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H-24768: One-Generation Reproduction Study in Rats______________________________________ DuPont-13784
TRADE SECRET
Study Title H-24768: One-Generation Reproduction Study in Rats
Volume 1 of 2
Laboratory Project ID: DuPont-13784
Authors: Eve Mylchreest, PhD. Joseph M. Lewis, B.A.
Study Completed on: October 19,2004 Performing Laboratories: E.I. du Pont de Nemours and Company
HaskellSMLaboratory for Health and Environmental Sciences P.O. Box 50 Newark, Delaware 19714-0050 U.S.A. E.I. du Pont de Nemours and Company Regional Analytical Services (RAS) DuPont Chemical Solutions Enterprise Jackson Laboratory Route 130 Chambers Works Deepwater, New Jersey 08023 U.S.A. W ork Request Number: Service Code Number:
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H-24768: One-Generation Reproduction Study in Rats
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GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT
This study was conducted in compliance with U.S. EPA TSCA (40 CFR part 792) Good Laboratory Practice Standards, which are compatible with the OECD Principles of Good Laboratory Practice (as revised in 1997) published in ENV/MC/CHEM(98)17, OECD, Paris, 1998, and MAFF Japan Good Laboratory Practice Standards (11 NohSan Number 6283) except for the item documented below. The item listed does not impact the validity of the study.
The bulk test substance characterization and stability analyses were performed at DuPont Regional Analytical Services (RAS), a non-GLP laboratory. These analyses were in compliance with regulatory guidelines. None of the aforementioned analyses were performed under Good Laboratory Practice Standards; however, the analyses were conducted in compliance with IS09002 regulations. All of the analyses are considered valid and sufficient for the purposes of this study.
Applicant / Sponsor: E.I. du Pont de Nemours and Company Wilmington, Delaware 19898 U.S.A.
Applicant / Sponsor:_______________________________________ _________
DuPont Representative
Date
2
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H-24768: One-Generation Reproduction Study in Rats
QUALITY ASSURANCE STATEMENT
DuPont-13784
Work Request Number: Study Code Number:
The conduct of this study has been subjected to periodic Quality Assurance inspections. The dates of inspection are indicated below.
Phase Audited
Audit Dates
Conduct:
6,11-Nov-2003; ll-Dec-2003; 12-Jan-2004; 3,6-Feb-2004
Tables/Appendices: 13-14,16,19-23,26-Apr-2004; 7,8-Jun-2004
Report/Records:
10-Feb-2004; 24,25-Mar-2004; 28-30-Jun-2004
Dates Reported to Study Director and Management
6,11-Nov-2003; ll-Dec-2003; 12-Jan-2004; 3,6-Feb-2004
26-Apr-2004; 8-Jun-2004
12-Feb-2004; 25-Mar-2004 30-Jun-2004
Reported by:
Matthewj Frentzel Quality Assurance Auditor
1Date
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CERTIFICATION
We, the undersigned, declare that this report provides an accurate evaluation of data obtained from this study.
Analytical Evaluations by:
Qds*jtr C~
Janet C. M aslanka., B.S. Senior Staff Chemist
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D ate
Anatomic Pathology Evaluations by:
Steven R. Frame, D.V.M ., Ph.D. Diplomate A.C.V.P.
Principal Research Pathologist
Anatomic Pathology Peer Review
Evaluations by:
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Peter C! Mann, D .V ^ f Diplomate A.C.V.P. Veterinary Pathologist
Approved by:
Scott E. Loveless, Ph.D. Research Manager and D irector
Prepared by:
Chtusjl--
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J / 1 Joseph MrXewis, B J
Associate Scientist
Issued by Study Director:
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TABLE OF CONTENTS
Page
GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT..........................................2
QUALITY ASSURANCE STATEMENT...................................................................................... 3
CERTIFICATION.............................................................................................................................4
LIST OF TABLES............................................................................................................................7
LIST OF APPENDICES...................................................................................................................8
STUDY INFORMATION............................................................................................................... 9
STUDY PERSONNEL...................................................................................................................10
SUMMARY.................................................................................................................................... 11
INTRODUCTION........................................................................................................................... 13
OBJECTIVE...................................................................................................................................13
MATERIALS AND METHODS....................................................................................................13
A. Sponsor And Test Facility...................................................................................................13
B. Study Design.......................................................................................................................14
C. Analytical............................................................................................................................14
D. Test Species........................................................................................................................16
E. Animal Husbandry..............................................................................................................16
F. Pretest and Quarantine Period........................................
18
G. Assignment to Groups and Study Start - Randomization.................................................. 18
H. Clinical Observations and Mortality - Pi Rats................................................................ 19
I. Pi Rats - Body Weights and Body Weight Gains.............................................................. 19
J. Pi Rats - Food Consumption and Food Efficiency............................................................ 19
K. Breeding............................................................................................................................. 20
L. Estrous Cycle Evaluation........................................................
20
M. Gestation Procedures..............................................................
20
N. Lactation Procedures...............................................................
20
O. Anatomic Pathology................................................................
21
DATA ANALYSES....................................................................................................................... 23
RECORDS AND SAMPLE STORAGE....................................................................................... 25
RESULTS AND DISCUSSION.........................................................
26
REPRODUCTIVE TOXICOLOGY.............................................................................................. 27
A. Pi Rats - Clinical Observations and Mortality................................................................... 27
B. Pi Rats - Body Weights and Body Weight Gains.............................................................. 27
C. Pi Rats - Food Consumption and Food Efficiency............................................................ 28
D. Estrous Cycle Parameters in Pi Females............................................................................ 28
E. Reproductive Indices in Pi Rats..............................................
28
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F. Fi Offspring Data................................................................................................................29 G. Reproductive Toxicology Conclusions.............................................................................. 29
ANATOMICAL PATHOLOGY.....................................................................................................30 A. Cause of Death - Pi Adult Rats.......................................................................................... 30 B. Liver Weight Data - Pi Adult Rats..................................................................................... 30 C. Gross Findings - Pi Adult Rats.......................................................................................... 30 D. Microscopic Findings - Pi Adult R ats............................................................................... 30 E. Anatomic Pathology Conclusions...................................................................................... 31
CONCLUSIONS.............................................................................................................................32
REFERENCES...............................................................................................................................33
TABLES.......................................................................................................................................... 34
APPENDICES................................................................................................................................73
VOLUME 2...................................................................................................................................313
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LIST OF TABLES
Page
TABLE 1 SUMMARY OF CLINICAL OBSERVATIONS IN Pi MALE RATS........................................................36 TABLE 2 SUMMARY OF CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING PREMATING.........37 TABLE 3 SUMMARY OF CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING GESTATION..........38 TABLE 4 SUMMARY OF CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING LACTATION..........39 TABLE 5 MEAN BODY WEIGHTS OF Pi MALE RATS........................................................................................40 TABLE 6 MEAN BODY WEIGHT GAINS OF P, MALE RATS..............................................................................42 TABLE 7 MEAN BODY WEIGHTS OF P, FEMALE RATS DURING PREMATING..........................................44 TABLE 8 MEAN BODY WEIGHT GAINS OF Pj FEMALE RATS DURING PREMATING.............................. 46 TABLE 9 MEAN BODY WEIGHTS OF Pj FEMALE RATS DURING GESTATION...........................................48 TABLE 10 MEAN BODY WEIGHT GAINS OF Pj FEMALE RATS DURING GESTATION...............................49 TABLE 11 MEAN BODY WEIGHTS OF Pt FEMALE RATS DURING LACTATION......................................... 50 TABLE 12 MEAN BODY WEIGHT GAINS OF P, FEMALE RATS DURING LACTATION.............................. 51 TABLE 13 MEAN DAILY FOOD CONSUMPTION OF Pj MALE RATS DURING PREMATING...................... 52 TABLE 14 MEAN DAILY FOOD EFFICIENCY OF P, MALE RATS DURING PREMATING............................ 54 TABLE 15 MEAN DAILY FOOD CONSUMPTION OF Pi FEMALE RATS DURING PREMATING.................56 TABLE 16 MEAN DAILY FOOD EFFICIENCY OF Pt FEMALE RATS DURING PREMATING.......................58 TABLE 17 MEAN DAILY FOOD CONSUMPTION OF Pi FEMALE RATS DURING GESTATION..................60 TABLE 18 MEAN FOOD EFFICIENCY OF Pi FEMALE RATS DURING GESTATION....................................61 TABLE 19 MEAN ESTROUS CYCLE PARAMETERS AND PRECOITAL INTERVAL
IN P, FEMALE RATS...........................................................................................................................................62 TABLE 20 SUMMARY OF REPRODUCTIVE INDICES: P, GENERATION......................................................63 TABLE 21 MEAN PUP NUMBERS AND SURVIVAL: F, GENERATION..........................................................64 TABLE 22 SUMMARY OF PUP CLINICAL OBSERVATIONS: Fi GENERATION...........................................65 TABLE 23 MEAN PUP WEIGHTS: F, GENERATION...........................................................................................66 TABLE 24 MEAN FINAL BODY AND ORGAN WEIGHTS FROM MALE RATS - Pi ADULTS........................ 67 TABLE 25 MEAN FINAL BODY AND ORGAN WEIGHTS FROM FEMALE RATS - Pi ADULTS...................68 TABLE 26 INCIDENCES OF GROSS OBSERVATIONS IN MALE RATS - P, ADULTS.................................... 69 TABLE 27 INCIDENCES OF GROSS OBSERVATIONS IN FEMALE RATS - P, ADULTS................................ 70 TABLE 28 INCIDENCES AND LESION GRADES OF MICROSCOPIC OBSERVATIONS
IN MALE RATS Pi ADULTS............................................................................................................................................................ 71 TABLE 29 INCIDENCES AND LESION GRADES OF MICROSCOPIC OBSERVATIONS IN FEMALE RATS - Pi ADULTS........................................................................................................................ 72
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LIST OF APPENDICES
Page
APPENDIX A CERTIFICATE OF ANALYSIS.......................................................................................................... 74 APPENDIX B PROTOCOL AND PROTOCOL AMENDMENTS............................................................................. 76 APPENDIX C ANALYTICAL DATA........................................................................................................................ 100 APPENDIX D INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN Pi MALE RATS.119 APPENDIX E INDIVIDUAL CLINICAL OBSERVATIONS IN P! FEMALE RATS DURING PREMATING ..128 APPENDIX F INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING GESTATION... 138 APPENDIX G INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA
IN Pi FEMALE RATS DURING LACTATION.................................................................................................148 APPENDIX H INDIVIDUAL BODY WEIGHTS OF P! MALE RATS AND MORTALITY DATA.................. 158 APPENDIX I INDIVIDUAL BODY WEIGHT GAINS OF P, MALE RATS........................................................ 168 APPENDIX J INDIVIDUAL BODY WEIGHTS OF Pj FEMALE RATS DURING PREMATING AND
MORTALITY DATA........................................................................................................................................... 178 APPENDIX K INDIVIDUAL BODY WEIGHT GAINS OF P! FEMALE RATS DURING PREMATING........ 188 APPENDIX L INDIVIDUAL BODY WEIGHTS OF P, FEMALE RATS DURING GESTATION..................... 198 APPENDIX M INDIVIDUAL BODY WEIGHT GAINS OF P, FEMALE RATS DURING GESTATION........ 204 APPENDIX N INDIVIDUAL BODY WEIGHTS OF Pj FEMALE RATS DURING LACTATION..................... 210 APPENDIX O INDIVIDUAL BODY WEIGHT GAINS OF P, FEMALE RATS DURING LACTATION.......... 216 APPENDIX P INDIVIDUAL FOOD CONSUMPTION BY P, MALE RATS DURING PREMATING.............. 222 APPENDIX Q INDIVIDUAL FOOD CONSUMPTION BY P, FEMALE RATS DURING PREMATING........ 232 APPENDIX R INDIVIDUAL FOOD CONSUMPTION BY Pj FEMALE RATS DURING GESTATION......... 242 APPENDIX S INDIVIDUAL ANIMAL ESTROUS CYCLE PARAMETERS IN P, FEMALE RATS
DURING PREMATING AND COHABITATION............................................................................................. 248 APPENDIX T INDIVIDUAL ANIMAL ESTROUS CYCLE STAGES IN P, FEMALE RATS DURING
PREMATING AND COHABITATION............................................................................................................. 254 APPENDIX U INDIVIDUAL MATING DATA AND GESTATION LENGTH: P, RATS...................................260 APPENDIX V INDIVIDUAL IMPLANTATION SITE DATA, IMPLANTATION EFFICIENCY, AND
CORPOR LUTEA COUNTS: Pj RATS.............................................................................................................. 266 APPENDIX W INDIVIDUAL PUP SURVIVAL: Fj GENERATION.................................................................... 272 APPENDIX X INDIVIDUAL LITTER CLINICAL OBSERVATIONS: F] GENERATION.................................298 APPENDIX Y INDIVIDUAL PUP WEIGHTS: F, GENERATION .............................................................. 303 VOLUME 2 a313 APPENDIX Z INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS P, ADULTS.........................314 APPENDIX AA INDIVIDUAL ANIMAL PATHOLOGY DATA Pi ADULTS.................................................... 331
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H-24768: One-Generation Reproduction Study in Rats
STUDY INFORMATION
DuPont-13784
Haskell Number: 24768
Puritv: Known Impurities:
Stability: The test substance appeared to be stable under the conditions of the study; no evidence of instability was observed.
Sponsor: E. I. du Pont de Nemours and Company Wilmington, Delaware 19898 U.S.A.
Study Initiated/Completed: October 27, 2003 / (see report cover page)
In-Life Initiated/Completed: October 30, 2003 / February 16, 2004
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STUDY PERSONNEL
Study Director: Eve Mylchreest, PhD. Management: Jeannette M. Erhardt, PhD., C.I.H.
Study Author: Joseph M. Lewis, B.A. Primary Technician: Gregory L. Poindexter
Management: Arthur J. O'Neill, B.S.
Analytical Chemist: Janet C. Maslanka, B.S. Management: S. Mark Kennedy, PhD.
Anatomic Pathologist: Steven R. Frame, D.V.M., PhD., Diplomate A.C.V.P. Peer Review Anatomic Pathologist: Peter C. Mann, D.V.M., Diplomate A.C.V.P.
Management: Steven R. Frame, D.V.M., PhD.
Toxicology Report Preparation: Mary K. LaRoe Wanda F. Dinbokowitz
Management: KimD. Birkmeyer, M.S.
Laboratory Veterinarian: Thomas W. Mayer, D.V.M., A.C.L.A.M. Janice L. Connell, M.S., B.A., C.I.H.
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SUMMARY
This one-generation reproduction study was conducted with H-24768 as a follow-up to a previously conducted 90-day subchronic toxicity and one-generation reproduction study with the same test substance. The purpose of this study was to determine the repeatability of fertility and estrous cycle effects observed in the first study and to establish a no-observed-adverse effect level for reproductive parameters with this test substance.
Throughout this study, Crl:CD(SD)IGS BR rats (24/sex/dose level) were dosed with H-24768 once daily by gavage at dose levels 0,1,10, or 25 mg/kg/day. The vehicle was deionized water and the dose volume was 5 ml/kg/day. Following 72 days of dosing (premating), the Pi generation males and females were cohoused within their respective treatment groups to produce Fi litters. Dams were allowed to deliver and rear their offspring until postpartum day 4. Clinical observations, body weight, and food consumption in Pj rats were recorded weekly throughout the study (food consumption was not measured during cohabitation nor thereafter for males). Estrous cycle parameters (percent days in diestrus, proestrus, and estrus) and estrous cycle length were evaluated for 3 weeks prior to and during cohabitation in Pi rats. Fi litter examinations (pup viability, individual pup weights, clinical observations) were performed at birth and on lactation day 4.
After litter production, all Pi rats were given a gross pathological examination, the liver was weighed, and the liver and reproductive organs saved for possible histopathological examination. Uterine implantation sites and ovarian corpora lutea were counted in Pi female rats. Target organs (liver) and gross lesions from 10 randomly selected Pi rats in the control and 25 mg/kg/day groups were examined microscopically. Reproductive organs from Pi rats that did not produce offspring were examined microscopically.
There were no effects considered to be related to H-24768 treatment on the following parameters at any concentration:
Mortality and clinical observations in Pj males and females
Body weight, weight gain and food consumption in Pi males and females
Estrous cycle parameters in Pi females
Mating, precoital interval, and fertility in Pi males and females
Gestation length, number of implantation sites, implantation efficiency, and number of corpora lutea in Pi females
Number of pups (bom, bom alive, alive on day 4), sex ratio, and survival indices during the lactation period (day 0-4) in Fi litters
Clinical observations and body weights in Fi litters during lactation (days 0-4)
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Gross lesions in Pi rats
Microscopic observations in the liver of Pi rats
Microscopic observations in the reproductive organs from Pi rats that did not produce offspring
The only effect considered to be related to H-24768 treatment was an increase in liver weight in Pi male and female rats dosed with 25 mg/kg/day. This effect was not accompanied by gross or histological changes to the liver and was considered a non-adverse physiological adaptive response.
Under the conditions of this study, the no-observed-effect level (NOEL)afor Pi rats, Fi offspring, and reproductive parameters, including fertility, was 25 mg/kg/day, the highest dose tested. The apparent increase in estrous cycle length and the decreased fertility reported in the first study are unlikely to be test substance-related. Thus, the overall lowest-observed effect level (LOEL) for reproductive parameters is 100 mg/kg/day, based on reduced pup survival and weight during lactation observed in the first study. The overall NOEL for reproductive parameters is 25 mg/kg/day, which is the same as the NOEL for subchronic toxicity observed in both studies.
a The NOEL for this study is defined as the highest dose at which toxicologically important effects attributable to the test substance were not detected. Thus, for this study, the NOEL is equivalent to the NOEL as defined by the United States Environmental Protection Agency (1985) and to the no-observed-adverse-effect level (NOAEL) as defined by the European Union (1994).
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* INTRODUCTION
*'
The test substance, H-24768, is
was tested Previously in a combined 90-
day subchronic toxicity and one-feneration reproauction study.(1) In the previous study, rats were
dosed with 0,25,100, or 500 mg/kg/day H-24768 and there was no no-observed-effect level
(NOEL) for reproductive evaluations. This conclusion was based on reductions in the fertility
index in Pj rats in all dose groups. Estrous cycle length was prolonged in Pi rats in all dose
groups, but the toxicological significance of the change was unclear. Other adverse, compound-
related effects observed in Pi rats dosed with 500 mg/kg/day included decrements in body weight
parameters and food efficiency and reduced number of implantation sites. Adverse, compound-
related effects in 100 and/or 500 mg/kg/day groups included reductions in mean litter size,
number of pups bom and bom alive, pup survival during lactation, and pup weight at birth and
during lactation.
OBJECTIVE
The purpose of this study was to determine the repeatability of the fertility and estrous cycle effects and to establish a no-observed-effect level (NOEL) for reproductive toxicity of the test substance. Effects of the test substance on the gonadal function, conception, parturition of male and female Crl:CD(SD)IGS BR rats over one generation were evaluated.
MATERIALS AND METHODS
A. Sponsor And Test Facility
This study was sponsored by DuPont Chemical Solutions Enterprise (DCSE), E. I. du Pont de Nemours and Company, Wilmington, Delaware and was conducted at DuPont Haskell Laboratory for Health and Environmental Sciences, E. I. du Pont de Nemours and Company, Newark, Delaware, and at Regional Analytical Services (RAS) at Jackson Laboratories (test substance stability), Deepwater, New Jersey. Sponsor approval of the study was indicated by issuance of the Work Authorization Form.
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B. Study Design
1. Experimental Design
Treatment Groups and Daily Dosage Group Number Pi Male Pi Female NoVGroup Daily Dosage (mg/kg/day)a
1-0 m -o v-o vn-o
n-o IV-0 VI-0 Vffl-0
24
24 24 24
0 (Control) 1 (Low) 10 (Intermediate) 25 (High)
a Weight of test substance per kg of animal body weight at a dose volume of 5 mL/kg.
Animals
Adult Males Pregnant Females Nonpregnant Females Fi Pups___________
Sacrifice Schedule Schedule
After siring litters (Test Days 96-97) On day 4 of lactation With pregnant females On day 4 of lactation____________
2. Selection of Dose Levels
The dose levels for this study were selected based on the results from the previous 90-day and one-generation reproduction study.(1) Dose levels of 1,10, and 25 mg/kg/day were selected for the current study, where 25 mg/kg/day was expected to produce effects on fertility and liver effects in the Pi generation. The 1 and 10 mg/kg/day were expected to represent either a doseresponse for fertility effects or the NOEL for reproductive toxicity.
C. Analytical (Appendix C)
1. Vehicle The vehicle was deionized water.
2. Test Substance The test substance was supplied by the sponsor. The test substance was assigned Haskell Laboratory Number H-24768. This is the same batch of test substance that was used in a previous 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations.(1)
The stability of the test substance over the course of the study was confirmed by physical property analyses conducted near the beginning and end of the study by the DuPont Regional Analytical Services (RAS) (Appendix C).
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3. Preparation, Administration, and Analysis of Test Formulations
a. Test Formulation Preparation Formulations of the test substance in the vehicle (deionized water) were prepared daily and stored at room temperature until used. Once refrigerated storage stability was established (Appendix C), formulations were prepared twice a week and stored refrigerated. The method of mixing the test substance with the vehicle was documented in the study records.
b. Test Formulation Administration The test substance was administered orally as it is a potential route for human exposure. The test substance was administered by gavage once daily.
Dosing Schedule All animals were dosed daily by gavage for approximately 70 days prior to cohabitation and
during the cohabitation period (up to 2 weeks).
Pi male rats and Pi female rats showing no evidence of copulation continued to be dosed after the end of the cohabitation period until sacrifice.
Females showing evidence of copulation were dosed throughout gestation.
Pregnant females in the process of delivery or showing signs of delivery were not dosed.
Females were dosed after delivering litters, through lactation, up to sacrifice.
Females that did not deliver a litter continued to be dosed until sacrifice.
c. Test Formulation Sampling Samples of each test formulation (approximately 3 mL) were taken 3 times during the study. Analyses addressed concentration, uniformity of mixing, and 5-hour room temperature stability. Samples were submitted shortly after test formulation preparation to the Analytical Chemistry Group at Haskell, except for stability samples s which were submitted after being stored refrigerated for 7 days.
If samples could not be analyzed at the specified times, they were frozen until analyses could be conducted. On days samples were taken, the formulations remaining after dosing were stored at room temperature for possible additional analysis.
d. Test Formulation Analysis (Appendix C)
The analytical method used is described in Appendix C. Results from the analysis of the test formulation samples indicated that the test substance was uniformly mixed, at the expected concentrations, and stable in the vehicle for 5 hours at room temperature at all dose levels.
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D. Test Species
The rat was selected for this study as it is a preferred species for reproductive toxicity testing as recommended by the regulatory guidelines. The Crl:CD(SD)IGS BR strain was chosen because extensive background data are available from the literature, the supplier, and previous studies with other compounds at DuPont Haskell Laboratory. This species and strain are also considered suitable relative to longevity, hardiness, and incidence of spontaneous diseases.
On October 16,2003,108 male and 109 female Crl:CD(SD)IGS BR rats, with an assigned birth date of August 22, 2003 were received from Charles River Laboratories, Inc., Raleigh, North Carolina for use on this study. The rats were approximately 55 days old and weighed approximately 138.2-183.3 grams (males) and approximately 126.0-158.7 grams (females) at arrival. Male and female rats were nonsiblings.
The rats were approximately 69 days old at the start of treatment, and in the body weight ranges 246.7-318.0 grams (males) and 179.0-235.5 grams (females).
E. Animal Husbandry
1. Identification
a. Pretest Prior to assignment to groups, each rat was assigned a temporary cage identification.
b. After Assignment to Treatment Groups A unique number was assigned to each rat and an identification number was tattooed on their tail and recorded on the cage card.
2. Housing All male rats were housed individually during non-mating periods in stainless steel, wire-mesh cages suspended above cageboards.
a. Pretest and Premating All rats were housed individually in stainless steel, wire-mesh cages suspended above cageboards.
b. Cohabitation Period All rats were housed as breeding pairs in stainless steel, wire-mesh cages suspended above cageboard. At the end of the cohabitation period, females without evidence of copulation were housed individually in polycarbonate pans.
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c. Gestation Period (Females with evidence of copulation) Days 0-20: Dams were housed individually in stainless steel, wire-mesh cages suspended
above cageboards. Day 20-Delivery: Females were housed individually in polycarbonate pans with bedding.
d. Lactation Period Dams were housed with their litters in polycarbonate pans with bedding.
3. Environmental Conditions - Animal Rooms
a. Temperature Animal rooms were maintained at an acceptable temperature of 18-26C (targeted at 22-24C).
b. Humidity Animal rooms were maintained at an acceptable relative humidity of 30%-70% (targeted at 40%60%).
c. Lighting Animal rooms were artificially illuminated (fluorescent light) on a 12-hour light/dark cycle (approximately 0600-1800 hours).
Occasional excursions outside the accepted ranges were minor and did not affect the study.
4. Feed and Water
a. Feed All rats were fed pelleted PMI Nutrition International, Certified Rodent LabDiet 5002 ad libitum.
b. Water Tap water from United Water Delaware was provided ad libitum.
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5. Health Monitoring Program As specified in the Haskell Laboratory animal health and environmental monitoring program, the following procedures are performed periodically to ensure that contaminant levels are below those that would be expected to impact the scientific integrity of the study:
Water samples are analyzed for total bacterial counts, and the presence of coliforms, lead, and other contaminants.
Samples from freshly washed cages and cage racks are analyzed to ensure adequate sanitation by the cagewashers.
Certified animal feed is used, guaranteed by the manufacturer to meet specified nutritional requirements and not to exceed stated maximum doses of key contaminants, including specified heavy metals, aflatoxin, chlorinated hydrocarbons, and organophosphates. The presence of these contaminants below the maximum dose stated by the manufacturer would not be expected to impact the integrity of the study.
The animal health and environmental monitoring program is administered by the attending laboratory animal veterinarian. Evaluation of these data did not indicate any conditions that affected the validity of the study.
F. Pretest and Quarantine Period Upon arrival at Haskell Laboratory, the rats were quarantined for at least 6 days. The rats were observed daily for any clinically apparent signs of disease or injury and weighed 3 times.
One rat that died during the pretest period was necropsied to check for the presence of disease; none was evident.
On the basis of acceptable body weight gains and clinical observations, all surviving rats were released from quarantine on test day -8 by the laboratory animal veterinarian or designee.
G. Assignment to Groups and Study Start - Randomization Rats of each sex were ranked by their most recently recorded body weight and randomly assigned to control and experimental groups. The randomization resulted in a distribution in which the mean body weights for all groups within a sex were not statistically different (p > 0.05).
Rats not assigned to a test group, at the discretion of the study director were released for use in other studies, or were sacrificed by carbon dioxide euthanasia and discarded without pathological
evaluation.
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H. Clinical Observations and Mortality - Pi Rats
Clinical observations were performed at least once weekly throughout the premating, gestation, and lactation periods. Each of the adult rats was individually handled and carefully examined for abnormal behavior and/or appearance. Mortality, moribundity, pertinent behavioral changes, signs of difficult or prolonged parturition, and all signs of overt toxicity were recorded.
Cage-side examinations were conducted twice daily throughout the study. Mortality, moribundity, pertinent behavioral changes, signs of difficult or prolonged parturition, and all signs of overt toxicity at the cage-side examination were recorded by exception (i.e., the new clinical sign was recorded and previous clinical signs were verified and, if present, recorded).
I. Pi Rats - Body Weights and Body Weight Gains 1. Premating Period
All Pi rats were weighed once a week.
2. Gestation and Lactation Periods Pi females were weighed on days 0,7,14, and 21 of gestation.
Pi females were weighed on days 0 and 4 of lactation. Females without evidence of copulation, those that copulated and did not deliver a litter, and males were weighed on a weekly schedule.
J. Pi Rats - Food Consumption and Food Efficiency
Each feeder was weighed at the beginning and end of the weekly food consumption interval and the final weight of the feeder and the amount of spillage from the feeder during the interval was subtracted from the initial feeder weight. From the food consumption and body weight data, the mean daily food efficiency was calculated.
1. Premating and Cohabitation Periods
Individual food consumption was determined weekly throughout the period, ending test day 71. Food consumption was not determined during cohabitation.
2. Gestation and Lactation Periods
Individual food consumption of pregnant Pi females was recorded on gestation days 0,7,14, and 21, and for lactating females on lactation days 0 and 4. Food consumption was not measured for females without evidence of copulation, females that did not deliver a litter, or for males.
Although food consumption data were collected during lactation, evaluation of these data / '""n indicated that it was not necessary to meet the objective of this study, thus the data are not
presented in this report but are included in the study records.
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K. Breeding
1. Cohousing Each female was continually housed on a 1:1 basis with a randomly selected, nonsibling male of the same dosage level, in the male's cage. On the day copulation was confirmed, the female was transferred back to individual cage housing.
2. Start of Cohabitation Animals were cohoused after 72 days (approximately 10 weeks) of exposure to the test substance. The day animals were first cohoused was designated as day 1 of cohabitation.
3. Duration of Cohabitation Period Animals were cohoused until evidence of copulation was observed or until 2 weeks had elapsed. The cohabitation period ended in the morning of day 15 of cohabitation.
4. Evidence of Copulation Once daily, each female was examined for an intravaginal copulation plug or sperm in the vaginal lavage sample, either of which was considered evidence of copulation. The day evidence of copulation was observed was designated as day 0 of gestation.
L. Estrous Cycle Evaluation
Vaginal lavage samples were collected daily from all Pj female rats in order to determine the stages of the estrous cycle. Vaginal lavage samples were collected beginning 3 weeks prior to mating, and continuing until copulation was confirmed, or the cohabitation period ended. The vaginal lavage sample collected on the day copulation was confirmed was not used for estrous cycle evaluation. Vaginal lavage samples were examined microscopically for determination of the stage of the estrous cycle (diestrus, estrus, proestrus).
M. Gestation Procedures
After being transferred into polycarbonate pans (on day 20 of gestation for mated females, or at the end of the cohabitation period for females without evidence of copulation), female rats were observed at least twice daily for signs of delivery and offspring.
N. Lactation Procedures
The day when delivery was complete was designated day 0 postpartum. At each examination period (days 0 and 4 postpartum), offspring were individually handled and examined for abnormal behavior and appearance; any dead or abnormal pups were recorded.
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1. Day 0 Postpartum Live and dead pups in each litter were counted by sex as soon as possible after delivery was completed. Live pups in each litter were individually weighed.
2. Day 4 Postpartum Live pups in each litter were counted by sex and individually weighed. All pups were euthanized (by decapitation) and discarded without pathological examination.
O. Anatomic Pathology
1. Pi Adults
a. Euthanasia and Postmortem Examinations
All Pi parental generation rats were subjected to a gross pathological examination, including those for which mating did not result in production of offspring. The uteri of all cohabited females were examined for the presence and number of implantation sites and corpora lutea counts were recorded. All gross lesions were preserved in appropriate fixative for possible future histopathological examination.
The following tissues and all gross lesions were collected from all Pi adults sacrificed by design. All collected tissues were preserved in appropriate fixative for possible future histopathological examination.
Organ Weights from Pi Adults Both Sexes Liver
Tissues Collected from Pi Adults Sacrificed by Design
Male
Female
Both Sexes
Testes3
Epididymides3 Prostate
Seminal Vesicles Coagulating Glands
Ovaries (with oviducts) Uterus Vagina Cervix
Gross Observations' Liver
a The right testis and epididymis was placed in Bouin's solution. The left testis and epididymis was frozen for possible sperm count evaluations. All other tissues (reproductive and non-reproductive) collected from male and female rats were placed in formalin.
b Gross lesions observed at necropsy for which histopathology was not appropriate or would not be additive were generally not collected.
Histopathological examination of the liver was conducted for the first 10 parental rats (the first 10 consecutive animal numbers in each group) surviving to scheduled sacrifice in the Pi male and female high-dose and control groups. The liver was examined for one additional male rat in the Pi control group because a gross lesion was observed at necropsy.
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There were 12 adult pairs with impaired reproductive performance (e.g., failure to mate, conceive, sire, or deliver healthy offspring). The reproductive organs of these rats were evaluated. The uterus was examined for one additional female rat in the Pi control group because a gross lesion was observed at necropsy. In addition, most gross lesions were evaluated microscopically.
Sperm count determination was not performed since it was not considered necessary to meet the objective of this study; tissues were discarded.
2. Offspring
Offspring that were found dead during the lactation period underwent an external examination and were discarded.
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DATA ANALYSES
The following table lists the indices of reproductive function that were calculated for the Pi adults.
Reproductive Function Calculations
Mating Index (%) Fertility Index (%)
Gestation Index (%) Implantation Efficiency (%)C Pups Bom Alive (%) Viability Index (%)C'd
Number Copulateda
Number Cohabited
Number Number
PCroepeunlaantetbda
Number of Litters with at Least One Live Pup Number of Litters
Number of Pups Bom Number of Implantation Sites
Number of P u d s Bom Alive Number of Pups Bom
Number of P ud s Alive Dav 4 Preculline Number of pups bom alive
x 100 x 100
x 100 x 100 x 100 x 100
a Evidence of copulation = intravaginal copulatory plug, sperm in vaginal lavage, found dead pregnant, or delivery of a litter,
b Including those found dead pregnant during gestation. c To be determined for each litter. Mean and standard deviation for each dose level will be calculated, d Excluding litters sacrificed due to death of dam during lactation.
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Statistical Methods
Parameter
Preliminary Test
If preliminary test is not significant
If preliminary test is significant
Body Weight Body Weight Gain Food Consumption Food Efficiency Gestation Length Organ Weight Implantation Site Numbers Implantation Efficiency Corpora Lutea Counts Mean Number of Pups Per Litter Percent Born Alive 0-4 Day Viability Precoital Interval Estrous Cycle Parameters
Levene's test for homogeneity and Shapiro-Wilk test for
normality
One-way analysis of variance and Dunnett's
test6
Kruskall-Wallis test and Dunn's test
Incidence of Clinical Observations Mating Index Fertility Index
Sex Ratio (Covariate: litter size) Mean Pup Weights
(Covariate: litter size)
None
Cochran-Armitage test for trend6
Levene's test for homogeneity and Shapiro-Wilk test for
normalityc
Analysis of covariance Non-parametric analysis
and Dunnett-Hsu(10)
of covariance(II)
a If the Shapiro-Wilk test was not significant but Levene's test was significant, a robust version of Dunnett's test was used. If the Shapiro-Wilk test was significant, Kruskal-Wallis test was followed with Dunn's test,
b If there was significant non-monotonicity in the dose-response, then Fisher's exact test(12) was used with a Bonferroni correction, c A normalizing, variance stabilizing transformation was used as needed.
For each parameter analyzed with a trend test, the test was applied to the data sequentially. If a significant dose-response was detected, data from the top dose group were excluded and the test repeated until no significant trend was detected.(13) For litter parameters, the proportion of affected pups per litter or the litter mean was used as the experimental unit for statistical evaluation/14^ The level of significance selected was p < 0.05. Additional statistical tests were used, and other parameters analyzed, if deemed necessary.
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RECORDS AND SAMPLE STORAGE
Laboratory-specific or site-specific raw data, such as personnel files and equipment records will be retained by the facility where the work was done. All original records or true copies of original records (sponsor-supplied characterization of the test substance), will be retained at DuPont Haskell Laboratory, E.I. du Pont de Nemours and Company, Newark, Delaware or at Iron Mountain Records Management, 200 Todds Lane, Wilmington, Delaware.
A sample of the test substance was collected for archive purposes and retained at DuPont Haskell Laboratory. Specimens (if applicable), raw data, and the final report will be retained at DuPont Haskell Laboratory, Newark, Delaware, or at Iron Mountain Records Management, Wilmington, Delaware.
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RESULTS AND DISCUSSION
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REPRODUCTIVE TOXICOLOGY
A. Pi Rats - Clinical Observations and Mortality
1. Pi Males: (Table 1, Appendix D)
There was no test substance-related mortality during the study (refer to Anatomic Pathology, Section A, for more details). There were no test substance-related clinical observations at any dose level.
2. Pi Females: (Tables 2-4, Appendices E-G)
There was no test substance-related mortality during the study (refer to Anatomic Pathology, Section A, for more details). There were no test substance-related clinical observations during premating, gestation, or lactation at any dose level.
B. Pi Rats - Body Weights and Body Weight Gains
1. Pi Males: (Tables 5-6, Appendices H-I)
There were no test substance-related effects on body weights and body weight gains at any dose level. Occasional findings of statistically significant increases or decreases in weekly body weight gain (days 28-36 and 85-92 at 25 and 10 mg/kg/day, respectively) were considered spurious due to their sporadic nature, lack of dose-response relationship, and/or lack of effect on final body weight or overall body weight gain.
2. Pi Females: (Tables 7-12, Appendices J-O)
There were no test substance-related effects on body weights and body weight gains during premating, gestation, or lactation at any dose level. Occasional findings of statistically significant increases or decreases in weekly body weight gain (days 1-8 and 43-50 at 25 and 10 mg/kg/day, respectively) were considered spurious due to their sporadic nature, lack of doseresponse relationship, and/or lack of effect on final body weight or overall body weight gain.
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C. Pi Rats - Food Consumption and Food Efficiency
1. Pi Males: (Tables 13-14, Appendix P)
There were no test substance-related effects on food consumption or food efficiency in Pi males during premating at any dose level. The reduced food efficiency on days 28-36 was consistent with the reduced weight gain during this weekly interval and was considered spurious.
2. Pi Females: (Tables 15-18, Appendices Q-R)
There were no test substance-related effects on food consumption or food efficiency in Pi females during premating, or gestation at any dose level. Occasional findings of statistically significant increases or decreases in weekly food consumption (days 15-22 at 25 mg/kg/day) or food efficiency (days 22-28 and 50-56 at 10 mg/kg/day) were considered spurious due to their sporadic nature, lack of dose-response relationship, and/or lack of effect on overall food consumption or food efficiency. The statistically significant changes in weekly food efficiency on days 1-8 and 43-50 at 25 and 10 mg/kg/day, respectively, were consistent with the changes in weight gain during these weekly intervals and were considered spurious.
D. Estrous Cycle Parameters in Pi Females (Table 19, Appendices S-T)
There were no test substance-related effects on the mean percent days in estrus, diestrus, or proestrus, or mean estrous cycle length at any dose level. As shown in the table below, the mean length of the estrous cycle was similar across groups. This differs from the previous study,(1) in which mean estrous cycle length at all dose levels was higher than in the control group. The differing results for estrous cycle length can be easily attributable to normal variability in this parameter since values in both studies were within the testing laboratory's historical control range (4.1-4.9; 14 studies from 1999-2003) and the apparent dose-related trend was in opposite directions in the 2 studies.
Reproductive Toxicology Text Table 1. Estrous Cycle Parameters in Pj Females
Dose (mg/kg/day)
J ______ 10_______ 25_______ 100
4.7 4.9
4.5 4.4
4.1
500 4.8
E. Reproductive Indices in Pi Rats (Tables 19-20, Appendices S-V)
There were no test substance-related effects on the length of the precoital interval, mating, fertility, gestation length, number of implantation sites, implantation efficiency, or number of corpora lutea at any dose level. As shown in the table below, the fertility index was similar
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across groups. This differs from the previous study(1), in which the fertility index at all dose levels was lower than in the control group. Although fertility indices of 55%-65% in the first study are outside the testing laboratory's historical control range (72%-100%; 10 studies from 1999-2003), it is likely to have been incidental for the following reasons: 1) the low fertility in the first study was similar at all dose levels and thus, was not dose-related; 2) there were no other corroborative findings of reproductive toxicity (histopathological changes in reproductive organs, anovulation, hypospermia, aspermia) in the first study that would be predictive of low fertility; 3) the low fertility observed in the first study at 25 mg/kg/day (55%) was not reproduced in the second study, where it was 100%.
Reproductive Toxicology Text Table 2. Fertility Index3in Rats Dosed with H-24768
Study
Dose (mg/kg/day)
Report Numbers _ 0
1 10 25 100
85 -
- 55 58
JH i
92
88 91 100
-
a. Fertility Index = Number o f pregnant females X 100/Number of females that mated
500 65
-
F. Fi Offspring Data
1. Litter Size, Sex Ratio and Pup Survival (Table 21, Appendix W)
There were no test substance-related effects on the number of pups bom, bom alive, and alive on day 4, nor were there any effects on sex ratio, or survival indices during lactation days 0-4 at any dose level.
2. Clinical Observations in Fi Pups (Table 22, Appendix X)
There were no test substance-related clinical observations at any dose level. Clinical observations were limited to one pup in the 25 mg/kg/day displaying subcutaneous hemorrhage, a relatively common finding in neonates of this strain.
3. Pup Weights (Table 23, Appendix Y)
There were no test substance-related effects on pup weights at birth or on day 4 of lactation at any dose level.
G. Reproductive Toxicology Conclusions There were no effects on Pi rats, Fi offspring, or reproductive parameters, including fertility. The apparent increase in estrous cycle length and the decreased fertility reported in the first study(1) are unlikely to be test substance-related.
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ANATOMICAL PATHOLOGY
A. Cause of Death - Pi Adult Rats (Appendices AA)
There was no test substance related mortality. All rats survived until the scheduled sacrifice date.
B. Liver Weight Data - Pi Adult Rats (Tables 24-25, Appendix Z)
Test substance-related and statistically significant increases in liver weight parameters were present in male and female rats administered 25 mg/kg/day of the test substance. Liver weight relative to body weight in these groups was 110% and 114% of the control group mean for males and females, respectively. These liver weight increases were not associated with microscopic evidence of liver toxicity and thus were considered a physiologic response to metabolism of a xenobiotic and were not toxicologically adverse.
C. Gross Findings - Pi Adult Rats (Tables 26-27, Appendix AA)
There were no test substance-related gross observations. All gross observations noted at necropsy were interpreted to be naturally occurring background lesions that are typical of rats of this age and strain.
D. Microscopic Findings - Pi Adult Rats (Tables 28-29; Appendix AA)
Liver
There were no test-substance related microscopic observations in the liver. In a previous 90-day study in rats(1) with the test substance, minimal microscopic hepatocellular hypertrophy was observed in some male rats, but not female rats, exposed to 25 mg/kg/day of the test substance. In the current study, definitive microscopic hepatocellular hypertrophy was not observed in males or females exposed to 25 mg/kg/day. Nevertheless, evidence of liver hypertrophy was present in males and females administered 25 mg/kg/day based on the mild increases in liver weights.
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p } Adult Rats With Suspected Impaired Reproductive Performance
No test substance-related microscopic findings were present in the reproductive organs of 12 Pj adult pairs that failed to produce litters. Microscopic evaluation of the 12 pairs revealed a morphological explanation for infertility in 4 Pi females, which had decreased or no corpora lutea in the ovary. This finding was not test substance-related and was observed in 1,2, 1, and 0 Pi females in the 0 ,1,10, and 25 mg/kg/day groups, respectively. The cause of the infertility in the remaining 8 pairs was not determined.
E. Anatomic Pathology Conclusions No adverse findings were present in male or female groups administered up to 25 mg/kg/day of the test substance. Nonadverse, test substance-related findings were limited to mild physiological increases in liver weight in males and females administered to 25 mg/kg/day.
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CONCLUSIONS
Under the conditions of this study, the-observed-effect level (NOEL)a for Pi rats, Fi offspring, and reproductive parameters, including fertility, was 25 mg/kg/day, the highest dose tested. The apparent increase in estrous cycle length and the decreased fertility reported in the first study are unlikely to be test substance-related. Thus, the overall lowest-observed effect level (LOEL) for reproductive parameters is 100 mg/kg/day, based on reduced pup survival and weight during lactation observed in the first study. The overall NOEL for reproductive parameters is 25 mg/kg/day, which is the same as the NOEL for subchronic toxicity observed in both studies.
The NOEL for this study is defined as the highest dose at which toxicologically important effects attributable to the test substance were not detected. Thus, for this study, the NOEL is equivalent to the NOEL as defined by the United States Environmental Protection Agency<15) and to the no-observed-adverse-effect level (NOAEL) as defined by the European Union.<16)
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REFERENCES
1. DuPont Haskell Laboratory. (2002). 90-Day Gavage Study in Rats with One-Generation
R eproduction valuations. Unpublished Report. DuPont Haskell Laboratory
< )uPont Haskell Laboratory Medical Research Project Number (MR)|
11
2. Levene, H. (1960). Robust test for equality of variances. Contributions to Probability and Statistics (J. Olkin, ed.), pp 278-292. Stanford University Press, Palo Alto.
3. Shapiro, S.S. and Wilk., M.B. (1965). An analysis of variance test for normality (complete samples). Biometrika 52, 591-611.
4. Snedecor, G.W. and Cochran, W.G. (1967). Statistical Methods, 6thedition, pp 246-248 and 349-352. The Iowa State University Press, Iowa.
5. Dunnett, C.W. (1964). New tables for multiple comparisons with a control. Biometrics 20, 482-491.
6. Dunnett, C.W. (1980). Pairwise multiple comparisons in the unequal variance case. J. Amer. Statist. Assoc. 75, 796-800.
7. Tamhane, A.C. (1979). A comparison of procedures for multiple comparison of means with unequal variances. J. Amer. Statist. Assoc. 74, 471-480.
8. Kruskal, W.H. and Wallis, W.A. (1952). Use of ranks in one-criterion analysis of variance. J. Amer. Statist. Assoc. 47, 583-621.
9. Dunn, O.J. (1964). Multiple contrasts using rank sums. Technometrics 6, 241-252.
10. Hsu, J.C. (1992). The Factor Analytic Approach to Simultaneous Inference in the General Linear Model. Journal of Computational and Graphical Statistics 1,151-168.
11. Stephenson, W.R., Jacobson, D. (1988). A comparison of Nonparametric Analysis of Covariance Techniques, Communications in Statistics - Simulations 17. 17(2), 451-461.
12. Fisher, R.A. (1985). Statistical Methods for Research Workers, 13th edition. Haffner, New York.
13. Selwyn, M.R. (1995). The use of trend tests to determine a no-observable-effect level in animal safety studies. Journal of the American College of Toxicology 14(2), 158-168.
14. Haseman, J.K. and Hogan, M.D. (1975). Selection of the experimental unit in teratology studies. Teratology, 12,165-171.
15. Hazard Evaluation Division, Standard Evaluation Procedure, Toxicity Potential: Guidance for Analysis and Evaluation of Subchronic and Chronic Exposure Studies Paynter, O. E. et al., United States Environmental Protection Agency, Office of Pesticide Programs, Washington, D.C., 20406. EPA-540/9-85-020. (June 1985).
16. Risk Assessment of Notified New Substances. Technical Guidance Document (XI/283/94-EN), Chapter I, Sections 2.24 and 2.25. 1994.
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TABLES
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TABLES EXPLANATORY NOTES Notes Test Days 1-73 = Premating period Test Days 73-87 = Cohabitation period
Abbreviations G = Gestation N/n = Number
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TABLE 1 SUMMARY OF CLINICAL OBSERVATIONS IN Pi MALE RATS
NUMBER OF RATS WITH GIVEN SIGN
GROUP: DOSE ( MG/KG/DAY):
N:
1-0
III-O
V-0
VII-0
0 1 10 25
24 24 24 24
OBSERVATION
ALOPECIA COLORED DISCHARGE E Y E ( S ) COLORED DISCHARGE PENIS SCAB SORE STAINED CAGEBOARD TEETH CLIPPED TEETH CROOKED TEETH MISSING
222 102 001 000 001 001 100 001 101
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05):
A Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant - next to control mean indicates no analyses were performed
significant
2 0 0 1 0 0 0 0 0
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TABLE 2 SUMMARY OF CLINICAL OBSERVATIONS IN P, FEMALE RATS DURING PREMATING
NUMBER OF RATS WITH GIVEN SIGN
GROUP DOSE (MG/KG/DAY)
N
II-O 0
24
IV -0 1 24
VI-0 10 24
V III-0 25 24
OBSERVATION
ALOPECIA SCAB
75 10
6 0
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05):
~ Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant - next to control mean indicates no analyses were performed
significant
7 0
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TABLE 3 SUMMARY OF CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING GESTATION
NUMBER OF RATS WITH GIVEN SIGN
GROUP DOSE (MG/KG/DAY)
N
II-O 0
23
IV -0 1 24
VI-0 10 20
V III-0 25 20
OBSERVATION
ALOPECIA SCAB
47 10
4 0
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05):
A Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant ~ next to control mean indicates no analyses were performed
significant
7 0
Note: This table contains data from females with evidence of copulation observed.
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TABLE 4 SUMMARY OF CLINICAL OBSERVATIONS IN Pt FEMALE RATS DURING LACTATION
NUMBER OF RATS WITH GIVEN SIGN
GROUP DOSE (MG/KG/DAY)
N
II-O 202
IV-0 1 21
VI-0 10 19
V III-0 25 22
OBSERVATION
ALOPECIA
466
COLORED DISCHARGE VAGINAL OPENING
1
2
0
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05}:
A Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant ~ next to control mean indicates no analyses were performed
significant
6
1
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Group : Dose (mg/kg/day) T e s t Day
1
15 22 28 36 43 50 56 63 71
TABLE 5 MEAN BODY WEIGHTS (grams) OF Pi MALE RATS
1-0
III-O
V-0
0 1 10
286.0 14.2(24)
324.7 19.5(24)
362.2 22.5(24)
395.5 26.5(24)
417.3 28.7(24)
443.2 33.3(24)
464.4 32.7(24)
476.3 37.4(24)
487.9 33.9(24)
500.5 35.8(24)
511.0 37.3(24)
286.7 14.2(24)
326.3 21.1(24)
366.0 27.3(24)
399.6 31.9 (24)
420.8 34.4(24)
447.2 34.2(24)
471.2 36.4(24)
486.5 37.8(24)
499.7 39.5(24)
513.6 41.2(24)
527.1 42.0(24)
287.5 15.3(24)
327.5 22.1(24)
363.7 30.0(24)
398.8 34.1(24)
419.1 37.1(24)
440.7 39.3 (24)
463.1 42.4(24)
478.8 46.0(24)
493.2 46.5(24)
506.4 47.5(24)
518.8 50.5(24)
40
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VII-0 25
289.7 12.3(24)
32 9 . 9 16.9(24)
367.4 20.0(24)
399.3 22.3(24)
418.9 26.3 (24)
439.6 29.5(24)
460.3 34.8(24)
474.9 36.1(24)
487.3 37.4(24)
499.5 37.1(24)
512.8 41.0(24)
H-24768: One-Generation Reproduction Study in Rats
TABLE 5 (Continued) MEAN BODY WEIGHTS (grams) OF Pi MALE RATS
Group : Dose (mg/kg/day)
1-0 0
III-O 1
V-0 10
T e s t Day 78
513.4 38.7(24)
530.5 42.2(24)
521.1 50.2(24)
85
526.2
540.0
529.9
40.6(24)
41.8(24)
51.3(24)
92
533.7
550.0
543.0
42.7(24)
46.8(24)
50.6(24)
Data summarized as:
Mean Standard Deviation (n)
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05):
A Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant - next to control mean indicates no analyses were performed
significant
Note: Test Day 71 = Last day of premating period that data were recorded.
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VII-0 25
514.2 43.7(24)
527.3 44.5(24)
533.0 47.9(24)
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r"
" ....................
" ............ -
~ ................
)--
" ~ ...................
~j
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TABLE MEAN BODY WEIGHT GAINS (grams) OF Pj MALE RATS
Group: Dose (mg/kg/day) : T e s t Day
1-8
8-15
15-22
22-28
28-36 36-43
43-50
50-56
56-63
63-71
71-78
1-0 0
38.8 8.0(24)
37.4 7.8(24)
33.3 6.9(24)
21.9 5.1(24)
25.9 6.7(24)
21.2 6.1(24)
11.8 13.9(24)
11.6 7.5(24)
12.6 6.6(24)
10.5 6.1(24)
2.4 10.1(24)
I1I-0 1
39.6 10.5(24)
39.7 8.5(24)
33.7 6.7(24)
21.1 4.9(24)
26.5 6.1(24)
24.0 5.9(24)
15.3 4.7(24)
13.2 4.5(24)
13.8 5.7(24)
13.6 6.0(24)
3.4 9.8(24)
V-0 10
39.9 9.2(24)
36.2 13.0(24)
35.1 8 .6 (24)
20.2 12.3(24)
21.7 5.6(24)
22.4 9.7(24)
15.7 7.1(24)
14.4 6.7(24)
13.2 6.5(24)
12.3 8.1(24)
2.3 8.9(24)
VII-0 25
40.1 7.2(24)
37.6 6.9(24)
31.9 4.8(24)
19.6 6.0(24)
20.7* 6.9(24)
20.7 7.4(24)
14.6 6.0 (24)
12.4 3.7(24)
12.2 5.6(24)
13.3 7 .3 (24)
1.3 8.9(24)
C o m p a n y S a n itize d . Does not contain TSCA CBS
42
H-24768: One-Generation Reproduction Study in Rats________________________________ _________ ___________________________
DuPont-13784
TABLE 6 (Continued) MEAN BODY WEIGHT GAINS (grams) OF Pi MALE RATS
Group : Dose (m g/kg/day):
1-0 0
III-O 1
V-0 10
T e s t Day 78-85
12.7 10.3(24)
9.6 7.9(24)
8.8 14.8(24)
85-92
7.5 9.6(24)
9.9 8.3(24)
13.1 7.6(24)
1-92
247.7 36.0(24)
263.3 38.3(24)
255.5 39.2(24)
Data summarized as:
Mean Standard Deviation (n)
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05):
A Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) significant @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant ~ next to control mean indicates no analyses were performed
Note: Test Day 71 = Last day of premating period that data were recorded.
