ASTM E857-05(2012)
(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
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.
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.
The use of this practice allows for observation of signs of toxicity in addition to mortality.
The dose-response curve provides additional information about the response of birds to a test substance.
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).
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 and health practices and determine the applicability of regulatory limitations prior to use. For specific precautionary statements see Section 6.
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Designation: E857 − 05 (Reapproved 2012)
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 2. Referenced Documents
2.1 ASTM Standards:
1.1 This practice describes a procedure for determining the
IEEE/ASTM SI 10 American National Standard for Use of
subacute dietary toxicity of a test substance administered to
theInternationalSystemofUnits(SI):TheModernMetric
birds in their daily diet. The LC value time to mortality and
System
slope of the dose response curve may also be derived.
1.2 This practice is applicable to substances that can be
3. Terminology
mixed uniformly into the diet.
3.1 Definitions of Terms Specific to This Standard:
3.1.1 LC —the statistically derived estimate of the concen-
1.3 This practice is intended primarily to be used with the
young of the following species: northern bobwhite (Colinus tration of a test substance in the diet that would be expected to
cause 50 % mortality to the test population under the specified
virginianus), Japanese quail (Coturnix japonica), mallard
(Anas platyrhynchos), and ring-necked pheasant (Phasianus test conditions.
colchicus). Other species or age groups, for example, with
3.1.2 concentration—the weight of test substance per unit
wild-trapped birds, may be used with appropriate husbandry
weight of diet.
modifications to the practice.
3.1.3 substance or test substance—the element, chemical
compound, formulation, known mixture, or material mixed in
1.4 This standard is used routinely to address avian regula-
diets and fed to birds for the purpose of determining an LC .
tory testing requirements. Modifications to the procedures
described in this standard have been proposed and are being
3.1.4 negative control—a group of birds maintained under
evaluated to better address the needs of the latest risk assess-
conditions identical to the test birds except for the absence of
ment procedures. Specifically, the latest procedures call for
the test substance in their diet.
individual bird feed consumption measurements so that a more
3.1.5 positive control—a group of birds maintained under
precise dose can be determined. While such procedures may
conditions identical to the test birds except for the replacement
replace procedures described in the current standard, there is
ofthetestsubstanceinthedietwithasubstanceknowntoelicit
no certainty that the newest procedures will work as
a consistent toxic response.
anticipated, and validation is not complete. Therefore, the
3.2 Units and Symbols:
current guideline has utility prior to validation and acceptance
3.2.1 Refer to IEEE/ASTM SI 10.
of a modified standard.
1.5 This standard does not purport to address all of the
4. Summary of Practice
safety concerns, if any, associated with its use. It is the
4.1 This practice describes how to determine the subacute
responsibility of the user of this standard to establish appro-
dietary toxicity of a test substance when administered to birds
priate safety and health practices and determine the applica-
in their daily diet. The median lethal concentration (LC )in
bility of regulatory limitations prior to use. For specific
the diet is a measure of a specific toxic effect (that is, lethality).
precautionary statements see Section 6.
The LC has been used as a comparable index of toxicity.
However, other expressions of toxicity also may be appropri-
ate.
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 April 1, 2012. Published June 2012. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
ε1
approved in 1981. Last previous edition approved in 2005 as E857 – 05 . DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/E0857-05R12. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E857 − 05 (2012)
4.2 Groups of birds of the same species are fed diets 7. Facilities
containing a test substance or mixture of substances at selected
7.1 Species requirements will vary, but pens and cages
concentrations for 5 days. This is followed by a minimum of 3
should include adequate room, clean food and water, heated
days (or for as long as the birds continue to exhibit toxic signs)
areas for young birds, and protection from excessive distur-
on untreated food. The test substance is mixed into the diets,
bance. Space requirements have not been standardized for
usually in a geometric series of concentrations.
species normally used in this test. However, adherence to the
general guidelines and principles found in the National Insti-
4.3 General observations of the signs of toxicity and the
acceptance of the test substance in the diet also must be tutes of Health and the National Academy of Science publica-
tions (2, 3, 4) in addition to literature published on individual
reported.
species should provide a basis for a humane approach to space
4.4 Concurrent negative controls must be maintained
requirements. Pens or cages must be placed so as to prevent
throughout the test. A positive control also may be used.
cross-contamination (5).
