STUDY NO. 09-4347 

SPONSOR STUDY NO. MA-252E-93-23 

PRELIMINARY EMBRYO-FETAL TOXICITY STUDY 

IN RABBITS VIA WHOLE-BODY INHALATION EXPOSURE 

Final Report 

 Submitted to:

 Attn: 

 Date: 15 January 2010 

Page 1 of 175 

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LIST OF ABBREVIATIONS 

Abbreviation Term 

hr(s) hour(s) 

min(s) minute(s) 

F Female(s) 

GD or GES Gestation Day 

Lpm liters per minute 

mg/L milligrams of test substance per liter of air 

ppm parts per million 

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Preliminary Embryo-Fetal Toxicity Study 

in Rabbits via Whole-Body Inhalation Exposure 

SUMMARY 

The objective of this study was to assess any gross maternal and/or embryo-fetal toxicity 

of in a non-rodent species, the rabbit, following whole-body inhalation 

exposure of (every day from Gestation Day (GD) 6 to GD 28, 

inclusively), covering the period of major organogenesis (which extends from 

implantation to the day prior to expected delivery, approximately GD 6 to GD 28), so 

that a suitable range of exposure levels could be selected for a definitive embryo-fetal 

toxicity study. 

Thirty-two time-mated female New Zealand White rabbits were distributed into 4 groups 

(1 control and 3 treated groups) of 8 dams/group. These animals received whole-body 

inhalation exposures every day with clean air (air control) or with at 

exposure concentrations of 2,500, 10,000 or 15,000 ppm from GD 6 to GD 28 (GD 0 = 

day of mating confirmation). The exposure durations were 6 hours per day for 7 days per 

week. 

All animals were euthanized and necropsied on GD 29. The following parameters were 

evaluated for all animals: viability, clinical observations, body weights and feed 

consumption. A macroscopic postmortem evaluation was performed on GD 29, during 

which corpora lutea, implantation data and uterine weights were recorded. The fetuses 

were removed, weighed (live and recently dead fetuses), sexed and examined externally 

for defects. Placentas were examined and weighed. 

The target and mean analytical (IR) and nominal concentrations are summarized as follows: 

Group 

Target 

Concentration 

(ppm) 

Analytical 

Concentration 

(ppm) 

Nominal 

Concentration 

(ppm) 

1 0 0.0 0 

2 2,500 2,449 NA 

3 10,000 10,103 NA 

4 15,000 14,958 24,750* 

*the combined nominal concentration for all 3 exposed groups 

There were no effects of exposures on survival, clinical signs, body weights, food 

consumption or maternal or pup findings at sacrifice. Therefore, the no-observed-effect 

level (NOEL) for adult pregnant female rabbits for systemic and reproductive and 

developmental toxicity was 15,000 ppm of 

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TABLE OF CONTENTS 

COVER PAGE.....................................................................................................................1

SIGNATURE PAGE ...........................................................................................................2

LIST OF ABBREVIATIONS..............................................................................................3

SUMMARY.........................................................................................................................4

TABLE OF CONTENTS.....................................................................................................5

1. INTRODUCTION..................................................................................................8

2. MATERIALS AND METHODS

2.1. Study Management ......................................................................................8

2.2. Study Dates ..................................................................................................8

2.3. Experimental Outline...................................................................................9

2.4. Justifications ................................................................................................9

2.5. Test Substance ...........................................................................................10

2.6. Test Animals ..............................................................................................12

2.7. Animal Assignment ...................................................................................13

2.8. Animal Identification.................................................................................13

2.9. Veterinary Care..........................................................................................13

2.10. Husbandry During Non-Exposure Periods ................................................13

2.11. Husbandry During Exposure Periods ........................................................15

2.12. Test Article Administration and Chamber Operation................................16

2.13. Experimental Evaluations ..........................................................................19

2.14. Terminal Observations...............................................................................20

2.15. Statistical Analysis.....................................................................................21

2.16. Major Computer Systems ..........................................................................22

2.17. Data Storage...............................................................................................22

2.18. Regulatory References...............................................................................22

2.19. Protocol Deviation .....................................................................................23

3. RESULTS AND DISCUSSION

3.1. Chamber Monitoring..................................................................................24

3.2. Maternal Data ............................................................................................25

3.3. Fetal Data...................................................................................................26

4. CONCLUSION ....................................................................................................27

REFERENCES ..................................................................................................................28

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TABLE OF CONTENTS 

FIGURES 

1. Diagram of Generation System and Exposure Chamber 

 Group 1 ........................................................................................................................29

 Groups 2-4 ...................................................................................................................30

2. Mean Body Weights ....................................................................................................31

3. Mean Food Consumption Values.................................................................................32

GENERAL PREFACE ......................................................................................................33

TABLES

1. Summary of Survival ...................................................................................................34

2. Summary of In-Chamber Observations .......................................................................35

3. Summary of Daily Viability Observations ..................................................................37

4. Summary of Gestation Physical Examination Findings ..............................................39

5. Mean Gestation Body Weights ....................................................................................42

6. Mean Gestation Weight Changes ................................................................................45

7. Mean Gestation Food Consumption Values ................................................................48

8. Incidence Summary Report of Gross Necropsy Observation by Animal....................51

9. Summary of Pregnancy................................................................................................53

10. Summary of Cesarean Section Data ............................................................................54

11. Mean Gravid Uterine Adjusted Body Weights............................................................55

12. Mean Litter Weight Data .............................................................................................56

13. Summary of Fetal Observations...................................................................................57

APPENDICES

A. Chamber Monitoring Results.......................................................................................58

B. Individual Animal Termination History ......................................................................66

C. Individual Gestation Daily Viability Observations .....................................................67

D. Individual Gestation Physical Examination Findings..................................................69

E. Individual Gestation Body Weights.............................................................................77

F. Individual Gestation Body Weight Changes ...............................................................89

G. Individual Gestation Food Consumption Values.......................................................101

H. Raw Data Listing of Gross Observations with Modifiers..........................................113

I. Individual Cesarean Section Data..............................................................................116

J. Individual Gravid Uterine Adjusted Body Weights ..................................................120

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TABLE OF CONTENTS 

K. Litter Weight Data .....................................................................................................124

Individual Fetal Weights............................................................................................125

 Individual Placental Weights .....................................................................................129

L. Individual Fetal Observations....................................................................................133

M. Equipment List...........................................................................................................148

N. Prestudy Chamber Distribution Samples...................................................................150

O. Miran Calibration.......................................................................................................151

P. Protocol and Protocol Amendments ..........................................................................154

Q. Testing Facility Personnel .........................................................................................175

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1. INTRODUCTION 

The purpose of this study was to assess gross maternal and/or embryo-fetal 

toxicity of in a non-rodent species, the rabbit, following whole 

body inhalation exposure (every day from Gestation Day (GD) 6 to GD 28, 

inclusively), covering the period of major organogenesis (which extends from 

implantation to the day prior to expected delivery, approximately GD 6 to 

GD 28). 

2. MATERIALS AND METHODS 

2.1. STUDY MANAGEMENT 

2.1.1. SPONSOR 

2.1.2. SPONSOR REPRESENTATIVE 

2.1.3. TESTING FACILITY 

Huntingdon Life Sciences 

100 Mettlers Road 

East Millstone, New Jersey 08875-2360 

2.1.4. STUDY DIRECTOR 

Gary M. Hoffman, BA, DABT 

2.2. STUDY DATES 

2.2.1. STUDY INITIATION 

24 July 2009 (Date Study Director signed the Protocol) 

2.2.2. ANIMAL RECEIPT DATE 

20 August 2009 

2.2.3. EXPOSURE INITIATION 

24 and 25 August 2009 

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2.2.4. EXPOSURE TERMINATION 

15 and 16 September 2009 

2.2.5. TERMINAL SACRIFICE 

16 and 17 September 2009 

2.2.6. STUDY COMPLETION 

15 January 2010 (Date Final Report is signed by the Study 

Director) 

2.3. EXPERIMENTAL OUTLINE 

Four (4) experimental groups (1 control and 3 treated groups) received 

whole-body inhalation exposures every day with clean air or with 

 at the exposure concentrations summarized below. The animals 

were exposed every day from Gestation Day (GD) 6 to GD 28 (GD 0 = 

day of mating). Each group consisted of 8 time-mated females as outlined 

below: 

 Exposure Levelsa Test Animals (females) 

Group 

Group 

Designation (ppm) (mg/L) 

Total on 

Study Necropsy

1 Air Control 0 0 8 8 

2 Low 2,500 13 8 8 

3 Mid 10,000 53 8 8 

4 High 15,000 80 8 8 a

Exposures were 6 hours per day for 7 consecutive days per week. Exposure levels are 

expressed as ppm and equivalent mg/L of test substance; results are reported in ppm. 

The exposures were conducted via whole-body exposure. 

2.4. JUSTIFICATIONS 

2.4.1. ROUTE, DURATION AND FREQUENCY OF 

ADMINISTRATION 

The inhalation route is one of the potential routes of human 

exposure to this test article. The duration and frequency of 

exposures were as recommended in the relevant test guideline, 

ensuring adequate exposure of post-implantation embryo-fetal 

development.