VII-0 25
13.1 6.9(24)
5.7 6.6(24)
243.3 40.5(24)
pompany Sanitized. Does not contain tsca CBI
43
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
TABLE 7 MEAN BODY WEIGHTS (grams) OF PxFEMALE RATS DURING PREMATING
Group : Dose (mg/kg/day) Test Day
1
15
22
28 36 43 50 56 63
II-O 0
206.4 9.6(24)
221.2
11.7(24)
235.0 12.1(24)
246.9 14.4(24)
260.0 14.8(24)
269.1 14.1(24)
277.0 14.2(24)
278.0 16.8(24)
287.1 17.4(24)
291.9 16.2(24)
IV-0
1
209.0 13.2(24)
222.6
14.7(24)
235.3 15.7(24)
246.1 18.2 (24)
258.7 21.5(24)
270.1 21.1(24)
274.3 21.8(24)
280.1 21.6(24)
288.4 21.6(24)
294.4 25.0(24)
VI-0 10
205.6 10.9(24)
221.5 14.2 (24)
236.2 17.1(24)
251.4 18.1(24)
258.7 20.6(24)
269.8 23.4(24)
279.2 24.2(24)
286.3 25.5(24)
289.7 26.6(24)
295.7 30.2(24)
VIII-0 25
208.3 9.8(24)
217.9 11.5(24)
233.9 14.8(24)
246.6 14.9(24)
254.4 15.8(24)
264.6 15.8(24)
275.1 16.9(24)
280.1 17.3(24)
286.4 18.1(24)
291.4 18.4(24)
C om pany S anitized. D oes not contain TSCA CBI
44
H-24768: One-Generation Reproduction Study in Rats
) DuPont-13784
TABLE 7 (Continued) MEAN BODY WEIGHTS (grams) OF P! FEMALE RATS DURING PREMATING
Group : Dose (m g/kg/day):
II-O 0
IV-0 1
VI-0 10
T e s t Day 71
299.4 14.9(24)
300.0 24.8(24)
304.1 31.6(24)
Data summarized as:
Mean Standard Deviation (n)
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05):
A Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) significant @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant - next to control mean indicates no analyses were performed
Note: Test Day 71 = Last day of premating period that data were recorded.
V III-0 25
296.9 18.9(24
JPpmpany Sanitized. D oes not contain TSCA CB*
45
)
H-24768: One-Generation Reproduction Study in Rats
>
DuPont-13784
TABLE 8 MEAN BODY WEIGHT GAINS (grams) OF P, FEMALE RATS DURING PREMATING
Group : Dose (m g/kg/day): T e s t Day
1-8
8-15 15-22
22-28
28-36
36-43
43-50
50-56
56-63
63-71
II-O 0
14.8 8.3(24)
13.8 6.1(24)
11.8 8.8(24)
13.2 9.8(24)
9.1 8.9(24)
7.9 6.1(24)
1.1 7.4(24)
9.1 9.5(24)
4.8 7.6(24)
7.6 5.8(24)
IV-0 1
13.6 7.6(24)
12.6 5.6(24)
10.8 7.8(24)
12.6 9.6(24)
11.4 9.1(24)
4.2 7.2(24)
5.8 7.6(24)
8.3 6.9(24)
6.0 8.6(24)
5.7 8.0(24)
VI-0 10
16.0 6.1(24)
14.7 7.2(24)
15.2 8.2(24)
7.3 10.0(24)
11.1 7.3(24)
9.3 10.7 (24)
7.1 9.7(24)
3.5 7.8(24)
6.0 9.1(24)
8.4 6.9(24)
VIII-0 25
9.6* 5.2(24)
16.0 7.0(24)
12.7 6.6(24)
7.8 6.9(24)
10.2 6.3(24)
10.6 7.4(24)
4.9 7.9(24)
6.3 9.0(24)
5.1 7.0(24)
5.5 6.1(24)
C om pany Sanitized. Does not contain TSCA CD
46
y -- ..-- ~ ..... ' ...............................................)
H-24768: One-Generation Reproduction Study in Rats_______________________
DuPont-13784
TABLE 8 (Continued) MEAN BODY WEIGHT GAINS (grams) OF P, FEMALE RATS DURING PREMATING
Group: Dose (m g/kg/day):
II-O 0
IV-0 1
VI-0 10
T e s t Day 1-71
93.0 11.6(24)
91.0 18.4(24)
98.6 24.8(24)
Data summarized as:
Mean Standard Deviation (n)
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05):
A Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant ~ next to control mean indicates no analyses were performed
significant
Note: Test Day 71 = Last day of premating period that data were recorded.
V III-0 25
88.6 14.7(24)
.Company Sanitized. Does not contain TSCA CBI
47
)'
H-24768: One-Generation Reproduction Study in Rats
J
) DuPont-13784
TABLE 9 MEAN BODY WEIGHTS (grams) OF Pj FEMALE RATS DURING GESTATION
Group: Dose (m g/kg/day):
I I -0 0
IV-0 1
VI-0 10
V III-0 25
G e s t a t i o n Day 0
301.8 13.6(21)
300.5 22.5(21)
301.7 19.9(18)
300.4 19.6(20)
7
338.5
335.4
337.7
332.2
17.0(21)
23.5(21)
19.9(18)
17.5(20)
14
367.4
367.8
367.0
359.5
17.1(21)
25.5(21)
21.1(18)
19.2(20)
21 442.0 ________________________________________________ 2 4 . 7 (20)
445.6 37.9(21)
448.7 28.0(18)
443.7 19.3(20)
Data summarized as :
Mean Standard Deviation (n)
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05):
A Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant ~ next to control mean indicates no analyses were performed
significant
Note: This table contains data from animals with evidence of copulation that delivered a litter.
C om pany Sanitized. Does not contain TSCA CB!
48
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
TABLE 10 MEAN BODY WEIGHT GAINS (grams) OF Pj FEMALE RATS DURING GESTATION
Group: Dose (m g/kg/day):
II-O 0
I' -0 1
VI-0 10
G e s t a t i o n Day 0-7
36.6 7.6(21)
34 8 7 5(21)
36.0 5.8(18)
7-14
28.9 6.9(21)
32 4 5 7(21)
29.3 5.1(18)
14-21
76.0 18.0(20)
77 8 19 0 (21)
81.7 16.5(18)
0-21
140.4 19.8(20)
145.1 20.4(21)
147.1 19.5(18)
Data summarized as :
Mean Standard Deviation (n)
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05):
A Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant ~ next to control mean indicates no analyses were performed
significant
Note: This table contains data from animals with evidence of copulation that delivered a litter.
V III-0 25
31.8 6.3 (20)
27.3 4.8(20)
84.2 8.5 (20)
143.3 9.6(20)
'Company Sanitized. Does not contain tr c a C 8I
49
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
TABLE 11 MEAN BODY WEIGHTS (grams) OF Pj FEMALE RATS DURING LACTATION
Group : Dose (m g/kg/day):
II-O 0
IV-0
1
VI-0 10
L a c t a t i o n Day
0
330.7 17.6(22)
336.8 26.3(21)
333.2 24.5(19)
4
345.5
345.1
354.6
14.4(22)
23.1(21)
26.6(19)
Data summarized as:
Mean Standard Deviation (n)
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05):
A Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant ~ next to control mean indicates no analyses were performed
significant
VIII-0 25
324.5 14.7(22)
344.6 17.9(22)
Sanitized. Do*
- #* "
50
H-24768: One-Generation Reproduction Study in Rats
)
DuPont-13784
TABLE 12 MEAN BODY WEIGHT GAINS (grams) OF Pi FEMALE RATS DURING LACTATION
Group : Dose (m g/kg/day):
II-O 0
IV-0 1
VI-0 10
VIII 25
L a c t a t i o n Day
0-4
14.8
8.3 21.4 20.1
__________________________________________________1 0 , 0 ( 2 2 ) ____________1 3 . 7 (21)____________2 7 . 2 ( 1 9 ) ____________ 1 2 . 2 (22)
Data summarized as:
Mean Standard Deviation (n)
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05):
" Cochran-Armitage test for trend
'
* Parametric comparison to control (Dunnett/Tamhane-Dunnett)
@ Nonparametric comparison to control (Dunn's) significant
# Trend test (Jonckheere-Terpstra) significant
~ next to control mean indicates no analyses were performed
significant
.Company Sanitized. D oes n o t conte TSCA CBI
51
) ........... H-24768: ne-Generation Reproduction Study in Rats
)
)
DuPont-13784
TABUE 13 MEAN DAILY FOOD CONSUMPTION (grams/day) OF Pi MALE RATS DURING PREMATING
Group : Dose (m g/kg/day): T e s t Day
1-8
8-15
15-22
22-28
28-36
36-43
43-50
50-56
56-63
63-71
1-0 0
26.2 2.1(24)
26.3 2.1(24)
27.3 2.4(24)
28.1 2.2(24)
28.8 2.4(24)
27.9 2.2(24)
26.5 3.5(24)
26.9 6.5(24)
28.0 2.3(24)
27.4 2.6(24)
III-O 1
26.4 2.4(24)
27.1 2.5(24)
28.0 2.6(24)
28.1 2.7(24)
28.9 2.3(24)
28.2 2.4(24)
27.9 2.7(24)
28.1 2.9(24)
28.5 2.7(24)
27.8 2.3(24)
V-0 10
26.6 2.3 (24)
27.2 2.7(24)
28.1 3.1(24)
28.0 3.0(24)
27.8 3.1(24)
27.9 2.9(24)
27.9 3.1(24)
28.3 3.0(24)
29.0 2.6(24)
28.4 3.1(24)
VII-0 25
27.1 2.3(24)
27.5 2.0(24)
27.9 2.4(24)
28.1 3 .3 (24)
28.0 3.8(24)
28.2 3.4(24)
28.4 3.0(24)
28.1 2.8(24)
29.0 2.7(24)
28.2 3.2(24)
fSetttpany Sanitized. D oes not contain TSCA CB1
52
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
TABLE 13 (Continued)
MEAN DAILY FOOD CONSUMPTION (grams/day) OF P, MALE RATS DURING PREMATING
Group : Dose (m g/kg/day):
1-0 0
III-O 1
V-0 10
VII 25
T e s t Day
1-71
27.3
27.9
27.9
28.0
__________________________________________________ 2 . 1 ( 2 4 ) _____________ 2 . 3 (24)_____________ 2 . 5 ( 2 4 ) _____________ 2 . 6 ( 2 4 )
Data summarized as: Statistical Analysis:
Mean Standard Deviation (n)
Statistical significance is indicated by the following (p < 0.05):
A Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) significant @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant - next to control mean indicates no analyses were performed
Note: Test Day 71 = Last day of premating period that data were recorded.
C o m p a n y S a n itiz e d . D o e s no t contain TSCA CBI
53
H-24768: One-Generation Reproduction Study in Rats_____ _________________
DuPont-13784
TABLE 14 MEAN DAILY FOOD EFFICIENCY (grams weight gain/grams food consumed) OF P! MALE RATS DURING PREMATING
Group : Dose (m g/kg/day): T e s t Day
1-8
8-15
15-22
22-28
28-36
36-43
43-50
50-56
56-63
63-71
1-0 0
0.211 0.037(24)
0.203 0.041(24)
0.173 0.029(24)
0.129 0.028(24)
0.112 0.026(24)
0.108 0.028 (24)
0.054 0.108(24)
0.080 0.068(24)
0.063 0.029(24)
0.047 0.026(24)
III-O 1
0.212 0.042(24)
0.208 0.031(24)
0.171 0.026(24)
0.125 0.023(24)
0.115 0.024(24)
0.121 0.027(24)
0.078 0.022(24)
0.078 0.024(24)
0.069 0.027(24)
0.060 0.025(24)
V-0 10
0.213 0.038(24)
0.186 0.064(24)
0.179 0.043(24)
0.117 0.082(24)
0.098 0.025(24)
0.113 0.043(24)
0.078 0.032(24)
0.084 0.037(24)
0.065 0.032(24)
0.053 0.030(24)
VII-0 25
0.211 0.029(24)
0.195 0.029(24)
0.163 0.018(24)
0.114 0.028(24)
0.091* 0.025(24)
0.103 0.033(24)
0.073 0.028(24)
0.073 0.020(24)
0.061 0.029(24)
0.057 0.028(24)
Company sanitized. Does no! contain TSCA CBf
54
)'
)
H-24768: One-Generation Reproduction Study in Rats_______________________
DuPont-13784
TABLE 14 (Continued) MEAN DAILY FOOD EFFICIENCY (grams weight gain/grams food consumed) OF Pi MALE RATS DURING PREMATING
Group: Dose (m g/kg/day):
1-0 0
III-O 1
V-0 10
T e s t Day
1-71
0.117
0.123
___________________________________________________ 0 . 0 1 1 ( 2 4 ) __________0 . 0 1 0 (24)
0.118 0.012(24)
Data summarized as:
Mean Standard Deviation (n)
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05):
A Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant - next to control mean indicates no analyses were performed
significant
Note: Test Day 71 = Last day of premating period that data were recorded.
VII-0 25
0.113 0.010(24)
9s?
i. Does not contain cmTSCA
55
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
TABLE 15 MEAN DAILY FOOD CONSUMPTION (grams/day) OF Pi FEMALE RATS DURING PREMATING
Group : Dose (m g/kg/day): T e s t Day
1-8
8-15
15-22
22-28
28-36
36-43
43-50
50-56
56-63
63-71
II-O 0
19.0 1.3(24)
19.4 1.2(24)
19.1 1.3(24)
20.1 1.5(24)
19.7 1.1(24)
19.7 1.9(24)
19.4 1.6(24)
19.2 1.8(24)
19.7 1.5(24)
21.0 1.9(24)
IV-0 1
18.8 1.5(24)
19.8 1.6(24)
19.9 2.3(24)
20.3 2.7(24)
20.7 2.3(24)
20.0 1.8(24)
20.3 2.5(24)
19.9 2.5(24)
21.0 2.7(24)
21.7 2.6(24)
VI-0 10
18.3 2.0(24)
19.7 2.1(24)
20.2 1.9(24)
20.2 2.4(24)
20.3 2.4(24)
20.0 2.6(24)
20.4 2.7(24)
19.5 2.3(24)
21.1 3.1(24)
21.6 2.7(24)
V III-0 25
19.1 1.8 (24)
20.1 1.5(24)
20.4* 1.8(24)
19.6 1.7(24)
20.2 1.7(24)
20.7 1.5(24)
20.5 1.6(24)
19.8 1.8(24)
20.3 1.7(24)
20.9 2.1(24)
Sanitized. Does no! nonfa*n fftCA
1
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
TABLE 15 (Continued) MEAN DAILY FOOD CONSUMPTION (grams/day) OF Pj FEMALE RATS DURING PREMATING
Group : Dose (m g/kg/day):
II-O 0
IV-0 1
VI-0 10
T e s t Day 1-71
19.6 1.0(24)
20.3 1.9(24)
20.2 2.0(24)
Data summarized as:
Mean Standard Deviation (n)
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05):
A Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) significant @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant ~ next to control mean indicates no analyses were performed
Note: Test Day 71 = Last day of premating period that data were recorded.
V III-0 25
20.2 1.2 (24
f&mpany Sanitized. Does not contain T$CA CBI
57
j
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
TABLE 16 MEAN DAILY FOOD EFFICIENCY (grams weight gain/grams food consumed) OF Pi FEMALE RATS DURING PREMATING
Group : Dose (m g/kg/day): T e s t Day
1-8
8-15
15-22
22-28
28-36
36-43
43-50
50-56
56-63
63-71
II-O 0
0.110 0.058(24)
0.101 0.043(24)
0.087 0.064(24)
0.107 0.076(24)
0.056 0.059(24)
0.056 0.042(24)
0.006 0.053(24)
0.075 0.080(24)
0.033 0.053(24)
0.045 0.034(24)
IV-0 1
0.102 0.055(24)
0.091 0.042(24)
0.075 0.052(24)
0.100 0.069(24)
0.068 0.053(24)
0.029 0.054(24)
0.040 0.051(24)
0.069 0.057(24)
0.037 0.052(24)
0.032 0.048(24)
VI-0 10
0.122 0.041(24)
0.104 0.047(24)
0.106 0.055(24)
0.056* 0.079(24)
0.067 0.042(24)
0.063 0.075(24)
0.047* 0.066(24)
0.027* 0.068(24)
0.038 0.058(24)
0.047 0.036(24)
VIII-0 25
0.072* 0.038(24)
0.113 0.044(24)
0.087 0.040(24)
0.065 0.057(24)
0.063 0.038(24)
0.072 0.049(24)
0.034 0.055(24)
0.050 0.070(24)
0.034 0.048(24)
0.031 0.036(24)
.Company Sanitized. Does not contain TSCA CBf
58
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
TABLE 16 (Continued)
MEAN DAILY FOOD EFFICIENCY (grams weight gain/grams food consumed) OF Pi FEMALE RATS DURING PREMATING
Group : Dose (m g/kg/day):
II-O 0
IV-0 1
VI-0 10
V III-0 25
T e s t Day 1-71
0.068 0.007(24)
0.064 0.010(24)
0.069 0.012(24)
Data summarized as:
Mean Standard Deviation (n)
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05):
~ Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant - next to control mean indicates no analyses were performed
significant
Note: Test Day 71 = Last day of premating period that data were recorded.
0.063 0.009(24)
p o m p a n y Sanitized. D oes not contain t$ca CBI
59
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
1
si
1IijM fI)It >
TABLE 17 MEAN DAILY FOOD CONSUMPTION (grams) OF Pi FEMALE RATS DURING GESTATION
Group: Dose (m g/kg/day):
I I -0 0
IV-0 1
VI-0 10
G e s t a t i o n Day 0-7
25.0 4.8(21)
25.4 2. 5 (21)
25.3 2.0(17)
7-14
26.6 2 .0 (21)
26.3 2.3(21)
25.2 2.2(17)
14-21
24.5 3.5(20)
27.1 4.3(21)
26.0 2.2(18)
0-21
25.3 1 .6 (20)
26.3 2 .6 (21)
25.4 1.6(17)
Data summarized as:
Mean Standard Deviation (n)
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05):
^ Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) S Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant ~ next to control mean indicates no analyses were performed
significant
Note: This table contains data from animals with evidence of copulation that delivered a litter.
VIII-0 25
24.8 1.5(20)
25.3 1 .6 (20)
26.0 1.5 (20)
25.4 1 .2 (20)
f 35
I ii 3951 0"i 60
') ............................................................
""
"
H-24768: One-Generation Reproduction Study in Rats_______________________
DuPont-13784
TABLE 18 MEAN FOOD EFFICIENCY (grams weight gain/grams food consumed) OF Pi FEMALE RATS DURING GESTATION
Group : Dosage (mg/kg/day):
II-O 0
IV-0 1
VI-0 10
G e s t a t i o n Day 0-7
0.232 0.150(21)
0.196 0.037(21)
0.204 0.027(17)
7-14
0.155 0.036(21)
0.176 0.026(21)
0.166 0.025(17)
14-21
0.452 0.132(20)
0.413 0.098(21)
0.448 0.078(18)
0-21
0.265 0.041(20)
0.263 0.032(21)
0.273 0.033(17)
Data summarized as :
Mean Standard Deviation (n)
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05):
A Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant - next to control mean indicates no analyses were performed
significant
Note: This table contains data from animals with evidence of copulation that delivered a litter.
V III-0 25
0.183 0.034(20)
0.154 0.025(20)
0.464 0.056(20)
0.269 0.022(20)
Com pany Sanitized. D oes not contain TSCA CBI
61
H-24768: One-Generation Reproduction Study in Rats_________________________________________________________________________ DuPont-13784
TABLE 19
MEAN ESTROUS CYCLE PARAMETERS AND PRECOITAL INTERVAL IN P, FEMALE RATS
GROUP
DOSE (MG/KG/DAY)
PERCENT PERCENT PERCENT
OF DAYS OF DAYS OF DAYS
IN IN
IN
N ESTRUS DIESTRUS PROESTRUS
MEAN CYCLE LENGTH (DAYS)
MEAN PRECOITAL INTERVAL
(DAYS)
II-O
0
23 32%
57%
11%
4.7 (1.7)a
2.9(2.2)
IV -0
1
24 35%
55%
10%
4.5 (0.8)b
2.4(1.7)
VI-0
10
22 27%
59%
14%
4.4(0.5)
2.4(1.1)
V III-0
25
22 31%
59%
9%
4.1(0.4)
2.3(1.1)
a Standard deviation is presented in parentheses. b N = 23 c N = 20
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05) :
A Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant - next to control mean indicates no analyses were performed
significant
not contain TSCACBi
62
H-24768: One-Generation Reproduction Study in Rats
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TABLE 20
SUMMARY OF REPRODUCTIVE INDICES: P, GENERATION
MATERNAL GROUP: DOSE (MG/KG/DAY):
II-O 0
IV-0 1
VI-0 VIII-0 10 25
MATING INDEX {%)* (No. c o p u la te d /c o h o u s e d )
1 0 0 .0 (24/2 4)
100.0 91.7 91.7 (24/2 4) (2 2 /2 4 ) (2 2 /2 4 )
FERTILITY INDEX (%)b (No. p re g n a n t/c o p u la te d )
9 1 .7 (22/2 4)
8 7 .5 (21/2 4)
90.9 100.0 (20/2 2) (22/2 2)
GESTATION LENGTH (days)0 (No. in g rou p)
2 2 .5 2 2 .4 2 2 .4 22.3 (21) (21) (18) (20)
NUMBER OF IMPLANTATION SITES p e r p re g n a n t fe m a le
S ta n d a rd D e v ia tio n (No. in g ro u p )
1 5 .6 2 .2 (2 2 )
14.6 15.2 1 6.0 3 .4 (2 1 ) 3 .8 (2 0 ) 1 .4 (2 2 )
IMPLANTATION EFFICIENCY (%)d S ta n d a rd D e v ia tio n (No. in g ro u p )
9 1 .8 6 .0 (2 2 )
91.5 91.8 94.3 9 .4 (2 1 ) 6 .5 (1 9 ) 6 .7 (2 2 )
NUMBER OF CORPORA LUTEA S ta n d a rd D e v ia tio n (No. in g ro u p )
1 6 .0 2 .0 (2 2 )
15.5 15.5 16.8 2 .8 (2 1 ) 3 .3 (2 0 ) 1 .9 (2 2 )
a E vidence o f c o p u la tio n = In tra v a g in a l c o p u la tio n p lu g , sperm in v a g in a l la v a g e , im p la n ta tio n s observed a t necropsy, or d e liv e ry o f a lit t e r .
b Pregnant = D e liv e ry o f a lit t e r o r im p la n ta tio n s ite s a t necropsy, c G e s ta tio n le n g th c o u ld n o t be c a lc u la te d fo r those fem ales th a t were preg nant fo r
w hich no evidence o f c o p u la tio n was observed, d Number o f pups born/num ber o f im p la n ta tio n s ite s X 100.
Statistical Analysis: S t a t i s t i c a l s ig n if ic a n c e i s in d ic a t e d b y th e f o llo w in g A C ochran-A rm itage te s t fo r tre n d * P a ra m e tric com parison to c o n tro l (D unnett/T am hane-D unnett) s ig n ific a n t @ N o n p a ra m e tric com parison to c o n tro l (D unn 's) s ig n ific a n t # Trend te s t (Jo n ckh e e re -T e rp stra ) s ig n ific a n t ~ n e x t to c o n tro l mean in d ic a te s no a n a lyse s w ere p erfo rm ed
(p < 0 .0 5 ):
iC&Sp--W-py SanFfzecf. Does no! contain TSCA CBf
63
H-24768: One-Generation Reproduction Study in Rats
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TABLE 21
MEAN PUP NUMBERS AND SURVIVAL: Fi GENERATION
MATERNAL GROUP DOSE (MG/KG/DAY)
N
II-O 0 22
IV -0 1 21
V I-0 10 19
V III-0 25 22
Born Born A live Day 4
MEAN NUMBER OF PUPS/LITTER
14.4 14.3 14.3
13.5 13.4 13.1
14.7 14.7 14.6
15.1 15.0 14.9
Born Born A live Day 4
MEAN NUMBER OF MALE PUPS/LITTER
7.6 7.4 7.6 7.3 7.6 7.1
7.2 7.2 7.2
7.2 7.2 7.1
Born Born A liv e Day 4
MEAN NUMBER OF FEMALE PUPS/LITTER
6.8 6.1 6.7 6.1 6.7 6.0
7.5 7.5 7 .4
8.0 7.9 7.7
SURVIVAL (*)
Sex R atio (males)
G estation Index3 Mean % B orn A liv e 0-4 Day V i a b i l i t y
0.53
100.0 99.4 99.7
0.55
100.0 99.4 98.0
0.50
100.0 100.0
99.2
0.48
100.0 99.4 98.6
a Percent litters delivered having at least one live pup.
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05) :
~ Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) significant @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant ~ next to control mean indicates no analyses were performed
Statistics were performed on combined pups per litter only. Male and female data are presented for information only.
64
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H-24768: One-Generation Reproduction Study in Rats
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TABLE 22
SUMMARY OF PUP CLINICAL OBSERVATIONS: FxGENERATION
MATERNAL GROUP: DOSE (MG/KG/DAY):
II-O 0
IV -0 1
V I-0 10
V III-i 25
NUMBER OF RATS WITH GIVEN SIGN
OBSERVATIONS
SUBCUTANEOUS HEMORRHAGE
0 0 0 1(
TOTAL NUMBER OF SIGNS
0001
NUMBER OF LITTERS AFFECTED
0
0
0
1
TOTAL NUMBER OF LITTERS
22 21 19 22
Numbers outside the parentheses are the number of pups affected, the numbers in parentheses are the number of litters affected.
Statistical Analysis: Statistical significance is indicated by the following I (p < 0.05) :
~ Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant ~ next to control mean indicates no analyses were performed
significant
65 Company Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
TABLE 23
MEAN PUP WEIGHTS: Fi GENERATION
MATERNAL GROUP: DOSE (MG/KG/DAY):
N:
II-O 0 22
Day 0 Day 4
6.7 (0.8) 11.0 (1.6)
IV -0 1 21
V I-0 10 19
V III-0 25 22
MEAN PUP WEIGHTS ( g r a m s )
6.7 (0.7)
6.6 (0.6) 6.5 (0.5)
11.2 (1.7) 10.9 (1.4) 10.4 (1-2)
Day 0 Day 4
MEAN MALE PUP WEIGHTS ( g r a m s )
6.9 (0.8)
6.9 (0.7)
6.8 (0.6) 6.7 (0.5
11.2 (1.6) 11.5 (1.7) 11.1 (1.5) 10.7 (1.2
MEAN FEMALE PUP WEIGHTS ( g r a m s )
Day 0
6.5 (0.7)
6.5 (0.7)
6.5 (0.6) 6.3 (0.5
Day 4
10.7 (1.6) 10.9 (1.6) 10.6 (1.2) 10.1 (1.2)
Data summarized as: Mean (Standard Deviation)
Statistical Analysis: Statistical significance is indicated by the following (p < 0.05):
Cochran-Armitage test for trend * Parametric comparison to control (Dunnett/Tamhane-Dunnett) @ Nonparametric comparison to control (Dunn's) significant # Trend test (Jonckheere-Terpstra) significant ~ next to control mean indicates no analyses were performed
significant
Note: Statistical analyses were conducted on the combined pup weights. Male and female data are presented for information only.
66 Company Sanitized. Does no! contain TSCA r m
: r ~ ........
~ " j ~
.........
'
H-24768: One-Generation Reproduction Study in Rats_____________________________________________________________
__
)
DuPont-13784
TABLE 24
MEAN FINAL BODY AND ORGAN WEIGHTS FROM MALE RATS - Pi ADULTS
MEAN FINAL BODY AND ABSOLUTE ORGAN WEIGHTS(g r a m s )
Group: D osage(m g/kg/day)
1-0 0
III-O 1
V-0 10
F in a l Body W eight
539.2 44.0(24)
558.2 47.6(24)
553.1 50.7(24)
L iv e r
19.302 1.901(24)
20.809 3.226 (24)
20.102 2.429(24)
L iv e r /F in a l Body * 100
3.581 0.229(24)
3.725 0.501(24)
N ote: * P a ra m e tric co m p ariso n to c o n t r o l (D u n n ett/T am h an e-D u n n ett) @ N onparam etric com parison to c o n tro l (D unn's) s ig n if ic a n t
3.633 0.245(24)
s ig n ific a n t
V II-0 25
539.6 47.0(24)
21.303* 2.714(24)
3.938 0.231(24)
Sanitized. Does no! eca*`o TSCA CL-
67
H-24768: One-Generation Reproduction Study in Rats_________________________________________________________________________ DuPont-13784
TABLE 25
MEAN FINAL BODY AND ORGAN WEIGHTS FROM FEMALE RATS - Pj ADULTS
MEAN FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (g r a m s )
Group : D osage(m g/kg/day)
II-O 0
IV -0 1
V I-0 10
F in a l Body W eight
344.1 14.8(24)
344.0 22.2(24)
351.3 26.9(24)
L iv e r
13.861 1.144(24)
13.768 1.535(24)
14.411 1.706(24)
L i v e r / F i n a l Body * 100
4.030 0.303(24)
3.999 0.319(24)
4.103 0.397(24)
Note : * Param etric com parison to c o n tro l (Dunnett/Tam hane-Dunnett) s ig n if ic a n t
V III-0 25
341.4 20.3(24)
15.646* 1.546(23)
4.596* 0.452 (23)
C om pany Sanitized. Does not contain TSCA CBI
68
H-24768: One-Generation Reproduction Study in Rats
SITE/LESION:
LIVER DISCOLORATION
URINARY BLADDER CALCULUS
KIDNEYS DILATATION DEFORMITY
TESTES SMALL
TABLE 26 INCIDENCES OF GROSS OBSERVATIONS IN MALE RATS - Pi ADULTS
GROUP DESIGNATION: DOSE (mg/kg): NUMBER IN GROUP:
1-0 0 24
III-O 1 24
V-0 10 24
VII-0 25 24
1000
0010
0020 0 0 10
0 0 10
NOTE: INCIDENCES REFLECT THE NUMBER OF ANIMALS WITH A GIVEN LESION.
DuPont-13784
C om pany S a n itiz e d D oes not contain TSCA CBI
69
H-24768: One-Generation Reproduction Study in Rats
SITE/LESION:
UTERUS DISCOLORATION LESION, OTHER
SKIN ALOPECIA
TABLE 27 INCIDENCES OF GROSS OBSERVATIONS IN FEMALE RATS - Pi ADULTS
GROUP DESIGNATION: DOSE (mg/kg): NUMBER IN GROUP:
II-O 0 24
IV-0 1 24
VI-0 10 24
VIII-0 25 24
1000 0010
2000
NOTE: INCIDENCES REFLECT THE NUMBER OF ANIMALS WITH A GIVEN LESION.
)
DuPont-13784
Does not contain TSCA CSV
70
r .... ~ ~
.j....
)
H-24768: One-Generation Reproduction Study in Rats______________________________________________________________ ___________DuPont-13784
TABLE 28
INCIDENCES AND LESION GRADES OF MICROSCOPIC OBSERVATIONS IN MALE RATS - Pi ADULTS
LESION GRADES TISSUE/LESION (P,1,2,3,4)
GROUP DESIGNATION: DOSE (mg/kg): NUMBER IN GROUP:
1-0 0 24
III-O 1 24
V-0 10 24
VII -0 25 24
LIVER INFARCT, LOBAR INFLAMMATION, SUBACUTE/CHRONIC NECROSIS, FOCAL VACUOLATION, HEPATOCELLULAR
TESTES
EPIDIDYMIDES
PROSTATE INFLAMMATION, SUBACUTE/CHRONIC
SEMINAL VESICLES
COAGULATING GLANDS
OTHER KIDNEYS: HYDRONEPHROSIS, UNILATERAL KIDNEYS: NEPHROPATHY, CHRONIC PROGRESSIVE KIDNEYS: PYELONEPHRITIS URINARY BLADDER: INFLAMMATION/HYPERPLASIA
11 1 (1,-,-,-,-) 6 (-,6,-,-,-) 2 (-,2,-,-,-)
2
2
2 "
2
2
0 -
--
-
0 0 10 --- " 8 (-,8,-,-,-) - - 1 (-,1,-,-,-) - - 1 (-,1,-,-,-)
352
35
2
35 2 (-,-,1,1,-)' 1
2 2 (-,1,1,-,-)
3. 5
2
352
02 0
- 1 (-,1,-,-,-) -
- 2 (-,2,-,-,-)
-1-
-
1 (-,
-
NOTES : THE NUMBER OF ORGANS EXAMINED FOR EACH GROUP IS UNDERLINED. LESION GRADES: P = PRESENT; 1 = MINIMAL; 2 = MILD; 3 = MODERATE; 4 = SEVERE. LESION GRADES CORRESPOND BY POSITION WITH THE NUMBERS IN PARENTHESES, WHICH INDICATE HOW OFTEN EACH GRADE WAS OBSERVED. FOR EXAMPLE: (-,1,2,-,-) MEANS NO LESIONS WERE GRADED "PRESENT" (NON-GRADED LESIONS), 1 LESION WAS GRADED "MINIMAL", 2 LESIONS WERE GRADED "MILD", NO LESIONS WERE GRADED "MODERATE" AND NO LESIONS WERE GRADED "SEVERE".
Company Sanitized. Does nf
ra t,
71
)
H-24768: One-Generation Reproduction Study in Rats
)
DuPont-13784
TABLE 29
INCIDENCES AND LESION GRADES OF MICROSCOPIC OBSERVATIONS IN FEMALE RATS - Pi ADULTS
LESION GRADES TISSUE/LESION (P,1,2,3,4)
GROUP DESIGNATION: DOSE (rag/kg): NUMBER IN GROUP:
II-0 0 24
IV-0 1 24
VI-0 10 24
VIII-0 25 24
LIVER HEMATOPOIESIS, INCREASED EXTRAMEDULLARY INFLAMMATION, SUBACUTE/CHRONIC NECROSIS, FOCAL
OVARIES CORPORA LUTEA, DECREASED CYST, LUTEAL
UTERUS IMPLANTATION SITES
VAGINA HYPERTROPHY, MUCOSA
CERVIX
OTHER SKIN: HYPERKERATOSIS, FOLLICULAR SKIN: NO ABNORMALITIES DETECTED
10 2 (-,2,-,-,-) 2 (-,2,-,-,-) 1 (-,1 ,-,-,-)
2 1 (-,-,-,1,-) -
3 1 (1,-,-,-,-)
2 1
2
3 1 (-,1,-,-,-) 1 (1,-,-,-,-)
0
-
3 2
-
3
-
3
-
3
0
-
' 2)
0 10 - 2 (-,: - 4 (-, "-
5 1 (-,-,-,-,1)
-
2
-
1 (1,
52 --
5 1 (-,-,1,-,-)
2 -
52
00
---
NOTES : THE NUMBER OF ORGANS EXAMINED FOR EACH GROUP IS UNDERLINED. LESION GRADES: P = PRESENT; 1 = MINIMAL; 2 = MILD; 3 = MODERATE; 4 = SEVERE. LESION GRADES CORRESPOND BY POSITION WITH THE NUMBERS IN PARENTHESES, WHICH INDICATE HOW OFTEN EACH GRADE WAS OBSERVED. FOR EXAMPLE: ( - , 1 , 2 , - , - ) MEANS NO LESIONS WERE GRADED "PRESENT" (NON-GRADED LESIONS), 1 LESION WAS GRADED "MINIMAL", 2 LESIONS WERE GRADED "MILD", NO LESIONS WERE GRADED "MODERATE" AND NO LESIONS WERE GRADED "SEVERE" .
ISgmpany Sanitized. D oes not contain TSCA C1
72
H-24768: One-Generation Reproduction Study in Rats /^ m\.
DuPont-13784
APPENDICES
-73fcompany Sanitized. Does not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX A CERTIFICATE OF ANALYSIS
-74Gompany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
DuPont Specialty Chemicals Jackson Laboratory
R egional Analytical Services W ilmington, DE 19898
DuPont Specialty Chemicals
Date: January 29,2001 Haskell Laboratory for T oxicology & Industrial Medicine P .O .B ox 50 Newark, DE 19714-0050 Attention: G regory S . L adies, Ph.D.
A nalysis
Specifications
R esults
Approved by: Sharon Y . Suirency R egional A nalytical Services
-75-
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H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX B PROTOCOL AND PROTOCOL AMENDMENTS
-76bompany Sanitized. Does not contain TSCA CBt
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
DuPmt-lJ784
H-24768: Cue-Generation Reproduction Staaddy in Rats
Work Request Numb Service Co i r
Protocol
DuPont Animal Welfare Committee Number!
P age! o f 17
-77-
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H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H-24768 O ne G m eratim Reproduction Study in Rats
DuPoat-13784
TABLE OF CONTENTS
Page
INTRODUCTION.................................................................................................................................. 3
OBJECTIVE............................................................................................................................................3
SPONSOR AND TEST FACILITY..................................................................................................... 3
REGULATORY COMPLIANCE..........................................................................................................3
STUDY DESIGN.................................................................................................................................... 4
SELECTION OF DOSE LEVELS.........................................................................................................4
MATERIALS AND METHODS...........................................................................................................5 A. Vehicle........................................................................................................................................ 5 B. Test Substance............................................................................................................................5 C. Safety Precautions and Disposal c f Waste Material............................................................... 6 D. Animals....................................................................................................................................... 7 E. Animal Husbandry..................................................................................................................... 7 F. Randomizriian........................................................................................................................... 9 G. Parental (Pi) Rats..................................................................................................................... 10 H. Breeding.................................................................................................................................... 11 I Estrous Cycle Evaluation........................................................................................................ 11 J. Gestation Procedures............................................................................................................... 12 K Lactation Procedures................................................................................................................ 12 L. Anatomic Pathology................................................................................................................. 12
DATA ANALYSES..............................................................................................................................14
RECORDS AND SAMPLE STORAGE............................................................................................15
REFERENCES.....................................................................................................................
16
SIGNATURES...................................................................................................................................... 17
- 2-
-78-
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H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H-24768 One- Generation Reproduction Stncfy in Rats
DuPont-1376*1
INTRODUCTION
The test substance, H-24768, is
le purpose of the study is to determine a
NOEL (no-observed-effect level) for reproductive toxicity of the test substance.
OBJECTIVE
The objective of this study is to evaluate the effect o f the test substance on the gonadal function, conception, and parturition of male and female Crl:CD(SD)IGS BR rats over one generation.
SPONSOR AND TEST FACILITY
This study is sponsored by DuPont Chemical Solutions Enterprise (DCSE), E. L du Port de Nemours and Company, Wilmington, Delaware. H ie sponsor's approval was effective the date the sponsor authorized the work on the Work Authorization Form. The study will be conducted at DuPont Haskell Laboratoryfor Health and Environmental Sciences, E I du Pont de Nemours and Company, Newark, Delaware and at Regional Analytical Services (RAS) sLJackson Laboratories (test substance stability), Deepwater, New Jersey.
REGULATORY COMPLIANCE
This study will be conducted in compliance with U. S. EPA TSCA (40 CFR part 792) Good Laboratory Practice Standards, which are consistent with the OECD Principles of Good Labordiory Practice (as revised in 1997) published in ENV/MC/CHEM(98)17 andMAFF Japan Good Laboratory Practice Standards (59 NohSanNo. 3850).<1'J,3) Areas afncncompliance will be documented in the final report
-j -
-79jCompany Sanitized. Does not contain TSCA CBi
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H-24768 O ne Generation Reprocbction Stncfy in Rats
DuPont-17 84
STUDY DESIGN
Study P aram eter
Study D ates
Initiation of test substance administration October 30,2003
In-life Completion Date
February 19, 2004 (Approximate)
T reatm ent G roups an d D aily D osage Group Number Pi Male P i Female No./Group Daily Dosage (mg/kg/day)"
1-0 H-0 24
0 (Control)
m -o IV-0 24 V-0 VI-0 24
1 (Low) 10 (Intermediate)
v n -o
vm -o
24
25 (High)
a Weight o ftest substance per leg o f anim d body weight at a dose volume o f 5 mL/kg
Animals
Adult Males Pregnant Females Nonpregnant Females Fi Pups
Sacrifice Schedule Schedule
After siring litters (sL discretion of study director) On day 4 of lactation With pregnant females On day 4 of lactation________________________
SELECTION OF DOSE LEVELS
The dose levelsforthis study were selectedbasedcnthe results from a 90-day gavage study in rats with one-generation reproduction evaluations.*^ in which rats used for the reproduction evaluation were dosed by oral gavage with 2 5 ,1 0 0 , or 500 mg/kg/day during a 10-week premating period, cohabitiion (up to 2 weeks), gestriion, and lactation. Under the conditions of this study, there was no NOEL for reproductive evaluations. This w as based on reductions in the fertility index in P i rats in all dose groups. Estrous cycle length w as prolonged in Pi rats in all dose groups, but the toxicological significance of this change is unclear. Other adverse, compound-related effects observed in Pi rats dosed with 500 mg/kg/day included decrements in body weight parameters and food efficiency and reduced number o f implantriion sites. Adverse, compound-related effects in 100 and/or 500 mg/kg/day groups included reductions in mean litter size, number of pops bom and bom alive, p ip survival during lactation, and pup weight at hiith and during lactriian. Dose levels of 1,10, and 25 mg/kg/day were selected for the current study, where 25 mg/kg/day is expected to produce effects on fertility and 1 mg/kg/day is expected to represent the NOEL for reproductive toxicity.
- 4-
-80Dompany Sanitized, Does net
t CA CB'
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H-24768 One- GeaerglicMi Rqprodncttoa Study in Rats
MATERIALS AND METHODS
DuPont-13784
A. Vehicle The vehicle will be deionized water.
B. Test Substance
1. Identification
The test substance, a tan paste, comprised of polymers of known purity and composition, was supplied by the sponsor. The test substance will be identified in this protocol and in the study records bythe Haskell Number, H-24768 o rbythe Haskell Sample Number (24768, batch number 60). This is the same batch that was used in a previous 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations/4*
3. Test Substance Stability
The stability of the test substance over the course o f the study will be determined by the sponsor. Neat samples for analysis of stability will be taken at the beginning and end of the treatment period and will be sent to Jackson Labordory, Deepwater, New Jersey.
4. Test Substance Administration, Preparation, and Sampling
a Administration
The test substance will be administered orally as it is a potential route for human exposure. The test substance will be administered by gavage once daily. All animals will be dosed daily by gavage for approximately 70 days prior to cohabitation and during the cohabitation period (up to 2 weeks). Pi male andfemale r d s showing no evidence of cqpuldicn will continue to be dosed after the end o f the cchatritriicn period until sacrifice. Females showing evidence of copulation will be dosed throughout gestation Pregnant females in the process o f delivery or showing signs of delivery will not be dosed From gestation day 18 until delivery, dose volumes will be based on the gestdion day 18 body weights. The volume of test substance or vehicle given to each rat will be based on the most recently recorded body weight The dose volume will be 5 mL/kg. Male andfemale control id s will be similarly treated with deionized water at the same dose volume as used in the other groups.
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H-24768 One-Generalia a Reproduction Study in. Rats_______________________________________ DTiPoat-13784
b. Preparation
FormulEtions of the test substance in the vehicle (deionized water) will be prepared daily and stored zt room tem periure until used Once refiigeried storage stability has been established, formulations will be prepared twice a week and stored refrig eried The method c f mixing the test substance with the vehicle will be documented in the study records.
c. Sampling
Samples of each test solution (approximately 3 mL) will be taken 3 times during the study. If necessary, additional samples may be taken ft the discretion of the study director or designee. Analyses will address concentration, uniformity of mixing, and stability. Samples will be submitte d shortly after preparation to the Analytical Chemistry Group at Haskell.
F ir s t sa m p lin g - from dose preparation near the beginning of the study. Addresses uniformity of mixing, concentration, and 5-hour room temperature stability and 7-day refrigerated stability. Six independent samples from each test solution will be collected: Concentriionverification: V ehicle-1 sam ple/TestForm ulation-2 samples Analyzed immediately when samples are taken Room Temperature 5 hours: Test F o rm u latio n -1 sample Held at room temperature for five hours and then analyzed Refrigerated 7 Days: Test Formulftion - 3 samples Concentration verified.on analysis: 2 o f the 3 samples - After 7 days refrigeration 1 remaining sample - After 5 hours room temperfture
S eco n d a n d T h ir d S a m p lin g s - from dose preparation near the middle and end of the study. Addresses concentration verification.
Samples of the vehicle and 2 samples from each concentration of the formulftions will be analyzed imme diftely following submission.
If samples cannot be analyzed at the specified times, they will be frozen until analyses can be conducted On days samples are taken, the formuleticns remaining after dosing will be stored at room temperature for additional analysis. The analytical method used will be documented in the Analytical Chemistry Group study records.
C. Safety Precautions and Disposal of Waste Material
Good housekeeping procedures will be practiced to avoid potential health hazards and contamination of dosing solution preparation facilities. To avoid skin contact, gloves will be worn when handling either the test substance or dosing formulations. In addition, the test substance will be handled in a chemical hood Dosing formulations will be prepared in properly ventild:ed areas. Animal carcasses, feces, and unused dosing formulations will be incinerated
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H-24768 One-Generation Reprodoction Stm t/ in Rats_______________________________________ DuPont-13784
D. Animals 1. Species (Strain)
Crl:CD(SD)IGS BR rats
2. Reason for Selection The rat -was selected for this study as it is a preferred species for reproductive toxicity testing as recommended by the guidelines. The Crl:CD(SD)BR strain was chosen because extensive background information is available from the literature, the supplier, a id previous studies with other compounds st DuPont Haskell Laboratory. This strain is also considered suitable relative to longevity, hardiness, and incidence of spontaneous disease.
3. Source Charles River Laboratories, Inc., Raleigh, N.C.
4. Description Approximately 108 male and 108 female rats (no male-female siblings), requested to be approximately 56 days of age,and weighing 151-175 grams and 126-150 grams, respectively.
5. Identified!on a Pretest
Temporary cage identification b. After Assignment to Tredment Groups
Each rat will be assigned a unique number and an identification number will be tattooed on the tail.
E. Animal Husbandry 1. Environmental Conditions
Animal rooms will be maintained at an acceptable tem periure of 22 + 3C and relative humidity of 50% 20%. Animal rooms w ill be artificially illuminated (fluorescent light) on a 12-hour light/dark cycle (approximately 0600-1800 hours).
2. Caging All male rats will be housed individually during non-mating periods in stainless steel, wire-medi cages.
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H-24768 Qae-Generation- Reproduction Stuty in Rats________________________________________DuPont-13784
a Pretest and Bremating Periods
All lets will be housed individually in stainless steel, wire-mesh cages,
b. Cohabitation Period
All rats will be housed as breeding pairs in stainless steel, wire-mesh cages. At the end of the cohahitriion period, females without evidence o f copulation will be housed individually in polycarbonate pans.
c. Gestation Period
Days 0-20:
Females will be housed individually in stainless Steel, wire-mesh cages.
Day 20-Delivery: Females will be housed individually in polycarbonate pans.
d Lactation Period
Adult females will be housed with their litters in polycarbonate pana
The stainless steel, wire-mesh cages will be suspended above csgeboard Polycarbonate pans will contain bedding.
3. Food
All rrisw ill be provided tap water and pelleted PMI Nutrition International, Inc. Certified Rodent LabDiet 5002 a d libitum.
4. W rier
W rier from United W ater Delaware will be available a d libitum.
5. Animal Health Monitoring
As specified in the DuPont Haskell Laboratory animal health and environmental monitoring program, the following procedures are performed periodically to ensure th ri contaminant levels are below those that would be expected to impact the scientific integrity o fthe study:
W rier samples are analyzed for total bacterial counts, andthe presence of coliforms, lead, and other contaminants.
Feed samples are analyzed for total bacterial, spate and fungal counts.
Samples from freshly washed cages and cage racks are analyzed to ensure adequrie sanitation by the cagewashers.
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Certified animal feed is used, guaraileed by the manufacturer to meet specified nutritional requirements an d n o tto exceed stated maximum concentraicns o f key contaminants, including specifiedheavy metals, aflatoxin, chlorinriedhydrocarbons, and organophosphates. The presence ofthese contaminants belowthe maximum concentration stated by the manufacturer would not be expected to impact the integrity o f the study.
The animal health and environmental monitoring program is administered by the attending laboratory animal veterinarian. Data are maintained separately from study records and may be included in the final report at the discretion of the study director.
6. Quarantine
Rats will be quarantined for et least 6 days, and then released for the study upon the approval of the Laboratory Animal Veterinarian or his designee.
Rats that die or are sacrificed/ extremis during the pretest period will be necrqpsiedto check for the presence o f disease. Dependent upon these findings, further diagnostic procedures may be employed et the discretion of the study director, the pathologist assigned to the study, or the laboratory veterinarian.
F. Randomization
Rats o f each sex will be ranked by their most recently recorded body weight and randomly assigned to control and experimental groips. The randomization should result in a distribution in which the mean body weights for all groups within a sex are not statistically different (p > 0.05). Animals that lose excessive weight or that are ill prior to the start o f dosing will be removed from the study and replaced, if possible.
Rats net assigned to a test group, at the discretion o f the study director may be released for use in other studies, or will be sacrificed by carbon dioxide euthanasia and discarded without pathological
evaluation.
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G. Parental (Pi) Rats
1. Clinical Observations
Cage-site examinations will be conducted at least once daily throughout the study. Moribund rats will be sacrificed At least once weekly throughout the premeting feeding, gestation, and laetriion periods, each o f the Pi parental rats will be individually handled and carefully examined for abnormal behavior and/or appearance.
2. Body Weight Measurements
a Premriing Period
All Pi rats will be weighed once a week.
b. Gestation and Lactdion Periods
Pi females will be weighed on days 0 ,7 ,1 4 , and 21 of gestation.
Pi females will be weighed on days 0 and 4 of lactation
Females without evidence of copulation, that copulrie and do not deliver a litter, and males will continue to be weighed on a weekly schedule.
3. Food Consumption and FoodESidency
a. Premriing and Cohabitation Periods
Individual food consumption will be determined weekly throughout the period, ending approximately at test day 70. Food consumption will not be determined during cohabitation.
From these determinations and body weight data, individual daily food consumption and food efficiency will be calculated
b. Gestation and Lactation Periods
Individual food consumption of pregnant Pi females will be recorded on gestation days 0 ,7 ,1 4 , and 21. Food consumption will not be measured for females without evidence of copulation and for males. Food consumption will not be measured during lactriion.
From these determinations and body weight data, individual daily food consumption and food efficiency will be calculated
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H. Breeding
1. Start of Cohabitation
Animals will be cchoused after approximately 10 weeks c exposure to the test substance, (designated day 1 o f cohabitation).
2. Duration of Cohabitation Period
Animals will be cchoused until evidence of copulation is observed or 2 weeks have elapsed The cchabitriion period will end in the morning o f day 15 of cohabitation.
3. Evidence of Copula!on
Once daily, each female will be examined for the presence of an intravaginal copulsticn plug or sperm in vaginal lavage sample. The day evidence of copulation is observed is designated as day 0 of gestation
4. Cohousing
Each female will be continually housed on a 1:1 basis with a randomly selected, nonsibling male of the same dosage level, in the male's cage. On the day cqpulation is confirmed, the female will be transferred back to individual cage housing.
Based on the outcome of the first mating and at the discretion of the study director, the females may be cchoused again in the manner outlined above, except with different males, to produce a second set of litters
1 Estrous Cycle Evaluation
Vaginal lavage samples will be collected daily from all Pi female tsts in order to determine the stages o f the estrous cycle. Vaginal lavage samples will be collected beginning 3 weeks prior to mriing, and continuing until copulation is confirmed, or the cohabitation period has ended Vaginal lavage samples will be examined microscopically for determinEticn of the stage of the estrous cycle (diestrus, estrus, proestrus).
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J. Gestation Procedures
After being transferred into polycarbonste pans (on day 20 o f gestation for m dedfem ales, or at the end of the cchatataronperiodfor females without evidence of copulation), female rats will be observed at least twice daily for signs of delivery and offspring.
K. Lactation Procedures
The day when delivery is complete is designated day 0 postpartum. At each exam inaicn period, offerin g will be individually handled and examine d for abnormal behavior and appearance ; any dead or abnormal p ip s will be recorded
1. Day 0 Postpartum
liv e and dead p ip s in each litter will be counted by sex as soon as possible after delivery is completed Live p ip s in each litter will be individually weighed
2. Day 4 Postpartum
liv e pups in each litter will be counted by sex and individually weighed All p ip s will be euthanized (by decapitation) and discarded without pathological examination.
L. Anatomic Pathology
1. Pi Adults
a Method of Euthanasia
Carbon dioxide euthanasia
b. Postmodern Examinations
All Pi parental generation rats will be subjected to gross pathological examination, including those that die (found dead, accidentally killed) or are sacrificed in extremis prior to the end of dosing a id those for which mating did not result in production of offspring. The uteri of all cohabited females will be examinedfor the presence and number of implantation sites and corpora lutea counts will be recorded All gross lesions will be preserved in appropriate fixative for possible future histopathological examination.
