ASTM E1023-1984(2014) 7482 Standard Guide for Assessing the Hazard of a Material to Aquatic Organisms and Their Uses《评定材料对水生生物及其使用中存在的危险性的标准指南》.pdf

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1、Designation: E1023 84 (Reapproved 2014)Standard Guide forAssessing the Hazard of a Material to Aquatic Organismsand Their Uses1This standard is issued under the fixed designation E1023; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revisio

2、n, 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 describes a stepwise process for usinginformation concerning the biological, chemical, physi

3、cal, andtoxicological properties of a material to identify adverse effectslikely to occur to aquatic organisms and their uses as a result ofrelease of the material to the environment. The material willusually be a specific chemical, although it might be a group ofchemicals that have very similar bio

4、logical, chemical, physical,and toxicological properties and are usually produced, used,and discarded together.1.2 The hazard assessment process is complex and requiresdecisions at a number of points; thus, the validity of a hazardassessment depends on the soundness of those decisions, aswell as the

5、 accuracy of the information used. All decisionsshould be based on reasonable worst-case analyses so that anappropriate assessment can be completed for the least cost thatis consistent with scientific validity.1.3 This guide assumes that the reader is knowledgeable inaquatic toxicology and related p

6、ertinent areas. A list of generalreferences is provided (1).21.4 This guide does not describe or reference detailedprocedures for estimating or measuring environmentalconcentrations, or procedures for determining the maximumconcentration of test material that is acceptable in the food ofpredators of

7、 aquatic life. However, this guide does describehow such information should be used when assessing thehazard of a material to aquatic organisms and their uses.1.5 Because assessment of hazard to aquatic organisms andtheir uses is a relatively new activity within aquatic toxicology,most of the guidan

8、ce provided herein is qualitative rather thanquantitative. When possible, confidence limits should be cal-culated and taken into account.1.6 This guide provides guidance for assessing hazard butdoes not provide guidance on how to take into account socialconsiderations in order to judge the acceptabi

9、lity of the hazard.Judgments concerning acceptability are social as well asscientific, and are outside the scope of this guide.1.7 This guide is arranged as follows:SectionReferenced Documents 2Descriptions of Terms Specific to This Standard 3Summary of Guide 4Significance and Use 5Four Basic Concep

10、ts 6The Iteration 6.1The Two Elements 6.2The Possible Decisions 6.3The Phased Approach 6.4Phase IUse of Low-Cost (Existing) Information 7Collection of Available Data 7.1Initial Estimates of Environmental Concentrations 7.2Initial Estimate of Toxicity to Aquatic Organisms 7.3Initial Estimate of Bioac

11、cumulation by Aquatic Organ-isms 7.4Phase I Hazard Assessment 7.5Phase IIUse of Medium-Cost Information 8Improved Estimates of Environmental Concentrations 8.2Acute Toxicity to Aquatic Animals 8.3Toxicity to Algae 8.4Expansion of Short-Term Testing 8.5Bioaccumulation 8.6Phase II Hazard Assessment 8.

12、7Phase IIIUse of High-Cost Information 9Refined Estimates of Environmental Concentrations 9.2Chronic Toxicity to Aquatic Animals 9.3Use of Acute-Chronic Ratios 9.4Toxicity to Aquatic Plants 9.5Bioconcentration 9.6Bioaccumulation from Food 9.7Phase III Hazard Assessment 9.8AppendixesAppendix X1 Produ

13、ction, Use, Disposal, and Other ReleaseAppendix X2 Biological ConsiderationsAppendix X3 Chemical ConsiderationsAppendix X4 Physical ConsiderationsAppendix X5 Toxicological ConsiderationsAppendix X6 Estimating Environmental ConcentrationsAppendix X7 Selection of Test SpeciesAppendix X8 Long-Term Toxi

14、city Tests1This guide is under the jurisdiction ofASTM Committee E50 on EnvironmentalAssessment, Risk Management and Corrective Action and is the direct responsibil-ity of Subcommittee E50.47 on Biological Effects and Environmental Fate.Current edition approved Oct. 1, 2014. Published December 2014.

