1、Designation: D 6485 99 (Reapproved 2004)Standard Guide forRisk Characterization of Acute and Irritant Effects of Short-Term Exposure to Volatile Organic Chemicals Emitted fromBedding Sets1This standard is issued under the fixed designation D 6485; the number immediately following the designation ind
2、icates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide provides guidance to individu
3、als and orga-nizations for conducting risk characterization of exposure tovolatile organic chemicals (VOCs) emitted from bedding setsor an ensemble of a mattress and supporting box spring.1.2 This guide is for risk characterization of short-termexposures to a new bedding set brought into a residenti
4、alindoor environment. The risk characterization considerationspresented in this guide are applicable to both the generalpopulation and sensitive subgroups, such as convalescingadults.1.3 The risk characterization addressed in this guide islimited to acute health and irritation effects resulting from
5、short-term exposure to VOCs in indoor air. Although certainprocedures described in this guide may be applicable toassessing long-term exposure, the guide does not addresscancer and other chronic health effects.1.4 VOC emissions from bedding sets, as in the case ofother household furnishings, usually
6、 are highest when theproducts are new. A used bedding set may also emit VOCs,either from the original materials or as a result of its use. Theprocedures presented in this guide also are applicable to usedbedding sets.1.5 Risk characterization procedures described in this guideshould be carried out u
7、nder the supervision of a qualifiedtoxicologist or risk assessment specialist, or both.1.6 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices
8、and determine the applica-bility of regulatory limitations prior to its use.2. Referenced Documents2.1 ASTM Standards:2D 1356 Terminology Relating to Sampling and Analysis ofAtmospheresD 6177 Practice for Determining Emission Profiles of Vola-tile Organic Chemicals Emitted from Bedding SetsD 6178 Pr
9、actice for Estimation of Short-Term InhalationExposure to Volatile Organic Chemicals Emitted fromBedding SetsE 609 Terminology Relating to PesticidesE 943 Terminology Relating to Biological Effects and En-vironmental FateE 1542 Terminology Relating to Occupational Health andSafety2.2 Government Stan
10、dards:3EPA 600/R 92/047 Reference Guide to Odor Thresholds forHazardousAir Pollution in the CleanAirActAmendmentsof 199016 CFR 1500 Federal Hazardous Substances Act Regula-tions29 CFR 1910 Safety and Health Standards for GeneralIndustry3. Terminology3.1 DefinitionsFor definitions of terms used in th
11、is guide,refer to Terminology D 1356.3.2 Definitions of Terms Specific to This Standard:3.2.1 acute exposure guideline levels (AEGLs),nrepresent short-term threshold or ceiling exposure valuesintended for the protection of the general public, including1This guide is under the jurisdiction of ASTM Co
12、mmittee D22 on Sampling andAnalysis of Atmospheres and is the direct responsibility of Subcommittee D22.05on Indoor Air.Current edition approved October 1, 2004. Published December 2004. Originallyapproved in 1999. Last previous edition approved in 1999 as D 6485 - 99.2For referenced ASTM standards,
13、 visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from Superintendent of Documents, U.S. Government PrintingOffice, Washington, D.C
14、. 20402.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.susceptible or sensitive individuals, but not hypersusceptible orhypersensitive individuals (1).43.2.1.1 DiscussionAEGLs are for once-in-a-lifetime ex-posure due to accidental r
15、eleases. Three AEGLs, each repre-senting distinct biological endpoints (sensory irritation ornotable discomfort, irreversible or serious effect, and life-threatening effects or death) for four different exposure periodsranging from 30 min to 8 h, are derived.3.2.2 bedding set, nan ensemble that incl
16、udes a mattressfor sleeping and a supporting box spring.3.2.3 ceiling, na maximum allowable air concentration,established by the Occupational Safety and Health Adminis-tration (OSHA), that must not be exceeded during any part ofthe workday.3.2.4 emission profile, na time-series of emission rates for
17、one or more chemicals.3.2.5 hazard index (HI), na summation of hazard quo-tients (see 3.2.6) for chemicals potentially having similar targetorgan effects or for chemicals that are considered to haveadditive effects.3.2.6 hazard quotient (HQ), nthe ratio of the exposurecalculated for a chemical to th
18、e toxicity/irritancy threshold orreference value for that chemical (2).3.2.6.1 DiscussionIf a HQ exceeds a value of 1, therewould be a concern for potential toxic/irritant effects. A HQ isnot to be interpreted as a statistical probability, for example, aratio of 0.001 does not mean that there is a o
19、ne in a thousandchance of an effect occurring.3.2.7 inhalation reference concentration (RfC), nan esti-mate (with uncertainty spanning an order of magnitude) of thedaily exposure to the human population (including sensitivesubgroups) that is likely to be without an appreciable risk ofdeleterious eff
20、ects (2).3.2.7.1 DiscussionThe time period under consideration isup to and including seven years, or a portion of a lifetime, forsubchronic RfC and a lifetime for chronic RfC. In accordancewith the U.S. Environmental Protection Agency (EPA) (3), theuncertainty in the estimates for RfC spans an order