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The following tissues and all gross lesions will be collected from all Pi adults sacrificed by design and preserved in appropriate fixative for possible future histcpathological examiniion.
O rg an W eights from P i A dults Both Sexes Liver
Tissues C ollected from P i A d d is Sacrificed by D esign
M ale
F em ale
B eth Sexes
Testes"
Epididymides" Prostate
Seminal Vesicles Coagulating Glands
Ovaries (with oviducts)
Uterus Vagina Cervix
Gross Observations1' Liver
a The right testis and epiderm is wall be placedia Bonin's sdutioa. T he left testis and epldii^ams v ill be firozen for posaU e sperm connt evaluations, AIL other tissues (rqjroductive andnon-iqiroduclive) collected from male and female rats will be placedin formalin.
b Grossleao n s observed at necropsy for which histppathdogy is not appropriate or wouldnot be additive will generally not be collected
Histopathological examination of the liver will be ccnductedforthe first 10 parental rats (the first 10 consecutive animal numbers in each group) surviving to scheduled sacrifice in the Pi male and female high-dose and control groups. If there are treatment-related changes in the liver in the high-dose group, the livers will be examined for the first 10 parental rats (the first 10 consecutive animal numbers in each group) surviving to scheduled sacrifice in the Pi male and female mid- and low-dose groups in order to further delineate or establish a "no-observed-
adverse-effect level."
Reproductive organs o f rrirs with impaired reproductive performance (e.g., failure to mate, conceive, sire, or deliver healthy offspring-, or effects in estrous cyclicity or sperm counts) will be evaludred Most gross lesions and target organs from low and intermediste levels will also be evaluated microscopically. Selected gross observriicns for which a microscopic diagnosis would not be additive (e.g., osteoarthritis, pododermatitis, tail chronic dermatitis, calculus, and deformities o f the teeth, toe, tail, or ear pinnae) will be saved, but will generally not be processed for microscopic evaturiiort.
Gross lesions firom rats that are found dead or accidentally killed (tissue integrity permitting), or are sacrificed in extremis may be further processed to slides for possible histopathological evaluation at the discretion of the stuffy director or reproductive toxicologist
Tissues firom rats removed from study (for other than out-of-range body weight on test day 0), will not be processed for microscopic evaluation unless considerednecessary by the study director or pathologist
2. Offspring
Offspring that are found dead during the lactation period will undergo an external examination.
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H-24768 One-Generation R eproductionStadia Rats
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DATA ANALYSES
The following table lists the indices o f reproductive function that will be calculated for the Pi adults.
R eproductive F o n ctio n C alcritattons
Mating Index (%) Fertility Index (%)
Gestaticn Index (%) Implantation Efficiency (% )' Pups B a n Alive (%)` Viability Index (%)M
Number Copulated' Number Cohabited
= N um ba Pregnant1 N umbs: Copulated' Number of L ilias with
= at Least Cfae Live P ud Number of L iltas
= Number o f Puds B a n Number of Implantation Sites
= N u m b a of P uds B om Alive N um ba of P ip s Bern
= N u m b a o f Puds A live Dav 4 Preculline N u m b a ofpops bam alive
x 100 x 100
x 100 x 100 x 100 x 100
a EMdence of ccpulatim = intravaginal copnlatQiy ping, spetm invagm allavage, found deadpregaant, or delivery o f aKtter.
b Inducing tliose found dead pregnant during gestation. c To be determined for each litter. Mean and standard deviation for each dose level will be calculated d Excluding litters sacrificed doe to death of dam dufing lactation.
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H-24768 O ne Generation. Reproduction Study in Rats_______________________________________ DnPcnt-H784
Statistical M ethods
Parameter
Preliminary Test
I f prefimmaiy test is not significant
Ifprrii urinary test is significant
Body Weight Body Weight Gain Food Consumption FoodEffidency Gestation Length Organ W dght Implantation. Site Numbers Implantation Efficiency Mean Number ofPups Per litter Percent Bran Alive 0-4 Day Viability Precdtal Interval Estrons Cyde Parameters Sperm Counts
Levene's test for
homogeneity*5 and Shapiro-Wilt test*6*for
a normality
One-way analysis of variance*5 andDurmetfs
t e t 1"
Kruskall-WaUistest*15 and Dunn's test*15
Incidence of Clinical Observations
Mating Index Fertility Index Sex Ratio Mean Pop Weights
(Covariates litter size, sex ratio) (Cavan ate: Dupwdftht)
None None
Codiran-Armitage test for trenti5
Analysis o f covariance*5
Durmett-Hsn*15
a I f th e Shapiro-Wili test is not sigiificant but Levends test is significant, a robustveisioa of Dunnett's test will be u sed If the Shapiro-Wilk test is significant, Kruskal-Waffis test is followed with Durm's te s t
For litter parameters, the proportion of affected fetuses per litter or the litter mean will be used as the experimental unit for statistical evaludion<14) The level of significance selected is p < 0.05. Additional statistical tests will be used, and other parameters analyzed, if deemed necessary.
RECORDS AND SAMPLE STORAGE
Labordiory-specific or site-specific raw data, such as personnel files and equipment records will be retained by the facility where the work was done. All original records or true copies of original records (sponsor-supplied characterization o f the test substance), will be retained at DuPont Haskell Laboratory, E l du Pont de Nemours and Company, Newark, Delaware or at Iron Mountain Records Management, 200 Todds Lane, Wilmington, Delaware."
A sample of the test substance will be collected for archive purposes and retained at DuPont Haskell Laboratory. Specimens (if ^splicable), raw data, and the final report will be retaine d st DuPont Haskell Laboratory, Newark, Delaware, or at Iron Mountain Records Management, Wilmington, Delaware.
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REFERENCES
1. EPA/F1FRA. Good Laboratory Practice Standards (40 CFR 160). (1989).
2. OECD Principles of Good Laboratory Practice (as revised in 1997, published in ENV/M C/CHEM(9 8)17.
3. MAFF Japan Good Laboratory Practice Standards (59 NohSan No. 3850).
4. DuPont Haskell Laboratory. (2002). 90-Day Gavage Study in Rets with One-Generation Reproductior^Evaluations. Unpublished Report DuPont Haskell Laboratory^
SdyCod^fcpji M M H ttlD uluPP'ant Haskell Laboratory Medical Research Project Numberf
Levene, H. (1960). Robust testfor equality o f variances. Contributions to Probability and Statistics (J. Olkin, ed), pp 278-292. Stanford University Press, Palo Alto. 6. Shapiro,S.S. and Wilk., M B. (1965) An analysis of variance testfor normality (complete samples). Biom etrika 52, 591-611. 7. Snedecor, G W . and Cochran, W.G. (1967). Statistical M ethods, 64 edition, pp 246-248 and 349-352. The Iowa State University Press, Iowa Durmett, C.W. (1964) Newtables for multiple comparisons with a control. Biometrics 20, 482-491. 9. Dunnett, C.W. (1980). Pairwise multiple comparisons in the unequal variance case. J. Amer. Statist Assoc. 75, 796-800. 10. Tamhane, A.C. (1979). A comparison ofproceduresformultiple comparison of meanswith unequal variances. J. Amer. S tiis t Assoc. 74,471-480.
11. Kruskal, W.H. andWallis, W.A. (1952). Use ofranks in one-criterion analysis of variance. J. Amer. Statist Assoc. 47,583-621.
12. Dunn, 0 .1 (1964). Multiple contrasts using rank sums. Technometrics 6,241-252.
13. Hsu, J.C. (1992). The Factor Analytic Approach to Simultaneous Inference in the General Linear Model. Journal of Computational and Graphical Statistics 1,151-168.
14. Haseman, J.K. and Hogan, M.D. (1975). Selection of the experimental unit in teratology
studies. Teratology, 12, 165-171.
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SIGNATURES
Approved by: ^
V _,E^cMylchrsest Study Director
ll-Oet- zooj
Date
C L t y iX
(} 'JJoseph SML.Lcewis
Study Author
- Stop i
Date
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H-24768: One-Generation Reproduction Study In Rats Work Request Number Service Code Number PROTOCOL AMENDMENT 1
DuPont-137 84
The Protocol is amended as follows:
1. Page 5, Materials and Methods, B. Test Substance, 4. Test Substance Administration, Preparation, and Sampling, a Administration, replace paragraph with the following:
The test substance will be administered orally as it is a potential route for human exposure. The test substance will be administered by gavage once daily.
D osing Schedule All animals will be dosed daily by gavage for approximately 70 days prior to cohabitation
and during the cohabitation period (up to 2 weeks). Pi male rats and P i female rats showing no evidence of copulation will continue to be dosed
after the end ofthe cohabitation period until sacrifice. Females rowing evidence c f copulation will be dosed throughout gestriion. Pregnant females in the process of delivery or showing signs o f delivery will not be dosed Females will be dosed after delivering litters, through lactation, up to sacrifice. Females that do not deliver a litter will continue to be dosed until sacrifice.
Rationale: This section was reworded to clearly describe the dosing schedule for all animals, adding thri. pregnant females will be dosed after delivering litters up to sacrifice.
2. Page 7, Materials and Methods, EL Animal Husbandry, 1. Environmental Conditions, first sentence, change to: "Animal rooms will be maintained at an acceptable temperature of 18-26C (targeted st 22-24C) and maintained at an acceptable relriive humidity of 30%-70% (targeted at 40%-60%>"
Rationale: To include an updated statementfor animal room temperature andhumidity that is consistent with Haskell Laboratory SOPs, the Anim al W elfare A ct (AWA), and the ILAR's (Institute for Labordxuy Animal Research) Guidefo r the Care and Use o fLaboratory Animals.
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3. Protocol, Page 10, Materials and Methods, G. Parental (Pi) Rats, 1. Clinical Observations, replace the current section with the following: "Clinical observations will be performed at least once weekly throughout the premating, gestation, and lactation periods, each of the Pi adult rats will be individually handled and carefully examinedfor abnormal behavior and/or appearance. Mortality, mcribundity, pertinent behavioral changes, signs of difficult orprolongedparturition, and all signs of overt toxicity will be recorded Cage-side examinations will be conducted at least once daily throughout the study. Mortality, moribundity, pertinent behavioral changes, signs o f difficult or prolonged parturition, and all signs of overt toxicity at the cage-side examinaticm will be recorded by exception (previous clinical signs will be verified and, if present, the signs will be recorded with the new sign) "
Rationale: To clarify the Clinical Observation procedures.
4. Protocol, Page 10, Materials and Methods, G. Parental (Pi) Rats, 3. Food Consumption and Food Efficiency, b. Gestrtion and Lactation Periods, first paragraph, first sentence, add rt the end of the sentence: ". . . and lactation days 0 and 4."
Rationale: Food consumption data will be collected during lactation
Approved by:
Study Author
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H-24768: One-Generation Reproduction Study Bi Rats Work Request NumberI B B , Service Code NumbeifiBfc'J PROTOCOL AMENDMENT 2
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The Protocol is amended as follows:
1. a. Page 3, Regulatory Compliance, first sentence, rq>lace: "which are consistentwith the OECD Principles cf Good Laboratory Practice (as revised in 1997)publidied in ENV/MC/CHEM(98)17 andMAFF Japan Good Laboratory Practice Standards (59 NcfaSan No. 3850)."with (changes are inbold):
"which are com patible with the OECD Principles of GoodLaboratory Practice (asrevisedin 1997)pubMiedin ENV/MC/CHEM(98)17, O EC D , P a ris, 1998, andMAFF Japan Good Laboratory Practice Standards (11 N ohSan N um ber 628J).<2'3,`"
1. b. Page 16, References, Reference Numbers 2 and 3, changeto (changes are in bold):
2. OECD Principles of Good Laboratory Practice (as revised in 1997,published in ENV/MC/CHEM(98)17, O EC D , P a ris, 1998. 3. MAFF Japan Good Laboratory Practice Standards (11 N ohSan N o. 6823).
Rationale: To update Good Laboratory Practice Standards for OECD andMAFF Japax
2. Page 13, Materials and Methods, L. Anatomic Pathology, 1. Pj Adults:, b. Postmortem Examinriions, 4thparagraph, change to:
"Gross lesions observed at necropsy may be further processedto slides for possible histcpathological evaluation at the discretion cf the pathologist, study director, or reproductive toxicologist."
Rationale: To update the process for evaluating gross lesions.
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Work Request NumberI
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PROTOCOL AMENDMENT 2 (Continued)
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3. a Page 15, Data Analyses, Statistical Methods, the following changes are made:
- First section - Parameters beginningwith "Body Weight," afta theparameta c "Implantation Efficiency," add "Corpora Ltea Counta"
- Second section - Pramelas beginningwith `Incidence of Clinical Observations," for statistical method of Cothran-Annitage test far trend, add footnote "b" and addfootnote "b" text to the footnotes below the table.
- Third section - Pramelas cf "Sex Ratio" and "Mean Pup Weights," change the statistical methods, which includes the addition offootnote "c" and add footnote "c" text to the footnotes below the table
Replace Statistical Methods section with the following (changes are in bold):
S ta tistic a l M ethods
Parameter
Preliminary Test
I f prdhminary test is not significant
Ifpreliminary te stis significant
Bocfy Weight
Body Weight Gam Food Consumption
FoodEffidency Gestation Length
Organ Weight Implantation Site Numbers Implantation Efirdency Corporato te a Counts Mean Number ofP ips Per litter Percent B cm Alive 0-4 Day Viability Precdtal Interval Estrous Cyde Parameters Sperm Counts
Leveae's test for homogeneity^ and Shapiro*Wlk test(7) for
nonnality*
One-way analysis of vanance andDrmnetfs
test?'1'19
Krnskall-Wallis testi12' and Dunn's test*19
Indolence o f Clinical Observations Mating Index Fertility Index
Sex Ratio (Covariate: litter size) Mean Pup Weights
(Covariate: litter size)
None
Cochran-Armitage test for trem 9*
Levene's test for homogeneity*9 and Shapiro-Wiik test for
normality
Analysis of covariance and Dunnett-HsnTM
N o n -p ar am etric analysis of
covarianceTM
a If theShajiro-WIlk test is not s ig n ific u n tm l^ e n d s testis agmJScant, a robust version c f Durmetfs test will h e m e i. If the Shapiro-Walk testis significant, Kruskal-WaJfis test isfollow el with Dunn's test,
b I f there is significant ixminonotonicify in the dose-response, tlienFislier's exact test*19 is used w ith a Bonferroni correction, c A normafiring, variance stabiliring transformation will be used as needed.
For eachparameta analyzedwifti a trend test, ftietestwill be appliedto the data sequentially. If a significant dose-req>oise is detected, data from the top dose group will be excluded and the test repeated *
untilno significant trendis detectedTM F a littaparameters, theprcpcrticn of affectedp u p sp a litta a the litta meanwill be used as the experimental unit f a statistical evaluation.TM The levd of
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H-24768: Oae-Geaeratjon Reproduction Stuffy in Rats
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H-24768: One-Generation Reproduction Study In Rats Work Request Number] Service Code Number,
PROTOCOL AMENDMENT 2 (Continued)
significance selected isp < 0.05. Additional statistical tests will be used, and oilierparameters analyzed, if deemednecessary.
2. b. Page 16,References,2refaencesareaddedtocoincidewithlhechangesinthestatistical:methc>ds section Replacethe reference sectionwith the following (additions are in bold):
REFERENCES
2. EPAMKRA GoodLabcratcry Practice Standards (40 CFR160). (1989).
3. OECD Principles cf GoodLabcratcry Practice (as revised in 1997,publishedin
ENV/MC/CHEM(98)17.
4. MAFFJapanGoodLabaratoryPracticeStandards(59NdiSanNo. 3850).
5. DuPont Haskell Laboratory. (2002). 90-Day Gavage Study in Rats with Qne-Generaticn
_
rations. Unpublished Report DuPont Haskell Laboratory ^
a
J cat Haskell Laboratory Medical Researdi Project N um beraM M H H jstudy
6. Leveae, H. (1960). Robust test for equality of variances. Contributions to PrcbcM ity and Statistics (J. ODrin, ed ),pp 278-292. Stanford University Press, Palo Alto.
7. Shapiro, S.S. and W ilt, MB. (1965). An analysis of variance test for normality (complete sauries). Biomririka 52,591-611.
8. Snedeccr, G.W. and Cochran, W.G. (1967). Statistical Methods, 601edition, pp 246-248 and 349352. The Iowa State University Press, Iowa.
9. Dunnett, C.W. (1964). New tables for multiple comparisonswith a control. Biometrics 20,482-491. 10. Dunnett, C.W. (1980). Pairwise multiple comparisons in the unequal variance case. J. Amer. Statist.
Assoc. 75,796-800. 11. Tamhane, A.C. (1979). A comparison ofprocedures for multiple comparison of meanswith unequal
variances J. Amer. Statist Assoc. 74,471-480. 12. Kruskal, W.H and Wallis, W.A (1952). Use of ranks in cne-criterion analysis of variance. J. Amer.
Statist Assoc. 47,583-621. 13. Dunn, O.J. (1964). Multiple contrastsusing rank sums. Techncmetrics 6,241-252. 14. Hsu, J.C. (1992). The Factor Analytic Approach to Simultaneous Inference in the General Linear
Model Journal of Computational and Graphical Statistics 1,151-168. 15. Stephenson, W .R ., Jacobson, D . (1988). A com parison o f N o n p aram etric A nalysis o f
C ovariance T echniques, C om m unications in S tatistics - S im ulations 17.17(2), 451-461.
16. F ish er, R .A . (1985). S tatistical M ethodsfo r R esearch W orkers, 13th ed itio n . H aiT ner, N ew Y ork.
17. S dw yn, M.R.(1995). T he use o f tren d tests to determ ine a no-ob serv ab le-eflect level in anim al
safety stu d ies. Journal o f th e Am erican College o f Toxicology 14(2), 158-168. 18. Haseman, J.K. andHc>gan,M.D. (1975). Selection cf the experimental unit in teratology studies
Teratology, 12,165-171.
Rationale: Theparameter cf "Corpora Lutea Counts" will undergo statistical analysis, the Statistical Methods are updatedtoreflect more appropriatemethods for analyzing the data, andtheRtferences are updated to coincidewith the additional statisticalparameters.
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H-24768: Cbie-Generation Reprodnctiaa Stocfr in Rats
H-24768: One-Generation Reproduction Study Si Rats Work Request Number Service Code Number
. PROTOCOL AMENDMENT 2 (Continued)
DuPont-137 84
Approved by: Approved by:
Eve Mylchreest Study Director
Joseph M. Lewis Study Author
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APPENDIX C ANALYTICAL DATA
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/ - s H-24768: ONE GENERATION REPRODUCTION STUDY IN RATS
ANALYSIS FOR H-24768 IN DOSING FORMULATIONS
Medical Research Project Number: Haskell Sample Number: Analytical Report Number:
SUMMARY
On October 30, 2003, dosing formulations containing H-24768 at the concentrations of 0.20, 2.00, and 5.00 mg/mL were collected. These samples were analyzed to determine concentration verification and 5-hour room temperature stability. Dosing formulations from the same preparation and levels were collected on November 6,2003 after 7 days of refrigeration and analyzed for refrigerated stability followed by 5 hours at room temperature. On December 15, 2003 and January 26, 2004, dosing formulations at the same levels were collected and analyzed for concentration verification. A 0 mg/mL (control) sample was collected and submitted with each sampling.
H-24768 as used in this report refers to active components in H-24768.
Concentrations of the active ingredient (a.i.) in H-24768 in the formulations were determined by high-performance liquid chromatography (HPLC) with MS detection.
The formulation vehicle for the study was deionized water.
Results from analysis of the dosing formulations collected for concentration verification and stability on October 30, 2003 indicated that test substance was uniformly mixed (C.V.'s = 0.6, 0.5, and 0.9, respectively), at the expected concentrations ( 4.5%) and stable in the vehicle for 5 hours at room temperature. Results from the analysis of samples collected November 6, 2003 from the same preparation after 7 days of refrigeration indicated that the test substance was stable for both the 7 days of refrigeration and the 7 days of refrigeration followed by 5 hours at room temperature. Results from the analysis of the dosing samples collected on December 15, 2003 for concentration verification indicated that the test substance was adequately mixed (CV of less than 10) and at the expected concentrations ( 14%) in all levels. Results from the analysis of the dosing samples collected on January 26,2004 for concentration verification indicated that the test substance was adequately mixed (CV of less than 10) and at the expected concentrations ( 2.2%) in all levels.
H-24768 was not detected in the 0 mg/mL (control) sample.
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SAMPLE SUBMITTAL
Test Substance Stability Analyses
Samples of H-24768 were supplied by the study technician near the beginning and end of the study for stability analysis and analyzed by the DuPont Regional Analytical Services (RAS). Methods and results for the stability analysis of the test substance are documented in the study records (DuPont Haskell Laboratory Medical Research Project NumbeiflBHBHBBHService C odejB irj
Formulation Sample Analyses
On October 30, 2003, samples from dosing formulations containing H-24768 at concentrations of 0.20, 2.00, and 5.00 mg/mL were collected. These samples were analyzed to determine concentration verification and 5-hour room temperature stability. Samples from the same preparation were collected on November 6,2003, to determine 7-day refrigerated stability and 5hour room temperature stability. On December 15,2003 and January 26,2004, dosing formulations were collected and analyzed for concentration verification. A 0 mg/mL (control) sample was collected and submitted with each sampling.
All dosing formulation samples were collected on the same day the formulations were prepared except for stability samples which were analyzed when received or when reanalysis was necessary.
The formulation vehicle for the study was deionized water.
METHODS
1. Analytical Methods
a. Recovery Sample Analysis
Concurrent with dosing formulation analyses, recovery of H-24768 from spiked Nanopure water was tested at the targeted low, mid, and high levels to confirm the suitability of the analytical method. A stock solution of H-24768 was prepared in 50:50 Nanopure water/acetonitrile and used to prepare the recovery samples at the 0.2 mg/mL (low), 2.0 mg/mL (mid) and 5.0 mg/mL (high) level in 100 mL volumetric flasks. The samples were diluted with 50:50 Nanopure water/acetonitrile. The samples were then processed and analyzed in the same manner as the dosing samples at similar concentrations.
b. Dosing Formulation Treatment
Each dosing sample (1 mL) was diluted to 100 mL with 50:50 Nanopure water/acetonitrile to dissolve the H-24768 in the formulation. The dosing samples were analyzed after further dilution with 50:50 Nanopure water/acetonitrile to an expected concentration of approximately 0.0005 mg/mL prior to analysis.
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c. Chromatographic Conditions
Concentrations of the active ingredient (a.i.) in H-24768 in the formulations were determined by high-performance liquid chromatography (HPLC) with mass spectroscopy (MS) detection.
HPLC Instrument: MS Instrument:
Model 2795, Waters ZQ, Micromass
LC Parameters: Column: Mobile Phase:
Luna 3u C18 (2), 20 mm x 2mm
A - 25 mM ammonium acetate in water
B - acetonitrile (ACN)
C - 25 mM ammonium acetate in 80% ACN/20% Water
Gradient:
Time (min) % A %B % c Flow (mL/min)
0
40 0 60
0.3
5 0 0 100 0.3
6.5 0 0 100 0.3
6.51
0 100 0
0.3
8.5
0 100 0
0.3
8.51
40 0 60
0.3
12
40 0 60
0.3
Column Temperature: Injection Volume: Column Switch:
30C 35 pL 1.25 and 7 min
MS Parameters: Ionization mode: Capillary voltage: Cone voltage: Source Temperature:
Desolvation Temperature: Data Acquisition Function:
Electrospray, positive ions 3.5 kV 30 V
120C
500C 6-2 TBA ethoxylates: SIR of 690.5,734.5, 778.6, 822.6, 866.6 m/z; 0-7 min 8-2 TBA ethoxylates: SIR of 790.5, 834.6, 878.6, 922.7, 966.7 m/z; 0-7 min 10-2 TBA ethoxylates: SIR of 890.6, 934.6, 978.7, 1022.7, 1066.7 m/z; 0-7 min
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d. Calibration and Quantitation
DuPont-13784
A primary stock solution of the reference compound, H-24768 (test substance, purity 99+%), was made in 50:50 Nano-pure water/acetonitrile. Calibration standards were prepared on each analysis day by dilution with 50:50 Nano-pure water/acetonitrile at concentrations that bracketed the samples being analyzed. Triplicate injections of calibration solutions were made and peak areas were determined by electronic integration. The calibration curves were generated by regression analysis of the peak area data obtained from chromatographic analysis of the calibration solutions (see Figures la, lb, and lc for representative calibration curves). Data for test solutions was fitted to the calibration curve to determine the concentrations of H-24768. Test substance concentration verification in the vehicle was evaluated by calculating the coefficient of variation (C.V. = standard deviation/mean x 100) of the measured concentrations in the duplicate samples (concentration verification) for each dosing level. A coefficient of variation of less than or equal to 10% is the standard criterion at Haskell Laboratory for acceptable distribution of the test substance throughout the solution. The mean result of the concentration verification duplicate samples for each dosing level was used to determine the concentration of the test substance for the respective dosing levels. Stability was evaluated by using the mean result of the homogeneity samples as the baseline for comparing the corresponding stability results.
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ANALYTICAL RESULTS
A. Test Substance Stability Analysis
Analyses of bulk samples of H-24768 near the beginning and end of the study for stability indicated that the test substance was stable for the duration of the study. The stability of the H-24768 in the samples was based on the physical characterization of the test material. The analyses consisted of the density at 65 C, the upper cloud point, the surface tension, the residual ethylene oxide, the appearance^ and the percent fluoride. This work can be found in the study
recordsj|H H H V !|H -2 4 7 68A H H j
The following table summarizes the results of the analyses for stability.
Tvoe of Analyses
Sample Date
10/24/03
1/26/04
Density @65C
1.3172
1.3171
Upper Cloud Point (C)
91.8
91.3
Surface Tension (dynes/cm)
21.3
21.9
Residual
Appearance
Ethylene Oxide
ND OK
ND OK
% Fluoride
34.05a 33.63
a Result reported based on re-analysis of sample. The original analysis was lower than expected due to an error in the procedure for weighing the sample for analysis.
B. Chromatography
The concentration of H-24768 was expressed as the average value of the concentration for the
components peak areas. H-24768 eluted from the LC column as resolved peaks with average
retention times of approximately 2.0 minutes
^..6 ^ nutesa H H H H H Q and
5.2 minutes
Pea^ area was evaluated separately witRi^-espective
calibration curve. The concentration of H-24768 was expressed as the average value of the
concentration for the components from the three peak areas. Representative LC/MS
chromatograms are shown in Figures 2(a -1). Test substance was not detected in the 0 mg/mL
control.
C. Recovery Samples
Detailed analytical results of recovery samples are summarized in Table I. The variability of the analytical method was demonstrated by the coefficients of variation of the recovery results at each targeted dosing concentration over the course of the study. The measured concentrations of H-24768 for the 0.2 mg/mL level ranged from 98.0% to 107.7% of nominal (mean percent recovery = 102.2% 4.1, C.V. = 4%). The measured concentrations of H-24768 for the 2.0 mg/mL level ranged from 91.3% to 107.0% of nominal (mean percent recovery = 100.0% 6.5, C.V. = 7%). The measured concentrations of H-24768 for the 5.0 mg/mL level ranged from 90.1% to 102.4% of nominal (mean percent recovery = 97.4% 5.2, C.V. = 5%). Based on this data, the analytical method performed satisfactory for the all concentrations in the. study.
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D. Concentration Verification and Stability Samples
Analytical results from dosing formulations collected on October 30, 2003 and November 6,2003 (7 days refrigerated) and analyzed for concentration verification and stability (5 hours room temperature and 7 days refrigerated with 5 hours room temperature) are shown in Table II and Summary Table 1.
The following table summarizes the results for all concentration verification and stability analyses.
Preparation Day Sample Type
Nominal mg/mL
Measured3 Mean C.V. Stability15 Stability0 Stability*1 mg/mL % Nominal (%) % Nominal % Nominal % Nominal
30-0ct-03 Concentration
0 NDe
0.20 0.190,0.191
95.5 0.6
2.0 1.94, 1.92 96.5 0.5
5.0 4.87,4.80
96.6 0.9
a Mean results for the analysis of the duplicate samples, b Samples held 5 hours at room temperature, c Samples held refrigerated for 7 days. d Samples held refrigerated for 7 days then held 5 hours at room temperature, e Denotes none detected.
92.0 95.0 99.0
94.0 98.5 103.0
92.5 99.0 99.0
The data for samples collected on October 30,2003 and November 6,2003 indicates that the test substance was uniformly mixed in the vehicle at all levels (C.V.'s = 0.6,0.5, and 0.9,
respectively). The test substance was at the targeted concentration in the samples ( 4.5% of nominal) when collected and was stable in the vehicle when held 5 hours at room temperature, 7 days refrigerated and 7 days refrigerated followed by 5 hours at room temperature.
Test substance was not found in the 0 mg/mL samples.
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E. Concentration Verification Samples
Analytical results from dosing suspensions prepared December 15, 2003 and January 26, 2004 and analyzed for concentration verification are shown in Table m and Summary Table 1.
The following table summarizes the results for all concentration verification analyses.
Preparation Day
Nominal mg/mL
Measured2 mg/mL
Average % Nominal
CV %
15-Dec-2003 26-Jan-2004
0 0.20 2.0 5.0 0 0.20 2.0 5.0
NDb 0.173,0.171 1.79, 1.81 4.51, 4.69
NDb 0.194,0.197 2.00, 1.98 5.03, 4.74
----
86.0 1 90.0 1 92.0 3 ---- 98.0 1 99.5 1 97.8 4
a Duplicate samples per level were analyzed. C.V. calculated to verify uniformity o f mixture, b Denotes none detected.
The data for samples collected on December 15, 2003 indicate that the test substance was uniformly mixed in the vehicle at all levels (C.V.'s =1 ,1 , and 3, respectively) and that the test substance was at the targeted concentration ( 14% of nominal).
The data for samples collected on January 26,2004 indicate that the test substance was uniformly mixed in the vehicle at all levels (C.V.'s =1,1, and 4, respectively) and that the test substance was at the targeted concentration ( 2.2% of nominal).
Test substance was not found in the 0 mg/mL samples.
F. Conclusions
Analyses of bulk samples of H-24768 near the beginning and end of the study for stability indicated that the test substance was stable for the duration of the study.
Data from the analysis of the samples at the start of the study indicate that the test substance was mixed uniformly, was at the targeted levels and stable under the conditions of study. The data for the concentration verification indicated that the test substance was mixed uniformly in the vehicle and at the targeted concentration during the study. Test substance was not found in the 0 mg/mL samples.
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Table I. Recovery of H-24768 Added to Dosing Vehicle
Sample
mg/mL H-24768
Type
Nominal
Measured
R e c o v er y (A)
0.208
0.224
Recovery
0.201
0.197
Recovery
0.206
0.207
Recovery
0.206
0.211
Mean
Percent Nominal
107.7 98.0 100.5 102.4 102.2 4.1, C.V. 4%
Recovery Recovery Re c o v e r y Recovery
2.08 2.08 100.0 2.01 2.15 107.0 2.06 1.88 91.3 2.06 2.09 101.5
Mean 100.0 6.5, C.V. 7%
Recovery Recovery Recovery Recovery
5.10 4.97 97.5 5.03 5.00 99.4 5.05 4.55 90.1 5.02 5.14 102.4
Mean 97.4 5.2, C.V. 5%
(A) Processed with concentration verification samples from dosing prepared October 30,2003. (B) Processed with 7-day refrigerated samples from dosing prepared October 30,2003. (C) Processed with concentration verification samples from dosing prepared December 15,2003. (D) Processed with concentration verification samples from dosing prepared January 26,2004.
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Table H. Homogeneity and Stability of H-24768 in Dosing Formulations
Sample
mg/mL H-24768
Type Nominal Measured
30-0ct-2003
Concentration
Control
0.00
ND
Percent Nominal
--
#1 0.20 #2 0.20
0.190 0.191
95.0 95.5
Mean: 0.191 + 0.001
(95.5%)
C.V. 0.6%
#1 2.0
1.94 97.0
#2 2.0
1.92 96.0
Mean: 1.93 +0.01
(96.5%)
C.V. 0.5%
#1 5.0 4.87 97.4
#2 5.0 4.80 96.0
Mean: 4.83 0.04 C.V. 0.9%
(96.6%)
Stability 5-Hr. Room Temperature
7-Dav Refrigerated #1 #2
0.20 2.0 5.0
0.20 0.20
0.184 1.90 4.95
0.185 0.191
92.0 95.0 99.0
92.5 95.5
Mean: 0.188 0.004
(94.0%)
C.V.2%
#1 2.0
1.97 98.5
#2 2.0
1.96 98.0
Mean: 1.97 +0.01
(98.5%)
C.V. 0.5%
#1 5.0
5.29 105.8
#2 5.0
5.01 100.2
5-Hr. Room Temperature(C) 0.20
2.0 5.0
Mean: 5.150.19 C.V.4%
0.185 1.98 4.95
(103.0%)
92.5 99.0 99.0
(A) Denotes not detected. (B) The average measured concentration, average percent of nominal (in parentheses and based on average
measured), standard deviation, and coefficient of variation o f duplicate samples (mean result, n=2). (C) Stability samples held 5 hours at room temperature after 7 days of refrigeration.
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Table ID. Concentration Verification of H-24768 in Dosing Suspensions
Sample Type
mg/mL H-24768
Sample Date
Nominal
Measured
Concentration Verification
15-Dec-2003
Control
0.00 ND(A)
#1 0.20 0.173 #2 0.20 0.171
MeanTM: 0.172 +0.001 C.V. 1%
#1 2.0 1.79 #2 2.0 1.81
MeanTM: 1.80 +0.01 C.V. 1%
#1 5.0 4.51 #2 5.0 4.69
(B)
Mean : 4.60 +0.13 C.V.3%
Percent Nominal
--
86.5 85.5 (86.0%)
89.5 90.5 (90.0%)
90.2 93.8 (92.0%)
26-Jan-2004
Control #1
#2
#1
#2
#1 #2
0.00
ND(A)
--
0.20
0.194
97.5
0.20
0.197
98.5
MeanTM: 0.1960.001 C.V. 1%
(98.0%)
2.0 2.00 100.0 2.0 1.98 99.0
MeanTM: 1.99 +0.01 C.V. 1%
(99.5%)
5.0 5.03 100.6 5.0 4.74 94.8
MeanTM: 4.890.21 C.V. 4%
(97.8%)
(A) Denotes not detected. (B) The average measured concentration, average percent of nominal (in parentheses and based on averaged
measured), standard deviation, and coefficient o f variation of duplicate samples.
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H-24768 : One-Generation Reproduction Study in Rats
Figure 1 ; Representative Analytical Calibration Curves
Compound name Coefficient of Determination: RA2 = .999730 Calibration curve: -7 66 1 2 6 * xA2 -+- S.02863e+006 * x *+-1 45 8 .7 5 Response type: External Std, Area Curve type: 2nd Order, Origin: Exclude, Weighting: 1/x, Axis trans: None
DuPont-13784
Compound name
-Coefficient of Determination: R/'2 --T).999666
Calibration curve: -4 53 5 5 8 * x^2 + 3.63437e--006 * x h-1 0 6 3 7 .4
Response type: External Std, Area Curve type: 2nd Order, Origin: Exclude, Weighting: 1/x, Axis trans: None
Compound nam el
_
Coefficient of Dtermination: RA2 = .999699
Calibration curve: -1 3 8 78 5 * x^2 1,80792e-*-006 * x + -8 517.54
Response type: External Std, Area Curve type: 2nd Order, Origin: Exclude, Weighting: 1/x, Axis trans: None
(b)
(c)
Figure 1: Calibration curve showjng regression analysis of replicate, peak areas for calibration solutions of H-24768 based on (a)
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Figure 2 Representative HPLC/MS Chromatograms
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1
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Figure 2 (Continued) Representative HPLC/MS Chromatograms
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Figure 2 (Continued) Representative LC/MS Chromatograms
DuPont-13784
Figure 2e: Representative LC/MS chromatogram for t h e j |H B M |^ H |o f the 0.2 mg/mL H-24768 dosing formulation diluted to a nominal concentration of 0.0005 mg/mL. The mean measured concentration of the representative formulation is 0.196 mg/mL.
Figure 2f: Representative LC/MS chromatogram for t h e p | | | 0 H M t f ) f the 0.2 mg/mL H-24768 dosing formulation diluted to a nominal concentration of 0.0005 mg/mL. The mean measured concentration of the representative formulation is 0.196 mg/mL.
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Figure 2 (Continued) Representative LC/MS Chromatograms
f-4 Is
DuPont-13784
F1 :S IR o l S c h a n n e ls .E S t TIC
6 .3 4 7 8 4 -0 0 6
Figure 2g: Representative LC/MS chromatogram for thi analytical reference solution.
f 0.000412 mg/mL H-24768
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Figure 2 (Continued) Representative LC/MS Chromatograms
DuPont-13784
Figure 2i: Representative LC/MS chromatogram for th< analytical reference solution.
of 0.000412 mg/mL H-24768
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Figure 2 (Continued) Representative LC/MS Chromatograms
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Figure 2k: Representative LC/MS chromatogram for th e g B H H B H H o f the 0.206 mg/mL spiked dosing formulation diluted to nominal concentration of 0.0005 mg/mL of H-24768. The measured concentration o f the representative formulation is 0.211 mg/mL.
Figure 21: Representative LC/MS chromatogram for thepH H M B B H H K rf the 0.206 mg/mL spiked dosing formulation diluted to nominal concentration of 0.0005 mg/mL of H-24768. The measured concentration of the representative formulation is 0.211 mg/mL.
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TABLE 1
SUMMARY OF DOSING MIXING AND STABILITY ANALYSES
Nominal: Concentration Verification
30-0ct-2003 #1
#2
Average Measured Cnnc..b Average Percent Nominal
Standard Deviation** Coefficient of Variation
Stabilitv Samles 5-Hour Room Temperature
7-Day Refrigerated #1
#2
Average Measured Conc.b Average Percent Nominal
Standard Deviat.ionb Coefficient of Variation 5-Hour Room Temneraturec
Concentration Verification 15-Dec-2003 #1
Dosing Concentration of H-24768 (mg/mL)
0.20 2.0
5.0
0.190 f95.0a 0.191 (95.5) 0.191 (95.5) 0.001 0.6%
0.184 (92.0)
0.185 (92.5) 0.191 (95.5) 0.188 (94.0) 0.004 2% 0.185 (92.5)
1.94 (97.0) 1.92 (96.0) 1.93 (96.5) 0.01 0.5%
1.90 (95.0)
1.97 (98.5) 1.96 (98.0) 1.97 (98.5) 0.01 0.5% 1.98 (99.0)
4.87 (97.4) 4.80 (96.0) 4.83 (96.6) 0.04 0.9%
4.95 (99.0)
5.29 (105.8)
5.01 (100.2)
5.15 (103.0) 0.19
4% 4.95 (99.0)
0.173 (86.5)
1.79 (89.5)
4.51 (90.2)
#2
Average Measured Cone.** Average Percent Nominal
Standard Deviationb Coefficient, of Variation"
26-Jan-2004 #1
0.171 (85.5) 0.172 (86.0) 0.001
1%
0.194 (97.5)
1.81 (90.5) 1.80 (90.0) 0.01
1%
2.00 (100.0)
4.69 (93.8) 4.60 (92.0) 0.13 3%
5.03 (100.6)
#2
Average Measured Conc.b Average Percent Nominal
Standard Deviation** __Coefficient of Variation______
0.197 (98.5) 0.196 (98.0) 0.001 1%
1.98 (99.0) 1.99 (99.5) 0.01 1%
4.74 (94.8) 4.89 (97.8)
0.21 4%
a Numbers in parentheses are the respective percent of nominal values. b Statistics based on the average measured concentration (mg/mL) of duplicate samples of each dosing level, c Samples held 5 hours at room temperature after 7 days o f refrigeration.
- 118-
Gipmpany Sanitized. Does not contain TSCA C8I
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX D INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA
IN Pi MALE RATS
-119 tesinpany Sanitized. Does not contain TSCA CBl
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN PI MALE RATS
GROUP: 1-0
CONCENTRATION: 0 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
1 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
2 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
3 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
4 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
5 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
6 ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 96
7 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
8 COLORED DISCHARGE LEFT EYE(S) RED TEETH CROOKED TEETH CLIPPED TEETH MISSING SACRIFICED BY DESIGN TEST DAY 96
9 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
10 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
11 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
12 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
13 ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S ) SACRIFICED BY DESIGN TEST DAY 97
43 50
48 56 48 48 49 50 63 96
15 97 28 97
- - 1ZU-
. ............. .......... ...... .
IpMfpaHy SanWzeH. tim m h etafn TSC A iw ?
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN PI MALE RATS
GROUP: 1-0
CONCENTRATION: 0 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
14 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
15 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
16 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
17 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
18 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
19 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
20 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
21 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
22 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
23 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
24 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
/**'*>\
- 121 -
Company Sanitized. D oes not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768 .
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
\W
V
j iINDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN PI MALE RATS
GROUP: III-O
CONCENTRATION: 1 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
25 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
26 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
27 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
28 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
29 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
30 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
31 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
32 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
33 ALOPECIA BOTH FRONT P A W (S ) ALOPECIA BOTH FRONT L E G (S ) ALOPECIA BOTH FRONT P A W (S ) ALOPECIA BOTH FRONT L E G (S ) SACRIFICED BY DESIGN TEST DAY 96
34 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
35 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
36 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
37 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
15 28 15 28 50 96 92 96
- 122-
J&Mipanj Sanitized Doe* not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN PI MALE RATS
GROUP: III-O
CONCENTRATION: 1 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
38 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
39 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
40 ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 97
41 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
42 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
43 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
44 NO ABNORMALITIES DETECTED _ SACRIFICED BY DESIGN TEST DAY 97
45 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
46 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
47 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
48 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
28 28
- 123 -
Company Sanitized. Does not contain TSCA CBi
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN PI MALE RATS
GROUP: V-0
CONCENTRATION: 10 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
49 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
50 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
51 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
52 COLORED DISCHARGE LEFT E Y E (S ) RED TEETH MISSING SACRIFICED BY DESIGN TEST DAY 96
53 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
54 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
55 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
56 ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 96
57 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
58 STAINED CAGEBOARD RED COLORED DISCHARGE PENIS RED SACRIFICED BY DESIGN TEST DAY 96
59 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
60 SORE LEFT FRONT TOE(S) SACRIFICED BY DESIGN TEST DAY 96
61 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
15 15 15 15
28 96 27 28 28 29 85 96
- 124Ctompany Sanitized. Does not contain TSCA CBI
y am ,.
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN PI MALE RATS
GROUP: V-0
CONCENTRATION: 10 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
62 ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S ) SACRIFICED BY DESIGN TEST DAY 97
63 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
64 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
65 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
66 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
67 COLORED DISCHARGE RIGHT E Y E (S ) RED TEETH CROOKED SACRIFICED BY DESIGN TEST DAY 97
68 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
69 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
70 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
71 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
72 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
8 97 28 97
88 85 97
- 125ICompany Sanitized. Does not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN PX MALE RATS
GROUP: VII-0
CONCENTRATION: 25 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
73 ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 96
74 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
75 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
76 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
77 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
78 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
79 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
80 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
81 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
82 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
83 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 96
84 ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 96
85 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
86 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
56 63 36 96
- 126ICompany Sanitized. Does not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN PI MALE RATS
GROUP: VII-0
CONCENTRATION: 25 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
87 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
88 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
89 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
90 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
91 SCAB TAIL SACRIFICED BY DESIGN TEST DAY 97
92 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
93 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
94 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
95 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
96 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 97
78 85
- 127Company Sanitized. Does not contain TSCA f
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX E INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING PREMATING
-128-
jCompany Sanitized. Does no! contain TSCA Got
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING PREMATING EXPLANATORY NOTES
Notes Test Day 71 == Last day of premating period that data were recorded.
- 129-
Company Sanitized. Does not contain TSCA C1
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
Z***"'-'
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS IN PI FEMALE RATS DURING PREMATING
GROUP: II-O
DOSE: 0 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
97 98 99 100 101 102 103 104
105 106
107
108 109
110 111 112 113 114
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
ALOPECIA PERINEUM ALOPECIA BOTH FRONT L E G {S ) ALOPECIA BOTH FRONT PAW(S)
NO ABNORMALITIES DETECTED
ALOPECIA CHEST SCAB CHEST
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S ) ALOPECIA RIGHT HIND QUARTERS
NO ABNORMALITIES DETECTED
ALOPECIA BOTH FRONT P AW(S ) ALOPECIA BOTH FRONT L E G (S )
ALOPECIA RIGHT FRONT L E G (S )
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
15 71 36 71 50 71
71 71 71 71 15 71 56 71 71 71
8 28 8 28 56 63
/***'v'
- 130pom pan y Sanitized. Does not contain TSCA CBi
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS IN PI FEMALE RATS DURING PREMATING
GROUP: II-O
DOSE: 0 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
115 NO ABNORMALITIES DETECTED 116 NO ABNORMALITIES DETECTED 117 NO ABNORMALITIES DETECTED 118 NO ABNORMALITIES DETECTED 119 ALOPECIA BOTH FRONT PAW(S) 120 ALOPECIA BOTH FRONT PAW(S)
ALOPECIA LEFT FRONT L E G (S )
28 28
28 43 56 71
-131 Company Sanitized. D oes not contain t sc a C.Rt
1
(
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
^INDIVIDUAL CLINICAL OBSERVATIONS IN PI FEMALE RATS DURING PREMATING
GROUP: IV-0
DOSE: 1 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
121 122 123 124 125
126 127 128 129
131 132 133 134
135
, 136 137
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S )
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S )
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S ) ALOPECIA BOTH FRONT L E G (S ) ALOPECIA BOTH FRONT PAW(S) ALOPECIA LEFT HIND QUARTERS
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S )
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
28 71 28 71
15 71 50 71
36 56 36 56 71 71 71 71 71 71 43 71 56 71
- 132 -
Company Sanitized. Doe* not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS IN PI FEMALE RATS DURING PREMATING
GROUP: IV-0
DOSE: 1 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
138 NO ABNORMALITIES DETECTED 139 NO ABNORMALITIES DETECTED 140 ALOPECIA RIGHT FRONT L EG{S )
ALOPECIA LEFT HIND QUARTERS 141 NO ABNORMALITIES DETECTED 142 NO ABNORMALITIES DETECTED 143 NO ABNORMALITIES DETECTED 144 NO ABNORMALITIES DETECTED
- 133 Company Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS IN PI FEMALE RATS DURING PREMATING
GROUP: VI-0
DOSE: 10 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
145 146
147 148 149
150 151 152 153 154 155 156 157 158 159 160
NO ABNORMALITIES DETECTED
ALOPECIA BOTH FRONT L E G (S ) ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S ) ALOPECIA BOTH FRONT L E G (S ) ALOPECIA BOTH FRONT PAW(S)
NO ABNORMALITIES DETECTED
ALOPECIA CHEST ALOPECIA ABDOMEN
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S ) ALOPECIA LEFT FRONT PA W (S ) ALOPECIA LEFT FRONT L E G (S )
ALOPECIA BOTH FRONT P A W (S ) ALOPECIA BOTH FRONT L E G (S )
ALOPECIA BOTH FRONT P A W (S ) ALOPECIA BOTH FRONT L E G (S )
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
28 36 50 56 50 56 71 71 71 71
8 63 71 71
22 36 22 36 71 71 71 71
8 71 8 71
43 71 43 71
- 134 Company Sanitized. Does not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H#24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS IN PI FEMALE RATS DURING PREMATING
GROUP: VI-0
DOSE: 10 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
161 NO ABNORMALITIES DETECTED 162 NO ABNORMALITIES DETECTED 163 NO ABNORMALITIES DETECTED 164 NO ABNORMALITIES DETECTED 165 ALOPECIA BOTH FRONT PAW(S)
ALOPECIA BOTH FRONT L E G (S ) 166 NO ABNORMALITIES DETECTED 167 NO ABNORMALITIES DETECTED 168 NO ABNORMALITIES DETECTED
- 135 ffsmtpany Sanitize! D oes no! contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
,H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS IN PI FEMALE RATS DURING PREMATING
GROUP: VIII-0
DOSE: 25 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
169 170 171 172 173 174
175
176
177 178 179 180 181 182 183 184 185
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
ALOPECIA BOTH FRONT P AW(S )
NO ABNORMALITIES DETECTED
ALOPECIA BOTH FRONT PAW(S ) ALOPECIA BOTH FRONT L E G (S ) ALOPECIA BOTH FRONT L E G (S )
ALOPECIA BOTH FRONT PA W (S ) ALOPECIA BOTH FRONT L E G (S )
ALOPECIA BOTH FRONT L EG(S ) ALOPECIA BOTH FRONT PAW(S ) ALOPECIA PERINEUM ALOPECIA BOTH FRONT PAW(S } ALOPECIA BOTH FRONT L E G (S )
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
ALOPECIA BOTH FRONT PAW(S;
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
63 71
8 71 8 50 63 71 56 71 56 71 1 50 8 50 28 71 63 71 63 71
22 71
1
- 136 Company Sanitized. Does no! contain TSCA CB
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS IN PI FEMALE RATS DURING PREMATING
GROUP: VIII-0
DOSE: 25 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
186 ALOPECIA BOTH FRONT PAW(S) 187 ALOPECIA BOTH FRONT PAW(S ) 188 NO ABNORMALITIES DETECTED 189 NO ABNORMALITIES DETECTED 190 NO ABNORMALITIES DETECTED 191 NO ABNORMALITIES DETECTED 192 NO ABNORMALITIES DETECTED
71 71 15 71
- 137'Company Sanitized. Does not contain TSCA CBt
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX F INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS
DURING GESTATION
-138 Company Sanitized. Does not contain TSCA CE:
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING GESTATION EXPLANATORY NOTES
Note This Appendix contains data from females with evidence of copulation observed.
-139 -
Company Sanitized. Does not contain TSCA CM
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS IN PI FEMALE RATS DURING GESTATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
97 98 99 100 101 102 103 104
105 106
107
108 109
110 111 112
VAGINAL PLUG
SPERM POSITIVE
SPERM POSITIVE
SPERM POSITIVE
SPERM POSITIVE
SPERM POSITIVE
SPERM POSITIVE
ALOPECIA PERINEUM ALOPECIA BOTH FRONT L EG(S ) ALOPECIA BOTH FRONT PAW(S) SPERM POSITIVE
SPERM POSITIVE
ALOPECIA CHEST SCAB CHEST SPERM POSITIVE
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT LEG(S) ALOPECIA RIGHT HIND QUARTERS SPERM POSITIVE
SPERM POSITIVE
SPERM POSITIVE ALOPECIA RIGHT FRONT L EG(S )
SPERM POSITIVE
SPERM POSITIVE
VAGINAL PLUG
00
00
00
00
00
00
00
0 21 0 21 0 21 00
00
0 21 00 00
0 21 0 21 0 21 00
00
00 7 21
00
00
00
- 140ompany Sanitized. Does not contain TSCA CB
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS IN PI FEMALE RATS DURING GESTATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
113 VAGINAL PLUG 114 SPERM POSITIVE 115 SPERM POSITIVE 116 VAGINAL PLUG 117 SPERM POSITIVE 118 SPERM POSITIVE 119 SPERM POSITIVE
00 00 00 00 00 00 00
- 141 SrODQMny Sanitized, Does not contain TSCA CB!
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768 H^4768 _
IBtJINDIVIDUAL CLINICAL OBSERVATIONS IN PI FEMALE RATS DURING GESTATION
GROUP: IV-0
DOSE: 1 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
121 122 123 124 125
126 127 128 129
130 131 132 133 134
135
SPERM POSITIVE
SPERM POSITIVE
VAGINAL PLUG ALOPECIA BOTH FRONT PAW(S)
SPERM POSITIVE
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S ) VAGINAL PLUG
SPERM POSITIVE
SPERM POSITIVE
SPERM POSITIVE
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S ) VAGINAL PLUG
VAGINAL PLUG
VAGINAL PLUG
SPERM POSITIVE ALOPECIA BOTH FRONT PAW(S)
VAGINAL PLUG
ALOPECIA BOTH FRONT L E G (S ) ALOPECIA BOTH FRONT PAW(S) ALOPECIA LEFT HIND QUARTERS SPERM POSITIVE ALOPECIA BASE TAIL
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT LEG(S) SPERM POSITIVE ALOPECIA BACK
00
00
00 7 21
00
0 21 0 21 00
00
00
00
0 21 0 21 00
00
00
00 21 21
00
0 21 0 21 0 21 00 7 21
0 21 0 21 00 14 21
- 142-
pmspan SanWzeA Does nor contain TSCAGB|
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768 INDIVIDUAL CLINICAL OBSERVATIONS IN PI FEMALE RATS DURING GESTATION
GROUP: IV-0
DOSE: 1 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
136 VAGINAL PLUG 137 SPERM POSITIVE 138 SPERM POSITIVE 139 SPERM POSITIVE 140 ALOPECIA RIGHT FRONT L E G (S )
ALOPECIA LEFT HIND QUARTERS SPERM POSITIVE 141 SPERM POSITIVE 142 VAGINAL PLUG 143 SPERM POSITIVE 144 VAGINAL PLUG
00 00
00 00 0 21 0 21 00 00 00 00
00
-143-
Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS IN PI FEMALE RATS DURING GESTATION
GROUP: VI-0
DOSE: 10 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
145 146
148 149
150
152 153 154 155 156 157 158 160 161 162 163
SPERM POSITIVE
ALOPECIA BOTH FRONT LEG(S) ALOPECIA BOTH FRONT PAW(S) SPERM POSITIVE
ALOPECIA ABDOMEN SPERM POSITIVE
ALOPECIA LEFT FRONT PAW(S) ALOPECIA LEFT FRONT L E G (S ) SPERM POSITIVE ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S )
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT LEG(S) SPERM POSITIVE
VAGINAL PLUG
VAGINAL PLUG
SPERM POSITIVE
SPERM POSITIVE
SPERM POSITIVE
SPERM POSITIVE
SPERM POSITIVE
SPERM POSITIVE
SPERM POSITIVE
SPERM POSITIVE
VAGINAL PLUG
00
0 21 0 21 00
0 21 00
07 07 00 14 21 14 21
0 21 0 21 00
00
00
00
00
00
00
00
00
00
00
00
-144pmpany Sanitized. Does not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H#24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS IN PI FEMALE RATS DURING GESTATION
GROUP: VI-0
DOSE: 10 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
165 SPERM POSITIVE 166 SPERM POSITIVE 167 SPERM POSITIVE 168 SPERM POSITIVE
00 00 00 00
-145-
Sanitized. Does nof contain tsc a c w
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
'___________________ - ________ -- ........... ..................................
