ANSI ASTM E1302-2013 Standard Guide for Acute Animal Toxicity Testing of Water-Miscible Metalworking Fluids《在水可溶混合的金属加工液条件下对动物剧毒性测试的指南》.pdf

1、Designation: E1302 13 An American National StandardStandard Guide forAcute Animal Toxicity Testing of Water-MiscibleMetalworking Fluids1This standard is issued under the fixed designation E1302; the number immediately following the designation indicates the year oforiginal adoption or, in the case o

2、f revision, 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. Scope*1.1 This guide defines acute animal toxicity tests and setsforth the references for procedures to

3、 assess the acute toxicityof water-miscible metalworking fluids as manufactured.1.2 Although water-miscible metalworking fluids are typi-cally used at high dilution, dilution rates vary widely.Additionally, there is potential for exposure to the metalwork-ing fluid as manufactured.1.3 This standard

4、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 use.2. Referenced Documents2.1 ASTM S

5、tandards:2E758 Test Method for Mammalian Acute Percutaneous Tox-icity (Withdrawn 2010)3E981 Test Method for Estimating Sensory Irritancy of Air-borne ChemicalsE993 Test Method for Evaluation of Delayed Contact Hy-persensitivity (Withdrawn 2010)3E1103 Test Method for Determining Subchronic DermalToxi

6、city (Withdrawn 2010)3E1542 Terminology Relating to Occupational Health andSafetyE2523 Terminology for Metalworking Fluids and Opera-tions2.2 CPSC Standards:416 CFR Part 150016 CFR Part 1500.316 CFR Part 1500.4016 CFR Part 1500.4116 CFR Part 1500.422.3 DOT Standards:449 CFR Part 173, Appendix A49 CF

7、R Part 173.343a149 CFR Part 173.343a249 CFR Part 173.343a32.4 EPATSCA Standards:440 CFR 79240 CFR 870.110040 CFR 870.120040 CFR 870.130040 CFR 870.240040 CFR 870.250040 CFR 870.26002.5 OSHA Standards:429 CFR 1910.120029 CFR 1910.1200 Appendix A, 3(a) and 6(a)29 CFR 1910.1200 Appendix A, 3(b) and 6(b

8、)29 CFR 1910.1200 Appendix A, 3(c) and 6(c)29 CFR 1910.1200 Appendix A, 43. Terminology3.1 For definitions of terms in this practice relating totoxicological testing, refer to Terminology E2523. For defini-tions of terms in this practice relating to occupational healthand safety, refer to Terminolog

9、y E1542.3.2 Definitions of Terms Specific to This Standard:3.2.1 limit test, nan acute toxicity test in which, if noill-effects occur at a pre-selected maximum dose, no furthertesting at greater exposure levels is required.http:/sis.nlm.nih.gov/enviro/iupacglossary/glossaryl.html1This test method is

10、 under the jurisdiction of ASTM Committee E34 onOccupational Health and Safety and is the direct responsibility of SubcommitteeE34.50 on Health and Safety Standards for Metal Working Fluids.Current edition approved July 1, 2013. Published July 2013. Originally approvedin 1989. Last previous edition

11、approved in 2012 as E1302 - 12. DOI: 10.1520/E1302-13.2For referenced ASTM standards, 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.3The la

12、st approved version of this historical standard is referenced onwww.astm.org.4Available from Supt. of Documents, U. S. Government Printing Office,Washington, DC 20402.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, We

13、st Conshohocken, PA 19428-2959. United States14. Significance and Use4.1 Application of this guide will provide information onthe acute toxicity of water-miscible metalworking fluids andwill assist the user in evaluating the potential health hazards ofthe fluid and developing appropriate work practi

14、ces. A water-miscible metalworking fluid is a concentrate designed to bediluted in water for use.4.2 Water-miscible metalworking fluids are complex chemi-cal mixtures. The United States Occupational Safety andHealth Administration (OSHA) Hazard Communication Stan-dard (see A1.8) outlines procedures

15、for the hazard determina-tion of mixtures and states that if a mixture has not been testedas a whole, then the mixture shall be assumed to present thesame hazards as do the components that comprise 1 % (byweight or volume) or greater of the mixture, except that themixture shall be assumed to present

