ASTM D6485-99

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Designation:D6485–99
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 D 6485; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope D 6177 Practice for Determining Emission Profiles ofVola-
tile Organic Chemicals Emitted from Bedding Sets
1.1 This guide provides guidance to individuals and orga-
D 6178 Practice for Estimation of Short-Term Inhalation
nizations for conducting risk characterization of exposure to
Exposure to Volatile Organic Chemicals Emitted from
volatile organic chemicals (VOCs) emitted from bedding sets
Bedding Sets
or an ensemble of a mattress and supporting box spring.
E 609 Terminology Relating to Pesticides
1.2 This guide is for risk characterization of short-term
E 943 Terminology Relating to Biological Effects and En-
exposures to a new bedding set brought into a residential
vironmental Fate
indoor environment. The risk characterization considerations
E 1542 Terminology Relating to Occupational Health and
presented in this guide are applicable to both the general
Safety
population and sensitive subgroups, such as convalescing
2.2 Government Standards:
adults.
EPA600/R 92/047 Reference Guide to Odor Thresholds for
1.3 The risk characterization addressed in this guide is
HazardousAirPollutionintheCleanAirActAmendments
limited to acute health and irritation effects resulting from
of 1990
short-term exposure to VOCs in indoor air. Although certain
16 CFR 1500 Federal Hazardous Substances Act Regula-
procedures described in this guide may be applicable to
tions
assessing long-term exposure, the guide does not address
29 CFR 1910 Safety and Health Standards for General
cancer and other chronic health effects.
Industry
1.4 VOC emissions from bedding sets, as in the case of
other household furnishings, usually are highest when the
3. Terminology
products are new. A used bedding set may also emit VOCs,
3.1 Definitions—For definitions of terms used in this guide,
either from the original materials or as a result of its use. The
refer to Terminology D 1356.
procedures presented in this guide also are applicable to used
3.2 Definitions of Terms Specific to This Standard:
bedding sets.
3.2.1 acute exposure guideline levels (AEGLs),
1.5 Risk characterization procedures described in this guide
n—represent short-term threshold or ceiling exposure values
should be carried out under the supervision of a qualified
intended for the protection of the general public, including
toxicologist or risk assessment specialist, or both.
susceptibleorsensitiveindividuals,butnothypersusceptibleor
1.6 This standard does not purport to address all of the
hypersensitive individuals (1).
safety concerns, if any, associated with its use. It is the
3.2.1.1 Discussion—AEGLs are for once-in-a-lifetime ex-
responsibility of the user of this standard to establish appro-
posure due to accidental releases. Three AEGLs, each repre-
priate safety and health practices and determine the applica-
senting distinct biological endpoints (sensory irritation or
bility of regulatory limitations prior to its use.
notable discomfort, irreversible or serious effect, and life-
2. Referenced Documents threatening effects or death) for four different exposure periods
ranging from 30 min to 8 h, are derived.
2.1 ASTM Standards:
3.2.2 bedding set, n—an ensemble that includes a mattress
D 1356 Terminology Relating to Sampling and Analysis of
for sleeping and a supporting box spring.
Atmospheres
1 3
This test method is under the jurisdiction of ASTM Committee D-22 on Annual Book of ASTM Standards, Vol 11.05.
Sampling and Analysis of Atmospheres and is the direct responsibility of Subcom- Available from Superintendent of Documents, U.S. Government Printing
mittee D22.05 on Indoor Air. Office, Washington, D.C. 20402.
Current edition approved Nov. 10, 1999. Published February 2000. The boldface numbers in parentheses refer to the list of references at the end of
Annual Book of ASTM Standards, Vol 11.03. this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
D6485–99
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
in air that must not be exceeded during any 8-h work shift or
tration (OSHA), that must not be exceeded during any part of
40-h work-week (2).
the workday.
3.2.14 potential inhaled dose, n—the estimated dose of an
3.2.4 emission profile, n—atime-seriesofemissionratesfor
airborne chemical that an individual is likely to have inhaled
one or more chemicals.
within a specified period of time. It is calculated as the product
3.2.5 hazard index (HI), n—a summation of hazard quo-
of air concentration to which an individual is exposed times
tients(see3.2.6)forchemicalspotentiallyhavingsimilartarget
breathing rate times duration of exposure.
organ effects or for chemicals that are considered to have
3.2.14.1 Discussion—The potential inhaled dose can be
additive effects.
different from the dose actually absorbed by a target organ.
3.2.6 hazard quotient (HQ), n—the ratio of the exposure
3.2.15 short-term exposure, n—an exposure of one week or
calculated for a chemical to the toxicity/irritancy threshold or
less in duration.
reference value for that chemical (2).
3.2.16 short-term exposure limit (STEL), n—an American
Conference of Governmental and Industrial Hygienists
3.2.6.1 Discussion—If a HQ exceeds a value of 1, there
(ACGIH)-recommended 15-min time-weighted-average air
would be a concern for potential toxic/irritant effects.AHQ is
concentration of a chemical that should not be exceeded at any
not to be interpreted as a statistical probability, for example, a
time during a workday, even if the 8-h time-weighted-average
ratio of 0.001 does not mean that there is a one in a thousand
level is within the threshold limit value (TLV) (2).
chance of an effect occurring.