GROUP: VIII-0
DOSE: 25 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
169 170 171 172
173 174
175
176
177 178 180 181 183 185 186
SPERM POSITIVE
VAGINAL PLUG
SPERM POSITIVE
ALOPECIA BOTH FRONT PAW(S) VAGINAL PLUG ALOPECIA BOTH FRONT LEG(S) ALOPECIA BOTH SIDE(S)
SPERM POSITIVE
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S ) SPERM POSITIVE
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L EG(S ) VAGINAL PLUG ALOPECIA LEFT SIDE(S)
ALOPECIA PERINEUM ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S ) SPERM POSITIVE
SPERM POSITIVE
SPERM POSITIVE
SPERM POSITIVE
SPERM POSITIVE
SPERM POSITIVE
SPERM POSITIVE
ALOPECIA BOTH FRONT PAW(S) SPERM POSITIVE
00
00
00
0 21 00 7 21 14 21
00
0 21 0 21 00
0 21 0 21 00 14 21
0 21 0 21 0 21 00
00
00
00
00
00
00
0 21 00
- 146-
ompsmy Sanitized Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
'INDIVIDUAL CLINICAL OBSERVATIONS IN PI FEMALE RATS DURING GESTATION
GROUP: VIII-0
DOSE: 25 MG/KG/DAY
ANIMAL NIMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
187 ALOPECIA BOTH FRONT PAW(S) SPERM POSITIVE
189 SPERM POSITIVE
190 VAGINAL PLUG ALOPECIA RIGHT FRONT L E G (S )
191 SPERM POSITIVE
192 SPERM POSITIVE
0 14 00
00
00 14 21
00
00
- 147Company Sanitized. Does not contain TSCA CB!
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX G INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA
IN Pi FEMALE RATS DURING LACTATION
- 148 -
ICompany Sanitized. Does not contain TSCACBi
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN Pi FEMALE RATS DURING LACTATION
EXPLANATORY NOTES
Note
Test days for animal fates are determined from the initiation of test substance administration, designated as Day 1 of test.
/#p\
- 149-
Company Sanitized Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
OBSERVATIONS AND MORTALITY DATA IN PI FEMALE RATS DURING LACTATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
97 98 99 100 101 102 103 104
105 106
108 109 110
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 101
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 110
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 102
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 106
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 101
COLORED DISCHARGE VAGINAL OPENING RED SACRIFICED BY DESIGN TEST DAY 101
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 102
ALOPECIA PERINEUM ALOPECIA BOTH FRONT L E G (S ) ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 103
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 104
ALOPECIA CHEST ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT LEG(S) SACRIFICED BY DESIGN TEST DAY 100
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 101
ALOPECIA RIGHT FRONT LEG(S) SACRIFICED BY DESIGN TEST DAY .101
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 103
04
04 04 04
04 44 44
04
- 150-
pom patif Sanitized. Does not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
IT MNDr mIrVTIr iDT UT Az iLr . CLINICAL OBSERVATIONS AND MORTALITY DATA IN PI FEMALE RATS DURING LACTATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
112 113 114 115 116 117 118 119 120 -
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 104
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 100
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 104
ALOPECIA BOTH FRONT PAW(S)i SACRIFICED BY DESIGN TEST DAY 103
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 101
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 101
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 103
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 101
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 100
-151 Company Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
^ H^4768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN PI FEMALE RATS DURING LACTATION
GROUP: IV-0
DOSE: 1 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
121 122 123 124 125
126 128 129
130 131 132 133 134
COLORED DISCHARGE VAGINAL OPENING RED SACRIFICED BY DESIGN TEST DAY 102
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 102
ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 100
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 100
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S ) SACRIFICED BY DESIGN TEST DAY 101
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 103
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 103
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S ) SACRIFICED BY DESIGN TEST DAY 103
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 101
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 100
ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 103
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 103
ALOPECIA BOTH FRONT L E G (S ) ALOPECIA BOTH FRONT PAW(S) ALOPECIA LEFT HIND QUARTERS ALOPECIA BASE TAIL SACRIFICED BY DESIGN TEST DAY 101
-
00
04
04 04
04 04
04
04 04 04 04
- 152pmpany Sanitized. Does no! contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN PI FEMALE RATS DURING LACTATION
GROUP: IV-0
DOSE: 1 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
135
136 137 139 141 142 143 144
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S ) ALOPECIA BACK SACRIFICED BY DESIGN TEST DAY 101
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 100
COLORED DISCHARGE VAGINAL OPENING RED SACRIFICED BY DESIGN TEST DAY 100
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 103
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 100
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 102
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 103
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 102
FIRST DAY LAST DAY OBSERVED OBSERVED
04 04 04
00
-153-
ICompany Sanitized. Does not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN PI FEMALE RATS DURING LACTATION
GROUP: V I -0
DOSE: 10 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
146
148
149
150
152 153 154 155 156 158 159 160 161
ALOPECIA BOTH FRONT L E G (S ) ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 102
ALOPECIA ABDOMEN ALOPECIA CHEST SACRIFICED BY DESIGN TEST DAY 102
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S ) SACRIFICED BY DESIGN TEST DAY 101
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S ) SACRIFICED BY DESIGN TEST DAY 101
ALOPECIA RIGHT SIDE(S) SACRIFICED BY DESIGN TEST DAY 103
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 103
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 103
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 101
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 102
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 101
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 101
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 101
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 103
04 04
04 04
04 04
04 04
44
- 154!Company Sanitized. Does not confab TSCA CB!
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN PI FEMALE RATS DURING LACTATION
GROUP: VI-0
DOSE: 10 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
162 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 101
163 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 101
165 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 101
166 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 103
167 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 104
168 ALOPECIA BACK SACRIFICED BY DESIGN TEST DAY 102
- 155ompany Sanitized. D oes not contain TSCA CBt
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN PI FEMALE RATS DURING LACTATION
GROUP: VIII-0
DOSE: 25 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
169 170 171 172
173 174 175
176
177 178 180 181
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 102
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 102
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 100
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S ) ALOPECIA BOTH SIDE(S) SACRIFICED BY DESIGN TEST DAY 103
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 100
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S ) SACRIFICED BY DESIGN TEST DAY 103
ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S ) ALOPECIA LEFT SIDE(S) SACRIFICED BY DESIGN TEST DAY 100
ALOPECIA PERINEUM ALOPECIA BOTH FRONT PAW(S) ALOPECIA BOTH FRONT L E G (S ) SACRIFICED BY DESIGN TEST DAY 103
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 101
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 103
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 101
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 103
04 04 04
04 04
04 04 04
04 04 04
*
-156-
$mpany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
f INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN PI FEMALE RATS DURING LACTATION
GROUP: VIII-0
DOSE: 25 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY LAST DAY OBSERVED OBSERVED
182
183 185 186 187 188 189 190 191 192
ALOPECIA BOTH FRONT PAW(S) ALOPECIA LEFT HIND QUARTERS COLORED DISCHARGE VAGINAL OPENING RED SACRIFICED BY DESIGN TEST DAY 102
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 100
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 103
ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 100
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 101
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 101
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 101
NO ABNORMALITIES DETECTED SACRIFICED' BY DESIGN TEST DAY 102
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 102
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 102
04 04 00
04
i
- 157-
jpgmpany Sanitized. Does not contain TSC.ACB!
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX H INDIVIDUAL BODY WEIGHTS OF Pi MALE RATS AND MORTALITY DATA
- 158 Company Sanitized. Does not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL BODY WEIGHTS OF P, MALE RATS AND MORTALITY DATA EXPLANATORY NOTES
Notes Test Days 1-73 = Premating period Test Days 73-87 = Cohabitation period
Abbreviations
SD = Sacrificed by design
Summary Section SD. = Standard Deviation S.E. = Standard Error N = Number in Group
1
- 159 ty m p a n y Sanitized. D oes not contain TSCA CBl
w'
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
a
I n d i v i d u a l b o d y w e i g h t s (g) o f p i m a l e r a t s a n d m o r t a l i t y d a t a
GROUP: 1-0
DOSE: 0 MG/KG/DAY
DAYS
ON TEST :
ANIMAL NUMBER
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
MEAN S.D. S.E. N
1 8 15 22 28 36 43
264.0 296.0 301.3 300.5 293.7 287.1 304.4 287.5 267.1 272.4 302.5 290.0 267.3 259.2 290.6 309.3 267.3 273.4 291.7 296.8 280.7 293.1 285.7 281.4
286.0 14.2 2.9 24
308.6 334.9 337.8 345.1 341.1 332.1 351.1 324.0 295.2 306.8 338.3 325.0 307.3 295.2 335.4 364.6 293.1 289.8 328.6 338.8 327.1 330.4 324.2 319.2
324.7 19.5 4.0 24
349.3 345.6 375.2 386.0 378.6 375.9 394.5 357.3 337.1 348.8 382.4 360.7 342.7 324.0 379.5 406.8 334.9 313.3 372.8 373.6 367.9 368.5 365.7 351.0
362.2 22.5 4.6 24
382.4 360.7 412.9 425.1 414.4 419.5 440.1 391.6 364.2 384.7 415.8 381.6 380.9 356.3 414.6 448.5 360.7 345.2 408.0 401-0 396.9 398.4 400.8 386.8
395.5 26.5 5.4 24
400.7 390.8 436.7 450.1 436.2 447.2 463.6 413.4 386.7 410.3 438.6 410.2 402.6 363.8 435.9 471.5 380.5 358.9 424.9 428.5 420.9 420.2 423.9 400.0
417.3 28.7 5.9 24
415.7 411.5 472.5 478.6 462.6 477.1 504.4 433.0 411.4 437.5 470.4 430.5 429.8 388.1 463.2 505.3 407.4 375.2 461.5 447.0 446.4 436.8 451.2 420.8
443.2 33.3 6.8 24
448.2 441.6 493.1 495.2 482.7 506.0 530.3 453.0 425.8 472.9 487.5 444.1 453.5 409.2 480.1 515.5 430.1 395.5 482.1 468.8 470.6 455.5 464.7 440.5
464.4 32.7 6.7 24
i
- 160-
t e w " * Sanitized Does not contain TSCA <7Ri
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
INDIVIDUAL BODY WEIGHTS (g) OF PI MALE RATS AND MORTALITY DATA
GROUP: 1-0
DOSE: 0 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER 1 2 3 4 5 6 7 8 9
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
MEAN S.D. S.E. N
50
465.3 457.8 503.4 515.5 494.3 532.5 547.8 406.7 443.8 490.7 508.6 456.7 463.2 424.5 492.4 533.9 439.0 410.4 498.8 461.6 479.9 465.0 480.5 457.7
476.3 37.4 7.6 24
56
472.0 476.1 498.8 526.6 503.9 541.0 552.8 440.5 455.6 497.2 514.9 480.7 476.9 434.2 503.4 545.5 452.8 422.6 501.5 481.5 495.4 470.8 493.8 470.0
487.9 33.9 6.9 24
63
485.3 480.0 513.0 537.3 510.7 560.4 580.7 468.4 463.9 507.7 534.6 487.6 488.7 446.7 508.0 556.5 462.3 428.9 513.6 498.1 506.2 490.2 497.5 484.8
500.5 35.8 7.3 24
71
494.5 479.4 524.9 544.8 510.6 581.0 593.3 485.7 464.2 523.2 540.2 496.0 502.8 466.7 522.4 568.6 474.6 431.2 521.0 510.6 523.2 497.5 506.0 501.8
511.0 37.3 7.6 24
78
507.8 504.9 526.3 552.5 505.4 583.4 601.8 494.4 466.9 538.7 548.8 488.6 512.8 460.9 516.5 546.2 464.7 423.8 519.1 512.1 528.4 502.2 517.7 498.1
513.4 38.7 7.9 24
85
528.8 519.6 534.4 559.0 516.8 605.5 614.8 504.6 443.4 550.7 557.3 499.4 528.0 476.1 532.0 570.2 474.8 454.9 532.9 530.1 542.9 521.2 513.4 517.0
526.2 40.6 8.3 24
92
535.2 525.7 541.1 576.5 530.1 623.1 627.7 509.9 480.5 544.4 569.4 509.2 532.7 480.6 537.6 579.6 475.0 441.6 538.2 538.5 550.3 514.0 523.1 524.7
SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96)
SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97)
533.7 42.7 8.7 24
-161 lpWsp SaftTOze. D oes wot contain TSCA CBt
H-24768: One-Generation Reproduction Study in Rats
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
DuPont-13784
INDIVIDUAL BODY WEIGHTS (g) OF PI MALE RATS AND MORTALITY DATA
GROUP : III-O
DOSE: 1 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48
MEAN S.D. S.E. N
1 8 15 22 28 36 43
246.7 276.8 290.6 287.6 296.8 281.9 277.8 299.2 283.1 289.3 272.2 300.9 275.5 270.2 306.9 301.6 278.7 285.8 288.6 311.8 278.7 285.8 304.5 290.2
286.7 14.2 2.9 24
286.2 317.4 323.3 319.2 355.9 323.8 299.6 333.3 312.2 338.5 300.9 350.6 301.4 301.3 360.4 356.7 334.7 332.8 321.1 354.6 310.2 317.3 351.2 328.6
326.3 21.1 4.3 24
319.4 355.6 361.3 342.3 407.4 367.7 333.9 381.3 338.4 382.3 341.2 387.3 330.9 330.0 412.0 404.3 392.4 378.8 359.9 393.6 347.5 349.6 392.6 373.2
366.0 27.3 5.6 24
349.6 380.3 394.7 372.2 436.1 401.8 371.1 424.8 365.2 412.8 365.8 422.1 358.7 352.3 456.6 445.4 428.3 416.9 394.2 430.4 377.3 379.6 434.7 420.3
399.6 31.9 6.5 24
373.1 400.9 414.1 388.8 453.9 432.7 391.4 446.7 384.3 438.8 382.0 446.2 375.9 368.3 490.6 470.6 446.2 443.6 416.1 447.4 398.5 392.1 454.7 441.5
420.8 34.4 7.0 24
405.2 422.2 444.9 413.3 473.7 448.7 419.0 486.5 406.8 460.1 413.2 477.3 412.9 394.8 523.3 502.9 465.1 470.2 440.6 466.8 427.2 419.3 478.9 460.8
447.2 34.2 7.0 24
429.4 457.6 467.0 437.9 487.7 473.5 445.9 520.0 424.8 492.0 436.8 508.6 435.7 407.5 548.1 530.6 483.8 495.2 461.8 486.8 452.5 433.6 502.6 489.2
471.2 36.4 7.4 24
- 162 Company Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 76 8
INDIVIDUAL BODY WEIGHTS (g) OF PI MALE RATS AND MORTALITY DATA
GROUP: III-O
DOSE: 1 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48
MEAN S.D. S.E. N
50 56 63 71 78 85 92
448.1 475.2 480.7 449.2 508.9 487.6 465.5 538.2 439.6 498.6 445.3 522.5 453.8 421.2 573.5 539.2 502.1 512.4 481.5 498.1 462.4 443.5 523.2 506.3
486.5 37.8 7.7 24
461.6 483.0 494.5 464.0 519.4 496.0 479.1 557.0 450.7 519.2 457.1 535.4 475.6 426.5 589.7 555.9 513.4 524.2 490.4 512.8 469.1 457.3 534.0 527.9
499.7 39.5 8.1 24
482.0 495.7 504.2 486.2 525.6 516.4 497.7 572.4 464.8 540.0 457.9 553.5 487.8 433.9 610.5 571.7 518.2 543.2 501.9 525.6 485.3 468.5 544.8 537.5
513.6 41.2 8.4 24
501.0 500.6 512.3 493.4 533.7 524.0 513.2 590.8 481.6 547.6 473.8 565.4 498.5 439.3 616.8 587.3 539.5 556.9 511.9 549.9 506.1 483.7 561.2 562.0
527.1 42.0 8.6 24
515.7 510.0 524.6 492.4 544.5 535.6 513.9 585.4 476.4 544.3 484.2 547.1 477.0 441.3 615.1 601.7 533.9 560.7 514.3 561.2 514.3 497.5 573.3 567.0
530.5 42.2 8.6 24
525.1 517.2 532.8 500.2 552.0 536.7 522.5 594.0 496.0 567.9 489.2 560.1 473.0 447.8 603.1 615.2 545.2 573.4 535.5 572.8 535.1 509.0 576.1 580.7
540.0 41.8 8.5 24
530.8 524.5 541.4 509.0 555.7 542.8 531.1 612.6 503.3 575.9 484.8 575.7 480.4 451.8 641.9 627.6 561.0 582.5 534.9 582.1 537.7 528.1 591.4 592.3
SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97)
550.0 46.8 9.6 24
-163 -
IfisSpS SanHIze. D o es no! co n iato TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
INDIVIDUAL BODY WEIGHTS (g) OF PI MALE RATS AND MORTALITY DATA
GROUP: V-0
DOSE: 10 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72
MEAN S.D. S.E. N
1 8 15 22 28 36 43
276.0 278.4 302.7 291.3 254.5 295.8 294.5 305.4 264.3 288.2 277.4 301.9 274.4 268.1 288.4 302.4 271.8 288.2 294.5 318.0 274.1 290.3 295.8 304.5
287.5 15.3 3.1 24
315.3 318.0 351.9 333.0 278.3 345.7 338.6 359.9 295.5 321.1 306.8 348.9 325.0 302.6 320.2 348.2 305.1 338.4 328.2 353.4 297.9 328.9 337.8 360.2
327.5 22.1 4.5 24
346.9 348.6 386.3 322.4 292.7 388.8 376.4 403.3 330.1 360.9 349.1 397.7 371.1 334.6 367.0 395.6 329.4 380.6 362.0 403.6 331.4 367.7 375.6 406.7
363.7 30.0 6.1 24
384.8 382.7 424.6 380.2 311.4 433.1 409.3 452.9 350.7 397.6 379.8 438.9 394.4 370.7 402.2 430.5 365.3 415.2 396.1 445.7 358.7 395.9 407.2 443.9
398.8 34.1 7.0 24
409.3 404.1 446.3 415.5 329.8 454.0 429.6 465.9 363.9 365.3 401.1 459.8 415.6 387.3 426.8 464.9 390.8 436.0 419.1 475.4 380.8 419.1 431.2 465.8
419.1 37.1 7.6 24
432.7 429.1 469.9 430.1 349.2 479.2 462.2 490.5 372.4 384.8 416.7 485.9 444.3 414.0 454.7 487.6 406.3 458.9 434.9 493.4 400.2 438.2 458.8 483.1
440.7 39.3 8.0 24
459.2 448.1 490.5 430.0 365.9 510.7 477.8 518.7 383.5 430.6 441.2 509.7 464.4 432.4 483.1 514.9 434.4 480.7 440.8 517.3 423.6 453.7 480.5 523.6
463.1 42.4 8.7 24
I
- 164-
Efynpany Sanitized. D oes no! contain TSCA O il
H-24768: One-Generation Reproduction Study in Rats
REPRODUCTIVE AMD F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
DuPont-13784
INDIVIDUAL BODY WEIGHTS (g) OF PI MALE RATS AND MORTALITY DATA
GROUP: V-0
DOSE: 10 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72
MEAN S.D. S.E. N
50 56 63 71 78 85 92
477.6 468.3 506.3 445.0 373.4 532.0 505.8 534.8 393.3 444.7 458.5 528.4 485.8 437.4 499.3 544.8 459.0 493.3 441.8 525.8 434.8 466.3 488.5 546.4
478.8 46.0 9.4 24
497.4 482.1 534.0 466.9 380.9 534.2 512.7 551.7 406.2 471.8 470.7 538.3 508.1 454.8 509.4 556.0 477.5 501.8 444.9 543.6 447.0 477.8 504.8 564.1
493.2 46.5 9.5 24
508.1 496.3 548.3 492.2 397.6 547.8 526.3 563.9 405.8 482.1 485.6 552.8 539.3 464.8 522.2 574.0 487.5 515.8 464.0 553.3 462.4 480.9 508.8 574.6
506.4 47.5 9.7 24
516.1 504.2 557.1 519.2 406.9 570.9 537.8 595.7 409.3 487.4 493.1 567.5 547.6 472.6 538.6 578.3 500.0 521.4 483.5 581.6 475.8 484.1 520.6 580.9
518.8 50.5 10.3 24
526.5 523.6 562.9 532.1 420.4 569.6 536.8 594.1 415.3 482.0 486.5 557.3 544.3 466.7 535.5 593.0 496.1 529.6 490.2 594.5 483.0 480.1 504.9 580.7
521.1 50.2 10.3 24
542.1 536.0 571.0 529.7 438.2 583.8 544.7 600.6 420.5 502.3 506.5 568.0 557.0 474.8 543.5 571.3 499.4 550.7 447.3 610.4 492.4 495.4 536.5 595.7
529.9 51.3 10.5 24
552.2 549.6 577.9 556.0 455.8 589.2 564.7 618.8 427.5 521.9 512.5 581.1 566.1 491.6 551.3 590.0 509.1 548.5 479.6 630.3 499.9 508.6 545.2 605.3
SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97)
543.0 50.6 10.3 24
-165 Cempiffly Sanitized. D oes not contain TSCA CB
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
INDIVIDUAL BODY WEIGHTS (g) OF PI MALE RATS AND MORTALITY DATA
GROUP: VII-0
DOSE: 25 MG/KG/DAY
DAYS ON TEST :
ANIMAL NUMBER
73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96
MEAN S.D. S.E. N
1 8 15 22 28 36 43
264.0 284.4 299.1 310.0 279.7 278.4 292.1 294.2 269.0 292.6 289.2 296.3 291.8 278.4 298.2 298.0 284.5 298.8 292.0 309.8 267.7 291.5 287.6 306.2
289.7 12.3 2.5 24
289.2 332.5 340.1 351.4 311.8 320.9 329.4 337.0 300.2 322.2 326.7 341.3 339.8 329.4 341.9 335.9 332.3 337.1 327.4 361.8 303.4 332.7 318.1 354.3
329.9 16.9 3.5 24
328.8 382.0 381.7 391.4 347.8 356.5 354.0 381.4 326.5 352.6 366.4 372.7 382.5 375.0 382.8 361.4 374.4 373.8 361.7 407.2 343.1 377.3 346.9 390.2
367.4 20.0 4.1 24
357.8 420.8 414.0 427.8 379.4 391.6 386.3 419.1 348.7 381.3 400.5 401.4 406.6 409.9 415.6 387.9 410.7 415.6 397.4 435.7 369.3 410.5 375.9 419.6
399.3 22.3 4.5 24
367.3 447.9 435.2 438.3 401.6 410.0 405.8 441.6 353.3 403.1 421.9 421.0 432.0 431.1 440.6 407.8 431.2 437.9 406.4 459.9 384.6 43 9.0 393.1 443.1
418.9 26.3 5.4 24
377.4 465.7 452.8 453.9 423.9 418.2 428.5 452.5 365.1 424.2 439.9 446.9 459.9 458.6 469.1 427.3 458.1 459.6 440.5 490.6 398.5 461.8 417.4 459.8
439.6 29.5 6.0 24
3 85.3 494.0 468.7 478.9 443.3 433.2 446.6 466.9 366.4 441.9 466.4 474.1 481.1 485.6 486.2 446.8 473.0 488.7 455.6 520.0 422.6 487.-2 441.8 493.0
460.3 34.8 7.1 24
-166
iSaftpiriy Sanitized. Does not contain TSCACB
H-24768: One-Generation Reproduction Study in Rats
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
DuPont-13784
INDIVIDUAL BODY WEIGHTS (g) OF PI MALE RATS AND MORTALITY DATA
GROUP: VII-0
DOSE: 25 MG/KG/DAY
DAYS
ON TEST:
ANIMAL NUMBER
73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96
MEAN S.D. S.E. N
50 56 63 71 78 85 92
393.5 508.6 481.0 481.4 448.0 442.3 463.2 487.3 393.0 456.2 481.3 489.3 494.0 513.9 503.6 459.6 488.8 502.1 473.8 540.8 432.5 503.2 450.5 510.7
474.9 36.1 7.4 24
402.9 522.9 499.6 489.0 464.6 455.6 473.3 501.0 397.5 465.4 491.4 501.2 506.1 526.4 509.8 468.8 503.8 516.0 485.4 555.4 444.9 517.6 471.0 525.4
487.3 37.4 7.6 24
408.6 522.4 499.1 498.7 482.8 468.8 491.9 515.3 412.7 485.9 507.4 518.6 524.9 543.1 516.7 479.1 518.2 526.1 494.4 569.9 460.0 525.6 481.6 537.1
499.5 37.1 7.6 24
409.1 551.2 522.2 511.5 503.4 485.6 502.5 540.6 418.1 491.3 511.0 538.5 540.3 554.7 522.5 486.8 530.2 534.8 501.0 588.9 473.4 543.7 492.9 554.1
512.8 41.0 8.4 24
408.2 546.5 532.6 531.3 509.0 482.4 500.7 562.0 416.6 486.0 495.8 541.7 529.4 555.0 522.9 487.9 542.4 526.4 509.0 596.0 463.8 547.6 492.9 554.4
514.2 43.7 8.9 24
417.0 566.8 557.0 531.7 523.0 495.8 511.6 581.4 431.9 504.2 521.9 563.9 543.3 566.2 530.8 493.4 554.9 526.9 513.4 607.4 474.4 559.8 514.0 564.9
527.3 44.5 9.1 24
412.9 579.1 571.7 544.7 524.7 499.9 526.5 590.5 427.4 515.3 537.4 567.7 556.1 574.5 531.2 503.9 558.8 529.7 512.5 617.3 468.8 562.2 516.9 563.0
SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 96) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97) SD (DAY 97)
533.0 47.9 9.8 24
-167Coiftpafiy Sanitize. oes no contain TSCA CBT
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX I INDIVIDUAL BODY WEIGHT GAINS OF Pi MALE RATS
-168Ifefftpariy HaftlHzeS. Goes no! contain TSCA GBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL BODY WEIGHT GAINS OF Pi MALE RATS EXPLANATORY NOTES
Notes
Test Days 1-73 = Premating period Test Days 73-87 = Cohabitation period
Abbreviations
Summary Section SD. = Standard Deviation S.E. = Standard Error N = Number in Group
-169^ t p n y Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 76 8
DuPont-13784
DAYS ON TEST:
ANIMAL NUMBER
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
MEAN S.D. S.E. N
INDIVIDUAL BODY WEIGHT GAINS (g) OF PI MALE RATS
GROUP: 1-0
DOSE: 0 MG/KG/DAY
1-8
8-15
15-22
22-28
28-36
36-43
43-50
44.6 38.9 36.5 44.6 47.4 45.0 46.7 36.5 28.1 34.4 35.8 35.0 40.0 36.0 44.8 55.3 25.8 16.4 36.9 42.0 46.4 37.3 38.5 37.8
38.8 8.0 1.6
24
40.7 10.7 37.4 40.9 37.5 43.8 43.4 33.3 41.9 42.0 44.1 35.7 35.4 28.8 44.1 42.2 41.8 23.5 44.2 34.8 40.8 38.1 41.5 31.8
37.4 7.8 1.6
24
33.1 15.1 37.7 39.1 35.8 43.6 45.6 34.3 27.1 35.9 33.4 20.9 38.2 32.3 35.1 41.7 25.8 31.9 35.2 27.4 29.0 29.9 35.1 35.8
33.3 6.9 1.4
24
18.3 30.1 23.8 25.0 21.8 27.7 23.5 21.8 22.5 25.6 22.8 28.6 21.7
7.5 21.3 23.0 19.8 13.7 16.9 27.5 24.0 21.8 23.1 13.2
21.9 5.1 1.0
24
15.0 20.7 35.8 28.5 26.4 29.9 40.8 19.6 24.7 27.2 31.8 20.3 27.2 24.3 27.3 33.8 26.9 16.3 36.6 18.5 25.5 16.6 27.3 20.8
25.9 6.7 1.4
24
32.5 30.1 20.6 16.6 20.1 28.9 25.9 20.0 14.4 35.4 17.1 13.6 23.7 21.1 16.9 10.2 22.7 20.3 20.6 21.8 24.2 18.7 13.5 19.7
21.2 6.1 1.2
24
17.1 16.2 10.3 20.3 11.6 26.5 17.5 -46.3 18.0 17.8 21.1 12.6
9.7 15.3 12.3 18.4
8.9 14.9 16.7 -7.2
9.3 9.5 15.8 17.2
11.8 13.9
2.8 24
-170Ip ttp a iiy Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
^4768
hbj
DAYS ON TEST:
SfIMAL NUMBER
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
MEAN S.D. S.E. N
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
INDIVIDUAL BODY WEIGHT GAINS (g) OF PI MALE RATS
GROUP: 1-0
DOSE: 0 MG/KG/DAY
50-56
56-63
63-71
71-78
78-85
85-92
1-92
6.7 18.3 -4.6 11.1
9.6 8.5 5.0 33.8 11.8 6.5 6.3 24.0 13.7 9.7 11.0 11.6 13.8 12.2 2.7 19.9 15.5 5.8 13.3 12.3
11.6 7.5 1.5
24
13.3 3.9
14.2 10.7
6.8 19.4 27.9 27.9
8.3 10.5 19.7
6.9 11.8 12.5
4.6 11.0
9.5 6.3 12.1 16.6 10.8 19.4 3.7 14.8
12.6 6.6 1.3
24
9.2 -0.6 11.9
7.5 -0.1 20.6 12.6 17.3
0.3 15.5
5.6 8.4 14.1 20.0 14.4 12.1 12.3 2.3 7.4 12.5 17.0 7.3 8.5 17.0
10.5 6.1 1.2
24
13.3 25.5
1.4 7.7 -5.2 2.4 8.5 8.7 2.7 15.5 8.6 -7.4 10.0 -5.8 -5.9 -22.4 -9.9 -7.4 -1.9 1.5 5.2 4.7 11.7 -3.7
2.4 10.1
2.1 24
21.0 14.7
8.1 6.5 11.4 22.1 13.0 10.2 -23.5 12.0 8.5 10.8 15.2 15.2 15.5 24.0 10.1 31.1 13.8 18.0 14.5 19.0 -4.3 18.9
12.7 10.3
2.1 24
6.4 6.1 6.7 17.5 13.3 17.6 12.9 5.3 37.1 -6.3 12.1 9.8 4.7 4.5 5.6 9.4 0.2 -13.3 5.3 8.4 7.4 -7.2, 9.7 7.7
7.5 9.6 2.0 24
271.2 229.7 239.8 276.0 236.4 336.0 323.3 222.4 213.4 272.0 266.9 219.2 265.4 221.4 247.0 270.3 207.7 168.2 246.5 241.7 269.6 220.9 237.4 243.3
247.7 36.0 7.3 24
- 171 Company Sanitized. D oes not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H^4768 _
M]
DAYS ON TEST:
ANIMAL NUMBER
25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48
MEAN S.D. S.E. N
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 76 8
INDIVIDUAL BODY WEIGHT GAINS (g) OF PI MALE RATS
GROUP: III- 0
DOSE: 1 MG/KG/DAY
1-8
8-15
15-22
22-28
28-36
36-43
43-50
39.5 40.6 32.7 31.6 59.1 41.9 21.8 34.1 29.1 49.2 28.7 49.7 25.9 31.1 53.5 55.1 56.0 47.0 32.5 42.8 31.5. 31.5 46.7 38.4
39.6 10.5
2.1 24
33.2 38.2 38.0 23.1 51.5 43.9 34.3 48.0 26.2 43.8 40.3 36.7 29.5 28.7 51.6 47.6 57.7 46.0 38.8 39.0 37.3 32.3 41.4 44.6
39.7 8.5 1.7
24
30.2 24.7 33.4 29.9 28.7 34.1 37.2 43.5 26.8 30.5 24.6 34.8 27.8 22.3 44.6 41.1 35.9 38.1 34.3 36.8 29.8 30.0 42.1 47.1
33.7 6.7 1.4
24
23.5 20.6 19.4 16.6 17.8 30.9 20.3 21.9 19.1 26.0 16.2 24.1 17.2 16.0 34.0 25.2 17.9 26.7 21.9 17.0 21.2 12.5 20.0 21.2
21.1 4.9 1.0
24
32.1 21.3 30.8 24.5 19.8 16.0 27.6 39.8 22.5 21.3 31.2 31.1 37.0 26.5 32.7 32.3 18.9 26.6 24.5 19.4 28.7 27.2 24.2 19.3
26.5 6.1 1.2
24
24.2 35.4 22.1 24.6 14.0 24.8 26.9 33.5 18.0 31.9 23.6 31.3 22.8 12.7 24.8 27.7 18.7 25.0 21.2 20.0 25.3 14.3 23.7 28.4
24.0 5.9 1.2
24
18.7 17.6 13.7 11.3 21.2 14.1 19.6 18.2 14.8
6.6 8.5 13.9 18.1 13.7 25.4 8.6 18.3 17.2 19.7 11.3 9.9 9.9 20.6 17.1
15.3 4.7 1.0
24
- 172-
'fstipany Sanitized. D oes not contain TSCA C8I
H-24768: One-Generation Reproduction Study in Rats
REPRODUCTIVE AMD F E R T IL IT Y EFFECTS WITH H -2 4 76 8
DuPont-13784
DAYS ON TEST:
ANIMAL NUMBER
25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48
MEAN S.D. S.E. N
INDIVIDUAL BODY WEIGHT GAINS (g) OF PI MALE RATS
GROUP: III-O
DOSE: 1 MG/KG/DAY
50-56
56-63
63-71
71-78
78-85
85-92
1-92
13.5 7.8
13.8 14.8 10.5
8.4 13.6 18.8 11.1 20.6 11.8 12.9 21.8
5.3 16.2 16.7 11.3 11.8
8.9 14.7
6.7 13.8 10.8 21.6
13.2 4.5 0.9
24
20.4 12.7
9.7 22.2
6.2 20.4 18.6 15.4 14.1 20.8
0.8 18.1 12.2
7.4 20.8 15.8
4.8 19.0 11.5 12.8 16.2 11.2 10.8
9.6
13.8 5.7 1.2
24
19.0 4.9 8.1 7.2 8.1 7.6
15.5 18.4 16.8
7.6 15.9 11.9 10.7
5.4 6.3 15.6 21.3 13.7 10.0 24.3 20.8 15.2 16.4 24.5
13.6 6.0 1.2
24
14.7 9.4
12.3 - 1.0 10.8 11.6
0.7 -5.4 -5.2 -3.3 10.4 -18.3 -21.5
2.0 -1.7 14.4 -5.6
3.8 2.4 11.3 8.2 13.8 12.1 5.0
3.4 9.8 2.0 24
9.4 7.2 8.2 7.8 7.5 1.1 8.6 8.6 19.6 23.6 5.0 13.0 -4.0 6.5 -12.0 13.5 11.3 12.7 21.2 11.6 20.8 11.5 2.8 13.7
9.6 7.9 1.6 24
5.7 7.3 8.6 8.8 3.7 6.1 8.6 18.6 7.3 8.0 -4.4 15.6 7.4 4.0 38.8 12.4 15.8 9.1 -0.6 9.3 2.6 19.1 15.3 11.6
9.9 8.3 1.7 24
284.1 247.7 250.8 221.4 258.9 260.9 253.3 313.4 220.2 286.6 212.6 274.8 204.9 181.6 335.0 326.0 282.3 296.7 246.3 270.3 259.0 242.3 286.9 302.1
263.3 38.3 7.8 24
- 173Efompany S an itized Does not confalo TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 76 8
DuPont-13784
DAYS ON TEST:
ANIMAL NUMBER
49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65
66
67 68 69 70 71 72
MEAN S.D. S.E. N
INDIVIDUAL BODY WEIGHT GAINS (g) OF PI MALE RATS
GROUP: V-0
DOSE: 10 MG/KG/DAY
1 CO
8-15
15-22
22-28
28-36
36-43
43-50
39.3 39.6 49.2 41.7 23.8 49.9 44.1 54.5 31.2 32.9 29.4 47.0 50.6 34.5 31.8 45.8 33.3 50.2 33.7 35.4 23.8 38.6 42.0 55.7
39.9 9.2 1.9
24
31.6 30.6 34.4 -10.6 14.4 43.1 37.8 43.4 34.6 39.8 42.3 48.8 46.1 32.0 46.8 47.4 24.3 42.2 33.8 50.2 33.5 38.8 37.8 46.5
36.2 13.0
2.7 24
37.9 34.1 38.3 57.8 18.7 44:'3 32.9 49.6 20.6 36.7 30.7 41.2 23.3 36.1 35.2 34.9 35.9 34.6 34.1 42.1 27.3 28.2 31.6 37.2
35.1 8.6 1.7
24
24.5 21.4 21.7 35.3 18.4 20.9 20.3 13.0 13.2 -32.3 21.3 20.9 21.2 16.6 24.6 34.4 25.5 20.8 23.0 29.7 22.1 23.2 24.0 21.9
20.2 12.3
2.5 24
23.4 25.0 23.6 14.6 19.4 25.2 32.6 24.6
8.5 19.5 15.6 26.1 28.7 26.7 27.9 22.7 15.5 22.9 15.8 18.0 19.4 19.1 27.6 17.3
21.7 5.6 1.1
24
26.5 19.0 20.6 -0.1 16.7 31.5 15.6 28.2 11.1 45.8 24.5 23.8 20.1 18.4 28.4 27.3 28.1 21.8
5.9 23.9 23.4 15.5 21.7 40.5
22.4 9.7 2.0
24
18.4 20.2 15.8 15.0
7.5 21.3 28.0 16.1
9.8 14.1 17.3 18.7 21.4
5.0 16.2 29.9 24.6 12.6
1.0 8.5 11.2 12.6 8.0 22.8
15.7 7.1 1.5
24
- 174-
Company Sanitized. Does not contain tsca CBI
H-24768: One-Generation Reproduction Study in Rats
REPRODUCTIVE AMD F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
DuPont-13784
DAYS ON TEST:
ANIMAL NUMBER
49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72
MEAN S.D. S.E. N
INDIVIDUAL BODY WEIGHT GAINS (g) OF PI MALE RATS
GROUP: V-0
DOSE: 10 MG/KG/DAY
50-56
56-63
63-71
71-78
78-85
85-92
1-92
19.8 13.8 27.7 21.9
7.5 2.2 6.9 16.9 12.9 27.1 12.2 9.9 22.3 17.4 10.1 11.2 18.5 8.5 3.1 17.8 12.2 11.5 16.3 17.7
14.4 6.7 1.4
24
10.7 14.2 14.3 25.3 16.7 13.6 13.6 12.2 -0.4 10.3 14.9 14.5 31.2 10.0 12.8 18.0 10.0 14.0 19.1
9.7 15.4
3.1 4.0 10.5
13.2 6.5 1.3
24
8.0 7.9 8.8 27.0 9.3 23.1 11.5 31.8 3.5 5.3 7.5 14.7 8.3 7.8 16.4 4.3 12.5 5.6 19.5 28.3 13.4 3.2 11.8 6.3
12.3 8.1 1.7
24
10.4 19.4
5.8 12.9 13.5 -1.3 - 1.0 -1.6
6.0 -5.4 -6.6 -10.2 -3.3 -5.9 -3.1 14.7 -3.9
8.2 6.7 12.9 7.2 -4.0 -15.7 -0.2
2.3 8.9 1.8 24
15..6 12..4
8..1 -2 ,.4 17 .8 14..2
7 .9 6..5 5..2 20..3 20..0 10..7 12 .7 8,.1 8..0 -21..7 3..3 21,.1 -42 .9 15,.9 9..4 15..3 31..6 15..0
8..8 14..8
3 .0 24
10 .1 13 .6
6..9 26..3 17..6
5..4 20..0 18..2
7 ,.0 19..6
6..0 13 .1
9 .1 16..8
7 .8 18..7
9..7 -2 .2 32 .3 19..9
7 .5 13 .2
8..7 9..6
13 .1 7 .6 1..5
24
276..2 271..2 275..2 264,.7 201,.3 293 ,.4 270..2 313 ,.4 163 .2 233..7 235..1 279..2 291..7 223 .5 262 .9 287..6 237..3 260..3 185..1 312..3 225..8 218..3 249..4 300.,8
255..5 39..2 8..0 24
- 175 Company Sanitized. Does no! contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
1^4768
Jl
DAYS ON TEST:
SFIMAL NUMBER
73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96
MEAN S.D. S.E. N
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
INDIVIDUAL BODY WEIGHT GAINS (g) OF PI MALE RATS
GROUP: VII- 0
DOSE: 25 MG/KG/DAY
1-8
8-15
15-22
22-28
28-36
36-43
43-50
25.2 48.1 41.0 41.4 32.1 42.5 37.3 42.8 31.2 29.6 37.5 45.0 48.0 51.0 43.7 37.9 47.8 38.3 35.4 52.0 35.7 41.2 30.5 48.1
40.1 7.2 1.5
24
39.6 49.5 41.6 40.0 36.0 35.6 24.6 44.4 26.3 30.4 39.7 31.4 42.7 45.6 40.9 25.5 42.1 36.7 34.3 45.4 39.7 44.6 28.8 35.9
37.6 6.9 1.4
24
29.0 38.8 32.3 36.4 31.6 35.1 32.3 37.7 22.2 28.7 34.1 28.7 24.1 34.9 32.8 26.5 36.3 41.8 35.7 28.5 26.2 33.2 29.0 29.4
31.9 4.8 1.0
24
9.5 27.1 21.2 10.5 22.2 18.4 19.5 22.5
4.6 21.8 21.4 19.6 25.4 21.2 25.0 19.9 20.5 22.3
9.0 24.2 15.3 28.5 17.2 23.5
19.6 6.0 1.2
24
10.1 17.8 17.6 15.6 22.3
8.2 22.7 10.9 11.8 21.1 18.0 25.9 27.9 27.5 28.5 19.5 26.9 21.7 34.1 30.7 13.9 22.8 24.3 16.7
20.7 6.9 1.4
24
7.9 28.3 15.9 25.0 19.4 15.0 18.1 14.4
1.3 17.7 26.5 27.2 21.2 27.0 17.1 19.5 14.9 29.1 15.1 29.4 24.1 25.4 24.4 33.2
20.7 7.4 1.5
24
8.2 14.6 12.3
2.5 4.7 9.1 16.6 20.4 26.6 14.3 14.9 15.2 12.9 28.3 17.4 12.8 15.8 13.4 18.2 20.8 9.9 16.0 8.7 17.7
14.6 6.0 1.2
24
-176Stompany Sanitized. Does not contain TSCA Cfl?
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
3#24768 *
3
DAYS ON TEST:
3IMAL NUMBER
73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96
MEAN S.D. S.E. N
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL BODY WEIGHT GAINS (g) OF PI MALE RATS
GROUP: VII- 0
DOSE: 25 MG/KG/DAY
50-56
56-63
63-71
71-78
78-85
85-92
1-92
9.4 14.3 18.6
7.6 16.6 13.3 10.1 13.7
4.5 9.2 10.1 11.9 12.1 12.5 6.2 9.2 15.0 13.9 11.6 14.6 12.4 14.4 20.5 14.7
12.4 3.7 0.8
24
5.7 -0.5 -0.5
9.7 18.2 13.2 18.6 14.3 15.2 20.5 16.0 17.4 18.8 16.7
6.9 10.3 14.4 10.1
9.0 14.5 15.1
8.0 10.6 11.7
12.2 5.6 1.1
24
0.5 28.8 23.1 12.8 20.6 16.8 10.6 25.3
5.4 5.4 3.6 19.9 15.4 11.6 5.8 7.7 12.0 8.7 6.6 19.0 13.4 18.1 11.3 17.0
13.3 7.3 1.5
24
-0.9 -4.7 10.4 19.8
5.6 -3.2 -1.8 21.4 -1.5 -5.3 -15.2
3.2 -10.9
0.3 0.4 1.1 12.2 -8.4 8.0 7.1 -9.6 3.9 0.0 0.3
1.3 8.9 1.8 24
8.8 20.3 24.4
0.4 14.0 13.4 10.9 19.4 15.3 18.2 26.1 22.2 13.9 11.2
7.9 5.5 12.5 0.5 4.4 11.4 10.6 12.2 21.1 10.5
13.1 6.9 1.4
24
-4.1 12.3 14.7 13.0
1.7 4.1 14.9 9.1 -4.5 11.1 15.5 3.8 12.8 8.3 0.4 10.5 3.9 2.8 -0.9 9.9 -5.6 2.4 2.9 -1.9
5.7 6.6 1.4 24
148.9 294.7 272.6 234.7 245.0 221.5 234.4 296.3 158.4 222.7 248.2 271.4 264.3 296.1 233.0 205.9 274.3 230.9 220.5 307.5 201.1 270.7 229.3 256.8
243.3 40.5 8.3 24
- 177ICompany Sanitized. Does not contain TSCA CB<
*
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX J INDIVIDUAL BODY WEIGHTS OF Pi FEMALE RATS DURING PREMATING
AND MORTALITY DATA
- 178 Company Sanitized. Does not contain TSCA C!
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
Note Test Day 71
INDIVIDUAL BODY WEIGHTS OF Pi FEMALE RATS DURING PREMATING AND MORTALITY DATA EXPLANATORY NOTES
== Last day of premating period that data were recorded.
Abbreviations
SD = Sacrificed by design
Summary Section SD. = Standard Deviation S.E. = Standard Error N = Number in Group
- 179Cbmpany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 76 8
INDIVIDUAL BODY WEIGHTS (g) OF P I FEMALE RATS DURING PREMATING AND MORTALITY DATA
GROUP: II-O
DOSE: 0 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120
MEAN S.D. S.E. N
1 8 15 22 28 36 43
204.3 195.2 207.9 219.4 199.2 188.2 201.8 214.2 198.5 206.9 205.1 220.6 194.5 204.9 207.7 214.5 192.0 209.6 218.3 201.0 212.8 202.6 208.8 226.7
206.4 9.6 2.0
24
213.9 210.5 218.0 232.6 210.5 200.4 219.0 218.0 222.7 216.9 239.1 236.3 212.9 227.6 233.9 236.1 217.0 231.0 225.7 202.1 220.8 202.3 222.7 239.9
221.2 11.7 2.4 24
235.0 222.9 230.2 256.6 222.6 217.3 231.9 233.0 233.0 234.6 253.1 246.6 214.4 243.4 239.4 245.7 219.6 244.2 252.4 222.1 234.1 221.7 238.9 248.4
235.0 12.1 2.5 24
239.1 223.5 251.2 262.2 244.5 221.8 242.7 249.8 244.8 232.4 280.1 270.1 223.5 265.0 253.8 243.4 242.9 248.5 257.3 231.4 244.3 246.5 249.6 256.0
246.8 14.4 2.9 24
251.5 240.7 251.0 267.0 253.0 234.2 259.5 244.6 257.7 253.0 277.0 282.1 246.0 274.6 264.7 268.2 246.5 270.8 271.1 232.9 262.7 282.8 270.4 279.0
260.0 14.8 3.0 24
262.5 250.1 260.7 271.1 266.7 240.3 268.7 255.2 272.6 266.4 289.1 292.6 255.3 284.4 276.6 261.8 269.7 286.6 281.9 247.0 277.8 258.5 274.7 288.1
269.1 14.1 2.9 24
267.4 265.7 275.1 279.2 262.1 252.0 280.2 275.7 278.6 269.0 300.9 304.3 258.8 294.6 286.1 278.3 266.1 293.6 285.8 252.2 277.5 267.1 285.1 291.6
277.0 14.2 2.9 24
- 180Kfrmpany Sanitized. Does not contain TSCA CBl
H-24768: One-Generation Reproduction Study in Rats
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 76 8
H# 24768 _
wKKmJ INDIVIDUAL BODY WEIGHTS (g) o f PI FEMALE RATS DURING PREMATING .
