ASTM E857-05(2019)
(Practice)Standard Practice for Conducting Subacute Dietary Toxicity Tests with Avian Species
Standard Practice for Conducting Subacute Dietary Toxicity Tests with Avian Species
SIGNIFICANCE AND USE
5.1 This practice provides a means of measuring the susceptibility of an avian species to a test substance in its diet under controlled conditions. The LC50 obtained in this test is a conditional measure of subacute toxicity because consumption is voluntary, and because the dietary route may introduce metabolic transformations of the test substance that might be absent in other exposure techniques.
5.2 Use of this practice contributes to the evaluation of the hazards of chemicals to birds because exposure is analogous to most field exposures, that is, through dietary intake.
5.3 The use of this practice allows for observation of signs of toxicity in addition to mortality.
5.4 The dose-response curve provides additional information about the response of birds to a test substance.
5.5 This practice can be used to study the effects of test substances in combination in order to simulate situations where birds may be exposed to more than one substance simultaneously (1).3
5.6 This practice provides one basis for deciding whether additional toxicity testing should be conducted with birds.
SCOPE
1.1 This practice describes a procedure for determining the subacute dietary toxicity of a test substance administered to birds in their daily diet. The LC50 value time to mortality and slope of the dose response curve may also be derived.
1.2 This practice is applicable to substances that can be mixed uniformly into the diet.
1.3 This practice is intended primarily to be used with the young of the following species: northern bobwhite (Colinus virginianus), Japanese quail (Coturnix japonica), mallard (Anas platyrhynchos), and ring-necked pheasant (Phasianus colchicus). Other species or age groups, for example, with wild-trapped birds, may be used with appropriate husbandry modifications to the practice.
1.4 This standard is used routinely to address avian regulatory testing requirements. Modifications to the procedures described in this standard have been proposed and are being evaluated to better address the needs of the latest risk assessment procedures. Specifically, the latest procedures call for individual bird feed consumption measurements so that a more precise dose can be determined. While such procedures may replace procedures described in the current standard, there is no certainty that the newest procedures will work as anticipated, and validation is not complete. Therefore, the current guideline has utility prior to validation and acceptance of a modified standard.
1.5 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.
1.6 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
Relations
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: E857 − 05 (Reapproved 2019)
Standard Practice for
Conducting Subacute Dietary Toxicity Tests with Avian
Species
This standard is issued under the fixed designation E857; 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 ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.1 This practice describes a procedure for determining the
mendations issued by the World Trade Organization Technical
subacute dietary toxicity of a test substance administered to
Barriers to Trade (TBT) Committee.
birds in their daily diet. The LC value time to mortality and
slope of the dose response curve may also be derived.
2. Referenced Documents
1.2 This practice is applicable to substances that can be
2.1 ASTM Standards:
mixed uniformly into the diet.
IEEE/ASTM SI 10 American National Standard for Use of
1.3 This practice is intended primarily to be used with the
theInternationalSystemofUnits(SI):TheModernMetric
young of the following species: northern bobwhite (Colinus
System
virginianus), Japanese quail (Coturnix japonica), mallard
3. Terminology
(Anas platyrhynchos), and ring-necked pheasant (Phasianus
colchicus). Other species or age groups, for example, with
3.1 Definitions of Terms Specific to This Standard:
wild-trapped birds, may be used with appropriate husbandry
3.1.1 LC —the statistically derived estimate of the concen-
modifications to the practice.
tration of a test substance in the diet that would be expected to
cause 50 % mortality to the test population under the specified
1.4 This standard is used routinely to address avian regula-
test conditions.
tory testing requirements. Modifications to the procedures
described in this standard have been proposed and are being
3.1.2 concentration—the weight of test substance per unit
evaluated to better address the needs of the latest risk assess-
weight of diet.
ment procedures. Specifically, the latest procedures call for
3.1.3 substance or test substance—the element, chemical
individual bird feed consumption measurements so that a more
compound, formulation, known mixture, or material mixed in
precise dose can be determined. While such procedures may
diets and fed to birds for the purpose of determining an LC .
replace procedures described in the current standard, there is
3.1.4 negative control—a group of birds maintained under
no certainty that the newest procedures will work as
conditions identical to the test birds except for the absence of
anticipated, and validation is not complete. Therefore, the
the test substance in their diet.
current guideline has utility prior to validation and acceptance
3.1.5 positive control—a group of birds maintained under
of a modified standard.
conditions identical to the test birds except for the replacement
1.5 This standard does not purport to address all of the
ofthetestsubstanceinthedietwithasubstanceknowntoelicit
safety concerns, if any, associated with its use. It is the
a consistent toxic response.