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2.4.2. EXPOSURE LEVEL SELECTION 

A pilot 4-week inhalation study was performed with male and 

female CD rats exposed to target levels of 0, 2,000, 4,500, 7,500 

and 10,000 ppm of Effects were limited to mild 

reversible alterations in some hematology parameters at 10,000 pm 

and to a lesser extent at 7,500 ppm. Based on the above 

information, a high exposure level of 15,000 ppm was selected for 

this study to provide slight maternal toxicity while lower levels of 

10,000 and 2,500 ppm were selected to provide a range of possible 

effects including a NOEL or NOAEL. 

2.4.3. TEST ANIMAL SELECTION 

The rabbit is accepted by Regulatory Authorities as a surrogate for 

humans in the detection of effects on embryo-fetal development. It 

is the preferred non-rodent species for developmental toxicity 

testing, for practical reasons and in view of the large amount of 

accumulated background information in the species. 

2.4.4. NUMBER OF ANIMALS 

The number of animals in this study (8 time-mated females/group) 

was considered the minimum necessary to allow for meaningful 

interpretation of the outcome. The number of animals per group in 

this study was within the range of the number of animals per group 

that are routinely used in preliminary embryo-fetal toxicity studies 

by Developmental and Reproductive Toxicologists. This number 

is the lowest number of pregnant animals that allows reliable 

interpretation of the data (i.e., accounting for variability, such as 

number of pregnant females per group, maternal toxicity, number 

of litters evaluated for developmental abnormalities, fetal deaths, 

etc.). 

2.5. TEST SUBSTANCE 

 or 

2.5.1. TEST SUBSTANCE CATEGORY 

Industrial chemical used as a possible refrigerant and solvent. 

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2.5.2. MANUFACTURER/SUPPLIER 

2.5.3. LOT NUMBERS 

41024-37 

41024-38 

KP-4 

TOX-4 

TOX-5 

TOX-7 

2.5.4. PURITY 

Approximately 100% as per Certificates of Analysis 

2.5.5. DESCRIPTION 

Liquid in cylinder 

2.5.6. DATES RECEIVED 

41024-37 and 41024-38: 18 May 2009 

KP-4, TOX-4, TOX-5 and TOX-7: 17 June 2009 

2.5.7. EXPIRATION DATES 

Not available 

2.5.8. ANALYSIS 

Documentation of the identity, strength, purity, composition, 

stability, and method of synthesis, fabrication, and/or derivation of 

the test substance and the maintenance of these records were the 

responsibility of the Sponsor. 

2.5.9. STORAGE 

Room temperature 

2.5.10. ARCHIVAL SAMPLE 

Archival samples were not required for this study. 

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2.5.11. DISPOSITION 

The unused portion of the test substance (Lot Nos. 41024-37, 

TOX-4 and TOX-5) was returned to the Sponsor on 30 September 

2009. Test substance Lot Nos. 41024-38, KP-4 and TOX-7 were 

retained by the Testing Facility for use on future studies. 

2.6. TEST ANIMALS 

2.6.1. SPECIES 

Albino Rabbits

New Zealand White 

2.6.2. SUPPLIER 

Covance Research Products 

Denver, Pennsylvania 

2.6.3. NUMBER OF ANIMALS 

Received: 

36 time-mated females 

Placed on test: 

32 time-mated females 

2.6.4. AGE AT RECEIPT 

Approximately 6 months at receipt on GD 1 or 2, where GD 0 is 

the day of mating. 

2.6.5. AGE AT INITIATION OF EXPOSURE 

Approximately 6 months old. 

2.6.6. WEIGHT AT INITIATION OF EXPOSURE (KILOGRAMS) 

Mean Range 

3.3 3.0 to 3.9 

2.6.7. STABILIZATION PERIOD 

The stabilization period was restricted to approximately 4 to 5 days 

prior to commencement of exposures, as dictated by the mating 

and delivery schedule for the animals. 

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2.7. ANIMAL ASSIGNMENT 

More animals than required for the study were purchased and stabilized. 

Animals considered suitable for study were randomly assigned to control 

or treated groups upon arrival (4 groups of 8 animals/group). 

Prior to exposures, the body weights obtained on GD 4 were reviewed to 

ensure minimization of inter-group variability based on those body 

weights. 

Information as to the disposition of all animals not utilized in the study is 

maintained in the study file. 

2.8. ANIMAL IDENTIFICATION 

Each animal was identified with an ear-tag bearing its assigned animal 

number. The assigned animal number plus the study number comprised 

the unique animal number for each animal. In addition, each cage was 

provided with a cage card which was color-coded for exposure level 

identification and contained study number and animal number 

information. 

2.9. VETERINARY CARE 

Animals were monitored by the technical staff for any conditions requiring 

possible veterinary care. 

2.10. HUSBANDRY DURING NON-EXPOSURE PERIODS 

2.10.1. FACILITIES MANAGEMENT/ANIMAL HUSBANDRY 

Currently acceptable practices of good animal husbandry were 

followed e.g., Guide for the Care and Use of Laboratory Animals; 

National Academy Press, 1996. Huntingdon Life Sciences, East 

Millstone, New Jersey is fully accredited by the Association for 

Assessment and Accreditation of Laboratory Animal Care 

International (AAALAC). 

2.10.2. HOUSING 

All animals were housed individually in stainless steel suspended 

cages with grid bottoms. A stainless steel food hopper was 

attached to each cage. 

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2.10.3. FEED 

Global High Fiber Diet #2031C (Harlan Teklad, Madison, WI) was 

available without restriction. Fresh feed was presented daily. 

2.10.4. FEED ANALYSIS 

Analysis of each feed lot used during this study was performed by 

the manufacturer. Results were provided to the Testing Facility 

and are maintained on file at the Testing Facility. There were no 

known contaminants in the feed that were expected to interfere 

with the results of this study. 

2.10.5. WATER 

Water (Elizabethtown Water Company, Westfield, New Jersey) 

was available without restriction via an automated watering 

system. 

2.10.6. WATER ANALYSIS 

Water analyses are conducted by Elizabethtown Water Company, 

Westfield, New Jersey (Raritan-Millstone Plant) to ensure that 

water meets standards specified under the EPA Federal Safe 

Drinking Water Act Regulations (40 CFR Part 141). In addition, 

water samples are collected biannually from representative rooms 

in the Testing Facility; chemical and microbiological water 

analyses are conducted on these samples by a subcontract 

laboratory. Results of all water analyses are maintained on file at 

the Testing Facility. There were no known contaminants in the 

water which were expected to interfere with the results of this 

study. 

2.10.7. ENVIRONMENTAL CONDITIONS 

Light/Dark Cycle 

A twelve-hour light/dark cycle controlled via an automatic timer 

was provided. 

Temperature 

Temperature was monitored in accordance with Testing Facility 

SOPs and maintained within the specified range to the maximum 

extent possible. 

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Desired Range: 16 to 22°C 

Daily Average Range: 16 to 21°C 

Relative Humidity 

Relative humidity was monitored in accordance with Testing 

Facility SOPs and maintained within the specified range to the 

maximum extent possible. 

Desired Range: 30 to 70% 

Daily Average Range: 52 to 63% 

2.10.8. ENRICHMENT 

Animals were provided with enrichment devices (toys and/or feed 

treats) as per Testing Facility SOP. 

2.11. HUSBANDRY DURING EXPOSURE PERIODS 

Animals were individually housed in suspended, stainless steel cages. 

2.11.1. FEED 

None was provided during exposure. 

2.11.2. WATER 

None was provided during exposure. 

2.11.3. ENVIRONMENTAL CONDITIONS 

Chamber temperature and relative humidity were recorded every 

half-hour during exposure and maintained, to the maximum extent 

possible, within the ranges presented below. Excursions outside 

the specified range did not affect the integrity of the study. 

Temperature 

Desired: 16 to 24°C 

Actual: 14 to 20°C 

Relative Humidity 

Desired: 40 to 60% 

Actual: 56 to 72% 

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2.12. TEST ARTICLE ADMINISTRATION AND 

CHAMBER OPERATION 

2.12.1. ROUTE OF ADMINISTRATION 

Inhalation as a vapor by whole-body exposure. 

2.12.2. FREQUENCY AND DURATION OF ADMINISTRATION 

Animals were exposed for 6 hours per day once every day at 

approximately the same time each day, on GD 6 to 28 inclusive, 

where GD 0 was the day of mating. 

2.12.3. PRE-STUDY TRIALS 

The test substance was administered as a vapor in the breathing air 

of the animals. The test atmosphere was generated by an 

appropriate procedure determined during pre-study trials. The 

trials were performed to evaluate the optimal set of conditions and 

equipment to generate a stable atmosphere at the target exposure 

levels and maintain uniform conditions throughout the exposure 

chambers. 

2.12.4. EXPOSURE PROCEDURE 

Group 1 

Houseline nitrogen was delivered from a regulator with a 

backpressure gauge via 1⁄4” tubing to a flowmeter regulated by a 

metering valve. This nitrogen flow (~ 20 Lpm) was then directed 

into the chamber turret of the 1 m3

 glass and stainless steel 

exposure chamber where it was mixed with room air as it was 

drawn into the chamber. 

Groups 2, 3 and 4 

Houseline nitrogen was delivered from a regulator with a 

backpressure gauge through a stainless steel fitting to create three 

flow systems: the test substance pressurization flow, the purge 

flow and the volatilization flow. 

