1、Designation:D648599 (Reapproved 2004) Designation: D6485 11Standard 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 D6485; the number immediately following t
2、he designation indicates 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 () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide provides gui
3、dance to individuals and organizations for conducting risk characterization of exposure to volatileorganic chemicals (VOCs) emitted from bedding sets or an ensemble of a mattress and supporting box spring.1.2 This guide is for risk characterization of short-term exposures to a new bedding set brough
4、t into a residential indoorenvironment. The risk characterization considerations presented in this guide are applicable to both the general population andsensitive subgroups, such as convalescing adults.1.3 The risk characterization addressed in this guide is limited to acute health and irritation e
5、ffects resulting from short-termexposure to VOCs in indoor air. Although certain procedures described in this guide may be applicable to assessing long-termexposure, the guide does not address cancer and other chronic health effects.1.4 VOC emissions from bedding sets, as in the case of other househ
6、old furnishings, usually are highest when the products arenew. A used bedding set may also emit VOCs, either from the original materials or as a result of its use. The procedures presentedin this guide also are applicable to used bedding sets.1.5 Risk characterization procedures described in this gu
7、ide should be carried out under the supervision of a qualifiedtoxicologist or risk assessment specialist, or both.1.61.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.7 This standard does not purport to address all of the
8、safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatorylimitations prior to its use.2. Referenced Documents2.1 ASTM Standards:2D1356 Terminology Relating
9、to Sampling and Analysis of AtmospheresD6177 Practice for Determining Emission Profiles of Volatile Organic Chemicals Emitted from Bedding SetsD6178 Practice for Estimation of Short-term Inhalation Exposure to Volatile Organic Chemicals Emitted from Bedding SetsE609 Terminology Relating to Pesticide
10、sE943 Terminology Relating to Biological Effects and Environmental FateE1542 Terminology Relating to Occupational Health and Safety2.2 Government Standards:3EPA 600/R 92/047 Reference Guide to Odor Thresholds for Hazardous Air Pollution in the Clean Air Act Amendments of 199016 CFR 1500 Federal Haza
11、rdous Substances Act Regulations29 CFR 1910 Safety and Health Standards for General Industry3. Terminology3.1 DefinitionsFor definitions of terms used in this guide, refer to Terminology D1356.1This guide is under the jurisdiction of ASTM Committee D22 on Sampling and Analysis of Atmospheres and is
12、the direct responsibility of Subcommittee on Air Qualityand is the direct responsibility of Subcommittee D22.05 on Indoor Air.Current edition approved OctoberMarch 1, 2004.2011. Published December 2004.March 2011. Originally approved in 1999. Last previous edition approved in 19992004as D6485 - 99(2
13、004). DOI: 10.1520/D6485-99R04.10.1520/D6485-11.2For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3Available fro
14、m Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.3Available from U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:/www.access.gpo.gov.1This document is not an ASTM standard and is int
15、ended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the curr
16、ent versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.2 Definitions of Terms Specific to This Standard:3.2.1 acute exposure guideline levels (AEGLs)
17、, nrepresent short-term threshold or ceiling exposure values intended for theprotection of the general public, including susceptible or sensitive individuals, but not hypersusceptible or hypersensitiveindividuals (1).43.2.1.1 DiscussionAEGLs are for once-in-a-lifetime exposure due to accidental rele
18、ases. Three AEGLs, each representingdistinct biological endpoints (sensory irritation or notable discomfort, irreversible or serious effect, and life-threatening effects ordeath) for four different exposure periods ranging from 30 min to 8 h, are derived.3.2.2 bedding set, nan ensemble that includes
19、 a mattress for sleeping and a supporting box spring.3.2.3 ceiling, na maximum allowable air concentration, established by the Occupational Safety and Health Administration(OSHA), that must not be exceeded during any part of the workday.3.2.4 emission profile, na time-series of emission rates for on
