ASTM D6485-99(2004)
(Guide)Standard Guide for Risk Characterization of Acute and Irritant Effects of Short-Term Exposure to Volatile Organic Chemicals Emitted from Bedding Sets
Standard Guide for Risk Characterization of Acute and Irritant Effects of Short-Term Exposure to Volatile Organic Chemicals Emitted from Bedding Sets
SIGNIFICANCE AND USE
The objective of this guide is to describe procedures and data sources for conducting risk characterization of acute inhalation exposure to chemicals emitted from bedding sets. Risk characterization can be used to identify chemical(s) that pose potentially significant human health risks for the scenario(s) and population(s) selected for exposure assessment. Such identification of chemicals 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 problems for any individual chemical emitted by the bedding set.
SCOPE
1.1 This guide provides guidance to individuals and organizations for conducting risk characterization of exposure 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 residential indoor environment. The risk characterization considerations presented in this guide are applicable to both the general population and sensitive subgroups, such as convalescing adults.
1.3 The risk characterization addressed in this guide is limited to acute health and irritation effects resulting from short-term exposure to VOCs in indoor air. Although certain procedures described in this guide may be applicable to assessing long-term exposure, the guide does not address cancer and other chronic health effects.
1.4 VOC emissions from bedding sets, as in the case of other household furnishings, usually are highest when the products are new. A used bedding set may also emit VOCs, either from the original materials or as a result of its use. The procedures presented in this guide also are applicable to used bedding sets.
1.5 Risk characterization procedures described in this guide should be carried out under the supervision of a qualified toxicologist or risk assessment specialist, or both.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to its use.
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Designation:D6485–99 (Reapproved 2004)
Standard Guide for
Risk Characterization of Acute and Irritant Effects of Short-
Term Exposure to Volatile Organic Chemicals Emitted from
Bedding Sets
This standard is issued under the fixed designation D6485; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
1.1 This guide provides guidance to individuals and orga- 2.1 ASTM Standards:
nizations for conducting risk characterization of exposure to D1356 Terminology Relating to Sampling and Analysis of
volatile organic chemicals (VOCs) emitted from bedding sets Atmospheres
or an ensemble of a mattress and supporting box spring. D6177 Practice for Determining Emission Profiles of Vola-
1.2 This guide is for risk characterization of short-term tile Organic Chemicals Emitted from Bedding Sets
exposures to a new bedding set brought into a residential D6178 Practice for Estimation of Short-term Inhalation
indoor environment. The risk characterization considerations Exposure to Volatile Organic Chemicals Emitted from
presented in this guide are applicable to both the general Bedding Sets
population and sensitive subgroups, such as convalescing E609 Terminology Relating to Pesticides
adults. E943 Terminology Relating to Biological Effects and Envi-
1.3 The risk characterization addressed in this guide is ronmental Fate
limited to acute health and irritation effects resulting from E1542 Terminology Relating to Occupational Health and
short-term exposure to VOCs in indoor air. Although certain Safety
procedures described in this guide may be applicable to 2.2 Government Standards:
assessing long-term exposure, the guide does not address EPA600/R 92/047 Reference Guide to Odor Thresholds for
cancer and other chronic health effects. HazardousAirPollutionintheCleanAirActAmendments
1.4 VOC emissions from bedding sets, as in the case of of 1990
other household furnishings, usually are highest when the 16 CFR 1500 Federal Hazardous Substances Act Regula-
products are new. A used bedding set may also emit VOCs, tions
either from the original materials or as a result of its use. The 29 CFR 1910 Safety and Health Standards for General
procedures presented in this guide also are applicable to used Industry
bedding sets.
3. Terminology
1.5 Risk characterization procedures described in this guide
should be carried out under the supervision of a qualified 3.1 Definitions—For definitions of terms used in this guide,
refer to Terminology D1356.
toxicologist or risk assessment specialist, or both.
1.6 This standard does not purport to address all of the 3.2 Definitions of Terms Specific to This Standard:
3.2.1 acute exposure guideline levels (AEGLs),
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro- n—represent short-term threshold or ceiling exposure values
intended for the protection of the general public, including
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to its use.