The nitrogen for the test substance pressurization flow was 

delivered from a regulator with a backpressure gauge via 1⁄4” 

tubing through a toggle valve attached to a backpressure gauge into 

the vapor inlet valve of the test substance cylinder. The houseline 

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nitrogen regulator valve was used to adjust and maintain the 

pressure within the cylinder. From the pressurized cylinder, the 

test substance flowed from the liquid outlet valve through another 

toggle valve then through a filter to prevent equipment 

contamination. From the filter, the test substance was directed into 

a stainless steel “T” piece where one side of the “T” was directed 

towards the Group 2 exposure system, while the other side of the 

“T” piece was directed towards the Groups 3 and 4 systems where 

a second stainless steel “T” split the test substance flow and 

directed it to the Group 3 and Group 4 exposure systems. 

The exposure system set-up and delivery was the same for all test 

groups. From the “T” pieces after the filter, the test substance 

flowed to a liquid flowmeter with a built-in regulator via 1/8” 

tubing. The outlet of the flowmeter was regulated by a metering 

valve. From this metering valve, the test substance flowed via 1/8” 

tubing onto the glass helix of a counter current volatilization 

chamber. This glass helix was heated by a nichrome wire which 

was controlled by an autotransformer and was inserted in the 

center of the glass tube that supported the helix. 

The nitrogen for the purge flow system was directed, via 1⁄4” tubing 

to a flowmeter regulated by a metering valve. The purge nitrogen 

was delivered via 1/8” tubing to the bottom of the tube containing 

the nichrome wire. This nitrogen flow continuously purged the 

area surrounding the nichrome wire within the tube, thereby, 

protecting the wire from oxidation. 

The nitrogen for the volatilization system was directed via 1⁄4” 

tubing to a flowmeter regulated by a metering valve. From the 

flowmeter, the volatilization nitrogen (~ 20 Lpm) flowed via 1⁄4” 

tubing to a ball and socket joint at the bottom of the volatilization 

chamber. This nitrogen flowed up through the volatilization 

chamber passing over the coil and volatilizing the test substance. 

The pressure within the counter-current volatilization chamber was 

maintained slightly negative to the room and was monitored with a 

magnehelic gauge. 

This test substance laden nitrogen exited the top of the 

volatilization chamber via 1⁄4” tubing, to the turret of the 1 m3

 glass 

and stainless steel exposure chamber. As the test substance laden 

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nitrogen was drawn into each of the chambers, it was mixed with 

room air. 

2.12.5. CHAMBER OPERATION 

The whole-body exposure chambers each had a volume of 

approximately 1000 liters (1 m3). Each chamber was operated at a 

minimum flow rate of 200 liters per minute. The final airflow was 

set to provide at least one air change (calculated by dividing the 

chamber volume by the airflow rate) in 5.0 minutes (12 air 

changes/hour) and a T99 equilibrium time (calculated by 

multiplying the air change by the exponential factor 4.6) of at most 

23 minutes: 

Group Airflow Rate Air Change T99

(Lpm) (min) (min)

1 219 4.6 21

2 219 4.6 21

3 211 4.7 22

4 214 4.7 21

This chamber size and airflow rates were considered adequate to 

maintain the oxygen level at least 19% and the animal loading 

factor below 5%. At the end of each exposure, all animals 

generally remained in the chamber for a minimum of 23 minutes. 

During this time, each chamber was operated at approximately the 

same flow rate using clean air only. The chambers were exhausted 

through the in house filtering system, which consisted of a coarse 

filter, a HEPA filter and activated charcoal. 

See Figure 1 and Appendix M for equipment details. 

2.12.6. NOMINAL CONCENTRATION 

The nominal concentration was determined by weighing the 

generation apparatus containing the test substance before and after 

the exposure and calculating as follows: 

Conc (ppm) = amount consumed (g) x 1000 (mg/g) x 1000 (μg/mg) x 22.4 (μL/μmole) x 295oK

exposure duration (min) x airflow (Lpm) x MW (μg/μmole) x 273oK 

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The nominal concentration was calculated for all three test 

substance-treated groups combined. 

The flow of air through the chamber was monitored using 

appropriate calibrated equipment. The test substance consumed 

(weight difference of the cylinder) during the exposure (kg) was 

divided by the total volume of air (m3) passing through the 

chamber to calculate the nominal concentration (ppm). 

During each exposure, measurements of airborne concentrations 

were performed in the animals’ breathing zone at least 4 times using 

an appropriate sampling procedure (~20 Lpm) and infrared (IR) 

spectrophotometric analytical procedure. 

See Appendix M for equipment details. 

2.12.7. PARTICLE SIZE DISTRIBUTION ANALYSIS 

During each week of exposure, particle size determinations were 

performed using a TSI Aerodynamic Particle Sizer to characterize 

the aerodynamic particle size distribution of any aerosol present. 

The samples were drawn for 20 seconds at a flow rate of 5.0 Lpm. 

The mass median aerodynamic diameter, geometric standard 

deviation and total mass concentration were calculated based on 

the amount of particles collected. 

See Appendix M for equipment details. 

2.13. EXPERIMENTAL EVALUATIONS 

2.13.1. VIABILITY CHECKS 

Animals were observed in their cages twice daily (once in the 

morning and once in the afternoon) for mortality, morbidity and 

signs of severe toxicity. 

2.13.2. PHYSICAL OBSERVATIONS 

Exposure Observations 

All visible animals were observed as a group at least once during 

each exposure. 

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Detailed Physical Examinations 

Animals were removed from their cages and examined pretest and 

weekly during the study period. Examinations included 

observations of general condition, skin and fur, eyes, nose, oral 

cavity, abdomen and external genitalia as well as evaluations of 

respiration and palpation for tissue masses. 

2.13.3. BODY WEIGHT 

Body weights were recorded for all animals on presumed GD 6 

through termination on GD 29. 

2.13.4. FOOD CONSUMPTION 

Food was available without restriction 7 days/week. Animals were 

presented with full feeders of known weight. Feeders were 

reweighed on the following day and the resulting weight was 

subtracted from the original feeder weight to obtain the grams 

consumed. Food consumption was measured (weighed) daily from 

GD 4 through GD 29. 

2.14. TERMINAL OBSERVATIONS 

2.14.1. NECROPSY INFORMATION 

Necropsy was performed on 8 animals/group after 28 days of 

exposure. 

Method of Euthanasia 

Adult females: intravenous injection of sodium pentobarbital. 

Fetuses: intraperitoneal injection of sodium pentobarbital. 

2.14.2. TERMINAL EXAMINATIONS (SCHEDULED 

TERMINATIONS) 

A necropsy (macroscopic examination) comprised of an external 

examination followed by an internal examination (excluding the 

cranial cavity) was performed. Minor sporadic lesions common to 

this strain of animal (i.e. localized patchy hair loss) were not 

sampled or recorded. 

The intact uterus (ovaries attached) was removed from the 

abdominal cavity and weighed intact for visibly pregnant animals 

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only. Corpora lutea were counted and the number per ovary 

recorded. 

The uterus was then opened and the number and location of the 

following were recorded for each uterine horn: 

• live fetuses 

• dead fetuses (recently dead, no significant degeneration) 

• late embryo-fetal deaths (recognizable dead embryo/fetus 

undergoing degeneration, regardless of size) 

• early embryonic deaths (evidence of implantation, but no 

recognizable embryo), or stain-positive 

The placenta associated with each fetus was examined 

macroscopically and weighed. 

For apparently non-pregnant animals, and for apparently empty 

uterine horns, the number of uterine implantation sites were 

checked after staining with ammonium sulphide [modification of 

the Salewski staining technique (Salewski, 1964)].

The uteri and ovaries of apparently non-pregnant rabbits were 

retained in neutral buffered 10% formalin and discarded at the end 

of the study when authorized by the Study Director. 

2.14.3. FETAL EXAMINATIONS 

External Examinations (live fetuses) 

All live GD 29 fetuses, and any recently-dead fetuses without 

significant necrosis, were weighed, sexed, individually identified, 

and the fetuses examined externally for abnormalities, including 

observation of the palate. All apparently normal fetuses were 

discarded after euthanasia and examination. 

2.15. STATISTICAL ANALYSIS 

Statistical analyses for maternal and embryo-fetal data were limited to 

descriptive statistics (mean, standard deviation and number). Data for nonpregnant animals were excluded from the calculations. 

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2.16. MAJOR COMPUTER SYSTEMS 

The following major computer/software systems were utilized at 

Huntingdon Life Sciences, East Millstone, New Jersey. 

System Version Use 

Liberate Reporting 

System 

2.2 Generation of report tables for the clinical 

observations, body weight, food 

consumption and organ weight data in MS 

Word formats 

Microsoft Word 

and/or Excel 

 Additional formatting of report tables. 

REES Scientific 

Environmental 

Monitoring System 

WIN 1.5 Monitor and record temperature, humidity 

and/or light intensity readings of applicable 

rooms as well as the temperature readings 

of applicable refrigerators and/freezers 

TSI Aerodynamic 

Particle Sizer 

Spectrometer 

2.9 Acquisition of particle size data 

Xybion Path/Tox 

System 

4.2.2 Direct online capture of clinical 

observations, body weights, food 

consumption, organ weights and 

necropsy/fetal pathology data 

2.17. DATA STORAGE 

All raw data, preserved specimens, and retained samples, as well as the 

original study protocol and the original final report are to be maintained in 

the Archives of the Testing Facility upon completion of the study for at 

least ten years. Following this period, the Sponsor will determine the final 

disposition of these materials. 

