ASTM E1302-12
(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 and health practices and determine the applicability of regulatory limitations prior to use.
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Designation: E1302 − 12 AnAmerican 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.
4
1. Scope 2.2 CPSC Standards:
16 CFR Part 1500
1.1 This guide defines acute animal toxicity tests and sets
16 CFR Part 1500.3
forth the references for procedures to assess the acute toxicity
16 CFR Part 1500.40
of water-miscible metalworking fluids as manufactured.
16 CFR Part 1500.41
1.2 Although water-miscible metalworking fluids are typi-
16 CFR Part 1500.42
cally used at high dilution, dilution rates vary widely.
4
2.3 DOT Standards:
Additionally, there is potential for exposure to the metalwork-
49 CFR Part 173, Appendix A
ing fluid as manufactured.
49 CFR Part 173.343a1
1.3 This standard does not purport to address all of the
49 CFR Part 173.343a2
safety concerns, if any, associated with its use. It is the
49 CFR Part 173.343a3
responsibility of the user of this standard to establish appro-
4
2.4 EPA–TSCA Standards:
priate safety and health practices and determine the applica-
40 CFR 792
bility of regulatory limitations prior to use.
40 CFR 870.1100
40 CFR 870.1200
2. Referenced Documents
40 CFR 870.1300
2
2.1 ASTM Standards:
40 CFR 870.2400
E758 Test Method for MammalianAcute Percutaneous Tox-
40 CFR 870.2500
3
icity (Withdrawn 2010)
40 CFR 870.2600
E981 Test Method for Estimating Sensory Irritancy of Air-
4
2.5 OSHA Standards:
borne Chemicals
29 CFR 1910.1200
E993 Test Method for Evaluation of Delayed Contact Hy-
3 29 CFR 1910.1200 Appendix A, 3(a) and 6(a)
persensitivity (Withdrawn 2010)
29 CFR 1910.1200 Appendix A, 3(b) and 6(b)
E1103 Test Method for Determining Subchronic Dermal
3 29 CFR 1910.1200 Appendix A, 3(c) and 6(c)
Toxicity (Withdrawn 2010)
29 CFR 1910.1200 Appendix A, 4
E1542 Terminology Relating to Occupational Health and
Safety
3. Terminology
E2523 Terminology for Metalworking Fluids and Opera-
3.1 For definitions of terms in this practice relating to
tions
toxicological testing, refer to Terminology E2523. For defini-
tions of terms in this practice relating to occupational health
1
This test method is under the jurisdiction of ASTM Committee E34 on
and safety, refer to Terminology E1542.
Occupational Health and Safety and is the direct responsibility of Subcommittee
E34.50 on Health and Safety Standards for Metal Working Fluids.
3.2 Definitions of Terms Specific to This Standard:
Current edition approved Nov. 1, 2012. Published November 2012. Originally
3.2.1 limit test, n—an acute toxicity test in which, if no
approved in 1989. Last previous edition approved in 2007 as E1302 - 00 (2007).
ill-effects occur at a pre-selected maximum dose, no further
DOI: 10.1520/E1302-12.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
testing at greater exposure levels is required.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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E1302 − 12
4. Significance and Use 4.3.4 Eye Irritation—Eye irritation tests provide an indica-
tion of the potential of the fluid to cause eye irritation or
4.1 Application of this guide will provide information on
damage upon direct contact (see A1.4).An irritant is defined as
the acute toxicity of water-miscible metalworking fluids and
a chemical that is not corrosive, but causes a reversible
will assist the user in evaluating the potential health hazards of
inflammatory effect on living tissue by chemical action at the
the fluid and developing appropriate work practices. A water-
site of contact. Endpoint: degree of irritation.
miscible metalworking fluid is a concentrate designed to be
4.3.5 Skin Irritation or Corrosion—Skin irritation or corro-
diluted in water for use.
sion tests indicate the potential of the fluid to produce irritation
or damage to skin (see A1.5).Acorrosive chemical is one that
4.2 Water-miscible metalworking fluids are complex chemi-
causes visible destruction of, or irreversible alterations in,
cal mixtures. The United States Occupational Safety and
livingtissuebychemicalactionatthesiteofcontact.Endpoint:
Health Ad
...
Designation: E1302 − 00 (Reapproved 2007) E1302 − 12 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 and health practices and determine the applicability of regulatory
limitations prior to use.
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
16 CFR Part 1500.3
16 CFR Part 1500.40
16 CFR Part 1500.41
16 CFR Part 1500.42
4
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
4
2.4 EPA–TSCA Standards:
40 CFR 792
40 CFR 870.1100
40 CFR 870.1200
40 CFR 870.1300
40 CFR 870.2400
40 CFR 870.2500
40 CFR 870.2600
4
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
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E1302 − 12
3. Terminology
3.1 For definitions of terms in this practice relating to toxicological testing, refer to Terminology E2523. For definitions of terms
in this practice 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 occur at a pre-selected maximum dose, no further testing at
greater exposure levels is required.
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, 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 b
...
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