15、 Originallyapproved in 1984. Last previous edition approved in 2007 as E1023-84(2007). DOI:10.1520/E1023-84R14.2Boldface numbers in parentheses refer to the list of references at the end of thisstandard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-295

16、9. United States11.8 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to us

17、e.2. Referenced Documents2.1 ASTM Standards:3D1129 Terminology Relating to WaterE724 Guide for Conducting Static Acute Toxicity TestsStarting with Embryos of Four Species of SaltwaterBivalve MolluscsE729 Guide for Conducting Acute Toxicity Tests on TestMaterials with Fishes, Macroinvertebrates, and

18、Amphib-iansE943 Terminology Relating to Biological Effects and Envi-ronmental FateE1022 Guide for Conducting Bioconcentration Tests withFishes and Saltwater Bivalve MollusksIEEE/SI 10 American National Standard for Use of theInternational System of Units (SI): The Modern MetricSystem3. Terminology3.

19、1 Definitions of Terms Specific to This Standard:3.1.1 acute-chronic ratiothe quotient of an appropriatemeasure of the acute toxicity (usually the 96-h LC50) of amaterial to a species divided by the result of a life-cycle, partiallife-cycle, or early life-stage test in the same water on the samemate

20、rial with the same species.3.1.2 bioaccumulationthe net uptake of a material fromwater and from food.3.1.3 environmental concentration (EnC)theconcentration, duration, form, and location of a material inenvironmental waters, sediments, or the food of aquatic organ-isms.3.1.4 hazard assessmentthe ide

21、ntification of the adverseeffects likely to result from specified releases(s) of a material.3.1.5 maximum acceptable toxicant concentration(MATC)the highest concentration of a material that wouldhave no statistically significant observed adverse effect on thesurvival, growth, or reproduction of the

22、test species duringcontinuous exposure throughout a life-cycle or partial life-cycle toxicity test. Such tests usually indicate that the MATC isbetween two tested concentrations.3.1.6 no-observed-effect concentration (NOEC)the high-est tested concentration of a material at which the measuredparamete

23、rs of a specific population of test organisms under testconditions show no statistically significant adverse differencefrom the control treatment. When derived from a life-cycle orpartial life-cycle test, it is the same as the lower limit on theMATC.3.1.7 safety factorthe quotient of a toxicological

24、ly signifi-cant concentration divided by an appropriate EnC.3.2 For definitions of other terms used in this guide, refer toTerminology E943 and D1129, Guides E724 and E729, andPractice E1022. For an explanation of units and symbols, referto IEEE/SI 10.4. Summary of Guide4.1 This guide describes an i

25、terative process for assessingthe hazard of a material to aquatic organisms and their uses byconsidering the relationship between the materials measuredor estimated environmental concentration(s) and the adverseeffects likely to result. Unavailable necessary informationconcerning environmental conce

26、ntrations and adverse effects isobtained through a stepwise program that starts with inexpen-sive information and progresses to expensive information ifnecessary. At the end of each iteration the estimated ormeasured environmental concentration(s) are compared withinformation on possible adverse eff

27、ects to determine theadequacy of the available data for assessing hazard. If it is notpossible to conclude that hazard is either minimal or potentiallyexcessive, the available data are judged inadequate to charac-terize the hazard. If desired, appropriate additional informationis identified and obta

28、ined, so that hazard can be reassessed. Theprocess is repeated until the hazard is adequately characterized.5. Significance and Use5.1 Adverse effects on natural populations of aquatic organ-isms and their uses have demonstrated the need to assess thehazards of many new, and some presently used, mat

29、erials. Theprocess described herein will help producers, users, regulatoryagencies, and others to efficiently and adequately comparealternative materials, completely assess a final candidatematerial, or reassess the hazard of a material already in use.5.2 Sequential assessment and feedback allow app

30、ropriatejudgments concerning efficient use of resources, thereby mini-mizing unnecessary testing and focusing effort on the informa-tion most pertinent to each material. For different materials andsituations, assessment of hazard will appropriately be based onsubstantially different amounts and kind

31、s of biological,chemical, physical, and toxicological data.5.3 Assessment of the hazard of a material to aquaticorganisms and their uses should never be considered completefor all time. Reassessment should be considered if the amountof production, use, or disposal increases, new uses arediscovered,

32、or new information on biological, chemical,physical, or toxicological properties becomes available. Peri-odic review will help assure that new circumstances andinformation receive prompt appropriate attention.5.4 If there is substantial transformation to another material,the hazard of both materials

33、 may need to be assessed.5.5 In many cases, consideration of adverse effects shouldnot end with completion of the hazard assessment. Additionalsteps should often include risk assessment, decisions concern-ing acceptability of identified hazards and risks, and mitigativeactions.3For referenced ASTM s

