ASTM E1302-2000(2007) 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标准指南》.pdf

1、Designation: E 1302 00 (Reapproved 2007)An American National StandardStandard Guide forAcute Animal Toxicity Testing of Water-MiscibleMetalworking Fluids1This standard is issued under the fixed designation E 1302; the number immediately following the designation indicates the year oforiginal adoptio

2、n or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide defines acute animal toxicity tests and setsforth the reference

3、s for procedures to 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. Addi-tionally, there is potential for exposure to the metalworkingfluid as manufactured

4、.1.3 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 use.2. Referenced

5、Documents2.1 ASTM Standards:2E 758 Test Method for Mammalian Acute PercutaneousToxicityE 981 Test Method for Estimating Sensory Irritancy ofAirborne ChemicalsE 993 Test Method for Evaluation of Delayed ContactHypersensitivityE 1103 Test Method for Determining Subchronic DermalToxicity2.2 CPSC Standa

6、rds:316 CFR Part 150016 CFR Part 1500.316 CFR Part 1500.4016 CFR Part 1500.4116 CFR Part 1500.422.3 DOT Standards:349 CFR Part 173, Appendix A49 CFR Part 173.343a149 CFR Part 173.343a249 CFR Part 173.343a32.4 EPATSCA Standards:340 CFR 79240 CFR 870.110040 CFR 870.120040 CFR 870.130040 CFR 870.240040

7、 CFR 870.250040 CFR 870.26002.5 OSHA Standards:329 CFR 1910.120029 CFR 1910.1200 Appendix A, 3(a) and 6(a)29 CFR 1910.1200 Appendix A, 3(b) and 6(b)29 CFR 1910.1200 Appendix A, 3(c) and 6(c)29 CFR 1910.1200 Appendix A, 43. Significance and Use3.1 Application of this guide will provide information on

8、the acute toxicity of water-miscible metalworking fluids andwill assist the user in evaluating the potential health hazards ofthe fluid and developing appropriate work practices. A water-miscible metalworking fluid is a concentrate designed to bediluted in water for use.3.2 Water-miscible metalworki

9、ng fluids are complex chemi-cal mixtures. The United States Occupational Safety andHealth Administration (OSHA) Hazard Communication Stan-dard (see A1.8) outlines procedures for the hazard determina-tion of mixtures and states that if a mixture has not been testedas a whole, then the mixture shall b

10、e 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 a carcinogenic hazard if itcontains a component in concentrations of 0.1 % or greater,which is considered to be a carcinogen

11、(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 health profes-sional, qualified in evaluating toxicological data.1This test method is under the jurisdiction of ASTM Committe

12、e 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 April 1, 2007. Published June 2007. Originallyapproved in 1989. Last previous edition approved in 2000 as E 1302 - 00.2For re

13、ferenced 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.3Available from Supt. of Documents, U. S. Government Printing Office

14、,Washington, DC 20402.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.3 Acute toxicology testing of water-miscible metalwork-ing fluids consists of several individual tests including acuteoral, dermal, or inhalation toxicity, eye i

15、rritation, skin irritationor corrosion, or both, skin sensitization, and sensory irritation.Certain protocols for acute oral, dermal, and inhalation toxicitytests are limit tests; further multi-dose testing (for example,Test Method E 1103) should take place if mortality is noted onany of these tests

16、. The referenced protocols specify the speciesand number of animals required. Selection of tests conductedshould be designed to minimize the number of animals used.3.3.1 Acute Oral ToxicityAcute oral toxicity tests (seeA1.1) provide information on health hazards likely to arisefrom short-term exposu

17、re by the oral route. Results of this typeof test are used to develop warning 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 ot

18、her testing. Endpoint: mortality.3.3.2 Acute Dermal ToxicityAcute dermal toxicity tests(seeA1.2) 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 ad

19、dition, some measure of irritationcaused by the fluid may be obtained by observing local tissuedamage at the sight of application. Endpoint: mortality.3.3.3 Acute Inhalation ToxicityAcute inhalation toxicitytests give an indication of relative toxicity (see A1.3). Theresults provide an indication of

20、 the potential of the fluid tocause death and other adverse health effects when inhaled fora specified time period. Endpoint: mortality.3.3.4 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 ir

21、ritant is defined asa chemical that is not corrosive, but causes a reversibleinflammatory effect on living tissue by chemical action at thesite of contact. Endpoint: degree of irritation.3.3.5 Skin Irritation or CorrosionSkin irritation or corro-sion tests indicate the potential of the fluid to prod

22、uce irritationor damage to skin (see A1.5). A corrosive chemical is one thatcauses visible destruction of, or irreversible alterations in,living tissue by chemical action at the site of contact. Endpoint:irritation or corrosion.3.3.6 Skin SensitizationA chemical sensitizer is a materialthat causes a

23、 substantial proportion of exposed people oranimals to develop an allergic 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 var

24、iations in compound administration and degree ofreaction to a sensitizing 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.3.3.7

