ml
Ref. "
25
25
30
30
30
30
23
23
23
23
22
22
28
28
28
28
28
28
 Toluene
IA
0.04
1.04
mg/m3
Valeric acid, 3-methyl-
Valenc acid, 3-meihyl
Vinylphenol, p-
Vinylphenol. p-
Xylene, m + p- (breath, non-smokers)
Xylene. m + p- (breath, smokers)
Xylene, o- (breath, non-smokers)
Xylene. m + p- (homes, non-smokers)
Xylene. m -*• p- (homes, smokers)
Xylene, o- (breath, smokers)
Xylene. o- (homes, non-smokers)
Xylene. o- (homes, smokers)
Xylenol, 2, 6-
Xylenol. 2. 6-
MS
SS
MS
SS
IA
IA
IA
IA
IA
IA
IA
IA
MS
SS
20.00
20.00
21.00
21.00
2.10
5.50
0.80
10.00
10.00
1.60
4.00
3.20
8.00
8.00
261.00
384.00
51.00
45.00



13.00
20.00

5.20
7.10
16.00
20.00
Mg/cig
Mg/cig
Mg/cig
Mg/cig
Mg/mJ
Mg/m3
Mg/m3
Mg/m3
Mg/m3
Mg/m3
Mg/m3
Mg/m3
Mg/cig
Mg/cig
23
23
23
23
30
30
30
30
30
30
30
30
23
23
 ' Listings are given in alphabetical order by compound and special conditions are noted in parentheses within the column labeled
   'Compound'. The sample type is categorized  in the second column as I A, indoor air; SS, sidettream smoke:  MS, mainstream
   smoke; P. associated with paniculate matter; and V, associated with volatile compounds.
 b Reference numbers are as follows: 1, Alfheim and Ramdahl, 1984; 2. Ayer and Yeager, 1982; 3, Badre et al.. 1978; 4, Brunnemann
   et al., 1976; 5,  Brunnemann et al., 1977; 6, Brunnemann et al., 1978; 7, Brunnemann et al., 1980; 8, Brunnemann et al.. 1983, 9,
   Brunnemann and Hoffmann, 1975; 10, Brunnemann and Hoffmann, 1978:  11, Elliott and Rowe, 1975; 12, Fischer et al., 1978; 13,
   Galuskinova, 1964; 14, Grimmer et al.. 1977a;  15, Grimmer et al., 1977b; 16, Grimmer et al., 1987; 17, Harmsen  and Effenberger,
   1957; 18, Hinds and  First, 1975; 19, Hugod et al. 1978; 20, Just et al., 1972; 21, Liu et al., 1974; 22. Pryor el al., 1983; 23, Sakuma
   et al.. 1983; 24. Sakuma et al.. 1984a; 25. Sakuma et al.. 1984b; 26. Schmettz et al.. 1976; 27. Sexton et al., 1984; 28, Sorsa et al..
   1985. 29. Stehlik et al.. 1982; 30. Wallace and Pellizzari.  1986; and 31. Williams el al.. 1985.

-------
                                                                                                93
genotoxicity,  one may calculate, in an additive
fashion,  the  'total  genotoxic  potential*  of  a
cigarette. Comparative human exposure could then
be  calculated by  knowing the total genotoxic
potential of a cigarette, room air volume, and the
air  exchange  rate.  If one were to  make a  crude
estimate  of  the bacterial  mutagenicity  of  'a
cigarette' by using the upper concentration ranges
from Table 1 and Salmonella potency range for
the 10 bacterial mutagens (1 rev/100  mg  to  1
rev/0.10 /ig), the  calculated mutagenic  potency
[/tg of compound/cigarette X revertants//tg com-
pound]  of a cigarette would be  approximately
0.5-45 revertants per cigarette.  If all of the com-
pounds  in Table 2 except the known  negatives
were to be shown to be Salmonella mutagens, one
could estimate the mutagenic activity level  to be
as high as 1500 revertants/cigarette. Obviously,
this method of summing the total genotoxic activ-
ity for a ' typical cigarette' is most useful when the
chemical and bioassay values are quantitatively
accurate, when all genotoxicants have been identi-
fied and bioassayed properly, and when synergis-
tic and/or antagonistic interactions do not inter-
fere. Because one  would  not expect  this list  of
bacterial  mutagens to  be  inclusive  of all  the
mutagens  and because one cannot presently rule
out all possible types of interactions, this type of
calculation would estimate only the lower limits of
mutagenicity  as  will be clearly demonstrated be-
low.
   Upon testing an acetone extract of SS particles,
Lofroth et al. (1983)  found the extract prefer-
entially mutagenic in S, typhimurium TA98 in the
presence of S9. The observed response using TA98
corresponded to 15000 revertants per  cigarette.
Upon using a cigarette-smoking machine in a 15-
m3 room, Ldfroth and Lazaridis (1986) calculated
that their results represent the equivalent of 30000
revertants per cigarette for MS and 10000-20000
revertants  per  cigarette  for SS when  using  S.
typhimurium  TA98 with S9 activation. In  1987,
Ling et al., using the same methods, observed for
strain TA98  a range of 17200-31300 revertants
per cigarette for SS organics tested using the plate
incorporation protocol and a range  of 36000-
118300 revertants per cigarette using a micro-as-
say preincubation protocol. In addition, they ob-
served significant activity using TA100 without
TABLE 2
THE GENOTOXICITY OF COMPOUNDS ASSOCIATED
WITH ENVIRONMENTAL TOBACCO SMOKE
Compound
Acetamide


Acetic acid
Acrolein
Anthracene




Benz{ a (anthracene




Benzene




Benzo(
-------
94
TABLE 2 (continued)
TABLE 2 (continued)
Compound
Hydroquinone

Indenofl, 2. 3-o/]pyrene
Isoquinoline
Limonene
Naphthalene
Nicotine

Nitrosodiethylamine. N'-









Nitrosodimethylamine, N'-














Nitrosonornicotine
Nilrosopyrrolidine
Perylene
Phenanthrene




Phenol

Pyrene




Pyridine

CAS Number
123-31-9

193-39-5
119-65-3
5989-27-5
91-20-3
54-11-5

55-18-5









62-75-9














16543-55-8
930-55-2
198-55-0
85-01-8




108-95-2

129-00-0




110-86-1

Bioassay results '
ALC
ST
CCC
ST
ST
ST
NEU
ST
CCC
CT
CYC
L5
MDR
MST
REC
SCE
ST
V79
ARA
CCC
CT
CYG
CYG
L5
MNT
MST
NEU
SCE
SRL
SRL
ST
V79
YEA
CCC
CCC
SCE
ALC
CCC
CT
CYC
ST
NEU
ST
CCC
CT
CYC
ST
V79
SCE
ST
+
NEG
+
NEG
NEG
NEG
NEG
NEG
+
+
+
+
+
NEG
+
+
+
+
+
+
+
+
NEG
+
+ /-
NEG
+
+
+
+
+
+
+
+
+
NEG
+
I
NEG
NEG
NEG
NEG
NEG
I
NEG
NEG
NEG
NEG
+
NEG
                                                       Compound
              CAS Number
Bioassay results'
Styrene
Toluene
100-42-5
108-88-3
CCC
SCE
ST
+
NEG
NEG
                                                       * Bioassay information is extracted from Graedel et al., 1986.
                                                         Abbreviations used for bioassay results are as follows: ALC.
                                                         Allium cytogenetics assays; ARA, Arabidopsis mutagen as-
                                                         say; ASPH, Aspergillus mutagen assay; CCC, whole animal
                                                         carcinogen assays; CT, cell transformation  bioassays; CY,
                                                         mammalian  cytogenetic  bioassays;  L5, L5178Y  mouse
                                                         lymphoma assay;  MDR,  mammalian cell DNA repair as-
                                                         says;  MNT, micronucleus assays;  MST, mouse spot test;
                                                         NEU.  Neurospora  assays;  REC,  DNA  repair-deficient
                                                         bacterial  assays;  SCE. sistcr-chromatid  exchange assays;
                                                         SRL,  sex-linked recessive lethal assays in Drosophila; ST,
                                                         Salmonella assays; TRM, Tradescantia mutagen assays; V79,
                                                         V79 Chinese hamster mutation assays;  and YEA, Yeast
                                                         mutation tests. Results are recorded as  +,  positive; NEG.
                                                         negative; and I, Indefinite.

                                                       activation.  Ong  et al.  (1984)  examined the muta-
                                                       genicity of SS using 5.  typhimurium  TA98W (an
                                                       antibiotic-resistant  strain of TA98) in an in situ
                                                       impinger system. They stated  that '...  the con-
                                                       centration  of cigarette smoke  that could be de-
                                                       tected for mutagenic activity was 0.0065 cigarette
                                                       per  ml.'  Because  the concentration  of cigarette
                                                       smoke  in  these  experiments was equivalent  to
                                                       approximately 0.036 cigarettes/ml and the ob-
                                                       served  response  was  approximately  40 induced
                                                       mutants/ml, they (Ong et al., 1984) observed 1111
                                                       [(40 rev/ml) • (1 ml/0.036  cig)]   revertants per
                                                       cigarette.  However, if one  assumes from their
                                                       calculations that 0.0065  cigarettes would give  a
                                                       doubling (- 20 induced revertants) of the sponta-
                                                       neous  revertant  number,  the activity  of SS is ap-
                                                       proximately  3080  [(20  rev/doubling)  • (1  dou-
                                                       bling/0.0065 cigarettes)]  revertants per cigarette.
                                                       The 3- to 10-fold difference between the results of
                                                       the  L8froth et al. (1983) and Ong  et al. (1984) is
                                                       most likely due to differences in the collection and
                                                       exposure systems used, although, once again, one
                                                       cannot rule out the role of  differences in chemical
                                                       interactions. LSfroth et al. (1983) collected only
                                                       paniculate matter and tested the extracted organic
                                                       material, whereas Ong et  al. (1984), while attempt-
                                                       ing to test total SS, probably assayed primarily the

-------
                                                                                                95
nonparticulate, semi-volatile organic material that
would dissolve in the fluid medium. Although the
methods of  Lofroth et al. (1983) and Ong et  al.
(1984) did not identify the specific genotoxicants
responsible  for the biological activity, the direct
bioassay of the emissions did  provide  a more
accurate determination of the  total mutagenic
potential of  a cigarette.
   Knowing the amounts and bioassay activity of
SS constituents or the total mutagenic activity of a
'typical cigarette' also  does not  necessarily indi-
cate that one can accurately estimate human ex-
posure to genotoxic (ETS) emissions. For both MS
and SS, the  amount of a specific material that is
emitted from a cigarette ranges from sub-nano-
gram per cigarette levels to milligram per cigarette
levels.  The  concentrations of  constituents  in
smoke-impacted  spaces  range  from  ng/m3  to
mg/m3; however, the calculation of ambient con-
centrations  from  cigarette  emission rates is not
always simple because ETS levels are functions of
smoking rate,  ventilation, sink rate, mixing, and
volume  of the space (National Research Council,
1986). Also, each  individual  compound  may  be
removed from the ambient air at different rates
due to these functions.  For example, genotoxicant
exposure levels can be approximated  by measur-
ing respirable paniculate (RSP) levels and measur-
ing the  level of specific genotoxicants associated
with the particles.  RSP  levels  in a  one-smoker
residence can vary by 3 orders of magnitude from
approximately 17 to 5000 Mg/m3  (National Re-
search  Council,  1986). Similarly,  most IA con-
centrations (Table 1) for specific  compounds span
at least  2 orders of magnitude; however, the rela-
tive  amounts of components with  SS are often
different from the relative  amounts found in  IA
samples. It is also unlikely that all SS  carcinogens
have been identified. By collecting indoor air par-
ticulate   matter  and  bioassaying  the extracted
organic  matter using  S.  typhimurium TM677 in
modified  bioassay, Lewtas et  al.  (1987) dem-
onstrated that particle-associated mutagenicity per
cubic volume of air was greatest in the homes with
cigarette smoking and correlated with  the number
of cigarettes smoked. The mutagenic  activity per
cigarette, however, could  not be calculated in this
study due to the presence of other potential sources
of mutagens such as woodstoves, gas appliances,
cooking, etc. Recently. Husgafvel-Pursiainen et al.
(1986) demonstrated that indoor  airborne  par-
ticulate matter collected  in 3  restaurants where
smoking occurred gave up to 2370 revertants/m3
air. On the basis of optical particle counting, they
attributed the  majority of the airborne paniculate
matter to cigarette smoking; however, they also
did not estimate mutagenicity on a per cigarette
basis. Husgafvel-Pursiainen et al. (1986), however.
did show  that the levels of polynuclear aromatic
compounds roughly correlated with the mutagenic
activity.   Human  exposure  to  tobacco-smoke
genotoxicants, therefore,  is highly  variable and
difficult to assess by evaluating individual compo-
nents and/or  equivalent  bioassay  activity  levels
emitted into ambient air.
   In order to explore the use of bacterial bioas-
says in evaluating  ETS,  our  laboratory has ex-
amined some of the alternative  methods that can
be used for evaluating ETS. The approaches used
are briefly described in the Materials and methods
section. As part of one study (Morin et al., 1987),
filters used to collect SS  particles were extracted
with  various   solvents,  solvent-exchanged  to
DMSO, and bioassayed. Depending upon the ex-
traction conditions,  tester strain, and activation
conditions the revertants per cigarette ranged from
400 to 19000 (Fig. 1). Results using TA98 with S9
of  ~ 19000  revertants/cigarette resemble  data
obtained by Lofroth et al. (1983).
   Because the work of Ong  et al. (1984) dem-
onstrated  that the semi-volatile  and volatile com-
ponents of SS may  be  mutagenic.  we decided to
assess  the  total mutagenic potential of  both MS
and SS. Using  the sequential trapping train method
described, we collected  volatile,  semi-volatile, and
paniculate-bound  organics simultaneously  from
both  MS  and SS  using separate trapping trains.
Each of the fractions from both trains was bioas-
sayed  separately  in  the Salmonella mutagenicity
assay.  No mutagenicity was associated with the
cold trap (volatile fraction) of either the MS or SS
when evaluated as gases  in the Tedlar dessicator
system (Hughes et al., 1987). Table 3  summarizes
the results for the other components of the trap-
ping trains. Both the bubbler and sand trap sam-
ples were  mutagenic for MS and SS; therefore,
both  the  particulate and  the semi-volatile  com-
ponents were mutagenic. The revertants/cigarette

-------
96
TEST CONDITION (Solvent/Strain/Actlvauonl
  OC*/T» IOO/-S9
4C£/UIOO/«S9
ICE/UW/-S9
KOH/TMOO/-S9
7777/\^
3°-s
P" 	
         0        3        10        15        20
              SEVERTANTS UN THOUSANDS) PER CIGARETTE
Fig. 1.  Salmonella typhimurium mutagenicity of sidestream
cigarette smoke when tested using various solvent extraction
systems, strains of 5. typhimurium, and activation conditions.
Abbreviations are as follows: ACE, Acetone; DCM, Dichloro
methane; MEOH, Methanol; TA98 and TA100 for respective
strains of  5. typhimurium; + S9, with exogenous activation;
and — S9 without exogenous activation.

value  of 35200 is approximately twice  the 19000
and 15 000 values previously seen with particle-as-
sociated  fractions;  however, when  the cigarette
machine  was not used  to generate  a puff mode
sample and the cigarettes were allowed to smolder,
this value was  reduced  to 23 250 revertants per
cigarette. It has been demonstrated previously that
the products produced during puffing and natural
smoldering are  somewhat  different due  to gen-
erated temperatures, the rate of  mass transfer of
oxygen to the  tobacco  source,  properties  of the
cigarette  paper,  etc. (Baker,  1981, 1982).  There-
fore, it is reasonable that the mutagenicity of both
MS and SS varies with the degree of puffing. The
effect of  burn conditions can  also  be noted  by
examining the revertants/^ g of organic material
values in Table 3. Compared on  a per mass of
organic material basis, the MS organics are 2-3
times as mutagenic as the SS organics. This dem-
onstrates  that  the  mainstream  and  sidestream
combustion processes  produce different  relative
amounts  of bacterial mutagens.  One  also  could
speculate -  from knowledge of the 2  types of
combustion processes and differences in MS and
SS chemistry  - that  the  quantitative distribution
of mutagens in MS and SS is  different. Due to the
mass of organic material produced, however,  SS
organics make a larger contribution to the total
mutagenic activity of a cigarette. It  is interesting
to note that within our laboratory the response of
benzo[a]pyrene (B[a]P) in Salmonella typhimurium
TA98 with exogenous activation is approximately
20 revertants//ig; therefore, one can  calculate that
total cigarette bacterial mutagenicity is equivalent
to   ~ 2.6 mg  of  B[a]P.  Approximately  70%
(61600/86 300) of the total mutagenicity is associ-
ated with the sand trap (paniculate)  samples. This
proportion also is approximately the same for the
MS  and  SS  samples.  Overall,  the SS  sample
accounted for approximately  60%  of the total
mutagenicity on a per cigarette basis.
  The  best way presently available  to assess  hu-
man exposure to genotoxic ETS compounds is by
the analysis of the fluids and tissues of exposed
individuals. Exposure of target tissues and sites to
genotoxic constituents of ETS depends on several
factors, including the number of cigarettes smoked
TABLE 3
THE SALMONELLA TYPHIMURIUM TA98 MUTAGENICITY OF MAINSTREAM AND SIDESTREAM TOBACCO SMOKE
COLLECTED IN A PUFF MODE
Fraction

Main
Side
Total
Ethanol bubbler
Rev/Mg •
8.1
2.7


Rev/cig "
7557
17099
24656
Sand trap
Rev/Mg
4.0
1.6


Rev/cig
26400
35 200 c
61600
Bubbler + sand
Rev/cig
33957
52299
86256
a S. typhimurium TA98 mean revertants per plate per /ig of organic material collected using a preincubation bioassay. Determined
  using a linear regression model (Myers et al., 1981)
h S. typhimurium TA98 revertants per cigarette calculated from (Rev//jg)x(;jg of fraction/cigarette).
•• When puff mode was not used and the cigarettes were allowed to smolder, this value was 23 253 rev/cig.

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                                                                                                 97
in an enclosed area,  the size and nature of the
area,  the  degree  of room  ventilation,  breathing
rates and volume, absorption of the genotoxicants,
body  distribution and excretion, and metabolism.
The uptake of individual agents from ETS can be
determined using chemical methods. For example,
one can measure  products such as  thiocyanate,
carboxyhemoglobin, nicotine and cotinine in phys-
iological fluids. However,  some of  these  (e.g.,
thiocyanate due to HCN exposure and carboxy-
hemoglobin from CO exposure) do not originate
exclusively from SS (National Research Council,
1986). The quantitative  aspects of other chemical
and   biochemical  markers  such  as  cotinine,
hydroxyproline,  /V-nitrosoproline, and aromatic
amines  are still somewhat questionable (National
Research Council, 1986). In  addition, when one
bioassays  an agent individually, it may  not be
known  whether or not  different genotoxic  com-
pounds  are absorbed, distributed, metabolized, and
excreted at the same rate as each other. The use of
a noncompound-specific measurement of exposure
to  genotoxicants,  therefore,  would  be  very
advantageous. The monitoring of nonsmokers'
urine  for mutagenic potential using bacterial as-
says provides a possible means of evaluating in
vivo  exposure  to ETS  genotoxicants. In  1977.
Yamasaki and Ames  reported  the  presence of
bacterial mutagens in  the  urine  of smokers. As
noted by IARC (1986),  a number of studies have
confirmed the  finding  of Yamasaki  and Ames;
however, there is a wide variation in the results of
these  studies. Much of this variation may be due
to dietary factors (Sasson et al., 1985). The studies
that have examined the urine  mutagenicity of pas-
sive smokers (Putzrath  et  al., 1981;  Bos et al.,
1983; Sorsa et al., 1985) demonstrated increased
mutagenicity  in adult passive smokers. These stud-
ies generally  examined  small  numbers  of people
and did not control for  dietary factors; therefore,
the results might be considered somewhat ambigu-
ous. In spite of the shortcomings, these studies did
support the use of bacterial bioassays as a screen-
ing tool for  human exposure  to ETS genotoxi-
cants; however,  more effort is needed  in impro-
ving and standardizing the  methods and in creat-
ing the  proper controls for other environmental
factors such as diet.
   In  summary, our studies support previous stud-
ies  that  demonstrated  that  ETS particle-bound
organic material is  mutagenic. In addition,  our
studies demonstrated that some semi-volatile  and
volatile components were mutagenic; however, the
highly volatile compounds (for both MS and SS)
collected in the third-stage  liquid nitrogen cold
trap were not mutagenic. Within these studies, the
total mutagenicity was divided among 4 fractions
approximately  as  follows:   SS sand  trap (par-
ticulate) fraction, 40%; MS sand trap (paniculate)
fraction,  30%; SS  solvent (semi-volatile)  fraction.
20%; and MS solvent (semi-volatile) trap  fraction,
10%.  Results  also gave  an  indication   that  the
frequency with which a cigarette is puffed affects
the total  amount of mutagenic  material produced.
Although these studies illustrate the usefulness of
bacterial  mutagenicity bioassays for characterizing
ETS,  there  are  also  other uses (e.g..  identifying
specific genotoxicants) for which  bacterial  assays
will find  great utility.

Acknowledgements

  The technical assistance  of Linda  Monteith,
Debra Simmons, Jack Callahan. Ken  Davis,  and
Jeff Keever is gratefully appreciated. The authors
wish to thank Dr. Goran LSfroth and Ms Virginia
Houk for their careful review and suggestions for
the manuscript. The research described in  this
paper  has  been reviewed  by  the Health Effects
Research Laboratory, U.S. Environmental Protec-
tion Agency, and  approved  for publication.  Ap-
proval does not signify  that the  contents  neces-
sarily reflect the views and policies of  the Agency
nor does the mention of trade names or commer-
cial products  constitute endorsement  or recom-
mendation  for use.

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              Reprinted from ENVIRONMENTAL SCIENCE & TECHNOLOGY. VoL 23, Page 610, May 1989
                lit © 1989 by the American Chemical Society and reprinted by permiMion of the copyright owner.
Characterization  of Environmental  Tobacco Smoke

Goran Lofroth,r Robert M. Burton,* Unda Forehand,5 S. Katharine Hammond,11 Robert L. Seila,*
Roy B. ZweJdinger,* and Joellen Lewtas*-1-
Heatth Effects Research Laboratory and Atmospheric Research and Exposure Assessment Laboratory, U.S. Environmental
Protection Agency, Research Triangle Park, North Carolina 27711, Environmental Health Research & Testing Inc., Research
Triangle Park. North Carolina, and Department of Family and Community Medicine, University of Massachusetts Medical
School, Worcester, Massachusetts
• Environmental tobacco smoke (ETS) has been analyzed
with respect to several components following smoking of
research cigarettes in an experimental chamber.  Param-
eters analyzed and their airborne yield per cigarette in-
cluded particulate matter (10 mg) and its mutagenic ac-
tivity in a Salmonella bioassay, carbon monoxide (67 mg),
nitrogen oxides (2 mg), nicotine (0.8-3.3 mg), formaldehyde
(2 mg), acetaldehyde (2.4 mg), acrolein (0.56 mg), benzene
(0.5 mg), and several unsaturated aliphatic hydrocarbons
(e.g., 1,3-butadiene) of which isoprene (3.1  mg) had the
highest yield. ETS from commercial cigarettes was like-
wise analyzed in the experimental chamber and at a public
location. The relative component composition for ETS is
similar when generated from either research or commercial
cigarettes.   All components analyzed  were present  at
concentrations  above the background  concentrations.
Isoprene might  be utilized as a tobacco smoke tracer for
unsaturated aliphatic hydrocarbons.

Introduction
  Environmental tobacco smoke (ETS), which is derived
primarily from sidestream smoke emitted between puffs,
is a major contributor to indoor air pollution wherever
smoking occurs (1, 2).  ETS differs both chemically and
physically from  the precursor sidestream smoke, presum-
ably due to chemical and physical transformations that
occur as  the mixture is  diluted and aged.  Chemical
characterization studies have focused on mainstream and
sidestream smoke (1).  Data are lacking, however, on the
presence and concentration of potentially toxic and car-
cinogenic components in tobacco-smoke-polluted indoor
environments. An ideal ETS tracer air contaminant is not
available for total ETS exposure (2), although nicotine is
the best available tracer.
  In this study we investigated the concentration of a
number of genotoxic  components as well as potential
tracers of ETS under controlled and environmental con-
ditions. Some of the components measured are routinely
monitored air pollutants including carbon monoxide, ni-
trogen oxides, and particulate matter. A series of aldeh-
ydes and alkenes were measured in these studies, including
several that are carcinogenic. The mutagenicity of the
particulate phase was assayed in Salmonella typhimurium,
Nicotine was measurd as an ETS tracer.  Indoor chamber
experiments were performed at the EPA facility at the
University of North Carolina, Chapel Hill, partly in con-
junction with studies  on  the urinary cotinine (nicotine
metabolite)  concentration and excretion rate in young
children following exposure to sidestream cigarette smoke
  'Visiting Scientist at U.S. EPA from Nordic School of Public
Health, P.O. Box 12133, S-402 42 Gothenburg, Sweden.
  1 Atmospheric Research and Exposure Assessment Laboratory,
U.S. EPA.
  'Environmental Health Research & Testing Inc.
  1 University of Massachusetts.
  x Health Effects Research Laboratory, Genetic Bioassay Branch,
MD68, U.S. EPA.
     (3).  Indoor measurements were also made in a tavern.

     Experimental Section
       Chamber and Smoking.  The tests were performed in
     a 13.6-m3 Plexiglas chamber (4) set at a ventilation rate
     of 3.55 air changes h~l; in addition, air removed by the
     sampling added  ~0.50 air changes h~l.  The air in the
     chamber was circulated by a fan at 1.35 m3 h"1.  The tem-
     perature and the relative humidity are given in Table I.
       Research cigarettes of the type 2R1 (5), which had been
     equilibrated at 22 °C at 60% relativity humidity for 48 h,
     were smoked by machine (RM30, Heinr. Borgwalt, Ham-
     burg, FRG). One cigarette was lighted every 30 min and
     was smoked with a 35-mL puff of 2 s every minute until
     extinguished  after ~12 min.  Mainstream smoke was
     vented to the outside of the  chamber.  The cigarettes
     weighed ~ 1.2 g, of which 0.9-1.0 g was consumed.
       One adult and one child were present in the chamber
     during the 4-h tests in the first series of nine experiments.
     Six additional experiments were performed with the re-
     search cigarettes smoked by machine later in a second
     series, including two tests with no smoking, two tests (13
     and 14) similar to the first series, (one cigarette every 30
     min), and two tests (15 and 16) with one cigarette every
     15 min. In tests 15 and 16, decay of components in the
     chamber was  measured. Subsequently, in a third series
     of chamber tests, the emissions from two different com-
     mercial cigarette brands (A and B, both low-tar  and •
     nicotine brands) were analyzed  in the chamber with regular
     smoking by one person without any applied ventilation.
       Sampling  and Analysis.  Particle Sampling and
     Analysis. Total suspended particles (TSP) were collected
     in duplicate on preweighed Teflon-coated glass fiber filters
     (Pallflex)  at 1.7  m3 h'1 by modified Anderson samplers
     consisting of the 10-mm preseparator and the backup filter.
     TSP was also measured continuously by an Electric Aer-
     osol Analyzer, EAA (Thermo-System, Inc., Model 3030),
     with measurements taken every 9 or 10 rnm. Particles were
     also collected in triplicate with personal sampling pumps
     (Model P4000, Du Pont, Kennett Square, PA) at 1.7 and
     3 L min"1.
       Nicotine. Nicotine was collected on bisulfate-impreg-
     nated filters (6) placed downstream from the particle filters
     on the personal samplers (first  series) or on both Anderson
     and personal samplers (second series).  Extraction and gas
     chromatography analysis of nicotine was performed as
     described by  Hammond et al. (6).
       Particle Mutagenicity.  The filters were extracted by
     sonication in dichloromethane,  and the extract was brought
     to a fixed volume. Aliquots of the solution were distributed
     into 4-mL vials together with 5 nL of dimethyl sulfoxide
     (DMSO) and then evaporated by  nitrogen gas at 35 °C.
     The vials were kept capped at -20 °C until bioassayed.
        The mutagenicity was determined by a microsuspension
     assay developed by Kado et aL (7) and modified by De-
     Marini et al.  (in preparation) using Salmonella TA98 in
     the presence of S9 (8). The microsuspension was modified
     by using a bacterial suspension concentrated 5 times  in-
610  Environ. Set Techno!., Vol. 23, No. 5. 1989
0013-936X/89/0923-0610$01.50/0  © 1989 American Chemical Society

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Table I. Average Chamber Concentrations (±SD) and Average Airborne Yield* for Carbon Monoxide, Nitrogen Oxides. Total
Suspended Particles, Particle Mutagenicity, and Nicotine daring Smoking of One Cigarette Every 30 Minutes (Tests 1-9,13,
and 14) and Every 15 Minutes (Tests 15 and 16) in a 13.6-m1 Chamber with an Air Exchange of 3.55 h'1.
              component                 series 11-9

     relative humidity, %                  53 ± 4
     temperature, °C                     24 ± 0.5
     carbon monoxide, mg/m3              2.48 ± 0.29
     nitric oxide, Mg/m3                   68.0 ± 6.0*
     nitrogen oxides,'' Mg/m3               72.8 ± 6.9*
     total suspended particles, Mg/m3
       by mas*                         349 ± 39
       by EAA«                         349 ± 45?
     mutagenitity, revertants/m3
       personal sampler                   628 ± 49
       Anderson sampler                  494 ± 58
     nicotine, Mg/m3
       personal sampler 1-9               29 ± 7
       personal sampler 13-16             nd
       Anderson sampler 13,14            nd
series II 13 and 14

   29± 1
   23 ±0
   1.79 ± 0.81
   61.0 ± 2.8
   65.0 ± 8.5

   321 ±25
   513 ± 47

   nd*
   517 ±40

   nd
   127 ±23
   150 ± 14
 15 and 16     airborne yield per cigarette*
34 ±0
23 ±0
4.76 ± 0.21
139 ±6
139 ±9

934 ±46
1223 ±84

nd
837 ±76

nd
228 ±49
nd
6
6
67 mg
6
1950 ng

10 mg
b

17300 revertants
13400 revertants

800 Mg
3300 Mg
6
   • Unconnected for surface removal * Not applicable. * Based on eight tests. d Expressed as NO from total concentration of NO and NO*.
 * Assuming unit density. 'Based on four tests, 'nd, not determined.                                          	
 stead of 10 times, 0.015 M phosphate-buffered saline in-
 stead of 0.15 M, no shaking during the 90-min incubation
 of the vials at 37 °C, and addition of histidine and biotin
 to the plate bottom agar instead of to the top agar.
   The combined sample from the  duplicate Anderson
 filters from each experiment was tested with six doses
 corresponding to 25-300 L of air in duplicate tests with
 duplicate vials for each dose and test.  The combined
 sample from the personal filters from each experiment was
 tested with three doses corresponding to 50-200 L of air
 in one test, with triplicate vials for each dose. The response
 was calculated by linear regression using doses on the linear
 or almost linear part of the dose-response curve.
   Carbon Monoxide and Nitrogen Oxides.  Carbon
 monoxide (CO)  was measured continuously by nondis-
 persive infrared absorption (Bendix 8501-5), and nitrogen
 oxides NO, (Le., NO plus NOj) were measured indirectly
 by chemiluminescence (Bendix 8101-B).  Data points were
 recorded every 3 min.
   Hydrocarbons. Air was collected in evacuated stainless
 steel canisters (9), and the sample was then subjected to
 speciated gas chromatographic analysis by the method
 described by McElroy et al. (10). Samples in the first
 experimental series were collected as grab samples at a
 peak concentration of carbon monoxide in the chamber,
 whereas samples in the second series were collected over
 the entire smoking period (4 h).
   Aldehydes. Aldehydes were collected in the second
 series at a rate  of 1.0 L min"1 using 2,4-dinitrophenyl-
 hydrazine-coated silica  gel cartridges for collection and
 high-performance liquid chromatography for analysis of
 the hydrazone derivatives as described by Tejada (11).
   Calculations. The average chamber concentrations
 were calculated as the average value between 1 h after start
 until the end of the experiments. When sampling included
 the first hour, the average concentration was calculated
 by normalizing to the continuous CO concentration; this
 correction was approximately 5%. Likewise, grab samples
 of hydrocarbons were normalized to the average concen-
 tration from the peak concentration, when the sample had
 been collected. The airborne yield, expressed as amount
 per cigarette, was calculated from the average concentra-
 tion by using the known smoking frequency, the chamber
 volume, and the total air exchange rate.
   Environmental Sampling.  The impact of tobacco
 smoke was determined  in two studies in a local tavern.
 The main room in which sampling took place had a volume
    of ~ 180 m3 (I = 15 m, w = 4 m, and h — 3 m) and was
    variously occuplied by 5-25 persons, many of whom were
    smoking.
      Indoor TSP and nicotine were collected on a Teflon-
    coated glass fiber filter and a second bisulfate-impregnated
    filter, respectively, at 20 L/min by an Anderson sampler.
    Particulate matter was measured by taking 120-s readings
    each 1/2 h over the 3- or 4-h study with a piezobalance
    Model 3500 (TSI Inc., St Paul, MN) both indoors and
    outdoors with at least two cleaning cycles per hour. Indoor
    and outdoor carbon monoxide was determined with two
    General Electric  Model 15ECS3CO3 carbon  monoxide
    detectors (Wilmington, MA) that had been calibrated at
    zero and 60 ppm CO.  Indoor aldehydes and indoor and
    outdoor hydrocarbons were collected and analyzed as de-
    scribed for the chamber studies.  The hydrocarbon sam-
    pling  was performed during only 2 h in each of the two
    studies.

    Results
      The concentrations and calculated yields are given in
    Table I for components that were analyzed in all chamber
    tests in the first and second series. Carbon monoxide and
    nitrogen oxides were determined continuously every 3 min,
    and their concentrations varied in a saw-toothed form with
    the smoking cycle of one cigarette every 30 min. The ratio
    of the average maTimnin to the minimum concentration
    was ~3. The average concentration of carbon monoxide
    was about 65-70% of the mummum concentration; similar
    ratios were found for nitrogen oxides.
      Particle concentrations measured by EAA had the same
    type of variation, but the resolution was less because the
    analyses were performed less frequently.  The average
    concentration of particles as measured by EAA (assuming
    unit density) was in good agreement with the concentration
    obtained by filter collection in the first series and over-
    estimated the particle concentration in  the second series
    under lower relative humidity. Due  to the organic char-
    acter  of ETS, however, the density would be expected to
    be somewhat less than 1.0.
      The nicotine  concentrations and yields were  lower
    during the first series than during the second series, with
    yields of 800  Mg/cigarette and 3300 Mg/cigarette, respec-
    tively. There were several differences in the two series.
    In the first series, the chamber contained more adsorbant
    surfaces:  two persons, mother and child, television  set,
    crib, chair, and a curtain, all of which were absent in the
                                                                       Environ. Set Tectmot. Vot 23  No. 5, 1989  611

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Table II. Selected Hydrocarbon Concentrations 
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  Finally, available portable equipment was used to sam-
ple and analyze the air in a tavern during normal smoking
conditions. All ETS components that were analyzed in-
doors and outdoors were highly elevated  in the indoor
environment (Table V).  Furthermore, none of the ana-
lyzed components was conspicuously much higher or much
lower relative to each other than what would have been
expected from the studies of the airborne yield of research
cigarettes.

