ASTM E1302-13(2017)

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

• Status: Historical
• Publication Date: 30-Sep-2017
• ICS: 11.100.99 - Other standards related to laboratory medicine
• Technical Committee: E34 - Occupational Health and Safety
• Drafting Committee: E34.50 - Health and Safety Standards for Metal Working Fluids

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E1302 − 13 (Reapproved 2017) An American National Standard
Standard Guide for
Acute Animal Toxicity Testing of Water-Miscible
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.
2.2 CPSC Standards:
1.2 Although water-miscible metalworking fluids are typi-
6 CFR Part 1500
cally used at high dilution, dilution rates vary widely.
16 CFR Part 1500.3
Additionally, there is potential for exposure to the metalwork-
16 CFR Part 1500.40
ing fluid as manufactured.
16 CFR Part 1500.41
1.3 This standard does not purport to address all of the
16 CFR Part 1500.42
safety concerns, if any, associated with its use. It is the 4
2.3 DOT Standards:
responsibility of the user of this standard to establish appro-
49 CFR Part 173, Appendix A
priate safety, health, and environmental practices and deter-
49 CFR Part 173.343a1
mine the applicability of regulatory limitations prior to use.
49 CFR Part 173.343a2
1.4 This international standard was developed in accor-
49 CFR Part 173.343a3
dance with internationally recognized principles on standard-
2.4 EPA-TSCA Standards:
ization established in the Decision on Principles for the
40 CFR 792
Development of International Standards, Guides and Recom-
40 CFR 870.1100
mendations issued by the World Trade Organization Technical
40 CFR 870.1200
Barriers to Trade (TBT) Committee.
40 CFR 870.1300
40 CFR 870.2400
2. Referenced Documents
40 CFR 870.2500
2.1 ASTM Standards:
40 CFR 870.2600
E758 Test Method for Mammalian Acute Percutaneous Tox-
2.5 OSHA Standards:
icity (Withdrawn 2010)
29 CFR 1910.1200
E981 Test Method for Estimating Sensory Irritancy of Air-
29 CFR 1910.1200 Appendix A, 3(a) and 6(a)
borne Chemicals
29 CFR 1910.1200 Appendix A, 3(b) and 6(b)
E993 Test Method for Evaluation of Delayed Contact Hy-
29 CFR 1910.1200 Appendix A, 3(c) and 6(c)
persensitivity (Withdrawn 2010)
29 CFR 1910.1200 Appendix A, 4
E1103 Test Method for Determining Subchronic Dermal
Toxicity (Withdrawn 2010)
3. Terminology
3.1 For definitions of terms in this guide relating to toxico-
logical testing, refer to Terminology E2523. For definitions of
This guide is under the jurisdiction of ASTM Committee E34 on Occupational
terms in this guide relating to occupational health and safety,
Health and Safety and is the direct responsibility of Subcommittee E34.50 on Health
and Safety Standards for Metal Working Fluids. refer to Terminology E1542.
Current edition approved Oct. 1, 2017. Published October 2017. Originally
3.2 Definitions of Terms Specific to This Standard:
approved in 1989. Last previous edition approved in 2013 as E1302 – 13. DOI:
10.1520/E1302-13R17. 3.2.1 limit test, n—an acute toxicity test in which, if no ill
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
effects occur at a pre-selected maximum dose, no further
contact ASTM Customer Service at [e-mail]. 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
E1302 − 13 (2017)
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 fluid to cause eye irritation or
damage upon direct contact (see A1.4). An irritant is defined as
4. Significance and Use
a chemical that is not corrosive, but causes a reversible
4.1 Application of this guide will provide information on inflammatory effect on living tissue by chemical action at the
site of contact. Endpoint: degree of irritation.
the acute toxicity of water-miscible metalworking fluids and
will assist the user in evaluating the potential health hazards of
4.3.5 Skin Irritation or Corrosion—Skin irritation or corro-
the fluid and developing appropriate work practices. A water-
sion tests indicate the potential of the fluid to produce irritation
miscible metalworking fluid is a concentrate designed to be
or damage to skin (see A1.5). A corrosive chemical is one that
diluted in water for use.
causes visible destruction of, or irreversible alterations in,
living tissue by chemical action at the site of contact. Endpoint:
4.2 Water-miscible metalworking fluids are complex chemi-
irritation or corrosion.
cal mixtures. The United States Occupational Safety and
4.3.6 Skin Sensitization—A chemical sensitizer is a material
Health Administration (OSHA) Hazard Communication Stan-
that causes a substantial proportion of exposed people or
dard (see A1.8) outlines procedures for the hazard determina-
animals to develop an allergic reaction in normal tissue after
tion of mixtures and states that if a mixture has not been tested
repeated exposure to the chemical. A number of methods are
as a whole, then the mixture shall be assumed to present the
available for measuring skin sensitization, however, there are
same hazards as do the components that comprise 1 % (by
differences in opinion on the most appropriate method. These
weight or volume) or greater of the mixture, except that the
are due to variations in compound administration and degree of
mixture shall be assumed to present a carcinogenic hazard if it
reaction to a sensitizing substance. Refer to the Code of
contains a component in concentrations of 0.1 % or greater,
Federal Regulations (CFR) for the various protocols (see
which is considered to be a carcinogen (as defined in OSHA
A1.6). Additionally, toxicology testing contract labs may have
Standard 29 CFR 1910.1200). The determination of when to
standard procedures for conducting these assays. Endpoint:
test a mixture as a whole and which toxicity tests are
sensitization.
appropriate for the product must be made by a health profes-
sional qualified in evaluating toxicological data. 4.3.7 Sensory Irritation—Upon exposure to a sensory
irritant, humans experience discomfort or a burning sensation
4.3 Acute toxicology testing of water-miscible metalwork-
of the eyes, nose, and throat, and may also cough. Test Method
ing fluids consists of several individual tests including acute
E981 (see A1.2.5) provides a means to evaluate the sensory
oral, dermal, or inhalation toxicity, eye irritation, skin irritation
irritant potential of airborne chemicals and mixtures, as well as
or corrosion, or both, skin sensitization, and sensory irritation.
a means to assess the comparative irritancy of compounds and
Certain protocols for acute oral, dermal, and inhalation toxicity
formulations. However, this test method cannot be used to
tests are limit tests; further multi-dose testing (for example,
evaluate the relative obnoxiousness of odors. End point: upper
Test Method E1103) should take place if mortality is noted on
respiratory tract irritation.
any of these tests. The referenced protocols specify the species
and number of animals required. Selection of tests conducted
4.4 A number of federal guidelines can be used to establish
should be designed to minimize the number of animals used.
general procedures for testing acute toxicity of metalworking
4.3.1 Acute Oral Toxicity—Acute oral toxicity tests (see
fluids. Several references are cited in Annex A1. Regardless of
A1.1) provide information on health hazards likely to arise
the method used, Good Laboratory Practices, as outlined by the
from short-term exposure by the oral route. Results of this type
United States Environmental Protection Agency (EPA 40 CFR
of test are used to develop warning statements on labels as may
792) (see A1.9) must be followed. The OSHA Hazard Com-
be required by OSHA Hazard Communication Standard 29
munication Standard (see A1.8) outlines the responsibilities of
CFR 1910.1200 (see A1.8) or Fed
...