25、 Sensory Irritation-Upon exposure to a sensory irri-tant, humans experience discomfort or a burning sensation ofthe eyes, nose, and throat, and may also cough. Test MethodE 981 (see A1.2.5) provides a means to evaluate the sensoryirritant potential of airborne chemicals and mixtures as well asa mean

26、s to assess the comparative irritancy of compounds andformulations. However, this test method cannot be used toevaluate the relative obnoxiousness of odors. End point: upperrespiratory tract irritation.3.4 A number of federal guidelines can be used to establishgeneral procedures for testing acute to

27、xicity of metalworkingfluids. Several references are cited in Annex A1. Regardless 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 th

28、e responsibilities ofchemical manufacturers, importers, and employers in thedetermination of chemical hazards and communication ofinformation on those hazards.3.5 The methods referenced in this guide or appropriatealternate methods such as those suggested by the Organizationfor Economic Cooperation

29、and Development (OECD) areacceptable for testing the acute toxicity of water-misciblemetalworking fluids. For each test outlined in Annex A1.1-A1.5, a table is included that highlights the similarities anddifferences between the test protocols.4. Keywords4.1 acute toxicity testing; dermal; eye; inha

30、lation; metal-working fluids; oralE 1302 00 (2007)2ANNEX(Mandatory Information)A1. REFERENCES 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

31、Environmental Protection Agency, Toxic SubstancesControl Act (EPA-TSCA): 40 CFR 870.1100.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 EP

32、A-TSCA: 40 CFR 870.1200.A1.2.4 OSHA: 29 CFR 1910.1200, Appendix A, 3(b) and6(b).A1.2.5 Test Method E 758.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.A1.3.4 OSHA: 29 CFR 1910.1200, Appendix A, 3(c) and6(c).

33、TABLE A1.1 Acute Oral ToxicityProtocolDose/AnimalToxicityClassNumber ofGroups/DoseLevelObservationTimeAdditionalEndpointsCPSC LD50 50 mg/kg nsA14 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 toxicit

34、yRatOSHA LD50 50 mg/kg nsAnsAnsAHighly toxicLD50 50 to 500 mg/kgToxicRatANot specified.TABLE A1.2 Acute Dermal ToxicityProtocolDose/AnimalToxicityClassNumber ofGroups/ DoseLevelDurationofContactObservationTimeCPSC LD50 200 mg/kg nsAUp to 24 h 14 daysHighly toxic Occluded,abraded, andintact skinLD50

35、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, male and femaleOSHA LD50 200 mg/kg nsA24 h nsAHighly toxicLD50 200 to 1000 mg/kgToxicRabbitANot specified.TABLE A1.3 Acute Inhalation ToxicityProtocolConcen

36、tration/AnimalToxicityClassNumberof groups/DoseLevelsExposureDurationObservationTimeAdditionalEndpointsCPSC LC50 2 mg/Lor 200 ppm -nsA1h nsAnsAHighly 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

37、ofbody toxicityRat; maleand femaleOSHA LC50 2 mg/Lor 200 ppmnsA1h nsAnsAHighly toxicLC502to20mg/Lor 2002000ppmToxicRatANot specified.E 1302 00 (2007)3A1.4 Eye IrritationSee 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

38、Irritation or CorrosionSee Table A1.5.A1.5.1 CPSC: 16 CFR 1500.41 (Irritation).A1.5.2 DOT: 49 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

39、 pig maximization test.A1.6.3 Split adjuvant technique.A1.6.4 Buehler test.A1.6.5 Open epicutaneous test.A1.6.6 Mauer optimization test.A1.6.7 Footpad technique in guinea pig.A1.6.8 Test Method E 993.A1.7 Sensory IrritationA1.7.1 Test Method E 981.A1.8 OSHA Hazard Communication StandardA1.8.1 29 CFR

40、 1910.1200.A1.9 Good Laboratory PracticesA1.9.1 (EPA) 40 CFR 792.A1.10 Federal Hazardous Substances 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

41、)DoseExposureTimeObservationTime andScoringCPSC Rabbit (6) 0.1 mL Unwashed 24, 48, 72 hundilutedfluid 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)Scor

42、ing-DraizeOSHA Rabbit (6) 0.1 mLundilutedfluidUnwashed 24, 48, 72 hScoring-DraizeAEPA protocol gives 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

43、andScoringCPSC Rabbit 0.5 mL 24 h mul- 24 and 72 h(Irritation) (6) undiluted tiple sites; Scoring-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 irreve

44、rsi-ble tissuealteration,necrosis, andulceration.EPA Rabbit 0.5 mL 4 h multiple After 4 h(TSCA) (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.O

45、SHA Rabbit 0.5 mL 4 h multiple 24 and(Irritation/ (6) undiluted sites; intact 72 hCorrosivity) Same 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 conserveanimals, the laboratory may

46、 want to conduct the EPA or CPSC procedures forirritation in conjunction with the DOT protocol. Using multiple sites, at end of 4 hremove some of the occlusions and measure for DOT corrosivity.E 1302 00 (2007)4ASTM International takes no position respecting the validity of any patent rights asserted

47、 in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the

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49、areful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or service