16、 a carcinogenic hazard if itcontains a component in concentrations of 0.1 % or greater,which is considered to be a carcinogen (as defined in OSHAStandard 29 CFR 1910.1200). The determination of when totest a mixture as a whole and which toxicity tests areappropriate for the product must be made by a

17、 healthprofessional, qualified in evaluating toxicological data.4.3 Acute toxicology testing of water-miscible metalwork-ing fluids consists of several individual tests including acuteoral, dermal, or inhalation toxicity, eye irritation, skin irritationor corrosion, or both, skin sensitization, and

18、sensory irritation.Certain protocols for acute oral, dermal, and inhalation toxicitytests are limit tests; further multi-dose testing (for example,Test Method E1103) should take place if mortality is noted onany of these tests. The referenced protocols specify the speciesand number of animals requir

19、ed. Selection of tests conductedshould be designed to minimize the number of animals used.4.3.1 Acute Oral ToxicityAcute oral toxicity tests (seeA1.1) provide information on health hazards likely to arisefrom short-term exposure by the oral route. Results of this typeof test are used to develop warn

20、ing statements on labels as maybe required by OSHA Hazard Communication Standard 29CFR 1910.1200 (see A1.8) or Federal Hazardous SubstancesAct (see A1.10). These are also used to establish a dosageregimen for subchronic and other testing. Endpoint: mortality.4.3.2 Acute Dermal ToxicityAcute dermal t

21、oxicity tests(see A1.2) provide information on health hazards likely to arisefrom short-term exposure by the dermal route and may provideinitial information on dermal absorption and the mode of toxicaction of a substance. In addition, some measure of irritationcaused by the fluid may be obtained by

22、observing local tissuedamage at the sight of application. Endpoint: mortality.4.3.3 Acute Inhalation ToxicityAcute inhalation toxicitytests give an indication of relative toxicity (see A1.3). Theresults provide an indication of the potential of the fluid tocause death and other adverse health effect

23、s when inhaled fora specified time period. Endpoint: mortality.4.3.4 Eye IrritationEye irritation tests provide an indica-tion of the potential of the fluid to cause eye irritation ordamage upon direct contact (see A1.4).An irritant is defined asa chemical that is not corrosive, but causes a reversi

24、bleinflammatory effect on living tissue by chemical action at thesite of contact. Endpoint: degree of irritation.4.3.5 Skin Irritation or CorrosionSkin irritation or corro-sion tests indicate the potential of the fluid to produce irritationor damage to skin (see A1.5). A corrosive chemical is one th

25、atcauses visible destruction of, or irreversible alterations in,living tissue by chemical action at the site of contact. Endpoint:irritation or corrosion.4.3.6 Skin SensitizationA chemical sensitizer is a materialthat causes a substantial proportion of exposed people oranimals to develop an allergic

26、 reaction in normal tissue afterrepeated exposure to the chemical. A number of methods areavailable for measuring skin sensitization, however, there aredifferences in opinion on the most appropriate method. Theseare due to variations in compound administration and degree ofreaction to a sensitizing

27、substance. Refer to the Code ofFederal Regulations (CFR) for the various protocols (seeA1.6). Additionally, toxicology testing contract labs may havestandard procedures for conducting these assays. Endpoint:sensitization.4.3.7 Sensory Irritation-Upon exposure to a sensoryirritant, humans experience

28、discomfort or a burning sensationof the eyes, nose, and throat, and may also cough. Test MethodE981 (see A1.2.5) provides a means to evaluate the sensoryirritant potential of airborne chemicals and mixtures as well asa means to assess the comparative irritancy of compounds andformulations. However,

29、this test method cannot be used toevaluate the relative obnoxiousness of odors. End point: upperrespiratory tract irritation.4.4 A number of federal guidelines can be used to establishgeneral procedures for testing acute toxicity of metalworkingfluids. Several references are cited in Annex A1. Regar

30、dless ofthe method used, Good Laboratory Practices, as outlined by theUnited States Environmental Protection Agency (EPA 40 CFR792) (see A1.9) must be followed. The OSHA Hazard Com-munication Standard (see A1.8) outlines the responsibilities ofchemical manufacturers, importers, and employers in thed

