ASTM E1302-23
(Guide)Standard Guide for Acute Animal Toxicity Testing of Water-Miscible Metalworking Fluids
Standard Guide for Acute Animal Toxicity Testing of Water-Miscible Metalworking Fluids
SIGNIFICANCE AND USE
4.1 Application of this guide will provide information on the acute toxicity of water-miscible metalworking fluids and will assist the user in evaluating the potential health hazards of the fluid and developing appropriate work practices. A water-miscible metalworking fluid is a concentrate designed to be diluted in water for use.
4.2 Water-miscible metalworking fluids are complex chemical mixtures. The United States Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (see A1.8) outlines procedures for the hazard determination of mixtures and states that if a mixture has not been tested as a whole, then the mixture shall be assumed to present the same hazards as do the components that comprise 1 % (by weight or volume) or greater of the mixture, except that the mixture shall be assumed to present a carcinogenic hazard if it contains a component in concentrations of 0.1 % or greater, which is considered to be a carcinogen (as defined in OSHA Standard 29 CFR 1910.1200). The determination of when to test a mixture as a whole and which toxicity tests are appropriate for the product must be made by a health professional qualified in evaluating toxicological data.
4.3 Acute toxicology testing of water-miscible metalworking fluids consists of several individual tests including acute oral, dermal, or inhalation toxicity, eye irritation, skin irritation or corrosion, or both, skin sensitization, and sensory irritation. Certain protocols for acute oral, dermal, and inhalation toxicity tests are limit tests; further multi-dose testing (for example, Test Method E1103) should take place if mortality is noted on any of these tests. The referenced protocols specify the species and number of animals required. Selection of tests conducted should be designed to minimize the number of animals used.
4.3.1 Acute Oral Toxicity—Acute oral toxicity tests (see A1.1) provide information on health hazards likely to arise from short-term exposure by the ...
SCOPE
1.1 This guide defines acute animal toxicity tests and sets forth the references for procedures to assess the acute toxicity of water-miscible metalworking fluids as manufactured.
1.2 Although water-miscible metalworking fluids are typically used at high dilution, dilution rates vary widely. Additionally, there is potential for exposure to the metalworking fluid as manufactured.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
General Information
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E1302 − 23 An American National Standard
Standard Guide for
Acute Animal Toxicity Testing of Water-Miscible
1
Metalworking Fluids
This standard is issued under the fixed designation E1302; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* E1542 Terminology Relating to Occupational Health and
Safety
1.1 This guide defines acute animal toxicity tests and sets
E2523 Terminology for Metalworking Fluids and Opera-
forth the references for procedures to assess the acute toxicity
tions
of water-miscible metalworking fluids as manufactured.
4
2.2 CPSC Standards:
1.2 Although water-miscible metalworking fluids are typi-
16 CFR Part 1500 Hazardous Substances and Articles
cally used at high dilution, dilution rates vary widely.
16 CFR Part 1500.3 Definitions
Additionally, there is potential for exposure to the metalwork-
16 CFR Part 1500.40 Method of Testing Toxic Substances
ing fluid as manufactured.
16 CFR Part 1500.41 Method of Testing Primary Irritant
1.3 This standard does not purport to address all of the
Substances
safety concerns, if any, associated with its use. It is the
16 CFR Part 1500.42 Test for Eye Irritants
responsibility of the user of this standard to establish appro-
4
2.3 DOT Standards:
priate safety, health, and environmental practices and deter-
49 CFR Part 173, Appendix A
mine the applicability of regulatory limitations prior to use.
49 CFR Part 173.343a1
1.4 This international standard was developed in accor-
49 CFR Part 173.343a2
dance with internationally recognized principles on standard-
49 CFR Part 173.343a3
ization established in the Decision on Principles for the
4
2.4 EPA-TSCA Standards:
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical 40 CFR 792 Good Laboratory Practice
40 CFR 870.1100 Acute Oral Toxicity
Barriers to Trade (TBT) Committee.
40 CFR 870.1200 Acute Dermal Toxicity
2. Referenced Documents 40 CFR 870.1300 Acute Inhalation Toxicity
2
40 CFR 870.2400 Acute Eye Irritation
2.1 ASTM Standards:
40 CFR 870.2500 Acute Dermal Irritation
E758 Test Method for Mammalian Acute Percutaneous Tox-
3
40 CFR 870.2600 Skin Sensitization
icity (Withdrawn 2010)
4
E981 Test Method for Estimating Sensory Irritancy of Air- 2.5 OSHA Standards:
borne Chemicals 29 CFR 1910.1200 Hazard Communication
E993 Test Method for Evaluation of Delayed Contact Hy- 29 CFR 1910.1200 Appendix A, 3(a) and 6(a)
3
persensitivity (Withdrawn 2010) 29 CFR 1910.1200 Appendix A, 3(b) and 6(b)
E1103 Test Method for Determining Subchronic Dermal 29 CFR 1910.1200 Appendix A, 3(c) and 6(c)
3
Toxicity (Withdrawn 2010) 29 CFR 1910.1200 Appendix A, 4
3. Terminology
1
This guide is under the jurisdiction of ASTM Committee E34 on Occupational
3.1 For definitions of terms in this guide relating to toxico-
Health and Safety and is the direct responsibility of Subcommittee E34.50 on Health
logical testing, refer to Terminology E2523. For definitions of
and Safety Standards for Metal Working Fluids.
terms in this guide relating to occupational health and safety,
Current edition approved April 1, 2023. Published April 2023. Originally
approved in 1989. Last previous edition approved in 2017 as E1302 – 13 (2017).
refer to Terminology E1542.