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 E1302 − 13 (Reapproved 2017) An American National Standard
Standard Guide for
Acute Animal Toxicity Testing of Water-Miscible
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 safety, health, and healthenvironmental 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
2.1 ASTM Standards:
E758 Test Method for Mammalian Acute Percutaneous Toxicity (Withdrawn 2010)
E981 Test Method for Estimating Sensory Irritancy of Airborne Chemicals
E993 Test Method for Evaluation of Delayed Contact Hypersensitivity (Withdrawn 2010)
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
2.2 CPSC Standards:
6 CFR Part 1500
16 CFR Part 1500.3
16 CFR Part 1500.40
16 CFR Part 1500.41
16 CFR Part 1500.42
2.3 DOT Standards:
49 CFR Part 173, Appendix A
49 CFR Part 173.343a1
49 CFR Part 173.343a2
49 CFR Part 173.343a3
2.4 EPA–TSCAEPA-TSCA Standards:
40 CFR 792
40 CFR 870.1100
40 CFR 870.1200
This test method 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 July 1, 2013Oct. 1, 2017. Published July 2013October 2017. Originally approved in 1989. Last previous edition approved in 20122013 as
E1302 - 12.E1302 – 13. DOI: 10.1520/E1302-13.10.1520/E1302-13R17.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
The last approved version of this historical standard is referenced on www.astm.org.
Available from Supt. of Documents, 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
E1302 − 13 (2017)
40 CFR 870.1300
40 CFR 870.2400
40 CFR 870.2500
40 CFR 870.2600
2.5 OSHA Standards:
29 CFR 1910.1200
29 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, 4
3. Terminology
3.1 For definitions of terms in this practiceguide relating to toxicological testing, refer to Terminology E2523. For definitions
of terms in this practiceguide relating to occupational health and safety, refer to Terminology E1542.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 limit test, n—an acute toxicity test in which, if no ill-effects ill effects occur at a pre-selected maximum dose, no further
testing at greater exposure levels is required. http://sis.nlm.nih.gov/enviro/iupacglossary/glossaryl.html
4. 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,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 oral route. Results of this type of test are used to develop warning statements on labels as may be
required by OSHA Hazard Communication Standard 29 CFR 1910.1200 (see A1.8) or Federal Hazardous Substances Act (see
A1.10). These are also used to establish a dosage regimen for subchronic and other testing. Endpoint: mortality.
4.3.2 Acute Dermal Toxicity—Acute dermal toxicity tests (see A1.2) provide information on health hazards likely to arise from
short-term exposure by the dermal route and may provide initial information on dermal absorption and the mode of toxic action
of a substance. In addition, some measure of irritation caused by the fluid may be obtained by observing local tissue damage at
the sight of application. Endpoint: mortality.
4.3.3 Acute Inhalation Toxicity—Acute inhalation toxicity tests give an indication of relative toxicity (see A1.3). The results
provide an indication of the potential of the fluid to cause death and other adverse health effects when inhaled for a specified time
period. Endpoint: mortality.
4.3.4 Eye Irritation—Eye irritation tests provide an indication of the potential of the fluid to cause eye irritation or damage upon
direct contact (see A1.4). An irritant is defined as a chemical that is not corrosive, but causes a reversible inflammatory effect on
living tissue by chemical action at the site of contact. Endpoint: degree of irritation.
4.3.5 Skin Irritation or Corrosion—Skin irritation or corrosion tests indicate the potential of the fluid to produce irritation or
damage to skin (see A1.5). A corrosive chemical is one that causes 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 Sensitization—A chemical sensitizer is a material that causes a substantial proportion of exposed people or animals
to develop an allergic reaction in normal tissue after repeated exposure to the chemical. A number of methods are available for
measuring skin sensitization, however, there are differences in opinion on the most appropriate method. These are due to variations
in compound administration and degree of reaction to a sensitizing substance. Refer to the Code of Federal Regulations (CFR) for
the various protocols (see A1.6). Additionally, toxicology testing contract labs may have standard procedures for conducting these
assays. Endpoint: sensitization.
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