31、etermination of chemical hazards and communication ofinformation on those hazards.4.5 The methods referenced in this guide or appropriatealternate methods such as those suggested by the Organizationfor Economic Cooperation and Development (OECD) areacceptable for testing the acute toxicity of water-

32、misciblemetalworking fluids. For each test outlined in AnnexA1.1-A1.5, a table is included that highlights the similaritiesand differences between the test protocols.5. Keywords5.1 acute toxicity testing; dermal; eye; inhalation; metal-working fluids; oralE1302 132ANNEX(Mandatory Information)A1. REF

33、ERENCES FOR ACUTE ANIMAL TOXICITY TESTINGA1.1 Acute Oral ToxicitySee Table A1.1.A1.1.1 Consumer Product Safety Commission (CPSC): 16CFR part 1500.3.A1.1.2 Department of Transportation (DOT): 49 CFR173.343a1.A1.1.3 Environmental Protection Agency, Toxic SubstancesControl Act (EPA-TSCA): 40 CFR 870.11

34、00.A1.1.4 Occupational Safety and Health Administration(OSHA), 29 CFR 1910.1200, Appendix A, 3(a) and 6(a).A1.2 Acute Dermal ToxicitySee Table A1.2.A1.2.1 CPSC: 16 CFR 1500.40.A1.2.2 DOT: 49 CFR 173.343a3.A1.2.3 EPA-TSCA: 40 CFR 870.1200.A1.2.4 OSHA: 29 CFR 1910.1200, Appendix A, 3(b) and6(b).A1.2.5

35、 Test Method E758.A1.3 Acute Inhalation ToxicitySee Table A1.3.A1.3.1 CPSC: 16 CFR part 1500.3.A1.3.2 EPA-TSCA: 40 CFR 870.1300.A1.3.3 DOT: 49 CFR 173.343a2.TABLE A1.1 Acute Oral ToxicityProtocolDose/AnimalToxicityClassNumber ofGroups/DoseLevelObservationTimeAdditionalEndpointsCPSC LD50 50 mg/kg nsA

36、14 days nsAHighly toxicLD50 50 mg to 5 g/kgToxicRatDOT LD50 50 mg/kg 1 48 h nsAPoison BRatEPA(TSCA)5 g/kg-limit test 1 14 days Externalobservationsof toxicityRatOSHA LD50 50 mg/kg nsAnsAnsAHighly toxicLD50 50 to 500 mg/kgToxicRatANot specified.TABLE A1.2 Acute Dermal ToxicityProtocolDose/AnimalToxic

37、ityClassNumber ofGroups/ DoseLevelDurationofContactObservationTimeCPSC LD50 200 mg/kg nsAUp to 24 h 14 daysHighly toxic Occluded,abraded, andintact skinLD50 200 to 2000 mg/kgToxicRabbitDOT LD50 200 mg/kg 1 24 h 48 hPoison BRabbitEPA(TSCA)2 g/kg-limit test 1 24 hOccluded andabraded skin14 daysRabbit,

38、 male and femaleOSHA LD50 200 mg/kg nsA24 h nsAHighly toxicLD50 200 to 1000 mg/kgToxicRabbitANot specified.TABLE A1.3 Acute Inhalation ToxicityProtocolConcentration/AnimalToxicityClassNumberof groups/DoseLevelsExposureDurationObservationTimeAdditionalEndpointsCPSC LC50 2 mg/Lor 200 ppm -nsA1h nsAnsA

39、Highly toxicLC502to20mg/Lor 20020 000ppmToxicRatDOT LC50 2 mg/L 1 1 h 48 h nsAPoison BRatEPA(TSCA)5 mg/L limit 1 4 h 14 days Externalobser-test whole vation ofbody toxicityRat; maleand femaleOSHA LC50 2 mg/Lor 200 ppmnsA1h nsAnsAHighly toxicLC502to20mg/Lor 2002000ppmToxicRatANot specified.E1302 133A