21、 of magni-tude.3.2.8 lethal concentration 50 (LC50), na calculated airconcentration of a substance for which inhalation is expected tocause the death of 50 % of an experimental animal population(2).3.2.9 lethal concentration low (LCLo), nthe lowest airconcentration of a substance introduced by the i
22、nhalation routeover any period of time that is reported to have caused death inhumans or animals (2).3.2.10 lowest-observed-adverse effect level (LOAEL),nthe lowest exposure at which there is a significant increasein an observable effect.3.2.11 minimal risk level (MRL), nan estimate of the dailyhuma
23、n exposure to a hazardous substance that is likely to bewithout appreciable risk of adverse noncancer health effectsover a specified duration of exposure.3.2.11.1 DiscussionMRLs are developed by the Agencyfor Toxic Substances and Disease Registry (ATSDR). They areintended to serve as a screening too
24、l to help public healthprofessionals and are derived for acute (1 to 14 days),intermediate (14 to 364 days), and chronic (365 days or longer)exposure durations and for oral and inhalation routes ofexposure (4, 5).3.2.12 no-observed-adverse-effect level (NOAEL), nthehighest concentration among all th
25、e available experimentalstudies at which no adverse health or toxic effect is observed(2).3.2.13 permissible exposure limit (PEL), nthe OSHA-mandated time-weighted-average concentration of a chemicalin air that must not be exceeded during any 8-h work shift or40-h work-week (2).3.2.14 potential inha
26、led dose, nthe estimated dose of anairborne chemical that an individual is likely to have inhaledwithin a specified period of time. It is calculated as the productof air concentration to which an individual is exposed timesbreathing rate times duration of exposure.3.2.14.1 DiscussionThe potential in
27、haled dose can bedifferent from the dose actually absorbed by a target organ.3.2.15 short-term exposure, nan exposure of one week orless in duration.3.2.16 short-term exposure limit (STEL), nan AmericanConference of Governmental and Industrial Hygienists(ACGIH)-recommended 15-min time-weighted-avera
28、ge airconcentration of a chemical that should not be exceeded at anytime during a workday, even if the 8-h time-weighted-averagelevel is within the threshold limit value (TLV) (2).3.2.17 threshold limit value (TLV), nestablished byACGIH as the recommended time-weighted-average air con-centration of
29、a chemical for a normal 8-h workday and a 40-hwork week, to which nearly all workers may be repeatedlyexposed without adverse effects (2).3.2.18 toxic concentration low (TCLo), nthe lowest airconcentration of a substance introduced by the inhalation routeover any period of time that is reported to h
30、ave produced anysignificant toxic effects in animals or humans (2).3.2.19 uncertainty factor, na number, greater than unity,to account for incomplete understanding of errors encounteredin extrapolating exposure or health effects derived for one setof conditions or basis to another.3.2.19.1 Discussio
31、nAn uncertainty or safety factor is usedto account for differences in toxicological effects within aspecies or between two species. For example, a factor of 10 or100 is used to apply TLVs applicable to workers to a generalpopulation.4. Summary of Guide4.1 This guide presents guidance on conducting r
32、isk char-acterization of short-term exposures to volatile organic chemi-cals emitted from new bedding sets in a residential environ-ment. The risk characterization discussed in this guide islimited to acute health and irritant effects of the short-termexposures.4.2 Four major steps in risk assessmen
33、t include hazardidentification, evaluation of health effects data (includingdose-response assessment), exposure assessment, and risk4The boldface numbers in parentheses refer to the list of references at the end ofthis standard.D 6485 99 (2004)2characterization (6, 7). This guide addresses hazard as
34、sess-ment, evaluation of health effects data, and risk characteriza-tion. Companion documents (see Practices D 6177 andD 6178) provide procedures for estimation of human exposureto emissions of VOCs from bedding sets when a new beddingset is first brought into a house.5. Significance and Use5.1 The
35、objective of this guide is to describe procedures anddata sources for conducting risk characterization of acuteinhalation exposure to chemicals emitted from bedding sets.Risk characterization can be used to identify chemical(s) thatpose potentially significant human health risks for the sce-nario(s)
36、 and population(s) selected for exposure assessment.Such identification of chemicals can help in identifying thecomponents or materials used in manufacture of bedding setsthat should be further examined. Risk characterization alsoincludes an assessment of potential odor problems for anyindividual ch
37、emical emitted by the bedding set.6. Exposure and Effects6.1 Concepts of Exposure and DoseIn very basic terms,exposure is defined as human contact with a chemical orphysical agent (see Terminology E 943). Exposure by means ofthe inhalation route is of interest in this document: It can beexpressed as
38、 the product of airborne concentration timesduration of exposure, provided that the concentration remainsconstant during the time period of interest. If the concentrationvaries over time, then exposure is defined as the area under thecurve obtained when concentration values are plotted againsttime.
