ASTM E857-2005(2012) 4375 Standard Practice for Conducting Subacute Dietary Toxicity Tests with Avian Species 《用鸟类进行亚极性饮食毒性试验的标准实施规程》.pdf

《ASTM E857-2005(2012) 4375 Standard Practice for Conducting Subacute Dietary Toxicity Tests with Avian Species 《用鸟类进行亚极性饮食毒性试验的标准实施规程》.pdf》由会员分享，可在线阅读，更多相关《ASTM E857-2005(2012) 4375 Standard Practice for Conducting Subacute Dietary Toxicity Tests with Avian Species 《用鸟类进行亚极性饮食毒性试验的标准实施规程》.pdf（5页珍藏版）》请在麦多课文档分享上搜索。

1、Designation: E857 05 (Reapproved 2012)Standard Practice forConducting Subacute Dietary Toxicity Tests with AvianSpecies1This standard is issued under the fixed designation E857; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the y

2、ear 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 practice describes a procedure for determining thesubacute dietary toxicity of a test substance administer

3、ed tobirds in their daily diet. The LC50value time to mortality andslope of the dose response curve may also be derived.1.2 This practice is applicable to substances that can bemixed uniformly into the diet.1.3 This practice is intended primarily to be used with theyoung of the following species: no

4、rthern bobwhite (Colinusvirginianus), Japanese quail (Coturnix japonica), mallard(Anas platyrhynchos), and ring-necked pheasant (Phasianuscolchicus). Other species or age groups, for example, withwild-trapped birds, may be used with appropriate husbandrymodifications to the practice.1.4 This standar

5、d is used routinely to address avian regula-tory testing requirements. Modifications to the proceduresdescribed in this standard have been proposed and are beingevaluated to better address the needs of the latest risk assess-ment procedures. Specifically, the latest procedures call forindividual bir

6、d feed consumption measurements so that a moreprecise dose can be determined. While such procedures mayreplace procedures described in the current standard, there isno certainty that the newest procedures will work as antici-pated, and validation is not complete. Therefore, the currentguideline has

7、utility prior to validation and acceptance of amodified standard.1.5 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 appl

8、ica-bility of regulatory limitations prior to use. For specificprecautionary statements see Section 6.2. Referenced Documents2.1 ASTM Standards:2IEEE/ASTM SI 10 American National Standard for Use ofthe International System of Units (SI): The Modern MetricSystem3. Terminology3.1 Definitions of Terms

9、Specific to This Standard:3.1.1 LC50the statistically derived estimate of the concen-tration of a test substance in the diet that would be expected tocause 50 % mortality to the test population under the specifiedtest conditions.3.1.2 concentrationthe weight of test substance per unitweight of diet.

10、3.1.3 substance or test substancethe element, chemicalcompound, formulation, known mixture, or material mixed indiets and fed to birds for the purpose of determining an LC50.3.1.4 negative controla group of birds maintained underconditions identical to the test birds except for the absence ofthe tes

11、t substance in their diet.3.1.5 positive controla group of birds maintained underconditions identical to the test birds except for the replacementof the test substance in the diet with a substance known to elicita consistent toxic response.3.2 Abbreviations:Units and Symbols:3.2.1 Refer to IEEE/ASTM

12、 SI 10.4. Summary of Practice4.1 This practice describes how to determine the subacutedietary toxicity of a test substance when administered to birdsin their daily diet. The median lethal concentration (LC50)inthe diet is a measure of a specific toxic effect (that is, lethality).The LC50has been use

13、d as a comparable index of toxicity.However, other expressions of toxicity also may be appropri-ate.1This practice is under the jurisdiction of ASTM Committee E47 on BiologicalEffects and Environmental Fate and is the direct responsibility of SubcommitteeE47.02 on Terrestrial Assessment and Toxicolo

14、gy.Current edition approved April 1, 2012. Published June 2012. Originallyapproved in 1981. Last previous edition approved in 2005 as E857 051. DOI:10.1520/E0857-05R12.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual

15、 Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.4.2 Groups of birds of the same species are fed dietscontaining a test substan

16、ce or mixture of substances at selectedconcentrations for 5 days. This is followed by a minimum of 3days (or for as long as the birds continue to exhibit toxic signs)on untreated food. The test substance is mixed into the diets,usually in a geometric series of concentrations.4.3 General observations

