ASTM E757-80(1995)

Test Method for Efficacy of Canine Reproduction Inhibitors (Withdrawn 2000)

SCOPE
1.1 This method covers the effectiveness of canine reproduction inhibitors. Any method for evaluating the use of a canine reproduction inhibitor should include recognition that the ultimate test for efficacy is whether it functions as an effective population control method under field conditions. While laboratory or pen test data are essential, final efficacy testing and determination must be accomplished under actual field condtions. No suitable standard laboratory test is available. The test method described here attempts to balance the need for and the feasibility of securing efficacy data.
1.2 This test method is intended for use primarily with monestrous members of the family Canidae. Because of great variation in reproductive physiology, (that is, delayed implantation in mustelids, delayed gestation in bats, uterine structural differences, estrous cycle variations, etc.) this method may not be readily applicable to other families and orders of mammals.

General Information

• Status: Withdrawn
• Publication Date: 31-Dec-1994
• Withdrawal Date: 09-Oct-2000
• ICS: 65.020.30 - Animal husbandry and breeding
• Technical Committee: E35 - Pesticides, Antimicrobials, and Alternative Control Agents

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: E 757 – 80 (Reapproved 1995)
Standard Test Method for
Efficacy of Canine Reproduction Inhibitors
This standard is issued under the fixed designation E 757; 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.
INTRODUCTION
Vertebrate animal control is an art as well as a science. The development and effective application
of control methods both require skills gained from extensive training and field experience. This is
particularly true in dealing with the life forms which are highly adaptable and capable of elementary
reasoning and thus develop widely varied individual behavior patterns. With these species, efficacy is
often unusually difficult to attain. Subcommittee E35.17 recognizes, therefore, that standard test
methods must be developed and control methods improved to advance the science and to provide
reasonable safeguards for legitimate environmental concerns.
1. Scope avoided since stress may cause or contribute to reproductive
aberrations particularly in wild-caught canids.
1.1 This test method covers the effectiveness of canine
3.2 Test Animals:
reproduction inhibitors. Any method for evaluating the use of
3.2.1 Test animals should be laboratory-reared or captured
a canine reproduction inhibitor should include recognition that
from wild environments.
the ultimate test for efficacy is whether it functions as an
3.2.2 Test animals should be reproductively mature adults
effective population control method under field conditions.
except where juvenile sex hormones might be employed. The
While laboratory or pen test data are essential, final efficacy
age and weight of test animals will vary but should not include
testing and determination must be accomplished under actual
very old, emaciated, obese, or seriously injured specimens.
field conditions. No suitable standard laboratory test is avail-
Any injuries from capture should be stabilized. The general
able. The test method described here attempts to balance the
condition of the test animals should be verified by a competent
need for and the feasibility of securing efficacy data.
individual, preferably a veterinarian.
1.2 This test method is intended for use primarily with
3.2.3 The sex and reproductive condition of animals used
monestrous members of the family Canidae. Because of great
will depend upon the type of gametocide, hormone-affector, or
variation in reproductive physiology, (that is, delayed implan-
other compound to be employed. In some instances, evaluation
tation in mustelids, delayed gestation in bats, uterine structural
of a compound or technique may require testing with both
differences, estrous cycle variation, etc.) this method may not
sexes to determine actual effects in the field. In some cases, the
be readily applicable to other families and orders of mammals.
opposite sex should be tested as a nontarget organism. For
2. Referenced Documents
example, evaluation of diethylstilbestrol (DES) would also
require testing of males since they are nontarget organisms
2.1 ASTM Standards:
with DES.
E 552 Test Method for Efficacy of Acute Mammalian Pre-
3.3 Reference Animals:
dacides
3.3.1 The terms “reference animals” and “reference group”
E 555 Practice for Determining Acute Oral LD50 for Test-
are used to denote a group of animals maintained similarly to
ing Vertebrate Control Agents
the test animals for the purpose of determining mortality due to
3. Laboratory Testing
illness, injuries, or other factors not related to test compounds.
3.3.2 Reference animals shall be of the same species and sex
3.1 All target specimens must be tested (see Practice E 555).
as the test animals. When domestic dogs are used as test
3.1.1 Efforts must be made to establish routine procedures
animals, the reference animals shall be of the same breed and
and approaches for all test animals. All undue stress should be
preferably of the same strain for uniformity. When wild species