7.2 Construction materials in contact with birds should not
5. Significance and Use
be toxic, nor be capable of adsorbing or absorbing test
5.1 This practice provides a means of measuring the sus-
substances. Materials that can be dissolved by water or
ceptibility of an avian species to a test substance in its diet
loosened by pecking should not be used. Stainless or galva-
under controlled conditions. The LC obtained in this test is a
nizedsteel,ormaterialscoatedwithplasticsareacceptable,but
conditional measure of subacute toxicity because consumption
other construction materials may also be useful. Any material
is voluntary, and because the dietary route may introduce
or pen shape is acceptable provided the birds are able to move
metabolic transformations of the test substance that might be
about freely and that pens can be kept clean.
absent in other exposure techniques.
7.3 Ventilation, photoperiod, and relative humidity require-
5.2 Use of this practice contributes to the evaluation of the
ments vary little among test species, and these factors are
hazards of chemicals to birds because exposure is analogous to
particularly critical to the well-being of young birds. Relative
most field exposures, that is, through dietary intake.
humidity should be maintained at 45 to 70 %. Higher humidi-
5.3 The use of this practice allows for observation of signs
ties may be appropriate for waterfowl. Photoperiod should be
of toxicity in addition to mortality.
a minimum of 14 h of light. The amount and duration of heat
for brooding is species specific (6, 7). A temperature gradient
5.4 The dose-response curve provides additional informa-
from approximately 38°C to approximately 22°C from an
tion about the response of birds to a test substance.
appropriate heat source should be established in brooders in
5.5 This practice can be used to study the effects of test
order to allow the birds to seek a proper temperature. Ventila-
substancesincombinationinordertosimulatesituationswhere
tion should follow guidelines in Guide for the Care and Use of
birds may be exposed to more than one substance simultane-
Laboratory Animals. Ventilation should be sufficient to supply
ously (1).
10 to 15 air changes per hour (2).
5.6 This practice provides one basis for deciding whether
8. Diets
additional toxicity testing should be conducted with birds.
8.1 Dietary requirements vary according to the species and
age of the test birds. Any unmedicated commercial diet that
6. Precautions
meets the minimum nutritional standards of the test species (8)
6.1 Contact with all test substances, solutions, and mixed
is sufficient.
dietsshouldbeminimizedwithappropriateprotectiveclothing,
gloves, eye protection, etc. The use of fume hoods and 8.2 Contaminated feed may compromise a study (9, 10, 11);
therefore, feed should be analyzed periodically to identify
increased ventilation in test rooms is necessary when handling
background contaminants. Analysis may be especially impor-
volatile substances. Mammalian toxicity and special handling
tant if the substance being tested is known or suspected of
procedures should be known before this practice is used.
synergistic or antagonistic action with possible contaminants.
6.2 Disposal of excess test substances, solutions, mixed
Maximum allowable levels of heavy metals, pesticides, and
diets, excreta, and treated birds should be done with consider-
other contaminants in feed have not been established.
ation for health and environmental safety, and in accordance
8.3 Test diets should always be fresh and clean. The
with all federal, state, and local regulations.
frequency that the diet is changed during a study is dependent
6.3 Cleaning and rinsing of glassware, feeders, and other
uponthephysicalandchemicalpropertiesofthetestsubstance,
equipment with volatile solvents should be performed only in
and the speed with which a test animal contaminates the feed
well-ventilated areas.
with fecal matter or water, or both.
6.4 Periodic medical examinations should be considered for
8.4 Test diets should be fed ad libitum.
all personnel caring for birds or handling test substances.
8.5 Feed should not be used past its normal shelf life
(usually 90 days).