GROUP: II -0
DOSE: 0 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120
MEAN S.D. S.E. N
50 56 63 71
265.4 260.1 275.3 288.9 279.0 250.7 289.7 279.8 281.4 264.1 304.5 318.5 252.2 290.2 286.5 270.7 274.0 287.2 285.4 248.2 291.9 262.8 279.9 286.0
278.0 16.8 3.4 24
276.5 272.2 271.1 283.2 281.7 274.1 303.1 273.5 288.0 279.8 312.7 321.1 271.4 303.5 294.6 290.0 273.1 309.3 292.2 248.5 289.7 269.7 300.8 310.6
287.1 17.4 3.5 24
282.4 275.5 291.3 285.3 279.0 276.4 298.6 289.3 292.8 278.2 311.5 317.4 277.5 309.1 298.9 293.7 288.9 310.6 312.6 251.2 307.2 271.1 299.9 306.1
291.9 16.2 3.3 24
282.0 285.3 290.9 303.1 286.0 285.4 302.9 294.7 295.7 285.8 314.0 324.1 286.7 319.2 307.7 305.7 291.5 324.0 310.1 270.2 306.1 284.9 312.1 318.5
SD (DAY 101) SD (DAY 110} SD (DAY 102) SD (DAY 106) SD (DAY 101) SD (DAY 101) SD (DAY 102) SD (DAY 103) SD (DAY 104) SD (DAY 100) SD (DAY 107) SD (DAY 101) SD (DAY 101) SD (DAY 103) SD (DAY 104) SD (DAY 104) SD (DAY 100) SD (DAY 104) SD (DAY 103) SD (DAY 101) SD (DAY 101) SD (DAY 103) SD (DAY 101) SD (DAY 100)
299.4 14.9 3.0 24
DuPont-13784
- 181 -
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
24768
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 76 8
IN D IVID U AL BODY WEIGHTS (g) OF P I FEMALE RATS DURING PREMATING AND MORTALITY DATA
GROUP: IV-0
DOSE: 1 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144
MEAN S.D. S.E. N
1 8 15 22 28 36 43
192.5 210.6 208.8 224.6 195.7 207.1 200.5 227.2 179.0 217.2 210.8 221.5 190.1 203.1 206.7 232.6 203.7 212.4 212.0 212.8 192.8 226.0 205.8 223.4
209.0 13.2 2.7 24
213.1 217.5 223.3 234.3 206.8 222.6 202.6 247.3 187.4 230.6 238.8 244.9 198.4 227.5 227.0 238.2 211.0 229.3 226.1 213.2 214.1 228.7 226.1 234.6
222.6 14.7 3.0 24
226.0 229.8 232.9 253.4 213.6 221.8 214.2 262.4 208.8 247.9 244.6 255.6 202.2 241.0 238.3 252.1 222.6 240.7 244.6 237.7 224.7 245.2 241.6 244.6
235.3 15.7 3.2 24
231.5 250.5 244.2 255.1 233.2 239.7 210.5 285.6 224.5 248.5 257.8 269.2 210.4 244.3 248.2 279.6 230.7 252.8 258.4 246.6 234.3 256.4 251.0 242.3
246.1 18.2 3.7 24
255.3 253.9 258.1 274.8 239.2 248.0 227.3 299.5 233.6 257.1 271.1 296.7 225.2 262.2 264.5 316.5 247.1 254.5 254.0 244.4 253.1 258.6 254.7 258.3
258.7 21.5 4.4 24
270.0 271.1 261.0 285.8 254.4 264.5 239.9 313.3 236.5 268.3 285.3 313.2 227.2 255.4 286.2 302.4 259.0 275.5 265.4 275.2 263.4 271.9 267.9 268.6
270.1 21.1 4.3 24
254.8 274.0 266.6 294.5 263.4 262.0 237.0 319.3 247.5 274.3 283.3 307.4 228.5 266.8 288.0 316.0 261.9 285.7 281.9 269.5 270.1 278.5 278.4 273.8
274.3 21.8 4.4 24
- 182 mpany Sanitized. D oes noi contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AMD F E R T IL IT Y EFFECTS WITH H -2 4 76 8
INDIVIDUAL BODY WEIGHTS (g) OF PI FEMALE RATS DURING PREMATING AND MORTALITY DATA
GROUP: IV-0
DOSE: 1 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144
MEAN S.D. S.E. N
50 56 63 71
271 6 292 2 262 7 294 7 265 4 269 1 244 9 320 7 255 3 282 7 279 9 310 7 232 4 275 2 299 8 320 7 264 3 289 8 285 5 299 9 273 4 274 8 281 1 276 1
280 1 21 6 44
24
280.0 302.5 276.6 311.8 271.3 268.9 255.3 328.0 254.7 285.5 292.8 317.5 242.7 282.5 299.5 322.2 280.3 302.9 279.5 304.3 284.6 287.5 307.0 283.5
288.4 21.6
4.4 24
277.6 300.5 283.1 316.3 278.3 276.9 250.8 342.3 263.2 298.7 295.6 332.7 248.7 294.6 329.7 327.4 268.4 308.5 290.1 300.4 282.3 296.2 319.8 282.7
294.4 25.0 5.1 24
276.6 304.9 292.7 321.8 283.0 282.8 263.5 346.2 268.4 297.4 296.3 340.1 251.0 300.2 333.0 338.8 290.6 321.8 314.5 307.7 291.3 291.9 306.1 279.8
SD (DAY 102) SD (DAY 102) SD (DAY 100) SD (DAY 100) SD (DAY 101) SD (DAY 103) SD (DAY 104) SD (DAY 103) SD (DAY 103) SD (DAY 101) SD (DAY 100) SD (DAY 103) SD (DAY 103) SD (DAY 101) SD (DAY 101) SD (DAY 100) SD (DAY 100) SD (DAY 104) SD (DAY 103) SD (DAY 110) SD (DAY 100) SD (DAY 102) SD (DAY 103) SD (DAY 102)
300.0 24.8 5.1 24
-183Sanitized. D oes not contain TSCA CBf
Z*"**'''
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL BODY WEIGHTS (g) OF PI FEMALE RATS DURING PREMATING AND MORTALITY DATA
GROUP: VI-0
DOSE: 10 MG/KG/DAY
DAYS ON TEST :
ANIMAL NUMBER
145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
MEAN S.D. S.E. N
1 8 15 22 28 36 43
182.9 200.0 203.5 211.4 201.5 216.6 214.7 214.6 208.5 203.1 209.6 218.2 198.8 207.4 223.8 212.9 187.1 210.6 205.4 210.8 179.0 198.0 202.6 212.4
205.6 10.9 2.2 24
203.2 213.7 216.0 227.6 220.8 235.5 227.5 230.0 223.9 228.0 231.9 228.4 214.9 218.4 248.9 231.3 202.9 230.7 210.6 238.3 181.0 206.5 218.2 228.1
221.5 14.2 2.9 24
212.5 218.2 224.3 242.0 243.8 256.8 245.5 249.3 240.9 243.4 238.6 241.2 231.1 237.1 277.0 235.0 215.5 235.0 230.1 264.4 204.3 211.0 226.6 245.6
236.2 17.1 3.5 24
222.2 240.3 237.6 265.5 258.1 257.3 267.7 267.5 245.8 253.9 263.6 263.9 246.9 240.0 301.4 252.2 233.3 248.2 256.5 259.6 214.6 229.3 243.0 265.6
251.4 18.1 3.7 24
233.8 246.4 243.2 270.0 276.8 268.9 277.9 252.6 263.8 260.4 275.3 267.5 275.4 255.0 319.4 253.0 231.0 267.6 254.8 268.7 222.4 230.7 240.8 254.1
258.7 20.6 4.2 24
230.2 247.3 253.6 281.8 296.0 285.3 280.5 271.6 276.5 277.3 282.3 268.9 277.0 264.1 336.1 267.9 235.1 295.0 272.3 280.4 230.8 246.3 252.5 267.2
269.8 23.4 4.8 24
252.0 263 .2 255.9 286.0 285.2 295.3 302.2 282.6 279.3 284.5 294.6 293.3 278.0 269.7 360.9 268.7 252.1 278.8 272.0 301.6 242.1 257.4 256.3 288.6
279.2 24.2 4.9 24
- 184 Company Sanitized. Does not confab t sc a CBf
H-24768: One-Generation Reproduction Study in Rats
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
DuPont-13784
BODY WEIGHTS (g) OF PI FEMALE RATS DURING PREMATING AND MORTALITY DATA
GROUP: VI-0
DOSE: 10 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
MEAN S.D. S.E. N
50 56 63 71
242.6 264.9 268.8 312.1 281.9 314.7 303.3 294.2 279.0 290.8 293.1 298.3 283.6 268.0 367.5 277.8 256.0 306.3 292.9 295.0 257.3 262.7 268.5 291.3
286.3 25.5 5.2 24
256.7 266.4 273.3 317.7 291.8 326.4 316.0 283.8 280.5 292.7 306.5 296.9 275.3 285.2 369.6 282.0 253.7 316.4 287.6 304.9 259.6 263.7 266.3 280.6
289.7 26.6 5.4 24
258.1 274.4 267.9 318.3 284.5 323.5 337.2 295.5 282.9 288.2 315.6 309.9 299.1 288.6 395.8 278.8 262.5 320.5 287.4 304.2 264.8 268.8 274.8 296.0
295.7 30.2 6.2 24
271.4 272.8 278.2 322.9 284.8 336.0 347.9 308.2 289.0 298.7 319.9 312.3 297.3 296.8 404.7 280.2 267.7 334.8 298.4 335.8 276.7 275.6 286.1 302.4
SD (DAY 104) SD (DAY 102) SD (DAY 107) SD (DAY 102) SD (DAY 101) SD (DAY 101) SD (DAY 107) SD (DAY 103) SD (DAY 103) SD (DAY 103) SD (DAY 101) SD (DAY 102) SD (DAY 104) SD (DAY 101) SD (DAY 101) SD (DAY 101) SD (DAY 103) SD (DAY 101) SD (DAY 101) SD (DAY 107) SD (DAY 101) SD (DAY 103) SD (DAY 104) SD (DAY 102)
304.1 31.6 6.4 24
- 185 .Com pany S anitized. D o es not erta? t s c a CHI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
INDIVIDUAL BODY WEIGHTS (g) OF PI FEMALE RATS DURING PREMATING AND MORTALITY DATA
GROUP: VIII-0
DOSE: 25 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192
MEAN S.D. S.E. N
1 8 15 22 28 36 43
202.2 205.9 206.7 208.7 207.3 200.6 206.7 214.9 201.7 200.4 212.4 224.7 209.8 215.4 212.8 213.5 197.2 195.5 204.1 223.2 193.1 201.4 204.8 235.5
208.3 9.8 2.0
24
215.3 218.9 210.0 218.1 217.0 209.2 218.7 227.5 202.5 216.9 219.1 243.5 218.7 214.2 224.2 212.2 210.6 207.0 208.6 239.3 204.3 210.4 215.7 246.8
217.9 11.5 2.3 24
235.3 233.6 239.7 248.7 237.5 218.4 233.1 243.4 213.1 228.1 223.6 258.0 243.1 232.7 240.4 222.2 227.6 225.6 217.5 262.1 213.2 214.4 235.9 266.3
233.9 14.8 3.0 24
247.8 255.7 249.6 256.1 244.4 236.5 246.8 259.1 228.2 238.1 239.0 261.7 258.5 264.1 247.3 227.1 242.7 235.1 238.3 271.1 215.8 225.5 254.9 275.7
246.6 14.9 3.0 24
250.7 262.1 262.0 258.3 252.5 241.1 239.4 261.2 234.0 246.6 248.7 279.5 272.2 268.3 265.8 234.1 257.7 246.5 244.2 290.1 233.2 227.7 255.8 273.4
254.4 15.8 3.2 24
261.4 269.4 264.7 273.1 257.5 241.8 258.2 273.4 247.2 257.2 265.1 291.3 281.9 279.9 274.5 246.7 270.3 251.4 255.1 282.6 249.4 231.0 272.6 294.1
264.6 15.8 3.2 24
271.2 275.5 273.5 286.2 278.6 262.3 272.6 278.9 252.4 273.6 269.1 303.9 296.0 278.6 287.8 258.0 279.1 259.7 250.6 305.8 252.9 253.7 273.6 309.9
275.1 16.9 3.5 24
- 186 Company Sanitized. Does not contain TSCA CBl
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
INDIVIDUS BODY WEIGHTS (g) OF PI FEMALE RATS DURING PREMATING AND MORTALITY DATA
GROUP: VIII-0
DOSE: 25 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
169 170 171 172 173 174 175 176 177 17 8 179 180 181 182 183 184 185 186 187 188 189 190 191 192
MEAN S.D. S.E. N
50 56 63 71
267.3 291.7 282.3 288.0 286.0 268.8 273.0 289.5 263.1 285.2 272.7 297.4 300.8 293.8 285.8 268.5 278.6 258.8 266.8 296.4 246.7 249.6 289.3 321.3
280.1 17.3 3.5 24
280.3 299.0 290.3 289.3 296.5 261.5 276.7 294.3 270.0 290.7 268.5 316.0 304.0 299.9 296.1 273.8 311.3 261.0 266.1 311.0 261.2 259.1 286.1 310.6
286.4 18.1 3.7 24
281.9 294.0 296.1 296.4 300.3 281.0 290.3 303.5 269.0 297.8 280.8 324.7 310.1 302.2 294.3 267.1 313.7 280.1 265.0 313.2 261.8 264.3 283.3 323.6
291.4 18.4 3.8 24
292.4 302.8 306.5 306.7 311.7 288.9 300.4 306.6 273.9 299.2 292.6 327.5 325.3 295.0 294.3 281.6 308.7 283.4 267.9 318.3 261.6 260.6 293.5 326.4
SD (DAY 102) SD (DAY 102) SD (DAY 100) SD (DAY 103) SD (DAY 100) SD (DAY 103) SD (DAY 100) SD (DAY 103) SD (DAY 101) SD (DAY 103) SD (DAY 107) SD (DAY 101) SD (DAY 103) SD (DAY 102) SD (DAY 100) SD (DAY 107) SD (DAY 103) SD (DAY 100) SD (DAY 101) SD (DAY 101) SD (DAY 101) SD (DAY 102) SD (DAY 102) SD (DAY 102)
296.9 18.9 3.9 24
- 187Company Sanitized. Does not contain TSCA C W
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX K INDIVIDUAL BODY WEIGHT GAINS OF Pi FEMALE RATS DURING PREMATING
- 188 Company Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL BODY WEIGHT GAINS OF Pi FEMALE RATS DURING PREMATING EXPLANATORY NOTES
Note Test Day 71
= Last day of premating period that data were recorded.
Abbreviations
Summary Section S.D. = Standard Deviation S.E. = Standard Error N = Number in Group
- 189jPompany Sanitized. D oes not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 76 8
IVIDUAL BODY WEIGHT GAINS ( g ) OF PI FEMALE RATS DURING PREMATING
GROUP: II-O
DOSE: 0 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120
MEAN S.D. S.E. N
1-8
8-15
15-22
22-28
28-36
36-43
43-50
9.6 15.3 10.1 13.2 11.3 12.2 17.2
3.8 24.2 10.0 34.0 15.7 18.4 22.7 26.2 21.6 25.0 21.4
7.4 1.1 8.0 -0.3 13.9 13.2
14.8 8.3 1.7
24
21.1 12.4 12.2 24.0 12.1 16.9 12.9 15.0 10.3 17.7 14.0 10.3
1.5 15.8
5.5 9.6 2.6 13.2 26.7 20.0 13.3 19.4 16.2 8.5
13.8 6.1 1.2
24
4.1 0.6 21.0 5.6 21.9 4.5 10.8 16.8 11.8 -2.2 27.0 23.5 9.1 21.6 14.4 -2.3 23.3 4.3 4.9 9.3 10.2 24.8 10.7 7.6
11.8 8.8 1.8
24
12.4 17.2 -0.2
4.8 8.5 12.4 16.8 -5.2 12.9 20.6 -3.1 12.0' 22.5 9.6 10.9 24.8 3.6 22.3 13.8 1.5 18.4 36.3 20.8 23.0
13.2 9.8 2.0
24
11.0 9.4 9.7 4.1
13.7 6.1 9.2
10.6 14.9 13.4 12.1 10.5
9.3 9.8 11.9 -6.4 23.2 15.8 10.8 14.1 15.1 -24.3 4.3 9.1
9.1 8.9 1.8 24
4.9 15.6 14.4
8.1 -4.6 11.7 11.5 20.5
6.0 2.6 11.8 11.7 3.5 10.2 9.5 16.5 -3.6 7.0 3.9 5.2 -0.3 8.6 10.4 3.5
7.9 6.1 1.3 24
-2.0 -5.6
0.2 9.7 16.9 -1.3 9.5 4.1 2.8 -4.9 3.6 14.2 -6.6 -4.4 0.4 -7.6 7.9 -6.4 -0.4 -4.0 14.4 -4.3 -5.2 -5.6
1.1 7.4 1.5 24
-190Ifm pany Sanitized. Does not contain TSC*
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
INDIVIDUAL BODY WEIGHT GAINS (g) OF PI FEMALE RATS DURING PREMATING
GROUP: II-O
DOSE: 0 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120
MEAN S.D. S.E. N
50-56
56-63
63-71
1-71
11.1 12.1 -4.2 -5.7
2.7 23.4 13.4 -6.3
6.6 15.7
8.2 2.6 19.2 13.3 8.1 19.3 -0.9 22.1 6.8 0.3 -2.2 6.9 20.9 24.6
9.1 9.5 1.9 24
5.9 3.3 20.2 2.1 -2.7 2.3 -4.5 15.8 4.8 -1.6 -1.2 -3.7 6.1 5.6 4.3 3.7 15.8 1.3 20.4 2.7 17.5 1.4 -0.9 -4.5
4.8 7.6 1.6 24
-0.4 9.8
-0.4 17.8
7.0 9.0 4.3 5.4 2.9 7.6 2.5 6.7 9.2 10.1 8.8 12.0 2.6 13.4 -2.5 19.0 -1.1 13.8 12.2 12.4
7.6 5.8 1.2 24
77.7 90.1 83.0 83.7 86.8 97.2 101.1 80.5 97.2 78.9 108.9 103.5 92.2 114.3 100.0 91.2 99.5 114.4 91.8 69.2 93.3 82.3 103.3 91.8
93.0 11.6
2.4 24
-191 Com pany Sanitized. Does nof
T<?CA OBI
H-24768: One-Generation Reproduction Study in Rats
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
DuPont-13784
IVIDUAL BODY WEIGHT GAINS (g) OF PI FEMALE RATS DURING PREMATING
GROUP: IV-0
DOSE: 1 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144
MEAN S.D. S.E. N
1-8
8-15
15-22
22-28
28-36
36-43
43-50
20.6 6.9
14.5 9.7
11.1 15.5
2.1 20.1
8.4 13.4 28.0 23.4
8.3 24.4 20.3
5.6 7.3 16.9 14.1 0.4 21.3 2.7 20.3 11.2
13.6 7.6 1.6
24
12.9 12.3
9.6 19.1
6.8 -0.8 11.6 15.1 21.4 17.3
5.8 10.7
3.8 13.5 11.3 13.9 11.6 11.4 18.5 24.5 10.6 16.5 15.5 10.0
12.6 5.6 1.1
24
5.5 20.7 11.3
1.7 19.6 17.9 -3.7 23.2 15.7
0.6 13.2 13.6
8.2 3.3 9.9 27.5 8.1 12.1 13.8 8.9 9.6 11.2 9.4 -2.3
10.8 7.8 1.6
24
23.8 3.4
13.9 19 .7
6.0 8.3 16.8 13.9 9.1 8.6 13.3 27.5 14.8 17.9 16.3 36.9 16.4 1.7 -4.4 -2.2 18.8 2.2 3.7 16.0
12.6 9.6 2.0
24
14.7 17.2
2.9 11.0 15.2 16.5 12.6 13.8
2.9 11.2 14.2 16.5
2.0 -6.8 21.7 -14.1 11.9 21.0 11.4 30.8 10.3 13.3 13.2 10.3
11.4 9.1 1.9
24
-15.2 2.9 5.6 8.7 9.0
-2.5 -2.9
6.0 11.0
6.0 -2.0 -5.8
1.3 11.4
1.8 13.6
2.9 10.2 16.5 -5.7
6.7 6.6 10.5 5.2
4.2 7.2 1.5 24
16.8 18.2 -3.9
0.2 2.0 7.1 7.9 1.4 7.8 8.4 -3.4 3.3 3.9 8.4 11.8 4.7 2.4 4.1 3.6 30.4 3.3 -3.7 2.7 2.3
5.8 7.6 1.6 24
- 192jpmpany Sanitized. Does not contain TSCA CSI
H-24768: One-Generation Reproduction Study in Rats
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 76 8
DuPont-13784
IVIDUAL BODY WEIGHT GAINS (g) OF PI FEMALE RATS DURING PREMATING
GROUP: IV-0
DOSE: 1 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
121 122 123 124 125 126 127 12 8 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144
MEAN S.D. S.E. N
50-56
56-63
63-71
1-71
8.4 10.3 13.9 17.1
5.9 -0.2 10.4
7.3 -0.6
2.8 12.9
6.8 10.3
7.3 -0.3
1.5 16.0 13.1 -6.0
4.4 11.2 12.7 25.9
7.4
8.3 6.9 1.4 24
-2.4 -2.0
6.5 4.5 7.0 8.0 -4.5 14.3 8.5 13.2 2.8 15.2 6.0 12.1 30.2 5.2 -11.9 5.6 10.6 -3.9 -2.3 8.7 12.8 -0.8
6.0 8.6 1.8 24
-1.0 4.4 9.6 5.5 4.7 5.9
12.7 3.9 5.2
-1.3 0.7 7.4 2.3 5.6 3.3
11.4 22.2 13.3 24.4
7.3 9.0 -4.3 -13.7 -2.9
5.6 8.0 1.6 24
84.1 94.3 83.9 97.2 87.3 75.7 63.0 119.0 89.4 80.2 85.5 118.6 60.9 97.1 126.3 106.2 86.9 109.4 102.5 94.9 98.5 65.9 100.3 56.4
91.0 18.4
3.8 24
-193 SfPnpany Sanitized. Does no! contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
DuPont-13784
IVIDUAL BODY WEIGHT GAINS (g) OF PI FEMALE RATS DURING PREMATING
GROUP: VI-0
DOSE: 10 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
MEAN S.D. S.E. N
1-8
8-15
15-22
22-28
28-36
36-43
43-50
20.3 13.7 12.5 16.2 19.3 18.9 12.8 15.4 15.4 24.9 22.3 10.2 16.1 11.0 25.1 18.4 15.8 20.1
5.2 27.5
2.0 8.5 15.6 15.7
16.0 6.1 1.2
24
9.3 4.5 8.3 14.4 23.0 21.3 18.0 19.3 17.0 15.4 6.7 12.8 16.2 18.7 28.1 3.7 12.6 4.3 19.5 26.1 23.3 4.5 8.4 17.5
14.7 7.2 1.5
24
9.7 22.1 13.3 23.5 14.3
0.5 22.2 18.2
4.9 10.5 25.0 22.7 15.8
2.9 24.4 17.2 17.8 13.2 26.4 -4.8 10.3 18.3 16.4 20.0
15.2 8.2 1.7
24
11.6 6.1 5.6 4.5
18.7 11.6 10.2 -14.9 18.0
6.5 11.7
3.6 28.5 15.0 18.0
0.8 -2.3 19.4 -1.7
9.1 7.8 1.4 -2.2 -11.5
7.3 10.0
2.0 24
-3.6 0.9
10.4 11.8 19.2 16.4
2.6 19.0 12.7 16.9
7.0 1.4 1.6 9.1 16.7 14.9 4.1 27.4 17.5 11.7 8.4 15.6 11.7 13.1
11.1 7.3 1.5
24
21.8 15.9
2.3 4.2 -10.8 10.0 21.7 11.0 2.8 7.2 12.3 24.4 1.0 5.6 24.8 0.8 17.0 -16.2 -0.3 21.2 11.3 11.1 3.8 21.4
9.3 10.7
2.2 24
-9.4 1.7
12.9 26.1 -3.3 19.4
1.1 11.6 -0.3
6.3 -1.5
5.0 5.6 -1.7 6.6 9.1 3.9 27.5 20.9 -6.6 15.2 5.3 12.2 2.7
7.1 9.7 2.0 24
-194jCompany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
iIVIDUAL BODY WEIGHT GAINS (g) OF PI FEMALE RATS DURING PREMATING
GROUP: VI-0
DOSE: 10 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
MEAN S.D. S.E. N
50-56
56-63
63-71
1-71
14.1 1.5 4.5 5.6 9.9
11.7 12.7 -10.4
1.5 1.9 13.4 -1.4 -8.3 17.2 2.1 4.2 -2.3 10.1 -5.3 9.9 2.3 1.0 -2.2 -10.7
3.5 7.8 1.6 24
1.4 8.0 -5.4 0.6 -7.3 -2.9 21.2 11.7 2.4 -4.5 9.1 13.0 23.8 3.4 26.2 -3.2 8.8 4.1 -0.2 -0.7 5.2 5.1 8.5 15.4
6.0 9.1 1.9 24
13.3 -1.6 10.3
4.6 0.3 12.5 10.7 12.7 6.1 10.5 4.3 2.4 -1.8 8.2 8.9 1.4 5.2 14.3 11.0 31.6 11.9 6.8 11.3 6.4
8.4 6.9 1.4 24
88.5 72.8 74.7 111.5 83.3 119.4 133.2 93.6 80.5 95.6 110.3 94.1 98.5 89.4 180.9 67.3 80.6 124.2 93.0 125.0 97 .7 77.6 83.5 90.0
98.6 24.8
5.1 24
- 195P c p p a n y S anitized. D oes not contain TSCA CB
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
INDIVIDUAL BODY WEIGHT GAINS (g) OF PI FEMALE RATS DURING PREMATING
GROUP: VIII-0
DOSE: 25 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192
MEAN S.D. S.E. N
1-8
8-15
15-22
22-28
28-36
36-43
43-50
13.1 13.0
3.3 9.4 9.7 8.6 12.0 12.6 0.8 16.5 6.7 18.8 8.9 -1.2 11.4 -1.3 13.4 11.5 4.5 16.1 11.2 9.0 10.9 11.3
9.6 5.2 1.1 24
20.0 14.7 29.7 30.6 20.5
9.2 14.4 15.9 10.6 11.2
4.5 14.5 24.4 18.5 16.2 10.0 17.0 18.6
8.9 22.8
8.9 4.0 20.2 19.5
16.0 7.0 1.4
24
12.5 22.1
9.9 7.4 6.9 18.1 13.7 15.7 15.1 10.0 15.4 3.7 15.4 31.4 6.9 4.9 15.1 9.5 20.8 9.0 2.6 11.1 19.0 9.4
12.7 6.6 1.3
24
2.9 6.4 12.4 2.2 8.1 4.6 -7.4 2.1 5.8 8.5 9.7 17.8 13.7 4.2 18.5 7.0 15.0 11.4 5.9 19.0 17.4 2.2 0.9 -2.3
7.7 6.9 1.4 24
10.7 7.3 2.7
14.8 5.0 0.7
18.8 12.2 13.2 10.6 16.4 11.8
9.7 11.6
8.7 12.6 12.6
4.9 10.9 -7.5 16.2
3.3 16.8 20.7
10.2 6.3 1.3
24
9.8 6.1 8.8 13.1 21.1 20.5 14.4 5.5 5.2 16.4 4.0 12.6 14.1 -1.3 13.3 11.3 8.8 8.3 -4.5 23.2 3.5 22.7 1.0 .15.8
10.6 7.4 1.5
24
-3.9 16.2
8.8 1.8 7.4 6.5 0.4 10.6 10.7 11.6 3.6 -6.5 4.8 15.2 -2.0 10.5 -0.5 -0.9 16.2 -9.4 -6.2 -4.1 15.7 11.4
4.9 7.9 1.6 24
-196Sbm pany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 76 8
IITOIVIDUAL BODY WEIGHT GAINS (g) OF Pi FEMALE RATS DURING PREMATING
GROUP: VIII-0
DOSE: 25 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192
MEAN S.D. S.E. N
50-56
56-63
63-71
1-71
13.0 7 .3 8.0 1.3
10.5 -7.3
3.7 4.8 6.9 5.5 -4.2 18.6 3.2 6.1 10.3 5.3 32.7 2.2 -0.7 14.6 14.5 9.5 -3.2 -10.7
6.3 9.0 1.8 24
1.6 -5.0
5.8 7.1 3.8 19.5 13.6 9.2 -1.0 7.1 12.3 8.7 6.1 2.3 -1.8 -6.7 2.4 19.1 -1.1 2.2 0.6 5.2 -2.8 13.0
5.0 7.0 1.4 24
10.5 8.8
10.4 10.3 11.4
7.9 10.1
3.1 4.9 1.4 11.8 2.8 15.2 -7.2 0.0 14.5 -5.0 3.3 2.9 5.1 -0.2 -3.7 10.2 2.8
5.5 6.1 1.2 24
90.2 96.9 99.8 98.0 104.4 88.3 93.7 91.7 72.2 98.8 80.2 102.8 115.5 79.6 81.5 68.1 111.5 87.9 63.8 95.1 68.5 59.2 88.7 90.9
88.6 14.7
3.0 24
- 197ompany Sanitized. Does not contain TSCA CS1
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX L INDIVIDUAL BODY WEIGHTS OF Pi FEMALE RATS DURING GESTATION
- 198 -
Psm pany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL BODY WEIGHTS OF P! FEMALE RATS DURING GESTATION
EXPLANATORY NOTES
Note
This appendix contains data from females with evidence of copulation observed. No gestation data were collected for females with no evidence of copulation (whether a litter was delivered or not).
Abbreviations
G = Gestation NLD = Evidence of copulation observed but no litter delivered;
data excluded from statistical analyses. = No Data
Summary Section S.D. = Standard Deviation S.E. = Standard Error N = Number in Group
-199fjm p an y Sanitized. D oes not contain TSCA CW m.. '
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL BODY WEIGHTS (g) OF PI FEMALE RATS DURING GESTATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
97 98 99 100 101 102 103 104 105 106 107 108 109 10 111 112 113 114 115 116 117 118 119 120
MEAN S.D. S.E. N
0 7 14 21
293.1 303.1 297.0 313.1 291.8 295.5 312.6 305.6 294.3 282.6 316.2 325.7 288.3 322.2 307.5 307.7 288.9 320.4 308.4 275.7 306.7 291.0 315.0
-
302.7 13.3 2.8 23
326.8 324.1 335.4 347.6 325.6 334.8 346.9 357.5 319.7 326.5 334.7 370.1 320.3 365.9 312.9 346.8 322.6 361.1 350.8 305.7 346.8 334.2 338.7
-
337.2 17.1 3.6 23
348.8 354.1 369.6 376.8 355.5 353.1 379.1 387.4 353.9 359.8 334.5 390.9 342.6 389.9 316.1 394.6 356.5 393.3 375.8 342.2 373.5 359.3 358.5
-
363.7 20.5 4.3 23
407.0 461.9 456.8 453.8 412.1 454.0 443.7 464.1 409.9 444.8 322.7 472.2 401.2 451.5 299.8
a 448.7 486.5 462.8 415.4 407.9 438.8 446.7
-
430.1 45.2 9.6 22
ANIMAL STATUS
NLD NLD
Z " * * ''
a Animal delivered prior to collection of Day 21G data.
- 200-
Pmpany sanitized. Does not contain TSCA TM
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
INDIVIDUAL BODY WEIGHTS (g) OF PI FEMALE RATS DURING GESTATION
GROUP: IV-0
DOSE: 1 MG/KG/DAY
GESTATION DAYS :
0
7 14
21
ANIMAL STATUS
ANIMAL NUMBER
121
281.8
320.0
360.2
438.2
122
302.4
339.0
373.4
449.4
123
294.0
324.1
348.4
435.2
124
327.3
356.5
390.3
468.8
125
287.2
304.5
338.9
427.4
126
290.8
327.7
361.0
443.8
127
278.2
321.3
347.6
306.9
NLD
128
349.9
378.4
407.6
485.4
129
269.1
309.5
331.9
388.6
130
296.2
348.6
383.2
416.0
131
294.9
334.2
369.6
417.9
132
335.2
3 82.6
420.5
527.0
133
259.7
294.7
323.3
381.1
134
297.7
329.1
353.2
427.8
135
325.2
359.7
400.7
507.9
136
326.1
360.3
399.2
511.8
137
274.9
310.4
343.8
410.5
138
320.4
330.5
338.2
324.1
NLD
139
313.7
341.3
367.9
452.8
'
140
324.4
324.7
314.4
316.6
NLD
141
290.9
315.8
352.8
435.9
142
293.5
332.6
369.3
442.0
143
309.9' 349.0
372.4
460.5
144
290.2
324.4
355.9
429.6
MEAN S.D. S.E. N
301.4 22.5
4.6 24
334.1 22.2 4.5 24
363.5 26.9 5.5 24
429.4 56.4 11.5 24
-201 -
Company Sanitized. Does not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AMD F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
INDIVIDUAL BODY WEIGHTS (g) OF Pi FEMALE RATS DURING GESTATION
GROUP: VI-0
DOSE: 10 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
MEAN S.D. S.E. N
0 7 14 21
273.7 284.0
~ 329.6 283.6 343.1
-
306.7 297.5 303.3 320.6 314.3 289.5 293.7
288.9 276.8 334.9 302.9
281.6 288.3 279.3 300.9
299.7 20.0 4.5 20
304.8 321.8
-
368.8 326.6 368.1
337.9 334.4 336.7 358.4 344.6 326.9 323.8
-
330.9 305.9 373.5 346.8
314.1 331.7 310.4 344.1
335.5 20.3 4.5 20
296.5 349.7
394.9 355.2 394.5
" 373.0 363.9 366.1 396.2 366.5 337.9 360.9
352.5 330.5 403.0 380.8
" 335.6 365.5 343.0 374.2
362.0 26.0 5.8 20
271.6 440.7
482.9 436.2 456.7
472.1 449.5 475.1 492.1 446.5 341.9 458.6
" 439.7 370.6 479.3 454.2
424.3 425.9 431.2 441.6
434.5 52.3 11.7 20
ANIMAL STATUS
NLD
NLD
- 202-
P&npany Santtee o
ggf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL BODY WEIGHTS (g) OF PI FEMALE RATS DURING GESTATION
GROUP: VIII-0
DOSE: 25 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192
MEAN S.D. S.E. N
0 7 14 21
286.9 323.1 305.9 299.0 310.5 283.7 296.5 316.3 280.5 308.7
-
323.2 321.0
-
300.5
-
323.6 289.8 273.0
-
266.4 268.7 300.1 330.9
300.4 19.6 4.4 20
321.9 362.9 334.6 326.0 334.8 318.0 327.6 341.5 324.3 342.7
350.9 348.3
-
330.1 -
349.6 315.4 317.1
302.1 297.5 340.3 357.8
332.2 17.5 3.9 20
341.0 394.4 362.5 354.1 370.5 341.7 345.7 362.7 354.2 369.6
379.4 376.9
361.8
376.6 351.4 343.2
326.8 323.2 364.8 389.4
359.5 19.2 4.3 20
418.3 463.2 459.2 436.3 463.0 424.9 445.2 442.2 445.7 454.7
470.8 459.8
453.9
460.6 418.1 425.4
411.3 412.2 442.5 466.5
443.7 19.3 4.3 20
ANIMAL STATUS
-203-
S a n R fze ct. o tto e h M n ftfA f f t
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX M INDIVIDUAL BODY WEIGHT GAINS OF Pi FEMALE RATS DURING GESTATION
7
-204-
^m npany Sanitize#. Does no! contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL BODY WEIGHT GAINS OF Pi FEMALE RATS DURING GESTATION
EXPLANATORY NOTES
Note
This appendix contains data from females with evidence of copulation observed. No gestation data were collected for females with no evidence of copulation (whether a litter was delivered or not).
Abbreviations
G = Gestation NLD = Evidence of copulation observed but no litter delivered;
data excluded from statistical analyses. = No Data
Summaiy Section S.D. = Standard Deviation S.E. = Standard Error N = Number in Group
-205EPP>panySanzed. D osano,
Tsca cm
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
J
INDIVIDUAL BODY WEIGHT GAINS (g) OF PI FEMALE RATS DURING GESTATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120
MEAN S.D. S.E. N
0-7
7-14
14-21
0-21
33.7 21.0 38.4 34.5 33.8 39.3 34.3 51.9 25.4 43.9 18.5 44.4 32.0 43.7
5.4 39.1 33.7 40.7 42.4 30.0 40.1 43.2 23.7
-
34.5 10.3
2.2 23
22.0 30.0 34.2 29.2 29.9 18.3 32.2 29.9 34.2 33.3 -0.2 20.8 22.3 24.0
3.2 47.8 33.9 32.2 25.0 36.5 26.7 25.1 19.8
"
26.5 10.3
2.1 23
58.2 107.8
87.2 77.0 56.6 100.9 64.6 76.7 56.0 85.0 -11.8 81.3 58.6 61.6 -16.3
-a 92.2 93.2 87.0 73.2 34.4 79.5 88.2
67.8 31.6
6.7 22
113.9 158.8 159.8 140.7 120.3 158.5 131.1 158.5 115.6 162.2
6.5 146.5 112.9 129.3
-7.7 -a
159.8 166.1 154.4 139.7 101.2 147.8 131.7
-
127.6 45.6 9.7 22
ANIMAL STATUS
NLD NLD
a Animal delivered prior to collection of Day 21G data.
-206Gempany Sanitized. D oes not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 76 8
IVIDUAL BODY WEIGHT GAINS (g) OF PI FEMALE RATS DURING GESTATION
GROUP: IV-0
DOSE: 1 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144
MEAN S.D. S.E. N
0-7
7-14
14-21
0-21
38.2 36.6 30.1 29.2 17.3 36.9 43.1 28.5 40.4 52.4 39.3 47.4 35.0 31.4 34.5 34.2 35.5 10.1 27.6
0.3 24.9 39.1 39.1 34.2
32.7 11.2
2.3 24
40,.2 34,.4 24,.3 33 ,.8 34,.4 33 ,.3 26,.3 29,.2 22 ,.4 34,.6 35,.4 37,.9 28,.6 24,.1 41,.0 38,.9 33 ,.4
7,.7 26,.6 -10,.3 37..0 36,.7 23,.4 31,.5
29,.4 11,.2
2..3 24
78..0 76..0 86..8 78..5 88..5 82,.8 -40..7 77 ,.8 56..7 32,.8 48..3 106..5 57,.8 74..6 107,.2 112..6 66..7 -14..1 84..9
2..2 83 .1 72 .7 88..1 73 .7
65..9 37..3
7,.6 24
156..4 147,,0 141..2 141..5 140..2 153..0
28..7 135,.5 119.,5 119..8 123,.0 191,.8 121..4 130,.1 182..7 185..7 135..6
3 .7 139..1
-7..8 145..0 148..5 150..6 139..4
128..0 50..3 10..3 24
ANIMAL STATUS
NLD
NLD NLD
-207-
Spmpany Sanitized. Does not contain TSCA CBi
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
INDIVIDUAL BODY WEIGHT GAINS (g) OF PI FEMALE RATS DURING GESTATION
GROUP: VI-0
DOSE: 10 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
MEAN S.D. S.E. N
0-7
7-14
14-21
0-21
31.1 37.8
39.2 43.0 25.0
31.2 36.9 33.4 37.8 30.3 37.4 30.1
42.0 29.1 38.6 43.9
32.5 43.4 31.1 43.2
35.9 5.6 1.3
20
-8.3 27.9
26.1 28.6 26.4
35.1 29.5 29.4 37.8 21.9 11.0 37.1
21.6 24.6 29.5 34.0
21.5 33.8 32.6 30.1
26.5 10.3
2.3 20
-24.9 91.0
88.0 81.0 62.2
99.1 85.6 109.0 95.9 80.0
4.0 97.7
87.2 40.1 76.3 73.4
88.7 60.4 88.2 67.4
72.5 32.7
7.3 20
-2.1 156.7
153.3 152.6 113.6
165.4 152.0 171.8 171.5 132.2
52.4 164.9
150.8 93.8
144.4 151.3
142.7 137.6 151.9 140.7
134.9 42.7 9.6 20
ANIMAL STATUS
NLD
NLD
-208-
Company Sanitized. Does not contain TSCA CSf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 76 8
INDIVIDUAL BODY WEIGHT GAINS (g) OF PI FEMALE RATS DURING GESTATION
GROUP: VIII-0
DOSE: 25 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192
MEAN S.D. S.E. N
0-7
7-14
14-21
0-21
35.0 39.8 28.7 27.0 24.3 34.3 31.1 25.2 43.8 34.0
27.7 27.3
29.6
26.0 25.6 44.1
35.7 28.8 40.2 26.9
31.8 6.3 1.4
20
19.1 31.5 27.9 28.1 35.7 23.7 18.1 21.2 29.9 26.9
28.5 28.6
31.7
27.0 36.0 26.1
24.7 25.7 24.5 31.6
27.3 4.8 1.1
20
77.3 68.8 96.7 82.2 92.5 83.2 99.5 79.5 91.5 85.1
91.4 82.9
92.1
84.0 66.7 82.2
84.5 89.0 77.7 77.1
84.2 8.5 1.9
20
131.4 140.1 153.3 137.3 152.5 141.2 148.7 125.9 165.2 146.0
147.6 138.8
153.4
137.0 128.3 152.4
144.9 143.5 142.4 135.6
143.3 9.6 2.1
20
ANIMAL STATUS
-209jPpmpany Sanitized. D oes not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX N INDIVIDUAL BODY WEIGHTS OF PxFEMALE RATS DURING LACTATION
-210l& m pany Sanitized. D oes not contain TSCA CW
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL BODY WEIGHTS OF p! FEMALE RATS DURING LACTATION EXPLANATORY NOTES
Notes
Unless stated otherwise, animals with no data did not deliver a litter and therefore had no lactation data collected.
Test days for animal fates are determined from the initiation of test substance administration.
Abbreviations
SD =
Sacrificed by Design No Data
Summary Section S.D. = Standard Deviation S.E. = Standard Error N = Number in Group
-211 gtompany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 7 6 8
REPRODUCTIVE AND F E R T IL IT Y E FFEC TS WITH H - 2 4 7 6 8
IN D IV ID U A L BODY WEIGHTS ( g ) OF P I FEMALE RATS DURING LACTATION
GROUP: I I - O
DOSE: 0 MG/KG/DAY
LACTATION DAYS :
0
4
ANIMAL NUMBER
97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120
323.9 334.3 339.2 345.9 320.0 324.7 325.2 347.5 326.0 336.6
347.5 280.8 343.5
334.8 326.7 356.3 343.1 305.2 342.8 315.7 307.2 347.8'
339.9 345.5 351.0 360.1 334.4 346.0 345.9 340.6 346.6 336.3
367.8 304.2 360.9
342.1 332.1 370.1 357.7 329.9 344.8 338.6 348.0 357.9
SD (DAY 101) SD (DAY 110) SD (DAY 102) SD (DAY 106) SD (DAY 101) SD (DAY 101) SD (DAY 102) SD (DAY 103) SD (DAY 104) SD (DAY 100) SD (DAY 107) SD (DAY 101) SD (DAY 101) SD (DAY 103) SD (DAY 104) SD (DAY 104) SD (DAY 100) SD (DAY 104) SD (DAY 103) SD (DAY 101) SD (DAY 101) SD (DAY 103) SD (DAY 101) SD (DAY 100)
-212-
SMifeed. Does
TseAca(
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
24768
REPRODUCTIVE AND F E R T IL IT Y EFFE C T S WITH H - 2 4 7 6 8
IN D IV ID U A L BODY WEIGHTS ( g ) OF P I FEMALE RATS DURING LACTA TIO N
GROUP: I V - 0
DOSE: 1 MG/KG/DAY
LACTATION DAYS:
0
4
ANIMAL NUMBER
121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144
304.5 345.9 327.4 342.4 307.9 310.4
373.0 316.2 317.0 372.8 398.2 314.3 316.7 370.4 366.8 333.8
317.4
348.5 334.7 337.7 316.7
345.2 345.2 334.6 354.5 318.4 319.8
391.1 320.0 348.1 351.3 395.0 319.9 332.3 373.8 365.8 327.1
327.6
346.5 350.4 363.6 316.6
SD (DAY 102) SD (DAY 102) SD (DAY 100) SD (DAY 100) SD (DAY 101) SD (DAY 103) SD (DAY 104) SD (DAY 103) SD (DAY 103) SD (DAY 101) SD (DAY 100) SD (DAY 103) SD (DAY 103) SD (DAY 101) SD (DAY 101) SD (DAY 100) SD (DAY 100) SD (DAY 104) SD (DAY 103) SD (DAY 110) SD (DAY 100) SD (DAY 102) SD (DAY 103) SD (DAY 102)
- 213 -
I*PWpany Sanitized. Does not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 7 6 8
REPRODUCTIVE AND F E R T IL IT Y E FF E C T S WITH H - 2 4 7 6 8
IN D IV ID U A L BODY WEIGHTS (g ) OF P I FEMALE RATS DURING LACTATION
GROUP: V I -0
DOSE: 10 MG/KG/DAY
LACTATION DAYS :
0
4
ANIMAL NUMBER
145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
311.9
352.4 305.7 374.7
331.3 328.4 325.5 379.5 352.2
329.9 314.2 331.5 302.0 375.1 343.3
306.9 314.4 310.1 342.6
331.5
363.3 315.1 376.6
330.7 ' 371.5 353.3 368.7 362.5
365.9 428.4 360.2 313.6 365.8 353.2
325.1 358.2 329.8 364.4 '
SD (DAY 104) SD (DAY 102) SD (DAY 107) SD (DAY 102) SD (DAY 101) SD (DAY 101) SD (DAY 107) SD (DAY 103) SD (DAY 103) SD (DAY 103) SD (DAY 101) SD (DAY 102) SD (DAY 104) SD (DAY 101) SD (DAY 101) SD (DAY 101) SD (DAY 103) SD (DAY 101) SD (DAY 101) SD (DAY 107) SD (DAY 101) SD (DAY 103) SD (DAY 104) SD (DAY 102)
-214-
fmpany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND F E R T IL IT Y EFFE C T S WITH H - 2 4 7 6 8
L H# 24768 IN D IV ID U A L BODY W EIGHTS ( g ) OF P I FEMALE RATS DURING LACTATION
GROUP: V I I I - 0
DOSE: 2 5 MG/KG/DAY
LACTATION DAYS :
0
4
ANIMAL NUMBER
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192
'
299.7 353.4 328.1 318.2 328.4 308.8 312.1 335.9 331.7 343.4
329.7 324.4 321.7 326.4
335.9 330.1 305.7 323.7 305.5 310.4 312.8 353.3
322.1 379.9 347.7 336.8 350.3 334.8 343.7 337.0 345.9 355.2
347.5 366.6 358.0 345.8
354.9 323.3 318.9 352.5 319.4 312.1 354.9 373.8
SD (DAY 102) SD (DAY 102) SD (DAY 100) SD (DAY 103) SD (DAY 100) SD (DAY 103) SD (DAY 100) SD (DAY 103) SD (DAY 101) SD (DAY 103) SD (DAY 107) SD (DAY 101) SD (DAY 103) SD (DAY 102) SD (DAY 100) SD (DAY 107) SD (DAY 103) SD (DAY 100) SD (DAY 101) SD (DAY 101) SD (DAY 101) SD (DAY 102) SD (DAY 102) SD (DAY 102)
- 215 -
Company Sanitized. Does not contata TSCA CB
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX O INDIVIDUAL BODY WEIGHT GAINS OF Pi FEMALE RATS DURING LACTATION
-216fCompany Sanitized. D oes not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL BODY WEIGHT GAINS OF Pi FEMALE RATS DURING LACTATION EXPLANATORY NOTES
Notes Unless stated otherwise, animals with no data did not deliver a litter and therefore had no lactation data collected.
Abbreviations
= No Data
Summary Section S.D. = Standard Deviation S.E. = Standard Error N = Number in Group
-217{Company Sanitized. Does not contain TSCA C8I
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
Z*0****.
REPRODUCTIVE AND F E R T IL IT Y E FFE C T S W ITH H - 2 4 7 6 8
,, H# 2 4 7 6 8
fllV l
" IN D IV ID U A L BODY WEIGHT GAINS ( g ) OF P I FEMALE RATS DURING LACTATION
GROUP: I I - O
DOSE: 0 MG/KG/DAY
LACTATION DAYS :
0-4
ANIMAL NIMBER
97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120
16.0 11.2 11.8 14.2 14.4 21.3 20.7 -6.9 20.6 -0.3
20.3 23.4 17.4
7.3 5.4 13.8 14.6 24.7 2.0 22.9 40.8 10.1
-218-
Company Sanitized. Does not contain TSCA CBS
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 7 6 8
REPRODUCTIVE AND F E R T IL IT Y E FF E C T S WITH H - 2 4 7 6 8
IN D IV ID U A L BODY WEIGHT GA IN S ( g ) OF P i FEMALE RATS DURING LACTATION
GROUP: I V - 0
DOSE: 1 MG/KG/DAY
LACTATION DAYS:
0-4
ANIMAL NUMBER
121 40.7 122 -0.7 123 7.2 124 12.1 125 10.5 126 9.4 127 128 18.1 129 3.8 130 31.1 131 -21.5 132 -3.2 133 5.6 134 15.6 135 3.4 136 - 1.0 137 -6.7 138 139 10.2 140 141 -2.0 142 15.7 143 25.9 144 -0.1
- 219 -
j&ompany Sanitized. Does not contain TSCA CB!
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 7 6 8
REPRODUCTIVE AND F E R T IL IT Y EFFE C T S W ITH H - 2 4 7 6 8
IN D IV ID U A L BODY WEIGHT G A IN S ( g ) OF P i FEMALE RATS DURING LACTATION
GROUP: V I - 0
DOSE: 1 0 MG/KG/DAY
LACTATION DAYS:
O!
ANIMAL NUMBER
145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
-
19.6 -
10.9 9.4 1.9
-0.6 43.1 27.8
10.3 -
36.0 114.2 28.7 11.6 -9.3
9.9 -
18.2 43.8 19.7 21.8
OH11 CO
-220JDpmpany Sanitized. Does not contain TSCA Cfil
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4768
REPRODUCTIVE AND F E R T IL IT Y E FFE C T S WITH H - 2 4 7 6 8
1
IN D IV ID U A L BODY WEIGHT GAINS ( g ) OF P i FEMALE RATS DURING LACTATION
GROUP: V I I I - 0
DOSE: 2 5 MG/KG/DAY
LACTATION DAYS:
0-4
ANIMAL NUMBER
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192
22.4 26.5 19.6 18.6 21.9 26.0 31.6 1.1 14.2 11.8
17.8 42.2 36.3 19.4
19.0 -6.8 13.2 28.8 13.9 1.7 42.1 20.5
-221 Pompany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX P INDIVIDUAL FOOD CONSUMPTION BY Pi MALE RATS DURING PREMATING
-2 22 -
gpm panf Sanitized. Does not contain TSCA C8I
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL FOOD CONSUMPTION BY Pi MALE RATS DURING PREMATING EXPLANATORY NOTES
Notes
Test Days 1-73 = Premating period Test Days 73-87 = Cohabitation period
Test Day 71
= Last day of premating period that data were recorded.