Discussion
  This study characterizes both exposure concentrations
and airborne yields for particulate matter and its muta-
genic activity, as well as nicotine, aldehydes, and alkenes.
This study provides documentation that the chamber ETS
exposure was comparable to that which people would en-
counter  in indoor environments where tobacco is being
smoked.  Additional chemical analyses and  subsequent
studies were conducted to relate the chamber ETS com-
ponents to the analysis of ETS in an indoor environment
   ETS and other air pollutants emitted into an indoor
environment can disappear by three routes:  ventilation,
surface deposition, and chemical reactions while airborne.
The ventilation rate in most indoor environments is 0.5
air change/h or higher, which means that the time frame
of interest is  a few hours or less.  Whereas  few, if any,
studies have dealt with chemical reactions of ETS com-
ponents, there is good evidence that smoke particles can
be removed by surface deposition (2,12), the process being
dependent on surface characteristics and mixing ratio.
Thus, the airborne yield of particulate tar can vary de-
pending on the experimental conditions.
   Among the gases studied, carbon monoxide is considered
to be sufficiently stable to be removed only  by ventilation.
This is also probably the case for the low molecular weight
hydrocarbons, ethene to isoprene, analyzed in the  present
investigation, whereas nicotine as well as  the aldehydes
may decay by surface adsorption or reaction. This phe-
nomenon may account for the divergent nicotine concen-
trations found in the first and second series (Table I),
because the chamber was different with respect to surface
characteristics in  these two series.
   Nitric oxide (NO) is the primary nitrogen oxide formed
in tobacco smoke (13), but it can slowly be oxidized to
nitrogen dioxide,  NO2 (14), or species detected as NO2.
The low contribution of NO2 to the total concentration of
nitrogen oxides found in the present study  (Table I) most
likely reflects the high ventilation rate, which would not
give sufficient time for the formation of NO2 from NO in
the chamber. In contrast, about 15-25% of the nitrogen
oxides detected in the smoking of commercial  cigarettes
(Table IV) was in the form of NO2, indicating that both
the higher concentration and the lower ventilation rate in
these tests resulted in a significant conversion.
   The determined ETS airborne yields of carbon mon-
oxide, nitrogen oxides, and nicotine (Table I)  are about
the same as those reported for sidestream smoke from
commercial cigarettes (13, 15, 16). The ETS yield of
particles is, however, lower by a factor of 2-3 than those
reported for sidestream smoke from commercial cigarettes
(16). One study of 2R1 cigarettes by Ueno and Peters (17)
found only 6-9 mg of particulate matter/cigarette based
on a sample collected with an Anderson cascade impactor
and 1-2 mg/ cigarette based on EAA measurements.
   The mutagenic yield of particulate matter, 13400-17 300
revertants/tigarette, is lower than the mutagenic emission,
36500-118000 revertants/cigarette, for sidestream ciga-
rette smoke collected in a small hood (18). These differ-
ences may be due to the differences between the sample
collection methods for sidestream smoke and ETS and
between the emission rate and airborne yield measure-
ments. In both cases, the loss of mutagens associated with
particles is likely due to loss of the particles to surfaces.
  The mutagenicity concentrations and yields determined
on particle extracts from the personal sampler were con-
sistently higher than those from the modified Anderson
sampler. The personal samplers have a 2-fold lower face
velocity (1.3 cm s~3) compared to the  Anderson sampler
(2.7 cm s~l).  The higher face velocity of the Anderson
sampler may result in the loss of the more volatile organics
and mutagens from the filter.  Recent studies comparing
face velocities substantiate this hypothisis (K. Hammond
et al., unpublished  data).  The mutagenic  response of
400-900 revertants/m3 of air is a range that may be en-
countered in moderately smoky environments and is higher
than that found for ambient outdoor air (79).
  Airborne yield is a direct measure of the components
present in a particular indoor environment and will vary
with the surface area and characteristics. The advantage
of this measurement is that it can be  directly used to
estimate indoor ETS compound concentrations based on
the number of cigarettes smoked and the  ventilation.
Emission factors for sidestream cigarette smoke  have
classically been determined by using a small-volume col-
lecting device surrounding the cigarette tip (16), and
emission factors for ETS particles and nicotine have been
determined in chambers with correction of surface removal
(6). Thus, it can be expected that airborne yields are less
than emission factors for components that are significantly
removed by processes other than ventilation.
  The emission of aliphatic hydrocarbons in sidesteam
smoke has not been assessed quantitatively previously,
although there are several earlier studies on  mainstream
smoke that have been summarized by  Elmenhorst and
Schultz (20). The airborne yields for sidestream smoke
found in the present study (Table U) are generally higher
than those found for mainstream smoke. Isoprene  is the
predominant unsaturated  hydrocarbon in sidestream
smoke (Tables II,  IV, and V),  and the concentrations
measured were well above the background concentrations.
There are several other sources for isoprene: It is exhaled
by man (21, 22) and rodents (23) and thus possibly by
other animals. It is emitted from vegetation, with ambient
concentrations generally below 15 mg/m3 (24, 25). It is
also produced during combustion, but the most likely
combustion source, wood combustion, gives much less
isoprene than ethene (26),  indicating that isoprene is a
minor constituent of the hydrocarbon emission.  The
carbonyl compounds studied (Table III) had airborne
yields of a magnitude reported earlier (15).
  The results presented in Table IV,  obtained in the
smoking of commercial cigarettes in the chamber,  show
that there is a similar relative distribution of major com-
ponents from such cigarettes when compared to the air-
borne yields from the research cigarettes 2R1. This is also
the fact for components measured in  a tavern (Table V)
in which a mixture of commercial cigarettes was  being
smoked. These comparisons between research cigarettes
and commercial cigarettes show that  both types of ciga-
rettes give rise to ETS with very similar composition.
  The ratio of nicotine to particles is ~ 160 Mg/mg for the
tavern samples (Table V), which is intermediate between
the ratios that can be calculated for the chamber study,
80 and 330 Mg/mg.  This may indicate that the tavern has
surface characteristics with respect to nicotine removal
intermediate between the occupied and unoccupied Plex-
iglas  chamber.

-------
  It is well-known that tobacco smoking causes cancer, and
recently a series of epidemiological studies reviewed by the
National Research Council (2) and others (27,28) have
reported excess lung cancer deaths in individuals exposed
to ETS. Cancer from passive smoking at sites other than
the lung is also a possibility (29).
  It is not known which of the many components present
in tobacco smoke and ETS are the most hazardous. It is
therefore important to analyze ETS for a variety of com-
ponents comprising both participate matter and gas-phase
constituents. We have in the present study determined
particulate matter and used a Salmonella mutagenicity
bioassay to measure genotoxicity (50).  Among the nu-
merous gas-phase compounds in ETS, aldehydes (1) and
unsaturated aliphatic hydrocarbons (31)  are  known or
potential animal carcinogens.  Although these compounds
have a relatively low carcinogenic potency, they might be
of importance in the total evaluation because they are
present in relatively high concentration. Among the un-
saturated hydrocarbons, isoprene might be used as a to-
bacco smoke tracer considering the low background con-
centration of this compound.  Studies are needed to ex-
amine other potential indoor sources of isoprene that could
interfere with its use as a tracer.

Acknowledgments

  We thank A. A. Strong for operation of the chamber, M
M. Dallas for technical bioassay support, and D. M. De-
Marini for advice and review comments.
  Registry No.  Carbon monoxide, 630-08-0; nitric  oxide,
10102-43-9; nitrogen oxides, 11104-93-1; nicotine, 54-11-5; ethene,
74-85-1; ethane, 74-84-0; propane, 115-07-1; propane, 74-98-6;
1,3-butadiene, 106-99-0; isoprene, 78-79-5;  benzene, 71-43-2;
formaldehyde, 50-00-0; acetaldehyde, 75-07-0; acrolein, 107-02-8.

Literature Cited
  (1)  Tobacco Smoking, IARC Monographs on the Evaluation
     of the Carcinogenic Risk of Chemicals; International Agency
     for Research on Cancer Lyon, France, 1986.
  (2)  Environmental Tobacco Smoke, N&tioaaLReteuch Council;
     National Academy Press:  Washington, DC, 1986.
  (3)  Goldstein, G. M.; Collier, A.; Etzel, R.; Lewtas, J.; Haley,
     N. In Indoor Air Quality and Climate; Seifert, B. et aL,
     Eds.; Institute for Water, Soil and Air Hygiene: Berlin,
     PRO, 1986; VoL 2, pp 61-67.
  (4)  Strong, A. A.; Penley, R.; Knelson, J. R Human exposure
     system for controlled ozone atmospheres. U.S. Environ-
     mental Protection Agency, Research Triangle Park, NC,
     1977; EPA-600/1-77-048.
  (5)  Tobacco and Health Research Institute The Reference and
     Research Cigarette Series; University of Kentucky: Lex-
     ington, KY, 1984.
  (6)  Hammond, S. K.; Leaderer, B. P.; Roche, A C.; Schenker,
     M. Atmos. Environ. 1987,21, 457-462.
  (7) Kado, N. Y.; Langley, D.; Eisenstadt, E. Mutat. Ret. 1983,
     121, 25-32.
  (8) Ames, B. N.; McCann, J.; YamasaJri, E. Mutat. Ret. 1975,
     31, 347-364.
  (9) Oliver, K. D.; PleS, J. D^ McClenny, W. A Atmot. Environ.
     198«, 20,1403-1411.
 (10) McElroy, F. P.; Thompson, V. L.; Holland, D. M.; Lonne-
     man, W. A; Seila, R.L.J.Air Pollut. Control Auoc. 1986,
     36, 710-714.
 (11) Tejada, S. B. Int. J.  Environ. Anal. Chem. 1986, 26,
     167-186.
 (12) Repace, J. L.; Lowrey, A. H. Science 1980,208, 464-472.
 (13) Norman, V.; Ihrig, A M.; Larson, T. M.; Moss, B. L. Beitr.
     Tabaktfonch. Int. 1983,12, 55-62.
 (14) Vilcins, G.; Lephardt,  J. O.  Chem. Ind. (London) 1975,
     974-975.
 (15) Klus, R;  Kuhn, R Beitr. Tabaktfonch. Int. 1982, 11,
     229-265.
 (16) Riekert, W. S.; Robinson, J. O; Collishaw, N. Am. J. Public
     Health 1984, 74, 228-231.
 (17) Ueno, Y.; Peters, L. K.  Aerosol Sci. Technol.  1986, 5,
     469-476.
 (18) Ling, P. L; Lofroth, G.; Lewtas, J. ToxicoL Lett. 1987,35,
     147-151.
 (19) Lofiroth, G.; Ling, P. L; Agurell, E. Mutat. Ret. 1988,202,
     103-110.
 (20) Elmenhorat, H.; Schultz, C. Beitr. Tabaktfonch. 1968, 4,
     90-123.
 (21) Conkle, J. P.; Camp, B. J.; Welch, B. E. Arch. Environ.
     Health 1975, JO, 290-295.
 (22) Gelmont, O.; Stein, R. A.; Mead, J. F. Biochem. Biophys.
     Res. Common. 1981, 99, 1456-1460.
 (23) Peter, H.; Wiegand, H. J.; Bolt, R M.; Greim, H.; Walter,
     G.; Berg, M.; Fiber, J. G. ToxicoL Lett. 1987, 36, 9-14.
 (24) Lamb, R; Westberg, R; Allwine, G. Atmot. Environ. 1986,
     20,1-8.
 (25) Trainer, M.; Williams, E. J.; Parrish, D. D.; Buhr, M. P.;
     Allwine, E. J.; Westberg, H. R; Fehsenfeld, F. C.; Liu, S.
     C. Nature 1987. 329, 705-707.
 (26) Kleindienst, T. E.; Shepson, P. B.; Edney, E. O.; Claxton,
     L. D.; Cupftt, L. T. Environ. Sci. Technol. 1986,20,493-501.
 (27) Wald, N. J.; Nanchahal, K.; Thompson, S. G.; Cuckle, H.
     S. Br. Med. J. 1986, 299,1217-1222.
 (28) Saracci, R.; Riboli, E. Mutat. Ret.  1989, 222,117-127.
 (29) Perahagen, G. Mutat. Ret. 1989, 222,129-135.
 (30) Claxton, L.; Morin, R. S.; Hughes, T. J.; Lewtas, J. Mutat.
     Ret. 1989.222, 81-99.
 (31) Lorroth, G. Mutat. Ret. 1989, 222, 73-80.
Received for review May 11,1988. Revised manuscript received
November 4,1988. Accepted December IS, 1988. The research
described in this article hat been reviewed by the Health Effects
Research Laboratory, U.S. Environmental Protection Agency,
and approved for publication. Approval does not signify that
the contents necessarily reflect the views and policies of the
Agency nor does mention of trade names or commercial products
constitute endorsement or recommendation for use.
 Corrections:

 mm should  be tun  as  follows:

 p.  610,  col. 2,  para.  "Sampling  and Analysis.   Particle  Sampling and
 Analysis.",  line 4:   consisting  of  the IQ-fim preseparator  and  the  backup
 filter.

 p.  613,  col. 2,  para.  3,  line 14:   [esoprene 1s emitted  from vegetation,  with
 ambient]  ... concentrations generally  below  15  MQ/m3  (24,  25).   It Is
•14  Environ. 3d. Technol.. Vol. 23. No. 5, 1989

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         ENVIRONMENTAL TOBACCO SMOKE:  MUTAGENIC EMISSION RATES AND
                THEIR RELATIONSHIP TO OTHER EMISSION FACTORS

                   Joellen Lewtas and Katharine Williams
              USEPA, Research Triangle Park, NC 27711, U.S.A.

                               Goran Lofroth
             Nordic School of Public Health, Gothenburg, Sweden

                             Katharine Hammond
                 University of Massachusetts Medical School
                        Worcester, MA 01605, U.S.A.

                               Brian Leaderer
             John B. Pierce, Yale University School of Medicine
                        New Haven, CT 06519, U.S.A.
                                  Abstract
     The objective of this study was to evaluate the emission rates and ex-
posure concentrations of mutagens,  nicotine,  and particles from cigarettes.
Studies were conducted  under  controlled laboratory and  chamber conditions
as well  as  in personal  residences.   The  mutagenicity  of  environmental
tobacco smoke  (ETS) was  evaluated  in three bioassays using  two strains of
Salmonella typhimurium.   Strain TA98 was used  in the  standard plate-incor-
poration and microsuspension  histidine  reversion assays; and  strain TM677
in a microsuspension  forward  mutation  assay.   The  mutagenicity, expressed
either per ug  particle  mass  or  per ug nicotine,  appeared  to  be a  rela-
tively constant factor that did not vary significantly between various cig-
arette brands.   These data  are  being used to model the  emissions  of muta-
gens to predict mutagenic exposure concentrations under various conditions.
                                Introduction
     The concentration  of  mutagens associated  with particulate  matter in
indoor air is substantially  increased  in  the presence  of tobacco smoke (1,
6, 7).  In a residential field study of 10 homes,  we found the mutagenicity
per cubic meter of  air sampled to be highly correlated  with the number of
cigarettes smoked  (4).   Recent  studies  of the mutagenicity  of  ETS  from
cigarettes either  smoked  or  smoldering,   suggest  that  the  mutagenicity
emitted per  cigarette  is relatively constant  (5,  7).   Controlled chamber
studies showed that the emission  rate  of  nicotine  and particles per cigar-
ette from sidestream smoke is also relatively constant (2).  The purpose of
this study was to  determine  the mutagenic emission rate  and its relation-
ship to respirable particulate matter and nicotine in environmental tobacco
smoke (ETS).

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                                  Methods
Environmental Tobacco Smoke  (ETS) Generation, Sampling and Analysis

     The smoking  experiments,  test chamber/ and  sample  collection methods
used are similar  to those described in detail by Hammond et al.  (2) and  are
summarized here.   KTS was  generated  by 4  smokers  smoking at  the rate  of
R cigarettes per  hour in a  34-m3 chamber.  In these experiments,  the  cham-
ber fresh  air  supply rate  was typically  2.6  air  changes  per  hour with  a
temperature of  19°C  and relative humidity  of  45%.   Particulate matter  was
collected on  37-mm Teflon-coated  glass  fiber  filters or  on 0.5-um milli-
pore type  FH.   Vapor-phase  nicotine was collected  downstream from the fil-
ters with a second filter impregnated with sodium  bisulfate.   The particu-
late filters were extracted with acetone by sonication  and solvent  exchanged
into dimethyl  sulfoxide for bioassay by using a  stream of dry  nitrogen to
evaporate the acetone.   The  sodium bisulfate-treated filters were  extracted
and analyzed for  nicotine as described by Hammond  et al.  (2).   Equilibrium
sampling and  calculation of emission rates  per gram of  tobacco  consumed
were determined as described by Hammond et al. (2)  for nicotine.
Mutagenicity Assays

     The principal  bioassay employed in this  study was a forward  mutation
assay described  originally by  Skopek et al.  (9)  that uses  S_.  typhimurium
strain TM677.   A microsuspension modification  of  this assay,  described  by
Lewtas et  al.  (4),  was used  to measure mutant frequency  (MF)  (mutants per
106 surviving  cells) by  plating and  counting both  8-azaquanine-resistant
(mutant) colonies and surviving colonies.  The mutagenicity in  this  bioas-
say was  compared to  that  obtained in Salmonella  typhimurium  strain TA99
that was conducted  by either (a) the plate-incorporation assay  of  protocol
of Maron and Ames (8),  which will be referred to here as the  standard Ames
assay, or  (b)  a microsuspension assay  described  originally  by  Kado  et al.
(3) and modified in our  laboratory  by  using 5x cell  concentration;  0.015M
phosphate  buffer, pH  7.4; and a reduced assay volume  that will  be  referred
to here as the microsuspension  reverse  assay.

     All of the  bioassays were  performed  with  the  addition of  Aroclor 1254-
induced male  Sprague-Dawley rat liver  S9  mixture prepared as described  in
the above-referenced  protocols.  The  initial  linear  portion  of the dose-
response curve  was used  to determine the mutagenicity expressed as  either
revertants per  rag of particles, per m3 of air,  or per cigarette.   In all
assays both solvent controls (negative) and positive  controls were assayed
simultaneously  as described in  the  protocols  (9,  B,  3).
                            Results and Discussion
      The mutagenicity of  ETS  was  compared across  six  brands  including
 brands  both high and  low  in tar and  nicotine,  filtered and unfiltered  as
 shown in Table  1.   Despite the  significant differences in the  cigarette
 brands, very little difference  in the  mutagenicity  of ETS was observed when
 measured either per ug  of  total  suspended  particulate  (TSP)   or per m3.

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The mutagenic emission rates shown in Table 1 were also very similar across
all six brands  and ranged  from 22,000-37,000 MF/g tobacco  consumed.   The
emission rate per cigarette would range from 11,000-18,500 MF/cig., assuming
that 0.5 g of tobacco is consumed per cigarette smoked.

     The ratio of  mutagenicity to  TSP  ranged from  0.7 to  1.4  MF/ug TSP.
The TSP and nicotine emission  rates  for  these  six brands was determined in
a similar series of experiments.  The ETS  nicotine emission rates (1.6-2.4
mg nicotine/g tobacco consumed) are  very  similar to that reported earlier by
Hammond et al. (2) for four brands.   Only Brand E (2.2 mg nicotine/g tobac-
co) is  identical  to Brand  B   (1.8  mg nicotine/g tobacco) in  this earlier
study.  Using this nicotine data from separate experiments, the ratio of MF
to nicotine  in  ETS  ranged from  8-16 MF/ug nicotine.   This  agrees  with
subsequent experiments not  reported here where we have measured both muta-
genicity and nicotine on the same samples.

     The blank  chamber  experiment  was  conducted without  smokers  present.
The TSP and mutagenicity  concentrations  in this  nonsmoking experiment are
typical of outside urban air (4).
Table 1:   Comparison  of  mutagenicity  of  ETS  across  several brands  and
          mutagenic emission  rates  compared  to  nicotine  and  particles

Cigarette
Brand
A*
B
C*
D*
E
pt

TSP
(ug/m3)
1177
1200
936
905
1318
901

Mutant
Frequency*
per m3
1178
1259
1186
1280
907
1025
Emission

Mutagen-
icity
(MF/g)
35,400
25,900
34,600
37,100
21,900
30,400
Rates

TSPb
(mg/g)
35.4
24.7
27.3
26.2
32.0
26.5
Ratio
of MF
to TSP
(MF/ug)
1.0
1.0
1.3
1.4
0.7
1.1
Ratio of
MF to
Nicotineb
(MF/ug)
10
16
15
12
8
Blank
Chamber
25
91
aMicrosuspension forward  mutation  assay  in TM677.   Determined  from five
 separate experiments from the  linear portion  of the dose-response curves.
^TSP and  nicotine  emission  rates  from  these  brands  were  determined  in
 separate chamber studies using the same protocol reported here.  The nico-
 tine emission  rates  in mg nicotine/g  tobacco  consumed were  2.4 (A),  1.6
 (B), 1.6 (C), 2.1  (D), and 2.2 (E).
*Unfiltered cigarette, all others are filtered.
*Low tar and nicotine

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Table 2:   Comparison of  ETS mutagenicity per ug  of TSP in different  bio-
          assays
                                                 Bioassays

ETS Sample
Micro
TM677
(MF/ug/ml)
Standard
TA98
(rev/ug)
Micro
TA98
(rev/ug/ml)
Chamber Brand  Ea                   0.69               2.9

Chamber 2R1b                       0.79               1.6          7.0
  Research Cigarette


aETS  from studies  in  34 m3 chamber at Yale TJ.;  other data shown in Table 1.
bETS  from  studies  in  13.6 m3  chamber  at  EPA  using cigarette  smoking ma-
 chine.  Ratio of  nicotine to TSP was 87 ug nicotine/mg TSP.
      ETS  is  present in  indoor air  in  sufficiently high  concentrations  to
measure the  mutagenicity  in  the  standard  Ames plate-incorporation  assay,
which requires  approximately  10 times the sample  mass  of the two microsus-
pension assays.   Table 2 provides  a comparison of the mutagenicity  of  ETS
per  ug of TSP for  several different cigarettes.   Although it  is possible
to use the standard Ames assay to measure the mutagenicity  of either side-
stream cigarette smoke or ETS, there is  one important  advantage to using a
microsuspension  assay.  The microsuspension  assays  require 3-10 times•less
sample, thereby  permitting  mutagenicity measurements  on  samples of  less
than 1 m3 of air.   These methods will facilitate evaluation of the mutagen-
icity of   personal   air  samples  in  human   exposure  assessment  studies.
                                  Disclaimer
      The research described in this  paper  has been reviewed by  the Health
 Effects Research  Laboratory,   U.S.   Environmental  Protection  Agency  and
 approved for publication.   Approval  does  not  signify  that  the  contents
 necessarily reflect the views and policies of the Agency  nor  does  mention
 of trade names  or commercial products constitute endorsement or recommenda-
 tion for use.
                                  References
 1.   Alfheim I., and Ramdahl  T.   Contribution of wood  combustion  to indoor
     air pollution as measured by  mutagenicity in Salmonella and polycyclic
     aromatic hydrocarbon concentration.   Environmental Mutagenesis 6
     (1984). 121-130.

-------
2.  Hammond,  S.K.,  Leaderer,  B.P.,  Roche, A.C., and  Schenker,  M.  Collec-
    tion and  analysis  of  nicotine  as a  marker for  environmental tobacco
    smoke.  Atmospheric Environment 21 (1987), 457-462.

3.  Kado, N.Y., Langley,  0.,  Eisenstadt,  E.   A simple  modification of the
    Salmonella liquid incubation assay:   Increased  sensitivity for detect-
    ing mutagens  in human  urine.   Mutation  Research  121   (1983),  25-32.

4.  Lewtas, J., Goto,  S.,  Williams,  K.,  Chuang, J.C.,  Petersen,  B.A., and
    Wilson, U.K.  The mutagenicity of indoor  air particles in a residential
    pilot field study:   Application and  evaluation of  new  methodologies.
    Atmospheric Environment 21 (1987),  443-449.

5.  Ling, P.I., Lofroth,  G.,  and  Lewtas, J.   Mutagenie determination  of
    passive smoking.  Toxicology Letters  35 (1987),  147-151.

6.  Lofroth, G., Nilsson,  L.,  and Alfheim I.   Passive smoking and urban air
    pollution:  Salmonella/microsome mutagenicity assay of  simultaneously
    collected indoor and outdoor particulate  matter.   In M.D.  Waters,  S.S.
    Sandhu, J. Lewtas,  L.  Claxton,  N.  Chernoff and S.  Nesnow (Eds.), Short-
    Term Bioassays in the Analysis  of Complex  Environmental Mixtures  III.
    New York:   Plenum Press, 1983,  pp.  515-525.

7.  Lofroth, G.,  and Lazaridis, G.  Environmental tobacco  smoke:   Compara-
    tive characterization by  mutagenicity assays of  sidestream  and  main-
    stream cigarette smoke.   Environmental Mutageneais  8  (1986),  693-704.

8.  Maron,  D.M.,   and  Ames,  B.M.   Revised  methods  for  the  Salmonella
    mutagenicity test.   Mutation Research 113 (1983),  173-215.

9.  Skopek, T.R.,  Liber,  H.L., Krolewski,  J.J.,  and  Thilly,  W.G.  Quantita-
    tive forward  mutation  assay  in  Salmonella  typhimurium using  8-aza-
    guanine resistance as a genetic marker.   Proceedings  National Academy
    Science 75 (1978),  410-414.

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Toxicology Letters. 35 (1987) 147-151                                                 147
Elsevier
TXL 01707

MUTAGENIC DETERMINATION OF PASSIVE SMOKING*

(Environmental tobacco smoke;  ETS; Salmonella/microsome mutagenicity test)
PER IVAR LING*, GORAN LOFROTH'-"" and JOELLEN LEWTAS*
* Department of Radiobiology. University of Stockholm. Stockholm; " Nordic School of Public Health.
Gothenburg (Sweden), and ' Genetic Bioassay Branch, EPA, Research Triangle Park, NC (U.S.A.)
(Received 29 August 1986)
(Revision received 22 September 1986)
(Accepted 24 September 1986)
SUMMARY

  The mutagenic activity of tobacco smoke has been further investigated with the plate-incorporation
method and a microsuspension technique of the Ames Salmonella assay. The microsuspension test gives
a higher response than the conventional plate incorporation test. It is possible to detect environmental
tobacco smoke (ETS) in moderately smoky indoor environments by collection of paniculate matter with
personal low volume samplers followed by  particle extraction and mutagenicity testing with the micro-
suspension assay.
INTRODUCTION

  Environmental tobacco smoke (ETS) is a very complex mixture of compounds
formed in the pyrolysis and combustion of tobacco products. Many of the com-
ponents are also formed in other anthropogenic combustion processes making it dif-
ficult  or impossible  to discriminate between  ETS and  other sources  if these
components are used as indicators. Tobacco specific components are nicotine, some
N-nitrosamines and probably also some N-heterocyclic hydrocarbons  and aromatic
amines [1] of which nicotine is being used for the specific determination of ETS
12,3].
• Presented at the International Experimental Toxicology Symposium on Passive Smoking. October
23-25, 1986. Essen (F.R.G.)
•• To whom correspondence and reprint requests should be addressed.

Abbreviations: DMSO, dimethyl sulfoxide; ETS, environmental tobacco smoke.

0378-4274/87/S 03.50 © Elsevier Science Publishers B.V. (Biomedical Division)

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148

  The Ames Salmonella mutagenicity test has earlier been employed to show that
the mutagenic response of indoor airborne paniculate matter is high in the presence
of habitual smoking and that the mutagenic activity mainly is associated with basic
components making it possible to discriminate the activity of ETS from other com-
bustion sources [4,5].
  Although the Salmonella plate incorporation assay is highly sensitive, the use of
low or  medium  volume air samplers in indoor environments may  require assay
methods which give higher responses. We are therefore studying the mutagenic ac-
tivity of tobacco smoke in a microsuspension  assay described by Kado  and co-
workers [6] as giving responses several times those obtained with the conventional
plateincorporation test.

METHODS

Sampling
  Mainstream cigarette smoke was collected on glass  fiber filter with a smoking
machine which was operated under normal conditions as described earlier  [5]. The
machine was placed in a 0.2 mj hood and the emitted sidestream smoke was col-
lected on glass fiber filter  with a flow rate of 10 mVh [5].
  Environmental samples were collected with a battery-operated system (AFC 123
Personal Air Sampler, Casella London  Ltd., England) on glass fiber filter (diam.
2.5 cm) with a flow rate of 2 1/min.
  For the present study, personal sampling was performed in an apartment during
a party representing a highly smoke-polluted environment and in an office with one
smoker representing more common indoor smoke conditions.
  The apartment, having a volume of about 100 m', was sampled for 8 h during
which it was well ventilated with open windows; 82 butts were found at the end.
  The office, having a volume of about 50 m1 and a ventilation rate exceeding 5
changes per hour, was sampled for 8  h  on two separate days during which 20 and
25 cigarettes were smoked, respectively.

Extraction and sample preparation
  Filters were extracted by sonication with acetone.
   For the preparation of samples for the plate incorporation mutagenicity assay, an
aliquot of the  extract was reduced to  a  small volume and then diluted with an ap-
propriate amount of DMSO [4,5]. The DMSO solution was stored at -20°C prior
to and between mutagenicity tests.
  For the preparation of samples for the microsuspension mutagenicity test, ali-
quots of the acetone extract  were dispensed into 8 cm  x 1.1 cm  sample tubes
together with 5 /»! DMSO. The samples were then evaporated under a stream of
nitrogen gas in a heating block at a temperature <40°C and the tubes sealed with
silicon rubber  stoppers and stored at  - 20°C until they were assayed.

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                                                                             149

Mutagenicity assays
  Mutagenicity was determined with the Ames Salmonella tester strains TA98 and
TA100 using the plate incorporation method  [7] and the microsuspension method
described by Kado et al. [6]. Slight differences exist between the performance of the
mutagenicity assays as described by Lofroth and Lazaridis [5]  and by Claxton [8]
and Austin et al.  [9]. The liver-S9 was obtained from Aroclor 1254-induced male
Sprague-Dawley rats. Addition of S9 was generally with 10% S9 in the S9-mix, i.e.
SO id S9 per plate for the plate-incorporation assay and  10 n\ S9 per tube for the
microsuspension assay.

RESULTS

  The mutagenic  activity of the cigarette smoke samples is given in Table I and  is
expressed as revertants per cigarette. The results obtained with the plate incorpora-
tion assay  agree  qualitatively and quantitatively with the previous study  [5].
Mainstream cigarette smoke  is mainly  mutagenic in  the  presence  of  S9. The
sidestream smoke is also active in the presence of S9, but has, in addition, mutagenic
activity in the absence of S9 with  the TA100 strain.
  The mutagenic  response in the microsuspension assay is higher and the  enhance-
TABLE I
THE MUTAGENIC RESPONSE OF SIDESTREAM AND MAINSTREAM CIGARETTE SMOKE
USING THE SALMONELLA PLATE INCORPORATION AND MICROSUSPENSION ASSAYS
Sample
Stream Collected   Revertants per cigarette1
type   paniculate  Plate incorporation assay
      tar
      mg/cig.
                       Microsuspension assay Ratio micro-
                                          susp./plate
                           TA98
            TA100
TA98
TAIOO  TA98 TA100
                           -S9   + S9  -S9   +S9   -S9  + S9   -S9    +S9  -S9
Swedish
brand

Research
brand 2R1
side-  21.8
main-  17.6

side-  17.0
main-  33.3

side-c  10.7
American
generic
American   side-d  10.5
generic
 2300 31300 23800 34200 16300  81900  118200 2.6    5.0

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150

mem over the plate  incorporation assay is  about three-fold with TA98 in the
presence of S9. The response with TA100 in the absence of S9 is also enhanced with
the microsuspension assay.
  The difference in the response obtained with the same type of sample from
American Generic cigarettes extracted and assayed in two different laboratories is
real; similar differences have been obtained with other tobacco smoke samples in-
dicating the need for normalizing the results  between laboratories.  -
  The results of two representative indoor samples assayed by the microsuspension
method are given in Table II. The sample from the highly polluted apartment was
judged to contain sufficient activity for four dose series; two of these were used for
assays with TA98 in the presence of S9 and two with TA100 in the absence of S9.
The samples from the moderately smoky office were each only subdivided into one
dose series which were  assayed with  TA98  in the presence of S9.
  The mutagenic responses detected in these indoor environments  agree  with
magnitudes which can  be estimated  from the air volume, the air exchange  rate, •
number of cigarettes smoked and their emission factor and considering that the con-
centrations are modulated by surface deposition [5,10].
TABLE II
THE MUTAGENIC ACTIVITY OF INDOOR PART1CULATE MATTER COLLECTED WITH A
LOW VOLUME SAMPLER IN ONE HIGHLY AND ONE" MODERATELY SMOKY ENVIRON-
MENT AS ASSAYED WITH THE SALMONELLA MICROSUSPENSION TECHNIQUE
Apartment during party
Dose
Liter air per plate
0*
16
32
64
128
(rev./mj air)'
Positive controls
0.5 Mg benzo(a)pyrene

1 .0 «ig sodium azide
Office with one smoker*
Revertams
TA98 + S9
41
89
187
271
451
(3200)

435

-
per plate*
TA100-S9
251
356
483
785
1091
(6800)

_(

1020
Dose
Liter air per plate
0"
64
128
256
512
(rev./m1 air)'

0.25 pg 2-amino-
anthracene

Revertants per
plate"
TA98 + S9
65
81
114
175
263
(400)

1660


' These samples were collected, extracted and assayed at the Genetic Bioassay Branch, EPA.
" Average of duplicate plates.
• Average of two samples from the two different days.
* Spontaneous control determined with three or more plates.
' Estimated from the linear part of the dose-response curve.
1 Not tested.

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                                                                                151


DISCUSSION

  The Salmonella microsuspension mutagenicity assay is sufficiently sensitive that
it is possible to detect the smoking of a few cigarettes in an average apartment or
house with a normal ventilation of 0.5-1 air changes per hour during a sampling
period of 8 h with a personal sampler having a flow rate  of 2-10 1/min.
  The major part of the mutagenic activity of environmental tobacco  smoke is caus-
ed by basic components [4,5], and if deemed necessary, simple fractionation and
mutagenicity test of the basic fraction can show whether a sample comprises tobacco
smoke. The Salmonella/nucrosome mutagenicity assay may thus be an alternative
or an adjunct to nicotine as a specific indicator of environmental tobacco smoke.
Further studies are, however, required to characterize indoor sources of mutagenic
activity as there may exist other sources of basic mutagenic components.

ACKNOWLEDGEMENT

  This study was partly supported by the Cooperative Agreement CR812935-01-0
between the U.S. Environmental Protection  Agency and  the Nordic School of
Public Health covering a OVS program for GL.

REFERENCES

 I  Chemistry and analysis of tobacco smoke, in Tobacco Smoking, Vol. 38, IARC Monographs on the
   Evaluation of the Carcinogenic Risk of Chemicals to Humans, IARC.  Lyon, 1986, pp. 83-126.
 2  M. Muramatus, S. Umemura, T. Okada and H. Tomita, Estimation of personal exposure to tobacco
   smoke with a newly developed nicotine personal monitor. Environ. Res., 35 (1984) 218-227.
 3  S.K. Hammond. B.P. Leaderer, A.C. Roche and M. Schenker. Collection and analysis of nicotine
   as a marker for environmental tobacco smoke, Atmos. Environ., 20 (1986) in press.
 4  C. Lofroth, L. Nilsson and I. Alfheim, Passive smoking and urban air pollution: Salmonella/m\-
   crosome mutagenicity assay of simultaneously collected indoor and outdoor paniculate matter, in
   M.D. Waters et al. (Eds.), Short-Term Bioassays in the Analysis of Complex Environmental Mixtures
   III, Plenum Press,  New York, 1983. pp. 515-525.
 5  G. Lofroth and G. Lazaridis, Environmental tobacco smoke: comparative characterization by
   mutagenicity  assays of sidestream and mainstream cigarette smoke. Environ.  Mutag., 8 (1986)
   693-704.
 6  N.Y. Kado, D. Langley and E. Eisenstadt, A simple modification of the Salmonella liquid-incubation
   assay. Mutation Res., 121 (1983) 25-32.
 7  D.M. Maron and B.N. Ames, Revised methods for the Salmonella mutagenicity test. Mutation Res..
   113(1983) 173-215.
 8  L.D. Claxton, Mutagenic and carcinogenic potency of diesel and related environmental emissions:
   Salmonella bioassay, Environ. Int., 5 (1981) 389-391.
 9  A.C. Austin, L.D. Claxton and J. Lewtas, Mutagenicity of fractionated organic emissions  from
   diesel, cigarette smoke condensate, coke oven, and roofing tar in the Ames assay.  Environ. Mutag.,
   7(1985)471-487.
10  J.L. Repace and A.H. Lowrey, Indoor air pollution, tobacco smoke, and public health. Science, 208
   (1980) 464-472.

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Toxicology Letters, 38 (1987) 279-290                                                   279
Elsevier
TXL 01853

THE EFFECT OF SOLVENT AND EXTRACTION METHODS ON THE
BACTERIAL  MUTAGENICITY OF SIDESTREAM CIGARETTE SMOKE

(Soxhlet extraction; sonication; Salmonella typhimurium; dichloromethane;
methanoi;  acetone; storage)
RANDALL S. MORIN"-'. JERRY J. TULIS" and LARRY D. CLAXTON"
'School of Public Health, University of North Carolina, Chapel Hill, NC275I4. and "Genetic Bioassay
Branch,  U.S. Environmental Protection Agency, Research Triangle Park, NC 27711 (U.S.A.)
(Received 16 March 1987)
(Revision received 10 May 1987)
(Accepted 6 June 1987)
SUMMARY

  The 'mutagenic activity of sidestream cigarette smoke particles was estimated by testing sidestream
cigarette smoke particles which had been collected under controlled burning conditions in the laboratory.
Two different  extraction  methods (Soxhlet and  ultrasonic  agitation) and  3 different  solvents
(dichloromethane, methanoi, and acetone) were compared for their efficiencies in the extraction of com-
pounds from sidestream cigarette smoke particles which are mutagenic in the Ames test. The mutagenic
activity of the sidestream smoke panicles was estimated to be 15 000-20 000 revertants per cigarette in
TA98 with metabolic activation and 12 000-17 000 revertants per cigarette in TA100 without metabolic
activation. Only weak mutagenic activity was detected in TA98 without activation and hi TA100 with
activation. Under test conditions used, ultrasonic agitation produced the most consistent results  and
acetone extraction produced the highest levels of mutagenic activity.
Address for correspondence:  Dr. Larry Claxton, (MD-68), Genetic Bioassay Branch, Health Effects
Research Laboratory,  U.S. Environmental Protection Agency, Research Triangle Park, NC 27711,
U.S.A.

Portions of this research were done in partial fulfillment of a doctoral degree (R.S.M.), School of Public
Health, University of North Carolina, Chapel Hill, NC.  U.S.A.

* Currently, Occupational  Health Staff Officer. U.S.  Army Health Services Command,  Ft. Sam
Houston, TX 78234, U.S.A.

Abbreviations: ETS. environmental tobacco smoke.

0378-4274/87/S 03.50  © 1987 Elsevier Science Publishers B.V. (Biomedical  Division)

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280

INTRODUCTION

  Environmental tobacco smoke (ETS) is composed of sidestream tobacco smoke
and exhaled tobacco smoke. Sidestream smoke enters the ambient air directly from
the burning tobacco source. Exhaled tobacco smoke is any combination of tobacco
smoke products (mainstream and sidestream) that have been inhaled and then exhal-
ed by an individual. The percentage of each mainstream smoke component exhaled
into the environment has  been reported to range from as low as 1 % to as high as
70% [1,2]. The ratios of the various smoke components in sidestream smoke com-
pared to mainstream smoke have been reported to range from  1.2- to 46-fold  [3].
A typical cigarette smoker inhales mainstream smoke for approximately 3 s, 8-10
times per cigarette. This is equivalent to  a total of 24-30 s out of a total average
burn time of 12 min for each cigarette [4].  Sidestream cigarette smoke, therefore,
is produced during 96% of the  total time a cigarette is burning.
  It  has been estimated that sidestream  smoke forms approximately 85% of the
total tobacco smoke in the ambient indoor air [5]. Therefore, both smokers and
non-smokers could be exposed, especially in indoor spaces with low levels of air ex-
change, to  significant levels of airborne pollutants.
  Although a great deal of effort has been expended characterizing the harmful con-
stituents of mainstream tobacco smoke, much less is known  about the toxic com-
ponents of sidestream tobacco smoke. Rickert et al. [6] tested 15 different brands
of cigarettes and reported that in. most cases considerably more tar, nicotine, and
carbon monoxide were present in the sidestream than in the mainstream smoke. The
findings from  a  1983  study demonstrated that indoor, air contaminated with
sidestream cigarette smoke can be more mutagenic than ambient outdoor air in an
urban area [7].  It  was reported that the smoke from one cigarette which is  diluted
in a structure with a volume of 300 m1 would result in mutagenic activity 2.5 times
that  found in urban ambient air.
  More than 2000 compounds have been identified in mainstream tobacco smoke
[8]. Since sidestream smoke would be expected to be similarly complex, it is difficult
to identify the  specific mutagenic constituents.  A recent report  by the  National
Research Council  [9] says  'Research is needed to standardize both the collection and
evaluation of ETS so that the effects of ETS  can be studied in the laboratories'.
They also recommend that 'Further in vitro assays of ETS are  needed'. The purpose
of this  paper is  to examine and  compare appropriate methods  for preparing
sidestream  smoke samples for mutagenicity studies.

MATERIALS AND METHODS

Collection of samples
  Sidestream cigarette smoke particles were collected by allowing a generic brand
(Price Breaker, Winn-Dixie Stores, Jacksonville,  FL) of king-size filter cigarettes

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                                                                          281

(738.5  mg  tobacco/cigarette, average of  10 cigarettes), to burn  in a  Plexiglas
chamber measuring 32 cm x 38 cm x 29 cm (volume = 0.0353 m3). The air inside
the chamber was exhausted by  a constant flow vacuum pump at a rate of 0.028
mVmin (1 cu. ft. of air per min). The air was pulled through a 142 mm diameter
Teflon-coated glass fiber filter (Pallflex Products Corp., Putnam, CT) supported in
a stainless steel filter stand. Filtered air was drawn into the chamber through three
1 cm diameter openings in the bottom of the chamber.
  Before sample collection, all filters were heated for 24 h at 175°C and then desic-
cated for 24 h. After sampling, each filter was folded  to enclose the sample and
rewrapped in aluminum foil. All samples were returned to the laboratory after col-
lection, usually within 2 h. To minimize sample degradation or reaction, samples
were stored on the filters in the dark at - 70°C.

Sample preparation
  During preparation of the samples for mutagenicity testing, all solvents were glass
distilled, high purity, spectroscopic grade (Burdick and Jackson, Muskegon, MI).
To reduce artifact contamination only glass, stainless steel, and Teflon equipment
was used in the preparation of samples. All materials were washed with Alkonox
and consequently rinsed with distilled water, 50% nitric acid, 50% sulfuric acid,
distilled water,  methanol,  and extraction solvent.
  Ultrasonic extraction.   Each 142 mm diameter  filter was divided into 8 replicate
pieces using stainless steel scissors. Each replicate  was placed in a 50 ml  glass vial
with a Teflon-lined screw cap along with  25 ml  of solvent. One of 3  different
solvents (dichloromethane, methanol, or acetone)  was used to extract the organic
material from the  filter pieces. The vials were held in a plastic rack and  placed in
a water bath sonicator (Sonicor, Model 401, Clean Room Products, Bay Shore, NY)
for 15 min at 25°C. Solvent was then decanted into a clean vial. The samples were
reextracted for  an  additional 15 min with 25 ml of fresh solvent. After the second
sonication, the  extracts were combined to yield a sample volume of approximately
50ml.
  Soxhlet extraction.    Each replicate was placed  in a 500 ml extraction flask with
250 ml of solvent and extracted for 24 h at a rate of 2-3 cycles/h using a standard
Soxhlet apparatus (Kontes Glassware, Vineland, NJ).
  Refluxing of cigarette smoke extracts.    Additional filters containing sidestream
cigarette smoke particles were extracted with acetone using the sonication procedure
above. The extracts were then split into 4 replicates. Three of the 4 replicates were
placed in individual 500 ml extraction flasks with 100 ml of acetone. The flasks were
attached to a Soxhlet extractor and refluxed for 8, 16, and 24 h respectively.
  Sample concentration and solvent exchange.   After each  of the above pro-
cedures, the extraction solvent was removed by rotary evaporation in individual 250
ml  round-bottom flasks. The samples were placed  in a 40°C water bath during the
evaporation procedure. Each sample was concentrated to a volume of approximate-

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282

ly 5-10 ml and then quantitatively transferred into 15 ml volumetric tubes. The
samples were concentrated to a volume of 1-2 ml by immersing the tubes in a 45°C
water bath while a stream of dry nitrogen was bubbled through the sample using
stainless steel needles. A known volume of DMSO was added to each sample and
the remaining extraction solvent was evaporated using the nitrogen purge method.
Representative samples were analyzed by gas chromatography prior to bioassay to
check for adequate removal of the extraction solvent. In all cases, an unused filter
from each lot was extracted to determine background levels of mutagenic activity
due to the  filter.

Salmonella mutagenicity testing
  The Salmonella typhimurium plate incorporation assay was performed as describ-
ed by Ames et al. [10], with 2 modifications consisting of: (1) adding a trace amount
of histidine to the agar base layer instead of the overlay agar and (2) incubating the
plates  for 72 h instead of 48 h. All samples were tested using Ames Salmonella
typhimurium tester strains TA98 and TA100 with and without exogenous metabolic
activation (S9)  unless otherwise indicated. The S9  was prepared in the manner
described by Ames et al. [10] from Aroclor-induced,  male CD-I  rats. Tester  strains
were obtained from Dr. Bruce Ames, University of California, Berkeley, CA and
maintained by the Genetic Bioassay Branch, Genetic Toxicology Division,  Health
Effects Research Laboratory, U.S. EPA Environmental Research Center, Research
Triangle Park, NC. All dose levels were run in triplicate, unless otherwise  noted.
Negative controls for spontaneous reversion and positive controls for each strain
were performed in triplicate for each experiment. The control chemicals used were
2-aminoanthracene for both strains with metabolic activation. Without metabolic
activation, 2-nitrofluorene and sodium azide were  used  as  positive controls  for
TA98 and TA100 respectively. Each sample was tested at 4-5  doses (5, 10, 50, 100,
300 ^I/plate). In most cases, these doses corresponded to 0.008, 0.016, 0.08, 0.16
and 0.48 cigarettes respectively.
   All plates were counted using an automatic plate counter (Artek Model 880, Artek
Systems Corp., Farmingdale, NY). Each plate was counted 3 times and a mean for
the 3 counts was recorded.  Data analysis was  accomplished using  the Ames test
curve fitting program of Stead et al. [11]. This program is a FORTRAN program which
fits a non-linear dose-response curve to the plate count data. Using the model slope
obtained from the dose-response curve, an estimate of mutagenicity was calculated
and expressed as the number of revertants per  cigarette.

RESULTS

Effect of extraction method and solvent
  Tables I and II present the bioassay results of the  experiments designed to com-
pare the efficiencies of 2  different extraction methods and 3 different extraction

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                                                                          283

TABLE I
THE EFFECT OF EXTRACTION METHOD AND SOLVENT ON THE MUTAGENIC ACTIVITY
OF  SIDESTREAM  CIGARETTE   SMOKE  PARTICLES  TESTED  IN  SALMONELLA
TYPHIMUR1UM TA98 WITH METABOLIC ACTIVATION
Average of 4 experiment*. 5 doses, 3 replicates per dose, analysis by the method of Scead et al. [11|.
Extraction           Number of revertants (thousands) per cigarette: as a function of extraction
method             solvent
	PCM*	MEOH*	ACET*	
Soxhlet             12.2 ± 10.2          10.9 ±7.5            11.4 ± 5.1
Ultrasonic	8.0 ± 3.2	11.3 ± 3.7	14.6 ± 1.8	
*DCM, dichloromethane; MEOH, methanol; ACET, acetone.
TABLE II
THE EFFECT OF EXTRACTION METHOD AND SOLVENT ON THE MUTAGENIC ACTIVITY
OF SIDESTREAM CIGARETTE  SMOKE  PARTICLES WHEN TESTED IN SALMONELLA
TYPH/MURIUM TA100 WITHOUT METABOLIC ACTIVATION
Average of 4 experiments.
Extraction           Number of revertants (thousands) per cigarette: as a function of extraction
method             solvent
	PCM*	  MEOH*	    ACET'	
Soxhlet             0.7 ±1.0            0.7  ± 1.2             1.9 ± 3.6
Ultrasonic           4.9 ± 3.7            0.4  ± 0.2   •         14.6 ± 6.5
'DCM, dichloromethane; MEOH; methanol; ACET, acetone.
TABLE 111
THE EFFECT OF REFLUXING ON THE  MUTAGENIC  ACTIVITY OF SIDESTREAM
CIGARETTE SMOKE PARTICULATE EXTRACT
Number of
hours
refluxed
0*
8
16
24
Number of revertants (thousands) per cigarette: S. typhimurium strain/activation
conditions
TA98/ •»- S9
19.6
15.3
17.2
16.2

TA98/- S9
0.5
1.9
3.8
l.i

TA100/ + S9
3.4
3.8
4.4
3.6

TAIOO/-
14.6
1.9
3.6
3.6

S9




'Extract tested for activity without refluxing.

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284

TABLE IV

THE EFFECT OF STORAGE ON THE MUTAGENICITY OF SIDESTREAM CIGARETTE SMOKE
PARTICLES	

Storage conditions and time                                  Number of revenants
                                                       (thousands) per cigarette
TA98 -i- S9 TAIOO - 59
Collected, extracted, bioassayed in less than 6 days
Extract stored frozen at - 70° C in DMSO for 23 days
Extract stored frozen at - 70° C in DMSO for 60 days
Panicles stored frozen at - 70° C in DMSO for 60 days
Panicles stored frozen at -70° C in DMSO for 180 days
17.1
15.9
5.1
9.3
11.5
14.6
3.3
1.7
2.1
0.4
solvents. For TA98 results with metabolic activation (Table I), the differences be-
tween the 2 methods and 3 solvents were small. The activity in TAIOO without
metabolic activation (Table II) was almost equal to that in TA98 with activation,
but only when ultrasonic agitation and acetone were used to extract the particles.

Effect of reflwdng cigarette smoke extracts
   Table III contains the mutagenicity data from the experiments conducted to deter-
mine whether or not the refluxing of sidestream cigarette smoke extracts affects
their mutagenic activity. The mutagenic activity in TA98 with metabolic activation
was not significantly affected by refluxing the extracts for up to 24 h. An increase
in activity in TA98 without metabolic activation was seen after refluxing. Significant
reductions in activity, however, were observed in TAIOO without metabolic activa-
tion after the extracts were refluxed.

Effect of storage time and conditions
   Sidestream cigarette smoke panicles and extracts were stored for different lengths
of time as either particles or as extracts in DMSO. Following storage, the samples
were tested for mutagenic activity in the Ames test. The results of this experiment
are contained in Table  IV.
   Substantial reductions in activity were observed in both TA98 with activation and
in TAIOO without activation. The largest reductions in activity were seen in TAIOO
without metabolic activation after the extracts had been frozen for 180 days in
DMSO. The reduction  in activity in TA98 was  much less  than the reduction in
TAIOO especially when  the samples were stored as particles rather than as extracts
in DMSO.

DISCUSSION

   As early as 1974, Kier et al.  [12] demonstrated the mutagenicity of mainstream

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                                                                         285

cigarette smoke condensate in Salmonella typhimurium strain TA1538  with  a
metabolic activation system prepared from poiychlorinated biphenyl-induced rat
liver tissue. Since 1974, numerous investigators have reported mutagenic activity for
mainstream cigarette smoke and cigarette smoke  condensates in  a variety  of
mutagenicity test systems [14-18]. More recently, extracts of sidestream cigarette
smoke particles have also been shown to be mutagenic in the Ames test [7,20]. As
in previous studies [7], the highest mutagenic response in this study (15 000-20 000,
revertants per cigarette) was observed in TA98 with metabolic activation (Table III).

Method of extraction
  Although Soxhlet extraction is the  most widely used procedure for the removal
of organic compounds from airborne paniculate samples, it has potential  for ar-
tifact formation and is a lengthy procedure usually requiring a minimum of 24-36
h. During this extraction process there  is opportunity for sample loss  due  to
volatilization. In addition, since this method requires a substantial  amount  of
glassware and laboratory hood space, it  is often not practical when numerous
samples are extracted in a short period of time.  Soxhlet extraction also has  been
reported to result  in the decomposition  of some known mutagenic compounds
[21-23].
  Ultrasonic agitation, an alternate method for the extraction of airborne particles,
has been reported to yield recoveries which are comparable to Soxhlet extraction
[23-26). Although this method requires less time, glassware, and supplies, the most
important advantage of sonication may be the reduction in the opportunity for sam-
ple loss. A number of extraction solvents have been used in both methods including
benzene, methanol, acetone, dichloromethane, acetonitrile, ethanol,  and mixtures
of 2 or more of these solvents [27].
  A number of studies have compared these extraction methods for ambient air par-
ticles [24,25,28-31]. In a recent investigation, Rives [32] compared the efficiencies
of sonication and Soxhlet extraction of woodsmoke particles. Using both mutagenic
activity and extractable mass as the criteria for his evaluation, he concluded that
either  method  can  be used for the extraction  of  mutagenic compounds from
woodsmoke. Despite individual preferences for one method over another, the recent
literature recommends both techniques equally [26,33].
  In this study (Tables I and II), the mutagenicity data indicate that the ultrasonic
extraction method is as effective or more effective than the Soxhlet procedure in ex-
tracting those compounds  from sidestream cigarette  smoke particles  which are
mutagenic in the Ames test. The use of sonication also resulted in more consistent
data than that obtained when Soxhlet extraction was used. These findings are in
agreement with Sawicki et al. [28] who reported that ultrasonic agitation was a more
reproducible extraction method than  Soxhlet extraction.
  We conclude that  both Soxhlet extraction and  ultrasonic agitation are effective
in the extraction of mutagens from sidestream cigarette smoke particles. Sonication

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286

requires less time and equipment and results in less opportunity for loss of sample
during extraction. Thus, sonication would  be the favored method in cases where
large numbers of samples require extraction in a short period  of time.
  The choice of a solvent for use in any extraction procedure is usually influenced
by the class or classes of compounds for which extraction is  desired. Numerous
solvents have been used by different investigators for the extraction of organic com-
pounds from  air paniculate samples for mutagenicity testing in the Ames  test
[27,34]. Acetone has been widely used by several investigators for air particle extrac-
tion; however, some do not recommend its use because of its reactivity with other
chemicals and its unavailability in pure form [35]. Other solvents and combinations
of solvents, such  as cyclohexane [36],  benzene/dichloromethane mixture [37],
cyclohexane, dichloromethane and acetone serially [38], methanol [39], and benzene
[40] have also been used for the extraction of rautagenic material from air particles.
Jungers and Lewtas [30] concluded that the preferred solvent for those studies in
which the non-mutagenic and sometimes bactericidal mass is  to be minimized is
dichloromethane. Krishna  et al. [25] compared  7 solvents or combinations of
solvents  and  reported  that sequential extraction with acetone followed   by
dichloromethane gave a higher response than acetone alone or acetone in combina-
tion with dichloromethane.  Of the solvents tested by Krishna et al. [25], cyclohexane
resulted in the lowest mutagenic response. Studies published by Jungers et al.  [29]
and Talcott and Wei [41]  report similar findings. In a recently published study,
acetone was the extraction solvent chosen by Alfheim and Ramdahl [20] in their
study which investigated the mutagenicity of wood and sidestream cigarette smoke.
In a comparison of 4 solvent systems, Talcott and Wei [41] using both Soxhlet  and
ultrasonic  reported  that  acetone  extracted  more mutagens  than  benzene,
chloroform, and methanol. Using both Soxhlet and ultrasonic extraction methods,
Goto et al. [42] concluded  that benzene, ethanol or methanol were the solvents of
choice for the detection of ambient air paniculate mutagenicity in the Ames test.
  These studies (Tables  I and II)  suggest that acetone was the solvent-of-choice
among those used for removal of organic compounds from sidestream cigarette par-
ticles. Use of methanol or dichloromethane as an extraction solvent greatly reduced
the ability to detect mutagens with TA100.

Effect of refluxing
  Goto et al. [42] cited the results of reflux experiments in their choice of extraction
solvent.  Increases  or  decreases in mutagenic  activity  were  seen when  several
mutagenic pure compounds were refluxed in various extraction solvents. Several of
the solvents evaluated by these  investigators resulted in significant changes in the
mutagenic activity of pure compounds when these compounds were refluxed in the
extraction solvent, including dichloromethane and acetone. The results obtained in
this study indicate  that refluxing extracts of sidestream cigarette  smoke panicles
does result in  an apparent  decrease in mutagenic activity in TA98 with metabolic

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                                                                          287

activation (Table III). Statistical analysis, however, does not demonstrate that this
difference is significant. Activity in TA100 without metabolic activation, however,
was significantly reduced after refluxing (Table III). These results suggest that the
compounds responsible for the mutagenicity in TA100 may be compounds which
are volatile or labile and, therefore, are lost during the refluxing process. Another
possibility is  that a chemical reaction occurs during the refluxing process which
results in the transformation of the mutagenic compounds into compounds which
are not mutagenic in the Ames test.
  While differences are seen in the mutagenicity of replicate samples of sidestream
cigarette smoke particles extracted with the 3 solvents compared in this study, these
differences are generally not  significant. The one significant difference is in  the
detection of direct-acting mutagens from sidestream cigarette smoke particles when
acetone was used (Table II). Extraction using acetone resulted in higher levels of ac-
tivity than seen with either dichloromethane or methanol.

Effect of storage
  It  has been reported  that cigarette smoke condensate  stored at refrigerator
temperatures showed no loss of activity after 40 days; however, a 50% drop in ac-
tivity in TA1538 was reported after the same  length of  storage time at  room
temperature [17]. The effect of storage of cigarette smoke particles or extracts on
the mutagenicity  of these substances was investigated in this study.  Substantial
reductions in the mutagenic activity of sidestream cigarette smoke particle extracts
were observed after storage as either  particles or  as extracts in DMSO  (Table IV).
After storage for 60 days at -70°C in DMSO, the activity in TA98 with metabolic
activation was reduced to 30% of the 'fresh* sample (less than 6 days storage).
Greater reductions in activity were observed in TA100 without metabolic activation,
as the samples contained only 12% of the activity of the 'fresh' samples. Storage
as particles for 180 days at -70°C resulted in a 33% reduction of activity in TA98
with metabolic activation compared to the 'fresh* sample. These  findings suggest
that the effect of sample storage should be considered when attempting to evaluate
the mutagenic activity of tobacco smoke particles. In general, it would seem prudent
to conduct bioassay of the samples as quickly as possible after collection.

CONCLUSIONS

  This study clearly demonstrates the mutagenicity of sidestream cigarette smoke
particle extracts in the Ames Salmonella mutagenicity assay. The level of mutagenic
activity of sidestream cigarette smoke particles was estimated from the slope of a
dose-response curve calculated using  the method of Stead et al. [11]. The number
of revertants in the Ames test was estimated to  be IS 000-20 000 per cigarette in
TA98 with metabolic activation and 12 000-17 000 per cigarette in TA100 without
metabolic activation. After refluxing acetone extracts of sidestream cigarette smoke

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288

particles,  the mutagenic activity in  TA100 without metabolic activation was
significantly reduced compared to extracts which were not  refluxed.
  Sidestream cigarette smoke particles were collected under experimental conditions
by burning cigarettes in a chamber and collecting the smoke particles on glass fiber
filters. The filters were extracted using either Soxhlet extraction or ultrasonic agita-
tion and one of 3 solvents (dichloromethane, methanol, or acetone). When the com-
binations  of extraction method and solvent were compared for their efficiency in
detecting mutagenic activity in the Ames test, the differences in mutagenic activity
were slight; however, ultrasonic agitation produced results which were more inter-
nally consistent  than results with Soxhlet extraction. Of the 3 solvents which were
compared, acetone yielded  statistically higher levels of activity than the other 2
solvents (dichloromethane and methanol) in TA100  without exogenous activation.
Differences in mutagenic activity in TA98 with metabolic activation among the 3
solvents, however,  were small.
  The effect of storing sidestream cigarette smoke particles and particle extracts on
the mutagenic activity was also investigated. Activity in both TA98 with metabolic
activation and TA100 without metabolic activation was found to be reduced after
storage either as particles or as extracts in DMSO. Storage in DMSO at  -70°C for
60 days resulted in  a reduction in mutagenic activity of 70% in TA98 with activa-
tion. Activity in TA100 without activation was reduced by  88% after the same
storage. When stored as particles, the reduction in activity in TA98 was less (33%);
however,  the decrease in activity in TA100 was over 90%.

ACKNOWLEDGEMENTS

  We want to thank the faculty of the School of Public Health, University of North
Carolina, Chapel Hill,  NC and the  Health  Effects Research Laboratory (HERL),
U.S. Environmental Protection Agency, Research Triangle Park, NC for providing
the opportunity for this research. The research described in  this article has been
reviewed by the HERL, U.S. Environmental Protection Agency, and approved for
publication. Approval does not signify that the contents necessarily reflect the views
and policies of the Agency nor does the mention of trade names or commercial pro-
ducts constitute endorsement  or recommendation for  use.

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                                                                                        289

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41 R. Talcott and E. Wei. Airborne mutagens bioassayed in Salmonella typhimurium, J. Natl. Cancer
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Mutanon Research. 202 (1988) 103-110
Elsevier
                                             103
MTR 04643
                  Public exposure  to environmental tobacco smoke

                    Goran Lofroth1<2, Per Ivar Ling  2  and Eva Agurell 2-3
     ' Nordic School of Public Health. Box 12133. S-402 42 Gothenburg, * Department of Radiobiology, University of Stockholm.
  S-106 91 Stockholm, and J Department of Genetic and Cellular Toxicology, University of Stockholm. S-106 91 Stockholm (Sweden)
                                      (Received 25 November 1987)
                                     (Revision received 28 March 1988)
                                        (Accepted 29 March 1988)
Keywords: Environmental tobacco smoke (ETS); Passive smoking; Personal sampling; Salmonella mutagenicity assay; Smoking

Summary

   Airborne particulate matter has been collected by personal samplers in public indoor areas and travel
situations with environmental tobacco smoke pollution. Following extraction, the samples were assayed for
mutagenicity  in the  presence of S9 with a sensitive  microsuspension test using Salmonella TA98. The
mutagenic responses of indoor air from public areas were much higher than those of ambient outdoor air.
Depending on the circumstances, the mutagenic  response varied in trains and airplanes but the results
show that physical  separation of non-smoking sections from smoking sections is  necessary in order to
achieve genuine non-smoking areas. Chemical fractionation and mutagenicity assay of  the basic fraction
show that Salmonella mutagenicity of airborne particulate matter might be used as a tobacco smoke-specific
indicator,  as the basic fraction of environmental tobacco smoke contains a large part  of the mutagenic
activity whereas this is not the case for outdoor ambient airborne particulate matter.
   Environmental tobacco smoke (ETS) is a com-
 plex  mixture of gases and particulate tar matter
 comprising numerous compounds. ETS is one of
 the most common air pollutants in industrialized
 and urban societies as 25-40% of the adult popu-
 lation are smokers and much smoking takes place
 indoors  causing pollution of the air breathed by
 everyone.
   Among  several  types  of pollution indices.
 Salmonella mutagenicity of  airborne  particulate
 matter has been  used  to study  the contribution
 from ETS in office buildings (Lofroth et al., 1983),
 restaurants (Husgafvel-Pursiainen et al., 1986) and
Correspondence: Gdran Ldfroth, Nordic School of  Public
Health. Box 12133. S-402 42 Gothenburg (Sweden).
homes  (van Houdt  et al..  1984;  Alfheim  and
Ramdahl.  1984;  Lofroth  and  Lazaridis, 1986:
•Lewtas et  al., 1987). In some studies (Lofroth et
al., 1983; Lofroth and Lazaridis. 1986)  the origin
of the mutagenic activity was ascertained by frac-
tionation in which a major part of  the activity 01
ETS was recovered in the basic fraction.
   The use of personal samplers for the collection
of particulate matter  coupled with  a more sensi-
tive mutagenicity  test,  a Salmonella microsuspen-
sion assay, was recently explored and found feasi-
ble (Ling  et al., 1987). These studies  have  now
been extended with  measurements of  the muta
genie response of airborne  particulate matter col-
lected during some typical situations outside honu
and work where involuntary exposure to ETS car
occur. The chemical behavior of ETS as comparec
0027-5107/88/$03.50 © 1988 Elsevier Science Publishers B.V. (Biomedical Division)

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104
to outdoor ambient paniculate matter with respect
to the contribution from  the basic fraction has
also been further studied.

Materials and methods

Sampling
  Indoor  airborne  paniculate  matter was  col-
lected on glass fiber filters with 2 battery-operated
personal  samplers  (Casella AFC  123,  Casella
London Inc., Great  Britain) using a flow rate of 2
1/min  for  each sampler  and  25-mm sampling
heads.  The samplers were  carried  in a small bag
keeping the sampling heads near  the  breathing
zone,  i.e. no more  than about  25 cm below the
mouth/nose region. Sampling  time varied from
less than  1  h to more  than 6  h depending on
location.  The  filters  were stored  in  Al-foil at
- 20 ° C within 2 h of the end of the sampling.
  Parallel  sampling  of  outdoor airborne  par-
ticulate matter was performed with a battery-oper-
ated portable sampler (Caseila HFS 800)  using a
flow rate  of 10 1/min  and a  35-mm sampling
head.  The sampling was made from a  car parked
at the nearby parking lot with the air intake of the
sampler placed outside the car.
  Experimental  sidestream smoke was collected
as described previously  (Ling et al.. 1987) from
machine-smoked cigarettes in a small 0.3-m3 hood.
A high-volume sample  of glass fiber filter-col-
lected  urban airborne paniculate matter was also
used for comparison.

Sample preparation
  The filters were extracted within  10 days after
sampling.  Extraction was performed with  acetone
using  a bath-type  sonicator. The  solution was
filtered through a No. 4 glass filter to remove glass
fiber debris.
  Fractionation with respect to  polarity into basic
and   non-basic  fractions  was  performed  by
liquid-liquid extraction with diethyl  ether and
sulfuric acid and sodium hydroxide aqueous solu-
tions as described earlier (Lofroth, 1981).
  For the microsuspension assay, aliquots of the
extract corresponding to known air  volumes were
transferred to  11 mm X 75 mm  sterile  glass tubes
containing 5 /*! dimethyl sulfoxide (DMSO). The
acetone was evaporated by a stream of nitrogen
gas with the tubes inserted in a heating block and
the evaporating solution was kept at < 40 ° C. The
tubes were finally stoppered using  sterile silicon
stoppers  and stored at - 20 ° C  until  they  were
used for the bioassay.
   For the plate incorporation assay, the  extract
was evaporated to a small volume  and then di-
luted  with DMSO. The samples were stored at
-20°C.

Bioassay
   The microsuspension  technique (Kado et al..
1983) was used with minor  modifications for all
environmental  samples  in   the  present  study.
Salmonella TA98 grown for about 13 h with rapid
shaking was centrifuged and  then resuspended in
1/10 of the original volume  in Vogel and  Bonner
(1956) medium E (instead of phosphate-buffered
saline) giving approximately 10'° cells/ml of which
0.1 ml was added to the sample tubes.
   The S9 was obtained from  livers of Aroclor
1254-induced male Sprague-Dawley rats. Its pro-
tein content was 33 rug/mi as determined by the
method of Lowry  et al.  (1951).  The S9 mix was
prepared as described by Ames  et al.  (1975) but
with Vogel and Bonner medium E instead of 0.2
M phosphate buffer for the  microsuspension as-
say. Each  sample tube received 0.1  ml S9  mix
containing 10% S9 or buffer without S9,  NADP
and glucose 6-phosphate.
   The sample  tubes, covered with sterile  caps.
were  then immediately  incubated for  90  min at
37 °C  with about 175 rpm shaking  after which 2
ml top agar containing  histidine and biotin were
added. Following Vortex mixing, the samples were
poured on minimal glucose agar  plates. The plates
were  incubated for 48  h at  37 ° C. Revertant col-
onies were then counted manually.
   The plate incorporation assay  was performed as
described by Maron and Ames (1983). The S9 mix
contained 4 or 10% S9  and 0.5  ml  was added to
each plate. The S9 amounts employed  were  those
which are routinely  used for other  outdoor am-
bient and indoor tobacco smoke samples.
   Depending on the amount of  sample available,
each sample was tested repeatedly on several occa-
sions with 1 plate per dose and 3-5 plates for the
spontaneous control. Some samples  were only
available  for 1 or 2 independent tests but larger

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                                                                                               105
samples were always tested 3 or 4 times. Each test
comprised positive control compounds. Blank filter
samples have been assayed and not found to give
any detectable mutagenic activity.
   The dose  response was evaluated  with  least
square linear regression using all plate counts in
the linear  or approximately  linear part of the
dose-response curve.

Results

Environmental samples
   During  this study  a number  of  samples of
airborne paniculate matter have been collected at
locations or  travel  situations  which people may
experience in their daily life.
   Table 1 relates the results from 2. visits to a
shopping  center  in  the  northern part  of the
Stockholm area and  2 visits to  the Stockholm
Central (railway)  station. The shopping center is
about 12 m high  and has a central 25 m X 45 m
indoor plaza with four 45-65-m-long extending
alleys. The Central station main hall has an indoor
area of 28 m x 119 m  and a height of about 15 m.
Despite these spacious designs, the indoor pollu-
tion, measured as  mutagenic  response  of par-
ticulate matter, is high  and is higher  than the
response of  simultaneously collected ambient out-
door air.
   Samples collected during train travel (Table 2}
were obtained in  the  common  type of passenger
cars containing 2 compartments separated by a
TABLE 1
MUTAGENIC ACTIVITY AND RESPONSE  IN TA98 + S9 OF AIRBORNE PARTICULATE MATTER COLLECTED IN
INDOOR PUBLIC AREAS AND SIMULTANEOUSLY AT NEARBY OUTDOOR LOCATIONS
Sample
location, date
and duration
Shopping center
861222
175 min


Benzofajpyrene "
Shopping center
861230
175 min


Benzo[a]pyrene
Central station
870116
235 min


Benzo(a)pyrene
Central station
870130
235 min


Benzo(a]pyrene
Indoors
Dose
(1 air/plate)
0
25
50
100
150
0.5 fig
0
25
50
100
150
0.5 fig
0
25
50
100
200
0.5 fig
0
25
50
100
200
0.5 fig

Counts
(rev./plate)
49
62
112
177
231
301
51
52
94
165
192
345
53
101
163
330
552
445
62
107
178
335
449
477
Outdoors
Response Dose
(rev./m3) (lair/plate)
0
75
1200 150
300


0
75
1000 150
300


0
200
2500 400
600


0
200
2200 400
600



Counts
(rev./plate)
49
46
58
55


51
58
82
85


53
71
149
236


62
59
75
77



Response
(rev./mj)

<50




140





260





<50



* Concurrent positive control.

