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ASTM E1302-00

(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

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.

General Information

Status
Historical
Publication Date
09-Mar-2000
ICS
11.120.01 - Pharmaceutics in general
Technical Committee
E34 - Occupational Health and Safety
Drafting Committee
E34.50 - Health and Safety Standards for Metal Working Fluids
Current Stage
Ref Project

Relations

Replaced By
ASTM E1302-00(2007) - Standard Guide for Acute Animal Toxicity Testing of Water-Miscible Metalworking Fluids
Effective Date
01-Apr-2007
Referred By
ASTM E2889-12(2017) - Standard Practice for Control of Respiratory Hazards in the Metal Removal Fluid Environment
Effective Date
10-Mar-2000
Referred By
ASTM E1497-23 - Standard Practice for Selection and Safe Use of Water-Miscible and Straight Oil Metal Removal Fluids
Effective Date
10-Mar-2000
Referred By
ASTM E2169-22 - Standard Practice for Selecting Antimicrobial Pesticides for Use in Water-Miscible Metalworking Fluids
Effective Date
10-Mar-2000
Referred By
ASTM E2148-21 - Standard Guide for Using Documents Related to Metalworking or Metal Removal Fluid Health and Safety
Effective Date
10-Mar-2000
Referred By
ASTM E2523-13(2018) - Standard Terminology for Metalworking Fluids and Operations
Effective Date
10-Mar-2000
Referred By
ASTM E2693-19 - Standard Practice for Prevention of Dermatitis in the Wet Metal Removal Fluid Environment
Effective Date
10-Mar-2000

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ASTM E1302-00 - Standard Guide for Acute Animal Toxicity Testing of Water-Miscible Metalworking FluidsASTM E1302-00 - Standard Guide for Acute Animal Toxicity Testing of Water-Miscible Metalworking Fluids
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ASTM E1302-00 - Standard Guide for Acute Animal Toxicity Testing of Water-Miscible Metalworking Fluids
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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
An American National Standard
Designation:E1302–00
Standard Guide for
Acute Animal Toxicity Testing of Water-Miscible
Metalworking Fluids
This standard is issued under the fixed designation E 1302; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope 49 CFR Part 173, Appendix A
49 CFR Part 173.343a1
1.1 This guide defines acute animal toxicity tests and sets
49 CFR Part 173.343a2
forth the references for procedures to assess the acute toxicity
49 CFR Part 173.343a3
of water-miscible metalworking fluids as manufactured.
2.4 EPA–TSCA Standards:
1.2 Although water-miscible metalworking fluids are typi-
40 CFR 792
cally used at high dilution, dilution rates vary widely. Addi-
40 CFR 870.1100
tionally, there is potential for exposure to the metalworking
40 CFR 870.1200
fluid as manufactured.
40 CFR 870.1300
1.3 This standard does not purport to address all of the
40 CFR 870.2400
safety concerns, if any, associated with its use. It is the
40 CFR 870.2500
responsibility of the user of this standard to establish appro-
40 CFR 870.2600
priate safety and health practices and determine the applica-
2.5 OSHA Standards:
bility of regulatory limitations prior to use.
29 CFR 1910.1200
2. Referenced Documents
29 CFR 1910.1200 Appendix A, 3(a) and 6(a)
29 CFR 1910.1200 Appendix A, 3(b) and 6(b)
2.1 ASTM Standards:
29 CFR 1910.1200 Appendix A, 3(c) and 6(c)
E 758 Test Method for Mammalian Acute Percutaneous
29 CFR 1910.1200 Appendix A, 4
Toxicity
E 981 Test Method for Estimating Sensory Irritancy of
3. Significance and Use
Airborne Chemicals
3.1 Application of this guide will provide information on
E 993 Test Method for Evaluation of Delayed Contact
the acute toxicity of water-miscible metalworking fluids and
Hypersensitivity
will assist the user in evaluating the potential health hazards of
E 1103 Test Method for Determining Subchronic Dermal
the fluid and developing appropriate work practices. A water-
Toxicity
miscible metalworking fluid is a concentrate designed to be
2.2 CPSC Standards:
diluted in water for use.
16 CFR Part 1500
3.2 Water-miscible metalworking fluids are complex chemi-
16 CFR Part 1500.3
cal mixtures. The United States Occupational Safety and
16 CFR Part 1500.40
Health Administration (OSHA) Hazard Communication Stan-
16 CFR Part 1500.41
dard (see A1.8) outlines procedures for the hazard determina-
16 CFR Part 1500.42
tion of mixtures and states that if a mixture has not been tested
2.3 DOT Standards:
as a whole, then the mixture shall be assumed to present the
same hazards as do the components that comprise 1 % (by
This test method is under the jurisdiction of ASTM Committee E34 on weight or volume) or greater of the mixture, except that the
Occupational Health and Safety and is the direct responsibility of Subcommittee
mixture shall be assumed to present a carcinogenic hazard if it
E34.50 on Health and Safety Standards for Metal Working Fluids.
contains a component in concentrations of 0.1 % or greater,
Current edition approved March 10, 2000. Published April 2000. Originally
e1
which is considered to be a carcinogen (as defined in OSHA
Published as E 1302 - 89. Last previous edition E 1302 - 89 (1994) .
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Standard 29 CFR 1910.1200). The determination of when to
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
test a mixture as a whole and which toxicity tests are
Standards volume information, refer to the standard’s Document Summary page on
appropriate for the product must be made by a health profes-
the ASTM website.
sional, qualified in evaluating toxicological data.
Available from Supt. of Documents, U. S. Government Printing Office,
Washington, DC 20402.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E1302–00
3.3 Acute toxicology testing of water-miscible metalwork- 3.3.6 Skin Sensitization—Achemical sensitizer is a material
ing fluids consists of several individual tests including acute that causes a substantial proportion of exposed people or
oral, dermal, or inhalation toxicity, eye irritation, skin irritation animals to develop an allergic reaction in normal tissue after
or corrosion, or both, skin sensitization, and sensory irritation. repeated exposure to the chemical. A number of methods are
Certain protocols for acute oral, dermal, and inhalation toxicity available for measuring skin sensitization, however, there are
tests are limit tests; further multi-dose testing (for example, differences in opinion on the most appropriate method. These
Test Method E 1103) should take place if mortality is noted on areduetovariationsincompoundadministrationanddegreeof
any of these tests. The referenced protocols specify the species reaction to a sensitizing substance. Refer to the Code of
and number of animals required. Selection of tests conducted Federal Regulations (CFR) for the various protocols (see
should be designed to minimize the number of animals used. A1.6). Additionally, toxicology testing contract labs may have
3.3.1 Acute Oral Toxicity—Acute oral toxicity tests (see standard procedures for conducting these assays. Endpoint:
A1.1) provide information on health hazards likely to arise sensitization.
from short-term exposure by the oral route. Results of this type 3.3.7 Sensory Irritation-—Upon exposure to a sensory irri-
of test are used to develop warning statements on labels as may tant, humans experience discomfort or a burning sensation of
be required by OSHA Hazard Communication Standard 29 the eyes, nose, and throat, and may also cough. Test Method E
CFR 1910.1200 (see A1.8) or Federal Hazardous Substances 981 (see A1.2.5) provides a means to evaluate the sensory
Act (see A1.10). These are also used to establish a dosage irritant potential of airborne chemicals and mixtures as well as
regimen for subchronic and other testing. Endpoint: mortality. a means to assess the comparative irritancy of compounds and
3.3.2 Acute Dermal Toxicity—Acute dermal toxicity tests formulations. However, this test method cannot be used to
(seeA1.2)provideinformationonhealthhazardslikelytoarise evaluate the relative obnoxiousness of odors. End point: upper
from short-term exposure by the dermal route and may provide respiratory tract irritation.
initial information on dermal absorption and the mode of toxic 3.4 Anumber of federal guidelines can be used to establish
action of a substance. In addition, some measure of irritation general procedures for testing acute toxicity of metalworking
caused by the fluid may be obtained by observing local tissue fluids. Several references are cited inAnnexA1. Regardless of
damage at the sight of application. Endpoint: mortality. themethodused,GoodLaboratoryPractices,asoutlinedbythe
3.3.3 Acute Inhalation Toxicity—Acute inhalation toxicity United States Environmental ProtectionAgency (EPA40 CFR
tests give an indication of relative toxicity (see A1.3). The 792) (see A1.9) must be followed. The OSHA Hazard Com-
results provide an indication of the potential of the fluid to munication Standard (seeA1.8) outlines the responsibilities of
cause death and other adverse health effects when inhaled for chemical manufacturers, importers, and employers in the
a specified time period. Endpoint: mortality. determination of chemical hazards and communication of
3.3.4 Eye Irritation—Eye irritation tests provide an indica- in
...

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4.1 Application of the approach described within this practice applies the science-based, risk-based, and statistics-based concepts and principles introduced in Guides E3106 and E3219.  
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1.2.3 Considerations on the different types of data analysis, model testing, and validation;  
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1.2.5 Life-cycle management of MVDA model.  
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4.1 Application of the approach described within this standard guide applies science-based concepts and principles introduced in the FDA’s initiative on pharmaceutical CGMPs for the 21st century.4  
4.2 This guide supports, and is consistent with, elements from ICH Q8 – Q11 and guidelines from USFDA, European Commission, Pharmaceutical Inspection Co-operation Scheme, and the China Food and Drug Administration.8  
4.3 According to FDA Guidance for Industry, PAT, “With real time quality assurance, the desired quality attributes are ensured through continuous assessment during manufacture. Data from production batches can serve to validate the process and reflect the total system design concept, essentially supporting validation with each manufacturing batch.” In other words, the accumulated product and process understanding used to identify the Critical Quality Attributes (CQAs), together with the control strategy, will enable control of the CQAs, providing the confidence needed to show validation with each batch. This is as opposed to a traditional discrete process validation approach.
SCOPE
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1.4 The principles in this guide may be applied to drug product or active pharmaceutical ingredient/drug substance pharmaceutical and biopharmaceutical batch or continuous manufacturing processes or supporting utility systems (for example, TOC for purified water and water for injection systems, and so forth).  
1.5 The principles in this guide may be applied during the development and manufacturing of a new process or product or for the improvement or redesign, or both, of an existing process.  
1.6 Continuous process verification may be applied to manufacturing processes that use monitoring systems that provide frequent and objective measurement of process data in real time. These processes may or may not employ in-, on-, or at-line analyzers/controllers that monitor, measure, analyze, and control the process performance. The associated processes may or may not have a design space.  
1.7 This guide may be used independently or in conjunction with other proposed E55 standards to be published by ASTM International.

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ASTM
ASTM F319-19(2024)(Practice)
Standard Practice for Polarized Light Detection of Flaws in Aerospace Transparency Heating Elements

SIGNIFICANCE AND USE
4.1 This practice is useful as a screening basis for acceptance or rejection of transparencies during manufacturing so that units with identifiable flaws will not be carried to final inspection for rejection at that time.  
4.2 This practice may also be employed as a go-no go technique for acceptance or rejection of the finished product.  
4.3 This practice is simple, inexpensive, and effective. Flaws identified by this practice, as with other optical methods, are limited to those that produce temperature gradients when electrically powered. Any other type of flaw, such as minor scratches parallel to the direction of electrical flow, are not detectable.
SCOPE
1.1 This practice covers a standard procedure for detecting flaws in the conductive coating (heater element) by the observation of polarized light patterns.  
1.2 This practice applies to coatings on surfaces of monolithic transparencies as well as to coatings imbedded in laminated structures.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 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. For specific precautionary statements, see Section 6.  
1.5 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.

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ASTM
ASTM D396-24(Specification)
Standard Specification for Fuel Oils

ABSTRACT
This specification covers grades of fuel oil intended for use in various types of fuel-oil-burning equipment under various climatic and operating conditions. These grades include the following: Grades No. 1 S5000, No. 1 S500, No. 2 S5000, and No. 2 S500 for use in domestic and small industrial burners; Grades No. 1 S5000 and No. 1 S500 adapted to vaporizing type burners or where storage conditions require low pour point fuel; Grades No. 4 (Light) and No. 4 (Heavy) for use in commercial/industrial burners; and Grades No. 5 (Light), No. 5 (Heavy), and No. 6 for use in industrial burners. Preheating is usually required for handling and proper atomization. The grades of fuel oil shall be homogeneous hydrocarbon oils, free from inorganic acid, and free from excessive amounts of solid or fibrous foreign matter. Grades containing residual components shall remain uniform in normal storage and not separate by gravity into light and heavy oil components outside the viscosity limits for the grade. The grades of fuel oil shall conform to the limiting requirements prescribed for: (1) flash point, (2) water and sediment, (3) physical distillation or simulated distillation, (4) kinematic viscosity, (5) Ramsbottom carbon residue, (6) ash, (7) sulfur, (8) copper strip corrosion, (9) density, and (10) pour point. The test methods for determining conformance to the specified properties are given.
SCOPE
1.1 This specification (see Note 1) covers grades of fuel oil intended for use in various types of fuel-oil-burning equipment under various climatic and operating conditions. These grades are described as follows:  
1.1.1 Grades No. 1 S5000, No. 1 S500, No. 1 S15, No. 2 S5000, No. 2 S500, and No. 2 S15 are middle distillate fuels for use in domestic and small industrial burners. Grades No. 1 S5000, No. 1 S500, and No. 1 S15 are particularly adapted to vaporizing type burners or where storage conditions require low pour point fuel.  
1.1.2 Grades B6–B20 S5000, B6–B20 S500, and B6–B20 S15 are middle distillate fuel/biodiesel blends for use in domestic and small industrial burners.  
1.1.3 Grades No. 4 (Light) and No. 4 are heavy distillate fuels or middle distillate/residual fuel blends used in commercial/industrial burners equipped for this viscosity range.  
1.1.4 Grades No. 5 (Light), No. 5 (Heavy), and No. 6 are residual fuels of increasing viscosity and boiling range, used in industrial burners. Preheating is usually required for handling and proper atomization.  
Note 1: For information on the significance of the terminology and test methods used in this specification, see Appendix X1.
Note 2: A more detailed description of the grades of fuel oils is given in X1.3.  
1.2 This specification is for the use of purchasing agencies in formulating specifications to be included in contracts for purchases of fuel oils and for the guidance of consumers of fuel oils in the selection of the grades most suitable for their needs.  
1.3 Nothing in this specification shall preclude observance of federal, state, or local regulations which can be more restrictive.  
1.4 The values stated in SI units are to be regarded as standard.  
1.4.1 Non-SI units are provided in Table 1 and Table 2 and in 7.1.2.1/7.1.2.2 because these are common units used in the industry.
Note 3: The generation and dissipation of static electricity can create problems in the handling of distillate burner fuel oils. For more information on the subject, see Guide D4865.  
1.5 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.

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