ASTM E1023-84(2007)
(Guide)Standard Guide for Assessing the Hazard of a Material to Aquatic Organisms and Their Uses
Standard Guide for Assessing the Hazard of a Material to Aquatic Organisms and Their Uses
SIGNIFICANCE AND USE
Adverse effects on natural populations of aquatic organisms and their uses have demonstrated the need to assess the hazards of many new, and some presently used, materials. The process described herein will help producers, users, regulatory agencies, and others to efficiently and adequately compare alternative materials, completely assess a final candidate material, or reassess the hazard of a material already in use.
Sequential assessment and feedback allow appropriate judgments concerning efficient use of resources, thereby minimizing unnecessary testing and focusing effort on the information most pertinent to each material. For different materials and situations, assessment of hazard will appropriately be based on substantially different amounts and kinds of biological, chemical, physical, and toxicological data.
Assessment of the hazard of a material to aquatic organisms and their uses should never be considered complete for all time. Reassessment should be considered if the amount of production, use, or disposal increases, new uses are discovered, or new information on biological, chemical, physical, or toxicological properties becomes available. Periodic review will help assure that new circumstances and information receive prompt appropriate attention.
If there is substantial transformation to another material, the hazard of both materials may need to be assessed.
In many cases, consideration of adverse effects should not end with completion of the hazard assessment. Additional steps should often include risk assessment, decisions concerning acceptability of identified hazards and risks, and mitigative actions.
Because this practice deals mostly with adverse effects on aquatic organisms and their uses, it is important that mitigative actions, such as improved treatment of aqueous effluents, not result in unacceptable effects on non-aquatic organisms. Thus, this standard should be used with other information in order to assess hazard to both aquatic ...
SCOPE
1.1 This guide describes a stepwise process for using information concerning the biological, chemical, physical, and toxicological properties of a material to identify adverse effects likely to occur to aquatic organisms and their uses as a result of release of the material to the environment. The material will usually be a specific chemical, although it might be a group of chemicals that have very similar biological, chemical, physical, and toxicological properties and are usually produced, used, and discarded together.
1.2 The hazard assessment process is complex and requires decisions at a number of points; thus, the validity of a hazard assessment depends on the soundness of those decisions, as well as the accuracy of the information used. All decisions should be based on reasonable worst-case analyses so that an appropriate assessment can be completed for the least cost that is consistent with scientific validity.
1.3 This guide assumes that the reader is knowledgeable in aquatic toxicology and related pertinent areas. A list of general references is provided ().
1.4 This guide does not describe or reference detailed procedures for estimating or measuring environmental concentrations, or procedures for determining the maximum concentration of test material that is acceptable in the food of predators of aquatic life. However, this guide does describe how such information should be used when assessing the hazard of a material to aquatic organisms and their uses.
1.5 Because assessment of hazard to aquatic organisms and their uses is a relatively new activity within aquatic toxicology, most of the guidance provided herein is qualitative rather than quantitative. When possible, confidence limits should be calculated and taken into account.
1.6 This guide provides guidance for assessing hazard but does not provide guidance on how to take into account social considerations in order to judge the acceptability of the h...
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Designation: E1023 − 84(Reapproved 2007)
Standard Guide for
Assessing the Hazard of a Material to Aquatic Organisms
and Their Uses
This standard is issued under the fixed designation E1023; 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 quantitative. When possible, confidence limits should be cal-
culated and taken into account.
1.1 This guide describes a stepwise process for using
1.6 This guide provides guidance for assessing hazard but
information concerning the biological, chemical, physical, and
does not provide guidance on how to take into account social
toxicologicalpropertiesofamaterialtoidentifyadverseeffects
considerations in order to judge the acceptability of the hazard.
likelytooccurtoaquaticorganismsandtheirusesasaresultof
Judgments concerning acceptability are social as well as
release of the material to the environment. The material will
scientific, and are outside the scope of this guide.
usually be a specific chemical, although it might be a group of
chemicalsthathaveverysimilarbiological,chemical,physical,
1.7 This guide is arranged as follows:
and toxicological properties and are usually produced, used,
Section
and discarded together.
