1、Designation: D6485 11D6485 18Standard 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 the designation indicates the y
2、ear 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 guidance to individuals and organ
3、izations describes procedures for conducting risk characterization ofexposure to volatile organic 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 brought into a
4、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 effects re
5、sulting from short-termexposure to VOCs in indoor air. Although certain procedures described in this guide may be applicable to assessing long-termexposure, the guide doesis not intended to address cancer and other chronic health effects.1.4 VOC emissions from bedding sets, as in the case of other h
6、ousehold furnishings, usually are highest when the products arenew.Aused 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
7、 guide should be carried out under the supervision of a qualifiedtoxicologist or risk assessment specialist, or both.1.6 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 safety, health, and healthenvironmental practices and determine theapplicability of regulatory limitations prior to its use.1.8 This international standard was devel
9、oped in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Referenced Documen
10、ts2.1 ASTM Standards:2D1356 Terminology Relating 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 B
11、edding SetsE609 Terminology Relating to PesticidesE943 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 Pollutants Lis
12、ted in the Clean Air ActAmendments of 19901 This guide is under the jurisdiction of ASTM Committee D22 on Air Quality and is the direct responsibility of Subcommittee D22.05 on Indoor Air.Current edition approved March 1, 2011April 15, 2018. Published March 2011May 2018. Originally approved in 1999.
13、 Last previous edition approved in 20042011 asD6485 99 (2004).D6485 11. DOI: 10.1520/D6485-11.10.1520/D6485-18.2 For 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 st
14、andards Document Summary page on the ASTM website.3 Available from U.S. Government Printing Office, Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401,20401-0001,http:/www.access.gpo.gov.This document is not an ASTM standard and is intended only to provide the
15、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 current versionof the standard
16、 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 States116 CFR 1500 Federal Hazardous Substances Act Regulations29 CFR 1910 Occupational Safety and Health Standards for General I
17、ndustry3. Terminology3.1 DefinitionsFor definitions of terms used in this guide, refer to Terminology D1356.D6485 1823.2 Definitions of Terms Specific to This Standard:3.2.1 acute exposure guideline levels (AEGLs), nrepresent short-term threshold or ceiling exposure values intended for theprotection
18、 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 releases. Three AEGLs, each representing distinct biologicalendpoints (sensory irritation o
19、r notable discomfort, irreversible or serious effect, and life-threatening effects or death) for fourdifferent exposure periods ranging from 30 min to 8 h, are derived.3.2.2 bedding set, nan ensemble that includes a mattress for sleeping and a supporting box spring.3.2.3 ceiling, ceiling limit, na m
20、aximum allowable air concentration, established by the Occupational Safety and HealthAdministration (OSHA), that must not be exceeded during any part of the workday.3.2.4 emission profile, na time-series of emission rates for one or more chemicals.3.2.5 hazard index (HI), na summation of hazard quot
21、ients (see3.2.6) 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 toxicity/irritancy threshold or referencevalue for that chemical chemica
22、l.(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 to be interpreted as astatistical probability, for example, a ratio of 0.001 does not mean that there is a one in a thousand chance of an effect occurring.3.2.7 inhalation
23、 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 deleteriouseffects effects.(2).3.2.7.1 DiscussionThe time period under consi
24、deration is up to and including seven years, or a portion of a lifetime, for subchronic RfC and a lifetimefor chronic RfC. In accordance with the U.S. Environmental Protection Agency (EPA) (32), the uncertainty in the estimates forRfC spans an order of magnitude.3.2.8 lethal concentration 50 (LC50),
25、 na calculated air concentration of a substance for which inhalation chemical in air towhich exposure for a specific length of time is expected to cause the death of 50 % of an experimental animal population deathin 50 % of a defined experimental animal population.(2).3.2.9 lethal concentration low
26、(LCLo),nthe lowest aircalculated concentration of a substance introduced by the inhalationroutechemical in air to which exposure over any period of time that is reported to have caused death in humans or animalsanimals.(2).3.2.10 lowest-observed-adverse effect level (LOAEL), nthe lowest exposure at