DOI: 10.1520/E1302-23.
2 3.2 Definitions of Terms Specific to This Standard:
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3 4
The last approved version of this historical standard is referenced on Available from Supt. of Documents, U.S. Government Printing Office,
www.astm.org. Washington, DC 20402.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E1302 − 23
3.2.1 limit test, n—an acute toxicity test in which, if no ill cause death and other adverse health effects when inhaled for
effects occur at a pre-selected maximum dose, no further a specified time period. Endpoint: mortality.
testing at greater exposure levels is required. 4.3.4 Eye Irritation—Eye irritation tests provide an indica-
http://sis.nlm.nih.gov/enviro/iupacglossary/glossaryl.html tion of the potential of the fl
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E1302 − 13 (Reapproved 2017) E1302 − 23 An American National Standard
Standard Guide for
Acute Animal Toxicity Testing of Water-Miscible
1
Metalworking Fluids
This standard is issued under the fixed designation E1302; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope*
1.1 This guide defines acute animal toxicity tests and sets forth the references for procedures to assess the acute toxicity of
water-miscible metalworking fluids as manufactured.
1.2 Although water-miscible metalworking fluids are typically used at high dilution, dilution rates vary widely. Additionally, there
is potential for exposure to the metalworking fluid as manufactured.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
3
E758 Test Method for Mammalian Acute Percutaneous Toxicity (Withdrawn 2010)
E981 Test Method for Estimating Sensory Irritancy of Airborne Chemicals
3
E993 Test Method for Evaluation of Delayed Contact Hypersensitivity (Withdrawn 2010)
3
E1103 Test Method for Determining Subchronic Dermal Toxicity (Withdrawn 2010)
E1542 Terminology Relating to Occupational Health and Safety
E2523 Terminology for Metalworking Fluids and Operations
4
2.2 CPSC Standards:
16 CFR Part 1500 CFR Part 1500Hazardous Substances and Articles
16 CFR Part 1500.3 CFR Part 1500.3Definitions
16 CFR Part 1500.40 CFR Part 1500.40Method of Testing Toxic Substances
16 CFR Part 1500.41 CFR Part 1500.41Method of Testing Primary Irritant Substances
16 CFR Part 1500.42 CFR Part 1500.42Test for Eye Irritants
1
This guide is under the jurisdiction of ASTM Committee E34 on Occupational Health and Safety and is the direct responsibility of Subcommittee E34.50 on Health and
Safety Standards for Metal Working Fluids.
Current edition approved Oct. 1, 2017April 1, 2023. Published October 2017April 2023. Originally approved in 1989. Last previous edition approved in 20132017 as
E1302 – 13.E1302 – 13 (2017). DOI: 10.1520/E1302-13R17.10.1520/E1302-23.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
4
Available from Supt. of Documents, U. S. U.S. Government Printing Office, Washington, DC 20402.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E1302 − 23
4
2.3 DOT Standards:
49 CFR Part 173, Appendix A CFR Part 173, Appendix A
49 CFR Part 173.343a1 CFR Part 173.343a1
49 CFR Part 173.343a2 CFR Part 173.343a2
49 CFR Part 173.343a3 CFR Part 173.343a3
4
2.4 EPA-TSCA Standards:
40 CFR 792 CFR 792Good Laboratory Practice
40 CFR 870.1100 CFR 870.1100Acute Oral Toxicity
40 CFR 870.1200 CFR 870.1200Acute Dermal Toxicity
40 CFR 870.1300 CFR 870.1300Acute Inhalation Toxicity
40 CFR 870.2400 CFR 870.2400Acute Eye Irritation
40 CFR 870.2500 CFR 870.2500Acute Dermal Irritation
40 CFR 870.2600 CFR 870.2600Skin Sensitization
4
2.5 OSHA Standards:
29 CFR 1910.1200 CFR 1910.1200Hazard Communication
29 CFR 1910.1200 Appendix A, 3(a) and 6(a) CFR 1910.1200 Appendix A, 3(a) and 6(a)
29 CFR 1910.1200 Appendix A, 3(b) and 6(b) CFR 1910.1200 Appendix A, 3(b) and 6(b)
29 CFR 1910.1200 Appendix A, 3(c) and 6(c) CFR 1910.1200 Appendix A, 3(c) and 6(c)
29 CFR 1910.1200 Appendix A, 4 CFR 1910.1200 Appendix A, 4
3. Terminology
3.1 For definitions of terms in this guide relating to toxicological testing, refer to Terminology E2
...
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