40、1.3.4 OSHA: 29 CFR 1910.1200, Appendix A, 3(c) and6(c).A1.4 Eye Irritation See Table A1.4.A1.4.1 CPSC: 16 CFR 1500.42.A1.4.2 EPA-TSCA: 40 CFR 870.2400.A1.4.3 OSHA: 29 CFR 1910.1200, Appendix A, 4.A1.5 Skin Irritation or CorrosionSee Table A1.5.A1.5.1 CPSC: 16 CFR 1500.41 (Irritation).A1.5.2 DOT: 49

41、CFR Part 173, Appendix A (Corrosion).A1.5.3 EPA-TSCA: 40 CFR 870.2500.A1.5.4 OSHA: 29 CFR 1910.1200, Appendix A, 4.A1.6 Skin Sensitization (40 CFR 8702600)A1.6.1 Freunds complete adjuvant test.A1.6.2 Guinea pig maximization test.A1.6.3 Split adjuvant technique.A1.6.4 Buehler test.A1.6.5 Open epicuta

42、neous test.A1.6.6 Mauer optimization test.A1.6.7 Footpad technique in guinea pig.A1.6.8 Test Method E993.A1.7 Sensory IrritationA1.7.1 Test Method E981.A1.8 OSHA Hazard Communication StandardA1.8.1 29 CFR 1910.1200.A1.9 Good Laboratory PracticesA1.9.1 (EPA) 40 CFR 792.A1.10 Federal Hazardous Substan

43、ces ActA1.10.1 (CPSC): 16 CFR 1500.TABLE A1.4 Eye IrritationNOTE 1It may not be necessary to conduct an eye irritation test if theskin irritation/corrosion test is severely positive.ProtocolAnimals(number)DoseExposureTimeObservationTime andScoringCPSC Rabbit (6) 0.1 mL Unwashed 24, 48, 72 hundiluted

44、fluid Scoring-DraizeEPAARabbit (9) 0.1 mL 6-unwashed 24, 48, 72 h,(TSCA) undiluted 3-washed for 4 and 7 daysfluid 1 min, 20 (every 3 days30 s after thereafterinstillation for 13 daysif injurypersists)Scoring-DraizeOSHA Rabbit (6) 0.1 mLundilutedfluidUnwashed 24, 48, 72 hScoring-DraizeAEPA protocol g

45、ives an indication of what happens when the eye is washedfollowing exposure. This may be useful information.TABLE A1.5 Skin Irritation or CorrosivityProtocolAnimals(number)DoseExposureTimeObservationTime andScoringCPSC Rabbit 0.5 mL 24 h mul- 24 and 72 h(Irritation) (6) undiluted tiple sites; Scorin

46、g-Draizefluid intact and (redness,abraded skin; scarring,occluded and swelling).DOTARabbit 0.5 mL 4 h intact skin; Score and(Corrosivity) (6) undiluted occluded wash afterfluid 4 h. Scoreat 48 hfor irreversi-ble tissuealteration,necrosis, andulceration.EPA Rabbit 0.5 mL 4 h multiple After 4 h(TSCA)

47、(6) undiluted sites; intact remove(Irritation) fluid skin; occlusion,occluded wash skin.Score at0.5to1,24, and 72h-Draize.Observefor amaximumof 14 daysuntilirritationsubsidesor determineif irrevers-ible.OSHA Rabbit 0.5 mL 4 h multiple 24 and(Irritation/ (6) undiluted sites; intact 72 hCorrosivity) S

48、ame as fluid and abraded Scoring-DOT for skin; Draizecorrosivity occluded (redness,scarring,andswelling).AThe DOT protocol is a measure of corrosivity only. In order to conserve animals,the laboratory may want to conduct the EPA or CPSC procedures for irritation inconjunction with the DOT protocol.

49、Using multiple sites, at end of 4 h remove someof the occlusions and measure for DOT corrosivity.E1302 134SUMMARY OF CHANGESCommittee E34 has identified the location of selected changes to this standard since the last issue (E1302 -12) that may impact the use of this standard. (Approved July 1, 2013)(1) Added reference to Terminologies E1542 and E2523 in 2.1.(2) Inserted new Terminology Section 3.(3) Renumbered subsequent sections.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin