ASTM E2045-22
(Practice)Standard Practice for Detailed Clinical Observations of Test Animals
Standard Practice for Detailed Clinical Observations of Test Animals
SIGNIFICANCE AND USE
3.1 This practice pertains to all forms of toxicological testing (acute, subchronic, or chronic) performed by any route of administration (inhalation, oral, dermal, ocular, or other).
3.2 The U.S. Environmental Protection Agency, Good Laboratory Practices for Nonclinical Laboratory Studies, as listed in 40 CFR, requires that a testing facility maintain specific standard operating procedures (SOPs) including an SOP covering clinical observations in test animals.
3.3 This practice serves as a basis for consistency in clinical observations and is not meant to serve as a comprehensive list of observations that may be observed. Actual procedures and forms to be used in recording observations must be described in individual study protocols.
SCOPE
1.1 This practice describes the terms used in observing and recording cutaneous, gastrointestinal, respiratory, reproductive, neuromuscular, ocular, and general clinical signs of animals undergoing toxicological testing. This practice also assists in properly observing and assessing laboratory animals for signs of disease or adverse effects of compound administration.
1.2 This practice includes codes and descriptions for a wide variety of clinical signs, anatomical locations, and other descriptive qualifiers, and a technique for scoring the extent or severity of clinical signs.
1.3 This practice assumes that the reader is knowledgeable in animal toxicology and related pertinent areas and is trained in making clinical observations.
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.
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.
General Information
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Standards Content (Sample)
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: E2045 − 22
Standard Practice for
1
Detailed Clinical Observations of Test Animals
This standard is issued under the fixed designation E2045; 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 Title 40, Code of Federal Regulations (CFR), Environmental
Protection Agency, Part 798, Health Effects Testing
1.1 This practice describes the terms used in observing and
2
Guidelines
recordingcutaneous,gastrointestinal,respiratory,reproductive,
neuromuscular, ocular, and general clinical signs of animals
3. Significance and Use
undergoing toxicological testing. This practice also assists in
properly observing and assessing laboratory animals for signs
3.1 This practice pertains to all forms of toxicological
of disease or adverse effects of compound administration.
testing (acute, subchronic, or chronic) performed by any route
of administration (inhalation, oral, dermal, ocular, or other).
1.2 This practice includes codes and descriptions for a wide
variety of clinical signs, anatomical locations, and other
3.2 The U.S. Environmental Protection Agency, Good
descriptive qualifiers, and a technique for scoring the extent or
Laboratory Practices for Nonclinical Laboratory Studies, as
severity of clinical signs.
listed in 40 CFR, requires that a testing facility maintain
specific standard operating procedures (SOPs) including an
1.3 This practice assumes that the reader is knowledgeable
SOP covering clinical observations in test animals.
in animal toxicology and related pertinent areas and is trained
in making clinical observations.
3.3 This practice serves as a basis for consistency in clinical
1.4 This standard does not purport to address all of the
observations and is not meant to serve as a comprehensive list
safety concerns, if any, associated with its use. It is the
of observations that may be observed. Actual procedures and
responsibility of the user of this standard to establish appro-
forms to be used in recording observations must be described
priate safety, health, and environmental practices and deter-
in individual study protocols.
mine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accor-
4. Procedure
dance with internationally recognized principles on standard-
4.1 Observe the health of an animal at a distance and of its
ization established in the Decision on Principles for the
housing environment to gain a general impression of its health.
Development of International Standards, Guides and Recom-
Alsonoteenvironmentalfactorssuchastemperature,humidity,
mendations issued by the World Trade Organization Technical
ventilation, air quality and hygienic conditions.
Barriers to Trade (TBT) Committee.
4.2 Observe each animal and note any subtle changes in
2. Referenced Documents
animal behavior, physical appearance, posture, gait,
vocalization, food and water consumption, and waste produc-
2.1 Federal Standards:
tion. See Section 5 for details.
Title 40, Code of Federal Regulations (CFR), Environmental
Protection Agency, Subchapter E, Pesticide Programs,
4.3 Observe animals blinded to treatment group, or at least
2
Part 160, Good Laboratory Practice Standards
in random order, to minimize unintentional bias.
Title 40, Code of Federal Regulations (CFR), Toxic Sub-
4.4 Note any dead animals and collect necessary tissues and
stances Control Act, Part 792, Good Laboratory Practice
data to minimize the extent of tissue decomposition.
2
Standards
4.5 Report animals that show signs of sickness so that
appropriate diagnosis, treatment, or euthanasia, if appropriate,
1
This practice is under the jurisdiction of ASTM Committee E50 on Environ- can be performed.
mental Assessment, Risk Management and Corrective Action and is the direct
responsibility of E50.47 on Biological Effects and Environmental Fate.
5. General Clinical Signs
Current edition approved Aug. 1, 2022. Published September 2022. Originally
approved in 1999. Last previous edition approved in 2009 as E2045 – 99(2014).
5.1 Note the overall activity, behavior, and condition of the
DOI: 10.1520/E2045-22.
2
animal. Determine the hydration status by examining skin
Available from U.S. Government Printing Office, Superintendent of
Documents, Washington, DC 20402. turgor, position of the eyes such as normal or sunken, mucous
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United St
...
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: E2045 − 99 (Reapproved 2014) E2045 − 22
Standard Practice for
1
Detailed Clinical Observations of Test Animals
This standard is issued under the fixed designation E2045; 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 practice describes the terms used in observing and recording cutaneous, gastrointestinal, respiratory, reproductive,
neuromuscular, ocular, and general clinical signs of animals undergoing toxicological testing. This practice also assists in properly
observing and assessing laboratory animals for signs of disease or adverse effects of compound administration.
1.2 This practice includes codes and descriptions for a wide variety of clinical signs, anatomical locations, and other descriptive
qualifiers, and a technique for scoring the extent or severity of clinical signs.
1.3 This practice assumes that the reader is knowledgeable in animal toxicology and related pertinent areas and is trained in
making clinical observations.
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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
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.
2. Referenced Documents
2.1 Federal Standards:
Title 40, Code of Federal Regulations (CFR), Environmental Protection Agency, Subchapter E, Pesticide Programs, Part 160,
2
Good Laboratory Practice Standards
2
Title 40, Code of Federal Regulations (CFR), Toxic Substances Control Act, Part 792, Good Laboratory Practice Standards
2
Title 40, Code of Federal Regulations (CFR), Environmental Protection Agency, Part 798, Health Effects Testing Guidelines
3. Significance and Use
3.1 This practice pertains to all forms of toxicological testing (acute, subchronic, or chronic) performed by any route of
administration (inhalation, oral, dermal, ocular, or other).
3.2 The U.S. Environmental Protection Agency, Good Laboratory Practices for Nonclinical Laboratory Studies, as listed in 40
CFR, requires that a testing facility maintain specific standard operating procedures (SOPs) including an SOP covering clinical
observations in test animals.
1
This practice is under the jurisdiction of ASTM Committee E50 on Environmental Assessment, Risk Management and Corrective Action and is the direct responsibility
of E50.47 on Biological Effects and Environmental Fate.
Current edition approved Oct. 1, 2014Aug. 1, 2022. Published December 2014September 2022. Originally approved in 1999. Last previous edition approved in 2009 as
E2045 – 99(2009).(2014). DOI: 10.1520/E2045-99R14.10.1520/E2045-22.
2
Available from U.S. Government Printing Office, Superintendent of Documents, 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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E2045 − 22
3.3 This practice serves as a basis for consistency in clinical observations. observations and is not meant to serve as a
comprehensive list of observations that may be observed. Actual procedures and forms to be used in recording observations must
be described in individual study protocols.
4. Procedure
4.1 Observe the health of an animal at a distance and of its housing environment to gain a general impression of its health. Also
note environmental factors such as temperature, humidity, ventilation, air quality and hygienic conditions.
4.2 Observe each animal and note any subtle changes in animal behavior, physical appearance, posture, gait, vocalization, food
and water consumption, and waste production. See Section 5 for details.
4.3 Observe control animals first, followed by test groups in order of increasing level of treatment. Observe positive control group,
if any, last.animals blinded to treatment group, or at least in random order, to minimize unintentional bias.
4.4 Note any dead anima
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