are used as test animals, the proportional numbers of
laboratory-reared or wild-caught animals, or both, in the
This test method is under the jurisdiction of ASTM Committee E-35 on
reference group shall be similar to those in the test group. The
Pesticides and is the direct responsibility of Subcommittee E35.17 on Vertebrate
Control Agents.
number of reference animals shall be the same as the number
Current edition approved Aug. 29, 1980. Published November 1980.
of test animals in each test group.
Annual Book of ASTM Standards, Vol 11.05.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
E 757
3.3.3 Reference animals shall be maintained concurrently the biochemical nature of the compounds employed and the
with test animals in cages or pens similar in size and type to physiological responses anticipated. For example, compounds
those used for test animals. Reference animals shall be main- expected or known to alter estrus, ovulation, or fertilization
tained under similar environmental conditions (temperature, might normally be administered immediately prior to or during
humidity, lighting, etc.) to those under which test animals are estrus. Those expected or known to alter implantation of
maintained. Test and reference animals shall be maintained on embryological development might be administered prior to or
similar nutritionally balanced diets. during estrus, or during gestation.
3.4 Pretest Conditioning: 4.1.4 Observations should be made of all parameters likely
3.4.1 Various stages of the reproduction cycle may be to be affected by the test compounds but should always include
affected by extrinsic biochemicals. Therefore, the test period mortality, intoxication symptoms, induced behavioral abnor-
will normally include those specific stages during which the malities, and alteration of the gestation period and parturition.
test compounds are expected to function. 4.1.5 All animals that are affected or die as a result of
3.4.2 Wild-caught animals should be maintained in captivity treatment should be examined for gross pathological and
for a period sufficient to acclimate them to captive conditions histological changes. Similar examinations of unaffected sur-
prior to application of the test gametocide, hormone affector, or vivors and reference animals are also desirable.
other test compound. The diet and general condition of test 4.2 Chronic Toxicity—Administer doses of the test chemical
animals should be stabilized for a minimum of 28 days prior to to adult rats and six adult target species of the appropriate sex
testing. daily for a 30-day period (see Practice E 555). This must be
3.4.3 Laboratory-reared and acclimated wild-caught ani- done at the appropriate time during the reproduction cycle.
mals should be maintained for 7 days prior to the test in the Routes of administration should be identical with those used in
type of pen or cage used in the test. field application. Use three or more dose levels. The highest
3.5 Animal Facilities—Cage or pen specifications may vary, dose used should produce a measurable level of effectiveness.
but the type of cage or pen used should permit freedom of The lowest dose should not produce any measurable adverse
movement sufficient to prevent undue stress of test animals. physiological or morphological effects. Following the test
The animal facilities shall meet the established standards which period, maintain the animals on a normal diet for an additional
are required by law or regulations. It is desirable that they meet 60 days. Necropsy all animals that die during the test and the
the guidelines suggested by the Institute of Laboratory Animal 60-day observation period. Observe, describe, and record
Resources, or approved by such organizations as the American organ changes, gross pathology, and histopathology. Sacrifice
Association of Accreditation of Laboratory Animal Care. all animals on the 91st day and evaluate gross anatomical
3.6 Number of Test Animals—The number of test animals changes or abnormalities.
will vary according to the statistical methods employed, and 4.3 Secondary Toxicity:
availability of animals. The number of test animals used in 4.3.1 Test for secondary toxicity in the following way: feed
each group shall be the same as the number of reference a nontarget or scavenger species prey animals containing a
animals. Extrapolation of data between species is not accept- known quantity of the chemical and observe whether the
able; therefore, laboratory tests must be made with each target chemical causes any adverse effects.
species. However, due to potential reproductive aberrations 4.3.2 Expose individual animals of one or more prey species
under laboratory confinement, particularly in wild-caught ani- to the chemical under simulated field conditions. Animals
mals, laboratory test data must be confirmed by data gained dosed in this manner are then euthanized and exclusively
under actual field conditions. offered no-choice ad libitum to the predator or scavenger
3.7 Analysis of Data—Data from all species should be species, which should include at least one species of bird
presented with accompanying narrative. Statistical treatment (raptor or scavenger) as well as the domestic dog.
alone may convey invalid conclusions. 4.3.3 Conduct replications of all tests when evidence of