17、 of the signs of toxicity and theacceptance of the test substance in the diet also must bereported.4.4 Concurrent negative controls must be maintainedthroughout the test. A positive control also may be used.5. Significance and Use5.1 This practice provides a means of measuring the sus-ceptibility of

18、 an avian species to a test substance in its dietunder controlled conditions. The LC50obtained in this test is aconditional measure of subacute toxicity because consumptionis voluntary, and because the dietary route may introducemetabolic transformations of the test substance that might beabsent in

19、other exposure techniques.5.2 Use of this practice contributes to the evaluation of thehazards of chemicals to birds because exposure is analogous tomost field exposures, that is, through dietary intake.5.3 The use of this practice allows for observation of signsof toxicity in addition to mortality.

20、5.4 The dose-response curve provides additional informa-tion about the response of birds to a test substance.5.5 This practice can be used to study the effects of testsubstances in combination in order to simulate situations wherebirds may be exposed to more than one substance simultane-ously (1).35

21、.6 This practice provides one basis for deciding whetheradditional toxicity testing should be conducted with birds.6. Precautions6.1 Contact with all test substances, solutions, and mixeddiets should be minimized with appropriate protective clothing,gloves, eye protection, etc. The use of fume hoods

22、 andincreased ventilation in test rooms is necessary when handlingvolatile substances. Mammalian toxicity and special handlingprocedures should be known before this practice is used.6.2 Disposal of excess test substances, solutions, mixeddiets, excreta, and treated birds should be done with consider

23、-ation for health and environmental safety, and in accordancewith all federal, state, and local regulations.6.3 Cleaning and rinsing of glassware, feeders, and otherequipment with volatile solvents should be performed only inwell-ventilated areas.6.4 Periodic medical examinations should be considere

24、d forall personnel caring for birds or handling test substances.7. Facilities7.1 Species requirements will vary, but pens and cagesshould include adequate room, clean food and water, heatedareas for young birds, and protection from excessive distur-bance. Space requirements have not been standardize

25、d forspecies normally used in this test. However, adherence to thegeneral guidelines and principles found in the National Insti-tutes of Health and the National Academy of Science publica-tions (2, 3, 4) in addition to literature published on individualspecies should provide a basis for a humane app

26、roach to spacerequirements. Pens or cages must be placed so as to preventcross-contamination (5).7.2 Construction materials in contact with birds should notbe toxic, nor be capable of adsorbing or absorbing testsubstances. Materials that can be dissolved by water orloosened by pecking should not be

27、used. Stainless or galva-nized steel, or materials coated with plastics are acceptable, butother construction materials may also be useful. Any materialor pen shape is acceptable provided the birds are able to moveabout freely and that pens can be kept clean.7.3 Ventilation, photoperiod, and relativ

28、e humidity require-ments vary little among test species, and these factors areparticularly critical to the well-being of young birds. Relativehumidity should be maintained at 45 to 70 %. Higher humidi-ties may be appropriate for waterfowl. Photoperiod should bea minimum of 14 h of light. The amount

29、and duration of heatfor brooding is species specific (6, 7). A temperature gradientfrom approximately 38C to approximately 22C from anappropriate heat source should be established in brooders inorder to allow the birds to seek a proper temperature. Ventila-tion should follow guidelines in Guide for

30、the Care and Use ofLaboratory Animals. Ventilation should be sufficient to supply10 to 15 air changes per hour (2).8. Diets8.1 Dietary requirements vary according to the species andage of the test birds. Any unmedicated commercial diet thatmeets the minimum nutritional standards of the test species

31、(8)is sufficient.8.2 Contaminated feed may compromise a study (9, 10, 11);therefore, feed should be analyzed periodically to identifybackground contaminants. Analysis may be especially impor-tant if the substance being tested is known or suspected ofsynergistic or antagonistic action with possible c

32、ontaminants.Maximum allowable levels of heavy metals, pesticides, andother contaminants in feed have not been established.8.3 Test diets should always be fresh and clean. Thefrequency that the diet is changed during a study is dependentupon the physical and chemical properties of the test substance,

33、and the speed with which a test animal contaminates the feedwith fecal matter or water, or both.8.4 Test diets should be fed ad libitum.8.5 Feed should not be used past its normal shelf life(usually 90 days).8.6 Treated test diets should be stored so as to maintain thestability of the test substance

