ASTM E2045-99(2014)
(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. 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 and health practices and determine the applicability of regulatory limitations prior to use.
General Information
Buy Standard
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: E2045 − 99 (Reapproved 2014)
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 3. Significance and Use
1.1 This practice describes the terms used in observing and 3.1 This practice pertains to all forms of toxicological
testing (acute, subchronic, or chronic) performed by any route
recordingcutaneous,gastrointestinal,respiratory,reproductive,
neuromuscular, ocular, and general clinical signs of animals of administration (inhalation, oral, dermal, ocular, or other).
undergoing toxicological testing. This practice also assists in
3.2 The U.S. Environmental Protection Agency, Good
properly observing and assessing laboratory animals for signs
Laboratory Practices for Nonclinical Laboratory Studies, as
of disease or adverse effects of compound administration.
listed in 40 CFR, requires that a testing facility maintain
specific standard operating procedures (SOPs) including an
1.2 This practice includes codes and descriptions for a wide
SOP covering clinical observations in test animals.
variety of clinical signs, anatomical locations, and other
descriptive qualifiers, and a technique for scoring the extent or
3.3 This practice serves as a basis for consistency in clinical
severity of clinical signs.
observations. Actual procedures and forms to be used in
recording observations must be described in individual study
1.3 This practice assumes that the reader is knowledgeable
protocols.
in animal toxicology and related pertinent areas and is trained
in making clinical observations.
4. Procedure
1.4 This standard does not purport to address all of the
4.1 Observe the health of an animal at a distance and of its
safety concerns, if any, associated with its use. It is the
housing environment to gain a general impression of its health.
responsibility of the user of this standard to establish appro-
Alsonoteenvironmentalfactorssuchastemperature,humidity,
priate safety and health practices and determine the applica-
ventilation, air quality and hygienic conditions.
bility of regulatory limitations prior to use.
4.2 Observe each animal and note any subtle changes in
animal behavior, physical appearance, posture, gait,
2. Referenced Documents
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
4.3 Observe control animals first, followed by test groups in
Protection Agency, Subchapter E, Pesticide Programs,
2
order of increasing level of treatment. Observe positive control
Part 160, Good Laboratory Practice Standards
group, if any, last.
Title 40, Code of Federal Regulations (CFR), Toxic Sub-
stances Control Act, Part 792, Good Laboratory Practice 4.4 Note any dead animals and collect necessary tissues and
2
Standards data before decomposition occurs.
Title 40, Code of Federal Regulations (CFR), Environmental
4.5 Report animals that show signs of sickness so that
Protection Agency, Part 798, Health Effects Testing
appropriate diagnosis, treatment, or euthanasia, if appropriate,
2
Guidelines
can be performed.
5. General Clinical Signs
1
This practice is under the jurisdiction of ASTM Committee E50 on Environ-
5.1 Note the overall activity, behavior, and condition of the
mental Assessment, Risk Management and Corrective Action and is the direct
animal. Determine the hydration status by examining skin
responsibility of E50.47 on Biological Effects and Environmental Fate.
Current edition approved Oct. 1, 2014. Published December 2014. Originally
turgor, position of the eyes such as normal or sunken, mucous
approved in 1999. Last previous edition approved in 2009 as E2045 – 99(2009).
membrane color, and capillary refill time. Look for asymmetry
DOI: 10.1520/E2045-99R14.
2
or the presence of abnormal swellings, hemorrhage or signs of
Available from U.S. Government Printing Office, Superintendent of
Documents, Washington, DC 20402. pain.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E2045 − 99 (2014)
5.2 The following are some general conditions along with 6.1.3 Swelling (SW) is an increase in tissue size or in-
suggested codes for record keeping that do not fall into any creased abnormal shape of the skin or other organs from
specific organ system. Refer to Annex A1 – Annex A3 for a abnormal presence of: air, that is, emphysema (SWA
...
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 2009) E2045 − 99 (Reapproved 2014)
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 and health practices and determine the applicability of regulatory
limitations prior to use.
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.
3.3 This practice serves as a basis for consistency in clinical observations. 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.
4.4 Note any dead animals and collect necessary tissues and data before decomposition occurs.
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 Nov. 1, 2009Oct. 1, 2014. Published March 2010December 2014. Originally approved in 1999. Last previous edition approved in 20032009 as
E2045 – 99(2003).(2009). DOI: 10.1520/E2045-99R09.10.1520/E2045-99R14.
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
---------------------- Page: 1 ----------------------
E2045 − 99 (2014)
4.5 Report animals that show signs of sickness so that appropriate diagnosis, treatment, or euthanasia, if appropriate, can be
performed.
5. General Clinical Signs
5.1 Note the overall activity, behavior, and condition of the animal. Determine the hydration status by examining skin turgor,
position of the eyes such as normal or sunken, mucous membrane color, and capillary refill time. Look for asymmetry or the
presence of abnormal swellings, hemor
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.