PESTICID2 ASSES31ENT GUIDELINES
SUBDIVISION B
HAZARD EVALUATION:
WILDLIFE AND AQUATIC ORGANISE
Series 71-3
Wild Megirod Toxlclty Teat
ADDENDUM 3 OS ERTA REPOPTIKC
Prepared ty:
Curtis E. Laird
Ecological Effects Branch
Evaluation Division
Project Jtenagen
Elizabeth M. K. Leovey, FhO
Hazard Evaluation Division
Office of Pesticide Programs
IB Environmental Protection A9ancy
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Subdivision E - Wild Manral Toxicity Test
Table of Contents of Addendum
Discussion
Introduction 2
Response to Public Contents 2
Guideline
Title/Cover Page 2
Table of Contents 2
I. Sumrory /Introduction 3
II. Materials/Methods 3
III. Discussion/Results 6
IV. Conclusion 6
V. References G
T«toles 7
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PESTICIEE ASSESSMENT GUIDELINES
WILDLIFE AND AQUATIC ORGflNISWS
wild ManiTBl Toxicity Test
Subdivision E, Series 71-3
DATA REPORTING
INTRODUCTION
A. Purpose
To provide a data reporting fozmat for a study of a wild mammal
toxidty test.
B. Objective
This Data Reporting Guideline is designed to aid the petitioner/
registrant in generating reports vhidi are cOnpatible with the Agency's
review process. Data submitters are encouraged to submit complete
reports following this guidance Syr efficient review by the Agency.
This guidance pertains to the substance of the data report. PR
Notice 86-5, effective on November 1, 1986 (available from the Registration
Support and Emergency Response Branch, Office of Pesticide Programs,
US EPA), pertains to the physical formating of reports (vhich are
referred to as "studies") and submittal packages. Some of the
requirements in PR Notice 86-5 are mandatory,
RESPONSE TO PUBLIC COMMENTS
There were no comments concerning this specific guideline in response to
the request for public, coments announced in the FEDERAL REGISTER notice of
October 15, 1986 (51 FR 36753).
GUIDELINE
The following describes the order and format for a study report item
by item.
TITLE/COVER PAGE
Refer to PR Notice 86-5.
TABLE CF CONTENTS
The Table of Contents should indicate the overall organization of the
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study, including table ard figures. It must follow the title, data confidentiality,
and GLP (if appropriate) pages as descrtiDed in PR Notice 86-5.
I. SUMM^/INTRDDUCTICN
A. Sponsor: (name of study owner) ;
B. Name(s) of principal investigator (B);
C. Location of study?
D. Location of raw data and final report;
E. Material: (Cannon/trade name);
F. Subject: (final or draft report, eight-day dietary LCso) ?
G. Test Doses: (control, concurrent vehicle control, #, #, #, #, # ppm);
H. Test Dates: Initiation (Date test started), and Termination (Date of
last day of observation) ;
I. Length of study] (days);
J, Results: (LCso value, 95% confidence limits, and no-observed-effects
level);
K. Test Material* (chemical name, formulation, and percent of active
ingredient) ;
L. Test Species/Strain: (both cannon and scientific name);
M. Source of Mammal i (company name, addressi or captive/wild) ;
N. Weight and physical condition at the initiation of study.
1 1 . MKTEKI AL/METHCDS
This section is a narrative which would include the following i terns »
A. Test Substance
1. Identification (this information may be provided by the laboratory
or sponsor) i
a. Chemical nans;
b. ConpoBition (qualitative ard quantitative description);
c. Percent active ingredient;
d. Molecular structure;
e. Source, lot and batch number; and
f . Identity ard percent corposition of inpurities in the test
substance.
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2. Preparation of test material (control/treatment):
a. Vehicle used to dissDlve test material (if used);
b. Amount of vehicle added to the control (if used); • •
c. Describe method used to get test material into diet;
d. Solubility of test material in ppm; and
e. Total amount of test material used.
B. Test Mammal
1. Rationale for selection of species if the species used is
different than those exposed to test substance's use pattern:
a. Test species name (both cannon and scientific); and
b. History of test organisms (strain, disease, and treatment),
2. Description of any pretest conditioning:
a. Health:
1. Sickness?
2. Injuries;
3. Abnormalities;
4. Name of medication (if used); and
5. Rretest diet;
b. Quarantine:
Number of days mammals were held.
3. Size/age/physical condition?
a. Age of each animal and hew determined;
b. Size (is weight of any animal more than + 20% of mean weight);
and
c. Physical condition of test aniirols.
4. Acclimation:
a. Daily feed consumption;
b. Daily behavior of test animal;
c. Body weights (beginning and end of acclimation);
d. Diet used;
e. Source of animal food and water;
f. Dimensions of pen(s); and
g. Length of photoperiod (in days).
C. Testing facility
1. Physical:
a. Size and construction of pen or cage with description of
any special features;
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b. Location of and availability of drinking v«ter;
c. Ventilation system in the laboratory; and
d. Identification of any special laboratory equipment unique
to the study.