39、Exposure is expressed as concentration multiplied bytime with resultant units such as ppm-h or mg/m3-h. Dose isthe quantity of chemical or physical agent that enters anorganism or target organ (see Terminology E 609), with unitssuch as mg. Dose also can be expressed as rate, with mass/timeunits such
40、 as mg/day. The dose rate can be normalized inrelation to body mass, with units such as mg/kg-day. A specificterm that is used in risk characterization is potential inhaleddosethe product of average concentration in an environmenttimes the duration in the environment times the averagebreathing rate
41、while in the environment, commonly expressedin mass units such as milligrams. Chronic exposure generallyrefers to a long-term perspective, such as repeated exposures orexposures throughout an individuals lifetime, whereas acuteexposure refers to a short-term perspective such as one week,one hour, or
42、 even an instantaneous exposure.6.2 Chronic Toxic EffectsIn the United States and in manyother countries, two forms of health effects assessment areused, depending on the nature of the toxic effect underconsideration: one is used for cancer and the other for toxiceffects other than cancer (7). This
43、is primarily because forcancer (a chronic toxic effect), a threshold for dose-responserelationship does not exist, or if one does exist, it is very lowand cannot be reliably identified. During the 1970s and 1980s,the emphasis of risk assessment was on cancer as the end point.On the other hand, for t
44、oxic effects other than cancer, astandard procedure used for evaluating health effects involvesidentifying the highest exposure among all experimental stud-ies at which no toxic effect was observed, that is, the NOAEL.Much of the emphasis related to noncancer effects has been onchronic effects (7).
45、In recent years, however, researchers suchas Berglund et al. (8) have been giving increased attention toacute effects by categorizing the effects of indoor air pollutantson human health into groups such as reversible effects includ-ing general symptoms such as headache, inflammatory irrita-tion such
46、 as rashes, and perceptions including odors.6.3 Acute EffectsThe scope of this guide relates to effectsof short-term exposure to airborne chemicals in indoor spaces.Specific guidelines available for considering acute effects ofexposure to chemicals in air are quite limited. MRLs arederived for acute
47、 exposure of 1 to 14 days (4, 5). Otherguidelines, such as AEGLs, being developed by the NationalAdvisory Committee Acute Exposure Guideline Levels forHazardous Substances (NAC/AEGL Committee) are appli-cable only for one-time, short-term hazardous exposures dur-ing chemical emergency situations (1)
48、. EPAs non-chronicRfCs are not for acute exposure but for subchronic exposuresof less than seven years (3).7. Procedures for Hazard Identification7.1 Identification of Chemicals:7.1.1 Compile a list of target chemicals that are identifiedthrough screening tests of emissions. Target chemicals are to
49、beselected by a qualified toxicologist or a risk assessmentspecialist based on their presence in the screening samples andtheir expected irritant or health effects. Information on proce-dures for emissions testing, including screening samples, isgiven in Practice D 6177. A list of target chemicals included inthe prior research on bedding sets is given in Table X1.1 (2).7.1.2 All target chemicals for which emissions data havebeen collected are of interest, even those whose measured airconcentrations are below their respective detection limits.NOTE 1In pr