Referenced Documents 2
Descriptions of Terms Specific to This Standard 3
1.2 The hazard assessment process is complex and requires
Summary of Guide 4
decisions at a number of points; thus, the validity of a hazard Significance and Use 5
Four Basic Concepts 6
assessment depends on the soundness of those decisions, as
The Iteration 6.1
well as the accuracy of the information used. All decisions
The Two Elements 6.2
The Possible Decisions 6.3
should be based on reasonable worst-case analyses so that an
The Phased Approach 6.4
appropriate assessment can be completed for the least cost that
Phase I—Use of Low-Cost (Existing) Information 7
is consistent with scientific validity.
Collection of Available Data 7.1
Initial Estimates of Environmental Concentrations 7.2
1.3 This guide assumes that the reader is knowledgeable in
Initial Estimate of Toxicity to Aquatic Organisms 7.3
aquatic toxicology and related pertinent areas.Alist of general
Initial Estimate of Bioaccumulation by Aquatic Organ-
isms 7.4
references is provided (1).
Phase I Hazard Assessment 7.5
1.4 This guide does not describe or reference detailed Phase II—Use of Medium-Cost Information 8
Improved Estimates of Environmental Concentrations 8.2
procedures for estimating or measuring environmental
Acute Toxicity to Aquatic Animals 8.3
concentrations, or procedures for determining the maximum
Toxicity to Algae 8.4
Expansion of Short-Term Testing 8.5
concentration of test material that is acceptable in the food of
Bioaccumulation 8.6
predators of aquatic life. However, this guide does describe
Phase II Hazard Assessment 8.7
how such information should be used when assessing the
Phase III—Use of High-Cost Information 9
hazard of a material to aquatic organisms and their uses. Refined Estimates of Environmental Concentrations 9.2
Chronic Toxicity to Aquatic Animals 9.3
1.5 Because assessment of hazard to aquatic organisms and
Use of Acute-Chronic Ratios 9.4
Toxicity to Aquatic Plants 9.5
their uses is a relatively new activity within aquatic toxicology,
Bioconcentration 9.6
most of the guidance provided herein is qualitative rather than
Bioaccumulation from Food 9.7
Phase III Hazard Assessment 9.8
Appendixes
Appendix X1 Production, Use, Disposal, and Other Release
ThisguideisunderthejurisdictionofASTMCommitteeE50onEnvironmental Appendix X2 Biological Considerations
Appendix X3 Chemical Considerations
Assessment, Risk Management and CorrectiveAction and is the direct responsibil-
Appendix X4 Physical Considerations
ity of Subcommittee E50.47 on Biological Effects and Environmental Fate.
Appendix X5 Toxicological Considerations
Current edition approved Oct. 1, 2007. Published October 2007. Originally
Appendix X6 Estimating Environmental Concentrations
approved in1984.Lastpreviouseditionapprovedin 2002asE1023-84(2002). DOI:
Appendix X7 Selection of Test Species
10.1520/E1023-84R07.
Appendix X8 Long-Term Toxicity Tests
Boldface numbers in parentheses refer to the list of references at the end of this
standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1023 − 84 (2007)
1.8 This standard does not purport to address all of the 3.1.7 safety factor—the quotient of a toxicologically signifi-
safety concerns, if any, associated with its use. It is the cant concentration divided by an appropriate EnC.
responsibility of the user of this standard to establish appro-
3.2 For definitions of other terms used in this guide, refer to
priate safety and health practices and determine the applica-
Terminology E943 and D1129, Guides E724 and E729, and
bility of regulatory limitations prior to use.
Practice E1022. For an explanation of units and symbols, refer
to IEEE/SI 10.