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter- 3.2 Units and Symbols:
mine the applicability of regulatory limitations prior to use.
3.2.1 Refer to IEEE/ASTM SI 10.
For specific precautionary statements see Section 6.
4. Summary of Practice
1.6 This international standard was developed in accor-
dance with internationally recognized principles on standard-
4.1 This practice describes how to determine the subacute
dietary toxicity of a test substance when administered to birds
in their daily diet. The median lethal concentration (LC )in
1 50
This practice is under the jurisdiction of ASTM Committee E50 on Environ-
mental Assessment, Risk Management and Corrective Action and is the direct
responsibility of Subcommittee E50.47 on Biological Effects and Environmental
Fate. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Feb. 1, 2019. Published February 2019. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approvedin1981.Lastpreviouseditionapprovedin2012asE857 – 05(2012).DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/E0857-05R19. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E857 − 05 (2019)
the diet is a measure of a specific toxic effect (that is, lethality). 6.4 Periodic medical examinations should be considered for
The LC has been used as a comparable index of toxicity. all personnel caring for birds or handling test substances.
However, other expressions of toxicity also may be appropri-
7. Facilities
ate.
7.1 Species requirements will vary, but pens and cages
4.2 Groups of birds of the same species are fed diets
should include adequate room, clean food and water, heated
containing a test substance or mixture of substances at selected
areas for young birds, and protection from excessive distur-
concentrations for 5 days. This is followed by a minimum of 3
bance. Space requirements have not been standardized for
days (or for as long as the birds continue to exhibit toxic signs)
species normally used in this test. However, adherence to the
on untreated food. The test substance is mixed into the diets,
general guidelines and principles found in the National Insti-
usually in a geometric series of concentrations.
tutes of Health and the National Academy of Science publica-
4.3 General observations of the signs of toxicity and the
tions (2, 3, 4) in addition to literature published on individual
acceptance of the test substance in the diet also must be
species should provide a basis for a humane approach to space
reported.
requirements. Pens or cages must be placed so as to prevent
cross-contamination (5).
4.4 Concurrent negative controls must be maintained
throughout the test. A positive control also may be used.
7.2 Construction materials in contact with birds should not
be toxic, nor be capable of adsorbing or absorbing test
5. Significance and Use
substances. Materials that can be dissolved by water or
5.1 This practice provides a means of measuring the sus-
loosened by pecking should not be used. Stainless or galva-
ceptibility of an avian species to a test substance in its diet
nizedsteel,ormaterialscoatedwithplasticsareacceptable,but
under controlled conditions. The LC obtained in this test is a
50 other construction materials may also be useful. Any material
conditional measure of subacute toxicity because consumption
or pen shape is acceptable provided the birds are able to move
is voluntary, and because the dietary route may introduce
about freely and that pens can be kept clean.
metabolic transformations of the test substance that might be
7.3 Ventilation, photoperiod, and relative humidity require-
absent in other exposure techniques.
ments vary little among test species, and these factors are
5.2 Use of this practice contributes to the evaluation of the
particularly critical to the well-being of young birds. Relative
hazards of chemicals to birds because exposure is analogous to
humidity should be maintained at 45 to 70 %. Higher humidi-
most field exposures, that is, through dietary intake.
ties may be appropriate for waterfowl. Photoperiod should be
a minimum of 14 h of light. The amount and duration of heat
5.3 The use of this practice allows for observation of signs
for brooding is species specific (6, 7). A temperature gradient
of toxicity in addition to mortality.
from approximately 38 °C to approximately 22 °C from an
5.4 The dose-response curve provides additional informa-
appropriate heat source should be established in brooders in
tion about the response of birds to a test substance.
order to allow the birds to seek a proper temperature. Ventila-
5.5 This practice can be used to study the effects of test
tion should follow guidelines in Guide for the Care and Use of
substancesincombinationinordertosimulatesituationswhere
Laboratory Animals. Ventilation should be sufficient to supply
birds may be exposed to more than one substance simultane-
10 to 15 air changes per hour (2).
ously (1).
8. Diets
5.6 This practice provides one basis for deciding whether
8.1 Dietary requirements vary according to the species and
additional toxicity testing should be conducted with birds.
age of the test birds. Any unmedicated commercial diet that
meets the minimum nutritional standards of the test species (8)
6. Precautions
is sufficient.
6.1 Contact with all test substances, solutions, and mixed
8.2 Contaminated feed may compromise a study (9, 10, 11);
dietsshouldbeminimizedwithappropriateprotectiveclothing,
therefore, feed should be analyzed periodically to identify
gloves, eye protection, etc. The use of fume hoods and
background contaminants. Analysis may be especially impor-
increased ventilation in test rooms is necessary when handling
tant if the substance being tested is known or suspected of
volatile substances. Mammalian toxicity and special handling
synergistic or antagonistic action with possible contaminants.
procedures should be known before this practice is used.