secondary effects exists. Euthanize and necropsy all test
4. Toxicity and Effective Dose Levels
predatory or scavenger animals for pathological organ changes
4.1 Acute Toxicity and Effective Dose Levels:
at the conclusion of the test period.
4.1.1 The acute oral LD50 in male laboratory rats should be
4.4 Toxicity to Nontarget Species—Select appropriate non-
established by standard toxicological procedures (see Practice
target species and sexes that might be affected and test
E 555) and should precede intensive testing on the target
identically with each gametocide, hormone-affector, or other
species. The target species and sex should be considered as the
test compound. These species routinely will include domestic
standard laboratory animal.
dogs when evaluating the effects of test compounds on other
4.1.2 Establish the effective oral dose (ED50) of test chemi-
canids.
cals by administration to a minimum of six animals of each
5. Behavioral Modification
target species and sex. These should be sexually mature adults
except where juvenile sex hormones are employed. Administer 5.1 The ability of vertebrate animals to communicate warn-
the chemicals after the upper digestive tract is void of food. In ings is well documented. Such behavioral changes induced by
carnivores, this generally requires a minimum of 4 h after ingestion of chemicals could affect efficacy when tested under
feeding. field conditions. When testing for acute effects and sublethal
4.1.3 The stages in the reproductive cycle during which test chronic effects, take special precautions to determine the
compounds should be administered may vary, depending on possibility of behavioral changes that might serve as visual,
E 757
auditory, or other communication cues to individuals of the posttreatment indices or counts will afford a better means of
target species. Conduct these observations in conjunction with determining effects on overall population densities. Such
the studies described in Section 4 and maintain records on any procedures may require data and observations for extended
such behavioral changes. periods of time.
8.1.1 When chemicals are to be administered by food baits,
6. Application Methods
a sample of baits and baiting locations should be monitored
6.1 If devices or carrier baits are required for reproduction daily by preparation of the baiting sites so that visitation and
inhibitor delivery, they must be laboratory and field-tested consumption of baits can be determined on the basis of animal
before being adopted as part of a delivery system. Laboratory tracks left at these sites. Such sites should be distributed
conditions are a restrictive environment for testing of devices through appropriate representative portions of the study area.
or carrier baits and for developing efficacy data, although Data recorded should include, as a minimum, the species
results of laboratory tests may be indicative of those which visiting and consuming baits, the number of baits consumed,
might be expected under field conditions. (See Ref. (1) for one and the rate of bait disappearance. This procedure may require
standardized baiting technique.) weeks of baiting to overcome the wariness of some species and
may require alteration of daily monitoring procedures.
7. Palatability (Acceptance)
8.1.2 Maximum effort should therefore by placed on appli-
7.1 A standard placebo for testing food acceptance by cation techniques with respect to: (a) differential movement
predatory or omnivorous animals does not exist because of the
and spatial characteristics of the target and nontarget species;
wide variation in species’ food habits and available natural (b) selectivity of the carrier (bait, mechanical device, etc.); and
foods, and the disparity between naturally occurring foods and (c) specific placement of the carrier in relation to the ecological
commercially prepared kennel rations. Preference, habituation, and behavioral characteristics of the target species. The selec-
and opportunity to feed are as important as relative availability tivity of various application techniques can sometimes be
in wild canine food habits. Palatability should be tested using determined prior to actual field testing of candidate com-
a suitable nutritionally balanced standard ration to which the pounds, by distribution of an appropriate carrier containing a
test animals are accustomed. For each test, the standard ration dye or other marker, followed by sampling for the presence of
will serve as the placebo for palatability tests of candidate test the marker in collected animals or their droppings. Tracers
materials. such as chlortetracycline, or other inert compounds should be
7.2 Palatability tests should be made with a minimum of six tested for acceptance prior to field trials since encapsulation or
adult males, or six adult nonpregnant females, and six juveniles “masking” may be required.
of the target species and sex if possible. The tests should be
8.1.3 Statistical evaluation of results should include the
free choice between the placebo and the candidate test mate- following:
rials, with sufficient amount of each to be in excess of each
8.1.3.1 Analysis of measurab
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