ASTM E1302-00(2007)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: E1302 − 00(Reapproved 2007) 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 16 CFR Part 1500.42
1.1 This guide defines acute animal toxicity tests and sets 2.3 DOT Standards:
forth the references for procedures to assess the acute toxicity 49 CFR Part 173, Appendix A
of water-miscible metalworking fluids as manufactured. 49 CFR Part 173.343a1
49 CFR Part 173.343a2
1.2 Although water-miscible metalworking fluids are typi-
49 CFR Part 173.343a3
cally used at high dilution, dilution rates vary widely.
Additionally, there is potential for exposure to the metalwork- 2.4 EPA–TSCA Standards:
ing fluid as manufactured. 40 CFR 792
40 CFR 870.1100
1.3 This standard does not purport to address all of the
40 CFR 870.1200
safety concerns, if any, associated with its use. It is the
40 CFR 870.1300
responsibility of the user of this standard to establish appro-
40 CFR 870.2400
priate safety and health practices and determine the applica-
40 CFR 870.2500
bility of regulatory limitations prior to use.
40 CFR 870.2600
2. Referenced Documents
2.5 OSHA Standards:
29 CFR 1910.1200
2.1 ASTM Standards:
E758 Test Method for MammalianAcute Percutaneous Tox- 29 CFR 1910.1200 Appendix A, 3(a) and 6(a)
29 CFR 1910.1200 Appendix A, 3(b) and 6(b)
icity (Withdrawn 2010)
29 CFR 1910.1200 Appendix A, 3(c) and 6(c)
E981 Test Method for Estimating Sensory Irritancy of Air-
29 CFR 1910.1200 Appendix A, 4
borne Chemicals
E993 Test Method for Evaluation of Delayed Contact Hy-
3. Significance and Use
persensitivity (Withdrawn 2010)
E1103 Test Method for Determining Subchronic Dermal
3.1 Application of this guide will provide information on
(Withdrawn 2010)
Toxicity
the acute toxicity of water-miscible metalworking fluids and
2.2 CPSC Standards:
will assist the user in evaluating the potential health hazards of
16 CFR Part 1500
the fluid and developing appropriate work practices. A water-
16 CFR Part 1500.3
miscible metalworking fluid is a concentrate designed to be
16 CFR Part 1500.40
diluted in water for use.
16 CFR Part 1500.41
3.2 Water-miscible metalworking fluids are complex chemi-
cal mixtures. The United States Occupational Safety and
This test method is under the jurisdiction of ASTM Committee E34 on
Health Administration (OSHA) Hazard Communication Stan-
Occupational Health and Safety and is the direct responsibility of Subcommittee
dard (see A1.8) outlines procedures for the hazard determina-
E34.50 on Health and Safety Standards for Metal Working Fluids.
tion of mixtures and states that if a mixture has not been tested
Current edition approved April 1, 2007. Published June 2007. Originally
approved in 1989. Last previous edition approved in 2000 as E1302 - 00. DOI:
as a whole, then the mixture shall be assumed to present the
10.1520/E1302-00R07.
same hazards as do the components that comprise 1 % (by
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
weight or volume) or greater of the mixture, except that the
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
mixture shall be assumed to present a carcinogenic hazard if it
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
contains a component in concentrations of 0.1 % or greater,
The last approved version of this historical standard is referenced on
which is considered to be a carcinogen (as defined in OSHA
www.astm.org.
Standard 29 CFR 1910.1200). The determination of when to
Available from Supt. of Documents, U. S. Government Printing Office,
Washington, DC 20402. test a mixture as a whole and which toxicity tests are
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E1302 − 00 (2007)
appropriate for the product must be made by a health 3.3.6 Skin Sensitization—Achemical sensitizer is a material
professional, qualified in evaluating toxicological data. that causes a substantial proportion of exposed people or
animals to develop an allergic reaction in normal tissue after
3.3 Acute toxicology testing of water-miscible metalwork-
repeated exposure to the chemical. A number of methods are
ing fluids consists of several individual tests including acute
available for measuring skin sensitization, however, there are
oral, dermal, or inhalation toxicity, eye irritation, skin irritation
differences in opinion on the most appropriate method. These
or corrosion, or both, skin sensitization, and sensory irritation.
areduetovariationsincompoundadministrationanddegreeof
Certain protocols for acute oral, dermal, and inhalation toxicity
reaction to a sensitizing substance. Refer to the Code of
tests are limit tests; further multi-dose testing (for example,
Federal Regulations (CFR) for the various protocols (see
Test Method E1103) should take place if mortality is noted on
A1.6). Additionally, toxicology testing contract labs may have
any of these tests. The referenced protocols specify the species
standard procedures for conducting these assays. Endpoint:
and number of animals required. Selection of tests conducted
sensitization.
should be designed to minimize the number of animals used.
3.3.1 Acute Oral Toxicity—Acute oral toxicity tests (see
3.3.7 Sensory Irritation-—Upon exposure to a sensory
A1.1) provide information on health hazards likely to arise
irritant, humans experience discomfort or a burning sensation
from short-term exposure by the oral route. Results of this type
of the eyes, nose, and throat, and may also cough. Test Method
of test are used to develop warning statements on labels as may
E981 (see A1.2.5) provides a means to evaluate the sensory
be required by OSHA Hazard Communication Standard 29
irritant potential of airborne chemicals and mixtures as well as
CFR 1910.1200 (see A1.8) or Federal Hazardous Substances
a means to assess the comparative irritancy of compounds and
Act (see A1.10). These are also used to establish a dosage
formulations. However, this test method cannot be used to
regimen for subchronic and other testing. Endpoint: mortality.
evaluate the relative obnoxiousness of odors. End point: upper
3.3.2 Acute Dermal Toxicity—Acute dermal toxicity tests
respiratory tract irritation.
(seeA1.2)provideinformationonhealthhazardslikelytoarise
3.4 A number of federal guidelines can be used to establish
from short-term exposure by the dermal route and may provide
general procedures for testing acute toxicity of metalworking
initial information on dermal absorption and the mode of toxic
fluids. Several references are cited in AnnexA1. Regardless of
action of a substance. In addition, some measure of irritation
themethodused,GoodLaboratoryPractices,asoutlinedbythe
caused by the fluid may be obtained by observing local tissue
United States Environmental ProtectionAgency (EPA40 CFR
damage at the sight of application. Endpoint: mortality.
792) (see A1.9) must be followed. The OSHA Hazard Com-
3.3.3 Acute Inhalation Toxicity—Acute inhalation toxicity
munication Standard (see A1.8) outlines the responsibilities of
tests give an indication of relative toxicity (see A1.3). The
chemical manufacturers, importers, and employers in the
results provide an indication of the potential of the fluid to
determination of chemical hazards and communication of
cause death and other adverse health effects when inhaled for
information on those hazards.
a specified time period. Endpoint: mortality.
...