2.18. REGULATORY REFERENCES 

2.18.1. TEST GUIDELINES 

There are no regulatory guidelines for this type of preliminary 

study, although the design was based on the OECD 414 and US 

EPA 870.3700 guidelines for embryo-fetal toxicity studies. 

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2.18.2. GOOD LABORATORY PRACTICES 

This study was performed according to protocol, at the Testing 

Facility according to Huntingdon Life Sciences’ Standard 

Operating Procedures. Quality Assurance (QA) inspections and 

auditing were not performed, as this was not conducted in full 

compliance with GLP. 

2.18.3. ANIMAL WELFARE ACT COMPLIANCE 

This study complied with all appropriate parts of the Animal 

Welfare Act Regulations: 9 CFR Parts 1 and 2 Final Rules, 

Federal Register, Volume 54, No. 168, August 31, 1989, pp. 

36112-36163 effective October 30, 1989 and 9 CFR Part 3 Animal 

Welfare Standards; Final Rule, Federal Register, Volume 56, No. 

32, February 15, 1991, pp. 6426-6505 effective March 18, 1991. 

2.19. PROTOCOL DEVIATION 

The following protocol deviation occurred during the study but was not 

considered to have compromised the validity or integrity of the study: 

Detailed physical examinations were performed on half of the dams in the 

afternoon rather than in the morning on GD 5. 

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3. RESULTS AND DISCUSSION 

3.1. CHAMBER MONITORING 

(Appendix A)

Pre-study chamber distribution analyses showed the test substance was 

evenly distributed within each chamber. The target and mean analytical 

(IR) and nominal concentrations are summarized as follows: 

Group 

Target 

Concentration 

(ppm) 

Analytical 

Concentration 

(ppm) 

Nominal 

Concentration 

(ppm) 

1 0 0.0 0 

2 2,500 2,400 NA 

3 10,000 10,000 NA 

4 15,000 15,000 24,750* 

*the combined nominal concentration for all 3 exposed groups 

The achieved mean exposure concentration for each group was very close to 

the respective target concentration. The differences between measured 

(total of 27,510 ppm) and nominal (24,750 ppm) concentrations were 

considered representative of minor differences in calibration of the IR 

spectrophotometer and/or the chamber airflows. Chamber environmental 

conditions averaged 18◦C and 62% relative humidity. 

Mean particle size distribution measurements for the exposures are 

summarized as follows: 

Group Test 

Substance 

Mass Median 

Aerodynamic 

Diameter 

(μm) 

Geometric 

Standard 

Deviation 

Total 

Mass 

Concentration 

(mg/m3

) 

1 Air Control 4.139 1.863 4.60 x 10-2

2 4.562 1.956 4.10 x 10-2

3 3.593 1.887 1.68 x 10-2

4 3.109 1.762 1.34 x 10-2

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These results indicated that the atmospheres were essentially vapor only, 

as expected, since there was no substantial difference between the test 

substance chambers and the air control chamber. 

3.2. MATERNAL DATA 

3.2.1. MORTALITY 

(Appendix B) 

There was no effect of exposure on survival for females at 

exposures up to 15,000 ppm. All females survived until the 

termination of the study. 

3.2.2. CLINICAL OBSERVATIONS 

(Tables 2, 3 and 4; Appendix C and D) 

In-chamber observations were within normal limits on all exposure 

days for all test groups. 

There were no exposure-related findings in the test substance 

exposed animals during the non-exposure intervals. Only 

transient, minor, non-adverse findings were observed in these 

exposure groups. 

3.2.3. GESTATION BODY WEIGHTS 

(Tables 5 and 6; Appendices E and F) 

There were no exposure-related differences in body weights and 

body weight gains in the test substance exposed animals during the 

gestation period as compared with the air control group. 

3.2.4. GESTATION FOOD CONSUMPTION 

(Table 7; Appendix G) 

There were no exposure-related differences in feed consumption in 

the test substance exposed animals, compared to the air control 

animals during the gestation period. 

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3.2.5. MATERNAL MACROSCOPIC POSTMORTEM 

EVALUATIONS 

(Table 8; Appendix H) 

There were no test substance related macroscopic abnormalities. 

Macroscopic findings were typical of the background findings seen 

in rats of this age. 

3.2.6. PREGNANCY OUTCOME AND CESAREAN SECTION 

DATA 

(Tables 9 and 10; Appendix I) 

One female at 15,000 ppm was not pregnant at scheduled 

termination, however this was not considered to be test substancerelated. In addition, slightly increased sex ratios (% male) were 

noted at ≥2,500 ppm, ranging from 18% to 44% as compared with 

mean control values. As there was no correlation with total 

number of fetuses, this was also not considered to be test 

substance-related. 

3.3. FETAL DATA 

3.3.1. GRAVID UTERINE, PLACENTAL AND FETAL WEIGHTS 

(Tables 11 and 12; Appendices J and K) 

Decreases in body weight changes from GD 6 to 29 were noted at 

≥2,500 ppm (-18%), but were considered non-test substancerelated as there were no significant differences in body weight 

between test substance-treated groups at GD 6 or GD 29. In 

addition, placental weights at ≥2,500 ppm were increased, ranging 

from 9% to 20% when compared with control values, although no 

correlations were noted with fetal weights. 

3.3.2. FETAL OBSERVATIONS: EXTERNAL FINDINGS 

(Table13; Appendix L) 

Exposures up to 15,000 ppm did not result in any test substancerelated external malformations. 

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4. CONCLUSION 

There were no effects of exposures on survival, clinical signs, body weights, food 

consumption or maternal or pup findings at sacrifice. Therefore, the no-observedeffect level (NOEL) for adult pregnant female rabbits for systemic and 

reproductive and developmental toxicity was 15,000 ppm of 

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REFERENCES 

Salewski, E. 1964. Farbemethode zum makroskopischen machweis von 

implantationsstellen am uterus der ratte. Archiv. Path. Exp. Pharmakol. 247: 367. 

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Group 1 

Chamber Generation System 

and Whole-Body Exposure Chamber Figure 1 

Notes: 

Sampling Ports H-7 (left-bottom), H-8 (left-top), H-1 (right-bottom) and 

H-2 (right-top) used for pretest distribution sampling, were located on the back wall of 

the chambers. 

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Groups 2, 3 and 4 

Chamber Generation System 

and Whole-Body Exposure Chamber Figure 1 

Notes: 

Sampling Ports H-7 (left-bottom), H-8 (left-top), H-1 (right-bottom) and 

H-2 (right-top) used for pretest distribution sampling, were located on the back wall of 

the chambers. 

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Mean Body Weights 

(grams) 

310032003300340035003600370038003900

4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 

Gestation Day

Body Weights (grams)

Group 1 - 0 ppmGroup 2 - 2,500 ppmGroup 3 - 10,000 ppmGroup 4 - 15,000 ppm

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Mean Food Consumption Values 

(grams/animal/day) 

120130140150160170180190200

4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 

Gestation Day

Food Consumption (g/animal/day)

GrouGrouGrouGrou

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General Preface 

General Notes

Individual animal data presented in this report may be rounded. Unrounded individual 

animal data were used to calculate the reported mean and standard deviation values. 

Therefore, use of the reported individual values to reproduce means, standard deviations 

and/or to perform any subsequent calculations may produce minor discrepancies between 

the calculated values and those presented in this report. 

The data collection system used for collecting the in-life and post-life data divides the 

study into phases. The phase utilized on this study was: 

Gestation Phase (GD or GES): Begins the day of confirmation of mating (GD 0). 

Corresponding exposure levels for each group were as follows: 

Group 1 - 0 ppm 

Group 2 - 2,500 ppm 

Group 3 - 10,000 ppm 

Group 4 - 15,000 ppm 

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Females Summary of Survival 

Dose Group 1 2 3 4 Exposure Level (ppm) 0 2,500 10,000 15,000 

 n (%) n (%) n (%) n (%) Number of females entered on study 8 8 8 8 

Removed before scheduled termination 

Died 0 (0) 0 (0) 0 (0) 0 (0) 

Moribund/elective sacrifice 0 (0) 0 (0) 0 (0) 0 (0) 

Total 0 (0) 0 (0) 0 (0) 0 (0) 

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Summary of In-Chamber Observationsa 

aObservations are based on total animals present in the chamber each day. 

All = 100% of animals exhibiting a given observation. 

Exposure Day 1 2 3 4 5 6 7 8 9 10 11 Gestation Day 6 7 8 9 10 11 12 13 14 15 16 Group 1 – 0 ppm

Within Normal Limits All All All All All All All All All All All 

Group 2 – 2,500 ppm Within Normal Limits All All All All All All All All All All All 

Group 3 – 10,000 ppm

Within Normal Limits All All All All All All All All All All All 

Group 4 – 15,000 ppm

Within Normal Limits All All All All All All All All All All All 

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Summary of In-Chamber Observationsa 

aObservations are based on total animals present in the chamber each day. 

All = 100% of animals exhibiting a given observation. 

Exposure Day 15 16 17 18 19 20 21 22 23 Gestation Day 20 21 22 23 24 25 26 27 28 Group 1 – 0 ppm

Within Normal Limits All All All All All All All All All 

Group 2 – 2,500 ppm Within Normal Limits All All All All All All All All All Group 3 – 10,000 ppm

Within Normal Limits All All All All All All All All All 

Group 4 – 15,000 ppm

Within Normal Limits All All All All All All All All All 

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Summary of Daily Viability Observations 

Preface Table 3 

Only animals with abnormal observations and intervals with findings are presented in this 

table; all other animals were considered to within normal limits at all other intervals. 