8.6 Treated test diets should be stored so as to maintain the
The boldface numbers in parentheses refer to the list of references at the end of
this practice. stability of the test substance in the diet.
E857 − 05 (2012)
9. Test Substance and Diet Preparation 11. Procedure
11.1 Range-Finding Test:
9.1 Knowledge of the physical, chemical, and biological
11.1.1 To determine the test concentrations to be used in a
properties of the test substance is important in test diet
definitivetest,arange-findingtestmaybeconductedfor5days
preparation.
using three to five widely spaced concentrations.
9.2 Test diets can be prepared by mixing the test substance
11.1.2 One procedure is to use an initial concentration of at
directly into the feed or by dissolving or suspending the test
least 5000 ppm with two to four geometrically spaced lower
substance in a solvent or carrier prior to mixing with the feed.
concentrations. If there is no mortality at the 5000-ppm level,
The use of solvents or carriers may be necessary to achieve a
and test procedures and numbers of birds per concentration are
uniform mix of the test substance in the feed.
the same as would be used in a definitive test, then the
9.3 The test substance is uniformly mixed into the diet. The
range-finding test may provide sufficient information to negate
physical and chemical properties of a test substance may cause
the need for a definitive test. If mortality does occur, then
variationintestdietconcentrationsanditisimportanttoensure
range-finding will suggest the approximate test concentrations
that the test substance is available in the diet at the same
to be used in a definitive test.
concentration throughout the treatment period.
11.2 Definitive Test:
9.4 In addition to homogeneity and stability testing required
11.2.1 Individual test birds should be randomly assigned to
by GLPs, it is recommended that concentrations of the test groups and to control and test diet concentrations.Assignment
substance in the diet be confirmed by analysis at the beginning
to groups and initial weighing of the test birds should be done
of the test. at the same time to avoid needless handling stress.
11.2.2 Water, and treated or untreated diets, should be
10. Test Organisms
available ad libitum.
11.2.3 The experimental (test and control) diets are avail-
10.1 This practice is intended primarily to be used with the
able for 5 days after which they are replaced with untreated
young of the following species: northern bobwhite (Colinus
feed. Birds are held for a minimum of 3 days following
virginianus), Japanese quail (Coturnix japonica), mallard
treatment.Insomesituations,itmaybenecessarytoextendthe
(Anas platyrhynchos), and ring-necked pheasant (Phasianus
observation period in order to investigate prolonged or delayed
colchicus). Other species may be used, but changes in diet,
effects.
caging, and other factors may be necessary (12, 13).
11.2.4 Body weight must be recorded at the initiation and
10.2 If laboratory or commercially reared birds are used in
conclusion of the treatment and observation phases. Feed
this practice they must come from the same source, and be of
consumption must be recorded for both the treatment and
the same age, because different strains or age cohorts can
observation phases; it is recommended that consumption dur-
introducevariabilityintothetest.Thesebirdsshouldbesimilar
ing the treatment phase be recorded separately for the first two
in appearance to a wild species. The parentage and dietary
days and the last three days. Additional information may be
history of purchased birds should be known. If captured wild
gathered by measuring feed consumption daily. If the study
birds are used, they should come from the same source and be
continues beyond 8 days, body weight and feed consumption
of similar maturity.
should be recorded weekly. Mortality, behavioral
abnormalities, and other signs of toxicity should be recorded
10.3 Birds that are deformed, injured, emaciated, or pheno-
each day during the test.
typically different from normal birds must not be used as test
11.2.5 Photoperiod during the test should be the same as
animals. The population of birds from which the test animals
during the conditioning period.
(treatedandcontrol)areselectedshallbeconsideredunsuitable
11.2.6 A minimum of 10 birds for each test concentration
for testing if mortality exceeds 5 % during the 3 days prior to
constitutes a treatment group, but groups may be subdivided
testing.
into replicates with a minimum of five birds per replicate. The
10.4 The preferred age for Japanese quail and northern
test concentrations should be geometrically spaced so as to
bobwhite is 14 days; for ring-necked pheasants, 10 days; and
result in 10
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