34、 in the diet.9. Test Substance and Diet Preparation9.1 Knowledge of the physical, chemical, and biologicalproperties of the test substance is important in test dietpreparation.9.2 Test diets can be prepared by mixing the test substancedirectly into the feed or by dissolving or suspending the test3Th

35、e boldface numbers in parentheses refer to the list of references at the end ofthis practice.E857 05 (2012)2substance in a solvent or carrier prior to mixing with the feed.The use of solvents or carriers may be necessary to achieve auniform mix of the test substance in the feed.9.3 The test substanc

36、e is uniformly mixed into the diet. Thephysical and chemical properties of a test substance may causevariation in test diet concentrations and it is important to ensurethat the test substance is available in the diet at the sameconcentration throughout the treatment period.9.4 In addition to homogen

37、eity and stability testing requiredby GLPs, it is recommended that concentrations of the testsubstance in the diet be confirmed by analysis at the beginningof the test.10. Test Organisms10.1 This practice is intended primarily to be used with theyoung of the following species: northern bobwhite (Col

38、inusvirginianus), Japanese quail (Coturnix japonica), mallard(Anas platyrhynchos), and ring-necked pheasant (Phasianuscolchicus). Other species may be used, but changes in diet,caging, and other factors may be necessary (12, 13).10.2 If laboratory or commercially reared birds are used inthis practic

39、e they must come from the same source, and be ofthe same age, because different strains or age cohorts canintroduce variability into the test. These birds should be similarin appearance to a wild species. The parentage and dietaryhistory of purchased birds should be known. If captured wildbirds are

40、used, they should come from the same source and beof similar maturity.10.3 Birds that are deformed, injured, emaciated, or pheno-typically different from normal birds must not be used as testanimals. The population of birds from which the test animals(treated and control) are selected shall be consi

41、dered unsuitablefor testing if mortality exceeds 5 % during the 3 days prior totesting.10.4 The preferred age for Japanese quail and northernbobwhite is 14 days; for ring-necked pheasants, 10 days; andfor mallards, 5 days (17). The preferred ages are based on theprobability that test birds of these

42、ages will not survive for 5days without eating (see 12.1.4). Tests with younger or olderbirds also can be used to determine the LC50(14, 15, 16). Ifdata from one test are to be considered comparable with datafrom another test, the ages of birds between the two testsshould deviate no more than one or

43、 two days.10.5 Young birds of the species listed in 1.3 shall beconditioned to the test parameters of caging, food, water, andphotoperiod from the time they hatch or are acquired until theinitiation of the test. An acclimation period of at least 3 days isrequired (see 10.3). Older birds shall be con

44、ditioned for at least7 days.11. Procedure11.1 Range-Finding Test:11.1.1 To determine the test concentrations to be used in adefinitive test, a range-finding test may be conducted for 5 daysusing three to five widely spaced concentrations.11.1.2 One procedure is to use an initial concentration of atl

45、east 5000 ppm with two to four geometrically spaced lowerconcentrations. If there is no mortality at the 5000-ppm level,and test procedures and numbers of birds per concentration arethe same as would be used in a definitive test, then therange-finding test may provide sufficient information to negat

46、ethe need for a definitive test. If mortality does occur, thenrange-finding will suggest the approximate test concentrationsto be used in a definitive test.11.2 Definitive Test:11.2.1 Individual test birds should be randomly assigned togroups and to control and test diet concentrations. Assignmentto

47、 groups and initial weighing of the test birds should be doneat the same time to avoid needless handling stress.11.2.2 Water, and treated or untreated diets, should beavailable ad libitum.11.2.3 The experimental (test and control) diets are avail-able for 5 days after which they are replaced with un

48、treatedfeed. Birds are held for a minimum of 3 days followingtreatment. In some situations, it may be necessary to extend theobservation period in order to investigate prolonged or delayedeffects.11.2.4 Body weight must be recorded at the initiation andconclusion of the treatment and observation pha

49、ses. Feedconsumption must be recorded for both the treatment andobservation phases; it is recommended that consumption dur-ing the treatment phase be recorded separately for the first twodays and the last three days. Additional information may begathered by measuring feed consumption daily. If the studycontinues beyond 8 days, body weight and feed consumptionshould be recorded weekly. Mortality, behavioral abnormali-ties, and other signs of toxicity should be recorded each dayduring the test.11.2.5 Photoperiod during the test should be the same asduring the conditioning peri