Corresponding exposure levels for each group were as follows: 

Group 1 - 0 ppm 

Group 2 - 2,500 ppm 

Group 3 - 10,000 ppm 

Group 4 - 15,000 ppm 

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Females Summary of Daily Viability Observations 

 Phase GES 

Day 1 2 14 15 16 17 18 21 23 24 26 

Session AM AM AM AM AM AM AM AM PM AM AM 

Observations Group Dermal General, Alopecia (Limbs) 1 1 Dermal General, Alopecia (Head/Neck) 3 1 Dermal General, Alopecia (Torso) 2 1 Dermal General, Scab(s) 4 1 Gastrointestinal, No Stool 2 1 Daily Observations, Red Exudate (Limbs/Tail) 2 1 Daily Observations, Decreased Fecal Volume 1 1 1 1 1 

2 1 2 1 1 1 4 1 1 

Daily Observations, No Stool 2 1 Daily Observations, Decreased Food Consumption 1 1 1 1 

2 1 1 2 1 1 4 1 1 

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Summary of Gestation 

Physical Examination Findings 

Preface Table 4 

Corresponding exposure levels for each group were as follows: 

Group 1 - 0 ppm 

Group 2 - 2,500 ppm 

Group 3 - 10,000 ppm 

Group 4 - 15,000 ppm 

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Females Summary of Gestation Physical Examination Findings 

 Phase GES 

Day 2 3 4 5 6 7 8 9 10 11 12 13 

Session PO PO PO PO PO PO PO PO PO PO PO PO P

Observations Group Examined 1 4 8 8 8 8 8 8 8 8 8 8 8 

2 4 8 8 8 8 8 8 8 8 8 8 8 3 4 8 8 8 8 8 8 8 8 8 8 8 4 4 8 8 8 8 8 8 8 8 8 8 8 

Within Normal Limits 1 3 7 7 7 8 8 8 8 8 8 8 8 

2 4 7 7 7 7 7 7 8 8 8 8 8 3 4 7 7 7 7 7 7 7 8 8 8 8 4 4 7 7 7 7 7 7 7 7 7 7 7 

Dermal General, Alopecia (Limbs) 1 1 1 1 1 Dermal General, Alopecia (Head/Neck) 3 1 1 1 1 1 1 1 Dermal General, Alopecia (Torso) 2 1 1 1 1 1 1 Dermal General, Ano-Genital Staining 1 Dermal General, Scab(s) 

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Females Summary of Gestation Physical Examination Findings 

 Phase GES 

Day 17 18 19 20 21 22 23 24 25 26 27 28 2

Session PO PO PO PO PO PO PO PO PO PO PO PO P

Observations Group Examined 1 8 8 8 8 8 8 8 8 8 8 8 8 

2 8 8 8 8 8 8 8 8 8 8 8 8 3 8 8 8 8 8 8 8 8 8 8 8 8 4 8 8 8 8 8 8 8 8 8 8 8 8 

Within Normal Limits 1 6 6 6 6 6 6 6 7 7 7 7 7 

2 8 8 8 8 7 7 6 7 6 6 6 6 3 8 8 8 8 7 7 7 7 7 7 7 6 4 8 8 8 8 8 7 7 7 7 7 7 7 

General Appearance, Red Exudate (Limbs/Tail) 2 1 Dermal General, Alopecia (Limbs) 2 1 1 1 1 

3 1 

Dermal General, Alopecia (Head/Neck) 1 1 1 1 1 1 1 1 

3 1 1 1 1 1 1 1 1 4 1 1 1 1 1 1 1 

Dermal General, Alopecia (Torso) 3 Dermal General, Ano-Genital Staining 1 1 1 1 1 1 1 1 1 1 1 1 1 

2 1 1 1 1 1 1 1 1 

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 Mean Gestation Body Weights 

Females (grams) 

 Phase GES  Day 4 6 7 8 9 10 11 12 13 14 Group 1 - 0 ppm Mean 3207.1 3237.9 3274.1 3288.7 3310.7 3320.4 3342.1 3377.2 3405.2 3442.1 SD 112.07 121.37 118.38 119.98 106.27 114.78 105.32 108.19 105.43 103.08 N 8 8 8 8 8 8 8 8 8 8 Group 2 - 2,500 ppm Mean 3363.0 3409.2 3427.9 3427.7 3442.9 3444.0 3466.0 3492.4 3489.0 3526.5 SD 129.43 125.84 116.40 117.56 107.12 118.33 107.16 106.25 110.53 110.20 N 8 8 8 8 8 8 8 8 8 8 Group 3 - 10,000 ppm Mean 3341.9 3386.4 3415.0 3412.4 3416.3 3421.1 3444.0 3473.0 3496.6 3524.1 SD 275.12 236.45 257.01 257.28 255.53 252.59 246.04 261.90 244.05 232.54 N 8 8 8 8 8 8 8 8 8 8 Group 4 - 15,000 ppm Mean 3237.5 3302.1 3312.6 3327.0 3332.7 3332.6 3352.2 3386.8 3400.5 3424.5 SD 332.75 322.66 327.10 326.53 341.50 329.68 340.63 347.80 349.49 349.33 N 7 7 7 7 7 7 7 7 7 7 

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 Mean Gestation Body Weights 

Females (grams) 

 Phase GES  Day 17 18 19 20 21 22 23 24 25 26 Group 1 - 0 ppm Mean 3468.3 3479.3 3516.1 3519.4 3549.3 3564.1 3571.9 3610.9 3625.9 3654.2 SD 131.72 136.97 132.21 131.78 134.39 138.21 129.53 131.94 137.48 156.11 N 8 8 8 8 8 8 8 8 8 8 Group 2 - 2,500 ppm Mean 3575.9 3599.6 3622.4 3624.4 3646.4 3666.0 3687.4 3705.1 3729.5 3732.2 SD 94.46 91.52 87.64 94.28 93.06 96.24 104.60 92.05 106.30 110.25 N 8 8 8 8 8 8 8 8 8 8 Group 3 - 10,000 ppm Mean 3571.5 3586.8 3604.0 3624.4 3636.5 3660.4 3679.8 3699.7 3715.3 3734.7 SD 228.98 217.20 220.75 229.31 231.59 231.75 220.70 222.93 219.14 208.45 N 8 8 8 8 8 8 8 8 8 8 Group 4 - 15,000 ppm Mean 3458.3 3474.5 3493.8 3500.2 3528.7 3552.1 3569.7 3595.8 3627.2 3643.7 SD 354.00 357.19 347.28 350.17 347.87 356.09 368.88 365.69 376.03 386.30 N 7 7 7 7 7 7 7 7 7 7 

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 Mean Gestation Body Weights 

Females (grams) 

 Phase GES  Day 29 Group 1 - 0 ppm Mean 3721.9 SD 171.73 N 8 Group 2 - 2,500 ppm Mean 3801.7 SD 113.35 N 8 Group 3 - 10,000 ppm Mean 3788.7 SD 197.07 N 8 Group 4 - 15,000 ppm Mean 3696.6 SD 394.84 N 7 

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 Mean Gestation Body Weight Changes 

Females (grams) 

 Phase GES  Day 4-6 6-7 7-8 8-9 9-10 10-11 11-12 12-13 13-14 14-15 Group 1 - 0 ppm Mean 30.8 36.2 14.5 22.0 9.7 21.7 35.0 28.0 36.9 31.8 SD 52.86 51.90 21.23 25.69 17.76 20.71 19.20 22.94 37.19 39.70 N 8 8 8 8 8 8 8 8 8 8 Group 2 - 2,500 ppm Mean 46.2 18.7 -0.2 15.2 1.1 22.0 26.4 -3.4 37.5 16.8 SD 25.29 39.89 11.57 19.00 28.22 29.80 30.14 35.29 44.72 40.43 N 8 8 8 8 8 8 8 8 8 8 Group 3 - 10,000 ppm Mean 44.5 28.6 -2.7 4.0 4.7 23.0 28.9 23.7 27.4 28.6 SD 70.19 44.60 18.10 24.25 45.53 28.22 26.56 22.98 20.11 14.64 N 8 8 8 8 8 8 8 8 8 8 Group 4 - 15,000 ppm Mean 64.6 10.6 14.4 5.7 -0.2 19.6 34.6 13.6 24.0 17.5 SD 108.85 61.66 45.35 25.57 18.71 30.45 41.85 20.49 37.67 28.03 N 7 7 7 7 7 7 7 7 7 7 

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 Mean Gestation Body Weight Changes 

Females (grams) 

 Phase GES  Day 17-18 18-19 19-20 20-21 21-22 22-23 23-24 24-25 25-26 26-27 Group 1 - 0 ppm Mean 11.0 36.9 3.3 29.8 14.8 7.9 39.0 15.0 28.3 16.1 SD 22.76 17.10 28.43 29.98 21.43 25.30 20.86 13.24 54.93 29.13 N 8 8 8 8 8 8 8 8 8 8 Group 2 - 2,500 ppm Mean 23.7 22.9 1.9 22.0 19.6 21.5 17.7 24.4 2.6 22.0 SD 29.70 13.01 16.24 27.98 23.44 25.17 33.99 32.86 39.34 18.47 N 8 8 8 8 8 8 8 8 8 8 Group 3 - 10,000 ppm Mean 15.3 17.2 20.5 12.1 23.9 19.4 19.9 15.6 19.3 17.3 SD 17.04 20.76 18.34 19.60 30.17 17.66 13.56 25.30 18.26 17.43 N 8 8 8 8 8 8 8 8 8 8 Group 4 - 15,000 ppm Mean 16.2 19.4 6.4 28.5 23.4 17.6 26.1 31.4 16.5 6.3 SD 10.55 16.51 10.17 10.48 24.18 19.40 18.04 24.30 23.24 18.22 N 7 7 7 7 7 7 7 7 7 7 