20、e or more chemicals.3.2.5 hazard index (HI), na summation of hazard quotients (see 3.2.6) for chemicals potentially having similar target organeffects or for chemicals that are considered to have additive effects.3.2.6 hazard quotient (HQ), nthe ratio of the exposure calculated for a chemical to the
21、 toxicity/irritancy threshold or referencevalue for that chemical (2).3.2.6.1 DiscussionIf a HQ exceeds a value of 1, there would be a concern for potential toxic/irritant effects. A HQ is not tobe interpreted as a statistical probability, for example, a ratio of 0.001 does not mean that there is a
22、one in a thousand chance ofan effect occurring.3.2.7 inhalation reference concentration (RfC), nan estimate (with uncertainty spanning an order of magnitude) of the dailyexposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleteriousef
23、fects (2).3.2.7.1 DiscussionThe time period under consideration is up to and including seven years, or a portion of a lifetime, forsubchronic RfC and a lifetime for chronic RfC. In accordance with the U.S. Environmental Protection Agency (EPA) (3), theuncertainty in the estimates for RfC spans an or
24、der of magnitude.3.2.8 lethal concentration 50 (LC50),na calculated air concentration of a substance for which inhalation is expected to causethe death of 50 % of an experimental animal population (2).3.2.9 lethal concentration low (LCLo) , nthe lowest air concentration of a substance introduced by
25、the inhalation route overany period of time that is reported to have caused death in humans or animals (2).3.2.10 lowest-observed-adverse effect level (LOAEL), nthe lowest exposure at which there is a significant increase in anobservable effect.3.2.11 minimal risk level (MRL), nan estimate of the da
26、ily human exposure to a hazardous substance that is likely to bewithout appreciable risk of adverse noncancer health effects over a specified duration of exposure.3.2.11.1 DiscussionMRLs are developed by the Agency for Toxic Substances and Disease Registry (ATSDR). They areintended to serve as a scr
27、eening tool to help public health professionals and are derived for acute (1 to 14 days), intermediate (14to 364 days), and chronic (365 days or longer) exposure durations and for oral and inhalation routes of exposure (4, 5).3.2.12 no-observed-adverse-effect level (NOAEL), nthe highest concentratio
28、n among all the available experimental studies atwhich 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 chemical in air thatmust not be exceeded during any 8-h work shift or 40-h work-week (2).3.2.1
29、4 potential inhaled dose, nthe estimated dose of an airborne chemical that an individual is likely to have inhaled withina specified period of time. It is calculated as the product of air concentration to which an individual is exposed times breathingrate times duration of exposure.3.2.14.1 Discussi
30、onThe potential inhaled dose can be different from the dose actually absorbed by a target organ.3.2.15 short-term exposure, nan exposure of one week or less in duration.3.2.16 short-term exposure limit (STEL), nan American Conference of Governmental and Industrial Hygienists (ACGIH)-recommended 15-m
31、in time-weighted-average air concentration of a chemical that should not be exceeded at any time during aworkday, even if the 8-h time-weighted-average level is within the threshold limit value (TLV) (2).3.2.17 threshold limit value (TLV), nestablished by ACGIH as the recommended time-weighted-avera
32、ge air concentration ofa chemical for a normal 8-h workday and a 40-h work week, to which nearly all workers may be repeatedly exposed withoutadverse effects (2).3.2.18 toxic concentration low (TCLo) , nthe lowest air concentration of a substance introduced by the inhalation route overany period of
33、time that is reported to have produced any significant toxic effects in animals or humans (2).3.2.19 uncertainty factor, na number, greater than unity, to account for incomplete understanding of errors encountered inextrapolating exposure or health effects derived for one set of conditions or basis
34、to another.3.2.19.1 DiscussionAn uncertainty or safety factor is used to account for differences in toxicological effects within a speciesor between two species. For example, a factor of 10 or 100 is used to apply TLVs applicable to workers to a general population.4The boldface numbers in parenthese
35、s refer to the list of references at the end of this standard.D6485 1124. Summary of Guide4.1 This guide presents guidance on conducting risk characterization of short-term exposures to volatile organic chemicalsemitted from new bedding sets in a residential environment. The risk characterization di