Abbreviations
Summary Section SD. = Standard Deviation S.E. = Standard Error N = Number in Group
-223jggmpany Sanitized. Does not contain TSCA C6I
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
^ ^ ^ ^ ^ ^ l T O I V I D U A L FOOD CONSUMPTION (g/day) BY PI MALE RATS DURING PREMATING
GROUP : 1 - 0
DOSE: 0 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
1 2
3 4 5
6
7
8
9
10 11 12
13 14 15 16 17 18 19
20 21 22
23 24
MEAN S.D. S.E. N
1-8
8-15
15-22
22-28
28-36
36-43
43-50
26.3 28.5 27.2 24.6 28.2 26.8 28.4 28.0 24.6 23.6 24.9 24.1 26.0 23.4 25.1 29.0 22.5 23.4 24.7 27.6 29.4 28.3 24.6 28.5
26.2
2.1
0.4 24
26.6 23.8 26.1 26.7 26.0 28.2 28.5 27.6 24.1 25.5 25.7 24.9 25.8 24.6 25.2 29.9 23.5
21.2
25.9 27.0 29.6 29.8 25.8 28.2
26.3
2.1
0.4 24
28.4 23.6 27.0 27.9 26.7 31.1 30.8 29.0 24.3 25.8 26.7 24.8 27.7 24.2 28.0 31.8 24.3 23.8 26.1 27.2 29.5 29.1 28.2 29.2
27.3 2.4 0.5
24
28.0 27.7 29.7 28.8 27.4 31.2 31.6 27.9 25.6 28.0 28.8 26.7 28.1 24.2 27.8 31.4 24.0 24.9 25.9 30.9 29.0 31.4 27.9 27.6
28.1
2.2
0.4 24
29.7 31.2 32.9 29.7 28.0 32.9 31.9 27.4 26.7 28.3 30.4 26.7 29.1 23.9 29.0 31.6 26.8 23.6 28.5 29.6 28.6 29.9 27.2 27.3
28.8 2.4 0.5
24
30.1 29.5 30.5 28.3 27.1 30.9 32.0 26.8 25.4 28.9 29.4 26.1 28.3 23.8 28.2 30.9 26.5 23.7 26.1 28.7 27.8 28.0 24.6 27.2
27.9
2.2
0.5 24
31.0 30.9 28.4 27.7 26.8 31.3 28.9 15.3 25.7 28.2 28.7 26.1 25.7 23.2 26.3 32.1 23.7 23.1 25.1 24.1 25.6 25.6 25.0 27.0
26.5 3.5 0.7
24
-224gSompany Sanitized Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
IVIDUAL FOOD CONSUMPTION (g/day) BY PI MALE RATS DURING PREMATING
GROUP: 1-0
DOSE: 0 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
1 2
3 4 5
6
7
8
9
10 11 12
13 14 15 16 17 18 19
20 21 22
23 24
MEAN S.D. S.E. N
50-56
56-63
63-71
28.5 32.2
22.1
28.0 27.9 29.7 47.9 25.0
6.5 26.4 28.3 26.8 27.1 23.9 26.8 29.8 24.0 23.8 25.1 28.9 28.0 26.5 25.8 27.5
26.9 6.5 1.3
24
31.5 28.3 26.4 27.2 26.9 30.0 31.0 32.5 24.7 27.9 28.6 26.6 28.6 24.9 26.2 30.2 24.9 25.1 26.0 30.6 29.4 28.9 26.4 29.8
28.0 2.3 0.5
24
29.4 27.1 28.6 23.9 23.8 31.4 30.8 32.0 23.4 27.5 26.9 26.3 27.1 25.7 26.0 29.4 26.7 23.6 24.5 29.8 31.6 27.0 26.5 28.8
27.4
2.6
0.5 24
1-71
29.0 28.3 28.0 27.2 26.8 30.4 31.9 27.3 23.4 27.0 27.9 25.9 27.3 24.2 26.8 30.6 24.8 23.6 25.8 28.4 28.9 28.4 26.2 28.1
27.3
2.1
0.4 24
-225jCompany Sanffzed. Does oof
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
p H#24768
REPRODUCTIVE AMD FERTILITY EFFECTS WITH H-24768
* ^ ^ ^ ^ ^ ^ ^ ^ K otVIDUAL FOOD CONSUMPTION (g/day) BY PI MALE RATS DURING PREMATING
GROUP: III-O
DOSE: 1 MG/KG/DAY
ON TEST:
ANIMAL NUMBER
25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48
MEAN S.D. S.E. N
1-8
8-15
15-22
22-28
28-36
36-43
43-50
23.3 25.7 24.0 26.4 30.0 26.3
22.8
26.7 24.9 26.7 24.9 29.0 24.5
22.0
29.9 30.5 29.6 28.0 27.1 27.5 23.8 26.7 26.4 27.6
26.4 2.4 0.5
24
23.5 26.5 24.2 25.9 29.5 26.8 23.9 28.9 24.2 27.7 25.7 28.6 24.6 23.2 31.9 29.6 32.0 28.2 29.6 27.8 25.3 25.5 27.9 28.4
27.1 2.5 0.5
24
24.1 26.8 25.5 26.9 30.5 28.1 26.3 32.3 26.1 30.1 26.5 29.1 25.1 23.5 32.6 28.8 33.0 29.9 28.9 29.3 25.6 26.0 27.6 30.5
28.0
2.6
0.5 24
24.9 27.8 26.1 26.8 27.3 30.2 26.4 32.5 25.4 29.1 28.4 29.1 25.0
22.8
34.0 29.5 32.6 31.3 28.3 26.8 26.5 26.6 26.8 30.5
28.1 2.7
0.6
24
28.0 27.4 27.6 27.9 29.5 27.1 27.5 32.9 25.9 30.4 28.8 32.0 28.6 25.0 35.2 29.6 30.0 30.2 28.2 26.7 27.5 28.4 28.2 30.4
28.9 2.3 0.5
24
25.5 27.0 26.8 26.2 30.8 27.3 25.8 32.0 25.7 30.5 29.3 30.4 27.0 23.1 31.9 29.2 28.4 29.8 27.9 28.0 26.1 26.6 28.9 32.3
28.2 2.4 0.5
24
26.8 27.1 24.7 26.2 31.6 27.3 25.2 31.8 25.5 27.4 27.8 28.1 26.4 23.0 34.1 28.4 31.4 29.2 27.9 27.9 24.7 27.1 28.3 32.6
27.9 2.7
0.6
24
/"'***'
-226Pompany Sanitized. Does not contain TSCA CBl
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL FOOD CONSUMPTION (g/day) BY PI MALE RATS DURING PREMATING
GROUP: III-O
DOSE: 1 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48
MEAN S.D. S.E. N
50-56
56-63
63-71
25.7 26.6 26.5 26.5 28.7 29.6 26.1 33.3 24.5 29.2 29.3 28.3 26.6 22.4 32.5 30.7 31.7 29.2 28.9 27.5 23.9 26.3 27.3 33.4
28.1 2.9
0.6
24
27.3 26.3 26.7 28.6 30.7 30.6 25.9 34.2 25.3 30.8 28.1 28.2 25.8 23.2 34.5 29.7 29.9 30.9 29.3 27.3 25.9 27.3 27.0 30.7
28.5 2.7
0.6
24
27.4 24.9 24.0 26.4 29.1 28.4 26.5 31.9 26.7 28.3 26.4 28.4 25.6
22.6
31.1 32.0 29.9 29.3 28.4 28.8 28.2 26.5 26.7 30.1
27.8 2.3 0.5
24
1-71
25.7 26.6 25.6 26.8 29.8 28.1 25.7 31.6 25.5 29.0 27.5 29.2 26.0 23.1 32.8 29.8 30.8 29.6 28.4 27.8 25.8 26.7 27.5 30.6
27.9 2.3 0.5
24
-227-
ISSiipiaiy Sanitized. Doe* not contain TSCA CBS
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL FOOD CONSUMPTION (g/day) BY PI MALE RATS DURING PREMATING
GROUP: V-0
DOSE: 10 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65
66
67
68
69 70 71 72
MEAN S.D. S.E. N
1-8
8-15
15-22
22-28
28-36
36-43
43-50
27.5 26.1 28.2 26.1 21.4 27.7 26.9 31.6 23.6 27.1 24.7 27.3 24.8 25.7 23.9 28.6 24.4 28.3 26.5 29.0 24.8 25.9 27.1 31.3
26.6 2.3 0.5
24
26.7 26.1 28.5
21.6
20.4 27.5 26.7 31.9 24.9 28.0 27.8 30.3 27.2 25.8 27.4 30.1 24.9 30.1 27.4 29.8 26.0 26.4 26.4 31.2
27.2 2.7
0.6
24
27.4 28.1 29.0 23.5 20.9 31.0 26.3 35.6 25.1 29.4 28.8 31.2 25.5 26.2 28.1 29.6 27.7 29.6 28.8 31.4 24.6 26.7 27.2 31.6
28.1 3.1
0.6
24
29.7 27.1 28.9 30.9 22.5 29.4 24.8 33.0 24.2 21.4 27.6 29.1 26.7 25.5 28.9 32.1 26.7 28.4 29.6 32.8 26.9 26.9 27.9 30.4
28.0 3.0
0.6
24
27.5 29.9 28.6 26.5 23.1 30.5 27.6 33.6 23.5 18.6 26.4 29.5 26.7 27.0 29.5 30.6 26.8 28.2 28.7 31.1 27.4 27.4 27.7 31.2
27.8 3.1
0.6
24
30.5 28.6 31.9 25.2 22.5 30.6 27.0 32.8
22.8
29.4 26.3 28.6 24.9 25.2 28.4 30.0 27.6 27.7 25.1 29.9 26.6 25.4 27.7 33.8
27.9 2.9
0.6
24
28.7 30.9 28.4 26.9 20.7 30.1 28.2 33.3 23 .4 25.7 27.2 29.7 26.6 24.2 27.9 32.7 29.7 28.1 23.9 27.8 27.7 26.3 27.4 33.4
27.9 3.1
0.6
24
-228i&mpany Sanitized. Doe* not contain TSCA CF
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
IljfilVIDUAL FOOD CONSUMPTION (g/day) BY PI MALE RATS DURING PREMATING
GROUP: V-0
DOSE: 10 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65
66
67
68
69 70 71 72
MEAN S.D. S.E. N
50-56
56-63
63-71
30.2 30.4 30.5 29.2 21.5 26.9 25.9 35.6 23.9 27.4 27.4 29.1 28.2 27.3 28.1 31.2 29.5 28.3 24.1 30.7 27.3 26.5 27.6 33.2
28.3 3.0
0.6
24
29.5 31.5 31.0 30.8 22.4 28.2 26.9 33.5
22.8
29.5 30.4 29.9 30.5 27.0 28.8 30.9 30.8 29.2 28.9 30.0 27.0 26.5 27.8 . 31.5
29.0
2.6
0 .5 24
29.0 29.4 28.4 31.4 22.3 30.6 26.5 35.5
21.1
27.8 28.2 29.6 29.6 25.0 28.9 30.2 28.0 27.0 27.9 32.5 26.8 24.9 29.3 30.6
28.4 3.1
0.6
24
1-71
28.6 28.8 29.3 27.2
21.8
29.3 26.7 33.7 23.5 26.4 27.5 29.4 27.1 25.9 28.0 30.6 27.6 28.5 27.1 30.5 26.5 26.3 27.6 31.8
27.9 2.5 0.5
24
-229'jgompany Sanitized. D oes not contain TSCA CB
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
:# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
UVIDUAL FOOD CONSUMPTION (g/day) BY PI MALE RATS DURING PREMATING
GROUP: VII-0
DOSE: 25 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
73 74 75 76 77 78 79 80 81 82 83 84 85
86
87
88
89 90 91 92 93 94 95 96
MEAN S.D. S.E. N
1-8
8-15
15-22
22-28
28-36
36-43
43-50
22.9 27.9 27.1 28.3 24.7 25.8 29.6 28.2 24.4 24.8 27.1 28.0 29.0 28.6 29.6 25.0 26.8 28.9 24.7 29.1 22.4 27.4 26.7 32.3
27.1 2.4 0.5
24
25.2 30.7 27.9 28.4 25.6 25.7 26.0 28.5 25.5 24.7 28.1 28.0 28.1 28.8 30.2 25.1 27.3 28.2 25.3 30.6 25.2 28.9 26.5 31.2
27.5
,2.0
0.4 24
25.3 32.3 27.8 28.2 27.0 27.6 28.8 30.9 23.1 23.9 27.1 27.6 28.4 29.6 30.3 25.5 29.4 30.2 28.0 28.3 23.4 29.8 27.3 30.0
27.9 2.4 0.5
24
23.7 33.3 28.1 25.9 26.8 27.4 29.7 31.1 17.9 26.9 28.8 29.4 28.6 29.6 31.9 25.7 29.8 29.9 24.0 30.1 25.1 30.2 27.8 31.7
28.0 3.3 0.7
24
22.4 32.6 25.9 26.4 27.4 24.9 30.2 28.5 16.4 26.3 27.2 30.1 29.2 30.9 34.0 24.7 29.3 30.1 29.4 31.3 24.7 29.7 28.5 32.1
28.0 3.7
0.8
24
23.7 34.6 26.5 26.7 26.2 26.3 29.6 28.4 18.8 24.8 29.1 29.8 28.9 30.6 32.2 24.0 29.1 30.9 28.4 30.7 26.0 29.6 29.1 33.4
28.2 3.4 0.7
24
23.8 35.4 27.2 25.6 26.0 24.4 30.1 29.9 26.7 24.1 29.2 29.8 27.3 30.6 31.0 25.1 28.7 29.5 27.7 32.9 25.5 28.4 29.3 33.1
28.4 3.0
0.6
24
-230-
fcsmpanjf Sanitized. Does not contain TSCA CB
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AMD FERTILITY EFFECTS WITH H-24768
INDIVIDUAL FOOD CONSUMPTION (g/day) BY PI MALE RATS DURING PREMATING
GROUP: VII-0
DOSE: 25 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
73 74 75 76 77 78
79
80 81 82 83 84 85
86
87
88
89 90 91 92 93 94 95 96
MEAN S.D. S.E. N
50-56
56-63
63-71
24.0 35.0 28.7 27.3 28.2 26.2 29.2 30.3 23.1 23.8 29.1 29.0 27.7 27.8 29.7 24.4 28.3 30.7 27.2 32.3 24.3 29.3 28.9 29.7
28.1
2.8 0.6
24
25.8 33.5 27.8 28.3 28.9 24.7 31.6 32.9 24.9 25.6 28.3 30.8 30.0 29.0 30.6 26.2 28.7 29.6 27.3 32.9 25.6 28.7 32.1 33.0
29.0 2.7
0.6
24
22.5 35.7 26.7 27.7 27.4 25.2 28.4 32.0 24.1 24.6 26.6 31.0 29.9 29.9 28.1 25.2 29.6 29.9 24.6 32.0 25.7 28.5 29.0 32.7
28.2 3.1
0.6
24
1-71
23.9 33.1 27.3 27.3 26.8 25.8 29.3 30.1 22.5 24.9 28.0 29.4 28.7 29.6 30.8 25.1 28.7 29.8 26.7 31.0 24.8 29.0 28.5 32.0
28.0
2.6
0.5 24
- 231 Company Sanitized. Does not contain TSCA CBl
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX Q INDIVIDUAL FOOD CONSUMPTION BY Pj FEMALE RATS DURING PREMATING
-232-
Does nefeonfafn TSCA.CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL FOOD CONSUMPTION BY P, FEMALE RATS DURING PREMATING EXPLANATORY NOTES
Note Test Day 71
= Last day of premating period that data were recorded.
Abbreviations
Summary Section S.D. = Standard Deviation S.E. = Standard Error N = Number in Group
/*****',.
<***^,
-233-
Xfotnpany Sanitized. Does not contain TSCA CBt
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL FOOD CONSUMPTION (g/day) BY PI FEMALE RATS DURING PREMATIN'
GROUP : II-O
DOSE: 0 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
97 98 99
100 101 102
103 104 105 106 107 108 109
110 111 112
113 114 115 116 117 118 119
120
MEAN S.D. S.E. N
1-8
8-15
15-22
22-28
28-36
36-43
43-50
18.9 17.4 17.0
20.1
18.2 17.3 18.7
20.1
19.7 18.5
21.0 20.1
19.1 21.7
20.1
19.4 19.0 19.3 18.4 16.7 17.6 18.0 19.5 19.4
19.0 1.3 0.3
24
21.4 16.8 19.1
20.0
19.9 19.4 20.9 19.7 18.9 19.5 19.7 20.9 19.2
20.8
18.3 18.8 18.6
20.2 20.8
18.7 18.0 17.1 20.3 18.7
19.4
1.2 0.2
24
20.7 17.0 18.4 18.0 19.2 18.0 18.6 19.2 19.0 18.3
20.0 21.2
18.6 21.3 18.5 18.5 19.8 18.8 18.8 18.3 17.2 18.6
22.2
19.8
19.1 1.3 0.3
24
20.8
19.5 18.4 18.4 19.3 18.9 19.4 17.9
20.0 20.0 20.8
20.9 20.3 20.7 19.3 20.7
21.2
21.5 19.5 18.3 19.5 24.8
22.6
19.2
20.1
1.5 0.3 24
20.8
19.1 18.9 18.7
20.2
18.9 19.3 19.0 18.8 19.2
20.8 22.8
19.8 20.5 21.3 18.7 20.7 19.7 19.1 18.3 19.9 17.9
20.6
18.9
19.7
1.1 0.2
24
20.5 20.4 20.9 18.3 18.5 19.1 21.4 21.7 18.9 19.1 20.4 25.0 16.5
20.8
17.7 19.0
20.2
20.5 18.8 18.6 17.6 17.2 23.1 17.9
19.7
2.0
0.4 24
21.1
19.9 17.7 19.7
20.2
19.0
20.1
19.2 17.7 18.8 20.4 23.4 18.1 19.3 17.7 18.3 19.4 19.7 19.9 17.1
20.8
16.4 22.3 18.2
19.4
1.6
0.3 24
-234fisinpanjf Sanitized Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
DuPont-13784
INDIVIDUAL FOOD CONSUMPTION ( g / d a y ) BY P I FEMALE RATS DURING PREMATING
GROUP: I I - O
DOSE: 0 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
97 98 99
100 101 102
103 104 105 106 107 108 109
110 111 112
113 114 115 116 117 118 119
120
MEAN S.D. S.E. N
50-56
56-63
63-71
21.6
18.1 17.7 14.5 19.3 21.3 19.7 20.9 18.7 19.7
20.1 21.1
18.3 19.2 19.2 19.4 18.7
21.1
17.8 17.0 18.1 17.1
22.6
20.7
19.3
1.8
0.4 24
22.5 18.4 20.3 18.3 19.1 20.4 16.8
22.1
19.5 19.1 19.4 20.5 20.5 19.6 16.5 19.7
20.0
20.3 20.7 18.1
20.8
19.3
22.6
18.8
19.7 1.5 0.3
24
24.5 21.9 18.5 19.6
20.1 22.2
19.5 20.7 20.7 19.9 19.9
22.2
26.0
21.8
17.5 20.4 20.5
22.2
19.0 22.5 19.7 20.9 23.4
20.1
21.0
1.9 0.4 24
1-71
21.3 18.9 18.7 18.6 19.4 19.5 19.4
20.0
19.2 19.2 20.3 21.9 19.7
20.6
18.6 19.3 19.8 20.3 19.3 18.4 18.9 18.7 21.9 19.2
19.6
1.0 0.2
24
-235Cffipany Sanitized Does not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL FOOD CONSUMPTION (g/day) BY PI FEMALE RATS DURING PREMATING
GROUP: IV-0
DOSE: 1 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
121
122
123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144
MEAN S.D. S.E. N
1-8
8-15
15-22
22-28
28-36
36-43
43-50
17.8 18.1 17.7 19.6 17.5 18.9 16.0 23.1 17.2 19-2 19.5 20.4 17.3 19.8 19-5 21.5 18.7 19.4 17.9 17.5 19.0 19.1 19.3 18.2
18.8 1.5 0.3
24
18.7
20.1
17.1 22.4 18.9 19.0 18.7 23.5 18.4 19.7
20.1 21.2
17.8 20.3 22.4 22.3 19.6 19.5 18.7 18.0 19.1 19.6
20.0
20.3
19.8
1.6
0.3 24
19.2
20.1
17.5 20.9 19.6 18.8 14.5 24.4 18.8 17.7 21.5 23.6 17.1 18.5
21.8
24.5
20.0
19.6 17.7 19.3 20.7 21.5 18.6
21.1
19.9 2.4 0.5
24
19.3 17.9 16.9 22.5 19.7 19.1 17.1 24.7 19.0 18.1
20.1
24.2 18.0
20.6
22.5 28.8 19.5 20.3 17.9 18.5 20.9 21.4 19.3 20.5
20,3 2.7
0.6
24
20.6 20.1
17.5 22.5 19.1
20.6
18.3 24.2 19.7 19.9
21.0
23.1 17.7 18.7 26.5 22.4 19.8 22.3 17.9
21.2
19.4
21.8
18.6 24.1
20.7 2.3 0.5
24
17.3 19.8 17.5 22.9 19.5 18.7 18.6
22.6
19.8 18.4
20.0 21.6
18.2 21.3 23.8 22.9
20.2 21.1
18.6 18.2 18.9 19.8 19.7
20.8
20.0 1.8
0.4 24
19.1
21.6
16.1 23.1 18.9
20.1
16.9 23.9 17.6 20.3 19.8 23.2 18.6 20.5 27.1
22.1 20.2 21.6
17.2 22.3 19.1 18.3 19.4 20.7
20.3 2.5 0.5
24
-236-
dffipaify S an itiz ed . D ee* Ho!co n tain TSCA CBV
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
INDIVIDUAL FOOD CONSUMPTION ( g / d a y ) BY P I FEMALE RATS DURING PREMATING
GROUP: I V -0
DOSE: 1 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
121 122
123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144
MEAN S.D. S.E. N
50-56
56-63
63-71
1-71
18.. 0 18.. 8 16..3 23 .. 1 17 .3 17 .. 8 18..5 2 2 .5 19 .. 0 17 .. 2 18.. 8 2 0 .9 2 1 .. 0 18.. 8 25..3 2 2 .. 1 18..5 2 2 .. 1 15..3 2 1 .4 18.. 8 2 2 .. 8 2 2 .3 19 .. 8
19.. 8 2 ..5 0 .5
24
19..3 19.. 0 17.. 8 2 2 .. 6 19.. 8 18.. 1 19.. 2 26.. 0 19,.7 2 0 .. 2 19.. 1 23 . 1 19 .7
21 .6
28 .9 2 2 .3 19 .9 2 2 .5 18 . 8
21 .0
18 . 2 23 .5 23 .4 2 0 .4
21 .0
2 .7 0 .5 24
2 1 .. 2 19..7 18.. 8 24.. 8 2 0 .. 0 25..5 19..3 24..4 19.. 2 2 0 .. 6 2 1 .. 2 2 1 .7 2 0 .7 2 2 .. 2 28.. 8 24.. 2 2 2 .. 8 24.. 2 2 2 .. 0 2 1 .. 1 19.. 1 2 1 .4 17.. 8 2 0 .. 2
2 1 .7 2 ,. 6 0 ,.5
24
19.. 1 19.. 6 17..4 2 2 .5 19 .. 1 19.. 8 17 .7 24.. 0 18..9 19.. 2 2 0 .. 2 2 2 .3 18.. 6 2 0 .3 24.. 8 23 .3 2 0 .. 0 2 1 .3 18..3 19..9 19..3 2 0 .9 19.. 8 2 0 .7
2 0 .3 1 .9 0 .4
24
-237SanRIzed. Doe* not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL FOOD CONSUMPTION ( g / d a y ) BY PI FEMALE RATS DURING PREMATING
GROUP: V I -0
DOSE: 10 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
MEAN S.D. S.E. N
00
i
8-15
15-22
22-28
28-36
36-43
43-50
18.2 17.3 17.6
21.6
18.7 19.2
21.1
17.2 18.1 19.9
20.0
17.6 16.9 16.8 22.3 19.5 15.4 19.8 15.4 19.6 14.2 16.1 17.9 18.4
18.3
2.0
0.4 24
17.3 16.8 19.0
21.1 21.1 21.6
23.9 21.9 19.7 19.2 19.8 19.4 17.8
20.0
24.1 18.2 17.2 20.5 19.1
22.6
17.3 17.5 17.9
20.8
19.7
2.1
0.4 24
17.2 19.6
20.8
23.0 19.5 20.4
22.0 21.8
20.3 19.7 21.3 20.9 17.7 18.6 25.5
20.6
17.9
22.6
19.6 18.5 18.1 19.7 18.8 21.5
20.2
1.9 0.4 24
17.4 18.9 20.4 20.4 23.2
20.8
23.5 20.5 20.3 19.8 23.6 20.3
22.0 20.0
26.6 18.0 16.9
22.1
17.4 20.4 17.3 20.5 17.9 17.2
20.2
2.4 0.5 24
16.6 18.8 19.3 20.9 23.2 21.3 24.0
21.8 20.0 20.2 20.2
19.9 19.8 19.3 26.3 19.8 16.4 23.7 19.1
20.1
17.8 21.9 17.3 19.2
20.3 2.4 0.5
24
18.3 18.8 19.7 21.7 15.9
22.8
24.1 21.9 18.5 17.7 20.4
21.1
17.4 18.5 27.5 19.3 18.2 20.4 18.2
20.8
18.7 22.3 17.2 20.7
20.0 2.6
0.5 24
16.9 19.0 20.3 25.2 18.0 23.3 24.9 22.5
2190.. 29
20.5 19.9 16.9 19.0 26.1 20.8 17.1 21.6 18.7 18.5 19.0 24.5 18.2 19.6
20.4 2.7 0.6
24
-238gtnpany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 76 8
IN DIVIDUAL FOOD CONSUMPTION ( g / d a y ) BY P I FEMALE RATS DURING PREMATING
GROUP: V I - 0
DOSE: 10 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
MEAN S.D. S.E. N
50-56
56-63
63-71
1-71
16. 9 17 .5 19. 4 2 1 .6 17. 8 2 1 .8 23. 3 18. 8 16. 7 19. 2 2 0 .1 2 0 .3 18. 4 2 0 .6 24. 9 18. 7 15. 5 2 1 .1 18. 5 2 0 .6 18. 0 23 .4 17 .7 17. 6
19. 5 2 .3 0 .5
24
18..3 18..9 2 0 ,.4 24.. 2 17.. 0 25.. 8 27 .7 23 .. 0 23 .. 0 18..4 2 1 ,. 0 2 0 .4 2 0 ,. 8 19..5 26,.9 19,. 6 16..7 2 2 ,. 2 2 0 ,. 2 18..5 2 0 .5 25..4 17..3 2 0 .5
2 1 .. 1 3.. 1 0 .. 6
24
2 0 ..5 19..5 2 2 ., 2 24.. 6 16..3 25..3 26.. 0 2 2 ,.4 19.. 1 2 0 .7 2 0 .7 18.. 6 2 0 ,. 0 2 1 .4 26.. 6 2 0 .. 0 18..3 23 .3 23 ,. 1 24..4 2 0 .. 8 24.. 2 18..7 2 1 .5
2 1 .. 6 2 ,.7 0 .5
24
17 .. 8 18..5 19..9 2 2 ..5 19.. 0 2 2 .3 24.. 1 2 1 ,.3 19,. 6 19 .5 2 0 .7 19 . 8 18 . 8 19 .4 25,.7 19..5 17.. 0 2 1 ,. 8 19,. 0 2 0 .4 18.. 2 2 1 .. 6 17..9 19.. 8
20 .2 2 .0
0 .4 24
-239-
ll p n y Sanitized. Does not contain TSCA CBI
,-****> N
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
INDIVIDUAL FOOD CONSUMPTION ( g / d a y ) BY P I FEMALE RATS DURING PREMATING
GROUP: V I I I - 0
DOSE: 25 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192
MEAN S.D. S.E. N
1-8
8-15
15-22
22-28
28-36
36-43
43-50
19,. 1 17,. 1 16..3 19,.3 18,. 1 16,.7 18,. 6 2 0 ,. 1 18,. 1 19,.5 19,. 6 2 1 ,. 1 19,. 2 18.. 0 18..7 2 2 .7 16.. 0 2 0 .5 19,. 1 2 2 ..7 17.. 6 2 0 ..5 19.. 1 2 1 ..5
19.. 1 1 .. 8 0 ..4
24
2 0 .7 2 1 .. 2 2 0 .3 2 2 .7 19..3 18.. 6 19.. 0 19..9 17..5 17.. 8 18..7 2 0 .. 8 2 1 .. 6 2 0 .9 18..7 18..3 2 0 .7 2 1 .3 2 0 .3 2 1 .. 8 17..4 2 0 .5 2 0 .9 2 2 .4
2 0 .. 1 1 ..5 0 ..3
24
2 0 ,. 8 23.. 1 19.. 8 2 2 .. 0 18,.9 19,.4 19,. 8 2 0 .4 18..5 18,.3 2 0 ,. 0 2 0 ,. 0 2 2 ,.7 23 ,. 8 18.. 8 16.. 2 2 2 ,. 6 2 1 ,. 8 2 1 .. 6 2 1 .. 6 17..9 19.. 2 2 1 .. 6 2 1 .. 1
2 0 ..4 1 .. 8 0 ..4
24
19.. 6 2 0 .7 2 0 ,. 1 2 2 .. 1 16,.9 18..5 16..9 19..5 17.. 1 18..7 19,. 1 2 0 .4 2 2 .. 1 2 0 .. 8 2 0 .. 1 16,. 6 2 1 .9 2 0 .4 2 0 ,, 0 2 2 ,.7 17.. 8 18..4 2 0 .3 2 0 .. 2
19.. 6 1 .7 0 .4
24
18.. 6 19..7 18..9 2 2 .5 18..3 18.. 1 19 .3 19 .5 18..9 18..3 2 0 .5 2 0 .9 2 0 ,. 8 2 1 .. 1 2 0 .. 1 17 ,.5 23 ,.3 2 0 ,. 1 2 1 .7 2 1 .. 2 19.. 0 2 2 .. 1 2 1 ,.9 23 .. 1
2 0 .. 2 1 .. 6 0 ..3
24
2 0 .. 1 2 0 .. 1 19 ,. 6 2 2 .4 2 0 .9 19..9 2 0 .7 18.. 2 19,. 2 2 2 .. 6 19,.5 2 1 .. 8 2 0 ,.4 2 0 ,. 0 2 0 .4 19 ,. 6 23,. 2 2 1 .. 0 2 0 ,. 0 2 1 .9 17.. 0 2 2 ..9 2 2 .3 2 2 .. 0
2 0 ..7 1 ..5 0 ..3
24
16..7 2 1 .3 2 0 .4 2 1 .. 8
20 .6
2 0 .. 2 19 . 8 19..5 2 0 .. 2 17..4 19,.9 2 2 .5 2 0 .. 8 2 1 ,. 6 2 0 .. 0 18.. 8 23 .. 6 2 1 .. 0 2 1 .. 6 2 2 .5 18..3 19.. 6 2 2 .. 0 2 2 ,. 1
2 0 .5 1 .. 6 0 ..3
24
- 240 -
fS m p a iiy S anitized. D oes n o t contain TSCA CBI
W
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
nJDIVIDUAL FOOD CONSUMPTION ( g / d a y ) BY P I FEMALE RATS DURING PREMATING
GROUP: V I I I - 0
DOSE: 25 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192
MEAN S.D. S.E. N
50-56
56-63
63-71
19.0
21.1 20.1
22.5
20.8
18.0 18.2 19.2 18.3 19.9 17.8 21.9
20.8
20.3 19.9 18.9 24.5 18.4 17.7 23.0 17.7 19.1 19.0 19.7
19.8
1.8
0.4 24
19.3 19.3
21.0
22.4
21.2
20.5
21.2
19.3 18.5 18.7 19.8 21.7 20.4
21.0
17.5 17.9 24.4 22.3
20.8 20.0
17.1
20.2
19.8
22.0
20.3 1.7 0.3
24
20.0 22.1
23.6 24.9
22.1 22.8
21.9
20.1
18.8 17.9 20.7
22.0
23.2 16.5 17.1 19.9 22.4 22.4 20.7 21.9 18.0 20.9
21.6 21.0
20.9
2.1
0.4 24
1-71
19.4
20.6 20.0
22.3 19.7 19.3 19.6 19.6 18.5 18.9 19.6 21.3
21.2
20.3 19.1 18.7 22.3
21.0
20.4 21.9 17.8 20.4 20.9
21.6
20.2 1.2 0.2
24
-241 Company Sanitized. Does not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX R INDIVIDUAL FOOD CONSUMPTION BY Pi FEMALE RATS DURING GESTATION
-242-
pompany Sanitized. Does not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL FOOD CONSUMPTION BY Pi FEMALE RATS DURING GESTATION
EXPLANATORY NOTES
Note
This appendix contains data from females with evidence of copulation observed. No gestation data were collected for females with no evidence of copulation (whether a litter was delivered or not).
Abbreviations
G = Gestation NLD = Evidence of copulation observed but no litter delivered; data excluded from statistical
analyses. = No Data
Summary Section S.D. = Standard Deviation S.E. = Standard Error N = Number in Group
-243 Sanitized. Ooas
com a,-,, T S M M (
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
H# 2 4 76 8
1
IN DIVIDUAL FOOD CONSUMPTION
(g/day)
BY P I FEMALE RATS DURING GESTATION
GROUP: I I - O
DOSE: 0 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
97 98 99
100 101 102
103 104 105 106 107 108 109
110 111 112
113 114 115 116 117 118 119
120
MEAN S.D. S.E. N
0-7
7-14
14-21
0-21
27.9
22.1
25.0 24.5 24.1 27.2 24.0 33.6
22.1
26.0 24.5 26.8 26.0 26.2 17.7 27.0 24.5
6.7 27.9 25.0 26.3 25.9 25.9
-
24.6 4.8
1.0
23
28.0 26.4 26.7 25.4 24.3 23.7 25.1 30.6 23.9 27.1 21.3 27.7 25.8 27.9 17.9 28.8 26.2 31.0 27.9 25.8 25.3 25.4 26.4
-
26.0
2.8 0.6
23
26.4 18.7 25.1 25.4 24.4 25.0
20.8
17.2 26.0 25.2
20.1
26.7 23.0 24.1 17.4
-a 27.6 31.3 27.5 25.9
21.0
19.5 28.4
-
23.9 3.8
0.8 22
27.4 22.4 25.6 25.1 24.2 25.3 23.3 27.1 24.0 26.1
22.0
27.1 24.9 26.1 17.6
-a 26.1 23.0 27.8 25.6 24.2 23.6 26.9
-
24.8 2.3 0.5
22
ANIMAL STATUS
NLD NLD
a Animal delivered prior to collection of Day 21G data.
-244JQompanjr Sanitized. Does not contain TSCA CBi
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
H# 2 4 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
INDIVIDUAL FOOD CONSUMPTION ( g / d a y ) BY P I FEMALE RATS DURING GESTATION
GROUP: I V - 0
DOSE: 1 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
121 122
123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144
MEAN S.D. S.E. N
o t -J
7-14
14-21
0-21
26.9
22.6
23.3 27.5
20.2
23.9 26.1 25.0 22.5 28.8 25.9 29.3 24.5 25.4 30.5 26.9 26.8 25.4
22.6
22.3 25.2 25.8 23.7 26.3
25.3 2.4 0.5
24
26.4 24.8 22.4 27.5
22.2
24.7 28'2 26.9 24.1 30.8 26.2 29.7 26.8 26.3 30.8 27.7 26.9 25.6 24.4 17.4 26.8 27.5 24.2 25.8
26.0 2.9
0.6
24
27.9 27.3 23.1 24.6 23.5 25.5 18.1 23.9 30.6 23.3 25.0 31.9 29.9 27.0 42.3 27.8 23.9 23.2 23.6 65.0 29.7 26.4 26.0 26.4
28.2 9.1
1.8
24
27.1 24.9 22.9 26.5
22.0
24.7 24.1 25.3 25.7 27.6 25.7 30.3 27.1 26.2 34.6 27.5 25.9 24.7 23.5 34.9 27.2 26.5 24.6 26.2
26.5 3.1
0.6
24
ANIMAL STATUS
NLD
NLD NLD
- 245 -
Company Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
INDIVIDUAL FOOD CONSUMPTION (g/day) BY PI FEMALE RATS DURING GESTATION
GROUP: V I -0
DOSE: 10 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
145 146 147 148 149 150 151 152 153 154a 155 156 157 158 159 160 161 162 163 164 165 166 167 168
MEAN S.D. S.E. N
0-7
7-14
14-21
0-21
25.4 23.8
-
27.0 25.9 26.7
-
24.3 25.3 63.8 24.1 23.5 24.5 26.0
-
26.8
20.8
25.7 26.8
24.2 29.5 23.7 26.4
27.2
8.8 2.0 20
19.2 23.6
-
27.3 25.5 25.8
22.9 25.4
-
26.2
22.2
24.0 28.7
-
24.9 21.4 27.9 25.9
-
21.8
28.0 24.9 26.8
24.9 2.5
0.6
19
16.5 27.4
27.9
22.8
26.8 -
25.9 26.1 31.4 24.7 24.3
22.0
29.4
_
26.7 23.2 24.7 26.1
24.3 23.6 27.0 25.6
25.3 3.1 0.7
20
20.3 24.9
27.4 24.7 26.4
" 24.4 25.6
25.0 23.4 23.5 28.1
26.2
21.8
26.1 26.3
23.4 27.0 25.2 26.3
25.0 1.9 0.4
19
ANIMAL STATUS
NLD
NLD
a Food data were not collected on Day 7G in error, thus correct food consumption could not be calculated for days 0-7, 7-14, and 0-21.
-246jCompany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
INDIVIDUAL FOOD CONSUMPTION ( g / d a y ) BY P I FEMALE RATS DURING GESTATION
GROUP: VIII-0
DOSE: 25 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
169 170 171 172 173 174 175 176 177 178 179 180 . 181 182 183 184 185 186 187 188 189 190 191 192
MEAN S.D. S.E. N
0-7
7-14
14-21
0-21
25.5 26.5 24.8 24.6
21.2
25.1 24.3 23.2 24.2 24.0
-
25.4 25.0
-
26.4
-
26.7 26.7 26.6
-
23.8 22.4 25.4 24.0
24.8 1.5 0.3
20
24.3 27.6 24.3 24.9 24.1 25.2 23.6 23.3 27.0 24.6
-
26.2 26.4
23.5
28.4 27.3 26.2
23.9 23.6 25.4 27.1
25.3
1.6
0.3
20
24.4 26.9 26.9 26.6 23.6 26.8 26.7
22.8
27.3 26.6
-
26.0 25.8
24.0
26.3 27.7 25.7
24.1 28.5 26.3 27.5
26.0 1.5 0.3
20
24.8 27.0 25.3 25.4 23.0 25.7 24.9 23.1 26.2 25.1
25.9 25.7
24.7
_
27.1 27.2 26.2
24.0 24.8 25.7 26.2
25.4
1.2
0.3
20
ANIMAL STATUS
-247-
Company Sanitized. D oes not contain TSCA CB1
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX S INDIVIDUAL ANIMAL ESTROUS CYCLE PARAMETERS IN Pi FEMALE RATS
DURING PREMATING AND COHABITATION
-248jBompany Sanitized. Does not contain TSCA f "
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL ESTROUS CYCLE PARAMETERS IN Pi FEMALE RATS DURING PREMATING AND COHABITATION
EXPLANATORY NOTES
Note
Days of cohousing for individual females are identified in the Appendix, "Individual Animal Estrous Cycle Stages in Pi Female Rats During Premating and Cohabitation."
Abbreviation = No Data
-249Company Sanitized. Does not contain TSGACBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL ESTROUS CYCLE PARAMETERS IN Px FEMALE RATS DURING PREMATING AND COHABITATION
GROUP II-O: 0 MG/KG/DAY
ANIMAL
NUMBER
97 98 99 100 101 102 103 104 105 106 107a 108 109 110 llla 112 113 114 115 116 117 118 119 120b
NUMBER OF DAYS OF DATA
COLLECTION
PERCENT OF
DAYS IN ESTRUS
PERCENT OF
DAYS IN DIESTRUS
PERCENT OF
DAYS IN PROESTRUS
MEAN
CYCLE
LENGTH
(days)
PRECOITAL
INTERVAL
(days)
21
57% 38%
5% 6 . 5 0
1
30
30% 57%
13% 4 .8 0
10
23
30% 65%
4% 4 . 0 0
3
26
23% 58%
19% 4 .2 0
6
22
27% 64%
9% 4 . 0 0
2
22
27% 50%
23% 5 .0 0
2
22
14% 64%
23% 4 .2 5
2
23
35% 61%
4% 4 . 0 0
3
23
22% 57%
22% 4 .0 0
4
21
38% 62%
0% 4 . 0 0
1
21
33% 57%
10% 4 .5 0
1
22
27% 73%
0% 4 . 0 0
2
20
35% 65%
0% 4 . 0 0
1
24
38% 58%
4% 4 . 5 0
4
23
22% 70%
9% 5 . 0 0
3
26
23% 62%
15% 4 .5 0
6
21
14% 71%
14% 4 .3 3
1
25
32% 56%
12% 4 .0 0
5
23
30% 57%
13% 4 .0 0
3
21
81% 14%
5% 1 2 . 0 0
1
22
23% 59%
18% 4 .6 7
2
23
35% 52%
13% 4 .2 5
3
21
33% 52%
14% 4 .0 0
1
35
43% 48%
10% 4 . 0 0 --
a Evidence of copulation detected, but animal did not deliver a litter, b No evidence of copulation was found but a litter was delivered; data excluded from
statistical analysis.
-250l^otnpany Sanitized. Does not contain TSCA CBt
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL ESTROUS CYCLE PARAMETERS IN Px FEMALE RATS DURING PREMATING AND COHABITATION
GROUP IV-0: 1 MG/KG/DAY
ANIMAL
NUMBER
121 122
123 124 125 126
127a 128 129 130 131 132 133 134 135 136 137
138a 139
140a 141 142 143 144
NUMBER OF DAYS OF DATA
COLLECTION
PERCENT OF
DAYS IN ESTRUS
PERCENT OF
DAYS IN DIESTRUS
PERCENT OF
DAYS IN PROESTRUS
MEAN CYCLE LENGTH (days)
PRECOITAL INTERVAL
(days)
22
9%
68%
23% 3.50
2
22
41% 59%
0 % 4.00
2
21
19% 57%
24% 4.67
1
21
33% 57%
10%
4.00
1
21
24% 57%
19% 4.00
1
23
22%
61%
17% 5.00
3
23
48% 39%
13% 6.67
3
22
32% 59%
9% 3.75
3
24
33% 63%
4% 4.00
4
21
10%
67%
24% 5.33
1
21
29% 67%
5% 4.25
1
24
38% 54%
8 % 4.25
4
23
39% 43%
17% 4.75
3
21
100%
0%
0% --
1
22
23% 59%
18% 5.00
2
21
38% 57%
5% 4.00
1
21
33% 52%
14% 4.67
1
21
48% 43%
10%
4.00
1
24
17% 83%
0 % 4.00
4
28
57% 39%
4% 6.67
8
21
33% 67%
0 % 4.00
1
23
39% 48%
13% 4.50
3
24
29% 63%
8 % 5.00
4
22
41% 59%
0 % 4.00
2
a Evidence of copulation detected, but animal did not deliver a litter.
-251Pompany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL ESTROUS CYCLE PARAMETERS IN Pi FEMALE RATS DURING PREMATING AND COHABITATION
GROUP VI-0: 10 MG/KG/DAY
ANIMAL NUMBER
NUMBER OF DAYS OF DATA
COLLECTION
PERCENT OF
DAYS IN ESTRUS
PERCENT OF
DAYS IN DIESTRUS
PERCENT OF
DAYS IN PROESTRUS
MEAN CYCLE LENGTH (days)
PRECOITAL INTERVAL
(days)
145a 146
147b 148 149 150
151C 152 153 154 155 156
157 158
159d 160 161 162 163
164 165 166 167 168
21
14% 67%
19% 5.00
1
23
26% 61%
13% 5.00
3
35 26% 74% 0 % 4.00 --
22
27% 50%
23% 4.00
2
20
50% 50%
0 % 5.67
1
21
24% 57%
19% 4.00
2
35
6 % 83%
11%
4.50
--
23
22%
52%
26% 4.00
3
23
39% 48%
13% 4.67
3
24
42% 50%
8 % 4.00
4
22
36% 59%
5% 5.00
2
23
26% 57%
17% 4.00
3
22
18% 59%
23% 4.00
2
21
24% 48%
29% 4.00
1
35 27% 59% 14% 5.00 --
22
27% 64%
9% 4.00
2
23
26% 61%
13% 4.00
3
21
14% 67%
19% 5.00
1
22
32% 59%
9% 4.00
2
35
14% 74%
11%
4.60
--
22
27% 6 8 %
5% 5.33
2
23
30% 52%
17% 4.00
3
25
28% 64%
8 % 4.25
5
23
35% 52%
13% 4.00
3
a Evidence of copulation detected, but animal did not deliver a litter, b No evidence of copulationwas observed but one live fetus was observed i n u t e r o at
necropsy; data excluded from statistical analysis, c No evidence of copulationwas found and no litter was delivered. d No evidence of copulationwas found but a litter was delivered; data excludedfrom
statistical analysis.
-252-
J&pmpany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL ESTROUS CYCLE PARAMETERS IN Pi FEMALE RATS DURING PREMATING AND COHABITATION
GROUP VIII-0: 25 MG/KG/DAY
ANIMAL
NUMBER
169 170 171 172 173 174 175 176 177 178
179a 180 181
182b 183
184a 185 186 187
188b 189 190 191 192
NUMBER OF DAYS OF DATA
COLLECTION
PERCENT OF
DAYS IN ESTRUS
PERCENT OF
DAYS IN DIESTRUS
PERCENT OF
DAYS IN PROESTRUS
MEAN CYCLE LENGTH {d a y s )
PRECOITAL INTERVAL
(days)
22
32% 55%
14% 5.33
2
22
27% 64%
9% 4.00
2
21
43% 48%
10%
4.00
1
24
33% 54%
13% 4.00
4
21
33% 57%
10%
3.75
1
23
30% 61%
9% 4.00
3
21
43% 52%
5% 4.00
1
24
33% 54%
13% 4.00
4
22
23% 59%
18% 3.75
2
24
38% 50%
13% 4.00
4
35
20%
71%
9%
4.25
--
21
29% 67%
5% 4.00
1
24
25% 50%
25% 4.00
4
35
26% 61%
13% 4.00 --
21
52% 38%
10%
4.00
1
35
20%
71%
9%
4.75
--
23
22%
74%
4% 4.00
3
21
33% 52%
14% 4.67
1
22
27% 6 8 %
5% 3.75
2
35
45% 45%
9%
4.00
--
22
27% 6 8 %
5% 4.25
2
23
39% 57%
4% 4.50
3
22
23% 77%
0 % 4.00
2
23
39% 52%
9% 4.00
3
a No evidence of copulation was found and no litter was delivered. b No evidence of copulation was found but a litter was delivered; data excluded from
statistical analysis.
-253 -
j&pmpany Sanitized. Does not confa'n TSCAcm
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
^ APPENDIX T INDIVIDUAL ANIMAL ESTROUS CYCLE STAGES IN Pi FEMALE RATS DURING PREMATING AND COHABITATION
-254Pompany Sanitized. Does not contain TSCA Cfi?
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL ESTROUS CYCLE STAGES IN P! FEMALE RATS DURING PREMATING AND COHABITATION
EXPLANATORY NOTES
Notes
Test Day 53 = First day of lavage. Empty cells = No Data
Abbreviations
D = Diestrus E = Estrus P = Proestrus X = No sample or stage could not be defined from sample.
-255 C om pany Sanitized. D oes not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL ESTROUS CYCLE STAGES IN Px FEMALE RATS DURING PREMATING AND COHABITATION GROUP II-O: 0 MG/KG/DAY
Lavage Days 18 19 20 22 23 24 25 26 27 28 29 30 31 32 33 34 35
EE EE
~D~ D
~~D~ D D D P
D 11
E D SSI ~D~ :
E
D
mD 11
D D!
D
~ d "~ P DD DDPE
E ~D~ " d - H DP
L_J id t j 13 Q
'E D D .D D b
. D D D D D D!
C om pany Sanitized. D oes not contain TSCA CBf
a Evidence o f c o p u la tio n d e te c te d , b u t anim al d id n o t d e liv e r a l i t t e r . b No e v id e n c e o f c o p u l a t i o n was fo u n d b u t a l i t t e r w as d e l i v e r e d ; d a t a e x c lu d e d from s t a t i s t i c a l a n a l y s i s .
-256-
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL ESTROUS CYCLE STAGES IN Px FEMALE RATS DURING PREMATING AND COHABITATION GROUP I V - 0 : 1 MG/KG/DAY
Company Sanitized. Does not eonfafn TSCA CBI
a Evidence o f c o p u la tio n d e te c te d , b u t anim al d id n o t d e liv e r a l i t t e r .
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL ESTROUS CYCLE STAGES IN Pi FEMALE RATS DURING PREMATING AND COHABITATION GROUP VI-0: 10 MG/KG/DAY
Animal Number 145a 146
152 153 154 155 156 157a 158 159d 160 161 162 163 164c 165 166 167 168
Hp~ D P pET" d " ! P
D ID
E Dnr
E D HcT
pE
ID P E
D
Lavage Days
13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35
gi
DDD D P E DDD
T> E D D D E E D D ~D~ P
11 D D E E D D D E _
mD P E
P E DD P
mD _ _ _ K E E E D X
D ZJ
~D~ H D B 'D H " d " SRI
D ifim B 6 x D D p
__
D D~- I .D D D P D O D D T T D " d"
~D~ " d- g " D ~D~ D D ~D~
D D P E D DiP E D D P
D D E E D DD P n r D P
E :D ,0 E E A l D 3 E . D D E
mE D D D TM D D, E
D 1 -3 D g P E DID IP
E E D D p EHB p
D
P EDD
D DQ
h rE E D D P E E
D 1 D D D D D D D' D I T ~ D ~ U D D D D
D D!E
B p E 'D Dl P
B D D E ______" I E E
O
D D D P zr> D D D g j
D D D
D
E D
E
It
BaBh
o D
E
1D
E
|D
P-!g
DP
d E
id
1p
g i!D E
D D D
E
ID P
Ip Q1 r \ iiSilllf
3
P
~D~
m ISM gBg IB HT s
m D,
`D D
D
P E
E"
E E '
p
E
B -E..!PJ
E!1
E
11
1
ffo m p a n y S anitized. D oes n o t co n tain TSCA CBI
a Evidence o f c o p u la tio n d e te c te d , b u t anim al d id n o t d e liv e r a l i t t e r .
b No e v id e n c e o f c o p u l a t i o n was o b s e r v e d b u t one l i v e f e t u s was o b s e r v e d in u te r o a t n e c r o p s y ;d a t a e x c lu d e d fro m s ta tis tic a l an aly sis.
c No e v id e n c e o f c o p u l a t i o n w as fo u n d an d no l i t t e r was d e l i v e r e d . d No e v id e n c e o f c o p u l a t i o n was fo u n d b u t a l i t t e r was d e l i v e r e d ; d a t a e x c lu d e d from s t a t i s t i c a l a n a l y s i s .
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL ESTROUS CYCLE STAGES IN Px FEMALE RATS DURING PREMATING AND COHABITATION GROUP VIII-0: 25 MG/KG/DAY
Lavage Days 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35
DDB E
E D ; ,&' P
DDE
D d : E D ~D~ H
D D .\ E
__ 1| j
s E D I D !~D~j
DB D *b DD
E mi
oE D ~d "1 E
D
1
B E E UD_ B E
D P E -D D [ E JD _ D I B I
TD ~ d ~ D ~ P ~ ~D ~ D ~ P ~ ~~D~ ~~D~ ~D~
DPE
~ KM
O o
E E D D , " 5 " " d " ~D ~ ~D ~ ~D ~ ~p~1 D ; p ~ D ~
EE
JL 2 E IT M
E E B
rz D ~D~ ~ rT D ~B~ D " d- D ~D~ ~B~ " d~ ~D~ -- D BM
DJj p m
mD D j
*
D P E D ~D ~ " d - I T " T5"~ " d " - D ~ " b " "T"~D ~ ~T
em D D E E x> - D P
E D ,D
~ e DBE
fepasy Sanitized. Does not contain TSCA CBi
a No evidence of copulation was found and no litter was delivered. b No evidence of copulation was found but a litter was delivered; data excluded from statistical analysis.
-259-
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX U INDIVIDUAL MATING DATA AND GESTATION LENGTH: Pi RATS
-260gSompany Sanitized. Does not contain tsc a c*si
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL MATING DATA AND GESTATION LENGTH: P, RATS EXPLANATORY NOTES
Abbreviations = No Plug/Sperm Observed or No Litter Produced = No Data
-261 -
Company Sanitized. Dees not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
H -24768
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 7 6 8
APPENDIX
INDIVIDUAL MATING DATA AND GESTATION LENGTH: PI GENERATION
GROUPS: 11-0,1-0
DOSE: 0 MG/KG/DAY
DuPont-13784
MALE TMAL#
97 98 99
100 101 102
103 104 105 106 107 108 109
110 111 112
113 114 115 116 117 118 119
120
MALE #1 ANIMAL#
1 2
3 4 5
6
7
8
9
10 11 12
13 14 15 16 17 18 19
20 21 22
23 24
PLUG/SPERM OBSERVED
+ + + + +
4*
+
444-
+ +
4-
+
4* 44" 4* 4* 4444-
-
MALE #2 ANIMAL#
PLUG OBSERVED
LITTER PRODUCED
4* 44-
+
44444-
+
444-
-
44444444* 4-
GESTATION LENGTH(days)
23 23
22
23
22 22
23 23 23
22
--
22
23
22
--
21 22 22
23 23
22
23 23
--
-262Jf?mPanYSanitized. Does not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
H -24 76 8
REPRODUCTIVE AND F E R T IL IT Y EFFECTS WITH H -2 4 76 8
APPENDIX (continued)
INDIVIDUAL MATING DATA AND GESTATION LENGTH: PI GENERATION
GROUPS: IV-0,III -0
DOSE: 1 MG/KG/DAY
DuPont-13784
MALE TMAL#
121 122
123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144
MALE #1 ANIMAL#
25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48
PLUG/SPERM OBSERVED
+ +
4*
+ + +
444-
+
4-
+ + + +
44-
+ + + +
444-
MALE #2 ANIMAL#
PLUG OBSERVED
LITTER PRODUCED
4444-
4-
4-
-
44* 444-
+
444*
+
444* 44-
GESTATION LENGTH(days)
23 23
22 22
23 23
--
23
22
23
22 22
23 23
22 22 22
--
22
--
22 22 22
23
-263ffompany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
H-24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL MATING DATA AND GESTATION LENGTH: PI GENERATION
GROUPS: VI-0,V-0
DOSE: 10 MG/KG/DAY
DuPont-13784
FEMALE ANIMAL#
145 146 147a 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
MALE #1 ANIMAL#
49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65
66
67
68
69 70 71 72
PLUG/SPERM OBSERVED
+ +
-
+ ~h +
-
+ + +
+ + + + + + + + + + +
MALE #2 ANIMAL#
PLUG OBSERVED
LITTER PRODUCED
-
+ + + + + + + + + +
+ +
+ + + +'
GESTATION LENGTH(days)
--
22
-- 23 23
22
-23 23
22 22 22
-23
-22
23 23
22
--
22
23
22 22
a No litter delivered, however, one live fetus was observed in uterus at necropsy.
-264-
S-pinpany Sanitized. Does not contain TSCA ef
H-24768: One-Generation Reproduction Study in Rats
H -24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL MATING DATA AND GESTATION LENGTH: PI GENERATION
GROUPS: VIII-0,VII-0
DOSE: 25 MG/KG/DAY
DuPont-13784
female
ANIMAL#
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192
MALE #1 PLUG/SPERM ANIMAL# OBSERVED
73 74 + 75 4* 76 + 77 + 78 479 4* 80 + 81 + 82 + 83 84 4* 85 +
86 -
87 +
88 -
89 + 90 + 91 + 92 93 + 94 + 95 + 96 +
MALE #2 ANIMAL#
PLUG OBSERVED
LITTER
GESTATION
PRODUCED LENGTH(days)
+ 23 + 23 + 22 + 22 + 22 + 23
4* 2 2 4* 2 2 4* 2 2 4- 2 2 ---
+ 23
4- 2 2
+-- + 22
---
+ 23
4- 2 2 4- 2 2 4* --
4* 2 2 4- 2 2
+ 23
4- 2 2
-265Company Sanitized. Does not contain TSCA CBS
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX V INDIVIDUAL IMPLANTATION SITE DATA, IMPLANTATION EFFICIENCY,
AND C O R P O R L U T E A COUNTS: Pi RATS
- 266 Company Sanitized, Does not contain TSCA CI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL IMPLANTATION SITE DATA, IMPLANTATION EFFICIENCY, AND CORPOR LUTEA COUNTS: Pi RATS
EXPLANATORY NOTES
Note
When the number of pups bom was greater than the number of implantation sites found in the uterus at necropsy, implantation efficiency could not be calculated and the number of implantation sites was excluded from the statistical analysis.
Abbreviations No Data
-267Company Sanitized. Does not contain TSCA CBT
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL IMPLANTATION S IT E DATA, IMPLANTATION E FFIC IEN C Y , AND CORPORA LUTEA COUNTS: P i RATS
GROUPS: I I - O
DOSE: 0 MG/KG/DAY
A nim al N um ber
Pups B orn
Number o f Im p la n ta tio n
Im p lan tatio n E ffic ie n c y
S ite s
(%)
C orpora L u tea Count
97 8 10 98 18 19 99 16 17 100 14 15 101 12 14 102 15 15 103 13 14 104 15 17 105 11 13 106 16 18 107 108 16 16 109 16 16 110 15 15 111 112 18 19 113 16 17 114 17 18 115 13 15 116 11 12 117 12 15 118 13 15 119 17 18 120 15 16
8 0 .0 9 4 .7 9 4 .1 93 .3 8 5.7 1 0 0 .0 9 2.9 8 8.2 8 4.6 8 8.9
1 0 0 .0 1 0 0 .0 1 0 0 .0
9 4.7 9 4.1 9 4.4 8 6.7 9 1.7 8 0.0 8 6.7 9 4 .4 9 3.8
12 19 18 15 14 15 15 17 14 18
16 17 17
19 17 18 15 12 14 15 18 17
-268Company Sanitized. Does not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL IMPLANTATION S IT E DATA, IMPLANTATION E F FIC IE N C Y , AND CORPORA LUTEA COUNTS: P i RATS
GROUPS: I V - 0
DOSE: 1 MG/KG/DAY
A nim al N um ber
Pups B orn
Number o f Im p la n ta tio n
Im p lan tatio n E ffic ie n c y
S ite s
(%)
C orpora L u tea Count
121 16 16
122 12 12
123 16 17
124 17 18
125 15 17
126 15 17
127
128 14 15
129 8 10
130 12 13
131 7 11
132 16 17
133 6
7
134 11 11
135 17 18
136 19 20
137 12 13
138
139 17 17
140
141 10 10
142 11 15
143 18 18
144 14 15
1 0 0 .0 1 0 0 .0 9 4 .1 9 4 .4 8 8.2 8 8.2
93 .3 8 0 .0 9 2 .3 63 .6 9 4 .1 85 .7 1 0 0 .0 9 4 .4 95 .0 9 2 .3
1 0 0 .0
1 0 0 .0 7 3.3 1 0 0 .0 9 3.3
16 12 17 18 17 18
16 13 15 11 17 9 12 19 20 13
17
15 16 18 16
-269Company Sanitized. Does not contain TSCA CB!