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 Mean Gestation Body Weight Changes 

Females (grams) 

 Phase GES  Day 6-29 Group 1 - 0 ppm Mean 483.9 SD 181.00 N 8 Group 2 - 2,500 ppm Mean 392.6 SD 130.68 N 8 Group 3 - 10,000 ppm Mean 402.3 SD 124.68 N 8 Group 4 - 15,000 ppm Mean 394.6 SD 224.90 N 7 

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 Mean Gestation Food Consumption Values 

Females (grams/animal/day) 

 Phase GES  Day 4-5 5-6 6-7 7-8 8-9 9-10 10-11 11-12 12-13 13-14 Group 1 - 0 ppm Mean 186.9 185.1 173.2 176.8 173.3 171.4 182.5 175.1 163.9 154.7 SD 22.19 13.61 18.59 22.34 17.11 27.84 18.63 18.96 30.64 42.95 N 8 8 8 8 8 8 8 8 8 8 Group 2 - 2,500 ppm Mean 185.7 181.9 169.0 171.0 168.7 165.1 166.9 156.2 141.4 128.4 SD 8.53 19.47 19.13 22.02 20.57 23.54 26.52 37.01 38.33 69.27 N 8 8 8 8 8 8 8 8 8 8 Group 3 - 10,000 ppm Mean 186.5 185.3 178.5 178.1 173.2 171.5 173.4 164.0 159.9 152.6 SD 13.72 17.82 23.13 28.04 33.88 28.91 28.21 36.03 26.90 31.01 N 8 8 8 8 8 7 8 8 8 8 Group 4 - 15,000 ppm Mean 176.6 176.9 158.0 164.1 158.1 157.6 155.0 150.2 141.5 132.7 SD 24.78 18.72 31.37 26.77 31.65 27.63 27.64 36.87 40.00 53.20 N 7 7 7 7 7 7 7 7 7 7 

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 Mean Gestation Food Consumption Values 

Females (grams/animal/day) 

 Phase GES  Day 16-17 17-18 18-19 19-20 20-21 21-22 22-23 23-24 24-25 25-26 Group 1 - 0 ppm (Air Control ) Mean 157.6 174.5 184.8 188.3 183.9 182.8 174.4 169.0 154.5 138.0 SD 64.59 42.13 14.49 9.34 11.92 10.93 22.02 22.90 32.71 55.98 N 8 8 8 8 7 8 7 7 7 8 Group 2 - 2,500 ppm Mean 154.5 163.9 163.4 159.9 160.9 161.7 165.4 149.1 148.9 134.5 SD 42.85 36.14 36.30 37.41 34.89 30.22 28.43 43.71 33.61 35.23 N 8 8 8 8 8 8 8 8 8 8 Group 3 - 10,000 ppm Mean 177.2 176.3 173.7 178.5 173.5 169.0 160.8 156.3 137.8 130.3 SD 20.52 22.42 22.56 23.09 26.81 37.16 37.67 36.33 37.74 37.09 N 8 8 8 8 8 8 8 8 8 8 Group 4 - 15,000 ppm Mean 147.5 146.9 150.1 156.2 159.5 158.0 159.5 153.2 141.9 137.3 SD 38.71 35.03 33.35 30.75 32.79 26.11 31.59 30.70 41.00 43.24 N 7 7 7 7 7 7 7 7 7 7 

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 Mean Gestation Food Consumption Values 

Females (grams/animal/day) 

 Phase GES  Day 28-29 6-29 Group 1 - 0 ppm Mean 150.4 166.7 SD 34.36 25.10 N 8 8 Group 2 - 2,500 ppm Mean 137.6 152.4 SD 31.83 33.49 N 8 8 Group 3 - 10,000 ppm Mean 138.7 162.1 SD 32.13 23.58 N 8 8 Group 4 - 15,000 ppm Mean 139.6 147.6 SD 24.91 33.96 N 7 7 

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 Incidence Summary Report 

for Gross Necropsy Observations 

Preface Table 8 

Corresponding dose levels for each group were as follows: 

Group 1 - 0 ppm 

Group 2 - 2,500 ppm 

Group 3 - 10,000 ppm 

Group 4 - 15,000 ppm 

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Females Summary of Pregnancy 

Dose Group 1 2 3 4 Exposure Level (ppm) 0 2,500 10,000 15,000 

 n (%) n (%) n (%) n (%) Number of females entered on study (mated) 8 8 8 8 

- Non pregnant 0 (0) 0 (0) 0 (0) 1 (13) - Pregnant 8 (100) 8 (100) 8 (100) 7 (88) 

Pregnant with termination before scheduled date 0 0 0 0 

Pregnant at scheduled termination 8 8 8 7 

- With total implantation loss 0 (0) 0 (0) 0 (0) 0 (0) - With viable fetuses 8 (100) 8 (100) 8 (100) 7 (100) 

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Females Summary of Cesarean Section Data 

 Corpora Implant- Resorptions Dead Live Fetuses Sex Rat Lutea ations Early Late Total Fetuses Male Female Total (% Mal

Group 1 - 0 ppm Mean 10.1 9.9 0.4 0.4 0.8 0.0 3.1 6.0 9.1 34.1 SD 2.36 1.96 0.74 1.06 1.16 0.00 0.99 1.07 1.13 9.3N 8 8 8 8 8 8 8 8 8 8 Group 2 - 2,500 ppm Mean 9.5 9.4 0.1 0.0 0.1 0.0 3.9 5.4 9.3 43.0 SD 1.51 1.41 0.35 0.00 0.35 0.00 0.99 1.85 1.39 13.6N 8 8 8 8 8 8 8 8 8 8 Group 3 - 10,000 ppm Mean 9.6 9.3 0.3 0.0 0.3 0.0 3.6 5.4 9.0 40.3 SD 1.41 1.28 0.46 0.00 0.46 0.00 1.06 1.30 1.51 10.0N 8 8 8 8 8 8 8 8 8 8 Group 4 - 15,000 ppm Mean 9.0 8.9 0.3 0.1 0.4 0.0 4.1 4.3 8.4 49.0 SD 1.15 1.46 0.49 0.38 0.53 0.00 1.46 1.60 1.62 18.6N 7 7 7 7 7 7 7 7 7 7 Impl. = Implantation 

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Mean Gravid Uterine Adjusted Body Weights 

Females (grams) 

 Bodyweight on Bodyweight on Bwt change Gravid Uterine Adj Bwt Adj bwt  Day 6 Day 29 Days 6-29 Weight Day 29 Days 

Group 1 - 0 ppm Mean 3237.9 3721.9 483.9 526.7 3195.2 -42.S.D. 121.37 171.73 181.00 47.34 194.14 197.N 8 8 8 8 8 8 Group 2 - 2,500 ppm Mean 3409.2 3801.7 392.6 548.2 3253.6 -155.S.D. 125.84 113.35 130.68 59.59 114.42 123.N 8 8 8 8 8 8 Group 3 - 10,000 ppm Mean 3386.4 3788.7 402.3 517.7 3271.0 -115.S.D. 236.45 197.07 124.68 74.59 192.46 141.N 8 8 8 8 8 8 Group 4 - 15,000 ppm Mean 3302.1 3696.6 394.6 513.3 3183.3 -118.S.D. 322.66 394.84 224.90 150.54 281.30 135.N 7 7 7 7 7 7 

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 Mean Litter Weight Data 

 (grams) Table 12 

 Total Litter Mean 

Animal Litter Fetal Fetal Placental 

Number Weight Weight Weight 

 

Group 1 – 0 ppm (Air Control) 

Mean 372.8 41.2 4.4 

SD 31.36 3.84 0.39 

N 8 8 8 

 

Group 2 – 2,500 ppm 

Mean 387.1 42.1 5.0 

SD 42.56 3.18 0.58 

N 8 8 8 

 

Group 3 – 10,000 ppm 

Mean 372.7 41.6 4.8 

SD 58.13 3.60 0.40 

N 8 8 8 

 

Group 4 – 15,000 ppm 

Mean 361.6 42.5 5.3 

SD 100.3 6.93 0.67 

N 7 7 7 

 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Summary of Fetal Observations 

 (External) 

Fetuses 

 Group 1 2 3 4 1 Observation External Examinations 73 74 72 59 8 No abnormality detected 

 76 72 72 60 8 

Skin/subcutis  Forepaw(s), subcutaneous hemorrhage 1  Hindpaw(s), subcutaneous hemorrhage 1 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Chamber Monitoring Results 

Cumulative Exposure Record 

GSD = Geometric Standard Deviation, MMAD = Mass Median Aerodynamic Diameter, TMC = Total Mass Concentration 

*Nominal concentration calculated for all 3 treated groups combined, see Group 4 for results. 