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106
sliding door;  one for smoking with 20 seats and
one for non-smoking with 60 seats. The high re-
sponses in the smoking compartment are not un-
expected and a dependence  on the number of
cigarettes smoked  is evident. Most samples col-
lected in the non-smoking compartment  have a
relatively low response but there is one exception
in the sample collected 870215. This  train was
congested and there was much passenger  move-
ment  with  frequent openings of  the door; the
smell  of tobacco smoke in the non-smoking com-
partment was apparent.
   Samples have been collected during 2 short air
nights and 2 transatlantic flights  (Table 3). The
short  flights  gave  only  samples sufficient  for 1
assay  with 1 plate per  dose  but  even with this
limitation a dose-dependent increase  can be ob-
served resulting in relatively high responses. There
is a substantial difference between the two trans-
atlantic flights which may be explained by the fact
that  the sample of 861029  was collected  in  a
non-smoking seat only 2 rows apart from  smoking
seats whereas the sample of 870516 was collected
in  an entire non-smoking section separated  from
smokers by the stewardess' areas.

Experimental tobacco smoke
  The  experimental cigarette sidestream smoke
(Table 4) was generated from a common  Swedish
filter brand which in this experiment gave 29.6 mg
tar particles/cigarette.  This sample was  used for
comparing the response in the regular assay and
TABLE 2
MUTAGENIC ACTIVITY AND RESPONSE IN TA98 + S9 OF AIRBORNE PARTICULATE MATTER COLLECTED DUR-
ING TRAIN TRAVEL IN SMOKING AND NON-SMOKING COMPARTMENTS
Sample, date and duration
Smoking
860921
250 min
5 cig. smoked
Benzo[a]pyrene J
Smoking
870208
275 min
25 cig. smoked
Benzofajpyrene
Non-smoking
861002
250 min

Benzo[a]pyrene
Non-smoking
870121
270 min

Benzo[a]pyrene
Non-smoking b
870215
240 min

Benzo( a jpyrene
Dose
(1 air/plate)
0
71
143
286
0.5 fig
0
75
150
300
0.5 jug
0
71
143
286
0.5 Mg
0
75
150
300
0.5 Mg
0
50
100
167
0.5 Mg
Counts
(rev./plate)
48
78
126
226
478
62
372
705
929
477
48
49
60
92
478
53
61
75
83
444
53
79
117
147
427
Response
(rev./m^)


600




3500




100




100




600


" Concurrent positive control.
h 2 additional non-smoking samples collected 870210 and 870219 gave responses of 100 rev./m3.

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                                                                                               107
the presently employed microsuspension assay and
for studies of the response of the basic and non-
basic fractions  of the smoke. For comparison, a
sample of urban airborne paniculate matter was
also  investigated and fractionated simultaneously.
   The total  response of the sidestream smoke
obtained in the present study in the microsuspen-
sion  assay  is higher than previously reported val-
ues (Ling et al., 1987). This is mainly due  to the
use  of the modified assay technique. Two other
experimental  cigarette sidestream samples  were
analyzed in the course of this study and the assays
gave 220000 and 290000 revertants/cigarette with
TA98 in  the presence of S9.
   The much higher response of the microsuspen-
sion  assay  (Table 4), known from previous  inves-
tigations (Kado et  al., 1983,  1986;  Ling et al..
1987), is evident for both the sidestream smoke
and  the urban paniculate sample.
   In the plate incorporation assay,  the response
in TA98 + S9  of the basic fraction of sidestream
smoke is about 67% of the total response. This is
in agreement with earlier studies in which 67 and
70% were obtained (Lofroth et al.. 1983; Lofroth
and Lazaridis, 1986).  In  the microsuspension as-
say, the  response of  the basic fraction is about
45% of  the  total response in TA98 + S9. This
lesser relative response of the basic fraction in the
microsuspension assay is further supported by the
results obtained  with 2  environmental samples.
The first sample  was  collected in an appartment
during a party and gave a response of 3200 rev./m3
(Ling et  al.. 1987) and showed after fractionation
that 45%  was present in the basic  fraction (data
not shown). The  second sample, collected in  the
non-smoking section (corner) of a coffee shop in
downtown Stockholm  (data not shown), had about
36% of the total response of 2200  rev./m3 in the
basic fraction. A contribution of about 400 rev./mj
from ambient outdoor paniculate matter would in
this case explain the fractionation result.
   Urban airborne paniculate matter has very lit-
TABLE 3

MUTAGENIC ACTIVITY AND RESPONSE IN TA98 + S9 OF AIRBORNE ^ARTICULATE MATTER COLLECTED DUR-
ING AIR TRAVEL IN NON-SMOKING SECTIONS
Sample, date, flight and duration
Gothenburg-Oslo
860919
SK886
38 mm
Oslo-Stockholm
860919
SK708
38 nun
Benzofajpyrene "
New York-Oslo
861029
SK902
360 min

Benzo[ a ]pyrene
New York-Stockholm
870516
SK904
390 min
Benzofojpyrene
Dose
(1 air/plate)
0
25
50
75
0
25
50
75
0.5 ,ig
0
24
48
96
192
0.5 Mg
0
50
100
200
0.5 Mg
Counts
(rev./plate)
52
66
78
91
52
70 .
96
143
467
46
65
82
117
193
403
68
87
96
111
634
Response
(rev./m3)


500



1000




800





200


" Concurrent positive control.

-------
108
TABLE 4
MUTAGENIC RESPONSE IN TA98  OF UNFRACTIONATED  AND FRACTIONATED  EXTRACTS OF CIGARETTE
SIDESTREAM PARTICULATE TAR AND AN URBAN PARTICULATE MATTER SAMPLE IN THE REGULAR PLATE
INCORPORATION ASSAY AND THE MICROSUSPENSION ASSAY AND THE ACTIVITY OF CONCURRENT POSITIVE
CONTROL COMPOUNDS
Sample
Unit
Plate incorporation
                           Microsuspension
                                     -S9
                                      •S9-10%
                                     -S9
                                       •59-10%
Sidestream smoke * Rev./cig.
Crude extract
Basic fraction
Non-basic fraction
2700
1000
1500
37000
25000
5400
70000
26000
19000
240000
110000
75000
Urban paniculate* b
Crude fraction
Basic fraction
Non-basic fraction

Positive controls
5.0 /tg quercetin
25.0 /ig quercetin
0.5 /ig benzoffljpyrene
2.5 fig benzofajpyrene

Spontaneous control
Rev./mg
Rev./plate
Rev./plate
               450
                20
               460
               318
  26
          520
           30
          430
385

 33
207

 36
                            3000
                             100
                            2700


                             257
26
                         4200
                          120
                         2200
                                                                 267
36
' The responses have been evaluated with 6 doses in the range 0.001-0.1 cig./plate in the plate incorporation and in the range
  0.00025-0.024 cig./plate in the microsuspension assay.
" The responses have been evaluated with 6 doses in the range 25-1600 jug/plate for both assays.
f -, not tested.
tie activity in the basic fraction (Table 4) which is
in agreement with  earlier results (LSfroth,  1981;
Lofroth et ah, 1983).

Discussion

Public indoor locations
   This exploratory study shows that typical pub-
lic indoor locations, a shopping center plaza and a
railway station waiting room, are much more pol-
luted than the  ambient outdoor air by mutagenic
compounds present in airborne paniculate matter.
Although the sampling and  analysis  cannot prove
the  origin of  the  increased  mutagenic activity,
smoking  is the only conceivable source. Concom-
itant with  an increase of the  mutagenic response
there is  consequently also  an increase  of other
pollutants, such  as nitrogen  oxides  and volatile
hydrocarbons which are not detected by the muta-
genicity  test. The level of  the indoor mutagenic
response of 1000-2500  revertants/m3  (Table 1)
can  be compared with an average response of 45
revertants/m3 (range 9-162) for seventy-six 24-h
                             samples  collected at street level  at  various  lo-
                             cations in Gothenburg (Sweden) and analyzed with
                             the  microsuspension  assay  with  TA98 + S9
                             (Lofroth et ah. unpublished results). The ambient
                             outdoor response of < 50-260 revertants/mj mea-
                             sured simultaneously in the present study  (Table
                             1) is  of  a reasonable magnitude considering  the
                             fact that these samples were collected during a few
                             hours in the afternoon when the traffic is of more
                             than the average 24-h intensity.
                             Train travel
                                The mutagenic responses of the air of smoking
                             train compartments (Table 2) are of an  expected
                             magnitude. The type of compartment sampled has
                             a volume of about  40  m3 and  assuming an effi-
                             cient air  mixing, the concentration of  600 and
                             3500 revertants/m3 following smoking of 5 and 25
                             cigarettes, respectively,  during  4-4.5  h may be
                             obtained with a combined ventilation and surface
                             removal  rate  (Repace  and Lowrey, 1980) corre-
                             sponding to about 9-12 air changes/h.

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                                                                                               109
  The  result from  the  non-smoking  compart-
ments (Table 3) shows that smoke from the smok-
ing compartment  can  penetrate  into  the  non-
smoking section. Although most samples only gave
a small response, an activity of 100 revertants/nr1
must be judged to be above the background as the
electrically powered  train mostly travels through
rural areas. Separation of non-smoking and smok-
ing compartments in a train is most easily done by
having  an entire smoking  car (or several) at  the
rear end of the train.

Air travel
   Tobacco smoke in airplanes has recently been
studied with  nicotine analysis  by Oldaker  and
Conrad (1987) who  found that  the average  nico-
tine concentration  in  the non-smoking sections
was about half of that in the smoking sections; 5.5
vs. 9.2 /ig/m3. The concentration  in the  non-
smoking  sections  correponds   to about 0.0013
cigarettes/m3 using the  sidestream  emission  of
nicotine (4.1  mg/cigarette) given by Rickert et al.
(1984). The mutagenic  response of 200-1000 re-
vertants/m3  (Table  3)  obtained  in  the  present
study corresponds to 0.001-0.005 cigarettes/m3 of
which the higher value best relates  to the situa-
tions investigated by  Oldaker  and  Conrad,  i.e.
non-smoking seats near smoking sections.
   The results of this study and of the investiga-
tion by Oldaker and Conrad (1987) indicate that if
smoking is permitted on airplanes,  the smoking
section ought to be physically separated from the
non-smoking sections, e.g. by stewardess' areas.

Chemical fractionation
   Using  the  plate incorporation  assay, previous
fractionation studies have shown that mutagens in
tobacco tar particulates to a large extent are basic
compounds responsible for more than  65% of the
response. The relative activity of the basic fraction
in  the microsuspension  assay is smaller with
slightly less than 50% of the total response being
recovered in  this fraction  (Table 4). This is, how-
ever, still significantly more than the correspond-
ing relative  response of  compounds  in ambient
paniculate matter with  a  very  small contribution
from the  basic  fraction. There  are no published
reports indicating that some commonly occurring
processes generate airborne paniculate matter with
a high portion of the mutagenic  activity  in  the
basic fraction. A conceivable  source of  basic
mutagenic compounds is cooking but it has only
given a weak correlation to the total indoor muta-
genic activity (van Houdt et al., 1984: Lewtas et
al., 1987).  The  sensitive  microsuspension  assay
might thus be used as a tobacco-specific analysis
if part of an  air paniculate sample is subjected to
fractionation, as has been  explored in this study
with analysis of a sample from a restaurant and a
sample  from  an  apartment (see  Results).  Such
differential analyses are deemed possible for mod-
erately  tobacco  smoke-polluted air  with  sample
sizes  2-3 times  larger than  those  used in  the
present  study of public indoor locations.

Mutagenic activity and other tobacco smoke indica-
tors
   Nicotine  has so  far been the only tobacco-
specific  air  pollutant. Its  value  as  an indicator
may, however, be limited as nicotine may not be a
health issue  and as  it may  be  prone to  rapid
adsorption to surface materials causing an  under-
estimate of the air pollution of other smoke com-
ponents. Among other compounds emitted in the
sidestream. several unsaturated hydrocarbons have
high emission factors  (L6froth et al.. 1987. and
unpublished  data). The  emission of isoprene is
about 2-3 mg/cigarette and this alkadiene may be
utilized as a semi-specific tobacco smoke indicator
although it  is  present at  low background con-
centrations   originating   from  natural  sources
(Gelmont et al., 1981; Lamb et  al..  1986).  An
advantage  with isoprene.  which  it shares with
mutagens in the  tar  particulates. is  that it is a
potential mutagen and carcinogen following mam-
malian  metabolism  (Longo et  al..  1985).  Ulti-
mately,  a combination of Salmonella mutagenicity
of particulates. isoprene and nicotine may be used
for a better estimate of  environmental tobacco
smoke.

Acknowledgement

   This  study was  partly  made  feasible  by  the
Cooperative Agreement CR812935-01  between the
U.S.  Environmental Protection  Agency  and  the
Nordic  School of Public Health covering a DVS
program for GL.

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110
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VARIABILITY OF MEASURES OF EXPOSURE TO
ENVIRONMENTAL TOBACCO SMOKE IN  THE HOME
David B. Coultas, Jonathan M.  Samet
Department of Medicine and
New Mexico Tumor Registry
University of New Mexico Medical  Center
Albuquerque, New Mexico  87131
John F. McCarthy, John D.  Spengler
Department of Environmental  Science  Engineering
Harvard School of Public Health
Boston, Massachusetts  02115
     We have assessed the variability  of four markers of environmental
tobacco smoke exposure in 10 homes with  20 nonsmoking and  11  smoking
household members.  We obtained exposure questionnaires, saliva  and urine
for cotinine, and air particle samples for respirable particles  and
nicotine on 10 sampling days:   every other day over  10  days,  and then  one
day every other week over 10 weeks.  The mean concentrations  of  respirable
particles in the 10 homes ranged from  32.4 ug/m^  to  76.9 ug/m^.  and
concentrations of nicotine ranged from 0.59  ug/m^ to 6.85  ug/nn.  A linear
regression model that included indicator variables for  the number of
smokers exposed to in the home and the season, and the  number of hours of
exposure as a continuous variable explained  nine  and 6% of the variability
of the respirable particle and the nicotine  concentrations, respectively.
The individual mean cotinine levels standardized  to  urinary creatinine
concentration, ranged from 3.89 ng/mg  Cr to  55.77 ng/mg Cr.  A linear
regression model that included the number of smokers exposed to  in the
home, the season, the age group, and the number of hours of exposure
explained 8% of the variability of the urinary cotinine levels.

     We conclude that because of the marked  variability of these measures,
multiple measurements are needed to establish a stable  profile of exposure
to environmental tobacco smoke in a particular home  or  individual.
Furthermore, detailed questions to quantitate exposure  offered little
additional information beyond whether  the subject was exposed or not.
                                           Proceedings.of  the APCA Conference
                  'A  •;i.;230 USA            on Indoor Air,  In Press

                                           Niagra Falls, 1988

-------
Introduction
     Passive smoking refers to the involuntary exposure of nonsmokers to
the combination of tobacco combustion products released by the burning
cigarette and smoke components exhaled by the active smoker*»2.  The
adverse health effects of passive smoking on children and adults have been
described in  numerous  epidemiologic investigations^.

     Although some health effects of passive smoking have been
convincingly demonstrated, many questions on the health effects of passive
smoking remain unanswered.  More precise description of exposure-response
relationships is needed for the adverse effects on children and for lung
cancer and nonmalignant effects on adults.  In most epidemiologic studies
on involuntary smoking published to date, exposure has been assessed with
questionnaires.  However, other indicators of exposure are available,
including atmospheric and biologic markers, which have received increasing
attention.

     We have assessed the variability of four markers of environmental
tobacco smoke exposure in 10 homes with 20 nonsmoking and 11 smoking
household members.  The markers of exposure included questionnaires,
respirable particles and nicotine from air samples, and urinary cotinine.

Methods
                              Sample Selection
     Between February and December, 1986, 149 nonsmoking volunteers, 18
years of age and older, were recruited from Albuquerque and surrounding
communities to participate in a study of the accuracy of questionnaire
assessment of exposure to environmental tobacco smoke3.  From this sample,
10 subjects volunteered their households for this investigation.

                              Data Collection
     We obtained exposure questionnaires, saliva and urine, and air
particle samples on 10 sampling days:  every other day over 10 days, and
then one day every other week over 10 weeks.  The questionnaires, and
saliva and urine specimens were obtained at the end of a 24-hour air
monitoring period (described below).  From the questionnaires we determined
the reported number of smokers and number of hours that the subjects were
exposed, during the previous 24 hours, to cigarettes, cigars, and pipes at
home, at work or school, in a vehicle, and in other places.  Questionnaires
were self-completed by the adults, and by a parent for children 13 years of
age and younger.  The saliva and urine specimens were frozen at -20°C until
the cotinine assays were performed.

                              Cotinine Assay
     Cotinine was quantitated by a double antibody radioimmunoassay, as
described by Langone et al. .  A specific antiserum produced in rabbits was
supplied by Dr. Helen Van Vunakis, Brandeis University.  Urine samples were
diluted 1:4 for the assay.  The sensitivity of the assay in our hands was
36 pg/tube or 0.78 ng/ml of urine (4204 pmol/L).  Urine creatinine
concentrations were determined by the Jaffe reaction^, and the cotinine
concentrations were standardized to the creatinine concentrations.  Assays
were performed without knowledge of questionnaire responses.

                           Particle Measurements
     In the major activity room of each home, Harvard School of Public
Health impactors6 operating at a flow rate of 4 liters/minute were used to
collect respirable particles and gaseous  nicotine samples.   Through a timed
solenoid switching valve, two impactors used a common, mass flow controlled

-------
pump, and each impactor operated  on  alternate  15  minute  collection  cycles.
Respirable particle samples were  collected  on  teflon  filters  (Membrana,
Inc.) and nicotine was collected  on  sodium  bisulfate  treated  glass  fiber
filters (Millipore Corp.)  to minimize  its volatilization.   After extraction
from the filter, analysis  for nicotine was  done on  a  Shimadzu GC7A  gas
chromatograph with a flame ionization  detector.   The  nicotine collection
and extraction procedure is a modification  of  that  described  by Hammond  et
al.7.  The recovery of nicotine by this  procedure has been  shown to be  98%
efficient.

                               Data Analysis
     Variability of questionnaire responses, respirable  particle and
nicotine concentrations, and urinary cotinine  levels  were assessed  with
univariate analyses.  From the questionnaires  the measures  of exposure  in
the home were the total number of smokers,  including  cigarettes, cigars,
and pipes, and the total number of hours exposed.   During the entire
sampling period there were only four days that any  subject  reported
exposure to a cigar smoker, the predominant exposure  was to cigarette
smoke.

     To examine .determinants of the  variability in  the measurements, we
used multiple linear regression.  The  dependent variables,  respirable
particles, nicotine, and urinary  cotinine,  were analyzed as continuous
variables.  For the independent variables,  indicators were  defined  for
house (HOUSE = 1-10), individual  (INDIVIDUAL = 1-20), age group (AGE GROUP
<18 years or .>18 years), season (SEASON  = March-April or May-October),  and
number of smokers per day (NUMBER =  0  or >!)•  The  other independent
variable, number of hours  (HOURS) exposed per  day was continuous.

     Data analyses were performed with standard programs of the
Statistical Analysis System8.

Results
     The 10 households included 11 cigarette smokers  and 20 nonsmokers
aged 1.5 to 74 years (Table I).   The types  of  homes included, eight
unattached, single family houses, one  mobile home,  and one  apartment.

     Reports on exposure to tobacco  smoke in the  home were  obtained for
all 10 sampling days from 17 subjects, and  for nine days from three
subjects.  The reported number of cigarette smokers in the  home per day did
not vary widely.  The median number  (range) of smokers per  day was  one  for
18 subjects (0-10), zero for one  subject (0-1), and four for  one subject
(2-25).  Greater variability was  reported for  the number of hours exposed
to cigarette smoke in the home (Table  I).

     Respirable particle and nicotine  concentrations  were obtained for  99%
of the sampling days (Figures 1 and  2).  The mean concentrations of
respirable particles in the 10 homes ranged from  32.4 ug/m3 (SD = 13.1)  to
76.9 ug/m3 (SD = 32.9) and concentrations of nicotine ranged  from 0.59ug/m3
(SD = 0.69) to 6.85 ug/m3 (SD = 8.21).  The degree  of variability with
sampling every other day or every other  week was  similar (data not shown).

     For the particle and nicotine measurements we  used  linear regression
to examine determinants of variability and  of  level.   A  model that included
indicator variables for the 10 houses  explained the greatest  variability
(Table II).  Compared to the model with  the house variables,  other models
that included specific exposure  variables explained markedly lower
percentages of the variability of levels.   Although not  statistically
       Pitts bur gn. PA 1 &;•„;. ,.;,•/*.
             4^2-232- *&ta

-------
significant, increases in respirable particles were associated with
exposure to one or more cigarette smokers in the home and with the colder
months, March and April (Table II).  There was no association with the
number of hours of exposure.  Nicotine levels also increased with exposure
to smokers in the home, but were not predicted by the season (Table II).

     Urinary cotinine levels were obtained on 187 specimens from the 20
nonsmokers.  The individual mean cotinine levels standardized to urinary
creatinine concentration, ranged from 3.89 ng/mg Cr (SD = 6.54) to 55.77
ng/mg Cr (SD = 32.02).  The mean levels and variability tended to be
greater in the children compared to the adults (Figures 3 and 4).  As with
the atmospheric measures, the variability was comparable with sampling
every other day or every other week (data not shown).

     For the urinary cotinine levels, we also examined determinants of
variability and determinants of concentration with linear regression.  A
model that included indicator variables for the 20 nonsmoking individuals
explained 47% of the variability in cotinine levels (Table III).  Compared
to this model, other models that included specific exposure variables and
age group explained much lower proportions of the variability.  Cotinine
levels were significantly (p<0.05) higher among children compared to adults
(Table III).  Although not significant, exposure to one or more smokers
resulted in higher cotinine levels compared to no exposure.  The number of
hours of reported exposure and the season were not significant predictors
of cotinine level.

Conclusions
     In a group of volunteers, from 10 homes, we found that concentrations
of respirable particles and nicotine, and urinary cotinine levels varied
widely within homes and individuals, respectively.  Sampling every other
day or every other week did not offer any advantage for establishing a
stable profile of exposure with these markers.  A moderate degree of the
variability of these measures was explained by variables representing
houses and individuals, but more specific measures of exposure contributed
little to explaining the variability.

     Many factors, which we were unable to measure, may contribute to the
variability of these measures of environmental tobacco smoke in the home.
For the atmospheric measurements, concentrations depend on the intensity
and duration of smoking, room size, ventilation, adsorption of smoke
components, methods of collection, and methods for measurement.  Particle
concentrations are also affected by sources other than tobacco smoking.
Furthermore, at a given level of nicotine exposure, urinary cotinine level
is also influenced by uptake, metabolism, and excretion, which are likely
to vary among individuals.  Finally, the ability to predict levels of these
markers is also limited by subjects' inability to comprehensively and
accurately describe the extent of exposure.

     The results of this investigation have several implications for the
measurement of environmental tobacco smoke in epidemiologic investigations.
Because of the marked variability of these measures, multiple measurements
are needed to establish a stable profile of exposure in a particular home
or for a particular individual.   Detailed questions quantitating exposure
to environmental  tobacco smoke seem to offer little information beyond
determining whether the subject  was exposed or not.  Future investigations
of methods for measurement of environmental  tobacco smoke must determine
the importance of other factors  that may contribute to the variability of

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atmospheric and biologic markers, the role of personal  monitoring, and the
relevance of these markers to acute and chronic health  effects of passive
smoking.

Acknowledgments
     Supported by a grant, EPA CR 811650 from the Environmental  Protection
Agency.  Dr. Coultas is recipient of an Edward Livingston Trudeau Scholar
Award from the American Lung Association.

     The authors thank Dr. Helen Van Vunakis  for providing the reagents
for the radioimmunoassay and Irene Walkiw for technical assistance in
performing the assays.

References
1.  "The Health Consequences of Smoking, a Report of the Surgeon General,"
    U.S. Department of Health and Human Services, U.S.  Department of Health
    and Human Services, Rockville, MD, 1986.   (DHHS (CDC) publication no.
    87-8398).

2.  "Environmental Tobacco Smoke.  Measuring  Exposures  and Assessing Health
    Effects," National Research Council, National Academy Press, Washington,
    DC, 1986.  (ISBN 0-309-03730-1).

3.  D. B. Coultas, G. T. Peake, J. M. Samet,  "Questionnaire assessment of
    lifetime and recent exposure to environmental tobacco smoke," Submitted
    for publication.

4.  J. J. Langone, H. B. Gjika, H. Van Vunakis, "Nicotine and its
    metabolites.  Radioimmunoassays for nicotine and cotinine,"  Biochemistry
    12: 5025.  (1973).

5.  W. R. Faulkner, J. W. King, "Renal function," in:  N. W. Tietz, ed.,
    Fundamentals of Clinical Chemistry, W. B. Saunders  Co., Philadelphia,
    P/C1976, pp. 975-1014.

6.  W. A. Turner, V. A. Marple, J. D. Spengler, "Indoor aerosol  impactor,"
    in:  B. Y. H. Liu, D. Pui, H. Fissan, eds., Aerosols.  Elsevier Science
    Publishing Co., Inc.  1984.

7-  S. K. Hammond, B. P. Leaderer, A. C. Roche, M. Schenker, "Collection
    and analysis of nicotine as a marker for  environmental tobacco smoke,"
    Atmospheric Environment 21: 457.  (1987).

8.  SAS Institute Inc., SAS User's Guide:  Statistics.   Version 5 edition.
    SAS Institute Inc., Gary NC.13557

-------
                                   Table I

         Description of Houses* and Subjects, and Reported Number of
            Hours Exposed to Cigarette Smoke 1n the Home per Day,
                               New Mexico, 1986
House/Subject
One
1
2
Two
3
4
5
Three
6
7
Four
8
9
10
Five
11
12
Six
13
14
Seven
IS
16
Eight
17
18
Nine
19
Ten
20
Number of Rooms
7


6


7


7

•
8

6


4

5


6

4

Age (yrs)

28
1.5

29
9
5

37
4.5

35
13
4

32
2

49
22

41
14

46
13

74

63
Sex

F
M

F
F
M

M
M

F
F
M

F
F

F
M

F
M

F
M

M

F
Hours/day Exposed
Median (range)

4.5 (0-11)
3.0 (0-7)

5.5 (0-10)
6.3 (2-13)
6.5 (0-11)

3.5 (2-8)
5.0 (2-10)

4.5 (4-9)
7.0 (3-12)
8.5 (7-14)

1.0 (0-19)
3.0 (0-19)

4.0 (0-10)
0.0 (0-3)

11.0 (0-16)
5.5 (0-14)

6.0 (3-13)
6.0 (0-13)

5.0 (4-7)

5.5 (2-16)
*Houses 1-6, 8-9 are unattached, single family homes,  7 Is  a  mobile  home,
 and 10 Is an apartment.

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                                  Table II

         Linear Regression Models* Predicting Resplrable Particle and
            Nicotine Concentrations In Air Samples from 10 Homes,
                               New Mexico, 1986
Dependent Variable
   Model  1
   Model  2
   Model  3
Resplrable particles
  (mg/m3)
     0.34
     0.08
     0.09
Nicotine
  (mg/m3)
     0.28
     0.04
     0.06
                                   Regression Coefficients'1' Model 3
                           One or More
                             Smokers
                      HOURS
                   Cold Months
Resplrable particles
  (mg/m3)
   +17.3
(7.4 - 27.2)
    +0.4
(-1.0 - 1.8)
    +8.9
(-1.1 - 18.9)
Nicotine
  (mg/m3)
    +2.1
(-1.7 - 5.9)
    +0.2
(-0.1 - 0.5)
    -0.7
(-2.5 - 1.1)
independent Variables:  Model 1 • HOUSE, Model 2 » NUMBER (0 or >1) +
 SEASON (March - April or May - October), Model 3 * NUMBER (0 or II) +
 HOURS (continuous) + SEASON (March - April or May - October).
     confidence Intervals 1n parentheses.

-------
                                  Table III

                    Linear Regression  Models* Predicting
            Urinary Cotinine Concentrations  from 20 Nonsmokers
                        Exposed to Tobacco Smoke,
                             New Mexico, 1986
Dependent Variable           Model  1            Model  2            Model  3
Urinary cotinine
  (ng/mg Cr)                   0.47               0.05               0.08
                             Regression Coefficients''' Model  3
                   One or More
                     Smokers        HOURS      Cold Months      Children
Urinary cotinine      +5.4          +0.8           -0.2           +5.4
  (ng/mg Cr)     (-4.8 - 15.6)   (0.0 - 1.6)   (-5.8 - 5.4)   (0.0 - 10.8)
Independent Variables:  Model  1 = INDIVIDUAL, Model  2 = NUMBER (0 or >1) +
 SEASON (March - April  or May - October), Model 3 = NUMBER (0 or >1) +
 HOURS (continuous) + SEASON (March - April  or May -  October) + AGE GROUP
 (<18 or >18 years).

     confidence intervals in parentheses.

-------
                                                                                                    o>
                                       Figure 1
                   Resplrable particle concentrations and means In 10 homes.
200
    RSP (ug/cubic m)
 150
 100
 50
       t
 *      *
+-     *
 *      +
I
+

*
-t-
                                             T
                               4       5       6       7       8       9       10
                                         House

-------
25
20
15
10
 5
                                    Figure 2

                     Nicotine concentrations and means in 10 homes.

   nicotine (ug/cubic m)
              I       *      _£_                      $      *
              f     *       *       ±     -4-      +      ±
       1       23456789       10
                                       House

-------
120





100





 80





 60





 40





 20
                                         Figure 3




                   Urinary cotinlne levels and means for children from 10 homes



   cotinine (ng/mg Cr)
*±        +        *"F+l        +
+      -±-               *        *                -4-       +
                                   7        9        10        12        16       18


                                         Subject


                                           child

-------
                                   Figure 4
               Urinary cotinine levels and means for adults from 10 homes.
120





100





 80





 60





 40




 20




  0
cotinlne (ng/mg Cr)
  _i_
  . T . ,
           s
~r
 .L
 T
                                        *
                                                              +
                                              *^
                         8
                                    11      13      14      15     17      19


                                        Subject

                                          adult
                                             20

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AMERICAN JOURNAL OF EPIDEMIOLOGY                                                Vol. 130. No. 2
Copyright ® 1989 by The Johns Hopkins University School of Hygiene and Public Health             Printed in U.S.A.
All rights reserved
     QUESTIONNAIRE ASSESSMENT OF  LIFETIME AND  RECENT
          EXPOSURE TO  ENVIRONMENTAL TOBACCO SMOKE

         DAVID B. COULTAS,'-2 GLENN T.  PEAKE,3*  AND JONATHAN M. SAMET1-2

         Coultas, D. B. (New Mexico Tumor  Registry, Cancer Center, U. of New Mexico
       Medical Center, Albuquerque, NM 87131), G. T. Peake, and J. M. Samet Ques-
       tionnaire assessment of lifetime and  recent exposure to environmental tobacco
       smoke. Am J Epidemic! 1989:130:338-47.
         In a sample of  149 adult nonsmokers recruited in New Mexico in 1986, the
       authors assessed  the reliability of questionnaire responses on lifetime exposure
       to tobacco smoke in the home. They also compared urinary cotinine  levels with
       questionnaire reports of environmental  tobacco  smoke  exposure  during the
       previous 24 hours. The agreement of responses obtained on two occasions within
       six months was high for parental smoking during childhood: 94% for  the mother
       and 93% for the father. For the amounts smoked  by the mother and the father
       during the subject's childhood, the agreement  between the two interviews was
       moderate: 52% and 39%, respectively. For the number of hours per day that each
       parent smoked in the home during the subject's childhood, the Spearman corre-
       lation coefficients  also indicated only moderate reliability (r = 0.18 for maternal
       smoking and r = 0.54 for paternal smoking). For each set of interviews, responses
       concerning recent tobacco  smoke exposure and urinary  cotinine levels were
       correlated to only a modest degree. The authors conclude that adults can reliably
       report whether household members smoked during their childhood, but informa-
       tion on quantitative aspects of smoking is reported less reliably.

         pyrrolidinones; questionnaires; tobacco smoke pollution
  The term "passive smoking" refers to the   ologic  investigations (1, 2). However, de-
involuntary exposure of nonsmokers to the   spite the evidence linking malignant and
combination of tobacco combustion prod-   nonmalignant diseases with active and pas-
ucts released by the burning cigarette and   sive smoking, tobacco  smoking  remains
smoke components exhaled by the active   highly  prevalent worldwide  (1).  In the
smoker (1, 2). The adverse health effects of   United States at present, about 30 per cent
passive smoking on children  and  adults   of adults are active cigarette smokers (3),
have been described in numerous epidemi-   so that a large proportion of nonsmokers


  Received for publication March 28, 1988, and in   New Mexico Medical Center, 900 Camino de Salud
final form October 11, 1988.                       NE, Albuquerque, NM 87131.
  1  New Mexico Tumor Registry, Cancer Center, Uni-     Supported by Grant EPA CR811650 from the En-
versity of New Mexico Medical Center, Albuquerque,   vironmental Protection Agency.
NM.                                          Dr. Coultas is a recipient of an Edward Livingston
  2  Departments of Medicine and of Family, Com-   Trudeau Scholar Award from the American Lung As-
munity, and Emergency Medicine, and the Interde-   sociation.
partmental  Program in Epidemiology, University of     The authors thank Dr. Helen  Van Vunakis for
New Mexico, Albuquerque, NM.                   providing the reagents for the radioimmunoassay and
  3  Department of Medicine, University of New Mex-   Irene Walkiw for technical assistance in performing
ico,  Albuquerque, NM.                           the assays. Special thanks to the interviewers and to
  *  Deceased.                                 Lee Fernando, Rita Elliott, and Rebecca Mosher for
  Reprint requests  to Dr. David B.  Coultas, New   their help in preparing the manuscript
Mexico Tumor Registry, Cancer Center, University of

                                         338

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               QUESTIONNAIRE ASSESSMENT OF TOBACCO SMOKE EXPOSURE
                                                                             339
in this country are involuntarily exposed to
environmental tobacco smoke (1, 2).
  Although some health effects of passive
smoking have been convincingly demon-
strated,  many  questions  on  the health
effects  of  passive  smoking  remain  un-
answered.  More precise  description  of
exposure-response relations is needed  for
assessment of the adverse effects on chil-
dren and the development of lung cancer.
Additionally, further studies  on exposure
to environmental tobacco  smoke in the
workplace  are warranted  because of the
high prevalence  of smoking among adults
and public concern about this source of
exposure. In most epidemiologic studies on
involuntary smoking published to date, ex-
posure has been assessed with question-
naires;  for the  purposes of .some inves-
tigations, the questionnaires have  spanned
the entire lifespans of the subjects. Ques-
tionnaires will  remain the most feasible
method for assessing exposure to environ-
mental tobacco smoke in new studies. How-
ever, the reliability and validity of question-
naire  measures  of involuntary smoking
have not been adequately characterized.
  In this study, we have assessed the reli-
ability of a comprehensive questionnaire
on lifetime exposure to environmental  to-
bacco smoke in 149 adult nonsmokers.
While validity is also of interest, no appro-
priate standard for comparison is available
for  a lifetime history. Questionnaire  re-
sponses with poor reliability are also likely
to have poor validity. In this sample,  we
also examined the relation between reports
of recent exposure to environmental  to-
bacco smoke and urinary cotinine  levels.