2. Referenced Documents
2.1 ASTM Standards:
4. Summary of Guide
D1129 Terminology Relating to Water
4.1 This guide describes an iterative process for assessing
E724 Guide for Conducting Static Acute Toxicity Tests
the hazard of a material to aquatic organisms and their uses by
Starting with Embryos of Four Species of Saltwater
considering the relationship between the material’s measured
Bivalve Molluscs
or estimated environmental concentration(s) and the adverse
E729 Guide for Conducting Acute Toxicity Tests on Test
effects likely to result. Unavailable necessary information
Materials with Fishes, Macroinvertebrates, and Amphib-
concerningenvironmentalconcentrationsandadverseeffectsis
ians
obtained through a stepwise program that starts with inexpen-
E943 Terminology Relating to Biological Effects and Envi-
sive information and progresses to expensive information if
ronmental Fate
necessary. At the end of each iteration the estimated or
E1022 Guide for Conducting Bioconcentration Tests with
measured environmental concentration(s) are compared with
Fishes and Saltwater Bivalve Mollusks
information on possible adverse effects to determine the
IEEE/SI 10 American National Standard for Use of the
adequacy of the available data for assessing hazard. If it is not
International System of Units (SI): The Modern Metric
possibletoconcludethathazardiseitherminimalorpotentially
System
excessive, the available data are judged inadequate to charac-
terize the hazard. If desired, appropriate additional information
3. Terminology
isidentifiedandobtained,sothathazardcanbereassessed.The
3.1 Definitions of Terms Specific to This Standard:
processisrepeateduntilthehazardisadequatelycharacterized.
3.1.1 acute-chronic ratio—the quotient of an appropriate
measure of the acute toxicity (usually the 96-h LC50) of a
5. Significance and Use
materialtoaspeciesdividedbytheresultofalife-cycle,partial
5.1 Adverse effects on natural populations of aquatic organ-
life-cycle, or early life-stage test in the same water on the same
isms and their uses have demonstrated the need to assess the
material with the same species.
hazards of many new, and some presently used, materials. The
3.1.2 bioaccumulation—the net uptake of a material from
process described herein will help producers, users, regulatory
water and from food.
agencies, and others to efficiently and adequately compare
3.1.3 environmental concentration (EnC)—the
alternative materials, completely assess a final candidate
concentration, duration, form, and location of a material in
material, or reassess the hazard of a material already in use.
environmental waters, sediments, or the food of aquatic organ-
5.2 Sequential assessment and feedback allow appropriate
isms.
judgments concerning efficient use of resources, thereby mini-
3.1.4 hazard assessment—the identification of the adverse
mizing unnecessary testing and focusing effort on the informa-
effects likely to result from specified releases(s) of a material.
tionmostpertinenttoeachmaterial.Fordifferentmaterialsand
3.1.5 maximum acceptable toxicant concentration
situations, assessment of hazard will appropriately be based on
(MATC)—the highest concentration of a material that would
substantially different amounts and kinds of biological,
have no statistically significant observed adverse effect on the
chemical, physical, and toxicological data.
survival, growth, or reproduction of the test species during
5.3 Assessment of the hazard of a material to aquatic
continuous exposure throughout a life-cycle or partial life-
organisms and their uses should never be considered complete
cycletoxicitytest.SuchtestsusuallyindicatethattheMATCis
for all time. Reassessment should be considered if the amount
between two tested concentrations.
of production, use, or disposal increases, new uses are
3.1.6 no-observed-effect concentration (NOEC)—the high-
discovered, or new information on biological, chemical,
est tested concentration of a material at which the measured
physical, or toxicological properties becomes available. Peri-
parameters of a specific population of test organisms under test
odic review will help assure that new circumstances and
conditions show no statistically significant adverse difference
information receive prompt appropriate attention.
from the control treatment. When derived from a life-cycle or
5.4 If there is substantial transformation to another material,
partial life-cycle test, it is the same as the lower limit on the
the hazard of both materials may need to be assessed.
MATC.