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL IMPLANTATION S IT E DATA, IMPLANTATION EFFICIEN CY , AND CORPORA LUTEA COUNTS: P x RATS
GROUPS: V I - 0
DOSE: 10 MG/KG/DAY
A nim al N um ber
Pups B orn
Number o f Im p la n ta tio n
Im p lan tatio n E ffic ie n c y
S ite s
(%)
C orpora L u tea Count
145
--
146 18
147 0
148 16
149 18
150 11
151
152 16
153 15
154 15
155 18
156 12
157
158 16
159 12
160 16
161 12
162 14
163 - 15
164
165 15
166 13
167 16
168 11
-- 19 1 18 18 14
17 17 15 18 14
17 12 17 14 15 17
16 14 17 14
--
9 4 .7 ----- a 8 8 .9 1 0 0 .0 7 8 .6
9 4 .1 8 8.2 1 0 0 .0 1 0 0 .0 8 5.7
9 4 .1 1 0 0 .0 9 4 .1 8 5.7 9 3.3 8 8.2
9 3 .8 9 2 .9 9 4 .1 7 8 .6
--
20 4 18 18 15
17 17 15 18 14
17 12 17 14 16 17
16 15 16 14
a No evidence of copulation was observed, but animal had one live fetus in uterus at necropsy; thus, gestation day was miscalculated. Data were excluded from implantation efficiency.
- 270 'p n ip a n y Sanitized. Dees not eontafn TSCA
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL IMPLANTATION S IT E DATA, IMPLANTATION EFFIC IEN C Y , AND CORPORA LUTEA COUNTS: P x RATS
GROUPS: V I I I - 0
DOSE: 25 MG/KG/DAY
A nim al N um ber
Pups B orn
Number o f Im p la n ta tio n
Im p lan tatio n E ffic ie n c y
S ite s
(%)
C orpora L u tea Count
169 12 170 11 171 16 172 15 173 17 174 16 175 16 176 15 177 15 178 16 179 180 15 181 16 182 16 183 16 184 185 16 186 13 187 18 188 18 189 14 190 13 191 14 192 15
14 14 16 16 17 16 18 15 16 16
17 16 17 16
16 13 19 18 16 16 15 16
8 5 .7 7 8 .6 1 0 0 .0 9 3 .8 1 0 0 .0 1 0 0 .0 8 8 .9 1 0 0 .0 9 3 .8 1 0 0 .0
8 8 .2 1 0 0 .0 9 4 .1 1 0 0 .0
1 0 0 .0 1 0 0 .0 9 4.7 1 0 0 .0 8 7 .5 8 1.3 9 3.3 93.8
14 14 18 16 17 16 19 15 16 16
17 16 20 16
16 22 19 18 16 16 15 18
-271 Sompany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX W INDIVIDUAL PUP SURVIVAL: FxGENERATION
-272jCompany Sanitized. Does no! contain TSCA CBi
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL PUP SURVIVAL: Fj GENERATION EXPLANATORY NOTES
Note Unless stated otherwise, a dash
indicates that there was no litter delivered.
Abbreviations = No Data
-273 Company Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
H-24768
REPRODUCTIVE AMD FERTILITY EFFECTS WITH H-24768
APPENDIX
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP; II-O
DOSE: 0 MG/KG/DAY
ANIMAL #
97 98 99
100 101 102
103 104 105 106 107 108 109
110 111 112
113 114 115 116 117 118 119
120
Mean S.D. S.E. N
BORN
8
18 16 14
12
15 13 15
11
16
-
16 16a 15
-
18 16 17 13
11 12
13 17 15
14.4 2.54 0.54
22
BORN ALIVE
8
18 16 14
12
15
12
15
11
16
-
16 15 15
-
18 16 17 13
11 12
13 17 15
14.3 2.55 0.54
22
NUMBER OF PUPS
DAY 4
8
18 16 14
12
15
12
15
11
16
16 15 15
-
18 16 17 13
11 12
13 16 15
14.3 2.51 0.54
22
DuPont-13784
a Includes one unsexable pup.
-274Company Sanitized. Does not contain TSCA CM
H-24768: One-Generation Reproduction Study in Rats
H-24768
3
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768 APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
ANIMAL #
97 98 99
100 101 102
103 104 105 106 107 108 109
110 111 112
113 114 115 116 117 118 119
120
Mean S.D. S.E. N
BORN
6
5
6 10
7
11 2
9 .5
9
-
8
9
11
-
9
6 11
8 2
5
6 12 10
7.6 2.82 0.60
22
NUMBER OF MALE PUPS
BORN ALIVE
DAY 4
6
5
6 10
7
11 2
9 5 9 -
8
9
11
-
9
6 11
8 2
5 '6
12 10
7.6 2.82 0.60
22
6
5
6 10
7
11 2
9 5 9 ~
8
9
11
" 9
6 11
8 2
5
6 12 10
7.6 2.82 0.60
22
DuPont-13784
-275Company Sanitized. Does not contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
H-24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
ANIMAL #
97 98 99
100 101 102
103 104 105 106 107 108 109
110 111 112
113 114 115 116 117 118 119
120
Mean S.D. S.E. N
BORN
2
13
10
4 5 4
11 6 6
7 -
8 6
4 9
10 6
5 9 7 7 5 5
6.8
2.67 0.57
22
NUMBER OF FEMALE PUPS
BORN ALIVE
DAY 4
2
13
10
4 5 4
10 6 6
7 -
8 6
4 9
10 6
5 9 7 7 5 5
6.7 2.60 0.56
22
2
13
10
4 5 4
10 6 6
7 -
8 6
4 9
10 6
5 9 7 7 4 5
6.7 2.64 0.56
22
DuPont-13784
-276-
Company Sanitized. Does not confa!n TSCA CBt
H-24768: One-Generation Reproduction Study in Rats
ANIMAL #
97 98 99
100 101 102
103 104 105 106 107 108 109
110 111 112
113 114 115 116 117 118 119
120
Mean S.D. S.E. N
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
NUMBER OF PUPS
SEX RATIO (MALES)
0.75 0.28 0.38 0.71 0.58 0.73 0.15 0.60 0.45 0.56
0.50 0.60 0.73
0.50 0.38 0.65 0.62 0.18 0.42 0.46 0.71 0.67
0.53 0.176 0.037
22
% BORN ALIVE
100.0 100.0 100.0 10 0 .0 100.0 100.0
92.3
100.0 100.0 100.0
100.0
93.8
100.0
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
99.4 2.06 0.44
22
0-4 DAY VIABILITY
10 0 .0 10 0 .0 10 0 .0 10 0 .0 10 0 .0 10 0 .0 10 0 .0 10 0 .0 10 0 .0 10 0 .0
10 0 .0 10 0 .0 100.0
10 0 .0 10 0 .0 100.0 100.0 100.0 100.0 100.0
94.1
100.0
99.7 1.25 0.27
22
DuPont-13784
-277Company Sanitized. Does not contain TSCA CBI
/ "" N
H-24768: One-Generation Reproduction Study in Rats
ANIMAL #
97 98 99
100 101 102
103 104 105 106 107 108 109
110 111 112
113 114 115 116 117 118 119
120
Mean S.D. S.E. N
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: FIA GENERATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
NUMBER OF MALE PUPS
% BORN ALIVE
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
-
10 0 .0 100.0 100.0
-
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
100.0 0.00 0.00
22
0-4 DAY VIABILITY
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
-
100.0 100.0 10 0 .0
-
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
10 0 .0 0.00 0.00
22
DuPont-13784
-278Company Sanitized Does not contain TSCA CB
H-24768: One-Generation Reproduction Study in Rats
H-24768
ANIMAL #
97 98 99
100 101 102
103 104 105 106 107 108 109
110 111 112
113 114 115 116 117 118 119
120
Mean S.D. S.E. N
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
NUMBER OF FEMALE PUPS
% BORN ALIVE
100.0 100.0 100.0 10 0 .0 10 0 .0 10 0 .0
90.9
100.0 10 0 .0 10 0 .0
-
10 0 .0 10 0 .0 1 0 0 .0
-
10 0 .0 10 0 .0 100.0 100.0 100.0 10 0 .0 100.0 100.0 100.0
99.6 1.94 0.41
22
0-4 DAY VIABILITY
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
-
100.0 100.0 100.0
-
100.0 100.0 100.0 100.0 100.0 100.0 100.0
80.0
100.0
99.1 4.26 0.91
22
DuPont-13784
-279Company Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: IV-0
DOSE: 1 MG/KG/DAY
ANIMAL #
121 122
123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144
Mean S.D. S.E. N
BORN
16
12
16 17 15 15
-
14 .8
12
7 16
6 11
17 19
12
-
17
-
10 11
18 14
13.5 3.68 0.80
21
BORN ALIVE
16
12
16 16 15 15
-
14
8 12
7 16
6 11
17 19
12
-
16 -
10
ii 18 14
13.4 3.60 0.79
21
NUMBER OF PUPS
DAY 4
16
12
16 15 15 14
14
8 12
7 16
6 11
16 19
10
16
-
10 11
18 13
13.1 3.56 0.78
21
DuPont-13784
-280ICompany Sanitized. Does not contain TSCA C6I
H-24768: One-Generation Reproduction Study in Rats
1H-24768
[
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: IV-0
DOSE: 1 MG/KG/DAY
ANIMAL #
121 122
123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144
Mean S.D. S.E. N
BORN
8 6 11 11 10 8
-
7 5
8
5 7 4 5
12
9
6
-
8
-
5 3 9
8
7.4 2.44 0.53
21
NUMBER OF MALE PUPS
BORN ALIVE
DAY
8 6 11 10 10 8
-
7 5
8
5 7 4 5
12
9
6
-
7
-
5 3 9
8
7.3 2.37 0.52
21
8 6 11
9
10
7
~
7 5
8
5 7 4 5
11
9 5
-
7
-
5 3 9
8
7. 2. 0.
21
DuPont-13784
-281 'Company Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: IV-0
DOSE: 1 MG/KG/DAY
ANIMAL #
121 122
123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144
Mean S.D. S.E. N
BORN
8 6
5
6
5 7
-
7 3 4
2
9
2 6
5
10 6
-
9
_
5
8
9
6
6 .1
2.26 0.49
21
NUMBER OF FEMALE PUPS
BORN ALIVE
DAY 4
8 6
5
6
5 7 7 3 4
2
9
2 6
5
10 6
_
9 5
8
9
6
6 .1
2.26 0.49
21
8 6
5
6
5 7 7 3 4
2
9
2 6
5
10
5 9 5
8
9 5
6.0
2.28 0.50
21
DuPont-13784
-282ICompany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
ANIMAL #
121 122
123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144
Mean S.D. S.E. N
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: IV-0
DOSE: 1 MG/KG/DAY
NUMBER OF PUPS
SEX RATIO (MALES)
0.50 0.50 0.69 0.65 0.67 0.53
-
0.50 0.63 0.67 0.71 0.44 0.67 0.45 0.71 0.47 0.50
-
0.47
-
0.50 0.27 0.50 0.57
0.55
0 .1 1 2
0.025
21
% BORN ALIVE
1 0 0 .0 1 0 0 .0 100.0
94.1
100.0 100.0
-
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
94.1
-
100.0 10 0 .0 10 0 .0 100.0
99.4 1.77 0.39
21
0-4 DAY VIABILITY
1 0 0 .0 100.0 1 0 0 .0
93.8
1 0 0 .0
93.3 -
1 0 0 .0 100.0 100.0 100.0 100.0 100.0 1 0 0 .0
94.1
100.0
83.3 -
1 0 0 .0
-
1 0 0 .0 10 0 .0 10 0 .0
92.9
98.0 4.25 0.93
21
DuPont-13784
- 283 -
feig>aay 'Sanitized Does rrofomfain TSCAC1I
H-24768: One-Generation Reproduction Study in Rats
ANIMAL #
121 122
123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144
Mean S.D. S.E. N
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: IV-0
DOSE: 1 MG/KG/DAY
NUMBER OF MALE PUPS
% BORN ALIVE
100.0 100.0 100.0
90.9
100.0 100.0
-
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
-
87.5
-
100.0 100.0 100.0 100.0
99.0 3.29 0.72
21
0-4 DAY VIABILITY
100.0 100.0 100.0
90.0
100.0
87.5 -
100.0 100.0 100.0 100.0 100.0 100.0 100.0
91.7
100.0
83.3 -
100.0
-
100.0 100.0 100.0 100.0
97.7 4.98 1.09
21
DuPont-13784
-284jCompany Sanitized. Does not contain TSCA CBS
H-24768: One-Generation Reproduction Study in Rats
ANIMAL #
121 122
123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144
Mean S.D. S.E. N
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: IV-0
DOSE: 1 MG/KG/DAY
NUMBER OF FEMALE PUPS
% BORN ALIVE
100.0 100.0 1 0 0 .0 1 0 0 .0 1 0 0 .0 1 0 0 .0
-
1 0 0 .0 10 0 .0 10 0 .0 10 0 .0 100.0 10 0 .0 10 0 .0 10 0 .0 1 0 0 .0 1 0 0 .0
-
1 0 0 .0
-
1 0 0 .0 100. 100.0 1 0 0 .0
10 0 .0 0.00 0.00
21
0-4 DAY VIABILITY
100.0 100.0 100.0 100.0 100.0 100.0
-
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
83.3
-
100.0
-
100.0 100.0 100.0
83.3
98.4 5.01 1.09
21
DuPont-13784
-285-
jCpmpany Sanitized. Does not contain TSCACBI
H-24768: One-Generation Reproduction Study in Rats
H-24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: VI-0
DOSE: 10 MG/KG/DAY
ANIMAL #
145 146 147a 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
Mean S.D. S.E. N
BORN
18_
16 18
11
16 15 15 18
12
16
12
16
12
14 15
-
15 13 16
11
14.7 2.29 0.52
19
BORN ALIVE
_
18 ~
16 18
11
16 15 15 18
12
16
12
16
12
14 15
15 13 16
11
14.7 2.29 0.52
19
NUMBER OF PUPS
DAY 4
_
17 -
16 18
10
16 15 15 18
12
16
12
16
12
14 15
15 13 16
11
14.6 2.32 0.53
19
DuPont-13784
t a Animal had one.live fetus in uterus at necropsy.
-286Pompany Sanitized. Does not contain TSCA CBf
*
H-24768: One-Generation Reproduction Study in Rats
1H-24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: VI-0
DOSE: 10 MG/KG/DAY
ANIMAL #
145 146 147a 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
Mean S.D. S.E. N
BORN
3
-
7 9 9
-
6 8 10 10 8
-
5 7 6 7 5 5
_
11 8 8 5
7.2 2 .1 0 0.48 19
NUMBER OF MALE PUPS
BORN ALIVE
_
3 " 7 9 9
6 8 10 10 8 " 5 7 6 7 5 5 " 11 8 8 5
7.2 2 .1 0 0.48 19
DAY 4
_
3 " 7 9 8 " 6 8 10 10 8 " 5 7 6 7 5 5 11 8 8 5
7.2 2.06 0.47 19
DuPont-13784
a Animal had one live fetus in uterus at necropsy.
-287Jgompany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
H-24768 _
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: VI-0
DOSE: 10 MG/KG/DAY
ANIMAL #
145 146 147a 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
Mean S.D. S.E. N
BORN
15
9 9
2
-
10
7 5
8
4 -
11
5
10
5 9
10
4 5
8 6
7.5 3.13 0.72 19
NUMBER OF FEMALE PUPS
BORN ALIVE
DAY 4
15
9 9
2
-
10
7 5
8
4 -
11
5
10
5 9
10
4 5
8 6
7.5 3.13 0.72 19
14
9 9
2
-
10
7 5
8
4 -
11
5
10
5 9
10
4 5
8 6
7.4 3.01 0.69 19
DuPont-13784
a Animal had one live fetus in uterus at necropsy.
-288 "Company Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
H-24768
3[
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: FIA GENERATION
GROUP: VI-0
DOSE: 10 MG/KG/DAY
NUMBER OF PUPS
ANIMAL #
145 146 147a 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
Mean S.D. S.E. N
SEX RATIO (MALES)
0 .17
0 ,.44 0 ,.50 0 ..82
0 .38 0 .53 0 ,.67 0 .56 0 ,.67
0 ,.31 0 .58 0 .38 0 .58 0 .36 0 .33
0 .73 0 .62 0 ,.50 0 .45
0 ,.50 0 ,.162 0 ,.037 19
% BORN ALIVE
1 0 0 .. 0
1 0 0 .. 0 1 0 0 .. 0 1 0 0 .. 0
1 0 0 .. 0 1 0 0 .. 0 1 0 0 .. 0 1 0 0 .. 0 1 0 0 .. 0
1 0 0 .. 0 1 0 0 .. 0 1 0 0 .. 0 1 0 0 .. 0 1 0 0 .. 0 1 0 0 .. 0
1 0 0 .. 0 1 0 0 .. 0 1 0 0 .. 0 1 0 0 .. 0
1 0 0 .. 0 0 .. 0 0 0 .. 0 0
19
0-4 DAY VIABILITY
94 .4 -
100 .0
1 0 0 ,. 0 90 .9 "
100 .0 100 .0 100 .0 100 .0 100 .0
--
100 .0 100 .0 100 .0 100 .0 100 .0 100 .0
-
100 .0 100 .0 100 .0 100 .0
99 . 2 2 .38 0 .55
19
DuPont-13784
Animal had one live fetus in uterus at necropsy.
-289PSompany Sanitized. Does not contain TSCA COI
H-24768: One-Generation Reproduction Study in Rats
ANIMAL #
145 146 147a 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
Mean S.D. S.E. N
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: VI-0
DOSE: 10 MG/KG/DAY
NUMBER OF MALE PUPS
% BORN ALIVE
-
100.0
-
100.0 100.0 100.0
-
100.0 100.0 100.0 100.0 100.0
-
100.0 100.0 100.0 100.0 100.0 100.0
-
100.0 100.0 100.0 100.0
100.0 0.00 0.00
19
0-4 DAY VIABILITY
-
100.0
-
100.0 100.0
88.9 -
100.0 100.0 100.0 100.0 100.0
-
100.0 100.0 100.0 100.0 100.0 100.0
-
100.0 100.0 100.0 100.0
99.4 2.55 0.58
19
DuPont-13784
a Animal had one live fetus in uterus at necropsy. ^ m p a n ^ n 'iliz e d . Does not contain TSC#
H-24768: One-Generation Reproduction Study in Rats
[mmH-24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: VI-0
DOSE: 10 MG/KG/DAY
NUMBER OF FEMALE PUPS
ANIMAL #
145 146 147a 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
Mean S.D. S.E. N
% BORN ALIVE
-
100.0
-
100.0 100.0 100.0
-
100.0 100.0 100.0 100.0 100.0
-
100.0 100.0 100.0 100.0 100.0 100.0
-
100.0 100.0 100.0 100.0
100.0 0.00 0.00
19
0-4 DAY VIABILITY
93.3
-
100.0 100.0 100.0
-
100.0 100.0 100.0 100.0 100.0
-
100.0 100.0 100.0 100.0 100.0 100.0
-
100.0 100.0 100.0 100.0
99.6 1.53 0.35
19
DuPont-13784
i
a Animal had one live fetus in uterus at necropsy.
-291 -
l$&rnpmtySanitized, oe*oftonfan TSC CB!
*
H-24768: One-Generation Reproduction Study in Rats
H-24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: VIII-0
DOSE: 25 MG/KG/DAY
ANIMAL #
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 .189 190 191 192
Mean S.D. S.E. N
BORN
12 11
16 15 17 16 16 15 15 16
-
15 16 16 16
-
16 13 18 18 14 13 14 15
15.1 1.75 0.37
22
BORN ALIVE
12 11
16 15 17 16 16 15 15 16
-
15 16 16 16
-
16 13 17 18 14
12
14 15
15.0 1.76 0.37
22
NUMBER OF PUPS
DAY 4
12 10
16 15 16 16 16 15 15 16
15 16 16 16
16 13 17 18 14
11
14 14
14.9 1.93 0.41
22
DuPont-13784
-292-
JS&TQpampSanitized. Does rwsfconfafn TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
H-24768
(
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: VIII-0
DOSE: 25 MG/RG/DAY
ANIMAL #
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192
Mean S.D. S.E. N
BORN
6
4 5 7
6 11
9 9 9
10
7 7 7 4 9 5
10
5
11 6 6
5
7.2
2.22
0.47
22
NUMBER OF MALE PUPS
BORN ALIVE
DAY 4
6
4 5 7
6 11
9 9 9
10
7 7 7 4 9 5
10
5
11 6 6
5
7.2
2.22
0.47
22
6
3 5 7
6 11
9 9 9
10
" 7 7 7 4 " 9 5
10
5
11 6 6
5
7.1 2.29 0.49
22
DuPont-13784
-293&pmpany Sanitized. Does not contain TSCA CBi
H-24768: One-Generation Reproduction Study in Rats
H-24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: VIII-0
DOSE: 25 MG/KG/DAY
ANIMAL #
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192
Mean S.D. S.E. N
BORN
6
7
11 8
11
5 7
6 6 6
-
8
9 9
12
7
8 8
13 3 7
8 10
8.0
2.38 0.51
22
NUMBER OF FEMALE PUPS
BORN ALIVE
DAY 4
6
7
11 8
11
5 7
6 6 6
~
8
9 9
12
~ 7
8
7 13
3
6 8 10
7.9 2.42 0.52
22
6
7
11 8
10
5 7
6 6 6
"
8
9 9
12
7
8
7 13
3 5
8
9
7.7 2.37 0.51
22
DuPont-13784
-294gtm pany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
H-24768
ANIMAL #
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192
Mean S.D. S.E. N
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: VIII-0
DOSE: 25 MG/KG/DAY
NUMBER OF PUPS
SEX RATIO (MALES)
0.50 0.36 0.31 0.47 0.35 0.69 0.56 0.60 0.60 0.63
0.47 0.44 0.44 0.25
0.56 0.38 0.56 0.28 0.79 0.46 0.43 0.33
0.48 0.137 0.029
22
% BORN ALIVE
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
100.0 100.0 100.0 100.0
100.0 100.0
94.4
100.0 100.0
92.3
100.0 100.0
99.4 1.98 0.42
22
0-4 DAY VIABILITY
100.0
90.9
100.0 100.0
94.1
100.0 100.0 100.0 100.0 100.0
100.0 100.0 100.0 100.0
100.0 100.0 100.0 100.0 100.0
91.7
100.0
93.3
98.6 3.01 0.64
22
DuPont-13784
-295-
JCpntyjarqf Sanitized. Ones rat contain TSCA CBf
H-24768: One-Generation Reproduction Study in Rats
H-24768
ANIMAL #
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192
Mean S.D. S.E. N
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: VIII-0
DOSE: 25 MG/KG/DAY
NUMBER OF MALE PUPS
% BORN ALIVE
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
-
100.0 100.0 100.0 100.0
-
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
100.0 0.00 0.00
22
0-4 DAY VIABILITY
100.0
75.0
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
-
100.0 100.0 100.0 100.0
-
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
98.9 5.33 1.14
22
DuPont-13784
-296-
IDompany Sanitized. Does not contain TSCA cp
H-24768: One-Generation Reproduction Study in Rats
H-24768
ANIMAL #
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192
Mean S.D. S.E. N
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL PUP SURVIVAL: F1A GENERATION
GROUP: VIII-0
DOSE: 25 MG/KG/DAY
NUMBER OF FEMALE PUPS
% BORN ALIVE
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
-
100.0 100.0 100.0 100.0
-
100.0 100.0
87.5
100.0 100.0
85.7
100.0 100.0
98.8 3.95 0.84
22
0-4 DAY VIABILITY
100.0 100.0 100.0 100.0
90.9
100.0 100.0 100.0 100.0 100.0
-
100.0 100.0 100.0 100.0
-
100.0 100.0 100.0 100.0 100.0
83.3
100.0
90.0
98.4 4.38 0.93
22
DuPont-13784
-297gompany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX X INDIVIDUAL LITTER CLINICAL OBSERVATIONS: Fi GENERATION
-298ICompany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
H-24768
3
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768 APPENDIX
INDIVIDUAL LITTER CLINICAL OBSERVATIONS: FlA GENERATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
ANIMAL LACTATION
NUMBER
DAY
SIGN INCIDENCE OBSERVATIONS
97 NO ABNORMALITIES DETECTED 98 NO ABNORMALITIES DETECTED 99 NO ABNORMALITIES DETECTED 1 0 0 NO ABNORMALITIES DETECTED 1 0 1 . NO ABNORMALITIES DETECTED 1 0 2 NO ABNORMALITIES DETECTED 103 NO ABNORMALITIES DETECTED 104 NO ABNORMALITIES DETECTED 105 NO ABNORMALITIES DETECTED 106 NO ABNORMALITIES DETECTED 108 NO ABNORMALITIES DETECTED 109 NO ABNORMALITIES DETECTED 1 1 0 NO ABNORMALITIES DETECTED 1 1 2 NO ABNORMALITIES DETECTED 113 NO ABNORMALITIES DETECTED 114 NO ABNORMALITIES DETECTED 115 NO ABNORMALITIES DETECTED 116 NO ABNORMALITIES DETECTED 117 NO ABNORMALITIES DETECTED 118 NO ABNORMALITIES DETECTED 119 NO ABNORMALITIES DETECTED 1 2 0 NO ABNORMALITIES DETECTED
DuPont-13784
4
-299-
H-24768: One-Generation Reproduction Study in Rats
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL LITTER CLINICAL OBSERVATIONS: FlA GENERATION
GROUP: IV-0
DOSE: 1 MG/KG/DAY
ANIMAL LACTATION
NUMBER
DAY
SIGN INCIDENCE OBSERVATIONS
1 2 1 NO ABNORMALITIES DETECTED 1 2 2 NO ABNORMALITIES DETECTED 123 NO ABNORMALITIES DETECTED 124 NO ABNORMALITIES DETECTED 125 NO ABNORMALITIES DETECTED 126 NO ABNORMALITIES DETECTED 128 NO ABNORMALITIES DETECTED 129 NO ABNORMALITIES DETECTED 130 NO ABNORMALITIES DETECTED 131 NO ABNORMALITIES DETECTED 132 NO ABNORMALITIES DETECTED 133 NO ABNORMALITIES DETECTED 134 NO ABNORMALITIES DETECTED 13 5 NO ABNORMALITIES DETECTED 136 NO ABNORMALITIES DETECTED 137 NO ABNORMALITIES DETECTED 139 NO ABNORMALITIES DETECTED 141 NO ABNORMALITIES DETECTED 142 NO ABNORMALITIES DETECTED 143 NO ABNORMALITIES DETECTED 144 NO ABNORMALITIES DETECTED
DuPont-13784
-300p m p m y Sanitize#. P e e sn o t contain TSCA e w
H-24768: One-Generation Reproduction Study in Rats
H-24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
APPENDIX (continued)
INDIVIDUAL LITTER CLINICAL OBSERVATIONS: F1A GENERATION
GROUP: VI-0
DOSE: 10 MG/KG/DAY
ANIMAL LACTATION
NUMBER
DAY
SIGN INCIDENCE OBSERVATIONS
146 NO ABNORMALITIES DETECTED 148 NO ABNORMALITIES DETECTED 149 NO ABNORMALITIES DETECTED 150 NO ABNORMALITIES DETECTED 152 NO ABNORMALITIES DETECTED 153 NO ABNORMALITIES DETECTED 154 NO ABNORMALITIES DETECTED 155 NO ABNORMALITIES DETECTED 156 NO ABNORMALITIES DETECTED 158 NO ABNORMALITIES DETECTED 159 NO ABNORMALITIES DETECTED 160 NO ABNORMALITIES DETECTED 161 NO ABNORMALITIES DETECTED 162 NO ABNORMALITIES DETECTED 163 NO ABNORMALITIES DETECTED 165 NO ABNORMALITIES DETECTED 166 NO ABNORMALITIES DETECTED 167 NO ABNORMALITIES DETECTED 168 NO ABNORMALITIES DETECTED
DuPont-13784
-301 Company Sanitized. Does not contain TSCA CBl
H-24768: One-Generation Reproduction Study in Rats
H-24768
REPRODUCTIVE AND FERTILITY EFFECTS WITH H-24768
}
APPENDIX (continued)
INDIVIDUAL LITTER CLINICAL OBSERVATIONS: F1A GENERATION
GROUP: VIII-0
DOSE: 25 MG/KG/DAY
ANIMAL LACTATION
NUMBER
DAY
SIGN INCIDENCE OBSERVATIONS
169 NO ABNORMALITIES DETECTED
170 NO ABNORMALITIES DETECTED
171 NO ABNORMALITIES DETECTED
172 NO ABNORMALITIES DETECTED
173 NO ABNORMALITIES DETECTED
174 NO ABNORMALITIES DETECTED
175 NO ABNORMALITIES DETECTED
176 NO ABNORMALITIES DETECTED
177 NO ABNORMALITIES DETECTED
178 NO ABNORMALITIES DETECTED
180 NO ABNORMALITIES DETECTED
181 NO ABNORMALITIES DETECTED
182 NO ABNORMALITIES DETECTED
183 NO ABNORMALITIES DETECTED
185 NO ABNORMALITIES DETECTED
186 NO ABNORMALITIES DETECTED
187 NO ABNORMALITIES DETECTED
188 NO ABNORMALITIES DETECTED
189 NO ABNORMALITIES DETECTED
190 NO ABNORMALITIES DETECTED
191 NO ABNORMALITIES DETECTED
192 DAY 0
1 OF 15 SUBCUTANEOUS HEMORRHAGE FACE
LITTER SUMMARY:
1
SUBCUTANEOUS HEMORRHAGE
DuPont-13784
-302Company Sanitized. Does not contain TSCA CB1
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX Y INDIVIDUAL PUP WEIGHTS: Fi GENERATION
-303-
'Company Sanitized. Does not contain T8CA CBI
H-24768: One-Generation Reproduction Study in Rats
INDIVIDUAL PUP WEIGHTS: Fj GENERATION EXPLANATORY NOTES
Note Animals with no data either did not mate or no litter was delivered.
DuPont-13784
. /"'S
-304Cotnpany Sanitized. Does not contain TSCA CBi
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
Individual Pup Weights (grams): Fi Generation
Lactation Day 0
Group: II-O
Dose: 0 mg/kg/day
Animal Humber
97 98 99
100 101 102
103 104 105 106 107 108 109
110 111 112
113 114 115 116 117 118 119
120
Pup Sex___________________________________ Pup Humber
1 2 345 6 78
3 8 . 0 8 . 0 7.8 7.9 7.5 7.8
9 7.3 7.0
s 6 . 8 6 . 6 6 . 6 7.0 6.7
9 6.5 6 . 6 6 . 1 5.9 6 . 1 6.9 6 . 0 6 . 8
3 6.3 6 . 0 5.8 6 . 1 6 . 2 5.9
9 5.5 5.5 5.9 5.5 5.5 5.9 5.7 6 . 1
3 7.4 6 . 2 7.8 7.0 7.9 7.4 7.6 6.5
9 7.1 7.2 7.2 6.5
S 6.3 6.7 6.3 6 . 1 5.8 6.9 6 . 2
9 6.3 6.3 5.9 6 . 6 6 . 0
3 6.9 6.3 6.7 6.4 6.9 6 . 2 5.7 6 . 1 9 6 . 0 6.4 5.5 6.3
7.6 7.6
9 7.5 7.5 7.3 7.6 7.1 7.2 6.7 7.1
<5 7.1 7.6 7.3 7.9 7.3 7.7 7.8 7.6 9 6.9 7.0 7.3 7.5 6 . 8 7.4
3 7.7 11.3 8 . 6 7.9 8 . 0 9 7.9 7.5 7.3 7.6 7.2 7.1
3 6 . 2 5.8 6.4 6.5 6 . 6 6.7 6 . 6 6.7 9 6 . 0 6 . 2 6 . 2 5.7 5.7 5.7 6.4
3 9
3 6 . 8 4.7 6 . 0 5.9 5.9 6.3 7.5 4.0 9 6.4 6.3 6 . 0 5.5 5.9 6 . 1 5.7 5.6 3 6.7 6.4 6.4 6.7 6 . 8 6.4 6 . 1 6 . 8 9 6.3 5.8 6 . 1 6 . 1 6.5 6 . 1
3 6 . 0 5.6 6.5 6 . 1 5.9 5.6 5.6 6 . 0 9 5.6 5.3 5.2 3.8
3 9 3 6 . 6 6 . 1 6 . 2 6.5 6 . 0 6 . 2 5.8 6 . 2 9 5.9 6 . 1 6 . 1 5.2 5.7 5.9 5.3 5.7
3 6 . 2 6 . 6 6 . 2 6 . 0 5.8 6.5 9 5.5 6 . 0 5.9 6 . 1 6.3 6 . 0 5.3 6.3
3 6 . 2 6.4 6 . 1 6.4 6.5 6 . 2 5.8 6 . 0 9 5.7 5.7 5.9 4.9 6.4 5.7
3 7.4 7.3 7.7 7.6 7.9 7.4 8 . 2 7.7 9 7.5 7.4 7.1 7.2 7.4 3 8 . 0 7.8 9 7.6 7.5 8.5 7.6 7.4 7.4 7.8 7.0
3 6.7 7.3 6.9 6 . 8 6.5 9 5.8 6 . 6 6.4 6.3 6.4 6 . 6 6 . 0
3 7.8 8 . 1 7.3 7.5 8.3 7.6 9 6.9 6.7 8 . 0 7.9 6.5 7.5 7.1 3 6.4 6.7 6.9 7.3 7.3 7.4 6 . 8 7.6 9 6.9 7.4 7.0 7.1 7.6 3 5.6 6.5 6 . 6 6.7 6 . 1 6 . 6 6.4 6 . 1 9 5.7 5.6 5.6 6.4 5.2
I00 :in
9 10
7.0 6.7 5.8 5.7 7.5 7.4
6.5 7.2 7.0 7.1 7.8
6.3
6.5 5.9 5.8
6.0
5.6 5.6 5.8 5.9
7.2
7.4 6 . 6 6.5 6.9
11
6.7
6.1
5.4 5.9
8.8
12
6.4
7.5
13
6.2
-305-
Company Sanitized. Does not contain TSCACBf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
Individual Pup Weights (grams): Fj. Gnration
Lactation Day 0
Group: IV-0
Dose: 1 mg/kg/day
Animal Pup
Humber Sex___________________________ Pup Humber
1 2 3 4 5 6 7 8 9 10 11 12
1 2 1 3 7.3 6.7 4.8 7.3 8.4 6.9 7.1 6 . 8 2 6 . 6 7.5 7.3 6 . 1 6.5 6 . 6 6 . 6 5.8
1 2 2 3 8 . 0 7.6 7.7 8.5 8 . 6 8 . 1 2 7.5 7.1 7.4 8 . 0 6 . 8 7.6
123 3 5.5 5.5 5.5 5.6 5.6 6 . 0 6 . 1 6 . 1 5.5 5.6 6 . 2 2 5.8 5.5 5.6 5.5 5.5
124 3 6.5 6.7 6.4 6 . 8 6 . 8 7.3 7.3 6.5 5.9 6 . 8 2 6 . 2 6 . 8 5.9 5.9 6 . 6 6 . 1
125 3 7.9 7.5 7.9 7.4 7.3 6.9 7.1 6 . 8 6 . 2 5.7 2 6.3 6 . 0 6.7 5.7 5.5
126 3 7.3 6 . 8 7.4 7.0 7.0 7.1 7.0 7.4 2 7.6 6.7 6.7 6.5 6 . 6 7.1 6.9
127 <3 2
128 3 7.3 7.8 7.6 7.8 7.9 7.9 6.7 2 6.7 7.0 7.5 6.7 7.1 7.2 7.1
129
3 6.9 5.8 6 . 6 6 . 2 6 . 2 2 6 . 0 5.7 6 . 2
130
3
6.3 8 . 0
7.5 6 . 8
7.3 6 . 8
7.2 7.3
2 6.4 6.5 6.5 6 . 2
131 <3 6.4 6 . 8 6.4 6 . 8 6.9 2 5.9 6 . 0
132 <3 6.5 6.5 6 . 6 6 . 6 6.4 6 . 1 6.5 2 6 . 1 5.8 6 . 2 5.7 6.7 5.2 6.5 6 . 2 6.3
133 3 7.9 8 . 8 9.0 8.3
2
8.6
8.2
134
3
8.5 8.4 ' 7.7 8 . 0
8.2
2 7.7 8 . 1 7.8 7.7 7.6 7.9
135 3 6.4 5.9 6.4 6 . 1 6 . 2 6.4 6.5 6 . 6 5.8 6 . 1 5.5 6 . 6 2 5.6 5.6 6 . 0 5.9 5.7
136 3 6.9 6.3 7.1 7.0 7.5 6 . 6 6.9 7.7 6 . 8 2 6 . 1 5.8 6.5 6 . 1 6 . 2 6.3 6 . 1 6 . 2 6.7 6.7
137 3 6.7 6.7 6 . 6 6.9 6.7 6 . 8 2 6 . 2 5.9 6.5 6 . 2 6.5 5.5
138 <3 2
139 3 5.8 6 . 0 5.9 6.5 6 . 2 6 . 0 6.5 2 6.4 6 . 2 6 . 0 5.8 6.7 6.3 6 . 0 6 . 0 5.9
140 3 2
141 <3 4.6 6.7 7.4 7.1 6.5 2 6 . 1 6 . 0 6 . 2 6 . 8 6.9
142 3 6.3 6.5 6 . 0 2 5.2 5.7 6 . 0 6 . 2 5.9 5.7 5.5 5.8
143 3 6.4 6 . 0 6 . 8 6 . 6 5.3 6 . 6 6 . 0 6.4 6.5 2 5.4 6.3 6 . 2 6 . 1 6 . 1 6 . 1 5.8 5.6 5.9
144 3 7.4 6.9 7.1 7.0 6 . 8 7.2 7.2 7.1 2 6.4 6.7 6.7 6.3 6 . 8 7.3
-306Company Sanitized. Does not contain TSCA CB1
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
Individual Pup Weights (grams):
Generation
Lactation Day 0
Group: VI-0
Dose: 10 mg/kg/day
Animal Pup Humber Sex____________________________________ Pup Humber
l 2 3 4 5 6 7 8 9 1 0 1 1 1 2 13 14 15
145 a
2
146 a 5.9 5.9 6.3 2 4.4 5.7 5.3 5.6 5.5 6 . 6 5.5 5.4 4.8 5.8 5.5 5.8 5.4 4.4 5.8
147a 148 149 150
a
2
a 8 . 0 6.7 7.3 7.4 7.3 8 . 1 7.0 2 7.1 6.5 6 . 8 6.7 6 . 8 6 . 6 6.7 7.0 6.3 a 7.0 6 . 8 7.0 6 . 0 6.5 6.4 6 . 2 6.9 7.4 2 6.7 6.5 7.2 6 . 6 6.3 6.9 6 . 2 6.3 5.9 a 7.0 6.3 7.0 7.2 6.5 4.7 3.1 6.7 6.9 2 6 . 8 6.7
151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
a
2
a 6.5 6.4 7.8 7.0 5.9 7.4 2 7.0 6.5 5.3 7.1 6.5 6.7 6.3 7.5 5.4 7.6 a 6 . 8 6.9 7.0 6.7 7.5 7.8 7.5 7.0 2 7.6 7.7 6 . 8 7.3 6.7 7.0 6.4 a 6.7 6 . 6 6.9 6.9 7.0 6.3 6 . 8 6.7 6.4 6 . 6 2 5.8 5.7 6.3 6.3 6 . 0
a 5.7 6.7 5.6 7.2 6 . 2 6 . 2 6 . 1 6 . 2 5.4 6.3 2 6 . 1 6 . 1 6 . 2 5.9 5.6 6 . 6 5.3 5.9 a 6 . 1 6 . 6 7.0 7.0 6.4 6.7 6 . 6 6 . 6 2 6 . 0 6.3 6 . 0 6 . 0
3
2
3 7.1 6.5 6 . 0 6.7 6.7 2 7.0 7.3 7.0 5.9 7.8 6.7 6.9 7.7 7.2 7.4 5.8 a 8.4 9.6 8 . 0 8 . 1 8 . 6 9.4 8.7 2 7.5 8 . 6 8 . 6 6.7 5.8 a 6.7 7.0 6 . 1 6 . 6 6 . 0 6 . 8 2 5.8 6 . 1 5.3 5.3 5.8 5.2 6.4 5.8 5.3 6 . 0 a 8 . 0 7.0 5.5 7.7 7.0 8 . 1 7.0 2 7.6 7.2 7.3 7.2 7.7
a 7.9 7.2 7.7 7.9 7.6 2 6 . 8 6 . 6 7.5 7.6 7.2 7.0 7.3 7.0 6.4 a 6.7 6.4 7.2 5.7 7.1 2 6.3 6 . 0 6 . 1 6 . 6 6.3 6 . 1 6.5 6.4 6 . 8 5.9
a
2
a 5.8 5.8 6 . 2 5.9 5.9 5.7 6 . 1 6 . 0 6 . 0 6 . 1 6.3 2 6 . 2 5.8 5.3 5.8 3 7.5 6.7 8 . 0 6 . 6 6.5 6 . 2 6 . 0 7.6 2 7.8 7.7 7.1 8 . 2 6 . 8 a 6 . 8 6 . 1 6 . 2 6 . 1 6 . 6 6 . 2 6.4 6.4 2 5.8 5.7 6 . 1 5.7 6.5 5.7 5.6 5.9 a 6 . 6 6 . 2 6.9 6.4 6.7 2 6 . 6 6 . 0 6.5 5.9 5.9 6 . 1
a Animal had one live fetus in uterus at necropsy.
-307Company Sanitized. Dees not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
Individual Pup Weights (grams): Fi Gnration
yf
Lactation Day 0
Group: VIII-O
Dose: 25 mg/kg/day
Animal Number
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192
Pup Sex_______________________________Pup Number
1 2 3456 78
a 7.6 7.3 7.3 7.4 8.3 8 . 1
o
00
? 7.8 7.9
6.5 7.7 7.0
a 8 . 2 7.0 7.7 7.1
00
to
? 6 . 8 5.9 7.7 7.9 7.4
5.4
6.7 6 . 8 6.3 6.7 6 . 6
2 6 . 0 6 . 1 5.3 6 . 2 6 . 2 6.3 6 . 0 6 . 2
6 6.9 6.7 6 . 1 6 . 2 6.9 6 . 8 6 . 2
S 6 . 1 6 . 0 6 . 2 6 . 2 6 . 6 6 . 1 5.9 6.4
a 6.5 6.4 6 . 1 6 . 1 6.3 6.4
9 5.7 6 . 0 6 . 1 5.6 4.9 5.7 5.4 5.7
6 7.2 6.7 6 . 8 5.1 7.5 6 . 0 7.7 6.4
9 6.4 7.1 6.3 6.3 6 . 8
<5 6 . 8 6.3 6.4 6.4 5.6 6.3 6 . 2 6.7
9 6 . 2 5.9 5.7 5.6 5.6 6 . 2 5.4
a 6.7 6 . 6 6.4 6.3 7.1 6.9 6 . 6 7.0
9 6 . 2 6.5 6 . 0 6.3 6.9 6.4
a 6.5 7.3 7.1 6 . 2 6 . 8 6.9 6.3 7.1
9 6 . 6 6.7 6.9 6 . 1 6 . 2 6.4
a 6 . 2 6 . 1 6.5 6 . 8 6 . 0 7.0 6 . 2 6.4
9 5.8 5.6 6 . 1 6.7 5.3 5.4
a 9 a 5.8 6.7 6.3 7.3 7.7 7.6 8 . 0 9 6.9 6 . 8 7.2 6 . 2 6.4 7.4 7.4 6 . 8 a 6.5 6 . 0 6.3 7.1 6.9 6.5 7.1 9 6.4 6.3 6.4 6 . 2 6 . 6 6 . 2 6.4 6 . 0 a 7.8 7.2 6.7 7.0 6.9 7.2 6 . 8 9 6 . 8 7.0 7.1 7.2 5.9 6 . 8 7.1 7.0 a 6.7 6.5 6 . 6 6.7 9 5.9 6 . 1 6 . 1 5.8 5.8 5.9 6 . 0 5.7
a 9 a 8 . 1 6 . 6 7.9 7.1 6 . 6 7.2 6.9 6 . 6 9 6 . 2 6.5 6.5 6.7 6.5 6 . 8 5.3 a 6 . 2 6.7 6.5 6.7 6 . 1 9 8.4 6 . 1 5.9 6 . 0 5.4 6 . 0 6.9 5.9 a 5.5 5.5 5.3 5.6 5.9 5.6 5.6 6 . 1 9 5.5 5.3 5.6 5.1 5.2 5.5 5.2 a 6 . 1 5.8 6 . 1 7.8 6 . 6 9 6 . 0 6.7 7.5 5.9 6 . 0 6 . 6 6.4 6.7 a 6.9 6 . 6 6 . 0 6.9 6 . 0 6.3 7.0 6.3 9 6.4 6 . 1 6 . 1 a 6.7 7.1 6.5 6 . 6 6.4 6 . 0 9 6.4 5.8 7.0 6 . 0 5.9 5.2 a 7.6 7.0 7.4 7.3 7.0 7.2 9 7.4 7.4 6.9 6 . 8 6 . 8 6 . 8 7.3 6.9 a 7.0 7.1 7.0 6.7 7.1 9 6.7 6.9 6.3 5.6 6.3 6 . 2 6.4 6 . 1
9
5.9
5.5
6.8
5.9
6.6
7.0
6.1
6.4
6.1
6.4
6.6
5.6 6.4 6.3
6.5
10 6.1
5.6
6.6
5.4
6.1
5.4 6.5 6.9
6.6
11 6.2 6.1 6.6
5.6
6.5 6.7
12
6.3 7.4
13 6.7
- 308 Company Sanitized. Does not contain TSCA C8F
Z*"**'.
\
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
Individual Pup Weights (grams): Fi Gnration
Lactation Day 4
Group: II-O
Dose: 0 mg/kg/day
Animal Humber
97 98 99
100 101 102
103 104 105 106 107 108 109
110 111 112
113 114 115 116 117 118 119
120
Pup Sex___________________________________ Pup Number
1 2 3456 7 8
3 15.9 15.2 14.8 15.4 15.4 15.6 9 13.5 14.7
3 1 0 . 6 9.4 12.5 1 2 . 1 1 1 . 2 9 11.5 11.4 11.4 10.4 11.4 1 0 . 6 1 1 . 6 9.8
3 1 0 . 0 10.3 10.4 1 0 . 0 9.5 1 0 . 2 9 9.7 9.5 9.4 9.6 8 . 6 9.6 1 0 . 0 1 0 . 2
3 11.9 11.9 1 2 . 0 1 2 . 6 12.7 1 1 . 0 10.7 10.5 9 1 2 . 6 11.9 1 0 . 2 1 2 . 2
3 1 2 . 6 1 1 . 1 11.4 10.4 1 2 . 0 11.5 1 1 . 6 9 10.5 11.7 1 1 . 1 1 1 . 1 1 2 . 0
3 10.5 10.4 11.7 1 0 . 6 10.3 1 0 . 6 9.9 10.9 9 10.7 9.3 1 1 . 0 10.4
3 1 2 . 8 12.4 9 1 2 . 8 11.3 1 2 . 1 1 2 . 1 12.5 12.4 1 2 . 1 1 2 . 0
3 1 1 . 2 11.9 12.5 12.3 1 1 . 8 11.9 1 1 . 6 1 1 . 8 9 1 1 . 0 11.9 1 1 . 6 1 1 . 0 1 0 . 8 1 1 . 2
3 13.3 14.2 14.1 13.8 13.7 9 12.7 1 2 . 8 13.7 13.6 13.6 13.8
3 1 0 . 1 9.1 9.5 10.3 9.8 9.7 9.2 9.1 9 8.3 8.3 8.3 8.7 7.8 8.3 8.3
6 9
3 1 1 . 6 7.3 9.5 1 0 . 0 11.7 9.5 9.9 8 . 0 9 9.9 1 1 . 1 8.9 9.4 1 0 . 2 1 0 . 2 9.7 10.4
3 1 1 . 2 1 0 . 2 1 0 . 6 1 0 . 2 10.9 9.7 10.3 10.5 9 9.8 1 0 . 0 1 0 . 0 1 0 . 2 1 0 . 2 10.4
3 9.8 9.7 1 0 . 6 1 0 . 0 1 0 . 6 9.9 10.9 9.9 9 9.2 9.5 9.9 6.3 3 9 3 8.7 8.3 8.9 8.4 8.4 8 . 8 9.3 8.5 9 7.8 8.3 8.7 6.7 7.6 8 . 6 8 . 1 7.9
3 9.5 9.3 1 0 . 1 10.5 10.3 10.4 9 9.1 1 0 . 6 9.4 9.8 9.6 8.9 1 0 . 0 9.5 6 9.2 9.8 9.5 9.2 8.7 9.9 8.7 8.4 9 6.9 8.3 8 . 0 9.3 9.0 8 . 0
3 12.5 13.3 1 1 . 2 1 2 . 2 1 2 . 6 12.3 11.7 12.4 9 1 1 . 6 11.9 1 2 . 2 11.7 1 1 . 8 3 13.2 12.4 9 12.4 13.0 1 1 . 6 12.5 12.5 12.5 1 2 . 1 1 2 . 8 3 1 1 . 8 11.9 1 0 . 6 11.5 12.4 9 11.5 1 2 . 2 11.3 1 1 . 2 11.4 1 1 . 6 9.8 3 13.1 1 2 . 0 10.9 1 2 . 1 12.3 12.7 9 1 2 . 2 1 1 . 1 1 0 . 8 1 2 . 1 9.8 11.9 10.9 3 1 2 . 0 11.5 11.7 1 1 . 2 1 1 . 1 10.4 1 0 . 2 9.6 9 11.4 1 1 . 1 11.3 1 0 . 8 3 10.7 11.4 10.5 1 0 . 0 9.9 1 0 . 0 1 0 . 6 10.7 9 8.4 9.1 10.4 9.9 9.7
9
12.5 9.1
12.1
11.1 12.2
11.3
8.7
10.8 10.8
9.5 8,4
10.2
9.4
12.6
11.1
10.7
10 12.0
9.4
12.0
11.3
12.8
11.0
9.5 9.8
11.2
8.3
11 10.2 10.8
10.8
9.1 9.4
12 11.2
11.6
13
10.2
-309jPpmpany Sanitized. Does not contain TSCA Cs
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
Individual Pup Weights (grams): Fi Gnration
Lactation Day 4
Group: IV-0
Dose: 1 mg/kg/day
Animal Number
121 122
123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144
Pup Sex___________________________ Pup Number
1 2 3456
3 11.4 9.2 11.4 13.1 1 1 . 2 8 . 1
s 1 1 . 1 11.7 1 0 . 6 9.6 11.9 1 0 . 8
9 1 2 . 6 12.5 13.6 13.7 11.3 1 2 . 8 1 2 . 1 12.5 1 2 . 0 1 2 . 8 1 2 . 0 1 1 . 8
93 8.4 8.4 9.4 8.3 7.8 8.7 8.4 8.3 8 . 6 9.1 8 . 0
93 11.4 1 2 . 6 9.6 11.4 12.4 11.3 9.3 10.4 10.7 1 0 . 8 1 0 . 0 9.3
93 1 1 . 1 11.9 9.6 11.4 1 2 . 1 1 1 . 0 9.1 10.3 10.7 1 0 . 1 10.9
9 10.5 1 1 . 1 1 0 . 1 10.5 10.4 9.7 10.4 1 0 . 2 10.5 1 0 . 1 9.3 9.4
s9
93 13.1 13.5 12.4 13.8 12.4 12.5 10.9 1 1 . 6 1 2 . 6 10.5 12.4 11.9
93 11.7 1 2 . 6 13.3 1 2 . 1 12.3 1 1 . 6 12.4 1 2 . 1
93 1 1 . 1 13.3 1 1 . 8 12.5 12.4 1 1 . 8 11.4 1 2 . 1 11.3 11.5
93 12.4 13.3 1 2 . 6 13.1 11.9 11.7 1 1 . 8
9 1 2 . 1 12.3 12.9 11.7 11.9 11.3 10.5 10.5 1 1 . 2 11.4 10.5 1 0 . 1
9
15.5 16.5 15.6 17.1 15.4 15.7
93 15.4 14.2 14.5 13.8 1 2 . 1 13.8 13.7 12.5 13.2 13.6 12.7
93
10.2 10.2
9.0 1 0 . 2
9.3 1 0 . 0
9.8 9.9 9.6 9.4 9.5
93
10.0 11.0
9.8 1 0 . 2
9.8 1 0 . 1
9.2 8.9 9.3 9.1 8.3 9.7
93 11.9 11.7 11.4 1 1 . 6 12.3 11.9 10.3 10.3 1 1 . 0 9.9
<3 9
S 8 . 1 8.5 8 . 1 8.7 9.9 8.7
9 9.9 10.3 9.1 8.5 8 . 8 9.3
9 d 11.3 1 0 . 6 11.5 10.7 12.9 9 1 0 . 6 10.7 11.3 11.7 1 1 . 1
93 1 0 . 6 1 0 . 6 11.3 1 0 . 2 9.7 9.7 10.3 1 0 . 6 10.7
93 1 0 . 6 1 0 . 6
9.3 1 0 . 8 1 0 . 8 1 0 . 0
9.9 9.7 9.9 8.5 8.3 9.0
93 1 2 . 2 1 1 . 8 11.3 1 2 . 1 1 2 . 0 12.4 1 1 . 2 1 1 . 8 1 1 . 8 1 0 . 6 11.4
7
12.6
10.7
9.1 10.9 12.3
10.8
10.5
10.2
12.5
12.0
10.3
10.6
10.2
9.0
8.2
9.2 9.2
9.8 8.3 9.7 12.3
8
11.9
10.0 8.2
11.5 11.4
11.5
10.3
10.9 10.5
8.8
9.5
10.6
11.3 9.5
12.1
9 9.0 10.7
11.6
8.7 9.8
10.2 8.6
9.9
10.5
8.6
10
8.7 11.4
9.3 9.6
11
8.3
10.4
12
-310pmpany Sanitized. Does not contain TSCA CBI
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
Individual Pup Weights (grams): Fx Gnration
Lactation Day 4
Group: VI-0
Dose: 10 mg/kg/day
Animal Pup Number Sex____________________________________Pup Number
1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 13 14 15
145 32
146 147a 148 149 150
23 9.2 8.5 9.9 8.5 8 . 8 9.8 8.5 9.4 6.4 8 . 0 7.8 8.7 9.8 9.0 7.0 8 . 8
<J 2 23 10.5 9.7 11.4 10.9 11.5 1 1 . 1 1 0 . 2
1 0 . 8 1 1 . 8 10.7 1 1 . 1 11.4 9.4 1 1 . 6 10.7 1 .0 .