27、which there is a significant increase in anobservable effect.dose of a chemical in a study or group of studies that produces statistically or biologically significant increasesin frequency or severity of adverse effects between the exposed population and its appropriate control.3.2.11 minimal risk l
28、evel (MRL), nan estimate of the daily 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 theAgency forToxic Substances and Disease Registry (ATSDR).The
29、y are intended to serve as a screeningtool to help public health professionals and are derived for acute (1 to 14 days), intermediate (14 to 364 days), and chronic (365days or longer) exposure durations and for oral and inhalation routes of exposure (43, 54).3.2.12 no-observed-adverse-effect level (
30、NOAEL), nthe highest concentration among all the available experimental studies atwhich no adverse health or toxic effect is observedthat dose of a chemical at which there are no statistically or biologicallysignificant increases in (frequency2). or severity of adverse effects seen between the expos
31、ed population and its appropriate control.4 The boldface numbers in parentheses refer to the list of references at the end of this standard.D6485 1833.2.12.1 DiscussionEffects may be produced at this dose, but they are not considered to be adverse.3.2.13 permissible exposure limit (PEL), nthe OSHA-m
32、andated 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).3.2.13 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 ca
33、lculated as the product of air concentration to which an individual is exposed times breathingrate times duration of exposure.3.2.13.1 DiscussionIt is calculated as the product of air concentration to which an individual is exposed times breathing rate times duration of exposure.The potential inhale
34、d dose can be different from the dose actually absorbed by a target organ.3.2.14 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-min time-weighted-avera
35、ge 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-average air concentration o
36、fa 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).3.2.15 toxic concentration low (TCLo),nthe lowest air concentration of a substance introduced by the inhalation route over anyperiod of time that is reported to
37、 have produced any significant toxic effects in animals or humans humans.(2).3.2.16 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 to another.3.2.16
38、.1 DiscussionAn uncertainty or safety factor is used to account for differences in toxicological effects within a species or between two species.For example, a factor of 10 or 100 is used to apply TLVs applicable to workers to a general population.in the calculation of anRfC to account for uncertain
39、ties in the extrapolation from the experimental data and exposure conditions.4. Summary of Guide4.1 This guide presents guidance ondescribes procedures for conducting risk characterization of short-term exposures to volatileorganic chemicals VOCs emitted from new bedding sets in a residential enviro
40、nment. The risk characterization discussed in thisguide is limited to addresses acute health 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 assessm
41、ent, and risk characterization (65, 76). This guide 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 beddi
42、ng set is first brought into a house.5. Significance 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) th
43、at pose potentiallysignificant human health risks for the scenario(s) and population(s) selected for exposure assessment. Such identification ofchemicals can help in identifying the components or materials used in the manufacture of bedding sets that should be furtherexamined. Risk characterization
44、also includes an assessment of potential odor problems for any individual chemicalodorsassociated with individual chemicals 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 or physicalagent (s
45、ee Terminology E943). Exposure by means of the inhalation route is of interest in this document: 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 ove
46、r time, then exposure is defined as the area under the curve obtained whenconcentration values 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
47、or target organ (see TerminologyD6485 184E609E943), with units such as mg. Dose also can be expressed as rate, with mass/time units such as mg/day. The dose rate canbe normalized in relation to body mass, with units such as mg/kg-day. A specific term that is used in risk characterization ispotential
48、 inhaled dosethe product of average concentration in an environment times the duration in the environment times theaverage breathing rate while in the environment, commonly expressed in mass units such as milligrams. Chronic exposuregenerally refers to a long-term perspective, such as repeated expos
49、ures or exposures throughout an individuals lifetime, whereasacute exposure refers to a short-term perspective 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 toxic effects other thancancer (76). This is primarily because for cancer (a chronic toxic effect), a threshold for dose-response relationship does