       MATERIALS AND METHODS
            Sample selection
  Between  February and December  of
1986, nonsmokers aged 18 years and older
were  recruited  from Albuquerque,  New
Mexico, and the  surrounding communities.
Recruitment  was accomplished  by  two
methods: advertisements and direct contact
with subjects from a population survey (4).
In both approaches, we asked for volunteers
to participate in a study of indoor air qual-
ity that  involved completing a  question-
naire on two occasions and providing saliva
and urine samples. The subjects were not
informed that the study was directed spe-
cifically at exposure  to environmental to-
bacco smoke. We attempted to stratify the
sample uniformly by age and by sex but
were not completely successful (table 1). Of
our sample, 62 per cent were female, and
only five  males were aged 60 years and
older.

             Data collection
  A structured questionnaire on lifetime
and recent exposure  to environmental to-
bacco smoke was administered by a trained
interviewer to each  subject on two occa-
sions separated by approximately four to
six months. Training involved familiariza-
tion and practice with  the questionnaire
and review of probing techniques, which
were  standardized.  The interviews  were
conducted by four interviewers who  com-
pleted 89.2, 5.4, 2.7, and 2.7 per cent of the
first interviews and 38.2, 6.7, 54.4, and 0.7
per cent of the second interviews, respec-
tively. We  asked  whether the  subject's
mother had smoked while  pregnant with
the subject, and we determined the smoking
status of parents, spouses, and others from
questions on whether  these persons had
smoked in the subject's home on a  daily
basis for six months  or more. These ques-
tions referred to two  time periods: birth to
age 18 years and age 19 years to the time
of the interview. These time periods were
chosen to correspond to the usual ages for

                TABLE l
Age and sex distribution of 149 participants in a study
     of involuntary exposure to tobacco smoke.
             New Mexico. 1986
Age
(years)
20-29
30-39
40-49
50-59
>60
Males
No.
12
20
9
10
5
%
21.4
35.7
16.1
17.9
8.9
Females
No.
17
27
15
15
19
%
18.3
29.0
16.1
16.1
20.4

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340
COULTAN IT AL.
living in  the  parents' horn* and subse-
quently  living outside the parents' horn*.
In addition,  for each smoker,  we asked
about the type(e) of tobacco smoked (ciga-
rette, pipe, or cigar), the amount of  each
type umokod in the home, the number of
yean aach type wai •moked, and the num-
ber of hours of exposure per day to  each
type in the home. Another net of question!
asked about the amount of exposure during
the previous 24 hours. The questions cov-
ered the number of smokers to  which the
subject was exposed, the type(s)  of tobacco
•moked (cigarette,  pipe,  or cigar), and the
number of hours of exposure. These ques-
tions were asked separately for exposures
at home, at work, in vehicles, and  at social
gatherings. At the  time of the interview, a
urine specimen was collected and frozen at
-'20 C until the cotinine assays were per-
formed.

             Catinint auay

  Cotinine  was quantltated by a double
antibody  radioimmunoassay as described
by Langone et al. (6). A specific  antiserum
produced in  rabbits was supplied by Dr.
Helen Van Vunakis of Brandeis University
(Waltham, MA). Urine  samples were di-
luted 1:4 for the assay. The  sensitivity of
the assay in our hands was 38 pg/tube or
0.78 ng/ml of urine (4,204 pmol/liter). Uri-
nary creatinine concentrations were deter-
mined by the Jaffa reaction (6),  and the
cotinine concentrations were standardised
iu the  creatinine  concentrations. Assays
were performed without knowledge of ques-
tionnaire responses.

              Data analytic

  Reliability was assessed by comparison
of the two lifetime histories  for the expo-
iure variables during the two time periods,
birth to age 18 years and age 19  years to
the time of the interview. Because of the
•mall number of pipe and cigar  smokers
among parents (n • 24)  and spouses (n «
4), we restricted our analysis to cigarette
smokers.  We  summarized  the  per  cent
        agreement between the first and second
        Interviews for categorical variables, which
        Included  mother's  smoking  during  preg-
        nancy; mother's, father's, and spouse's cig-
        arette smoking status; amount smoked, cat-
        egorized as less than one pack per day, one
        pack per day, and more than one pack per
        day; and number of other cigarette smokers
        in the household, categorized aa none, one,
        and two or more. To discount chance agree-
        ments between the first and second Inter-
        views, Cohen's kappa was calculated for ail
        categorical items and tested for significance
        (7, 8). Spearman  rank order correlation
        coefficients (9) were calculated for contin-
        uous variables,  which  included both the
        number of years and the number of hours
        per day that the subject's mother, father,
        spouse, and others had smoked.
          For questions on exposure to tobacco
        smoke during the  previous 24 hours, we
        created  summary  variables  for  cigarette
        smoke exposure only, because exposure  to
        pipe and cigar smokers was infrequent. The
        summary variables  for cigarette smoke ex-
        posure included the total number of hours
        of exposure and the total number of ciga-
        rette smokers in all locations. To examine
        the relation between measures  of  short
        term exposure to environmental tobacco
        smoke within and between interviews, we
        calculated Spearman rank order correla-
        tions (9).
          Data analyses were performed with stan-
        dard  programs of the Statistical  Analysis
        System (10).

                       RBSULTI
          Of the 158 subjects enrolled for the first
        interview,  149 (94 per cent) also completed
        the second interview. Of the nine subjects
        who  were not reinterviewed, there were
        seven males and two females, with mean
        ages  of 43.6 years and  43.0 years, respec-
        tively. This report is based on responses of
        those 149 subjects who were reinterviewed.
        The age range of the 149 subjects was 21-
        79 years (mean  « 43 years); 37.6 per cent
        were  males and 62.4 per cent were females
        (table 1).  The median  duration  between

-------
                QUESTIONNAIRE ANHENIMBNT OP TOBACCO HMOKB EXPOBURB             341

Intarviawa WM 17 waaka, with a rangt of 6-   and kappa atatiitic for tht numbtr of othtr
39 waaka.                                   dgiratta amokara in tha horn* during child-
  For tht pariod birth to aga  18  yaara,   hood wara 77.0 par cant and 0.47 (p <
agraamant batwaan tha flnt  and lacond   0,0001), raipactivaly,
intarviawa waa high for parantai smoking     In contraat to tha high reliability of rt-
•tatua during childhood (tabla 2). Tha par   iponaaa about parantai smoking itatua dur-
cant agraamant waa  ilmilar  for  mothar'i   ing childhood, ooncordanca waa low for ro-
and fathar'i smoking during childhood and   sponaaa about tha uaual amount imokad in
waa  lowaat  for matarnai amoking during   tha horaa by tha paranta during childhood
pragnancy, Tha parcantaga of unknown ra-   (tabla 3), Tha concordanca waa highaat for
•ponaaa waa  highaat for matarnai smoking   tha  amount amokad  by tha  mothar  and
during pragnancy, Tha par cant agraamant   lowaat  for tha amount amokad by  tha fa*

                                       TABLI 3
Ptntniajt of nantmokin rtporting txpoiun to partntat oigaHttt making during childhood, Ntw Mttloo, ItMM
                            Miumil imnlilni       Miumil imoklni       H»wrnil imoliini
           RtiponM           durini pnanaiuy       during childhood       clurlni childhood
                               (n • I4BI	(n»  149)	(n • UP)	
       Y.I
        Pint  inwrvltw             30,1                 ,16,0               08,7
        8«oond Inwrvttw           30,1                 33,8               Dfl,4
       No
        Pint  lnt»rvi«w             87,1                 63,4               43.6
        8*oond Interview           04.4                 07,1               43.0
       Unknown
        Flrat  Inurvltw             13J                 0,7                0.7
        Stcond InMrvliW           Ifl.fl                 0,0                0,7

       A|rt«m«nt
        Conoordano*              BA.O                 94.0               03.0
        Kappa                    Q.73*               0.87*	o.aa*	
  •p< 0,0001.

                                       TAIL* 1
  Ptntntatt of  nanimokun nportinf ttpotun to variaut amount* of ctianttti imoktd by tht partnti during
                 childhood and by tht ipotut during adulthood, Ntui Mtxieo,
Amount imokcd
Leu than on* pick/day
Flm Inwrvitw
SMond Intt rvl«w
OM pack/day
Flnt Intarvlcw
8»oond Intarvlaw
Mora than ona pack/day
Flm Intarviaw
Stoond inwrviaw
Unknown
Flnt Intarviaw
Saoond Intarviaw
Mturnal imokini
durlni childhood
In - 48)

A3.5
ao.o
30,«
33,0

0.3
16.7

10.4
10.4
Pittrnal imoklni
dunni flhlldhood
(n • 7B)

70,9
30.4
11.4
33,0

10,1
32.ft

7,6
8,0
IpouMl imokini
during adulthood
I/I-H4I

S4.4
40,0
7,8
31,3

0.3
38,1

1,6
0,0
      Agreement
        Concordance                  53.1                30,3               43.8
        Kappa                      0.82*              0.04*	-0.04*
  •p>0.08.                                                           ——

-------
342
COULTAS ET AL.
ther. Compared with the first interview, the
percentage of subjects reporting parental
smoking of one pack per day or more was
higher at the second interview.
  We also examined the  reliability of re-
sponses  on smoking status and amount
smoked by sex and by age. The findings
were similar to the overall analysis within
strata defined by either sex or age, above
and below age 40 years.
  Spearman correlations were used to de-
scribe the agreement between the first and
second interviews on the reported number
of years  and hours per day of exposure to
environmental tobacco smoke during child-
hood.  The  correlation coefficients  were
high for responses on the number of years
the parents  and  other smokers  in  the
household had smoked (table 4). However,
        for responses on the number of hours per
        day of smoke exposure in the home, the
        correlation coefficients were much  lower
        (table 4).
          We next examined the reliability  of re-
        ported smoke exposure during adulthood
        (tables 3 and 5). After age 18 years, the
        numbers of subjects living with either their
        mother (n = 8) or their father (n = 9) were
        small. For this small group of subjects, the
        concordance  of  responses on  parental
        smoking status was 100 per cent. Similarly,
        the per cent agreement on spouse's smoking
        status, as  obtained at the two  interviews,
        was 100 per cent (n = 67). For the amount
        currently smoked by the  spouse, the con-
        cordance was  lower (table 3).  Agreement
        between responses about the  number of
        other cigarette smokers in the household
                                      TABLE 4
       Mean years and hours per day of childhood cigarette smoke exposure reported by nonsmokers.
                                   New Mexico, 1986
Exposure variable
Maternal smoking
Years*
Hours/dayt
Paternal smoking
Years
Hours/day
Other household members'
smoking
Years
Hours/day
No.

33
31

57
55


26
20
First
interview

15^4
5.0

16.1
4.8


13.9
9.2
Second
interview

15.7
6.4

15.4
4.8


13.2
8.4
Spearman's
r

0.76
0.18

0.75
0.54


0.63
0.51
* MT")nrinir fha narinrl fWim Kirth tn acra 1A iraaN fnv Vinttr manv uaara Aid Via/aha cm/lira **iaarafrtaa9'*
  t "On average, during the period from birth to age 18 years, for how many hours per day were you exposed
to individuals' cigarette smoke?"
                                      TABLE 5
       Mean years and hours per day of adulthood cigarette smoke exposure reported by nonsmokers,
                                   New Mexico, 1986
Exposure variable
Spouse's smoking
Years*
Hours/dayt
Other household members' smoking
Years
Hours/day
No.

40
39

67
58
First
interview

16.2
5.9

8.3
12.7
Second
interview

16.4
5.5

8.2
10.3
Spearman's
r

0.95
0.25

0.78
0.54
  * "For how many years did he/she smoke cigarettes while you were sharing your home?"
  t "On average, how many hours per day were you exposed to their cigarette smoke?"

-------
                QUESTIONNAIRE ASSESSMENT OF TOBACCO SMOKE EXPOSURE
                                       343
was 74.0 per cent (n = 66), with a kappa
value of 0.50 (p < 0.0001).
  Correlations between  responses at the
two interviews were high for the number of
years the spouse and other smokers in the
household had smoked during the subject's
adulthood, but much  lower for the number
of hours per day of exposure during adult-
hood (table 5). Because of the small number
of subjects living  with their parents after
age 18 years, we did not calculate correla-
tion coefficients for these variables.
  Urine specimens were obtained from 98
per cent of the 149  subjects at the first
interview and 95  per cent  at the second
interview. The median urinary cotinine lev-
  els were zero at both interviews, with mean
  levels of 9.2 ng/mg of creatinine at the first
  interview and 7.3 ng/mg of creatinine at
  the second interview. Cotinine levels varied
  widely with the total number of smokers
  and the total number of hours of exposure
  to tobacco  smoke (in various situations)
  during the 24 hours prior to urine collection
  at both the first interview (figures 1 and 2)
  and the second interview (data not shown).
  The cotinine levels  correlated only mod-
  estly with the  questionnaire measures of
  exposure (table 6).
    We also assessed the stability of data on
  exposure,  as measured  by  questionnaire
  and by cotinine level (table 6). At the first
     100

      90

O    80
 O)
 *    70
 O)
*    60
LU
|    50

O    40
O
      30
20

 10

 0
                            
1

 NUMBER
                                                                      >3
  FIGURE 1. Urinary cotinine levels, standardized to urinary creatinine (Cr) concentration, among nonsmokers
interviewed about tobacco smoke exposure, by the total number of cigarette smokers the subject reported being
exposed to during the 24 hours prior to the first interview. Bars show the mean cotinine level for each group.
Values in parentheses indicate the number of subjects with nondetectable levels of cotinine. New Mexico, 1986.

-------
344
COULTAS ET AL.


0
O)
E
O)
c

LU
1
5
O






 f(n-23) . (n-21) , (n-3)

0.0 0.5-4.9 5.0-14.9 15.0-24.0
                                             HOURS
  FIGURE 2. Urinary cotinine levels, standardized to urinary creatinine (Cr) concentration, among nonsmoken
interviewed about tobacco smoke exposure, by the self-reported total number of hours that the subject was
exposed to cigarette smoke during the 24 hours prior to the first interview. Ban show the mean cotinine level
for each group. Values in parentheses indicate the number of subjects with nondetectable levels of cotinine.
New Mexico, 1986.
and second interviews, the mean responses
for the reported number of cigarette smok-
ers that the  subjects had been exposed to
during the previous 24 hours were 2.1 and
1.8, respectively, with 20 subjects at  the
first interview and 22 subjects at the second
interview reporting exposures in "crowds."
For the total number of hours of exposure
during the previous 24 hours, the  mean
responses at the first and second interviews
were  5.1  and 4.6,  respectively. Both  the
questionnaire variables and  the cotinine
data indicated a relatively stable pattern of
exposure. The Spearman correlation coef-
ficients  were somewhat  higher  for  the
        questionnaire-based indexes than for uri-
        nary cotinine levels.

                       DISCUSSION
          In a group of adult nonsmokers, we found
        high  reliability  for  reports  on  parental
        smoking and  on smoking by others in the
        home  (table  2)  but lower reliability for
        semiquantitative  exposure measures (ta-
        bles 3-5). Mean levels of urinary cotinine
        increased with exposure to cigarette smoke
        compared with no exposure (n =» 37) (fig-
        ures 1  and 2). However, within specific
        levels of exposure, the cotinine levels varied
        widely.  Across the follow-up period of sev-

-------
                QUESTIONNAIRE ASSESSMENT OF TOBACCO SMOKE EXPOSURE
                                                                               345
                 TABLE 6
 Spearman correlations between measures of exposure
 to environmental tobacco smoke during the 24 hours
      prior to interview. New Mexico, 1986
         Exposure variable
No.
Total no. of smokers to which subject
   was exposed
  Responses at the first and second
   interviews
  Response at the first interview and
   cotinine level
  Response at the second interview
   and continine level
Total no. of hours that subject was
   exposed to cigarette smoke
  Responses at the first and second
   interviews
  Response at the first interview and
   cotinine level
  Response at the second interview
   and cotinine level
Cotinine level
  Levels at the first and second
   interviews
143  0.50

143  0.24

139  0.21




144  0.62

145  0.32
  I
138  0.29


140  0.45
eral  months, exposures to environmental
tobacco smoke were relatively stable, as
were urinary cotinine levels (table 6). Most
subjects were able to provide responses to
the questions on maternal smoking during
pregnancy, parental smoking during child-
hood, and smoking  by a spouse  during
adulthood (tables 2 and 3).
  Several limitations of these data must be
considered. Because a standard for validat-
ing a lifetime history of exposure to envi-
ronmental  tobacco smoke is  unavailable,
we used repeatability as  an index of the
quality of questionnaire responses. We ad-
dressed the reliability of questions on  life-
time exposure at home, but not in the work-
place, an important source of exposure for
a substantial proportion of adults (11). In-
terview with a volunteer  subject does not
replicate the usual setting of a case-control
study, the design  most often used to ex-
amine lung cancer and passive smoking (1).
In that setting, recall bias  by ill subjects
may affect reliability of questionnaire re-
sponses  in  comparison with  a volunteer
population.
  Similar observations on the reliability of
questionnaire data  on  passive smoking
were recently reported by Pron et al. (12).
These investigators  interviewed 117 sub-
jects, controls in  a  case-control study  of
lung cancer, on two occasions separated by
an  average of six  months. Smoking by
spouses was reported with high reliability
(kappa = 0.89 for  both wife and husband).
Repeatability was  somewhat  lower  for
smoking by the mother (kappa = 0.76) and
by  the father (kappa  = 0.44). As in the
present study, repeatability of quantitative
estimates of duration of exposure was lower
than  for the categorical  descriptions  of
smoking by household members.
  Although neither the  investigation  of
Pron et al* (12) nor the present study di-
rectly  addresses validity of questionnaires
on lifetime passive smoking, the validity of
subjects' reports on smoking by parents and
spouses has been described. Sandier and
Shore (13) compared responses on parents'
smoking given by cases and controls with
responses given by the parents or siblings
of the index cases. Concordance was high
for whether the parents  had ever  smoked,
although the agreement was somewhat bet-
ter for smoking by the mother than  for
smoking by the father. Responses concern-
ing numbers of cigarettes  smoked did not
agree as  highly. In a follow-up study of a
nationwide sample, children's responses on
smoking by their  deceased parents closely
agreed with the information given 10 years
previously by the  parents themselves (14).
Other studies have shown that people gen-
erally report the  smoking habits of their
spouses  correctly  (14-19). However, peo-
ple's  reporting of quantitative aspects  of
the smoking behavior of their spouses tends
to be less valid (16,18,19).
  Smoking by parents  during childhood
and by a spouse during adulthood represent
the most important sources of household
exposure to environmental tobacco smoke.
The studies of subject reports for parents
and spouses  indicate  good validity of re-
sponses  on smoking by these household

-------
346
COULTAS ET AL.
members; the study of Pron et al. (12) and
the present study show that these reports
are also highly reliable.  Thus, exposure
measures based on cigarette smoking status
of parents and of spouses, as reported by
an index subject, are reported with a high
degree of validity and reliability, although
these measures  may only crudely quanti-
tate the dose of biologically relevant to-
bacco smoke components. In contrast, the
accuracy of more quantitative measures of
smoking by these household members is
lower. The resulting misclassification may
explain  the  failure to  find  exposure-
response relations for passive smoking and
lung cancer in some  studies (1, 20).
  We also compared responses to questions
on exposure during the previous 24 hours
with urinary cotinine level. The time period
for the questionnaire was  limited to the
previous 24 hours to reduce bias from faulty
recall. However, since this period is approx-
imately the half-life of cotinine  in non-
smokers (21, 22), the cotinine level repre-
sents not only exposure during the 24 hours
covered by the questionnaire but prior ex-
posure as well.
  We found modest  correlations between
the questionnaire-based measures of expo-
sure and urinary cotinine levels (table 6).
The level of correlation must be interpreted
in the context of the different lengths  of
time of exposure assessed by the question-
naire and  by the urinary  cotinine level.
Furthermore, at a given level of nicotine
exposure, urinary cotinine level  is also in-
fluenced by uptake, metabolism, and excre-
tion, which are likely to vary among indi-
viduals.
  Coultas et al. (23)  found  that question-
naire measures of household exposure were
not strong predictors of salivary cotinine
level. In 247 adult nonsmokers with a de-
tectable cotinine level, the subject's age, the
number of cigarettes smoked per day by the
spouse,  and the  number  of  cigarettes
smoked per day by  other smokers in the
household explained only 2 per cent of the
variance in cotinine  levels for females and
16 per cent of the variance for males. Even
        in active smokers, questionnaire responses
        on smoking behavior do not tightly predict
        cotinine concentrations in body fluids (24-
        27).  Higher correlations between urinary
        cotinine  levels and reported exposure to
        cigarette smoke  have been  reported for
        young children (28).  The  higher correla-
        tions in the studies of young children prob-
        ably reflect the time-activity patterns in
        this age group (29); parental smoking in the
        household is generally the dominant source
        of exposure.
          In adults, the weak relation between co-
        tinine level and reported smoke exposure
        implies that a single cotinine measurement
        should not be used to estimate exposure for
        individuals (23). However,  in our subjects,
        cotinine  levels  varied  among  exposure
        groups (figures 1 and 2), suggesting that
        cotinine measurements might be used as an
        index of mean exposure for members of a
        particular exposure group.
          Nonsmokers are exposed to environmen-
        tal tobacco smoke in  many different envi-
        ronments,  including the home,  the work-
        place,  and  other  private and public loca-
        tions.  Since subjects  in an epidemiologic
        investigation cannot  be  expected to com-
        prehensively describe the extent of expo-
        sure in each of these environments, mis-
        classification of the amount of exposure to
        environmental tobacco smoke must be an-
        ticipated from  the use of questionnaires.
        However, subjects can  provide  valid and
        reliable reports concerning  the smoking
        status of household members. The combi-
        nation of questionnaires and biologic mark-
        ers offers a feasible approach for assessing
        recent exposure to environmental tobacco
        smoke.

                       REFERENCES
         1. US Department of Health and Human Services.
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         2. National  Research Council Environmental to-
           bacco smoke: measuring exposures and assessing
           health effects. Washington, DC: National Acad-
           emy Press, 1986. (ISBN 0-309-03730-1).
         3. Centers for Disease Control. Cigarette smoking in

-------
                  QUESTIONNAIRE ASSESSMENT OF TOBACCO SMOKE EXPOSURE
                                            347
    the United States, 1986. MMWR 1987:36:581-5.
 4.  Samet JM, Coultas DB, Howard CA, et aL Respi-
    ratory diseases and cigarette smoking in an His-
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 5.  Langone JJ, Gjika HB, Van Vunakis V. Nicotine
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 6.  Faulkner WR, King JW. Renal function. In: Tietz
    NW, ed. Fundamentals of clinical chemistry. Phil-
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 7.  Fleiss JL.  Measuring nominal  scale agreement
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 8.  Maclure M, Willett WC. Misinterpretation  and
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    1987:126:161-9.
 9.  Colton T.  Statistics  in medicine. Boston, MA:
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10.  SAS Institute,  Inc. SAS user's guide:  statistics.
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11.  Friedman GD, Petitti DB, Bawol RD. Prevalence
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    Health 1983:73:401-5.
12.  Pron GE, Burch JD, Howe GR, et al. The reli-
    ability of passive smoking histories reported in a
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    1988:127:267-73.
13.  Sandier DP, Shore DL. Quality of data on parents'
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    Am J Epidemiol 1986:124:768-78.
14.  McLaughlin JK, Dietz MS, Mehl ES, et al. Reli-
    ability  of  surrogate  information on   cigarette
    smoking by type of informant. Am J Epidemiol
    1987:126:144-6.
15.  Rogot E, Reid D. The validity of data from next-
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    Int J Epidemiol 1975:4:51-4.
16.  Kolonel LN, Hirohata T.  Nomura AMY. Ade-
    quacy of survey data collected from substitute
    respondents. Am J Epidemiol 1977:106:476-84.
17.  Pershagen G. Validity of questionnaire data on
    smoking and other exposures with special refer-
    ence to environmental tobacco smoke. Ear J Re-
    spir Dis 1984;133(suppl):76-80.
18. Humble CG, Samet JM, Skipper BE. Comparison
    of self-  and surrogate-reported dietary informa-
    tion. Am J Epidemiol 1984;! 19:86-98.
19. Lerchen ML,  Samet JM. An assessment of the
    validity of questionnaire responses provided by a
    surviving spouse. Am J  Epidemiol 1986;123:
    481-9.
20. Humble CG, Samet JM. Pathak DR. Marriage to
    a smoker and lung cancer risk. Am J Public Health
    1987:77:598-602.
21. Kyerematen GA,  Damiano MD, Dvorchik BH, et
    aL Smoking-induced changes in nicotine disposi-
    tion: application of a new HPLC assay for nicotine
    and its metabolites.  Clin Pharmacol Ther 1982;
    32:769-80.
22. Sepkovic DW, Haley NJ, Hoffmann D. Elimina-
    tion from the body of tobacco smoke products by
    smokers and passive smokers.  (Letter). JAMA
    1986:256:863.
23. Coultas DB, Howard CA, Peake GT, et al. Salivary
    cotinine levels and  involuntary  tobacco smoke
    exposure in children and adults in New Mexico.
    Am Rev Respir Dis 1987; 136:305-9.
24. Benowitz NL, Hall SM, Herning RI, et al. Smok-
    ers of low-yield cigarettes do not consume less
    nicotine. N Engl J Med 1983:309:139-42.
25. Abrams  DB, Follick  MJ,  Biener  L, et al. Saliva
    cotinine as a measure of  smoking status in field
    settings. Am J Public Health 1987;77:846-8.
26. Lee PN. Lung cancer and passive smoking: asso-
    ciation an  artefact due  to  misclassification  of
    smoking habits? Toxicol Lett 1987:35:157-62.
27. Pierce JP, Dwyer T, DiGuisto E, et al. Cotinine
    validation of self-reported smoking in  commer-
    cially  run community surveys.  J Chronic Dis
    1987:40:689-95.
28. Greenberg RA, Haley NJ, Etzel RA, et al. Mea-
    suring the exposure of infants to tobacco smoke.
    N Engl J Med 1984:310:1075-8.
29. Harlos DP,  Marbury M, Samet J, et al. Relating
    indoor NO? levels to infant personal exposures.
    Atmosph Environ 1987:21:369-76.

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                                                                   Environmental Health Perspectives
                                                                          VoL 81,, pp. 173-182, 1990
Cotinine Analytical Workshop  Report:
Consideration of Analytical  Methods  for
Determining Cotinine  In Human  Body Fluids
as  a  Measure of Passive  Exposure to
Tobacco Smoke*
by Randall R. Watts,f John  J.  Langone,* George J. Knight,5
and  Joellen Lewtas*
           A two-day technical workshop was convened November 10-11, 1986, to discuss analytical
          approaches for determining trace amounts of cotinine in human body fluids resulting from pas-
          sive exposure to environmental tobacco smoke (ETS). The workshop, jointly sponsored by the U.S.
          Environmental Protection Agency and Centers for Disease Control, was attended by scientists
          with expertise in cotinine analytical methodology and/or conduct of human monitoring studies
          related to ETS. The workshop format included technical presentations, separate panel discussions
          on chromatography and immunoassay analytical approaches, and group discussions related to the
          quality assurance/quality control aspects of future monitoring programs. This report presents a
          consensus of opinion on general issues before the workshop panel participants and also a detailed
          comparison of several analytical approaches being used by the various represented laboratories.
          The salient features of the chromatography  and immunoassay analytical methods are discussed
          separately.
Introduction

  Environmental tobacco smoke (ETS) has increas-
ingly become a health concern since a series of epide-
miological studies between 1981 and 1986 (1-6)
  •Chairperson: J. Lewtas, US EPA, Research Triangle Park, NC;
Session chairpersons: F. Sperto, CDC. Atlanta, GA, R. Watts, US
EPA, Research Triangle Park, NC; invited speaker/panel partici-
pants included: Neal Benowitz and Peyton Jacob, San Francisco
General Medical Center; Colin Feyerabend, New Cross Hospital,
London, England; Nancy Haley, American Health Foundation;
George Knight, Foundation for Blood Research; Richard Kornfeld,
Battelle Columbus Laboratories; John Langone, Baylor College of
Medicine; Peter McElroy, Rosewell Park Memorial Institute; M. A.
H. Russell, Maudsley Hospital, London, England; Karl Verebey,
New York State Division of Substance Abuse Services; and Helen
Van Vunakis, Brandeis University.
  tU.S. Environmental Protection Agency,  Health  Effects
Research Laboratory, Research Triangle Park, NC 27711.
  tBaylor College of Medicine, Department of Medicine, One Bay-
lor Plaza, Houston, TX 77030.
  §Foundation for Blood Research, P. 0. Box 190, Scarborough,
ME 04074.
  Address reprint requests to R. R. Watts, U.S. Environmental
Protection Agency, Health Effects Research Laboratory, MD-68,
Research Triangle Park, NC 27711.
reported an association between tobacco smoke expo-
sure and increased risk of human lung cancer. Hum-
ble and co-workers (7) recently confirmed the health
risk conclusions of earlier researchers and reported
that people who never smoked and were married to
smokers had about a 2-fold increased risk of lung
cancer.
  Methods for determining the degree of exposure of
individuals has received much  attention in recent
years, and various biological markers have been stud-
ied as surrogate analytes for determining exposures.
A general consensus is that the nicotine metabolite,
cotinine, has the prerequisites of specificity, retention
time in the body, and detectable concentration levels
that make it the analyte  of choice for quantifying
exposures. In recent years a number of procedures
have been reported for  determining cotinine in
human body fluids. The majority of these procedures
use either a chromatographic technique or some form
of immunoassay analysis.
  This paper is a report from the two-day Cotinine
Analytical Workshop, which  was attended by invited
health scientists and analytical chemists recognized
for their  expertise in studies of population exposure

-------
174
WATTS ETAL
to ETS and/or analytical methodology related to
these studies. The workshop was jointly sponsored by
the U.S. Environmental Protection Agency (EPA) and
Centers for Disease Control (CDC) and was attended
by 32 scientists who shared their expertise in immu-
noassay or chromatography methods for cotinine and
provided guidance  for developing and  establishing
related programs for  determining passive exposures
to tobacco smoke. The meeting objective was to com-
pare  the various analytical approaches to cotinine
analysis and to make recommendations regarding the
general aspects of establishing and conducting moni-
toring programs. Discussions included quality assur-
ance/quality  control  (QA/QC)  programs to support
cotinine monitoring studies and also the possibility of
conducting a future interlaboratory methods compar-
ison study. The diverse analytical  approaches repre-
sented by  chromatography  and immunoassay
methods for cotinine  were separately discussed and
reported by respective work groups. The purpose of
this communication is to summarize discussions from
the immunoassay and chromatography  work groups
relevant to the aforementioned topics and to convey
the workshop general consensus on other joint issues
including QA/QC aspects of ETS studies.


Chromatography Group  Report

  The workshop participants with expertise in devel-
oping and applying  chromatography methods for
determining cotinine in biological fluids met in a one-
day session. The goal  of this session was to develop a
group consensus  on several key issues  including a)
general method considerations and approaches, b)
QA/QC programs  to support  cotinine  monitoring
studies, and c) considerations related to conducting
an  interlaboratory  methods comparison study.  The
following is a summary of the chromatography group
discussions and a draft of their  recommendations
related to topics a and c. The QA/QC recommenda-
tions are contained  in a separate section.


General Method Considerations

  Sample Type. The  body fluids discussed for moni-
toring tobacco smoke  exposure included blood serum,
saliva, and urine. Group consensus was that all three
are generally acceptable; however, the choice of a body
fluid to analyze should be predicated on the goals of
the specific monitoring program. For  studies that
require a quantitative assessment of exposure, blood
was recommended by  the group as  the fluid of choice
(8). Saliva was also considered  acceptable, and good
correlations were reported  between saliva and blood
for results from the same subject (9). Sample collection
considerations,  however, resulted in the selection of
blood as the sample medium of first choice. Analysis of
either blood or saliva for cotinine permits an estimate
of the degree of exposure to tobacco smoke in persons
passively exposed at home or in the work place. While
       cotinine determination in urine was also recommended
       for estimating exposure, it was generally felt that esti-
       mation based on urinary cotinine excretion would1 be
       less reliable than estimation based on plasma or sali-
       vary levels. Cotinine excretion is variable across  and
       within individuals depending on renal function, urine
       flow rate,  and urine  pH (10). Urine results may be
       expressed as micrograms of cotinine per milligram of
       creatinine in order to  correct, in part, for the variable
       dilution effects. This correction or normalization, how-
       ever, introduces additional variability since this
       requires another analytical  determination (and oppor-
       tunity for  experimental error), and creatinine excre-
       tion rates for individuals are also variable. Horstmann
       (11) reported creatinine excretion rate for 56 subjects
       to be 1.11  ± 0.68 g/day (mean ± SD).  Hoffman  and
       Brunneman (12) also  found 13 nonsmokers on a con-
       trolled diet to have creatinine values of 1.65 ± 0.5 g per
       24 hr urine (mean ± SD). The coefficients of variation
       between subjects for  these two studies were 61  and
       30%, respectively.
         Sample  Collection and  Handling. Chromatogra-
       phy procedures for cotinine generally require analysis
       of a 1 mL sample  with an additional  1 mL volume
       needed for reanalysis. A total sample volume of 2.5 to
       3.0  mL was therefore  recommended.  Glass and/or
       polypropylene sample tubes with screw cap closures
       were recommended. The polypropylene tubes were pre-
       ferred to avoid breakage during shipment. Minimum
       size sample tubes were suggested to reduce volume
       losses from freeze drying during long-term storage.
         Blood should be centrifuged at the field site and the
       serum samples frozen prior to shipment to the labora-
       tory. Urine should  be frozen soon  after collection to
       prevent bacterial degradation of  the sample. Saliva
       may be collected by expectoration into a sample tube;
       however, an alternative saliva collection  procedure
       that uses  highly  adsorbent dental  rolls  is recom-
       mended (IS). The subject is asked to place  a dental
       roll in the mouth for approximately 15 min. The sam-
       ple is then placed in a tube and frozen  prior to ship-
       ment  to  the laboratory.  The  thawed sample is
       regenerated at the laboratory by placing the dental
       roll in a glass syringe and  compressing with a glass
       plunger. The resultant clear liquid may then be  all-
       quoted for analysis.
         Shipment in a frozen condition with dry ice was
       recommended for all  three sample types to prevent
       bacterial degradation of the sample  matrix. Loss or
       degradation of the cotinine analyte was not consid-
       ered to be a problem since participants had found this
       compound  to be stable.
         Upon receipt at the laboratory, samples should be
       placed in a freezer (approximately — 20° C) until ana-
       lyzed. Samples that will be  held in excess of one year
       should be stored at -80°C. No cotinine degradation
       problems were reported for frozen samples. Precau-
       tions were  recommended, however, to prevent concen-
       tration errors resulting  from  freeze-drying  of
       samples stored over one year in a frost-free freezer.

