ASTM E1302-13(2017) Standard Guide for Acute Animal Toxicity Testing of Water-Miscible Metalworking Fluids.pdf

1、Designation: E1302 13 (Reapproved 2017) 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

2、 or, in the case of 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

3、 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.Additionally, there is potential for exposure to the metalwork-ing fluid 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, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use

5、.1.4 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers t

6、o Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2E758 Test Method for Mammalian Acute Percutaneous Tox-icity (Withdrawn 2010)3E981 Test Method for Estimating Sensory Irritancy of Air-borne ChemicalsE993 Test Method for Evaluation of Delayed Contact Hy-persensitivity (Withdrawn 2010

7、)3E1103 Test Method for Determining Subchronic DermalToxicity (Withdrawn 2010)3E1542 Terminology Relating to Occupational Health andSafetyE2523 Terminology for Metalworking Fluids and Opera-tions2.2 CPSC Standards:46 CFR Part 150016 CFR Part 1500.316 CFR Part 1500.4016 CFR Part 1500.4116 CFR Part 15

8、00.422.3 DOT Standards:449 CFR Part 173, Appendix A49 CFR Part 173.343a149 CFR Part 173.343a249 CFR Part 173.343a32.4 EPA-TSCA 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

9、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. Terminology3.1 For definitions of terms in this guide relating to toxico-logical testing, refer to Terminology E2523. For definitions ofterms in this guide relating to

10、 occupational health and safety,refer to Terminology E1542.3.2 Definitions of Terms Specific to This Standard:3.2.1 limit test, nan acute toxicity test in which, if no illeffects occur at a pre-selected maximum dose, no further1This guide is under the jurisdiction of ASTM Committee E34 on Occupation

11、alHealth and Safety and is the direct responsibility of Subcommittee E34.50 on Healthand Safety Standards for Metal Working Fluids.Current edition approved Oct. 1, 2017. Published October 2017. Originallyapproved in 1989. Last previous edition approved in 2013 as E1302 13. DOI:10.1520/E1302-13R17.2F

12、or 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 last approved version of this historical standard is refer

13、enced 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, West Conshohocken, PA 19428-2959. United StatesThis intern

14、ational standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Comm

15、ittee.1testing at greater exposure levels is required.http:/sis.nlm.nih.gov/enviro/iupacglossary/glossaryl.html4. 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

16、health hazards ofthe fluid and developing appropriate work practices. 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 (OSH

17、A) 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 be assumed to present thesame hazards as do the components that comprise 1 % (byweight or volume) or greater o

18、f 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 (as defined in OSHAStandard 29 CFR 1910.1200). The determination of when totest a mixture as a whole and whic

19、h toxicity tests areappropriate for the product must be made by a health profes-sional 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 irritati

20、on, 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 E1103) should take place if mortality is noted onany of these tests. The re

21、ferenced protocols specify the speciesand number of animals required. 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 th

22、e 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 other test

23、ing. Endpoint: mortality.4.3.2 Acute Dermal ToxicityAcute dermal toxicity 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,

24、 some measure of irritationcaused by the fluid may be obtained by 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 po

25、tential of the fluid tocause death and other adverse health effects 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 i

26、s 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.4.3.5 Skin Irritation or CorrosionSkin irritation or corro-sion tests indicate the potential of the fluid to produce irri

27、tationor 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.4.3.6 Skin SensitizationA chemical sensitizer is a materialthat causes a substan

28、tial 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 variations

29、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.4.3.7 Sensory

30、 IrritationUpon exposure to a sensoryirritant, humans experience 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

31、 the comparative irritancy of compounds andformulations. However, 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 m

32、etalworkingfluids. 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 the responsib

33、ilities ofchemical manufacturers, importers, and employers in thedetermination 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 Develo

34、pment (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.5. Keywords5.1 acute toxicity testing; dermal; eye; inhalation; m

35、etal-working fluids; oralE1302 13 (2017)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 Environmen

36、tal 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 EPA-TSCA: 40

37、 CFR 870.1200.A1.2.4 OSHA: 29 CFR 1910.1200, Appendix A, 3(b) and6(b).A1.2.5 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/AnimalToxicityClassNumbe

38、r 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 toxicityRatOSHA LD50 50 mg/kg nsAnsAnsAHighly toxicLD50 50 to 500 mg/kgTox

39、icRatANot 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 200 to 2000 mg/kgToxicRabbitDOT LD50 200 mg/kg 1 24 h 48 hPoison BR

40、abbitEPA(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 ToxicityProtocolConcentration/AnimalToxicityClassNumberof groups/DoseLevelsExposureDurati

41、onObservationTimeAdditionalEndpointsCPSC 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 ofbody toxicityRat; maleand femaleOSHA LC50 2 mg/Lor 200 ppmnsA1h n

42、sAnsAHighly toxicLC502to20mg/Lor 2002000ppmToxicRatANot specified.E1302 13 (2017)3A1.3.4 OSHA: 29 CFR 1910.1200, Appendix A, 3(c) and6(c).A1.4 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 Irritation o

43、r 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 870.2600)A1.6.1 Freunds complete adjuvant test.A1.6.2 Guinea pig maximi

44、zation 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 E993.A1.7 Sensory IrritationA1.7.1 Test Method E981.A1.8 OSHA Hazard Communication StandardA1.8.1 29 CFR 1910.1200.A1

45、.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)DoseExposure

46、TimeObservationTime 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)Scoring-DraizeOSH

47、A 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 andScoringCPS

48、C 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 irreversi-ble tissu

49、ealteration,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.OSHA 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 conserve animal