23 9.7 10.7 9.9 1 0 . 6 10.9 9.7 1 0 . 0 8 . 1 11.5 9.4 9.4 10.3 1 0 . 2 8 . 6 9.4 9.9 9.9 1 1 . 2
23 1 0 . 0 1 2 . 1 1 1 . 2 7.6 12.3 12.4 12.4 1 2 . 6 12.0 11.6
8.9
151 <2?
<23152
10.4 1 0 . 2 1 1 . 0 1 0 . 1 11.3 9.5 9.7 9.3 7.8 1 1 . 1 1 1 . 2 9.8 8.9 1 0 . 6 1 1 . 2 1 0 . 6
2153 3 10.4 1 0 . 6 1 2 . 2 1 0 . 2 10.5 9.2 9.6 10.5 8.9 1 0 . 0 11.3 10.3 9.0 1 0 . 6 11.4
2154 3 1 0 . 6 10.3 9.0 10.3 1 1 . 6 9.8 10.9 1 0 . 6 9.9 1 0 . 0 9.5 8.7 9.7 9.5 9.0
3155 9.2 9.8 7.5 9.8 10.5 10.4 10.5 10.5 9.9 9.7 2 8.9 9.0 9.8 9.6 8 . 0 8.3 1 0 . 0 9.9
<3156 11.5 11.7 1 1 . 8 11.3 1 2 . 0 1 1 . 1 1 0 . 8 11.4 2 10.9 10.9 10.4 10.4
157
<3 2
<3158 10.5 11.9 11.3 10.9 11.3 2 6.9 10.5 1 0 . 8 10.5 11.5 1 1 . 2 11.7 11.3 1 2 . 1 11.4 10.4
159
<3 14.6 15.1 16.3 14.4 16.6 14.5 15.3 2 11.4 10.7 14.2 13.4 14.4
<23160
11.3 1 0 . 2 1 1 . 2 9.3 1 1 . 6 1 1 . 8 8 . 6 10.3 9.8 1 0 . 2 1 1 . 1 9.1 9.4 9.2 9.0 1 0 . 2
161
<3 12.9 13.8 13.8 12.7 14.5 12.4 9.6 2 10.4 13.4 13.3 12.7 12.9
3162 13.2 13.1 1 2 . 8 12.7 13.4 2 12.7 11.9 11.5 13.0 13.0 1 1 . 0 11.3 1 2 . 1 11.7
<3163 11.4 9.7 11.9 1 1 . 6 10.4 2 9.9 10.5 1 0 . 8 1 2 . 1 1 0 . 0 9.9 1 1 . 1 9.8 10.5 11.4
164
3 2
<3165 10.7 1 0 . 2 9.9 9.3 9.7 9.7 1 0 . 1 1 0 . 0 1 0 . 2 9.3 9.6 2 9.9 9.0 9.8 9.7
<3166 13.0 13.0 11.7 10.9 12.3 10.9 11.7 1 2 . 0 2 10.9 1 2 . 2 1 1 . 6 1 2 . 8 1 2 . 8
<3167 1 0 . 1 9.5 9.2 8 . 6 9.6 9.9 9.4 9.5 2 9.8 8.5 9.1 1 0 . 6 9.0 9.0 8 . 8 9.5
3168 11.9 11.5 1 2 . 8 13.1 12.3 2 1 1 . 2 11.3 11.4 1 2 . 0 11.3 11.7
a Animal had one live fetus in uterus at necropsy.
-311 Company Sanitized. Does not contain TSCA CPf
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
Individual Pup Weights (grams): Fi Gnration
Lactation Day 4
Group: VIII-0
Dose: 25 mg/kg/day
Animal Number
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192
Pup Sex_______________________________Pup Number
i 2345 678
S 1 3 . 9 1 2 . 3 1 3 . 7 1 2 . 6 1 2 . 9 1 2 . 7 13.5 12.9 12.8 11.6 13.0 11.7
9 1 5 . 6 1 4 . 4 1 2 . 8 16.0 14.5 14.8 10.3 14.0 12.9 10.8
10.6 10.0 10.3 9.6 10.0
a9 9 . 3 9 . 7 1 0 . 7 9 . 7 9 . 8 8 . 9
9.6
9.9
9 1 0 . 4 1 0 . 2 1 0 . 1 1 0 . 0 1 1 . 5 1 1 . 2 1 1 . 0 9.6 10.0 9.7 9.6 10.1 10.1 9.3 9.6
10.6 10.7 10.3 11.0 9.6 10.8
a9 9 . 6 9 . 4 9 . 4 8 . 9 9 . 9 9 . 8 9 . 1
9.9
11.5 10.1 7.1 10.9 10.5 10.1 9.2 10.5
a9 1 0 . 7 9 . 4 9 . 6 1 0 . 2 1 0 . 4
8.9 10.0 10.7 9.8 10.4 10.2 9.1
a9 9 . 1 9 . 0 9 . 2 9 . 4 8 . 9 8 . 6 9 . 5
9.0
9 . 8 1 0 . 2 1 0 . 2 1 0 . 1 1 0 . 2 1 0 . 1 1 0 . 0 9.9
a9 9 . 3 9 . 6 9 . 0 8 . 7 9 . 5 1 0 . 3
10.1 11.8 10.6 12.3 10.7 11.7 11.6 11.4
a9 9.9 1 0 . 1 1 0 . 1 1 0 . 5 1 0 . 9 1 0 . 5
10.6 10.7 10.4 8.0
a9 9 . 0 1 0 . 4 9 . 3 9 . 3
9.8 10.4 10.7 10.5 9.1 9.5
a9
9a 1 0 . 5 8 . 8 1 0 . 9 7 . 3 1 0 . 3 1 0 . 9 1 0 . 6 9 . 5 9.9 1 0 . 5 9.9 9 . 6 9.9 1 0 . 0 9 . 6
9.6
a9 9 . 8
9.1 10.6 9.1 10.6 10.6 10.5
9 . 7 1 0 . 0 9.9 9 . 5 9 . 8 8 . 8 9 . 3
11.0 11.0 10.5 11.7 10.1 10.4 10.7
a9 1 0 . 6 9.9 1 0 . 9 9 . 4 1 0 . 6 1 1 . 2 1 1 . 3 1 0 . 9 a 10.1 10.2 9.3 10.1 9 9.5 9.7 9.4 9.6 10.2 9.5 9.0 10.0
a9
a 10.1 10.4 11.0 11.7 10.6 12.0 10.3 10.6
9 10.2 10.0 10.9 10.8 8.2 11.4 11.8
11.4 11.7 12.4 11.2 11.0
a9 9 . 7 1 1 . 0 1 1 . 0 8 . 5 1 2 . 1 1 1 . 2 1 1 . 6 9 . 8
7.2
a9 8 . 4
8.4 7.4
8.9 8.3
8.4 6.8
7.8 7.8
8.8 8.7
8.2 6.6
9.5
1 0 . 2 1 0 . 1 7.7
a9 9 . 4 1 0 . 0 8 . 9
8.9 10.0 8.8 9.1 9.6
10.8 9.6
10.2 10.2 10.4 10.4 10.5 10.4 10.2 10.1
a9 9 . 5 1 0 . 1 9.9
a 10.9 11.1 10.8 9.5 11.6 11.3
9 10.6 8.8 10.8 10.1 10.7
a 11.5 12.0 11.6 11.9 12.8 12.1
9 10.9 11.9 11.4 11.4 11.7 11.2 11.2 11.4
11.4 11.5 10.2 10.9 10.2
a9 1 0 . 8 1 0 . 5 1 0 . 4 1 0 . 2 1 0 . 6 1 0 . 5 1 0 . 1 1 0 . 0
9
9.2
9.3 10.7 10.2
9.5
11.7 10.0
9.7 11.1 8.6 11.2
8.6 8.5
9.9
11.4
10 9.9 8.1 10.2
9.9
10.3
7.5 8.6 10.4
11 9.8 9.8
9.4
7.7
10.5
12
9.2 10.0
13
9.9
-312R w npany Sanitized. Does not contain TSCA CBi
H-24768: One-Generation Reproduction Study in Rats
DuPont-13784
TRADE SECRET Study Title
H-24768: One-Generation Reproduction Study in Rats
Volume 2 of 2
Laboratory Project ID: DuPont-13784
AUTHORS: Eve Mylchreest, Ph.D. Joseph M. Lewis, B.A.
Study Completed on: October 19,2004
Performing Laboratories: E.I. du Pont de Nemours and Company HaskellSMLaboratory for Health and Environmental Sciences P.O. Box 50 Newark, Delaware 19714-0050 U.S.A.
E.I. du Pont de Nemours and Company Regional Analytical Services (RAS) DuPont Chemical Solutions Enterprise Jackson Laboratory Route 130 Chambers Works Deepwater, New Jersey 08023 U.S.A.
W ork Request Number: | ( | P |
Service Code Number: l f l H Q
Page 313 of 524 p o m p a n y S an itized. D oes not contain TSCA CB|
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX Z
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS Pi ADULTS
-314jpompany Sanitized. Does not contain TSCA c r i
H-24758: One-Generation Reproduction Study in Rats
INDIVIDUAL ANIMAL FIN A L BODY AND ORGAN WEIGHTS - P i ADULTS
FINAL BODY AND ABSOLUTE ORGAN WEIGHTS ( g r a m s ) FROM MALE RATS
GROUP :
1 -0 - 0 m g/kg
ANIMAL NUMBER
FINAL BODY
LIVER
1
5 3 5 .1
19.416
2
542.2
21.449
3
548.4
19.198
4
585.3
21.459
5
526.3
18.224
6
627.1
22.096
7
634.5
21.120
8
512.4
19.422
9
487.8
15.681
10
544.4
18.403
11
576.5
20.909
12
514.8
16.233
13
532.7
18.207
14
484.4
18.539
15
547.1
18.328
16
592.9
21.104
17
473.9
15.855
18
443.4
16.422
19
546.1
18.465
20
541.4
20.214
21
554.1
21.270
22
527.5
20.571
23
535.8
20.760
24
527.4
19.892
DuPont-13784
J3p*pany Sanitized. D om not contain TSCA 6BI
-315-
H-24758: One-Generation Reproduction Study in Rats
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - Pi ADULTS
FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM MALE RATS
GROUP :
III-O - 1 mg/kg
ANIMAL NUMBER
25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48
FINAL BODY
547.7 532.5 548.7 513.4 573.5 544.1 541.4 623.6 512.6 585.6 487.3 589.5 495.1 451.0 652.0 622.2 570.4 593.2 540.2 588.7 546.3 535.0 600.4 603.3
LIVER
17.229 18.347 18.441 17.067 21.649 20.920 19.565 23.107 16.836 23.736 15.142 20.903 28.023 15.846 24.769 25.026 22.939 22.499 19.697 20.830 20.169 21.053 20.624 24.995
DuPont-13784
-316-
H-24758: One-Generation Reproduction Study in Rats
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - P I ADULTS
FINAL BODY AND ABSOLUTE ORGAN WEIGHTS ( g r a m s ) FROM MALE RATS
GROUP :
V -0 - 10 m g/kg
[MAL 1BER
FINAL BODY
LIVER
49
553.7
17.740
50
564.7
19.048
51
600.0
23.753
52
562.4
19.902
53
467.4
16.764
54
595.6
22.256
55
577.7
21.453
56
635.9
24.119
57
436.6
17.143
58
528.7
18.821
59
523.0
18.364
60
590.9
19.380
61
565.3
19.843
62
498.3
17.520
63
560.0
20.369
64
612.3
24.257
65
516.9
19.069
66
557.4
18.400
67
504.2
19.403
68
627.9
21.578
69
505.3
16.660
70
516.3
19.890
71
558.9
21.916
72
615.5
24.803
)
DuPont-13784
Company Sanitized. Dees not contain TSCA CBI
-317-
H-24758: One-Generation Reproduction Study in Rats
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - P i ADULTS
FINAL BODY AND ABSOLUTE ORGAN WEIGHTS ( g r a m s ) FROM MALE RATS
GROUP :
V I I - 0 - 25 m g/kg
ANIMAL NUMBER
FINAL BODY
LIVER
73
424.2
16.274
74
595.5
26.820
75
582.6
23.697
76
548.3
21.893
77
534.5
20.319
78
510.8
19.670
79
531.7
21.051
80
607.0
23.438
81
439.7
15.356
82
522.1
22.475
83
540.3
20.864
84
577.7
24.212
85
556.4
21.332
86
569.1
23.094
87
536.8
20.916
88
515.6
18.454
I
89
552.0
20.189
90
545.6
23.090
91
501.0
18.500
92
614.8
25.127
93
476.5
18.434
94
572.5
22.911
95
526.0
20.066
96
568.5
23.098
DuPont-13784
I. Does not contain TSCA CBI
-318-
H-24758: One-Generation Reproduction Study in Rats
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - Pi ADULTS
RELATIVE ORGAN WEIGHTS (% of body weight) FROM MALE RATS
GROUP :
1 -0 - 0 m g/kg
ANIMAL NUMBER
LIVER
1 3.628 2 3.956 3 3.501 4 3.666 5 3.463 6 3.524 7 3.329 8 3.790 9 3.215
10 3 . 3 8 0 11 3 . 6 2 7 12 3 . 1 5 3 13 3 . 4 1 8
14 3 .8 2 7
15 3 . 3 5 0
16 3.559
17 3 . 3 4 6
18 3 . 7 0 4
19 3 . 3 8 1 20 3 . 7 3 4
21 3 . 8 3 9 22 3 . 9 0 0 23 3 .8 7 5 24 3 .7 7 2
DuPont-13784
^Company S anitized Does not contain TSCA CBl
-319-
H-24758: One-Generation Reproduction Study in Rats
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - PI ADULTS
RELATIVE ORGAN WEIGHTS {% of body weight) FROM MALE RATS
GROUP :
III-O - 1 mg/kg
ANIMAL NUMBER
LIVER
25 3.146 26 3.445 27 3.361 28 3.324 29 3.775 30 3.845 31 3.614 32 3.705 33 3.284 34 4.053 35 3.107 36 3.546 37 5.660 38 3.514 39 3.799 40 4.022 41 4.022 42 3.793 43 3.646 44 3.538 45 3.692 46 3.935 47 3.435 48 4.143
DuPont-13784
H-24758: One-Generation Reproduction Study in Rats
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - PI ADULTS
RELATIVE ORGAN WEIGHTS (% of body weight) FROM MALE RATS
GROUP :
V-0 - 10 mg/kg
ANIMAL NUMBER
LIVER
49 3.204 50 3.373 51 3.959 52 3.539 53 3.587 54 3.737 55 3.714 56 3.793 57 3.926 58 3.560 59 3.511 60 3.280 61 3.510 62 3.516 63 3.637 64 3.962 65 3.689 66 3.301 67 3.848 68 3.437 69 3.297 70 3.852 71 3.921 72 4.030
DuPont-13784
J&HHpany Sanitized. Does not contain TSCA CBI
-321-
H-24758: One-Generation Reproduction Study in Rats
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - PI ADULTS
RELATIVE ORGAN WEIGHTS (% of body weight) FROM MALE RATS
GROUP :
VII-0 - 25 mg/kg
ANIMAL NUMBER
LIVER
73 3.836 74 4.504 75 4.067 76 3.993 77 3.801 78 3.851 79 3.959 80 3.861 81 3.492 82 4.305 83 3.862 84 4.191 85 3.834 86 4.058 87 3.896 88 3.579 89 3.657 90 4.232 91 3.693 92 4.087 93 3.869 94 4.002 95 3.815 96 4.063
DuPont-13784
Sanitized. Does not contain TSCA CBI
-322-
H-24758: One-Generation Reproduction Study in Rats
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - Pi ADULTS
FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM FEMALE RATS
GROUP :
II-O - 0 mg/kg
IMAL MBER
97 98 99
100 101 102
103 104 105 106 107 108 109
110 111 112
113 114 115 116 117 118 119
120
FINAL BODY
339.9 345.5 351.0 360.1 334.4 346.0 345.9 340.6 346.6 336.3 338.7 367.8 304.2 360.9 319.4 342.1 332.1 370.1 357.7 329.9 344.8 338.6 348.0 357.9
LIVER
13.963 13.317 13.473 14.006 14.022 14.800 13.112 12.548 13.736 13.901 14.552 12.015 12.778 14.136 11.579 13.419 14.085 16.025 14.171 14.017 15.344 12.341 15.767 15.552
)
DuPont-13784
m V0sx U,eiUO*ou**a Prunes /luedui<s$
-323-
H-24758: One-Generation Reproduction Study in Rats
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - PI ADULTS
FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM FEMALE RATS
GROUP :
IV-0 - 1 mg/kg
ANIMAL NUMBER
FINAL BODY
LIVER
121
345.2
15.226
122
345.2
14.158
123
334.6
14.026
124
354.5
15.296
125
318.4
13.043
126
319.8
13.137
127
318.4
10.253
128
391.1
15.856
129
320.0
12.015
130
348.1
14.572
131
351.3
12.229
132
395.0
16.080
133
319.9
13.436
134
332.3
14.766
135
373.8
14.899
136
365.8
14.881
137
327.1
11.8 6 8
138
346.1
14.038
139
327.6
11.654
140
343.6
13.195
141
346.5
12.371
142
350.4
15.608
143
363.6
15.136
144
316.6
12.694
DuPont-13784
p e m p a n y S a n itized . Does not oonfafn TSCA CBI
-324-
H-24758: One-Generation Reproduction Study in Rats
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - PI ADULTS
FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM FEMALE RATS
GROUP :
VI-0 - 10 mg/kg
ANIMAL NUMBER
FINAL BODY
LIVER
145
295.5
10.554
146
331.5
14.422
147
351.7
11.671
148
363.3
15.816
149
315.1
14.107
150
376.6
13.792
151
361.0
16.507
152
330.7
11.209
153
371.5
15.045
154
353.3
14.499
155
368.7
15.021
156
362.5
14.871
157
331.5
13.515
158
365.9
16.871
159
428.4
16.646
160
360.2
15.669
161
313.6
12.596
162
365.8
14.775
163
353.2
16.434
164
353.7
12.352
165
325.1
14.640
166
358.2
15.026
167
329.8
15.308
168
364.4
14.514
DuPont-13784
C o m p a n y S a n itiz e d D oes no! contain TSCA CBI
-325-
H-24758: One-Generation Reproduction Study in Rats
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - PI ADULTS
FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM FEMALE RATS
GROUP :
ANIMAL NUMBER
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192
VIII-0 - 25 mg/kg
FINAL BODY
LIVER
322.1 379.9 347.7 336.8 350.3 334.8 343.7 337.0 345.9 355.2 302.5 347.5 366.6 358.0 345.8 309.5 354.9 323.3 318.9 352.5 319.4 312.1 354.9 373.8
14.100 14.983 14.896 16.226 15.667 14.988 15.639 14.784 16.916 15.784 11.464 16.644 16.886 17.946 15.894 14.893 13.850 13.645 18.637
NW 16.649 15.836 16.327 17.210
NW = NOT WEIGHED
)
DuPont-13784
SanifJzad. Does not confetn tqoa a
-326-
H-24758: One-Generation Reproduction Study in Rats___________ __________________________________________________ __
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - Pi ADULTS
RELATIVE ORGAN WEIGHTS {% of body weight) FROM FEMALE RATS
GROUP :
ANIMAL MBER
97 98 99
100 101 102
103 104 105 106 107 108 109
110 111 112
113 114 115 116 117 118 119
120
II-O - 0 mg/kg
LIVER
4.108 3.854 3.838 3.889 4.193 4.277 3.791 3.684 3.963 4.134 4.296 3.267 4.201 3.917 3.625 3.923 4.241 4.330 3.962 4.249 4.450 3.645 4.531 4.345
)
DuPont-13784
Sanitize!. Does not contain TSCA CBf
-327-
H-24758: One-Generation Reproduction Study in Rats
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - PI ADULTS
RELATIVE ORGAN WEIGHTS (% of body weight) FROM FEMALE RATS
GROUP :
IV-0 - 1 mg/kg
ANIMAL MBER
LIVER
1 2 1 4.411 1 2 2 4.101 123 4.192 124 4.315 125 4.096 126 4.108 127 3.220 128 4.054 129 3.755 130 4.186 131 3.481 132 4.071 133 4.200 134 4.444 135 3.986 136 4.068 137 3.628 138 4.056 139 3.557 140 3.840 141 3.570 142 4.454 143 4.163 144 4.009
)
DuPont-13784
IPompany Sanitized. Does nofcontain t s c a CBI
-328-
H-24758: One-Generation Reproduction Study in Rats
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - Pi ADULTS
RELATIVE ORGAN WEIGHTS (% of body weight) FROM FEMALE RATS
GROUP :
VI-0 - 10 mg/kg
ANIMAL NUMBER
145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
LIVER
3.572 4.351 3.318 4.353 4.477 3.662 4.573 3.389 4.050 4.104 4.074 4.102 4.077 4.611 3.886 4.350 4.017 4.039 4.653 3.492 4.503 4.195 4.642 3.983
DuPont-13784
SaniNzed. Does nofconMfn
3 -329-
H-24758: One-Generation Reproduction Study in Rats
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - PI ADULTS
RELATIVE ORGAN WEIGHTS (% of body weight) FROM FEMALE RATS
GROUP :
VIII-0 - 25 mg/kg
ANIMAL NUMBER
LIVER
169 4.378 170 3.944 171 4.284 172 4.818 173 4.472 174 4.477 175 4.550 176 4.387 177 4.890 178 4.444 179 3.790 180 4.790 181 4.606 182 5.013 183 4.596 184 4.812 185 3.903 186 4.221 187 5.844 188 NW 189 5.213 190 5.074 191 4.600 192 4.604
NW = NOT WEIGHED
DuPont-13784
-330-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
APPENDIX AA
INDIVIDUAL ANIMAL PATHOLOGY DATA Pi ADULTS
-331 -
JGnnpany Santtteed. Dww-rmt-enntsca cbi
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
KEY TO APPENDIX INDIVIDUAL ANIMAL PATHOLOGY DATA
MODE OF DEATH
SD: SACRIFICED BY DESIGN SE: SACRIFICED IN EXTREMIS FD: FOUND DEAD AK: ACCIDENTLY KILLED (INCLUDES ANIMALS PRESENTED DEAD OR MORIBUND THAT HAVE INJURED THEMSELVES OR WERE
INADVERTENTLY INJURED WHEN BEING HANDLED. IN-LIFE AND NECROPSY FINDINGS MAY BE USED TO MAKE THIS DETERMINATION.)
LESION GRADING
HISTOPATHOLOGICAL CHANGES ARE DESCRIBED ACCORDING TO THEIR MORPHOLOGIC CHARACTER, DISTRIBUTION AND SEVERITY. THE DISTRIBUTION (EXTENT OF TISSUE INVOLVEMENT) IS INDICATED, WHERE APPROPRIATE, BY MODIFIERS SUCH AS FOCAL, MULTIFOCAL, DIFFUSE, UNILATERAL, BILATERAL, ETC.; A SEVERITY SCORE, IF APPROPRIATE, IS ALSO ASSIGNED AS FOLLOWS:
PRESENT : MINIMAL :
MILD:
MODERATE :
SEVERE:
LESION PRESENT, SEVERITY NOT GRADED. THE AMOUNT OF CHANGE PRESENT BARELY EXCEEDS THAT WHICH IS CONSIDERED TO BE WITHIN NORMAL LIMITS. IN GENERAL, THE LESION IS EASILY IDENTIFIED BUT OF LIMITED SEVERITY. THE LESION PROBABLY DOES NOT PRODUCE
ANY FUNCTIONAL IMPAIRMENT. THE LESION IS PROMINENT BUT THERE IS SIGNIFICANT POTENTIAL FOR INCREASED SEVERITY. LIMITED TISSUE OR ORGAN
DYSFUNCTION IS POSSIBLE. THE DEGREE OF CHANGE IS EITHER AS COMPLETE AS CONSIDERED POSSIBLE OR GREAT ENOUGH IN INTENSITY OR EXTENT TO
EXPECT SIGNIFICANT TISSUE OR ORGAN DYSFUNCTION.
COMMENT:
GRADES MINIMAL THROUGH SEVERE REPRESENT PROGRESSIVE INVOLVEMENT/SEVERITY ALONG A CONTINUUM WITH MINIMAL LESIONS BEING THE LEAST SEVERE AND SEVERE LESIONS BEING THE MOST SEVERE. WHILE THE GRADES REFER TO THE MORPHOLOGICAL CHARACTERISTICS OF LESIONS, THEY ALSO INDICATE THEIR RELATIVE BIOLOGICAL SIGNIFICANCE.
GROSS OBSERVATIONS LISTING MULTIPLE MASSES FOR A TISSUE ARE DISTINGUISHED WITH LETTERS (i.e., A, B, C, D, etc.)
MICROSCOPIC CORRELATE (selected lesions)
THE MICROSCOPIC CORRELATE FOR SELECTED GROSS OBSERVATIONS, PRIMARILY MASSES, IS PROVIDED TO THE RIGHT OF THE RESPECTIVE GROSS OBSERVATION.
NEOPLASM DESIGNATIONS
*B: BENIGN NEOPLASM, PRIMARY SITE *M: MALIGNANT NEOPLASM, PRIMARY SITE *X: MALIGNANT NEOPLASM, METASTATIC OR SECONDARY SITE
ABBREVIATIONS NPT = NONPROTOCOL TISSUE NOS = NOT OTHERWISE SPECIFIED
C o m p a n y Sanitized. Does not eontaifn TSCA 1I
-332-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
1
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL - VACUOLATION, HEPATOCELLULAR, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
J jtm p a /iy Sanitized. Does not contain TSCA CBI
- 333 -
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
2
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: LIVER
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
piffy Wanfflzed. 0 o es not contain Twa c
-334-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
3
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: LIVER
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Company Sanitized. Does not contain TSCA C8I
-335-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
4
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING T IS S U E S WERE IN S U F F IC IE N T FOR M ICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCID EN CE TABLES: NONE
))
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
5
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: LIVER
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NO.T PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Company Sanitized. D oes n e t contain TSCA CS!
-337-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
6
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING T IS S U E S WERE IN S U F F IC IE N T FOR M ICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCID EN CE TABLES: NONE
))
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL # :
7
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
f SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Sanitized. Does no! contain TSCA CBT
-339-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
8
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SanIHzed. D oes noi confa? t *
-340-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
9
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: LIVER
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING T IS S U E S WERE IN S U F F IC IE N T FOR M ICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
10
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS:
NO A BN O R M A LITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: LIVER
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Company Sanitized. Does no! contain TSC4 rnr
-342-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL # :
11
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: COAGULATING GLANDS, EPIDIDYMIDES, PROSTATE, SEMINAL VESICLES, TESTES
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
f
3
O
a
3
>1 .'S
m
-343-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
12
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS:
NO A B N O R M A L IT IE S DETECTED
MICROSCOPIC CORRELATE (selected lesions):
M ICROSCOPIC OBSERV A TIO N S: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
pORlpany Sanitized. D ees not contain TSCA c u t
-344-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
13
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany Saniffeecf. Does nofconfafn TSCA CBI
-345-
))
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
14
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: LIVER
- DISCOLORATION, RED; ACESSORY LOBE TORSION
MICROSCOPIC CORRELATE (selected lesions): - INFARCT, LOBAR
MICROSCOPIC OBSERVATIONS: LIVER
- INFARCT, LOBAR - INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL - VACUOLATION, HEPATOCELLULAR, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
ipaiijr S an itized D oes not contain t s c a c m
-346-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
15
DAYS ON TEST: 97
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MODE OF DEATH: SD MICROSCOPIC CORRELATE (selected lesions):.
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: COAGULATING GLANDS, EPIDIDYMIDES, PROSTATE, SEMINAL VESICLES, TESTES
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
tS S ip asiy Sanitized. O oes no! contain TSCA CBI
-347-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
16
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany Sanitized. Does not contain TSCA CBI
-348-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
17
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Com pany Sanitized. Does not contain TSCA CBl
-349-
)
H-24758: One-Generation Reproduction Study in Rats
D uP ont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
18
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
llg M p afty Sanitized. Does not contain t s c a c a r
-350-
H-24758: One-Generation Reproduction Study in Rats
D u P o n t-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
19
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
CompArt? Sanitized. O ddi fioi contain CmtSCA
-351 -
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
20
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
p&mpany S a n itize d . D o e s n o t contain TSCA C B f
-352-
>
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
21
DAYS ON TEST: 97
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MODE OF DEATH: SD MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C o m p a n y S a n itized . D o e s n o t contain TSCA CBI
- 353 -
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
22
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING T IS S U E S WERE UNREMARKABLE M ICR O SCO PICA LLY : NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany S a n itize d , D oes not contain TSCA CR?
-354-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
23
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Company Sanitized. Does not contain TSCA CB'
-355-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: 1-0
DOSE: 0 mg/kg
ANIMAL #:
24
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
-356-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
25
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Com pany S anitized Does not contain TSCA c n
-357-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
26
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Ceswpany Sanitize?. D oes not contain TSCA CB?
- 358 -
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
27
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
S a n itiz e d D o e s no! confata tsc cma
-359-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
28
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Does no! contain tsc a
-360-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
29
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Sanitized. D oes not contain TSCA CBI
-361 -
))
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
30
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Cpmparqr Sanitized. Does not contain TSCA CBI
-362-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
31
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: COAGULATING GLANDS, EPIDIDYMIDES, PROSTATE, SEMINAL VESICLES, TESTES
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
pQ P ipany Sanitized. Does not contain TSCA CBf
-363-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
32
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
fi
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
F. D oes no t confata t r c a c o y
-364-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
33
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
D oes noi contain TSCA CHI
-365-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
34
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions) :
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
-366-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
35
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
P o m p a n y S a n itize d . D o e s n o t co n ta in TSCA c s t'
-367-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
36
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Sanitized. Does not contain TSCA CBI
-368-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
37
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
'Company Sanitized. D oes not contain TSCA CBI
-369-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
38
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Company Sanitized. Does not contain TSCA
2 -370-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
39
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Ui^MWiouseofl pezjHUBsvtoedui^
-371-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
40
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
!P9tnpany Sanitized. D oes not contain TSCA CBI
-372-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
41
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany Sanitized. Does not contain TSC.A CBl
-373 -
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
42
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: PROSTATE
- INFLAMMATION, SUBACUTE/CHRONIC, MILD
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: COAGULATING GLANDS, EPIDIDYMIDES, SEMINAL VESICLES, TESTES
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING T IS S U E S WERE IN S U F F IC IE N T FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN IN CID EN CE TABLES: NONE
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
43
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany S anitized Does not contain TSCA c w
-375-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
44
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: PROSTATE
- INFLAMMATION, SUBACUTE/CHRONIC, MODERATE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: COAGULATING GLANDS, EPIDIDYMIDES, SEMINAL VESICLES, TESTES
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING T IS S U E S WERE IN S U F F IC IE N T FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCID EN CE TABLES: NONE
y
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
45
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE {selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany Sanitized. D oes not contain TSCA CBS
-377-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
46
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Company Sanitized. Does not contain TSCA CBI
-378-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
47
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions)
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
ty m p a n y Sanitized. Does not contain TSCA CB
-379-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: III-O
DOSE: 1 mg/kg
ANIMAL #:
48
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Does not contain TSCA
-380-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
49
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: COAGULATING GLANDS, EPIDIDYMIDES, PROSTATE, SEMINAL VESICLES, TESTES
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: ' NONE
Sanitized D oes no! contain TSCA ceJI
-381-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
50
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
retf. D oes noi co n tata TSCA C 3!
-382-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
51
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: COAGULATING GLANDS, EPIDIDYMIDES, PROSTATE, SEMINAL VESICLES, TESTES
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
J S in p ayiy Sanitized. D oes not contain TSCA c b j
- 383-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
52
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Does no! contain T S C A C B t
-384-
>
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
53
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
JSpmpany Sanitized. Does not contain r s r a
-385-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
54
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
f. Does not contain t/* --
-386-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
55
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: COAGULATING GLANDS, EPIDIDYMIDES, PROSTATE, SEMINAL VESICLES, TESTES
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Company Sanitized. Does not confab TSCA cS t
-387-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
56
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: KIDNEYS
- DILATATION, RIGHT; PELVIS
MICROSCOPIC CORRELATE (selected lesions): - KIDNEYS: HYDRONEPHROSIS, UNILATERAL
MICROSCOPIC OBSERVATIONS: OTHER
- KIDNEYS: HYDRONEPHROSIS, UNILATERAL, MINIMAL - KIDNEYS: NEPHROPATHY, CHRONIC PROGRESSIVE, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Com pany Sanitized. Does not contain TSCA Cft
-388-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
57
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Ppntpeny Sanitized. Does no! contain t s c a C
-389-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
58
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: URINARY BLADDER KIDNEYS
- CALCULUS, SEVERE - DILATATION, BILATERAL; PELVIS - DEFORMITY, BILATERAL, IRREGULAR
MICROSCOPIC CORRELATE (selected lesions): - URINARY BLADDER: INFLAMMATION/HYPERPLASIA - KIDNEYS: PYELONEPHRITIS - KIDNEYS: PYELONEPHRITIS
MICROSCOPIC OBSERVATIONS : OTHER
- KIDNEYS: NEPHROPATHY, CHRONIC PROGRESSIVE, MINIMAL - KIDNEYS: PYELONEPHRITIS, MODERATE - URINARY BLADDER: INFLAMMATION/HYPERPLASIA, MODERATE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
iltized. D oes not confa 'r<s<r** "
-390-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
59
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
ISom pany SanRIzecl. B oasiM I a i r s fS C R CW
-391 -
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
60
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Does ftot contain T8C*
-392-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
61
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: PROSTATE
- INFLAMMATION, SUBACUTE/CHRONIC, MILD
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: COAGULATING GLANDS, EPIDIDYMIDES, SEMINAL VESICLES, TESTES
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
J&wpany Sanitized. Does not contain TSCA C B t
-393-
I)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
62
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Sanitized. D oes not contain TSCA CBf
-394-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
63
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
ifiiO VOSI
i
3
-395 -
H-24758: One-Generation Reproduction Study in Rats
)
)
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
64
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
I Does no! contain T8CA c
-396-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
65
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
I
TSCA OBI
-397-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
66
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
D oes not contain TSCA c w
-398-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
67
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: TESTES
- SMALL, LEFT
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
f. D oes no! confaFn t s c a fig f
-399-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
68
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: COAGULATING GLANDS, EPIDIDYMIDES, PROSTATE, SEMINAL VESICLES, TESTES
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
S&wniMfliy Banlllzetf. D oes no! contain r s e a c v
-400-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
69
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
^ o rh p a n y ianifaetiL 0od# rtdf contain TSCA d fli
-401 -
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
70
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
H-24758: One-Generation Reproduction Study in Rats
)
)
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
71
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Com pany Sanitized. Does n o te o * ^ *
cm
-403-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: V-0
DOSE: 10 mg/kg
ANIMAL #:
72
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany Sanitized. D oes not confafn trc>s
-404-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
73
DAYS ON TEST: 96
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MODE OF DEATH: SD MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: LIVER
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Ljampaoy S a n itized . Does not contain TSCA CBI
-405-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
74
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Sanitized. D oes not contain TSCA CB!
-406-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
75
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL - VACUOLATION, HEPATOCELLULAR, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany S a n itize d . D o e s not contain TSCA CBS
-407-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
76
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Com pany Sanitized. Does not contain TSCA CBf
-408-
i
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
77
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Com pany Sanitized. Does not contain tso a on?
-409-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
78
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL
- N E C R O SIS, FOCAL, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
jPompajijr Sanitized. Does not contain tsoa
-410-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL # :
79
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
i
I
M S' -t
a8
>
-411 -
))
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
80
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: LIVER
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
-412-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL # :
81
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Sanitized. D oes not contain TSCA CB1
-413-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
82
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Does rwf contain T8CA CBt
-414-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
83
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: PROSTATE
- INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: COAGULATING GLANDS, EPIDIDYMIDES, SEMINAL VESICLES, TESTES THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
84
DAYS ON TEST: 96
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
poM pany Sanffiz& D o e s n o t c o n ta in T B C A CBl
-416-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
85
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
S anitized. D oes not contain TSCA Ofit
-417-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
86
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
l&wnpany Sanitized. D oes no! confaln TSGA CBf
-418-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
87
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Company Sanitized. Does not contain TSCA CBf
-419-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
88
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: PROSTATE
- INFLAMMATION, SUBACUTE/CHRONIC, MILD
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: COAGULATING GLANDS, EPIDIDYMIDES, SEMINAL VESICLES, TESTES
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Bcmmanv Sanitized. Does not contain T r a
-420-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
89
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
-421 -
I
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
90
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
^ppany Sanitized. Poes notcontain TSCACBI
-422-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
91
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
D oes no t contain TSCA CBI
-423-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
92
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Does no! confaFn TSCA CB1
-424-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
93
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Com pany Sanitized. Does not contain TSCA CBI
-425-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
94
DAYS ON TEST: 97
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Com pany Sanitized. Does not contain TSCA CBi
-426-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
95
DAYS ON TEST: 97
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MODE OF DEATH: SD MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany Sanitized. D oes not contain TSCA CBJ
-427-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
MALE RATS
GROUP: VII-0
DOSE: 25 mg/kg
ANIMAL #:
96
DAYS ON TEST: 97
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MODE OF DEATH: SD MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany Sanitized. D oes no! contain TSCA CBI
-428-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-0
DOSE: 0 mg /kg
ANIMAL #:
97
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: LIVER
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Com pany SanIHzetf. Does not contain TSCA CBt
-429-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL # :
98
DAYS ON TEST: 110
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: LIVER
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
f. D oes not contain TSCA r e t
-430-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL #:
99
DAYS ON TEST: 102
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL - NECROSIS, FOCAL, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
T THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
iany Sanitized. Does not co nfafn TSCA CBf
-431 -
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-0
DOSE: 0 mg /kg
ANIMAL #:
100
DAYS ON TEST: 106
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: LIVER
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
& * * * * , . B0, M ,,lainTsf. a
-432-
H-24758: One-Generation Reproduction Study in Rats
)
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL #:
101
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: LIVER
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
JPjSBipany Sanitized. D oes not contain TSCA CSi
i
-433-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL #:
102
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- HEMATOPOIESIS, INCREASED EXTRAMEDULLARY, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
D
Ma
con tain TSCA CB(
-434-
H-24758: One-Generation Reproduction Study in Rats
)
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL #:
103
DAYS ON TEST: 102
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- HEMATOPOIESIS, INCREASED EXTRAMEDULLARY, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Com pany Sanitized. Does not contain TSCA C>
-435-
3
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL #:
104
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: SKIN
- ALOPECIA, MILD, INGUEN
MICROSCOPIC CORRELATE (selected lesions): - NO MICROSCOPIC ABNORMALITIES
MICROSCOPIC OBSERVATIONS: OTHER
- SKIN: NO ABNORMALITIES DETECTED
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: LIVER
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
f. D oes tiof eonfafn TSCA CBt
-436-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL #:
105
DAYS ON TEST: 104
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: LIVER THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES:
NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES:
D oes no! contain TSCA CBJ
-437-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL #:
106
DAYS ON TEST: 100
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MODE OF DEATH: SD MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
-438-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL # :
107
DAYS ON TEST: 107
MODE OF DEATH: SD
GROSS OBSERVATIONS: SKIN
ALOPECIA, RIGHT, INGUEN; RIGHT SHOULDER
MICROSCOPIC CORRELATE (selected lesions): - SKIN: HYPERKERATOSIS, FOLLICULAR
MICROSCOPIC OBSERVATIONS: OTHER OVARIES VAGINA
- SKIN: HYPERKERATOSIS, FOLLICULAR, MINIMAL - CORPORA LUTEA, DECREASED, MODERATE - HYPERTROPHY, MUCOSA, MILD
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: CERVIX, UTERUS
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany Sanitized. Does not contain TSCA c m
-439-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL #:
108
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
tSHifp'any Sanitized. D oes not contain TSCA c w
-440-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL #:
109
DAYS ON TEST: 101
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MODE OF DEATH: SD MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
jg& m pafy SanffteeS. Doe* not contain TSCA CBl
-441 -
H-247S8: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL #:
110
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
-442-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL #:
111
DAYS ON TEST: 104
MODE'OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: CERVIX, OTHER, OVARIES, UTERUS, VAGINA
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
E om pan y Sanitized Does no! contain TSCA C K
-443-
))
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL #:
112
DAYS ON TEST: 104
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions) :
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
jpontpany Sanitized.D oes no! contain TSCA c t i
-444-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
ANIMAL #:
113
GROSS OBSERVATIONS: UTERUS
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-0
DOSE: 0 mg/kg
DAYS ON TEST: 100
MODE OF DEATH: SD
- DISCOLORATION, DARK, BODY; ANTERIOR TO CERVIX, RAISED, 4MM DIA
MICROSCOPIC CORRELATE (selected lesions): - NOT CONFIRMED MICROSCOPICALLY
MICROSCOPIC OBSERVATIONS: UTERUS
- IMPLANTATION SITES
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany SanlHzwJ. D oes not contain TSCA C$i
-445-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-0
DOSE: 0 mg/kg
ANIMAL #:
114
DAYS ON TEST: 104
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
m *0S1 ^WWiouseoa 'pozifjueg
-446-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL #:
115
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
-447-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL #:
116
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Com pany Sanitized. Does not contain TSCA CBI
-448-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL #:
117
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Sanitized. D oes not contain t s c a <r>*
-449-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL #:
118
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES:
NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES:
D oes Wo!contain TSCA e n t
-450-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL #:
119
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Sanitized. Does not contain TSCA CBi
-451 -
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: II-O
DOSE: 0 mg/kg
ANIMAL #:
120
DAYS ON TEST: 100
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MODE OF DEATH: SD MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
jRpmpany Sanitized. Does not contain TSCA CBf
-452-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
121
DAYS ON TEST: 102
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany Sanitized. D oes not contain TSCA CBI
-453-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
122
DAYS ON TEST: 102
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT'FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Com pany Sanitized. Does not contain TSCA CBt
-454-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
123
DAYS ON TEST: 100
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany Sanitized. D oes not contain TSCA CBI
-455-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
124
DAYS ON TEST: 100
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
P om pany Sanfiized. Does not contain t $ ca
-456-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
125
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
|
I
D oes not contain TSCA CBI
-457-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
126
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Sanitized. Does not contain TSCA CBl
-458-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
127
DAYS ON TEST: 104
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: CERVIX, OVARIES, UTERUS, VAGINA
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
S^anpafiy Sanitized. B o o st ! contain TSCA CBI
-459-
1
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
128
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
l i m p a n y Sanitized. D ees n et contain t s c a '**!
-460-
)))
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
129
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
fiom pany Sanitized. D oes not contain TSCA CBI
-461 -
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
130
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Ktempany Sanitized. Does net contain TSCA CBt
-462-
H-24758: One-Generation Reproduction Study in Rats_____________________________________________ _____________________________________ DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
131
DAYS ON TEST: 100
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany Sanitized. D oes not contain TSCA CBI
-463-
)
H-24758: One-Generation Reproduction Study in Rats
)
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
132
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
4
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Does not contain TSCA C.m
-464-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
133
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Com pany Sanitized. Does not contain TSCA CBt
-465-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
134
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Company Sanitized. Does not contain TSCA CBl
-466-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
135
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany Sanitized. D oes not contain TSCA CB
-467-
))
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
136
DAYS ON TEST: 100
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
CeM pitny Sanitized. D oes not eoitfs* A* ri
-468-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE HATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
137
DAYS ON TEST: 100
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
-469-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
138
DAYS ON TEST: 104
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: OVARIES
- CORPORA LUTEA, DECREASED, SEVERE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: CERVIX, UTERUS, VAGINA
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C o m p a n y Sanitized. Does not contain TSCA m s
-470-
H-24758: One-Generation Reproduction Study in Rats
)
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
139
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
I. g o e s no t contain TSCA CBI
-471-
)
H-247S8: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
140
DAYS ON TEST: 110
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: OVARIES
- CORPORA LUTEA, DECREASED, SEVERE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: CERVIX, UTERUS, VAGINA
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
J& m p an y S anitized. D oes not contain Ts c a CBi
-472-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
141
DAYS ON TEST: 100
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Com pany Sanitized. Does not contain TSCA a m
-473-
J
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
142
DAYS ON TEST: 102
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Com pany Sanitized. D oes not contain TSCA
-474-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: IV-0
DOSE: 1 mg/kg
ANIMAL #:
143
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
jppmpany Sanitized. Does not contain TSCA
-475-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE EATS
GROUP: IV-0
DOSE: 1 ing/kg
ANIMAL #:
144
DAYS ON TEST: 102
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany Sanitized. D oes not contain TSCA CBI
-476-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
145
DAYS ON TEST: 104
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: CERVIX, OVARIES, UTERUS, VAGINA
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany Sanitized. D oes n o t contain TSCA CBI
-477-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
146
DAYS ON TEST: 102
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
LD oes not contain TSCA CBI
-478-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
147
DAYS ON TEST: 107
MODE OF DEATH: SD
GROSS OBSERVATIONS: UTERUS
- LESION, OTHER, ; ONE LIVE FETUS IN RIGHT UTERINE HORN
MICROSCOPIC CORRELATE (selected lesions): - NO MICROSCOPIC ABNORMALITIES
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: CERVIX, OVARIES, UTERUS, VAGINA
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany Sanitized. D oes not contain TSCA OBI
-479-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
148
DAYS ON TEST: 102
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
149
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
S anitized. D oes not contain TSGA R
-481 -
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
150
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
j
j 1 j ! j j
Com pany Sanitized. Does not contain TSCA c sn
-482-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
151
DAYS ON TEST: 107
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: OVARIES VAGINA
- CORPORA LUTEA, DECREASED, SEVERE - HYPERTROPHY, MUCOSA, MILD
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: CERVIX, UTERUS
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
F. D oes no! co ntain t s c a c m
-483-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
152
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT' FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Com pany Sanitized. Does not contain TSCA c m
-484-
y-- )
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
153
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany Sanitized. D oes not contain TSCA CfH
-485-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
154
DAYS ON TEST: 103
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MODE OF DEATH: SD MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany Sanitized. D oes not contain TSCA CWt
-486-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
155
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
B w n p a n y S a n ilk e d . D oes not contain TSCA CBf
-487-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
156
DAYS ON TEST: 102
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Sanitized. D oes not contain TSCA CBI
-488-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
157
DAYS ON TEST: 104
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: CERVIX, OVARIES, UTERUS, VAGINA
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Company S an itiz ed D oes no! contain T s c a c*
-489-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL # :
158
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
-490-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg /kg
ANIMAL #:
159
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
M ICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
-491 -
H-24758: One-Generation Reproduction Study in Rats______________________________________________________ ___________________ DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
160
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Company S an itized Does not contain
>
8
-492-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
161
DAYS ON TEST: 103
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MODE OF DEATH: SD MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany SanjFffzed. D oes no! co n ta in TSCA CBI
-493-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL # :
162
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT F*OR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Company S a n itiz e d . D o e s not
-494-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
163
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C o m p a n y S a n itized . D oes no t contain r Mtsca
-495-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
164
DAYS ON TEST: 107
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: CERVIX, OVARIES, UTERUS, VAGINA
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
'w rw S m i t e ,. D orn
TS04 r m
-496-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
165
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Com pany SanKfzeA Does not contain TSCA CBS
-497-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
166
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
I
I
f
Hofcontain TSCA CBt
-498-
l
H-24758; One-Generation Reproduction Study in Rats
DuPont-13784
ANIMAL #:
167
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
DAYS ON TEST: 104
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
no! contain Ts c a c m
-499-
)))
H-24758: One-Generation Reproduction Study in Rats_________________________________________________________ ________________ DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VI-0
DOSE: 10 mg/kg
ANIMAL #:
168
DAYS ON TEST: 102
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
CompanySaimzed. DoesnotconlaFnTSCA rM
-500-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
169
DAYS ON TEST: 102
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: LIVER
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Company Sanitized. Does nocn*tn TorA
3 -501-
)
H-24758: One-Generation Reproduction Study in Rats
D u P o n t-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
170
DAYS ON TEST: 102
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: LIVER
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Com pany Sanitized, Does not eontaln TSCA CSI
-502-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
171
DAYS ON TEST: 100
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: LIVER
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Company Sanitized. D oes not contain TSCA CBI
-503-
'j--
' ...
) ...
:
H-24758: One-Generation Reproduction Study in Rats_______________________________________________________ ____ ______________ DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
172
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- HEMATOPOIESIS, INCREASED EXTRAMEDULLARY, MINIMAL
- INFLAMMATION, SUBACUTE/ CH RO N IC, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany S an itiz ed D oes not contain TSCA CRI
-504-
))
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
173
DAYS ON TEST: 100
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
tfem pany Sanitized. Woes hoi contain T5CA 0 g |
-505-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
174
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING T IS S U E S WERE UNREMARKABLE M ICRO SCO PICA LLY : L IV E R
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
P o ip a n y Sanitized. Does not contain t s c a cr i
-506-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
175
DAYS ON TEST: 100
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: LIVER
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
C om pany Sanitized. D oes not contain TSCA Cfl?
-507-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
176
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Company Sanitized. D oes not contain TSCA CBl
-508-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
177
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- HEMATOPOIESIS, INCREASED EXTRAMEDULLARY, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Company Sanitized. Does not contain TSCA eS !
-509-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
178
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: LIVER
- INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
f. D oes not contain TSCA CB
-510-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
179
DAYS ON TEST: 107
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: OVARIES
CYST, LUTEAL
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: CERVIX, UTERUS, VAGINA
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
, Does not contain TSCA CW
-511 -
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
180
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
D oes no t contain TSCA CB1
-512-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
181
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Sanitized. Does not owtfrtn TSftA CIM
-513-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
182
DAYS ON TEST: 102
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
.C om pany S a n itiz e d D o es
notemWn r $ r a i
-514-
t
H-24758: One-Generation Reproduction Study in Rats
)
) DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
183
DAYS ON TEST: 100
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Sanitized. Does not contain TSCA C*
-515-
))
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
184
DAYS ON TEST: 107
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: CERVIX, OVARIES, UTERUS, VAGINA
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
.Company Sanitized. Does not contain T s r a c u t
-516-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
185
DAYS ON TEST: 103
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Company Sanitized. Does not contain TSCA C*i
-517-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
186
DAYS ON TEST: 100
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT1FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Cwnpany Sanitized. Does not contain TSCA Cgi;
-518-
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VII1-0
DOSE: 25 mg/kg
ANIMAL #:
187
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING T IS S U E S WERE IN S U F F IC IE N T FOR M ICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCID EN CE TABLES: NONE
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
188
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING T IS S U E S WERE IN S U F F IC IE N T FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCID EN CE TABLES: NONE
T ~ .` "
)
)
H-24758: One-Generation Reproduction Study in Rats________________________________________________________
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
189
DAYS ON TEST: 101
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
D oes no t contain Tsr*A r w
-521 -
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
190
DAYS ON TEST: 102
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING T IS S U E S WERE UNREMARKABLE M ICR O SCO PICA LLY : NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Does not contato TSCA OR
-522-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
191
DAYS ON TEST: 102
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
S anitized, D oes n o t contain t s c a c
-523-
)
H-24758: One-Generation Reproduction Study in Rats
DuPont-13784
INDIVIDUAL ANIMAL PATHOLOGY DATA
FEMALE RATS
GROUP: VIII-0
DOSE: 25 mg/kg
ANIMAL #:
192
DAYS ON TEST: 102
MODE OF DEATH: SD
GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED
MICROSCOPIC CORRELATE (selected lesions):
MICROSCOPIC OBSERVATIONS: NONE
THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE
THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINATION: NONE
THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE
SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COUNTED IN INCIDENCE TABLES: NONE
Company SanlHzetf. Does not contain TSCA CBl
-524-