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                               COTININE ANALYTICAL WORKSHOP REPORT
                                              175
Analytical Method Considerations
  The  group consensus was  that  the analytical
method should permit the determination of nicotine
and cotinine in a single  analysis and should allow a
clear separation  and distinction between these and
other analytes that may be present. The method
should be sufficiently sensitive to give good definition
of passive exposure and thereby yield analytical
results which will  show a distinction, for  example,
between a child or other nonsmoker that is exposed in
the home and one that is not. Tables 1  and  2 list the
range of detection  limits for both chromatography
and immunoassay methods.
  The  importance  of this sensitivity  consideration
was supported by the 1981 report of Hirayama (1) and
the 1987 report of Humble et al. (7) which showed an
increased risk of lung cancer for a spouse exposed to a
smoker in the home. Russell reported  that cotinine
levels in children's saliva averaged 0.44  ± 0.68 ng/mL
where  no  parents are smokers, 1.31 ± 1.21 ng/mL
where only the father smoked, 1.95 ± 1.71 where only
the mother smoked, and 3.38 ± 2.45 ng/mL where
both parents  are smokers (IS). This study used an
analytical method with a detection and quantification
limit of 0.1 ng/mL, which permitted classification of
the lowest exposures into exposure distributions dif-
fering by only 0.1 ng/mL. Over 30%  of the children
from nonsmoking homes had cotinine concentrations
below the 0.1 ng/mL detection limit. In the groups
where one or more parents smoked, the cotinines were
significantly (p < 0.01) elevated, and 50% of the chil-
dren of the lowest exposed group had less than 1 ng/
mL (when only the father  smoked). Table 1 shows
that several available chromatography  methods have
detection limits ranging  from 0.1 to 0.2 ng/mL while
the most sensitive  immunoassay method in Table 2
reports a 0.3 ng/mL detection limit.
  The  question of  analyte volatility losses during
analysis was discussed, and it was generally agreed
that if nicotine were included as an analyte, precau-
tions would need to be taken to prevent  loss during
concentration steps. Acidification to convert nicotine
to a salt form prevents losses during concentration.
  Cotinine primary standards  are used  in the free
base form by some analysts; however, a salt  form was
preferred by meeting participants, since the free base
form is hygroscopic and difficult to maintain at a
well-defined purity. A perchlorate salt of cotinine was
recommended for preparation of 1 mg/mL stock solu-
tions in 0.01 N HC1  (8). This standard solution could
be frozen and kept  indefinitely. The group consensus
was that a salt form of cotinine should be made avail-
able as a primary standard.
  Chemical analysis is usually accomplished by gas
chromatography  with nitrogen/phosphorus thermi-
onic detection (GC-NPD) or GC-mass  spectrometry
(GC-MS) using either electron impact ionization or
chemical ionization. Packed columns for GC were suc-
cessfully used; however, fused silica capillary columns
containing a methyl silicone or methyl phenyl silicone
liquid phase were recommended (see Table 1 HRGC
references).
  A  high-performance  liquid  chromatography
(HPLC) method using  a Ci8 reversed  phase column
with paired ion chromatography and UV detection (at
257 nm) was also reported by McElroy  where the
HPLC method of Machacek and Jiang (14) was modi-
fied for analyzing urine samples at passive exposure
levels. Further improvement in HPLC sensitivity and
detection limit is required before  application to the
more limited sample volumes generally available for
blood or saliva. HPLC was considered a very promis-
ing approach due to the highly efficient columns now
available and the stability  and  reproducibility of
response commonly obtainable by UV detection.
  The final  quantitation of residues in all methods
was accomplished with  internal standards and stan-
dard curves  developed from fortified blank samples.
It was recommended that standard curves be pre-
pared daily or with each batch of samples. A variety
of internal standards were used ranging from deuter-
ated cotinine and nicotine for GC-MS to  chemically
similar compounds for other GC or LC detectors.
  Table 1 lists the chromatography methods (14-17)
presented at the workshop and summarizes the sali-
ent features of each. Information  for this table was
derived  from questionnaire responses submitted by
each author/participant.
Chromatography Group
Recommendations
  The chromatography group recommended that an
interlaboratory methods  comparison study be con-
ducted prior to  any large-scale monitoring efforts
aimed at determining population exposure to tobacco
smoke. Specific  suggestions  and recommendations
relating  to method comparison studies were as
follows:
•Separate studies should be conducted for passive
 exposure levels  and active smoker levels.
•Statisticians should  be used in  planning  study
 samples.
• Blood, urine, and saliva should be included in each
 study.
• Immunoassay and chromatography methods should
 be included in each method comparison study.
•Samples should be fluids from exposed individuals
 and also from fortified  blanks in order to look for
 bias from chromatography or immunoassay methods
 through measurement of artifacts or metabolites
 related  to nicotine/cotinine.
•The study coordinator should supply standard refer-
 ence material(s) to each participating laboratory.

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176
                            WATTS ETAL
                          Table 1. Summary of passive exposure chromatography methods.
                      Machacek and
                        Jiang (14)
                   Jacob, et al. (15)    Verebey et al. (16)
                                     Feyerabend et al.
                                           (17)
                                    Kornfeld (pers6nal
                                     communication)
Sample type

Vol. analyzed, mL
Concentration step

Extraction method

Isolation step
Determination
Quantitation

Linear range
Detection limit
Quantification limit
CV,%
   recovery
Urine
N2 evaporated to
  dryness
SPE column
Chloroform elution
Acid/base partition
HPLC reverse-
   phase
Paired ion
  chromatography

Internal standard
Calibration curve
0-500 ng
<1 ng/mL
1 ng/mL
13
                    90
Blood, plasma,
  urine
1
N2 evaporated to
  dryness
Solvent extraction

Acid/base partition
 HRGC-NPD

  HRGC-MS
 Internal standard
 Calibration curve
.0-4000 ng/mL
 0.2 ng/mL
 0.5-5 ng/mL
 6.8 (3.0 ng/mL)
 12 (1.0 ng/mL)
 13 (0.5 ng/mL)
 107
Serum

0.5
None

Solvent extraction

Acid/base partition
                                                        HRGC-NPD
Internal standard
Calibration curve
40-400 ng/mL
5 ng/mL
5 ng/mL
5.6
                                    90
All biological fluids   Urine
N2 evaporated to
  dryness
Solvent extraction

None: plasma and
  saliva
  back extract
  urine
                  GC-NPD
Internal standard
Calibration curve
0-15,000 ng/mL
0.1 ng/mL
0.1 ng/mL
7.7
                  90
N2 evaporated
  solvent exchange
Solvent extraction

None
                  HRGC-MS
Internal standard
Calibration curve
1-500 ng/mL
0.13 ng/mL
0.25 ng/mL
6
                  85
 Immunoassay Group Report
   Participants in the workshop with expertise in the
 development and use of immunoassays for detecting
 cotinine in biological fluids met independently of the
 chromatography group to discuss and make recom-
 mendations regarding methodology and applications
 of immunoassay in monitoring passive as well as
 active exposure to tobacco smoke, QA/QC programs,
 and interlaboratory methods comparison. The follow-
 ing discussion presents an overview of the available
 immunoassay techniques  for cotinine analysis, their
 applications with advantages and disadvantages, and
 the views  and recommendations of the immunoassay
 panel members. There is notable agreement between
 this group and the chromatography group on most
 common issues outside the technical aspects specific
 to each methodology.
                                    General Method Considerations

                                      Introduction. The first radioimmunoassay (RIA)
                                    for  cotinine was reported in  1973 (18,19).  Antisera
                                    were raised in rabbits and goats immunized with a
                                    covalent conjugate prepared by linking cotinine 4'-
                                    carboxylic acid to immunogenic carrier proteins, such
                                    as bovine serum albumin and keyhole limpet hemocy-
                                    anin. The radioactive tracer was prepared by labeling
                                    a tyramine  derivative  of cotinine 4'-carboxylic  acid
                                    with "*!; since then, [^Jcotinine has been  prepared
                                    enzymatically (19) from [3H]nicotine and is now
                                    widely used. Another approach uses cotinine deriva-
                                    tized at the 1-position in the  pyridine ring for prepar-
                                    ing  the immunogen and as a precursor of an  125I-
                                    labeled tracer (20). The original assay has been used
                                    to measure cotinine levels in physiological fluids, e.g.,
                                    urine,  blood, saliva, amniotic  fluid, and spinal fluid
                                  Table 2. Summary of immunoassay methods.
                           Langone et al. (18)
                            Langone and Van
                              Vunakis (19)
                             Haley et al. (22)
                                Knight et al. (29)
                                  Bjercke et al. (-27,28)
Sample type and volume
analyzed, mL

Assay type

Quantitation

Detection limit, ng/mL
Quantitation limit, ng/mL
CV, %
Urine (0.02-0.05)
Serum (up to 0.5)
Saliva (0.02)
RIA (""I, 3H)

Internal standard
Calibration curve
2
2
6-10
Urine, plasma, saliva
(0.005-0.025)

RIA (JH)

Internal standard
Calibration curve
0.37
1
10
Urine (0.01)
Serum (0.1)

RIA (ml)

Internal standard
Calibration curve
0.3
1
10-15
Urine, serum, saliva
(0.1 in RIA; 0.01 in
microtiter plate
assays)
RIA (""I, »H), ELISA,1
FIA
Internal standard
Calibration curve
0.5-1.5
0.5-1.5
9-14
                                   i assay concentrated serum.

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                               COTININE ANALYTICAL WORKSHOP REPORT
                                                                                                  177
(18,19,21-28) of active smokers and serum, urine, and
saliva (24-26), of passive smokers.
  More recently, monoclonal antibodies specific  for
cotinine have been prepared and used to develop fluid
phase RIAs with the 125I- and 3H-labeled tracers as
well as enzyme-linked  immunosorbent  assays
(ELISA) and a fluorescence immunoassay (FIA) in a
microtiter  plate format (27,28). These  assays also
have been used to measure cotinine levels in fluids of
active  (27,28)  and passive smokers  (Langone et  al.,
unpublished results).
  Test Samples and Standards. Because the origi-
nal  RIAs  and  the monoclonal antibody-based
nonisotopic assays  have been developed  for analysis
of unextracted physiological fluids, careful attention
must be paid to possible nonspecific inhibition of
antigen-antibody binding resulting from effects of pH
or high concentrations of salts or urea, e.g., in urine.
In this regard the immunoassay group agreed and
strongly recommended that pooled standard samples
of serum, saliva, and urine containing known amounts
of added or  endogenous cotinine should be made
available through an agency such  as the National
Institute of Standards  and  Technology. There was
general agreement that GC/MS would  be the best
method to  establish the cotinine concentration  for
purposes of  methods comparison  and that levels
should cover the range from cotinine-free through
concentrations found in passive and active smokers.
Essentially cotinine-free samples might be collected
from a population that would represent a group with
minimal exposure to tobacco smoke (e.g., Mormons in
Utah).  The suggestion also was made that low-level or
essentially  cotinine-free fluids might be treated (e.g.,
by absorption with XAD-2 resin  or  charcoal) to
remove possible traces of cotinine. However,  because
absorption could remove other constituents that
might affect the assays, it was not considered to be a
firm recommendation.
  Although it was suggested that urine may be  the
fluid of choice for RIA analysis, there was no strong
consensus for priority over serum or saliva. In this
regard, one participant pointed out the advantage
that salivary cotinine levels determined by RIA  are
independent of saliva flow (Van  Vunakis and Regas,
unpublished results). The monoclonal antibody assays
also  have been used  to detect cotinine in saliva and
urine of passively exposed children (Langone et  al.,
unpublished  observations), and  these investigators
tended to favor the use of saliva. In addition to  the
use of  dental rolls as discussed by the chromatogra-
phy  group, one member of the immunoassay group
suggested that subjects chew a piece of Teflon tape to
stimulate the flow of saliva that is then collected in a
glass vial.  It  was pointed out that Teflon will  not
contaminate the sample. Regardless of which fluid is
tested,  it was recommended that samples  be cen-
trifuged (e.g., 20000 for 10-20 min or 100000 for  1-2
min) to sediment particulate matter before analysis.
Immunoassay group  participants concurred with  the
sample handling recommendations given in the Chro-
matography Group Report.


Comparison of the Assays

  The original RIA and variations of it are used by
the immunoassay group participants. Therefore, the
discussion focused on this method and the monoclonal
antibody based assays, the salient features of which
are summarized in Table 2.
  Reagents. The same immunogen was used to pro-
duce the  rabbit, goat,  or sheep antisera and  the
monoclonal antibodies. However, it was emphasized
that cotinine 4'-carboxylic acid (and the ^I-labeled
derivative) is a mixture of stereoisomers giving  rise
to a heterogeneous  population of polyclonal  antibo-
dies recognizing both natural (—)-cotinine and  the
(H-)-enantiomer. Also, conventional antisera contain a
population of antibodies that bind specifically to the
linkage group that joins cotinine to the imraunogenic
carrier protein and to the tyramine group in the 1251-
labeled derivative. The practical consequences are a
relatively shallow standard inhibition curve and the
failure to achieve 100% inhibition of immune binding
with (—)-cotinine. Although these problems are  cir-
cumvented by using (—)-pH] cotinine, this assay is
somewhat less sensitive, owing to the lower specific
activity and counting efficiency  achieved with  tri-
tium. Also, disposing of large volumes of radioactive
scintillation fluid is a major concern.
  Two approaches have been used with some  success
to improve the  quality of the 12SI-RIA with rabbit
antisera. They involve  removing antibridge group
antibodies by absorption with a nicotine-hemocyanin
conjugate (29) and preparing an 12SI-labeled  cotinine
derivative with a bridging group different from that
present  in the immunogen (30). In  contrast,
monoclonal antibodies to cotinine were produced  in a
way that avoided the problems inherent in the use of
polyclonal antisera (27,28). Although the immunogen
contained a mixture of isomers, the hybridomas were
screened using (—)-prI]cotinine to optimize chances of
detecting antibodies that preferentially recognize the
naturally occurring isomer, but not the bridging
group in the immunogen. Furthermore, it was pointed
out that monoclonal antibodies are preferred stan-
dard reagents for immunoassay because they are  con-
tinuously available and are homogeneous in terms of
binding affinity and specificity.
  The  specificity of any newly  produced  antiserum
must be fully characterized one time with a battery of
compounds that would include at least cotinine, nico-
tine, and metabolites such as nicotine N'-oxide,  nor-
nicotine,  and trans-3'-hydroxycotinine.  This
recommendation holds even for new antisera  pre-
pared with a proven immunogen, since the response of
individual  immunized  animals cannot be predicted.
However, all agreed that when the properties of the
antiserum had been established, it was unnecessary
for each laboratory that  received that  antiserum to

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178
WATTS ETAL
complete  a thorough  reexamination of specificity,
although it would be good laboratory practice to rou-
tinely compare the cotinine  and nicotine inhibition
curves.
  Immunoassay methods  have often  reported using
standard cotinine as the free base. However, because
cotinine is hygroscopic and difficult  to weigh  accu-
rately, all participants agreed that a nonhygroscopic
salt of cotinine, such as the perchlorate or fumarate,
would be the preferred standard.
  Assay  Performance. In the  original RIA,
antibody-bound and free-labeled cotinine were  sepa-
rated by the double-antibody method in which a het-
erologous  antibody directed against the species  of
anticotinine was used to precipitate antigen-antibody
complexes (18). Other techniques can  be used includ-
ing precipitation with  ammonium sulfate or polyeth-
ylene glycol (29).  Although  the latter  methods are
faster and less expensive, there was some concern
expressed that background radioactivity precipitated
by ammonium sulfate, when normal serum is used in
place of anti-cotinine, can exceed  10% of the added
amount of cotinine tracer.
  In contrast to the conventional  fluid phase RIAs,
the monoclonal antibody-based assays are carried out
in a solid-phase system in which a cotinine-polylysine
conjugate is passively  adsorbed to the surface of 96-
well plastic microtiter plates (27,28).  Immobilized
cotinine and fluid phase cotinine in the test sample
compete  for monoclonal  anticotinine, which  is
detected with a variety of enzyme-labeled antiimmu-
noglobulin reagents including the  bacterial  product,
protein A. Assay sensitivity can be enhanced by using
a sandwich procedure in  which rabbit anti-mouse
immunoglobulin  is added before (or  along with)
labeled protein A. It was  emphasized that protein A
reagents cannot be used to detect low levels of serum
cotinine, because host IgG will bind nonspecifically to
the microtiter wells giving high background binding
of the enzyme-labeled  protein A tracer.
  Compared to times when rabbit antisera were used,
assays with monoclonal antibodies were more sensi-
tive, the standard curves were steeper, and the anti-
gen-antibody  reaction was completely  inhibited  by
(—)-cotinine,  even when  the I25l-labeled tyramine
derivative was used  in RIA (28). There was  good
agreement between the levels of  cotinine found  in
saliva and serum of smokers determined by conven-
tional RIA, the monoclonal antibody ELISA and GC
(27,28). It was pointed out that high quality rabbit
antisera  also can be used in  the solid phase
nonisotopic immunoassays with liters  that can  be
100- to 1000-fold higher than in RIA (27,28).
  Specificity  and Sensitivity. Both  polyclonal and
monoclonal  antibodies are  specific for cotinine
(18,19,27). Approximately  50 to 100 compounds that
have been tested in the immunoassays including sev-
eral nicotine metabolites, related  tobacco alkaloids,
and other compounds that retain structural features
of either or both ring systems found in nicotine or
        cotinine fail to inhibit the antigen-antibody reactions
        at levels that would interfere in the assays.
         One  participant  emphasized  that  literally
        thousands of serum and urine samples from  both
        active smokers and nonsmokers had been analyzed
        over a period of several years and that few,  if any,
        false positives had been reported. Although the sub-
        jects studied are mainly from the U.S. and England,
        these data support the view that diet or other factors
        such as prescription or other drugs do not interfere in
        the  assays and are consistent with high specificity of
        anticotinine. It was pointed out that differences in
        diet or drug use must be considered when other popu-
        lations are studied, or at least be aware that interfer-
        ence in  the assays might arise from factors which
        have not appeared to date.
         The immunoassays generally can detect cotinine
        down to the ng/mL level or less (Table 2), although it
        was emphasized that sensitivity can be affected by
        the  need to dilute samples (e.g., urine) that may give
        spurious results when higher concentrations  are
        tested. This point was discussed at some length  with
        the  participants in agreement that a sensitivity for
        cotinine of 0.1 ng/mL of physiological fluids could not
        generally be achieved with confidence using the avail-
        able immunoassays. In this regard, it was pointed out
        that differences in sensitivity limits between chroma-
        tography and immunoassay  likely reflect fundamen-
        tal differences in methodology and are not  strictly
        comparable. GC methods, for example, might extract
        and analyze a considerably larger portion of sample
        than would be analyzed by immunoassay.
         Analytical Results. There was general agreement
        that cotinine concentration  should  be  expressed as
        nanogram per milliliter. However, urine values also
        should be given  as nanogram  per milligram  creati-
        nine, as  this ratio is used conventionally in the medi-
        cal  literature to account for differences in urine
        volume.  Because low levels  of creatinine  in  infants
        relative  to adults may  result  in misleading  values
        that fall into the range reported for active smokers,
        the  need  to  include  primary data for urine  was
        stressed. Furthermore,  experience  has  shown  that
        urinary  cotinine levels determined by conventional
        RIA generally  are 30 to  50% higher  than  values
        obtained for the same samples by GC. Discussion cen-
        tered on the possibility that the higher RIA  values
        may reflect cross-reactivity of anti-cotinine with
        £rcms-3'-hydroxycotinine, which recently has been
        reported to be a major nicotine metabolite found in
        smokers' urine at levels up to three times higher than
        cotinine (31).
         Since  this meeting, synthetic  £rarw-3'-hydroxyco-
        tinine (supplied by Dr. Peyton Jacob, San Francisco
        General Medical Center) has been  shown to cross-
        react only 1  to 2% compared  to  cotinine  in  the
        monoclonal antibody based  ELISA; one participant
        stated that he found only about  5% cross-reactivity
        with his rabbit  antiserum in  RIA.  This  degree of
        cross-reaction would not account for the discrepancy

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                               COTININE ANALYTICAL WORKSHOP REPORT
                                             179
                      Table 3. Summary comparison of cbromatograpby and RIA methods.

Sample type
Vol. analyzed, mL
Extraction and concentration
Quantification
Detection limit, ng/mL
Quantification limit, ng/mL
CV,%
Chromatography methods
Blood, saliva, urine
0.5-6
Yes
Internal standard
Calibration curve
0.1-5
0.1-5
5.6-13
RIA methods
Blood, saliva, urine
0.005-0.5
No
Internal standard
Calibration curve
0.3-2
0.5-2
6-15
in the urine values, and it was agreed that further
research was  needed to clarify  the basis  for the
differences.

Considerations in Selecting an
Analytical Technique
  Table 3 shows some comparisons for RIA and chro-
matography methods. Apparent  differences are in
sample volumes used, sample work-up requirements,
and limits of detection. RIA methods use less than
10% of the sample volumes required for chromatogra-
phy methods, and this is a major reason that RIA
detection limits are not as low as those for Chroma-
tography methods.  Because RIA methods do not
require sample manipulations such as extraction and
concentration, they are faster, simpler, and presuma-
bly less expensive. Chromatography procedures not
only have the advantage of increased sensitivities, but
also are more specific and can provide quantification
of both nicotine and cotinine  in a single analysis.
Workshop  participants agreed that  the choice
between these  two approaches  would depend on the
goals  of a particular  study. Both approaches have
been found to be 100%  effective in discriminating
smokers from nonsmokers (82}. This particular goal
would favor  the use of an RIA method. At least one
participant suggested that the more sensitive  chro-
matography  methods are recommended to character-
ize ETS exposures for plasma or saliva concentrations
when levels are less than 1 ng/mL.
  A compilation of literature values for cotinine con-
centrations in body fluids of nonsmokers before and
after documented ETS exposures is shown in Table 4.
This comparison indicates a similarity between
plasma and saliva concentrations, while urine values
are often a factor of two or more higher. This is a
primary reason that urine is often the fluid of choice
when  RIA  methods  are used in passive smoking
studies.

Quality Assurance for  Laboratories
Assaying Cotinine
  Participants in the cotinine workshop discussed the
need for developing a quality  assurance (QA) pro-
gram  for monitoring performance of laboratories
assaying cotinine for the purpose of assessing expo-
sure to ETS. When assuming many subjects, such a
QA program would  be essential to ensure that the
conclusions reached are based on reliable data. A one-
time exercise where the ability of laboratories to
measure cotinine levels found in both active smoking
and for passive exposure to ETS was considered as an
alternative possibility. This suggestion was prompted
by the realization that although published data on
cotinine levels found in body fluids for active smokers
show reasonable agreement,  levels  of cotinine
reported for subjects exposed to ETS show considera-
ble variation. Such differences might  not be unex-
pected when measuring the low levels  of cotinine
found in ETS exposure, given that the detection limits
for existing analytical methods approximate these
cotinine levels.
  To evaluate  the between-laboratory variation in
cotinine analyses, an international study was initi-
ated  by the Forschungsellschaft Rauchen  and
Gesundheit mBH in Hamburg (32). Eleven laborato-
ries experienced in measuring nicotine and cotinine
by RIA and/or GC participated. Serum and urine
specimens from eight nonsmokers and eight smokers,
and from  two  nonexposed nonsmokers spiked  with
nicotine and cotinine were distributed  on dry ice to
each laboratory. Results were returned and analyzed
by method and by laboratory. Recoveries on both the
urine and  serum specimens spiked with cotinine cor-
responding to levels found in smokers ranged from 79
to 119%, with the exception of one laboratory with a
20% recovery (the data from this laboratory  were
excluded from further analysis). The interlaboratory
coefficient of variation on these same samples was
excellent  (9-13%). The  coefficient of variation  on
samples from  smokers  was fairly large, however,
ranging from 18 to 45% for serum and  21 to 59% for
urine. Further, cotinine levels reported for urine were
about 60% higher than from those using RIA as com-
pared to GO, suggesting a possible interfering sub-
stance in  the immunoassay system. Cotinine levels
reported for nonsmokers  were  extremely variable,
and a number of laboratories could not detect cotinine
in serum  from exposed nonsmokers.  In addition,
cotinine values reported by some laboratories bore no
relationship to estimated ETS exposure, or they were
so high as to be unrealistic. In spite of this variability,
all laboratories were able to discriminate smokers
from nonsmokers with 100% effectiveness.

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180
WATTS ETAL
  Table 4. Mean or median concentrations of cotinine in nonsmokers before and after exposure to environmental tobaccp
                                                 smoke.
Plasma cotinine,
Study reference ng/mL

(33)
(31>)
(9)
(IS)
(35)
(36)
(25)
(37)
Before
0.82
1.1
0.8

0.9-1.7



After
2.04
7.3
1.8-2.5

2.6-3.3



Saliva cotinine,
ng/mL
Before
0.73
1.5
0.7
0.4
1.0-1.7


1.3-1.7
After
2.48
8.0
2.2-2.8
1.3-3.4
1.4-2.5


2.4-5.6
Urine cotinine,
ng/mL
Before
1.55
4.8
1.5

14
8.5


After
7.71
12.9
6.5-9.4

21-55
25.2
2.8-29.6

  The cotinine  results reported for  ETS exposure
 should be viewed with caution, however. A number of
 the  participants at  this conference workshop, who
 also were in the study,  indicated that the volumes
 provided were insufficient for repeat analysis using
 GC  or an assay was used which had not been opti-
 mized for measuring passive levels of cotinine. A fur-
 ther limitation  of the study was that recovery of
 spiked cotinine was only  assessed for smoking levels.
 Finally, immunoassays based on monoclonal antibo-
 dies were not included, nor were HPLC methods
 evaluated.
  This interlaboratory study indicates the need for
 further information on the reliability of data pro-
 vided by laboratories for study subjects exposed to
 ETS. A quality assurance program could provide such
 information, as well as  an  ongoing  assessment of
 quality and a mechanism for improving performance.


 QA Recommendations

  Interlaboratory  QA.  The  need  for  an
 interlaboratory quality assurance  program was
 endorsed  by most of the session participants, with
 some concern being expressed that the  number of
 samples  evaluated be  kept to reasonable limits to
 minimize unnecessary assays. It was recommended
 that such a  program should be administered by a QA
 coordinator laboratory. The coordinating  laboratory
 would be responsible for monitoring the performance
 of participating  laboratories and for providing speci-
 fied samples as standards and/or controls. This labo-
 ratory should have in-house expertise or have access
 to laboratories having expertise in both immunoassay
 and  high resolution gas chromatography/mass spec-
 trometry (HRGC-MS).
  Suggested objectives of the QA coordinator labora-
 tory include:

• To provide an objective measure of the precision and
 accuracy of  analytical  methods used routinely  by
 laboratories assaying  cotinine.
• To  identify preferred  method(s) for  measuring
 cotinine.
• To assess the reliability of results provided by dif-
 ferent  laboratories.
       • To provide a mechanism for improving performance
         through knowledge of the performance of others.
       - To serve as a resource center for communication and
         exchange of information among participants.

          Recommended  mechanisms for accomplishing the
       foregoing objectives are as follows:

          Interlaboratory Quality Assurance Studies:
       Quality Assurance Samples. The coordinator labo-
       ratory should periodically  conduct a blind or check
       sample study consisting of  authentic biological fluids
       (serum, urine, or saliva) with actual or spiked levels
       of cotinine. Samples should be selected to represent
       cotinine levels typical of those found in passive  and
       active smoking.  Authentic biological  samples with
       actual levels of cotinine are strongly recommended
       because only they will contain nicotine metabolites or
       other  substances that may  interfere  in  assays. In
       addition, blank samples spiked with known levels of
       cotinine should be  distributed to evaluate recovery.
       Finally, samples with high levels of cotinine should be
       diluted with negative specimens to check for linearity.
       Samples should ideally have target values assigned by
       the QA coordinating laboratory through use of refer-
       ence methods. Data returned by participants would be
       analyzed and reports containing results and a critique
       distributed.
          Field Study Samples. The QC coordinating labo-
       ratory may assist  organizations carrying out field
       studies in assessing the performance of the study lab-
       oratory on actual study subjects. The workshop con-
       sidered that this could be accomplished by submission
       at intervals of blind duplicates: duplicates of the same
       study subject  submitted at intervals to assess preci-
       sion; split  samples: sample is split with one portion
       being sent for analysis to  the study laboratory  and
       one  portion to the QC coordinating laboratory for
       comparison purposes; blanks: samples that are con-
       sidered free of analyte to serve as a check on environ-
       mental contamination.
          Ancillary Activities of the QA  Coordinating
       Laboratory: Primary Reference Standard(s). A
       strong consensus was reached that a well-character-
       ized, pure, primary reference standard be made avail-
       able.  This material should  be  aliquoted into
       quantities  sufficient to  allow any laboratory to use

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                                 COTININE ANALYTICAL WORKSHOP REPORT
                                                                                                      181
the standard for assay  calibration.  Handling and
storage information  should also  be provided along
with  suggested methods for preparing  secondary
standards.  It was generally agreed that cotinine
should be in the form of a salt, since cotinine freebase
is hygroscopic and, therefore, likely to vary in compo-
sition dependent on handling conditions. The perchlo-
rate  salt  was suggested  as one  possibility (see
chromatography group report). It was further recom-
mended that the standard be supplied in solution to
preclude errors due to dilution. The GC group made
the suggestion that the National Institute of Stan-
dards and  Technology might be  the  appropriate
agency to prepare such a standard. The QC coordinat-
ing laboratory could then distribute the standard.
  Biological Reference Samples. The  suggestion
was made that, in addition to providing  a primary
reference standard, the QA coordinating  laboratory
make available authentic  biological  samples  from
actual smokers and subjects exposed to ETS. Cotinine
concentrations would be established by the QA  coor-
dinating laboratory using a reference method(s) and
declared on  each reference  sample.  Such samples
would be important  because the  cotinine would be
present in the matrix (urine, serum, saliva) actually
used by analysts, thus allowing evaluation  of possible
matrix  interference.  In addition,  such  specimens
would contain nicotine, nicotine  metabolites other
than  cotinine, and other substances which might
interfere in the assay.
  The GC group also felt  that blank samples, i.e.,
those essentially free of cotinine would be desirable.
Suggested sources were bovine serum or human  sam-
ples with very low exposure to ETS. Pooled specimens
might be  necessary because obtaining sufficient vol-
ume of biological reference samples could prove  diffi-
cult.  Samples  would therefore  be  provided in
restricted  quantities only  to allow laboratories to
periodically evaluate their own method.
  Reference Method. Workshop participants also
discussed a  reference  method for  establishing
cotinine levels in biological samples. The consensus of
the group was that GC/MS  would be the ultimate
reference method because of its extreme specificity.
However, in the  group  discussion, the  GC group
pointed out that although the method is highly spe-
cific, it ultimately is no better than the reliability of
the extraction and evaporation methods  chosen to
prepare samples for analysis. A further concern was
that differences in assigned values  may result  from
differences attributable to  the  detection  method
(chemical  ionization or electron  impact).  Conse-
quently, it appears unlikely that a gold standard will
be available and acceptance  of a reference method
will depend ultimately on judgment of its  reliability.
Representatives of the National  Institute of Stan-
dards and Technology indicated that their practice is
to evaluate a variety  of independent methods, and if
sufficient agreement  is reached, a certified value is
provided, albeit with  the  understanding that confi-
dence limits are somewhat uncertain. In the absence
of agreement between various methods, NIST  pro-
vides a consensus value(s) for informational purposes.
  In the event that GC/MS is adopted as a reference
method, the implication for immunoassayists is  that
their performance would be judged against this stan-
dard. Judging immunoassay results against GC/MS is
not  without precedent, since  other immunoassays,
such as those for steroids, are already compared to
this method.
Postscript

  A cotinine spiked, freeze-dried human urine refer-
ence material is being prepared by the National Insti-
tute of Standards  and Technology  (formerly  the
National Bureau of  Standards). Three lots with  dif-
ferent cotinine concentration  levels  are  being  pre-
pared: a) an unspiked  blank level (< 1 ppb), 6) an
approximately  50 ppb low level, and  c) an approxi-
mately 500 ppb high level. This material (EPA/NIST
Reference Material 8444) is planned for issue during
the first quarter of 1989. The material  may be ordered
from: Office of Standard Reference Materials, Build-
ing 222 Room B-311, National Institute of Standards
and Technology, Gaithersburg, MD 20899. Telephone
301-975-6776. Technical information may be obtained
from  Dr. Lane Sander, Organic Analytical Research
Division,  Center  for Analytical Chemistry, NIST,
Gaithersburg, MD 20899. Telephone 301-975-3117.
  A cotinine perchlorate salt reference material is
also being planned for development by NIST. A date
has not been determined, however, for release of this
standard.

  The  research described in  this report has been reviewed by the
Health Effects Research Laboratory, U.S. Environmental Protec-
tion Agency, and approved for publication. Approval does not sig-
nify that the contents necessarily reflect the views and policies of
the Agency nor does mention of trade names or commercial prod-
ucts constitute endorsement or recommendation for use.
  The previously listed speaker/panel participants are acknowl-
edged for their workshop participation and vital contributions to
this report The authors are also appreciative of the attendance and
active  participation of the following university and government
agency representatives: Larry Claxton,  Ruth  Etzel, Linda Fore-
hand, George M. Goldstein, Elaine Gunter, Katharine Hammond,
Ed Hu, Henry S. Kahn, Kevin J. Kimboll, Dave Mage. Ronald K.
Mitchum, Judy Mumford, Todd C. Pasley, Terry Pechacek, George
Provenzano, D. W. Sepkovic, Wanda Whitfield, Ron Williams,
Deborah Winn, Stephen A. Wise, and Ou-Li Wong.
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182
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         ELIMINATION OF URINARY COTININE IN CHILDREN EXPOSED
            TO KNOWN LEVELS OF SIDE-STREAM CIGARETTE SMOKE
                          George M. Goldstein
                   U.S. Environmental Protection Agency
                        Research Triangle Park, NC

                              Albert Collier
                       University of North Carolina
                             Chapel Hill, NC

                                Ruth Etzel
                      Centers for Disease Control
                             Atlanta, Georgia

                             Joelien Lewtas
                  U.S. Environmental Protection Agency
                       Research Triangle Park, NC

                               Nancy Haley
                        American Health Foundation
                            Valhalla, New York

                                 Abstract
    The establishment of a  quantitative personal marker  of side-stream
smoke exposure in children is  important  in  the study of potential health
effects in this  group.   Cotinlne,  a  metabolite  of nicotine,  has  been
shown to  exhibit a  dose-response  relationship   to  side-stream  smoke
exposure in  adults,  and has  been  used to quantitate prior  exposure.
This study was undertaken to  determine the dose  of nicotine,  the  peak
level of urinary cotinine,  the  time  to peak cotinine levels,  and the
elimination half-life of cotinine in young children exposed  to a  con-
trolled amount of  side-stream smoke.   With an exposure  to 26.4  ug/rn^
of nicotine,  nine children,  averaging 2.03 years old had  peak cotinine/
creatinine levels  of  818 ng/mg.  The  time to  peak  cotinine  was  4.1
hours, with an elimination half-life of 28.7 hours.
                               Disclaimer
     Although the  research described  in  this  paper  has been  funded
wholly or  in part  by  the Health  Effects  Research Laboratory,  U.S.
Environmental Protection Agency through cooperative agreement 0CR812738-
01 to the Center for Environmental Medicine, University  of North Caro-
lina, it has not been  subjected to  the Agency's peer and policy  review
and therefore does not necessarily  reflect the  views of the  Agency and
no official endorsement should be inferred.

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                             Introduction
    Increased concern  has  been  expressed  about  the potential  health
risks associated with  the  exposure to  side-stream smoke  (21).  Recent
studies implicate exposure to side-stream smoke  as a particular health
risk in  infants and  young  children  (3,8,17,19).   Research into  the
health effects  of  exposure to  side-stream smoke  in children would  be
greatly aided if a  chemical  marker could be used  to  predict the level
of exposure  to  side-stream smoke.  Several  substances, isolated  from
tobacco smoke,  or   their   metabolic  products,  have been  measured  in
biological fluids  to  estimate  this  exposure  to  side-stream  smoke.
These substances include carboxyhemoglobin,  thiocyanate,  nicotine  and
cotinine (4,6,12,13,14,15).  Cotinine,  a metabolite  of nicotine,  has
been shown to be a  good indicator  of  the exposure  to  side-stream smoke
(14).  Studies  in   adults  have  shown  that  there  is  a  dose-response
relationship between the number  of cigarettes  smoked and  the  level  of
cotinine in the urine (9,13).  The elimination  half-life of cotinine in
the urine and in the blood has also been reported in adults (1,2,12).

    The use of cotinine as  an indicator of side-stream smoke exposure in
children has  been  studied  by Greenberg  et  al. (6). They  found  a  high
correlation between  the  exposure  of  children at  home to  side-stream
smoke and their levels of  urinary cotinine.  These results  suggested
that uninary  cotinine  may  be a useful  indicator  of side-stream smoke
exposure in infants and young children.   Etzel  et al. (4) provided data
on the elimination  half-life  of cotinine in the  urine of  newborn in-
fants exposed to side-stream smoke in utero. The  level  of  exposure for
both these studies  came from the self-reported smoking  behavior  of the
mother.

     Information on  the uptake  of  nicotine  and the  elimination  of its
metabolite,  cotinine in young  children,  age 1 to  3 years  of  age,  ex-
posed to side-stream smoke is  unavailable.  This  information is  con-
si derd critical because it  will allow one to  estimate  prior exposure,
rather than  rely on questionnaire  data.  This study was undertaken  to
determine the  exposure dose  of nicotine,  the peak  level  of  urinary
cotinine, the  time   to  peak levels  of   cotinine,  and the  elimination
half-life of urinary cotinine when children  are exposed to a controlled
amount of side-stream smoke.
                              Methodology
   Subjects:  Nine children (5 males,  4 females; mean age 2.03 yrs.; age
range 9 months to  3.5 yrs.),  accompanied  by  their parents  or guardians
were exposed to side-stream smoke generated by a smoking machine at the
rate of two cigarettes  per hour  for  a  total of four hours.  All children
were Individuals who had been exposed to side-stream cigarette smoke in
their home  environments.   The parents were  asked to refrain  from ex-
posing the  children  to side-stream smoke for three days  prior to the
chamber exposure,  during  the  day of exposure, and for  three days fol-
lowing the exposure. Urine samples were collected for cotinine analyses
each morning prior to the  exposure,  during the  exposure,  the evening

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following the exposure  and for  three  days following  the  exposure. Once
collected, the  urine  samples  were  coded,  frozen, and  shipped  to  the
American Health Foundation in  Valhalla,  New York, for analysis. Cotinine
was measured by radioimmunoassay (6,18). The concentration of  cotinlne in
the urine was  standardized by expressing it  as the  ratio  of  cotlnine/
creatinine,  ng/mg (18).

   Prior to  each  study,  the  children  received a  physical  examination
during which respiration  rate  and body  weight were determined. This  was
repeated at  the  end  of the exposure period.  This  study was approved by
the Committee on the  Protection of  the  Rights  of  Human  Subjects of  the
School of Medicine  of the University  of North  Carolina at  Chapel  Hill.

   Chamber: The  experiments  were performed  in  a  chamber,  13.6 np, with
3.55 air  changes  per  hour.   Temperature  was  maintained  at  2410.3  C,
with a  relative humidity of  55±5 Z.  The  air  within  the  chamber  was
mixed by a small boxer fan at  50CFM.

   Environmental Measurements:  Air  nicotine   levels  were  measured  on
bisulfice-impregnated filters  (7).  Each  exposure  concentration was  the
average of  3-6  filters,  collected over  the  four  hour  exposure period.

   Total Suspended Particulate values for the  study  were  averaged from
duplicate Anderson filter samples collected during each  4 hour exposure
at a  flow rate  of  1.7 m^ per hour.   A Thermo-Systems, Inc.  Model 3030
Electronic Aerosol Analyzer  made measurements  every 10  minutes.  Carbon
monoxide  (CO),  NO  and NOx were  measured continuously  and  reported  every
three minutes. CO was measured by nondispersive  infrared, (NDIR) while NO
and NOx were measured by  chemiluminescenee.

   Exposure: Research  grade  cigarettes,  2R1,   were smoked  by a smoking
machine,  [RM30, Heinr.  Borgwaldt,  Hamburg,FRG].  Prior to  the study,  the
cigarettes were conditioned at 22°C at 60% RH  for 48 hours. One  cigarette
was ignited  every  30  minutes  and  burned  for  about  12   minutes.  The
cigarette was puffed  once a minute, each  puff lasting 2  seconds  with a
draw of 35 ml (10,16).  All mainstream smoke was vented to the outside of
the chamber.

    Data Analyses: The  urine  half-life elimination  rate of  cotlnine  was
calculated by an interactive  pharmacokinetic  model'(11),   starting from
the peak urine level of cotinine.
                                 Results
     Concentrations of  gases in the  side-stream smoke peaked 15 minutes
after ignition  and  cycled at  30 minute  intervals.   Peak  levels  for CO
were 2.2±0.8  ppm;  NO,  54.814.3  ppb;  and  NOx,  58.815.3  ppb.  The mean
value for  the  air   concentration  of  nicotine  was  26.4l6.6yg/m^.  The
mean concentration of particulates, measured as TSP was 321.81 20.7ug/m^.
and by electronic aerosol analyzer was 345.4±51.2yg/m^.

   The dose of  nicotine that each child received was calculated from the
mean concentration of air  nicotine for that exposure, the average of the
child's respiratory rate,  and  the  child's tidal  volume  calculated from

-------
      Its body weight  (cable 1) using  the formula  of  Gautller ee_ al. (5).

         The diacribueion of baseline levels  of  urinary cot1nine appeared Co
      be blmodal, Indlcaclng Che possibility  of exposure of  several children
      Co side-scream smoke  prior Co encering Che  study. The mean  cocinlne/
      creaclnlne ratio for  one  group  was 36.5±17.3  ng/ag,  while  Che  other
      group vaa 190118 og/mg.

           Ac 4.1±1.4  hours after  exposure  Co  the first  cigarette,  peak
      levels of urine  cocinlne/creacinine averaged 393.7±209.8  ng/mg  in Che
      first group, and  1635±489 ng/mg  in Che second group (cable  1).   The
      average urine  elimination half-life  of cotlnine  was 28.7±13.1  hours
      wich a range of 14.6 Co 55.1  hours.

      Table 1:   Summary  of  Nicotine  and CoClnine  Levels  for  Each Exposure
Air
Nicocine
Subject Ug/m3
1 20
2 23
3 28
'4 35
5 23
6 23
7 18
8 35
9 33
Mean 26*7
±S.D.

Nlcocine
dose ug
26.9
20.3
21.8
23.8 •
24.9
23.9
12.9
28.0
29.5
23.6
±4.9

Baseline
co ci nine
ng/mg
43*
190b
208 b
21*
44*
37*
13*
172b
61*
37±17*
190±18b

T Peak
coCinlne
ng/mg
175*
1095&
2048 b
429*
429*
667*
238*
1762b
524*
394*
±210
1635b±
489
Time to
peak
(hours )
3.8*
6.3b
4. Ob
5.3*
5.8*
3.9*
2.9*
3.2b
1.9*
3.9*
±1.5
4.5b
±1.6
Tl/2
hours
38.9
24.2
14.6
15.1
55.1
20.3
33.1
22.1
35.3
28.7+13.1

tCotinine/CreaCinine ratio

aNon-exposed subjects

^Subjects suspected of having prior exposure Co smoke in the home environment

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                                Discussion
   This study was undertaken to describe the uptake of nicotine by young
children in a  controlled exposure to side-stream  smoke and the events
associated with  cotinine  elimination.  The  gaseous   and  particulate
fraction of  side-stream  smoke  reported  in  this   study  compare  very
favorably with  the  values  reported  by Hoffman  et^ al.  (9)  when their
data are adjusted  for the  differences  in  chamber  size, exhaust rate,
and the number of cigarettes consumed per hour.

   In this  study population,  the distribution  of baseline  levels  of
urinary cotinine was  bimodal.   One group had an average value of 36.5
ng/mg which compares  to  reported values of  14.5 (4)  and 19 ng/mg (9).
We believe that  the  other  group,  with an  average  value of 190 ng/mg,
had been exposed  recently to side-stream smoke.  This is supported by
values of  cotlnine/creatlnine  of  459  ng/mg (9) and   117  to  780 ng/mg
(12) reported in  exposed children.  For each child,  a dose of inhaled
nicotine was  calculated   from  the average  nicotine  concentration  for
that child's exposure.

   The distribution  of  the  peak levels  of cotinine  also  exhibited a
bimodal distribution (table  1).  The group  of subjects  with the initial
lower baseline level of  cotinine had a mean peak level  of cotinine/cre-
atine of 393.7  ng/mg  compared  to 1635 ng/mg value for the group that
may have had prior  exposure.    The  time  that   it  took to  reach peak
cotinine levels was 4.1  hours for the entire group.   This compares with
a reported value  of 2 hours by Wilcox et  al.   (20)  and  2 to 4 hours
reported by Hoffmann et  al. (9).  In the  paper  by Hoffmann et al. (9),
it is  Interesting to  note  that as  the  exposure  to  side-stream smoke
increases,  not  only  does the peak level of cotinine  increase, but the
time to peak also increases.  Our data suggest  that  this may have also
occurred, but  our data base is  too  limited to   compare the  group with
the presumed prior exposure with the group  that  had abstained for three
days. The time  course  of cotinine elimination as measured in the urine
appears to follow exponential kinetics. The average urine half-life was
28.7 hours.  This rate appears  to be shorter when  compared to a half-life
in neonates of  68 hours  reported by Etzel  e£ al.  (4) but within the 7
to 40 hours reported in  the  adult population (1,2,12).
                               Conclusion
     Although the study population was small, the data suggest that the
elimination half-life  of  urinary  cotinine in  very young  children is
similar to  that  reported  in  the  literature  for adults.   Future work
should replicate this study, while exercising control of the children's
exposure to  side-stream smoke  during  both the  pre and  post  chamber
exposure phase.

-------
                               References
 1.  Beeket,  A.H.,  Gorrod,  J.W.,  and Jenner,  P. The  analysis  of  nocotine-
    l'-N oxide in urine, in the presence  of nicotine and cotinine,  and
    its application to  the study of  in_ vivo  nicotine  metabolism In man.
    J. Pharm.  Pharmac.  23  (1971),  55s-61s.

 2.  Benowltz,  N.L., Kuyt,  P.,  Jacob, 111,  P.,  Jones, R.T., and  Osman,
    A-L.  Cotinine disposition and effects.  Clin.  Pharnacol.  Ther.  34
    (1983),  604-611.

 3.  Colley,  J.R.T., Holland,  W.W., and Corkhill, R.T. Influence  of pas-
    sive smoking  and  parental phlegm  on  pneumonia  and  bronchitis  in
    early childhood.  Lancet  11  (1974), 1031-1034.

 4.  Etzel, R.A., Greenberg, R.A., Haley, N.J., and Loda, F.A. Urine cotin-
    ine excretion  in  neonates  exposed  to  tobacco   smoke  products  in
    utero.  J. Pediatrics  107  (1985),  146-148.

 5.  Gaultier,  Cl., Boule,  M., Allaire, A.,  Clement,  A., and Glrard,  F.
    Growth of  lung volumes during the first  three  years of  life.  Bull.
    europ.  Physlopath.  reap.  15 (1979),  1103-1116.

 6.  Greenberg, R.A.,  Haley,  N.J.,  Etzel,  R.A., and Loda, F.A.  Measuring
    the exposure  of  infants  to tobacco  smoke.  New  England Journal  of
    Medicine 310 (1984), 1075-1078.

 7.  Hammond, S.K., Leaderer, B.P., Roche, A.C., and Schenker, M.  Collec-
    tion and analysis of nicotine as a marker for  environmental tobacco
    smoke.  Atmospheric Environment (In Press).

 8.  Harlap,  S.,  and Davis,  A.M. Infant admissions to hospital and maternal
    smoking. Lancet 11  (1974),  529-532.

 9.  Hoffmann,  D.,  Haley, N.J., Adams,  J.D., and Brunnemann.  Tobacco side-
    stream smoke:  uptake  by  nonsmokers.  Preventive Medicine 13  (1984),
    608-617.

10.  Hoffmann,  D.,  Adams, J.D.,  and Haley,  N.J. Reported Cigarette smoke
    values:  a  closer look. Am.  J.  of Public Health  73  (1983), 1050-1053.

11.  Johnston,  A.,  and  WooHard, R.C.  STRIPE:  An interactive computer
    program for the analysis  of  drug pharmacokinetics.  J.  Pharmacologi-
    cal Methods 9 (1983),  193.

12.  Luck, W.,   and Nau,H.  Nicotine and cotinine concentrations in serum
    and urine  of infants exposed via passive smoking or milk from smoking
    mothers.  J. of Pediatrics 107 (1985),  816-820.

13.  Matsukura, S., Taminato, T., Kitano, N., Seino,  Y., Hamada,  H., Uchi-
    hashi, M.,  Nakajlma,  H.,  and Hirata,  Y. Effects  of  environmental
    tobacco smoke on urinary  cotinine excretion in nonsmokers.  The New
    England Journal of  Medicine 311 (1984), 828-832.

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14. Matsukura,  S., Sakamoto, N. Seino, Y., Tamada, T., Matauyama, H., and
    Muranaka,  H. Cotinine excretion and dally cigarette smoking in habi-
    tuated smokers.  Clin. Pharmacol. Ther. 25 (1979), 555-561.

15. Pojer, R.,  WhitfieId, J.B., Poulos, V., Eckhard, I.F., Richmond, R.,
    and Hensley, W.J. Carboxyhemoglobin, cotinine, and thiocyanate assay
    compared for distinguishing smokers from non-smokers. Clin. Chem. 30
    (1984), 1377-1380.

16. Rickert, W., and Robinson, J.C. Estimating the hazards  of less hazard-
    ous cigarettes.   11.  Study  of cigarette  yields of  nicotine,  carbon
    monoxide,  and hydrogen  cyanide  in  relation  to levels  of cotinine,
    carboxyhemoglobin, and thiocyanate in  smokers.  J.  of Toxicology and
    Environmental Health 7 (1981), 391-403.

17. Samet, J.M., Tager, I.B., and Spizer,  F.E. The relationship between
    respiratory illness in childhood and chronic air-flow observation in
    adulthood.  Am. Rev. Respir. Dis. 127 (1983),  508-523.

18. Sepkovic,  D.W.,   and Haley, N.J.  Biomedical applications of cotinine
    quantitation in  smoking  related research. Am.  J.  Public Health 75
    (1985), 663-664.

19. Weiss, S.T., Tager, I.B., Schenker, M., and Spelzer, F.E. The health
    effects of  involuntary  smoking. Am.  Rev.  Respir.  Dis.  128 (1983),
    933-942.

20. Wilcox, R.G., Hughes,  J.,  and  Roland, J. Verification  of  smoking
    history in  patients  after  infarction  using  urinary  nicotine  and
    cotinine measurements. British Medical Journal 2 (1979),  1026-1028.

21. The health concequences of Involuntary smoking, a report of the Sur-
    geon General.  U.S.  Dept.   of  Health and  Human  Services  (1986).

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Home Air Nicotine  Levels  and  Urinary Cotinine  Excretion  in
Preschool  Children1'4
FREDERICK W. HENDERSON, HOLLY  F.  REID, ROBIN MORRIS,
OU-LI  WANG, PING C. HU, RONALD W.  HELMS,  LINDA  FOREHAND, JUDY MUMFORD,
JOELLEN  LEWTAS,  NANCY J.  HALEY, and S.  KATHARINE  HAMMOND
             Introduction
 Measurement of cotinine concentra-
 tions in body fluids has received recent
 scrutiny for its usefulness as an indica-
 tor of tobacco smoke exposure in adults
 and children (1-13). Average levels of coti-
 nine  in serum, saliva, and  urine differ
 significantly for unexposed individuals,
 those exposed passively to environmen-
 tal tobacco smoke (ETC), and active smok-
 ers. There remain questions,  however,
 regarding the extent to which cotinine lev-
 els in body fluids are quantitatively in-
 dicative of the intensity of ETS exposure
 among passive smokers. Lack of this
 knowledge and the absence of informa-
 tion regarding the extent to which single
 cotinine determinations are representa-
 tive for individuals has limited the use-
 fulness of cotinine measurements in epi-
 demiologic studies of the health effects
 of passive smoking.
   In the present study, we examined the
 relationship between levels of nicotine in
 the home air and levels of cotinine in
 urine of 27 children between 11 months
 and 5 yr of age. In addition, we obtained
 a midweek urine sample from study chil-
 dren for cotinine determination each of
 4 consecutive weeks to examine the sta-
 bility over time of this biologic marker
 of ETS exposure.

               NWtnOQS
 The children studied attended the research day
 care program of the Frank Porter Graham
 Child Development Center in  Chapel Hill,
 North Carolina. The respiratory disease re-
 search conducted in this population has been
 described previously (14-16). Children start
 attending  the Center between 6  wk and 3
 months of age and are followed continuous-
 ly to the age of kindergarten entry. They at-
 tend the day care program 8 h/day, 5 days/
 wk ani return home each ewning and on week-
 ends. Smoking is not permitted in child care
 areas of the day care center or in vans that
 are used to transport children  to and from
 the day care center. Twenty-seven children par-
 ticipated in the study: 15 from homes with
   SUMMARY Waanmtnadtna extant of <
   nlna/cmattnlne ratio* (CCH) hi 27 cMMn
                                                            landurinecott-
       OOt eXDOead to (
canualloi»a of ntaMloamr»maakwafadatan
fiMjM noufs on 2 cofUMCuow
landed a maaaren day cam program wham they
• (TTS) during tha daytime hour*. Average can-
id by active elf aampHng during tha evening and
                             Ufino MMHDJOS toe oottoww MM
   COUOCtOO D0VOfV| OUftn0v MM flftOC tflO tWO •MllpllflQ pOfMOB* III MJOmlOllf ROUT OaMjUOfluM
   urinaiamplaa lor CC« warn obtstfnadm^ study chlidmn to datatm^
   datarmlnattona o* OCR «am rapraaanHUita tor IndMdual chsMrnn. Fmaan cnMmn maided m homaa
   wtth amofcim. and 13 dM not Urine CCH conamleiHty dmttngulanad meat wpoeid and unawpoead
   CnlMIVfli HOWMMOTf tfMM OKpOOMJ OfNUPMI nMJ UnRO CCnB tlMt CIIJa9lM9Q fOUVIIOiy MOUOO tnO CntOTIOft
   OCR (30 ng/mg eottnloaoaattHna) that baat dtotinguwhad Mpmid and unaapoiad eMUnjn. In
   children eapoeid to ET8 In tha homo, than •** • Hgnmeant cormiaUon between average honw
   air nteotlna lava* and tha mitng* lugnlthm of urina OCR tha BJO roomlnga «nar tha homa ik
   monitoring parted* (r « OM; p • OttM). In study cMdran, urin* CCRa worn lomailably ctaMo
   0¥ar tha 1-month oeaarvotlon ported. Rank eorioloiloiicoaMfclanli«Dr*aquomiol»aaMyd»>innlno.
   tlona of CCfl warn constantly amour than r • OM; p < O0001.
smokers and 12 from homes without smok-
ers. Three pairs of siblings were studied: two
pairs from smoking homes and one pair from
a nonsmoking home. The study population
consisted of 15 males and 12 females; 14 black
and 13 white children. Their ages ranged from
11 months to 5 yr.

  Measurement of the Extent of Tobacco
         Smoking in the Home
Three methods were used to estimate the con-
centration of tobacco smoke present in home
air. (/) A questionnaire  was administered
with questions that identified the persons
who smoked in the home and how many cig-
arettes were smoked. (2) Parents were asked
to save the unsmoked portions of all cigarettes
smoked in the home over 2 consecutive mon-
itoring days. Parents were also asked to save
the remnants of cigarettes smoked in their cars
while riding with their children. Separate cig-
arette collections were made  for each study
day. (J) Active home air sampling for nico-
tine was performed simultaneously with cig-
arette remnant collections. Air sampling pumps
(Model 520; Gilian Co., Wayne, NJ) operat-
ing at 15 L/min were employed with Ander-
sen sampling heads (Particle Fractionating
Sampler, Andersen Co., Atlanta, GA). Teflon-
coated glass fiber filters (75  mm, T60A20;
Pallflex,  Putnam, CT) impregnated  with
aqueous 57t sodium bisulfate were used for
nicotine trapping (17). The pumps operated
from 5:00 r.u. to 7:00 A.M. for each of the
                                     2 days of monitoring. Separate air nicotine
                                     determinations were made for each study day.
                                     Sampling heads were kept in the child's main
                                     activity room during the evening hours, then
                                     moved to the child's bedroom at bedtime.
                                     (Received in original form Junt 22, 1988 and in
                                     rtvised form January 12, 7989)
                                       1 From the Department of Pediatrics, the Frank
                                     Porter Graham Child Development Center, the
                                     Department of Biostatistics, University of North
                                     Carolina, Environmental Health Research and Test-
                                     ing Inc. and the Health Effects Research Labora-
                                     tory United States Environmental Protection Agen-
                                     cy. Research Triangle Park, North Carolina; the
                                     American Health Foundation. Valhalla. New York;
                                     and the Department of Family and Community
                                     Medicine, University of Massachusetts, Worcester,
                                     Massachusetts.
                                       ' Supported by Co-operative Agreement CR
                                     80739202 from the U.S. Environmental Protection
                                     Agency and the University of North Carolina Center
                                     for Environmental Medicine
                                       1 Correspondence and  requests for reprints
                                     should be addressed to Frederick W. Henderson.
                                     MJX, CB 7220. University of North Carolina,
                                     Department of Pediatrics, Chapel Hill NC 2759*-
                                     7220.
                                       * This paper has been subjected to internal re-
                                     view by staff of the Health Effects Research Labo-
                                     ratory of the UiEnviionmenial Protection Agency
                                     and has been approved for  publication. Approval
                                     does not signify that the contents  necessarily re-
                                     flect the views and policies of the agency, nor does
                                     mention of trade names of commercial products
                                     coogituieendonemeaorrecomtnfnriarionforuae.

                                                                        197

-------
196
                                          HtMOCmOM, ROD. HOMW, WANO. HO, HfUM, FOMMANO, UUMFONO, UWTM, MALtY. AND HAMMOMO
                                Tin* line
1200 1500* 1700 2100*
1
2400 700* 930* 1200


                       Home air nicotin* monitoring


 *   Indicates scheduled urina collection

Fig. 1. Horn* air monitoring and urine collection scfwdula: time line tor both study days 1 and 2.
    Collection of Urine Specimens for
        Cotinine Determinations
 Urine specimens were obtained before, dur-
 ing, and at the end of the period of home
 air nicotine monitoring (figure 1). Children
 who were not toilet-trained (n = 9) did not
 have urine specimens collected at home. These
 children had the 3:00 P.M. and midmorning
 urine specimens specified by the protocol col-
 lected while they were at the day care center.
 In addition, urine specimens for cotinine de-
 termination were obtained on four consecu-
 tive Thursdays after  the home air monitor-
 ing period.

  Measurement of Nicotine and Cotinine
 Nicotine was eluted from sodium bisulfate-
 impregnated filters into ethanol and subse-
 quently quantitated by gas chromatography
 using described methods (17). Concentrations
 of cotinine in urine samples were determined
 by competitive-inhibition radioimmunoassay
 using rabbit cotinine antiserum and initiated
 cotinine (purchased from Helen VanVunakis,
 Brandeis University) (18). To adjust for urine
 dilution, urine cotinine concentrations were
 standardized to creatinine concentration and
 expressed as cotinine/creatinine ratios (CCR).

               Remits
    Comparability of Estimates of
    Quantity of Tobacco Smoked in
     Home and Classification of
          Exposure Status
 Except for one instance, there was agree-
 ment among the three measures of ex-
 posure employed: questionnaire, cigarette
 remnant collection, and active home air
 nicotine monitoring. Figure 2 shows the
 distribution of two consecutive home air
 nicotine determinations in homes where
 parents did or did not save cigarette rem-
 nants. Average air nicotine concentra-
 tions in homes where cigarette remnants
 were saved were consistently greater than
 0.5 ug/m1; all children from these homes
 were considered exposed to ETS in the
 home. One family that reported smok-
 ing in the home in questionnaire respons-
 es  saved no cigarette remnants. Average
 concentrations of  nicotine in home air
 were greater than 0.5 ug/mj on both
 monitoring days; therefore, this child was
 classified as exposed to ETS in the home.
Otherwise, children who lived in homes
where no cigarette remnants were saved
were classified as not exposed to ETS in
the home. The average concentration of
air nicotine in the homes of unexposed
children  was 0.34  ug/m1  (SEM, 0.07
ug/nr1) and in the homes of exposed chil-
dren was 3.74 ug/mj (SEM, 0.52 ug/m3).

  Accuracy of Exposure Assignment
  Using Midmorning Urine Cotinine
          Determinations
The study protocol specified that mid-
morning urine specimens for cotinine be
collected from study participants 6 times
over a 5-wk period (two consecutive
mornings after active home air nicotine
monitoring and four consecutive Thurs-
days thereafter).  A total of 153 of 162
(94%) of these urine specimens were suc-
cessfully obtained and assayed for coti-
nine and creatinine concentrations. The
distribution of CCR for these specimens
is plotted in figure 3 in relation  to ex-
posure status. A urine CCR criterion level
of 30 ng/mg resulted in the highest rate
of agreement in  exposure assignment.
Sixty-six of 69 (95%) midmorning urine
specimens obtained from 12 unexposed
children had CCRs < 30 ng/mg (first
column, figure 3). Urine specimens from
12 of 15 exposed children consistently (63
of 67; 94%) contained  greater  than 30
ng cotinine/mg creatinine (second col-
umn, figure 3). However, three exposed
children  consistently had urine CCRs
that clustered near the 30 ng/mg break-
point (13 of 18 = 72% of urine speci-
mens tested had CCR < 30 ng/mg) (third
column, figure 3). The sensitivity of urine
CCR was 80%;  12 of IS exposed chil-
dren were consistently designated as ex-
posed to ETS using urine CCR at the 30
ng/mg criterion level. Thus, for 24 chil-
dren (12 exposed and 12 unexposed), ac-
curacy of exposure categorization using
urine cotinine was excellent at the 30 ng/
mg criterion level. Only seven of 136 (5%)
urine specimens  tested  from these chil-
dren resulted in misctassification of ex-
posure status. The remaining three ex-
posed children were misclassified as not-
exposed by 13 of 18 (72%) urine cotinine
determinations using the 30 ng/mg CCR
criterion. Two-day average home air nico-
tine levels in the homes of these three chil-
dren were  1.45, 3.85, and 3.40 ug/m1.
Home air nicotine averaged 2.90 ug/mj
for the three children not classified as ex-
posed by urine cotinine compared to 3.95
ug/mj for the 12 children whose exposure
status was consistently correctly identi-
fied by urine cotinine determinations.
  The analyses that follow were per-
formed with and without the data from
the three exposed children with consis-
tently low urine CCRs. Exclusion of da-
ta of exposed children with low  CCRs
did not alter the pattern of any analytic
result; data shown are for  all exposed
children.

  Correlation of Home Air Nicotine
      and Urine Cotinine Levels
Among ETS-exposed children, there was
a significant positive correlation between
the average concentration of nicotine in
home air over the 2 days of monitoring
and the average logarithm of urine CCR
on the mornings after the 2 evenings of
home air monitoring.  In figure 4, aver-
age CCRs are plotted in relation to aver-
age home air nicotine levels for each of
the 15 exposed children. The Pearson
correlation for this set of data was r =
0.68; p = 0.006. The regression equation
for the linear correlation is given in the
figure legend.
           CIGARETTE REMNANTS SAVED

 Fig. 2. DtatrtbuUon o> ivataga homa air nicotine con-
 cantrattona tor horn** wftara ogartfl* ramnanti want
 and want not «avad; maaauratninn obtained on two
 conaacirtva daya paf home.

-------
KOMI MM MCOTWI LCVILS AND UMNAMV COT»«H« CKfWTKNI IN PMOCMOOL CMLMBI
                                                                                                             199
                                                             10001-
 1000 r-
I
?
UjKJO
Z

S
5
UJ
O  10
cr
3


                        100
             12 NOT EXPOSED       12 EXPOSED

                   EXPOSURE STATUS
      3EXPOSED
                                                               10
                                 1234567
                             AVERAGE HOME AIR NICOTINE (mcq/m3)
Fig. 3 (left). Distribution of al midmoming urine cotinine dalarminattona from: column 1,12 unexpoaad ciiildnn (geometric mean CCR, U7 ngfmg; SEM. 23 ng/mg);
column 2,12 exposed children consistently classified u exposed with the CCR (g*wn«ricm^nCCB,8«ng/mg;SEM. 7Bng/mg); and column 3. mr^Bxpowd children
connrtsntty classified M unsapossd by urine CCR (geometric mean CCR. 245 ng/mg; SEM, 2J ngAng).

Fig. 4 (right). Correlation between average horn* air nicotine concentrations tor two monitoring day* and average natural togailftm of urine CCR on (he mornings after
the two mooitoring days «or 15 ETS-«Kpc*ed children. The eolation hx the rsy               - 3.13 (SEM. 0.40) + O315 (SEM. 0.10) -average home air nicotine.
(F - lift p - 000&)
 Observations Relevant to the Use of
   Urine Cotinine Determinations in
        Epidemiologic Studies
The urine collection protocol allowed us
to examine whether time of urine collec-
tion during the day influenced urine coti-
nine levels. The means of logc CCR did
not differ significantly by sampling time.
Furthermore, individual children main-
tained their  absolute and relative levels
of cotinine excretion throughout the two
24-h study intervals. In exposed children,
rank correlations of sequential measure-
ments ranged from 0.68 < r < 0.93; 0.008
<  p < 0.03. There was no evidence that
routine evening ETS exposures  in chil-
dren exposed chronically  to ETS had
acute effects on urine cotinine levels. For
unexposed children, rank correlations of
sequential urine CCRs were more vari-
able, but as indicated previously the great
majority of urine specimens (48 of 51 =
94%) had CCRs  less than 30 ng/mg.
   We then  examined the stability  of
repeated urine cotinine/creatinine deter-
minations over a 1-month time period.
Urine specimens were collected while the
children were at the day care center on
each of four consecutive Thursdays. The
data of 14 exposed children are shown
in figure 5; one exposed child was absent
frequently from the Center during the 1-
month observation period.  In exposed
children, absolute and relative levels of
urine cotinine were very stable over time.
Rank correlations for sequential urine
CCRs were all r  > 0.88; p  =  0.0001.

             Discussion
Measurement of concentrations of coti-
nine in body fluids has been established
as a useful method for identifying active
smokers, persons exposed passively to en-
vironmental tobacco smoke, and neo-
nates exposed to nicotine and cotinine
in utero (1-13). Although active smokers
can be distinguished readily from pas-
sive smokers with cotinine assays, these
tests appear less accurate in distinguish-
ing persons who are routinely exposed
passively to ETS from those who are
sporadically exposed. Furthermore, our
knowledge of the usefulness of cotinine
determinations for ranking the intensity
of passive smoke exposure in populations
of individuals  is  fragmentary. Most in-
vestigators who  have attempted to ex-
amine this question have relied on ques-
tionnaire data to provide estimates of the
intensity of ETS exposure in study popu-
lations. In the present work, we employed
direct assays of home air nicotine concen-
trations to estimate the intensity of home
nicotine exposure for study children.
  The results of this study provide a firm-
er foundation for use of the CCR in urine
as a biologic marker of ETS exposure in
epidemiologic  studies involving young
children. Twelve of 15 preschool children
routinely exposed passively to tobacco
in the home had urine CCRs that were
consistently >  30 ng/mg, whereas 12 of
12 children without home ETS exposure
consistently had CCRs <  30 ng/mg.
Three exposed children (20%) had urine

-------
200


  1000
   H0NM9MON. ROD, MONMS, WMtt. HU, HIUM. F
-------
HOMI AM MCOTWC LfVfLS AND UMNAiff COTTMNt GtCMfTlON IN HMCIIOOt CMLOMOt
                                                                                                                               201
identifying  passive tobacco  smoke ex-
posure in young children. Because some
exposed children have relatively low lev-
els of cotinine  in urine, cotinine deter-
minations  should probably  be used  in
conjunction with questionnaire data re-
garding ETS exposure.  Data presented
here indicate that urinary CCRs are relat-
ed quantitatively to the intensity of home
tucoTinevexposure among ETS-exposed
children. This and the relative stability
of urine CCR over time support use  of
the assay in epidemiologic studies of ETS
exposure in young children.

               References
I.  Haley NJ. Axelrad CM. Tilton KA. Validation
of self-reported smoking behavior biochemical
analyses of cotinine and thiocyanate. Am J Public
Health  1983; 73:1204-7.
2.  Friedman CD. Petitti Da Bawol RD. Preva-
lence and correlates of passive smoking. Am J Pub-
lic Health 1983; 73:401-5.
3.  Jarvis MJ, Tuns tall-Pedoe H. Feyerabend C.
Vesey C. Sailoojee Y. Biochemical markers of smoke
absorption and self reported  exposure to passive
smoking. J Epidemic! Community Health  1984;
38:335-59.
4.  GreenbergRA, Haley NJ, Etzd RA, Loda FA.
Measuring the exposure of infants to tobacco
smoke: nicotine and cotinine in urine and saliva.
N Engl J Med 1984; 310:1075-8.
5.  Matsukura S, Taminato T, Kitano N,« at. Ef-
fects of environmental tobacco smoke on urinary
cotinine excretion in nonsmokers: evidence for pas-
sive smoking. N Engl J Med 1984; 311:828-32.
6.  Jarvis MJ. Russell MAH. Feyerabend C, etal.
Passive exposure to tobacco smoke: saliva cotinine
concentrations in a representative population sam-
ple of non-smoking schoolchildren. Br Med J 1985;
291:927-9.
7.  EtzelRA. GreenbergRA. Haley NJ. Loda FA.
Urine cotinine excretion in neonates exposed to
tobacco smoke products in utero. J Pediatr 1985;
107:146-8.
8.  Sepkovic DW, Haley NJ. Biomedical applica-
tion of cotinine quantitation in smoking related
research. Am J Public Health 1985; 75:663-5.
9.  PattishaUEN.StropeGL.EtzdRA.HelmsRW,
Haley NJ, Denny FW. Serum cotinine as a mea-
sure of tobacco smoke exposure in children. Am
J Dis Child  1985: 139:1101-4.
10.  Luck W, Nau H. Nicotine and cotinine con-
centrations in serum and urine of infants exposed
via passive smoking or milk from smoking mothers.
J Pediatr 1985; 107:816-20.
II.  Luck W, Nau H. Haitsen R, Steldinger  R. Ex-
tent of nicotine and cotinine transfer to the human
fetus,  placenta and aminiotic fluid of smoking
mothers. Dev Pharmacol Ther 1985; 8:384-95.
12.  Giusto ED, Eckhard I. Some properties of sali-
va cotinine measurements in indicating exposure
to tobacco smoking. Am J Public Health  1986;
76:1245-6.
13.  Coultas DB, Howard CA, Peake GT, Skipper
BJ, Samet JM. Salivary cotinine levels and involun-
tary tobacco smoke exposure in children and adults
in New Mexico. Am Rev Respir Dis 1987; 136:305-9.
14.  Henderson FW, Collier AM. Clyde WA Jr.
Denny FW. Respiratory syncytial virus infections,
reinfections, and immunity. A prospective longitu-
dinal study in young children. N Engl J Med 1979;
300:530-4.
15.  Henderson FW. Collier  AM. Sanyal MA, et
al. A longitudinal study of respiratory viruses and
bacteria in the etiology of acute otitis media with
effusion. N Engl J Med 1982; 306:1377-81.
16.  Pacini DL. Collier AM. Henderson FW.
Adenovimi infections and respiratory illnesses in
children in group day care. J Infect Dis  1987;
156:920-7.
17.  Hammond SK.LeadererBP, Roche AC, Schen-
ker  M. Collection and analysis  of nicotine as a
marker for environmental tobacco smoke. At-
mospheric Environment 1987; 21:457-62.
18.  Langone J J. Gjika HB. VanVunakis H. Nico-
tine and its metabolites: radkxnununoassavs for ruco-
tine and cotinine Biochemistry 1973; 12:5025-30.