3.2.17 threshold limit value (TLV), n—established by
3.2.7 inhalation reference concentration (RfC), n—an esti-
ACGIH as the recommended time-weighted-average air con-
mate (with uncertainty spanning an order of magnitude) of the
centration of a chemical for a normal 8-h workday and a 40-h
daily exposure to the human population (including sensitive
work week, to which nearly all workers may be repeatedly
subgroups) that is likely to be without an appreciable risk of
exposed without adverse effects (2).
deleterious effects (2).
3.2.18 toxic concentration low (TCL ), n—the lowest air
o
3.2.7.1 Discussion—The time period under consideration is
concentration of a substance introduced by the inhalation route
up to and including seven years, or a portion of a lifetime, for
over any period of time that is reported to have produced any
subchronic RfC and a lifetime for chronic RfC. In accordance
significant toxic effects in animals or humans (2).
with the U.S. Environmental ProtectionAgency (EPA) (3), the
3.2.19 uncertainty factor, n—a number, greater than unity,
uncertainty in the estimates for RfC spans an order of magni- to account for incomplete understanding of errors encountered
tude. in extrapolating exposure or health effects derived for one set
of conditions or basis to another.
3.2.8 lethal concentration 50 (LC ), n—a calculated air
3.2.19.1 Discussion—Anuncertaintyorsafetyfactorisused
concentrationofasubstanceforwhichinhalationisexpectedto
to account for differences in toxicological effects within a
cause the death of 50 % of an experimental animal population
species or between two species. For example, a factor of 10 or
(2).
100 is used to apply TLVs applicable to workers to a general
3.2.9 lethal concentration low (LCL ), n—the lowest air
o
population.
concentration of a substance introduced by the inhalation route
over any period of time that is reported to have caused death in
4. Summary of Guide
humans or animals (2).
4.1 This guide presents guidance on conducting risk char-
3.2.10 lowest-observed-adverse effect level (LOAEL),
acterization of short-term exposures to volatile organic chemi-
n—the lowest exposure at which there is a significant increase
cals emitted from new bedding sets in a residential environ-
in an observable effect. ment. The risk characterization discussed in this guide is
limited to acute health and irritant effects of the short-term
3.2.11 minimal risk level (MRL), n—anestimateofthedaily
exposures.
human exposure to a hazardous substance that is likely to be
4.2 Four major steps in risk assessment include hazard
without appreciable risk of adverse noncancer health effects
identification, evaluation of health effects data (including
over a specified duration of exposure.
dose-response assessment), exposure assessment, and risk
3.2.11.1 Discussion—MRLs are developed by the Agency
characterization (6, 7). This guide addresses hazard assess-
forToxic Substances and Disease Registry (ATSDR).They are
ment, evaluation of health effects data, and risk characteriza-
intended to serve as a screening tool to help public health
tion. Companion documents (see Practices D 6177 and
professionals and are derived for acute (1 to 14 days),
D 6178) provide procedures for estimation of human exposure
intermediate(14to364days),andchronic(365daysorlonger)
to emissions of VOCs from bedding sets when a new bedding
exposure durations and for oral and inhalation routes of
set is first brought into a house.
exposure (4, 5).
5. Significance and Use
3.2.12 no-observed-adverse-effect level (NOAEL), n—the
highest concentration among all the available experimental 5.1 The objective of this guide is to describe procedures and
studies at which no adverse health or toxic effect is observed
data sources for conducting risk characterization of acute
(2). inhalation exposure to chemicals emitted from bedding sets.
D6485–99
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
physicalagent(seeTerminologyE 943).Exposurebymeansof
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 D 6177.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 E 609), with units
such as mg. Dose also can be expressed as rate, with mass/time
NOTE 1—In prior research, risk characterization of exposure to chemi-
units such as mg/day. The dose rate can be normalized in
cals with concentrations below their detection limits was conducted by
relation to body mass, with units such as mg/kg-day.Aspecific
assuming that the respective air concentrations were one half of the
term that is used in risk characterization is potential inhaled
detection limit (2).
dose—the product of average concentration in an environment
7.2 Compilation of Inhalation Toxicity and Odor
times the duration in the environment times the average
Thresholds—Using data sources listed in 7.3, collect and
breathing rate while in the environment, commonly expressed
compile the following information for each chemical:
in mass units such as milligrams. Chronic exposure generally
7.2.1 Exposure levels reported to produce adverse health
referstoalong-termperspective,suchasrepeatedexposuresor
effects in humans,
exposures throughout an individual’s lifetime, whereas acute
7.2.2 Human exposure limits specified in regulatory stan-
exposure refers to a short-term perspective such as one week,
dards and guidelines,
one hour, or even an instantaneous exposure.
6.2 Chronic Toxic Effects—IntheUnitedStatesandinmany
7.2.3 Toxicological values for experimental mammals, and
other countries, two forms of health effects assessment are
7.2.4 Human odor threshold values.
used, depending on the nature of the toxic effect under
7.3 Data Sources for Health Effect, Toxicity, and Odor
consideration: one is used for cancer and the other for toxic
Threshold Information:
effects other than cancer (7). This is primarily because for
7.3.1 The major and primary source of published toxicity
cancer (a chronic toxic effect), a threshold for dose-response
information is the National Library of Medicine’s (NLM)
relationship does not exist, or if one does exist, it is very low
TOXNET system. There a
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