2. Biological:
a. Daily temperature measurarents;
b. Daily relative humidity measurements;
c. Daily photoperiod; and
d. Daily laboratory air exchange rate.
D. Test Exposure Parameters
1. Fange Finding Test!
a. Number of animals used;
b. Method used to determine dose levels;
c. Raw data for determining the end point;
d. Treatment and observation period; and
e. Any statistical analysis utilized.
E. Etefinitive Test
1. Number of animals used and a rationale for using less than
ten animals per treatment level, if appropriate;
2. Nunber of treatment levels;
3. Nam- of vehicle used;
4. References to toxicity of vehicle;
5. Were controls and vehicle controls used;
6. Raw mortality or effects data for each group;
7. Duration of treatment and observation periods;
S. Statistical analysis of the data;
9. Methodology for dosing;
10. Methodology for treatjnent diet preparation;
11. Toxlcologically related behavioral change;
12. Analysis of basal diet;
13. Criteria for end point of study;
14. Nunber of animals of each sex of animal tested;
15. Test diet; and
16. Methods used to calculated
F. Necropsies
1. No-effects-level (how determined);
2. MaxiiTun^acceptable^tolerated-concentration (MA1C); and
3. Gross and histological necropsies.
G. Bcdy Weight and Food Coneuiqption
1. Daily body weight by animal and level;
2. Total daily food consumption by animal and level; and
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3. Mean body veight fbr each test and control group at initiation
and termination of test.
H. Observation
1. Signs of intoxication/ temporal onset, duration, and concentrations
that showed effects;
2. The nc-ef feet-level 7 and
3. Slope of dose-response line.
I. Statistical Analysis
1. Cite references (author, title, journal, number, page, etc.); and
2. Rationale fbr deviations from the cited' method.
III. DISCUSSION/RESULTS
A. LCso I*1 PP11 i*^ 95% confidence limits, no-cbserved-effect level, slope
of the dcee response line, if the method provides a slope. (Optional
graphs, printouts, and other calculations nay be attached to the report).
B. Detailed description of the nature, incidence, tine of occurrence,
severity, and duration of all observed toxic effects, including death
and any other abnormal or unusual signs and synptoma. For exanple,
report any specific signs of intoxication associated with death and
the time of onset and remission of toxic signs. Also report marked
observations of fecal material and urine.
C. Gross pathological changes as noted by gross necropsies examination.
D. Describe control mammal parameters, behavior, and general health.
E. Indicate the test procedures vhich deviate fron the EPA guidelines and
provide a rationale fbr the change.
F. Report any other items related to the study vftiich may be of value
in hazard assessment or evaluation of the study, e.g. regurgitation.
IV. CONCLUSIONS
This is a sunrotion of the above section Discussion/Results.
V. REFERENCES
For instance, any references vhich were used in the development of the
study design must be cited.
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TABLE 1 .
CUMULATIVE MDRTBLITIES CF (Test aperies nane) Exposed
TO (Chemical) FOR FIVE DAYS
Concentration
ppm
XX
XX
XX
XX
XX
0
XX
XX
XX
XX
XX
1
XX
XX
XX
XX
XX
2
XX
XX
XX
XX
XX
Day of Death
3
XX
XX
XX
XX
XX
4
XX
XX
XX
XX
XX
5
xx :
XX
XX
XX :
XX
6
XX
XX
XX
XX
XX
7
XX
XX
XX
XX
XX
8
XX
XX
XX
XX
XX
Control
ppm
0
0
0
0
0
TABLE 2
CUMULATIVE MORTALITIES OF (Test species titans) Exposed
TO (Chemical) FOR EIGHT DAXB
Dead/Nurtoer Exposed
Day of Death
0
XX
XX
XX
XX
XX
1
XX
XX
XX
XX
XX
2
XX
XX
XX
XX
XX
3
XX
XX
XX
XX
XX
4
XX
XX
XX
XX
XX
5
XX
XX
XX
XX
XX
6
' XX
XX
XX
XX
XX
7
XX
XX
XX
XX
XX
8
xx
XX
XX
XX
XX
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O&BLE 3
DRILY BODY WEIGHT CF (Test species name) EXPOSED TO (Chemical)
FOR (f) DAYS
Material Gone.
ppn
Chemical's
ccntnon x
name
X
X
X
X
Control 0
EAILY ESTIMATED
Material Cone.
pro
Chanical ' s x
con ton
name x
X
x
X
Control 0
Body Vfeight/AnijTBl/bay
0123 45 67
X X X X XX XX
XXXX XX XX
XXXX XX XX
XXXX XX XX
XXXX XX XX
XXXX XX XX
TABLE 4
FOCD COICUMPTION CF (Test species name) EXPOSED TO
(Chemical) FOR EK5JT CAYS
Food COnsvatption/Animal/DaY
01234567
XXXXXXXX
xxxxxxxx
XXXXXXXX
XXXXXXXX
xxxxxxxx
XXXXXXXX
6
X
X
X
X
X
X
8
X
X
X
X
X
X
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