Maximum allowable levels of heavy metals, pesticides, and
6.2 Disposal of excess test substances, solutions, mixed
other contaminants in feed have not been established.
diets, excreta, and treated birds should be done with consider-
8.3 Test diets should always be fresh and clean. The
ation for health and environmental safety, and in accordance
frequency that the diet is changed during a study is dependent
with all federal, state, and local regulations.
uponthephysicalandchemicalpropertiesofthetestsubstance,
6.3 Cleaning and rinsing of glassware, feeders, and other
and the speed with which a test animal contaminates the feed
equipment with volatile solvents should be performed only in
with fecal matter or water, or both.
well-ventilated areas.
8.4 Test diets should be fed ad libitum.
8.5 Feed should not be used past its normal shelf life
The boldface numbers in parentheses refer to the list of references at the end of
this practice. (usually 90 days).
E857 − 05 (2019)
8.6 Treated test diets should be stored so as to maintain the initiation of the test.An acclimation period of at least 3 days is
stability of the test substance in the diet. required(see10.3).Olderbirdsshallbeconditionedforatleast
7 days.
9. Test Substance and Diet Preparation
11. Procedure
9.1 Knowledge of the physical, chemical, and biological
properties of the test substance is important in test diet
11.1 Range-Finding Test:
preparation.
11.1.1 To determine the test concentrations to be used in a
definitivetest,arange-findingtestmaybeconductedfor5days
9.2 Test diets can be prepared by mixing the test substance
using three to five widely spaced concentrations.
directly into the feed or by dissolving or suspending the test
substance in a solvent or carrier prior to mixing with the feed.
11.1.2 One procedure is to use an initial concentration of at
The use of solvents or carriers may be necessary to achieve a
least 5000 ppm with two to four geometrically spaced lower
uniform mix of the test substance in the feed.
concentrations. If there is no mortality at the 5000-ppm level,
and test procedures and numbers of birds per concentration are
9.3 The test substance is uniformly mixed into the diet. The
the same as would be used in a definitive test, then the
physical and chemical properties of a test substance may cause
range-finding test may provide sufficient information to negate
variationintestdietconcentrationsanditisimportanttoensure
the need for a definitive test. If mortality does occur, then
that the test substance is available in the diet at the same
range-finding will suggest the approximate test concentrations
concentration throughout the treatment period.
to be used in a definitive test.
9.4 In addition to homogeneity and stability testing required
11.2 Definitive Test:
by GLPs, it is recommended that concentrations of the test
substance in the diet be confirmed by analysis at the beginning
11.2.1 Individual test birds should be randomly assigned to
of the test.
groups and to control and test diet concentrations.Assignment
to groups and initial weighing of the test birds should be done
10. Test Organisms at the same time to avoid needless handling stress.
11.2.2 Water, and treated or untreated diets, should be
10.1 This practice is intended primarily to be used with the
available ad libitum.
young of the following species: northern bobwhite (Colinus
virginianus), Japanese quail (Coturnix japonica), mallard 11.2.3 The experimental (test and control) diets are avail-
(Anas platyrhynchos), and ring-necked pheasant (Phasianus able for 5 days after which they are replaced with untreated
colchicus). Other species may be used, but changes in diet, feed. Birds are held for a minimum of 3 days following
caging, and other factors may be necessary (12, 13). treatment.Insomesituations,itmaybenecessarytoextendthe
observation period in order to investigate prolonged or delayed
10.2 If laboratory or commercially reared birds are used in
effects.
this practice they must come from the same source, and be of
11.2.4 Body weight must be recorded at the initiation and
the same age, because different strains or age cohorts can
conclusion of the treatment and observation phases. Feed
introducevariabilityintothetest.Thesebirdsshouldbesimilar
consumption must be recorded for both the treatment and
in appearance to a wild species. The parentage and dietary
observation phases; it is recommended that consumption dur-
history of purchased birds should be known. If captured wild
ing the treatment phase be recorded separately for the first two
birds are used, they should come from the same source and be
days and the last three days. Additional information may be
of similar maturity.
gathered by measuring feed consumption daily. If the study
10.3 Birds that are deformed, injured, emaciated, or pheno-
continues beyond 8 days, body weight and feed consumption
typically different from normal birds must not be used as test
should be recorded weekly. Mortality, behavioral
animals. The population of birds from which the test animals
abnormalities, and other signs of toxicity sho
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.