Group 1 – 0 ppm Particle Size Ch

Day Date Exposure Nominal* Analytical Chamber Concentration Determinations 

 Number Mean Individual MMAD GSD TMC Temp

(ppm) (ppm) (ppm) (μm) (mg/m3) (

1 24-Aug-09 1 0 0.0 0.0 0.0 0.0 0.0 2 25-Aug-09 2 0 0.0 0.0 0.0 0.0 0.0 3 26-Aug-09 3 0 0.0 0.0 0.0 0.0 0.0 0.8463 1.492 2.77E-03 4 27-Aug-09 4 0 0.0 0.0 0.0 0.0 0.0 5 28-Aug-09 5 0 0.0 0.0 0.0 0.0 0.0 6 29-Aug-09 6 0 0.0 0.0 0.0 0.0 0.0 7 30-Aug-09 7 0 0.0 0.0 0.0 0.0 0.0 8 31-Aug-09 8 0 0.0 0.0 0.0 0.0 0.0 9 1-Sep-09 9 0 0.0 0.0 0.0 0.0 0.0 

10 2-Sep-09 10 0 0.0 0.0 0.0 0.0 0.0 7.056 2.396 6.76E-02 11 3-Sep-09 11 0 0.0 0.0 0.0 0.0 0.0 12 4-Sep-09 12 0 0.0 0.0 0.0 0.0 0.0 13 5-Sep-09 13 0 0.0 0.0 0.0 0.0 0.0 14 6-Sep-09 14 0 0.0 0.0 0.0 0.0 0.0 15 7-Sep-09 15 0 0.0 0.0 0.0 0.0 0.0 16 8-Sep-09 16 0 0.0 0.0 0.0 0.0 0.0 17 9-Sep-09 17 0 0.0 0.0 0.0 0.0 0.0 4.854 1.602 8.30E-02 18 10-Sep-09 18 0 0.0 0.0 0.0 0.0 0.0 19 11-Sep-09 19 0 0.0 0.0 0.0 0.0 0.0 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Chamber Monitoring Results 

Cumulative Exposure Record 

GSD = Geometric Standard Deviation, MMAD = Mass Median Aerodynamic Diameter, TMC = Total Mass Concentration 

*Nominal concentration calculated for all 3 treated groups combined, see Group 4 for results. 

Group 1 – 0 ppm Particle Size Ch

Day Date Exposure Nominal* Analytical Chamber Concentration Determinations 

 Number Mean Individual MMAD GSD TMC Temp

(ppm) (ppm) (ppm) (μm) (mg/m3) (

20 12-Sep-09 20 0 0.0 0.0 0.0 0.0 0.0 21 13-Sep-09 21 0 0.0 0.0 0.0 0.0 0.0 22 14-Sep-09 22 0 0.0 0.0 0.0 0.0 0.0 23 15-Sep-09 23 0 0.0 0.0 0.0 0.0 0.0 3.798 1.963 3.06E-02 24 16-Sep-09 24 0 0.0 0.0 0.0 0.0 0.0 

 Mean 0 0.0 4.139 1.863 4.60E-02 

 S.D. 0 0.0 2.581 0.408 0.04 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Chamber Monitoring Results 

Cumulative Exposure Record 

GSD = Geometric Standard Deviation, MMAD = Mass Median Aerodynamic Diameter, TMC = Total Mass Concentration 

*Nominal concentration calculated for all 3 treated groups combined, see Group 4 for results. 

Group 2 – 2,500 ppm Particle Size C

Day Date Exposure Nominal* Analytical Chamber Concentration Determinations 

 Number Mean Individual MMAD GSD TMC Tem

(ppm) (ppm) (ppm) (μm) (mg/m3) 

1 24-Aug-09 1 NA 2400 2600 2200 2400 2400 2 25-Aug-09 2 NA 2300 2100 2300 2300 2400 3 26-Aug-09 3 NA 2500 2600 2500 2400 2300 4.500 1.818 6.07E-02 4 27-Aug-09 4 NA 2600 2800 2500 2500 2600 5 28-Aug-09 5 NA 2400 2300 2000 2300 2800 6 29-Aug-09 6 NA 2500 2600 2500 2400 2500 7 30-Aug-09 7 NA 2300 2700 2000 2400 2100 8 31-Aug-09 8 NA 2300 2100 2100 2500 2300 9 1-Sep-09 9 NA 2500 2700 2700 2100 2300 

10 2-Sep-09 10 NA 2500 2300 2600 2500 2400 5.895 1.827 5.69E-02 11 3-Sep-09 11 NA 2700 3000 2500 2500 2700 12 4-Sep-09 12 NA 2200 2100 2100 2100 2500 13 5-Sep-09 13 NA 2500 3600 2000 2100 2200 14 6-Sep-09 14 NA 2500 2400 2600 2400 2600 15 7-Sep-09 15 NA 2500 2700 2900 2200 2200 16 8-Sep-09 16 NA 2500 2200 2600 3000 2300 17 9-Sep-09 17 NA 2800 3000 2700 2800 2700 6.906 2.196 4.17E-02 18 10-Sep-09 18 NA 2600 2700 2600 2400 2600 19 11-Sep-09 19 NA 2600 2600 2500 2600 2500 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Chamber Monitoring Results 

Cumulative Exposure Record 

GSD = Geometric Standard Deviation, MMAD = Mass Median Aerodynamic Diameter, TMC = Total Mass Concentration 

*Nominal concentration calculated for all 3 treated groups combined, see Group 4 for results. 

Group 2 – 2,500 ppm Particle Size C

Day Date Exposure Nominal* Analytical Chamber Concentration Determinations 

 Number Mean Individual MMAD GSD TMC Tem

(ppm) (ppm) (ppm) (μm) (mg/m3) 

20 12-Sep-09 20 NA 2400 2700 2000 2600 2300 21 13-Sep-09 21 NA 2400 2200 2300 2500 2500 22 14-Sep-09 22 NA 2400 2300 2100 2600 2400 23 15-Sep-09 23 NA 2500 2700 2100 2600 2400 0.9488 1.981 4.81E-03 24 16-Sep-09 24 NA 2400 2300 2400 2400 2400 

 Mean NA 2400 4.562 1.956 4.10E-02 

 S.D. 265 2.603 0.177 0.03 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Chamber Monitoring Results 

Cumulative Exposure Record 

GSD = Geometric Standard Deviation, MMAD = Mass Median Aerodynamic Diameter, TMC = Total Mass Concentration 

*Nominal concentration calculated for all 3 treated groups combined, see Group 4 for results. 

Group 3 – 10,000 ppm Particle Size C

Day Date Exposure Nominal* Analytical Chamber Concentration Determinations 

 Number Mean Individual MMAD GSD TMC Tem

(ppm) (ppm) (ppm) (μm) (mg/m3) 

1 24-Aug-09 1 NA 11000 12000 11000 11000 10000 2 25-Aug-09 2 NA 10000 9800 10000 10000 10000 3 26-Aug-09 3 NA 10000 9700 11000 10000 10000 5.538 2.241 2.50E-02 4 27-Aug-09 4 NA 9700 8900 9000 10000 11000 5 28-Aug-09 5 NA 10000 9700 10000 10000 10000 6 29-Aug-09 6 NA 10000 11000 10000 10000 10000 7 30-Aug-09 7 NA 9700 9200 10000 9400 10000 8 31-Aug-09 8 NA 10000 9700 11000 10000 10000 9 1-Sep-09 9 NA 10000 10000 9900 10000 9900 

10 2-Sep-09 10 NA 9700 9600 10000 9900 9300 5.222 1.807 3.15E-02 11 3-Sep-09 11 NA 10000 10000 9800 10000 10000 12 4-Sep-09 12 NA 10000 10000 10000 9800 11000 13 5-Sep-09 13 NA 10000 10000 9600 9600 11000 14 6-Sep-09 14 NA 10000 10000 10000 9900 11000 15 7-Sep-09 15 NA 9700 10000 10000 9700 9200 16 8-Sep-09 16 NA 9900 10000 10000 10000 9600 17 9-Sep-09 17 NA 10000 11000 10000 9900 9400 2.690 1.732 6.43E-03 18 10-Sep-09 18 NA 10000 11000 10000 10000 10000 19 11-Sep-09 19 NA 10000 11000 9700 9700 11000 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Chamber Monitoring Results 

Cumulative Exposure Record 

GSD = Geometric Standard Deviation, MMAD = Mass Median Aerodynamic Diameter, TMC = Total Mass Concentration 

*Nominal concentration calculated for all 3 treated groups combined, see Group 4 for results. 

Group 3 – 10,000 ppm Particle Size C

Day Date Exposure Nominal* Analytical Chamber Concentration Determinations 

 Number Mean Individual MMAD GSD TMC Tem

(ppm) (ppm) (ppm) (μm) (mg/m3) 

20 12-Sep-09 20 NA 10000 10000 10000 9800 10000 21 13-Sep-09 21 NA 9900 10000 9800 9800 10000 22 14-Sep-09 22 NA 11000 11000 11000 10000 12000 23 15-Sep-09 23 NA 10000 11000 10000 10000 10000 0.9220 1.766 4.08E-03 24 16-Sep-09 24 NA 10000 10000 9600 11000 10000 

 Mean NA 10000 3.593 1.887 1.68E-02 

 S.D. 565 2.190 0.238 0.01 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Chamber Monitoring Results 

Cumulative Exposure Record 

GSD = Geometric Standard Deviation, MMAD = Mass Median Aerodynamic Diameter, TMC = Total Mass Concentration 

*Nominal concentration calculated for all 3 treated groups combined, see Group 4 for results. 