36、scussed in this guide is limited to acutehealth and irritant effects of the short-term exposures.4.2 Four major steps in risk assessment include hazard identification, evaluation of health effects data (including dose-responseassessment), exposure assessment, and risk characterization (6, 7). This g
37、uide addresses hazard assessment, evaluation of healtheffects data, and risk characterization. Companion documents (see Practices D6177 and D6178) provide procedures for estimationof human exposure to emissions of VOCs from bedding sets when a new bedding set is first brought into a house.5. Signifi
38、cance and Use5.1 The objective of this guide is to describe procedures and data sources for conducting risk characterization of acute inhalationexposure to chemicals emitted from bedding sets. Risk characterization can be used to identify chemical(s) that pose potentiallysignificant human health ris
39、ks for the scenario(s) and population(s) selected for exposure assessment. Such identification ofchemicals can help in identifying the components or materials used in manufacture of bedding sets that should be further examined.Risk characterization also includes an assessment of potential odor probl
40、ems for any individual chemical emitted by the beddingset.6. Exposure and Effects6.1 Concepts of Exposure and DoseIn very basic terms, exposure is defined as human contact with a chemical or physicalagent (see Terminology E943). Exposure by means of the inhalation route is of interest in this docume
41、nt: It can be expressed asthe product of airborne concentration times duration of exposure, provided that the concentration remains constant during the timeperiod of interest. If the concentration varies over time, then exposure is defined as the area under the curve obtained whenconcentration value
42、s are plotted against time. Exposure is expressed as concentration multiplied by time with resultant units suchas ppm-h or mg/m3-h. Dose is the quantity of chemical or physical agent that enters an organism or target organ (see TerminologyE609), with units such as mg. Dose also can be expressed as r
43、ate, with mass/time units such as mg/day. The dose rate can benormalized in relation to body mass, with units such as mg/kg-day. A specific term that is used in risk characterization is potentialinhaled dosethe product of average concentration in an environment times the duration in the environment
44、times the averagebreathing rate while in the environment, commonly expressed in mass units such as milligrams. Chronic exposure generally refersto a long-term perspective, such as repeated exposures or exposures throughout an individuals lifetime, whereas acute exposurerefers to a short-term perspec
45、tive such as one week, one hour, or even an instantaneous exposure.6.2 Chronic Toxic EffectsIn the United States and in many other countries, two forms of health effects assessment are used,depending on the nature of the toxic effect under consideration: one is used for cancer and the other for toxi
46、c effects other thancancer (7). This is primarily because for cancer (a chronic toxic effect), a threshold for dose-response relationship does not exist,or if one does exist, it is very low and cannot be reliably identified. During the 1970s and 1980s, the emphasis of risk assessmentwas on cancer as
47、 the end point. On the other hand, for toxic effects other than cancer, a standard procedure used for evaluatinghealth effects involves identifying the highest exposure among all experimental studies at which no toxic effect was observed, thatis, the NOAEL. Much of the emphasis related to noncancer
48、effects has been on chronic effects (7). In recent years, however,researchers such as Berglund et al. (8) have been giving increased attention to acute effects by categorizing the effects of indoorair pollutants on human health into groups such as reversible effects including general symptoms such a
49、s headache, inflammatoryirritation such as rashes, and perceptions including odors.6.3 Acute EffectsThe scope of this guide relates to effects of short-term exposure to airborne chemicals in indoor spaces.Specific guidelines available for considering acute effects of exposure to chemicals in air are quite limited. MRLs are derived foracute exposure of 1 to 14 days (4, 5). Other guidelines, such as AEGLs, being developed by the National Advisory CommitteeAcute Exposure Guideline Levels for Hazardous Substances (NAC/AEGLCommittee) are applicable only for