1 2
This guide is under the jurisdiction ofASTM Committee D22 on Sampling and For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Analysis of Atmospheres and is the direct responsibility of Subcommittee D22.05 contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
on Indoor Air. Standards volume information, refer to the standard’s Document Summary page on
CurrenteditionapprovedOctober1,2004.PublishedDecember2004.Originally the ASTM website.
approved in 1999. Last previous edition approved in 1999 as D6485 - 99. DOI: Available from Superintendent of Documents, U.S. Government Printing
10.1520/D6485-99R04. Office, Washington, D.C. 20402.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
D6485–99 (2004)
susceptibleorsensitiveindividuals,butnothypersusceptibleor 3.2.11.1 Discussion—MRLs are developed by the Agency
hypersensitive individuals (1). forToxic Substances and Disease Registry (ATSDR).They are
intended to serve as a screening tool to help public health
3.2.1.1 Discussion—AEGLs are for once-in-a-lifetime ex-
posure due to accidental releases. Three AEGLs, each repre- professionals and are derived for acute (1 to 14 days),
intermediate(14to364days),andchronic(365daysorlonger)
senting distinct biological endpoints (sensory irritation or
notable discomfort, irreversible or serious effect, and life- exposure durations and for oral and inhalation routes of
exposure (4, 5).
threatening effects or death) for four different exposure periods
ranging from 30 min to 8 h, are derived. 3.2.12 no-observed-adverse-effect level (NOAEL), n—the
highest concentration among all the available experimental
3.2.2 bedding set, n—an ensemble that includes a mattress
for sleeping and a supporting box spring. studies at which no adverse health or toxic effect is observed
(2).
3.2.3 ceiling, n—a maximum allowable air concentration,
3.2.13 permissible exposure limit (PEL), n—the OSHA-
established by the Occupational Safety and Health Adminis-
mandated time-weighted-average concentration of a chemical
tration (OSHA), that must not be exceeded during any part of
in air that must not be exceeded during any 8-h work shift or
the workday.
40-h work-week (2).
3.2.4 emission profile, n—atime-seriesofemissionratesfor
3.2.14 potential inhaled dose, n—the estimated dose of an
one or more chemicals.
airborne chemical that an individual is likely to have inhaled
3.2.5 hazard index (HI), n—a summation of hazard quo-
within a specified period of time. It is calculated as the product
tients(see3.2.6)forchemicalspotentiallyhavingsimilartarget
of air concentration to which an individual is exposed times
organ effects or for chemicals that are considered to have
breathing rate times duration of exposure.
additive effects.
3.2.14.1 Discussion—The potential inhaled dose can be
3.2.6 hazard quotient (HQ), n—the ratio of the exposure
different from the dose actually absorbed by a target organ.
calculated for a chemical to the toxicity/irritancy threshold or
3.2.15 short-term exposure, n—an exposure of one week or
reference value for that chemical (2).
less in duration.
3.2.6.1 Discussion—If a HQ exceeds a value of 1, there
3.2.16 short-term exposure limit (STEL), n—an American
would be a concern for potential toxic/irritant effects.AHQ is
Conference of Governmental and Industrial Hygienists
not to be interpreted as a statistical probability, for example, a
(ACGIH)-recommended 15-min time-weighted-average air
ratio of 0.001 does not mean that there is a one in a thousand
concentration of a chemical that should not be exceeded at any
chance of an effect occurring.
time during a workday, even if the 8-h time-weighted-average
3.2.7 inhalation reference concentration (RfC), n—an esti-
level is within the threshold limit value (TLV) (2).
mate (with uncertainty spanning an order of magnitude) of the
3.2.17 threshold limit value (TLV), n—established by
daily exposure to the human population (including sensitive
ACGIH as the recommended time-weighted-average air con-
subgroups) that is likely to be without an appreciable risk of
centration of a chemical for a normal 8-h workday and a 40-h
deleterious effects (2).
work week, to which nearly all workers may be repeatedly
3.2.7.1 Discussion—The time period under consideration is
exposed without adverse effects (2).
up to and including seven years, or a portion of a lifetime, for
3.2.18 toxic concentration low (TCL ), n—the lowest air
o
subchronic RfC and a lifetime for chronic RfC. In accordance
concentration of a substance introduced by the inhalation route
with the U.S. Environmental ProtectionAgency (EPA) (3), the
over any period of time that is reported to have produced any
uncertainty in the estimates for RfC spans an order of magni-
significant toxic effects in animals or humans (2).
tude.
3.2.19 uncertainty factor, n—a number, greater than unity,
3.2.8 lethal concentration 50 (LC ), n—a calculated air
to account for incomplete understanding of errors encountered
concentrationofasubstanceforwhichinhalationisexpectedto
in extrapolating exposure or health effects derived for one set
cause the death of 50 % of an experimental animal population
of conditions or basis to another.
(2).
3.2.19.1 Discussion—Anuncertaintyorsafetyfactorisused
3.2.9 lethal concentration low (LCL ), n—the lowest air
o
to account for differences in toxicological effects within a
concentration of a substance introduced by the inhalation route
species or between two species. For example, a factor of 10 or
over any period of time that is reported to have caused death in
100 is used to apply TLVs applicable to workers to a general
humans or animals (2).
population.