34、tandards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.E1023 84 (2014)25.6 Because this practice deals mostly with adverse effectson aquat

35、ic organisms and their uses, it is important thatmitigative actions, such as improved treatment of aqueouseffluents, not result in unacceptable effects on non-aquaticorganisms. Thus, this standard should be used with otherinformation in order to assess hazard to both aquatic andnon-aquatic organisms

36、.6. Four Basic Concepts6.1 The Iteration (see Fig. 1)The basic principle used inthis hazard assessment process is the repetitive or iterativecomparison of measured or estimated EnCs of a material withconcentrations that cause adverse effects. When available dataare judged inadequate, needed data are

37、 identified. Unless thehazard assessment is terminated, necessary additional informa-tion is obtained and used with all other pertinent information toreassess hazard. The process is repeated until hazard isadequately characterized.6.2 Two Elements:6.2.1 The first element in assessing the hazard of a

38、 materialto aquatic organisms and their uses is the EnCs of the material.For some existing materials the EnCs may be measured, but inmost hazard assessments the concentrations, durations, forms,and locations of the material are predicted by starting withinformation on its anticipated or actual relea

39、se and then takinginto account its biological, chemical, and physical properties.The release may be from a single event, such as an applicationof a pesticide, or a series of events, such as the production, use,and disposal of a deicer. A material may have three kinds ofEnCs in a body of water, becau

40、se it might occur in the watercolumn, in sediment, and in food of aquatic organisms. Inaddition, EnCs may be different for different kinds of surfacewaters, different geographic areas, and different seasons of theyear. Also, determination of EnCs may have to consider totalversus available and short-

41、term peak concentrations versuslong-term average concentrations. Each iteration considers thepotential of a particular EnC to cause adverse effects, but theassessment of a material is not complete until the hazard ofeach and every EnC of that material has been adequatelyassessed. EnCs may aid in sel

42、ecting appropriate aquatic speciesto be used in tests, identifying and designing tests to beconducted, choosing test concentrations, and interpreting re-sults. Determination of EnCs should take into account not onlyall pertinent probable means of release, but also dilution,transport and transformati

43、ons, sinks and concentratingmechanisms, and degradation and degradation products.6.2.2 The second element essential to assessing hazard is thepossible adverse effects on aquatic organisms and their uses.For convenience, such effects can be placed in four categories:6.2.2.1 Acute and chronic toxicity

44、 to aquatic animals,6.2.2.2 Effects on uses of aquatic organisms, including sucheffects as flavor impairment and accumulation of unacceptableresidues,6.2.2.3 Effects on aquatic plants, including toxicity andstimulation, and6.2.2.4 Other effects on aquatic animals, such as avoidance.6.3 Possible Deci

45、sions:6.3.1 In each iteration, information concerning possibleadverse effects is used to decide whether the hazard due to aparticular EnC is minimal, potentially excessive, or uncertain.If the safety factor is large, that is, if the unacceptableconcentration is much greater than the EnC, hazard shou

46、ld bejudged minimal. If the safety factor is low, for example, if theunacceptable concentration is below the EnC and therefore thesafety factor is less than 1, the hazard should be judgedpotentially excessive because it is likely that the EnC willcause an unacceptable effect on aquatic organisms or

47、theirusers. If hazard cannot be judged either minimal or potentiallyexcessive, it is uncertain. The necessary minimum size of thesafety factor for judging the hazard of an EnC to be minimalwill vary from iteration to iteration because it will depend on(a) the amount, quality, and kind of data availa

48、ble concerningthe EnC and possible adverse effects and (b) the degree ofconfidence in the validity of any extrapolations and assump-tions that were used. The necessary minimum safety factor willespecially depend on the appropriateness, range, and number ofaquatic species for which data are available

49、. For this hazardFIG. 1 Flow-Chart of an IterationE1023 84 (2014)3assessment process to produce valid results, it is particularlyimportant that EnCs and adverse effects not be underestimated(see 6.4.5).6.3.2 A decision of minimal hazard should account for thefollowing considerations:6.3.2.1 The specified releases of the material will not resultin concentrations that are acutely toxic to appropriate andsensitive aquatic animals that will be exposed.6.3.2.2 Any expected long-term concentrations of the ma-terial in surface waters will not be chronically toxic toappropriate