5.5 In many cases, consideration of adverse effects should
not end with completion of the hazard assessment. Additional
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
steps should often include risk assessment, decisions concern-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
ing acceptability of identified hazards and risks, and mitigative
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. actions.
E1023 − 84 (2007)
5.6 Because this practice deals mostly with adverse effects assessed.EnCsmayaidinselectingappropriateaquaticspecies
on aquatic organisms and their uses, it is important that to be used in tests, identifying and designing tests to be
mitigative actions, such as improved treatment of aqueous conducted, choosing test concentrations, and interpreting re-
effluents, not result in unacceptable effects on non-aquatic sults. Determination of EnCs should take into account not only
organisms. Thus, this standard should be used with other all pertinent probable means of release, but also dilution,
information in order to assess hazard to both aquatic and transport and transformations, sinks and concentrating
non-aquatic organisms. mechanisms, and degradation and degradation products.
6.2.2 Thesecondelementessentialtoassessinghazardisthe
6. Four Basic Concepts
possible adverse effects on aquatic organisms and their uses.
6.1 The Iteration (see Fig. 1)—The basic principle used in For convenience, such effects can be placed in four categories:
this hazard assessment process is the repetitive or iterative
6.2.2.1 Acute and chronic toxicity to aquatic animals,
comparison of measured or estimated EnCs of a material with
6.2.2.2 Effects on uses of aquatic organisms, including such
concentrations that cause adverse effects. When available data
effects as flavor impairment and accumulation of unacceptable
are judged inadequate, needed data are identified. Unless the
residues,
hazard assessment is terminated, necessary additional informa-
6.2.2.3 Effects on aquatic plants, including toxicity and
tionisobtainedandusedwithallotherpertinentinformationto
stimulation, and
reassess hazard. The process is repeated until hazard is
6.2.2.4 Other effects on aquatic animals, such as avoidance.
adequately characterized.
6.3 Possible Decisions:
6.2 Two Elements:
6.2.1 The first element in assessing the hazard of a material 6.3.1 In each iteration, information concerning possible
to aquatic organisms and their uses is the EnCs of the material. adverse effects is used to decide whether the hazard due to a
For some existing materials the EnCs may be measured, but in particular EnC is minimal, potentially excessive, or uncertain.
most hazard assessments the concentrations, durations, forms, If the safety factor is large, that is, if the unacceptable
and locations of the material are predicted by starting with concentration is much greater than the EnC, hazard should be
information on its anticipated or actual release and then taking judged minimal. If the safety factor is low, for example, if the
into account its biological, chemical, and physical properties. unacceptable concentration is below the EnC and therefore the
The release may be from a single event, such as an application safety factor is less than 1, the hazard should be judged
ofapesticide,oraseriesofevents,suchastheproduction,use, potentially excessive because it is likely that the EnC will
and disposal of a deicer. A material may have three kinds of cause an unacceptable effect on aquatic organisms or their
EnCs in a body of water, because it might occur in the water users. If hazard cannot be judged either minimal or potentially
column, in sediment, and in food of aquatic organisms. In excessive, it is uncertain. The necessary minimum size of the
addition, EnCs may be different for different kinds of surface safety factor for judging the hazard of an EnC to be minimal
waters, different geographic areas, and different seasons of the will vary from iteration to iteration because it will depend on
year. Also, determination of EnCs may have to consider total (a) the amount, quality, and kind of data available concerning
versus available and short-term peak concentrations versus the EnC and possible adverse effects and (b) the degree of
long-term average concentrations. Each iteration considers the confidence in the validity of any extrapolations and assump-
potential of a particular EnC to cause adverse effects, but the tionsthatwereused.Thenecessaryminimumsafetyfactorwill
assessment of a material is not complete until the hazard of especiallydependontheappropriateness,range,andnumberof
each and every EnC of that material has been adequately aquatic species for which data are available. For this hazard
FIG. 1 Flow-Chart of an Iteration
E1023 − 84 (2007)
assessment process to produce valid results, it is particu
...
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