3.2.10 lowest-observed-adverse effect level (LOAEL),
n—the lowest exposure at which there is a significant increase
4. Summary of Guide
in an observable effect.
4.1 This guide presents guidance on conducting risk char-
3.2.11 minimal risk level (MRL), n—anestimateofthedaily
acterization of short-term exposures to volatile organic chemi-
human exposure to a hazardous substance that is likely to be
cals emitted from new bedding sets in a residential environ-
without appreciable risk of adverse noncancer health effects
ment. The risk characterization discussed in this guide is
over a specified duration of exposure.
limited to 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
The boldface numbers in parentheses refer to the list of references at the end of
this standard. dose-response assessment), exposure assessment, and risk
D6485–99 (2004)
characterization (6, 7). This guide addresses hazard assess- Much of the emphasis related to noncancer effects has been on
ment, evaluation of health effects data, and risk characteriza- chronic effects (7). In recent years, however, researchers such
tion. Companion documents (see Practices D6177 and D6178) as Berglund et al. (8) have been giving increased attention to
provide procedures for estimation of human exposure to acute effects by categorizing the effects of indoor air pollutants
emissions of VOCs from bedding sets when a new bedding set on human health into groups such as reversible effects includ-
is first brought into a house. ing general symptoms such as headache, inflammatory irrita-
tion such as rashes, and perceptions including odors.
5. Significance and Use
6.3 Acute Effects—The scope of this guide relates to effects
5.1 Theobjectiveofthisguideistodescribeproceduresand
of short-term exposure to airborne chemicals in indoor spaces.
data sources for conducting risk characterization of acute
Specific guidelines available for considering acute effects of
inhalation exposure to chemicals emitted from bedding sets.
exposure to chemicals in air are quite limited. MRLs are
Risk characterization can be used to identify chemical(s) that
derived for acute exposure of 1 to 14 days (4, 5). Other
pose potentially significant human health risks for the sce-
guidelines, such as AEGLs, being developed by the National
nario(s) and population(s) selected for exposure assessment.
Advisory Committee Acute Exposure Guideline Levels for
Such identification of chemicals can help in identifying the
Hazardous Substances (NAC/AEGL Committee) are appli-
components or materials used in manufacture of bedding sets cable only for one-time, short-term hazardous exposures dur-
that should be further examined. Risk characterization also
ing chemical emergency situations (1). EPA’s non-chronic
includes an assessment of potential odor problems for any RfCs are not for acute exposure but for subchronic exposures
individual chemical emitted by the bedding set.
of less than seven years (3).
6. Exposure and Effects
7. Procedures for Hazard Identification
6.1 Concepts of Exposure and Dose—In very basic terms,
7.1 Identification of Chemicals:
exposure is defined as human contact with a chemical or
7.1.1 Compile a list of target chemicals that are identified
physical agent (see Terminology E943). Exposure by means of
throughscreeningtestsofemissions.Targetchemicalsaretobe
the inhalation route is of interest in this document: It can be
selected by a qualified toxicologist or a risk assessment
expressed as the product of airborne concentration times
specialist based on their presence in the screening samples and
duration of exposure, provided that the concentration remains
their expected irritant or health effects. Information on proce-
constant during the time period of interest. If the concentration
dures for emissions testing, including screening samples, is
varies over time, then exposure is defined as the area under the
given in Practice D6177.Alist of target chemicals included in
curve obtained when concentration values are plotted against
the prior research on bedding sets is given in Table X1.1 (2).
time. Exposure is expressed as concentration multiplied by
7.1.2 All target chemicals for which emissions data have
time with resultant units such as ppm-h or mg/m -h. Dose is
been collected are of interest, even those whose measured air
the quantity of chemical or physical agent that enters an
concentrations are below their respective detection limits.
organism or target organ (see Terminology E609), with units
NOTE 1—In prior research, risk characterization of exposure to chemi-
suchasmg.Dosealsocanbeexpressedasrate,withmass/time
cals with concentrations below their detection limits was conducted by
units such as mg/day. The dose rate can be normalized in
assuming that the respective air concentrations were one half of the
relation to body mass, with units such as mg/kg-day.Aspecific
detection limit (2).
term that is used in risk characterization is potential inhaled
7.2 Compilation of Inhalation Toxicity and Odor
dose—the product of average concentration in an environment
times the duration in the environment times the average Thresholds—Using data sources listed in 7.3, collect and
compile the following information for each chemical:
breathing rate while in the environment, commonly expressed
in mass units such as milligrams. Chronic exposure generally 7.2.1 Exposure levels reported to produce adverse health
effects in humans,
referstoalong-termperspective,suchasrepeatedexposuresor
exposures throughout an individual’s lifetime, whe
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