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Original  Contributions
Passive   Smoking  on  Commercial

Airline   Flights
 Margaret E. Mattson, PhD; Gayle Boyd, PhD; David Byar, MD; Charles Brown. PhD;
 James F. Callahan, DPA; Donald Corle, MS; Joseph W. Cullen, PhD; Janet Greenblatt, MPH;
 Nancy J. Haley, PhD; S. Katharine Hammond, PhD; Joellen Lewtas, PhD; Warren Reeves
 In-flight exposure to nicotine, urinary cotinine levels, and symptom self-reports
 were assessed in a study of nine subjects (five passengers and four attendants) on
 four routine commercial flights each of approximately four hours' duration. Urine
 samples were collected for 72 hours following each flight. Exposures to nicotine
 measured during the flights using personal exposure monitors were found to be
 variable, with some nonsmoking areas attaining levels comparable to those in
 smoking sections. Attendants assigned to work in nonsmoking areas were not
 protected from smoke exposure. The type of aircraft ventilation was important in
 determining the levels of in-flight nicotine exposure. The environmental tobacco
 smoke levels that  occurred produced measurable levels of cotinine (a major
 metabolite of nicotine) in the urine of passengers and attendants. Passengers who
 experienced the greatest smoke exposure had the highest levels of urinary cotin-
 ine. Changes in eye and nose symptoms between the beginning and  end of the
 flights were significantly related both to nicotine exposure during the flight and to the
 subsequent urinary excretion of cotinine. In addition, subjects' perceptions of
 annoyance and smokiness  in the airplane cabin were also related  to in-flight
 nicotine exposure and urinary excretion measures.
                                                        (JAMA 1989-^6l«67-872)
  THE ADVERSE health effects on non-
  smokers of passive,  or  involuntary,
  smoking include lung cancer and respi-
  ratory  disease,  the latter especially
  among children, as well as acute irritant
  effects. The scientific evidence for these
  effects has been reviewed and codified
  in the Surgeon General's Report on the
  Health Consequences of Involuntary
  Smoking published in 1986.'
    Attention recently has been focused

            See also p 898.

  on the extent of exposure to  passive
  smoking experienced in various indoor
  environments where smoking is al-
  lowed.  The National Academy of Sci-
  ences reviewed the data on  passive
  smoking in relation to the quality of
   Fromihe National Cancer Institute. Bethesda. Md (Ore
  Manson.Boyd.Byar.8rown.Callahan.and Cullen and Mr
  Corle): Prospect Associates. Rockville. Md (Ms Greenb-
  latl); the American Health Foundation. Valhalla. NY (Or
  Haley); the University of Massachusetts Medical School.
  Worcester (Or Hammond): the Environmental Protection
  Agency. Research Triangle Park. NC(Drl_ewtas);and Air
  Canada. Montreal (Mr Reeves).
   This publication  does not necessarily relied EPA
  policy
   Repnni requests to the National Institutes ol Health.
  National Cancer Institute. Division o( Cancer Prevention
  and Control. 9000 Rockville Pike. Executive Plaza North.
  Room 330. Belhesda. MO 20692 (Or Mattson)
indoor air environments in two separate
reports also published in 1986. The first
is a more general statement, Environ-
mental Tobacco Smoke: Measuring Ex-
posures and Assessing Health Effects,1
and the second, specifically addressing
the environment of airline flights, is The
Airliner  Cabin  Environment: Air
Quality and Safety* The latter re-
commended a ban on smoking in all do-
mestic commercial flights for four major
reasons: to minimize irritation, to re-
duce health risks, to reduce fire haz-
ards, and to bring air cabin quality into
line with  standards for other closed
environments.
  Public opinion, by smokers and non-
smokers alike, is increasingly in favor of
restrictions on smoking in  public areas
and in the workplace.4-J However, there
are presently no regulatory standards
that specify limits on pollutants affect-
ing air quality in airplanes. Recent leg-
islation in the United States, enacted in
April 1988 on a trial basis, has banned
smoking on all  US carrier domestic
flights of two hours or less. The ban is
due to terminate in April 1990 unless
additional congressional action  occurs.'
In Canada,  smoking on flights of two
hours or less was banned by the govern-
ment in December of 1987. Subsequent-
ly, both major Canadian airlines volun-
tarily went beyond the two-hour ruling
and banned smoking on all North Amer-
ican flights. One US airline has volun-
tarily banned smoking on flights of any
length within the United States, except
flights to and from Hawaii.' On Jan 1,
1988, the California legislature enacted
a law that banned smoking on all forms
of public transportation, including all
intrastate airline flights,  and limited
smoking in transportation waiting ar-
eas. Reactions to the ban obtained in a
March  1988 survey of 677 passengers
and crew showed strong support among
nonsmokers (95%) and smokers (57%)
(University of San Francisco  news re-
lease, April 6,1988).
  The Surgeon General of the Public
Health  Service  requested  that the
Smoking, Tobacco,  and  Cancer Pro-
gram of the National Cancer  Institute
conduct a research study to measure
environmental tobacco smoke  exposure
on  typical  commercial flights. This
study was undertaken (1) to measure
nicotine levels in ambient air  during
flights of approximately four hours' du-
ration and urinary cotinine levels at var-
ious points during the three days after
the flights, and (2) to determine if these
exposure and excretion measurements
correlate with each other and with acute
symptoms  experienced  during the
flights.

METHODS
Subjects and Procedures
   Nine subjects (four attendants and
five passengers) participated on each of
four flights. Based on smoking chamber
data,1  we determined that this study
design would have 77% power for find-
ing a difference in urinary cotinine ex-
 cretion between subjects moderately
exposed  to  environmental  tobacco
 smoke and unexposed subjects. All sub-
jects were nonsmokers; were not regu-
 larly exposed to smoke;  were free of
 chronic respiratory disorders such as
 asthma,  bronchitis, or  emphysema;
  JAMA. February 10, 1989-Vol 261. No. 6
                                   Passive Smoking on Airlines — Malison et al  867

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Table 1.-Inflight Nicotine Exposure*
                                            Flight
  Variable
Attendants
t
2
3
4
passengers
&
6
7
a
9
Average No. of
smokers per
count (No. of
observations)
3.0 (St)
0.1 (NS)
9.8 (NS)
0.9 (S)
16.6 (S)
58.6 (S)
0.1 (NS-B)
0.6 (NS-B)
0.2 (NS-B)
*2 (9)
6.8 (S)
9.4 (NS)
0.2 (NS)
10.S (S)
0.8 (NS-8)
0.1 (NS-B)
3.5 (S)
0.3 (S)
12.6 (S)
3.9 (7)
0.7 (NS)
0.5 (S)
1.5 (S)
1.4 (NS)
5.5 (NS-B)
32.1 (S)
2.5 (NS-B)
8.3 (S)
27.5 (NS-B)
4.4 (7)
7.7 (NS)
9.5 (S)
7.5 (S)
5.4 (NS)
12.9 (S)
27.3 (NS-B)
8.4 (S)
71.0 (NS-8)
11.4 (S)
4.4 (S)
 "Nicotine values from personal monitoring pump (assigned work or seating area). Values were adjusted for
sampling time during which smoking was allowed. Units are micrograms per cubic meter (|ig/m>).
 fS indicates smoking section: NS. nonsmoking section; and NS-B. borderline between smoking and nonsmoking
sections.
were willing to be assigned to the smok-
ing section of aircraft; and volunteered
to participate in the study. The protocol
was approved by the human subjects
institutional  review board  of the  Na-
tional Institutes of Health and by the
participating airline. Eight of the nine
subjects were recruited from Air Cana-
da employees.
  Data collection for the entire study
took place over a 19-day period in May of
1988. The flights' schedules were as fol-
lows: flight 1, Toronto to San Francisco;
flight 2, San Francisco to Toronto; flight
3, Toronto to Vancouver; and flight 4,
Vancouver  to  Toronto.  Seventy-two
hours elapsed between all flights except
flights 2 and 3, which were separated by
four days. Flights 1 and 2 were on B727
jets with 100% fresh air. Flights 3 and 4
were on B767 jets with 50% of the air
recirculated.
  The same subjects participated in all
four flights. The five passenger subjects
(three  men and  two  women) were
seated in the smoking section or in the
nonsmoking section  bordering  the
smoking section.  The  four attendant
subjects (three men and one woman)
were assigned to  work in smoking or
nonsmoking sections of the cabin. All
subjects rotated  exposure conditions
over the four flights, shown in Table 1.
   Each flight had  four smoking section
rows, consisting of 24 seats in flights  1
and 2 and 28 seats in flights 3 and 4.
There were 78 seats in nonsmoking in
flights  1  and 2  and 93 in  3 and 4.
Although the smoking section was  fully
occupied on the first three flights and
there were only two empty seats on the
fourth  flight, some passengers in the
smoking  section  did not  smoke, eg,
study subjects and children. Logistical
considerations (ie, the airline's need for
a rapid turnaround of aircraft) pre-
vented a direct count of all cigarette
butts produced by smokers  on  the
flight. Smoking activity was estimated
by the field coordinator, who observed
the  smoking  section  at  intervals
throughout the flight and counted the
number of persons smoking each time.
  The  concentration of nicotine in the
cabin air was used as a marker or surro-
gate for the exposure to environmental
tobacco smoke. During the flights, nico-
tine was collected from the air by active
sampling as  described elsewhere.' A
personal exposure monitor consisting of
a pump sampling at 3 L/min through a
cassette  containing two  filters  was
used. The first filter collected particles
for a separate study of mutagenicity of
extractable organics to be  reported
elsewhere.  The  second  filter  was
treated with sodium bisulfate to collect
the nicotine. The nicotine on the treated
filters was desorbed in solvents and ana-
lyzed by gas chromatography with ni-
trogen-selective detection. The sensi-
tivity was 0.07 jjig of nicotine per cubic
meter.  Each  subject  wore an  active
sampling system during each flight to
measure his or her actual nicotine expo-
sure ("in-flight exposure").
  Exposure  to cigarette  smoke  be-
tween flights was monitored with both a
diary,  in which subjects recorded the
extent and duration of exposure outside
of the flights, and with a passive moni-
tor. For 72 hours before and after each
flight, each subject wore a small, light-
weight passive monitor that contained a
bisulfate-treated filter that collected
nicotine by diffusion. These filters were
also analyzed by gas  chromatography
with nitrogen-selective detection.'"10
   In addition to a preboarding baseline
urine sample, subjects collected all their
urine for  each of 12 six-hour periods
after the flight. They recorded the total
volume collected for each six-hour peri-
od and took a sample from the pooled
specimen. All samples were shipped in
dry ice to the testing laboratory and
analyzed  for cotinine  and  creatinine.
The method of cotinine analysis was ra-
dioimmunoassay, as described by Haley
et al."'u All cotinine values  were nor-
malized by creatinine excretion.
  Before each flight, all  subjects were
asked to  complete a simple question-
naire about  the following symptoms:
eyes (itching, burning, dryness,  teari-
ness, or increased blinking); nose (dry-
ness, itching, discharge, obstruction, or
stuffiness); dry mouth; coughing; sneez-
ing; scratchy or sore throat; and  head-
ache. These same questions were asked
at the completion of each flight  along
with additional questions concerning
annoyance from cigarette smoking dur-
ing the flight ("During this flight, were
you  annoyed or irritated by cigarette
smoke?") and an estimate of how smoky
the flight  appeared to be ("How smoky
was  the area of the plane in  which you
spent most of your time?").

Data Analysis
  Air nicotine concentrations (in micro-
grams of nicotine per cubic meter of air)
were corrected for the sampling time
during which smoking was  permitted
and the pumps activated. The lengths of
time the air sampling equipment was on
were as follows: flight 1,4.8 hours; flight
2,4.5 hours; flight 3, 4.0 hours; flight 4,
3.8 hours. Since all flights had minimal
time during which  smoking was cur-
tailed, these corrections were minor.
Levels of air nicotine were classified as
"high" (>12 tJLg/m1), "moderate" (1 to 12
jjig/m1), or "low" (<1 tig/m1). Statistical
significance was assessed by the Wil-
coxon-Mann-Whitney  rank  test1*  and
the  Mantel  linear trends test." Both
one- and  two-tailed P values have been
used, depending on whether the direc-
tion of the statistical comparison could
be anticipated from prior knowledge.
   Two types of analyses were done with
the urinary data. In the first analysis,
 the relationship between air nicotine
 exposure during the flight ("in-flight ex-
 posure")  and cotinine excretion over the
 72-hour period after the flight was ex-
 amined.  Twenty-four-hour moving av-
 erages, ie, an average of the four cotin-
 ine values for a consecutive 24-hour
 period, were created to smooth out vari-
 ability.1*  The cotinine moving average
 (MA) was computed for the mean cotin-
 ine values, normalized for creatinine in
 units of nanograms of cotinine per milli-
 gram of creatinine  as  follows  (where
 UCP indicates urine collection  period
 868   JAMA. February 10. 1989-Vol 261. No. 6
                                             Passive Smoking on Airlines—Malison et al

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    30 -
O)
c
'c
o
O
                                No. of Hours After Right

                         X High Exposure      • Low Exposure
 Rg 1. — Cotinine excretion over time. Twenty-four-hour moving average of ootinine excreted after flight. Value
 at ( = 0 is average urinary cotinine before boarding flight. High in-flight exposure is defined as nicotine
 exposure greater than median value. Units are nanograms of cotinine per milligram of creatinine. See text lor
 description of methods.
                                                                                    5.00
                                                                                    3.75
                                        £

                                        5 2.50
                                        O
                                        81

                                          1.25
                                                                                    0.00
                                                                                            + Subjects Not Reexposed
                                                                                            o Reexposed Subjects
                                                                                        0.00    1.25    2.50    3.75   5.00
                                                                                                  Log Nicotine
                                        Rg 2.—In-flight nicotine exposure and cotinine ex-
                                        cretion at 12 hours after flight. Values are natural
                                        logarithms of air nicotine (Ln (nicotine + 1|) and
                                        creatinine-normalized cotinine (Ln [cotinine + 1]).
                                        Regression line through data points for subjects not
                                        reexposed between flights, correlation coefficient =
                                        .74. P = . 0003.
 for the stated  interval):  MA  (at  12
 hours) = UCP (0 to 6 hours) 4- UCP (6
 to 12 hours) + UCP (12 to 18 hours) +
 UCP  (18 to 24 hours) divided by four,
 plotted at t = 12, the midpoint of that24-
 hour interval. MA (at 18 hours) = UCP
 (6 to 12 hours) -t- UCP (12 to 18 hours) +
 UCP  (18 to 24 hours) +  UCP (24 to 30
 hours) divided by four, and similarly for
 the remaining moving averages. Com-
 puted in this way, the 12 postflight urine
 collection periods yielded a single mov-
 ing average curve  consisting of nine
 points. Measured levels of in-flight air
 nicotine were  partitioned into those
 above and below the median value for all
 flights. Twenty-four-hour moving av-
 erages of cotinine  levels were  plotted
 against time separately for subjects re-
 ceiving high (above median) and  low
 (below median) in-flight exposure.
    In   the second analysis,  the dose-
  response relationship between nicotine
 exposure and cotinine excretion at 12
 hours was examined by scatter plots of
 in-flight exposure vs cotinine excretion
  using log-transformed values for all nic-
 otine and cotinine measures.  The total
  number of urinary points available for
 t = 12 hours was 29 (instead of 36), due to
  missing data.
    Linear plots  of both raw and creati-
 nine-normalized measures of  urinary
 cotinine and plots  of  the  log-trans-
  formed urinary cotinine data (original
 units were nanograms per milligram of
 creatinine)  done early in the analysis
  revealed marked variation for some in-
 dividuals. Some began a flight with un-
expectedly high  baseline  values.  For
some subjects, peak excretion of cotin-
ine occurred at irregular intervals, with
some subjects peaking early,  others
late, and some snowing multiple peaks.
The most likely explanation for the pat-
terns observed is that some subjects
were reexposed while not on a flight.
  The possibility of reexposure was an-
alyzed by examination of the interflight
nicotine badge worn between  flights
and  the  exposure  diaries.  Subjects
whose passive nicotine badge values in-
dicated exposure of 0.13 u,g of nicotine
or greater during the 72-hour between-
flight interval were considered to have
received at least moderately high re-
exposure. Data from the diaries docu-
menting the day  and time of exposures
were used in  combination with known
half-life values for cotinine to determine
which  collection intervals  were af-
fected. The mean baseline cotinine level
(nanograms of cotinine per milligram of
creatinine) of subjects with interflight
badge values  of 0.13 u,g of nicotine or
greater was  34.3, and 12.1 for  those
with badge values of less than 0.13 u-g of
nicotine.
   Urine samples collected after the fol-
lowing  flights were considered  unsuit-
able for analysis due to occurrence of
interflight exposures to tobacco smoke:
all data for attendant subjects 1 and 2,
flights 3 and  4 for attendant subject 3,
flight 1 for attendant subject 4,  flight 4
for passenger subject 5, and flight 3 for
passenger subject 8.  These reexposed
subjects were excluded from some ana-
lyses (Fig 1).
  Both questions about symptoms and
the  questions concerning  annoyance
and  smoke levels experienced  during
the flight were recorded on a six-point
scale from zero to five.  Differences in
the symptom scores before and after the
flight were calculated and categorized
into three groups of roughly equal size,
coded as 0, 1, and 2. For eye and nose
score changes, - 2 to 0 was classified as
none or mild, 1 to 2 as moderate, and 3 to
4  as  marked.  For  "annoyed" and
"smoky," the corresponding categories
were 0 to 2,3, and 4 to 5. A logarithmic
transform for both the nicotine values
from the personal sampling pumps and
the urinary cotinine values was used.
  These coded symptom score changes
were related to the nicotine and cotinine
values by  linear least squares regres-
sion with the continuous measurements
(air nicotine or urinary cotinine) treated
as the response variables. The analysis
for the self-reported symptoms used all
subjects and was based on those urinary
cotinine values obtained at  12 hours
after the flight, not moving  averages.
Twelve hours was chosen as  an appro-
priate point where there was minimal
contamination  from  reexposure  to
smoke experienced  later  during the
data collection period.

RESULTS
In-flight Nicotine Exposure
   Subject placement and exposure con-
ditions for the four flights along with in-
  JAMA. February 10. 1989-Vol 261. No. 6
                                                                                Passive Smoking on Airlines — Mattson et ai  869

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(light nicotine measurements of air con-
centrations from the  active personal
exposure monitors  worn  in-flight are
shown in Table 1. Measurable exposure
to  environmental  tobacco  smoke  oc-
curred for all subjects on all four flights.
Review of the in-flight logs kept by the
study field  coordinator of counts  of
smokers done at least hourly indicates a
maximum of eight smokers  at any one
time during the flight, with the average
number of smokers per count ranging
from 3.9 to 4.4 (Table 1). Table 2 also
shows the frequency distribution of the
in-flight nicotine readings and levels of
statistical significance for various group
comparisons.
  The personal exposure monitors of
subjects on flights with 100% fresh air (1
and 2)  recorded less exposure than
those on the two flights with 50% fresh
air and 50% recirculating air (3 and 4), a
statistically  significant difference  by
both tests, with two-tailed P values. On
flights 1 and 2, all passengers seated in
the nonsmoking section (five samples)
were exposed to less than  1 u.g/ms of
nicotine with a median exposure of 0.2
fig/m', while all passengers seated in
the nonsmoking section of flights 3 and 4
(five samples)  were exposed to more
than 2.5 M-g/m1 of nicotine, with a medi-
an exposure of 27 (ig/m*. Flight 4 from
Vancouver to Toronto had the highest
levels of air nicotine, with all exposed to
greater than 5 jig/m*.
  Passengers in the nonsmoking border
section  experienced variability in their
exposure, with some attaining expo-
sures comparable  to or higher  than
those in the smoking section. The three
highest  nonsmoking border readings
(27.3,27.5, and 71 ng/rn') were obtained
on the flights with 50% recirculating and
50% fresh air. There was also a differ-
ence in spatial configuration of the seat-
ing between the two types of aircraft.
All  nonsmoking  border readings  on
flights with recirculated air were great-
er than all nonsmoking border values on
flights with 100% fresh air. The differ-
ences between exposures  in the non-
smoking border and smoking sections
were not statistically significant.  No
passenger subjects in the  study were
placed in the center of the  nonsmoking
section far from the border with smok-
ing because of the expectation that ex-
posures there would be very low.
   Exposure among attendants was not
statistically different from  that of pas-
sengers, although none of the eight high
exposures observed on the flights oc-
curred among attendants (Table 2). Ex-
posure among attendants  assigned to
work in the smoking section was  not
different from that among  those work-
ing in the nonsmoking section.
Table 2.—Frequency Distribution of Air Nicotine Readings and Tests of Significance*
                                                                       Pt
                                   Moderate
                        Significantly    "
                 Low     Different?     WMW
                                                                           MLT
Flights 1 and 2
Flights 3 and 4
Attendants
Passengers
Passengers in smoking section
Passengers in nonsmoking border
Attendants in smoking section
Attendants in nonsmoking section
3
5
0
8
S
3
0
0
6
11
11
6
4
2
6
5
1}
I)
s}
1}
Yes
No
No
No
.054
.15
.075
.26
.040*
.093*
.058§
.30§
  •All readings are from personal pump monitors worn by all subjects during the (lights. Units are mfcrograms per
cubic meter (ng/m1). High • > 12 |ig/m'; moderate » 1 -12 iig/m': and low - < 1 mj/m1.
  \P values are from the comparison between the members of each of the pairs indicated. Listed are the P values
for the Wilcoxon-Mann-Whitney test (WMW) and Mantel linear trends test (MLT).
  {Two-tailed P value.
  §One-tailed P value.
    3.5


    3.0 -


    2.5-
'o
.9
f
-J




2.0
1.5
1.0
0.5
0

r 1S
T


-





           Nose Changes
              P = .031
Eye Changes
  P = .016
Annoyed
P = .002
 Smoky
P = .0003
 Fig 3.—Relationship of in-flight levels ot air nicotine measured by personal monitoring pump to symptoms and
 perceptions during flight. Units are micrograms of nicotine per cubic meter (log transformed: Ln [nicotine +•
 1]). Numbers of subjects in each category are shown above bars representing 1 SE. Black bars indicate
 marked changes; striped bars, moderate changes; and white bars, no or mild changes. P values are one-
 tailed. See text for description of scoring system.
 Urinary Cotinine Excretion
   Postflight urinary cotinine excretion
 over time in subjects without apprecia-
 ble reexposure between flights is shown
 in Fig 1. A median split was performed
 on the in-flight nicotine exposure values
 to divide these subjects into "high" and
 "low" nicotine exposure groups.  The
 median nicotine exposure value was 5.5
 jig/m1. The urinary cotinine level for
 each exposure  group  was  plotted
 against time  using a moving  24-hour
 average.  In the high-exposure group,
 cotinine  excretion  increased  quickly
 from preflight levels, rose to a peak val-
 ue, and monotonically decayed back to a
 value slightly above the preflight levels
 by 72 hours.  Similar plots of  cotinine
 excretion over time for only the reex-
 posed subjects showed highly elevated
 baselines,  irregular   excretion   time
             courses, and no relationship to in-flight
             nicotine exposure.
               Scatter plots of all data using differ-
             ent symbols to distinguish reexposed
             subjects were done to investigate dose-
             response relationships (Fig 2). Urinary
             cotinine excretion (creatinine correct-
             ed) at  12 hours after the  flight for
             subjects not reexposed showed  a clear
             correlation with nicotine  exposure re-
             ceived during the flight. The correlation
             coefficient  was  .74  with  P = .0003.
             There was no significant correlation be-
             tween the cotinine and nicotine values
             for the reexposed subjects.

              Self-reported Symptoms
                Dry  mouth,  coughing,  sneezing,
              scratchy or sore throat, and headache
              were not significantly related to nico-
              tine  exposure.  On  the  other hand,
 870   JAMA. February 10. 1989-Vol 261. No. 6
                                               Passive Smoking on Airlines — Mattson et al

-------
                                                                                  Table 3.—Air Nicotine Levels (vJ3/m>) in Various
                                                                                  Indoor Environments*
          Nose Change
            P=.004
Eye Change
  P=.O22
Rg 4.—Relationship of urinary cotinine excretion at 12 hours after flight to symptoms and perceptions during
(light. Units are nanograms of cotinine per milligram of creaUrune (log transformed: Ln (counine +• 1|).
Numbers of subjects in each category are shown above bars representing 1 SE. Black bars indicate marked
changes; striped bars, moderate changes; and white bars, no or mild changes. P values are one-tailed. See
text for description of scoring system.
changes in eye symptoms, nose symp-
toms,  annoyance with  smoking,  and
perception  of a  smoky  environment
were all related significantly to the nico-
tine exposures. These relationships are
illustrated in Fig 3.
  As with the nicotine analysis, no sig-
nificant relationships  were  seen be-
tween the 12-hour log-transformed uri-
nary cotinine values and  dry  mouth,
coughing, sneezing, scratchy  or sore
throat, or headache. Like the  nicotine
data just described, these urinary coti-
nine data also showed significant rela-
tionships to  eye and nose  symptom
changes as  well as to the  perception of
the smokiness in the aircraft cabin (Fig
4).  The relationship  for the annoyance
index was not statistically significant,
but the observed changes were in the
expected direction. Some evidence sug-
gests  that  changes  in  eye symptoms
may have been more marked in the two
subjects wearing contact lenses.

COMMENT
   Several other studies have measured
air nicotine  levels  in indoor environ'
ments and report that a wide variety of
factors act in combination to produce a
particular "microenvironment." Differ-
ences in methodology, such as type of
monitoring devices and assays, ventila-
tion,  selection  of sampling times and
 number of smokers  present, and their
location relative to sampling devices, all
 limit  precise comparisons across these
studies. However, the levels of nicotine
 found  in this study  are comparable to
the measurements  reported in other
 studies shown  in Table 3 and support
             the conclusion that air nicotine levels in
             the nonsmoking areas that border the
             smoking area may be at least as high as
             in similar indoor environments  fre-
             quented by smokers.
               A small number of studies have been
             published in  the scientific literature
             that  assess  environmental  tobacco
             smoke  specifically on  board aircraft.
             These studies have assessed exposure
             by measuring concentrations of carbon
             monoxide,*"  particulates," and  nico-
             tine,1*" with one also assessing physio-
             logical absorption (ie, blood nicotine) re-
             sulting from exposure,"  The  results
             from the two studies employing in-flight
             nicotine measurements are summarized
             in Table 3.
               In  this study, air levels of nicotine
             were highly variable, with some non-
             smoking areas attaining levels greater
             than  those  in some smoking sections.
             Seating section  was a  less important
             predictor of actual nicotine exposure.
             This  bears out travelers' anecdotal ob-
             servations that the section in which one
             sits is often not as important in deter-
             mining exposure to smoke as is the envi-
             ronment generated by one's neighbors.
             This environment is determined by sev-
             eral  factors,  including  the  number of
             cigarettes smoked by neighbors, seat-
             ing configuration, air flow patterns, and
             the percentage of recirculated air.  In
             these  flights,  the  average  number
             smoking at any one time was only about
             four  and was  never observed to  be
             greater than eight. This may represent
             relatively low exposure compared with
             flights with many more smokers.
               The type of ventilation appeared to be
Environment
Airp4anest



Airplanes!





Airplanes§
Trains|
Offices!
Offices^
Offices'.
Pubs, coffee
shops!

Cafetenas§
Lobbies.
waiting
f 00(71 Sj


Open
ventilation
Closed
ventilation
Room]
Submarine!

(NS)
(NSa)
(S)
(Sa)
(NS)
(NS)
(NS)
(S)
(S)
(S)




















Mean
14 (median - 2)
4 (median -3)
17 (median -12)
5 (median -S)
7 (geom-3)
13 (geom-8)
8 (geom-4)
11 (geom-7)
30 (geom-7)
26 (geom-22)
IS

09
19


5
to
26
37
7
1
3

65

1010

500
15-35
Range
01-71
0.1-10
0.3-59
0.7-1 1
NO-24
NO-40
NO-17
04-42
NCM12
NO-77
6-29
0.7-50
14 (peak)
9-31
3-28
25-52


12-42











  •NS indicates nonsmoking section; S, smoking sec-
tion. NSa. nonsmoking section (attendants); Sa. smok-
ing section (attendants); and NO. not detectable.
  tThis report.
  {Otdaker nonsmoking values were measured at or
near the border with smoking in three different types of
planes. Arithmetic means were presented originally":
geometric means (geom) were subsequently pub-
Sshed."
  fMuramatsu el al."
  {Summary across studies taken from National Acad-
emy of Sciences review of studies reported in the
literature between 1957 and  1980.' The number of
studies cited in the report are as follows: trains, three:
offices, one: pubs etc. three: lobbies etc. four: automo-
biles, one: rooms, one; and submarines, one.
  IHammond el al.'
 an important factor in the levels of air
 nicotine  attained.  Planes with 100%
 fresh air (flights 1 and 2) had significant-
 ly less ambient nicotine than those with
 50% fresh air and 50% recirculating
 (flights 3 and 4). Recalculation systems
 significantly increase the fuel economy
 and so are an integral part of the design
 of some newer aircraft. Passengers and
 attendants may be exposed to higher
 levels of environmental tobacco smoke
 in the next decade as the percentage of
 seat-hours on airplanes with recircula-
 tion systems increases from 30% in 1985
 to an estimated 40% in 1990.'
   Attendants are  not confined to the
 section in which they are assigned to
 work and move through all areas of the
 plane. Although the  attendants  were
 assigned either to the smoking or non-
 smoking sections,  in fact there  were
 only about four rows of smokers on each
 of the four flights and the attendants
 worked in both smoking and nonsmok-
 ing areas when they were assigned to
 the smoking area. Attendants assigned
 to nonsmoking areas may have received
 exposure from the first-class smoking
 section and from passing through  the
 JAMA. Feoruary 10. 1989-Vo* 261. No 6
                                                    Passive Smoking on Airlines - Malison el al   871

-------
smoking section in coach. This may ex-
plain why there was no significant dif-
ference in exposure between attendants
assigned to the two sections.
  Although  the levels of exposure of
attendants measured  by the personal
exposure pumps were less than those of
passengers (although  not  statistically
significant), the amount of nicotine and
other cigarette smoke products actually
inhaled and ingested  may have  been
greater due to the greater  physical ac-
tivity and increased respiratory rate of
the attendants.  If true, this, together
with the cumulative exposure attained
from long periods of flight duty, could
result in greater total exposure over the
course of an attendant's career.
  The levels of environmental tobacco
smoke  that occurred  during the  four-
hour flights led to  increased levels of
cotinine (a major metabolite of nicotine)
in the urine of both  passengers and at-
tendants. Subjects who experienced the
greatest   in-flight   nicotine  exposure
generally  had the highest levels of uri-
nary cotinine  and continued  to excrete
cotinine for 72 hours  after the flight.
The shape and time  course of the decay
pattern are consistent with a first-order
pharmacokinetic decay process follow-
ing an initial exposure to nicotine. The
peak level of cotinine excreted is related
to the dosage of nicotine received over
the range of exposures encountered.
   Reports on dose-response data under
conditions of environmental  tobacco
smoke  exposure are sparse,  especially
for  the nicotine  concentration  range
typically  encountered by  nonsmokers
under free-living conditions. This analy-
sis provides estimates of the response to
a  bolus  of  environmental  tobacco
smoke, delivered over a four-hour peri-
od,  shown by a subsequent increase in
urinary cotinine  excretion  over time
synchronized   across  subjects.  This
study  expands  upon  previous studies
employing single-point estimates  of co-
tinine or self-reported smoke exposure
levels"*  and  provides information on
the shape of the excretion curve,  delay
to peak, amplitude to the peak, approxi-
mate functional form,  and decay time of
cotinine excretion after environmental
tobacco smoke exposure.
   Changes between the beginning and
end of the flights in eye and nose symp-
toms indicative of  acute irritation  are
related both  to a measure of in-flight
nicotine exposure and to the later uri-
nary excretion of cotinine. In addition,
perceptions of annoyance and smoki-
ness in the airplane cabin were likewise
related to the  in-flight nicotine  expo-
sure  and urinary  cotinine  excretion
measures. Experimental studies  under
controlled conditions indicate  that in
smoky  environments,  eye,  nose,  and
throat  symptoms  gradually  increase
over time with the duration of exposure
even  when  smoke concentrations  re-
main constant. Annoyance tends to rise
quickly as soon as exposure begins and
then remain constant over time." The
irritant effects of cigarette smoke arc
reflected  in the numerous complaints
about smoky conditions by attendants
and passengers alike in records com-
piled by the Association of Flight Atten-
dants and in government and industry
surveys.""70 In these surveys, 60% of
nonsmoking passengers and  15% of
smokers reported  being annoyed by in-
flight tobacco smoke.14 Ninety-five per-
cent of cabin attendants reported irrita-
tion and annoyance," a with 69% in one
study"  perceiving smoky air  to be a
more serious concern than other work
environment conditions  such as tem-
perature, odors, dust levels, and noise.
  Taken together, data from this study
on  in-flight nicotine  exposure, subse-
quent cotinine  excretion, and  acute
symptoms demonstrate that total sepa-
ration of smoking  and nonsmoking sec-
tions was not achieved on the flights
studied. The exposures experienced by
passengers and attendants are compa-
rable to those in other closed environ-
ments where  smoking is allowed  and
represent another contributor to the cu-
mulative health risk,  acute  irritation,
and annoyance that  nonsmoking indi-
viduals receive from passive smoking.

  The urine analyses were supported by National
Cancer Institute grant CA 32617-05 to the Ameri-
can Healtb Foundation.
  The contributions of the following people to the
study are gratefully acknowledged by the authors:
Caryn Axdrad. MS; Neil Benowitz, MD; Neil Colli-
shaw, MA; John Fitzgerald; Clair Harvey; Thomas
Manuccia; Lorraine Poirier; Byron Rogers; Daniel
W. Sepkovic, PhD; Donald Shopland; Rachel Ten-
nant, RN; Debra Walsh, MS; Ronald Williams; and
Coyla Wosltie. In addition, we are most apprecia-
tive of the time and effort given by the nine partici-
pant volunteers, and Ms Vanessa Hooker provided
expert manuscript preparation assistance.

R«ta<«nc**

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 872   JAMA. February 10. 1989-Vol 261. No 6
                                                 Passive Smoking on Airlines — Walloon v ±\

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