Group 4 – 15,000 ppm Particle Size C

Day Date Exposure Nominal* Analytical Chamber Concentration Determinations 

 Number Mean Individual MMAD GSD TMC Tem

(ppm) (ppm) (ppm) (μm) (mg/m3) 

1 24-Aug-09 1 24000 15000 15000 15000 15000 15000 2 25-Aug-09 2 23000 15000 14000 15000 15000 15000 3 26-Aug-09 3 24000 15000 14000 14000 15000 15000 4.951 1.923 2.85E-02 4 27-Aug-09 4 24000 15000 15000 15000 15000 15000 5 28-Aug-09 5 24000 15000 15000 15000 15000 15000 6 29-Aug-09 6 24000 15000 15000 15000 15000 15000 7 30-Aug-09 7 24000 14000 15000 13000 14000 14000 8 31-Aug-09 8 27000 15000 14000 15000 15000 15000 9 1-Sep-09 9 24000 15000 15000 15000 15000 15000 

10 2-Sep-09 10 27000 15000 15000 15000 15000 15000 5.353 1.907 1.92E-02 11 3-Sep-09 11 25000 15000 15000 16000 15000 15000 12 4-Sep-09 12 25000 16000 15000 15000 16000 16000 13 5-Sep-09 13 26000 16000 15000 16000 15000 16000 14 6-Sep-09 14 25000 15000 15000 15000 15000 14000 15 7-Sep-09 15 25000 15000 14000 16000 15000 15000 16 8-Sep-09 16 25000 15000 14000 15000 15000 15000 17 9-Sep-09 17 25000 15000 15000 15000 15000 15000 1.210 1.660 2.14E-03 18 10-Sep-09 18 24000 15000 15000 15000 15000 16000 19 11-Sep-09 19 25000 15000 14000 14000 15000 15000 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Chamber Monitoring Results 

Cumulative Exposure Record 

GSD = Geometric Standard Deviation, MMAD = Mass Median Aerodynamic Diameter, TMC = Total Mass Concentration 

*Nominal concentration calculated for all 3 treated groups combined, see Group 4 for results. 

Group 4 – 15,000 ppm Particle Size C

Day Date Exposure Nominal* Analytical Chamber Concentration Determinations 

 Number Mean Individual MMAD GSD TMC Tem

(ppm) (ppm) (ppm) (μm) (mg/m3) 

20 12-Sep-09 20 24000 15000 15000 16000 16000 14000 21 13-Sep-09 21 25000 15000 15000 15000 15000 15000 22 14-Sep-09 22 25000 15000 15000 15000 16000 15000 23 15-Sep-09 23 25000 15000 15000 15000 15000 15000 0.922 1.559 3.61E-03 24 16-Sep-09 24 25000 15000 15000 15000 15000 15000 

 Mean NA 15000 3.109 1.762 1.34E-02 

 S.D. 521 2.368 0.181 0.01 

SANITIZED
Huntingdon Life Sciences 09-4347 Page 66 

 MA-252E-93-23 Final Report 

Females Individual Animal Termination History Appendix B 

a

T = Terminal Sacrifice 

b

Gestation Day 0 is defined as the day of mating confirmation Test article administration began on 

Gestation Day 6 for all animals. 

Animal 

Number 

Date of 

Death 

Type of

Deatha

 

Study 

Dayb 

Animal

Number 

Date of 

Death 

Type of 

Deatha

 

Study 

Dayb 

Group 1 – 0 ppm Group 3 – 10,000 ppm 

1551 16 Sep 09 T 29 3551 16 Sep 09 T 29 

1552 16 Sep 09 T 29 3552 16 Sep 09 T 29 

1553 16 Sep 09 T 29 3553 16 Sep 09 T 29 

1554 16 Sep 09 T 29 3554 16 Sep 09 T 29 

1555 17 Sep 09 T 29 3555 17 Sep 09 T 29 

1556 17 Sep 09 T 29 3556 17 Sep 09 T 29 

1557 17 Sep 09 T 29 3557 17 Sep 09 T 29 

1558 17 Sep 09 T 29 3558 17 Sep 09 T 29 

Group 2 – 2,500 ppm Group 4 – 15,000 ppm 

2551 16 Sep 09 T 29 4551 16 Sep 09 T 29 

2552 16 Sep 09 T 29 4552 16 Sep 09 T 29 

2553 16 Sep 09 T 29 4553 16 Sep 09 T 29 

2554 16 Sep 09 T 29 4554 16 Sep 09 T 29 

2555 17 Sep 09 T 29 4555 17 Sep 09 T 29 

2556 17 Sep 09 T 29 4556 17 Sep 09 T 29 

2557 17 Sep 09 T 29 4557 17 Sep 09 T 29 

2558 17 Sep 09 T 29 4558 17 Sep 09 T 29 

 SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Females Individual Gestation Daily Viability Observations 

 Phase GES Animal Day 1 2 14 15 16 17 18 21 23 24 Number Observations Session AM AM AM AM AM AM AM AM PM AM Group 1 - 0 ppm 1553 Daily observations, decreased fecal volume P P P 

 Daily observations, decreased food consumption P P 1558 Dermal general, alopecia (limbs) 2 Group 2 - 2,500 ppm 2552 Dermal general, alopecia (torso) 2  Gastrointestinal, no stool P  Daily observations, decreased fecal volume P P P  Daily observations, no stool P  Daily observations, decreased food consumption P P P 2557 Daily observations, red exudate (limbs/tail), hind paw(s) P  Daily observations, decreased fecal volume P P P  Daily observations, decreased food consumption P P P Group 3 - 10,000 ppm 3552 Dermal general, alopecia (head/neck) 2 AM = morning observation, PM = afternoon observation, P = present, 2 = moderate 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Females Individual Gestation Daily Viability Observations 

 Phase GES Animal Day 1 2 14 15 16 17 18 21 23 24 Number Observations Session AM AM AM AM AM AM AM AM PM AM Group 4 - 15,000 ppm 4552 Dermal general, scab(s), ear(s) P 4553 Daily observations, decreased fecal volume P 

 Daily observations, decreased food consumption P 4556 Daily observations, decreased fecal volume P 

 Daily observations, decreased food consumption P AM = morning observation, PM = afternoon observation, P = present 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Females Individual Gestation Physical Examination Findings 

Animal Phase GES Number Observations Day 2 3 4 5 6 7 8 9 10 11 1Group 1 - 0 ppm 1551 Within normal limits P P P P P P P P P P 1552 Within normal limits P P P P P P P P P P  Dermal general, ano-genital staining 1553 Within normal limits P P P P P P P P P P 1554 Within normal limits P P P P P P P P P P 1555 Within normal limits P P P P P P P P P P P 1556 Within normal limits P P P P P P P P P P P 1557 Within normal limits P P P P P P P P P P P 1558 Within normal limits P P P P P P P  Dermal general, alopecia (limbs) 2 2 2 2 Group 2 - 2,500 ppm 2551 Within normal limits P P P P P P P P P P P = present, 1 = slight, 2 = moderate 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Females Individual Gestation Physical Examination Findings 

Animal Phase GES Number Observations Day 2 3 4 5 6 7 8 9 10 11 1Group 2 - 2,500 ppm 2552 Within normal limits P P P P  Dermal general, alopecia (torso) 2 2 2 2 2 2 2553 Within normal limits P P P P P P P P P P 2554 Within normal limits P P P P P P P P P P 2555 Within normal limits P P P P P P P P P P P 2556 Within normal limits P P P P P P P P P P P 2557 Within normal limits P P P P P P P P P P P 2558 Within normal limits P P P P P P P P P P P Group 3 - 10,000 ppm 3551 Within normal limits P P P P P P P P P P 3552 Within normal limits P P P  Dermal general, alopecia (head/neck) 2 2 2 2 2 2 2 

P = present, 2 = moderate 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Females Individual Gestation Physical Examination Findings 

Animal Phase GES Number Observations Day 2 3 4 5 6 7 8 9 10 11 1Group 3 - 10,000 ppm 3553 Within normal limits P P P P P P P P P P 3554 Within normal limits P P P P P P P P P P 3555 Within normal limits P P P P P P P P P P P 3556 Within normal limits P P P P P P P P P P P 3557 Within normal limits P P P P P P P P P P P 3558 Within normal limits P P P P P P P P P P P Group 4 - 15,000 ppm 4551 np Within normal limits P P P P P P P P P P 4552 Within normal limits  Dermal general, scab(s), ear(s) P P P P P P P P P P 4553 Within normal limits P P P P P P P P P P np = not pregnant, P = present 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Females Individual Gestation Physical Examination Findings 

Animal Phase GES Number Observations Day 2 3 4 5 6 7 8 9 10 11 1Group 4 - 15,000 ppm 4554 Within normal limits P P P P P P P P P P 4555 Within normal limits P P P P P P P P P P P 4556 Within normal limits P P P P P P P P P P P 4557 Within normal limits P P P P P P P P P P P 4558 Within normal limits P P P P P P P P P P P P = present 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Females Individual Gestation Physical Examination Findings 

Animal Phase GES Number Observations Day 17 18 19 20 21 22 23 24 25 26 2Group 1 - 0 ppm 1551 Within normal limits P P P P P P P P P P P 1552 Dermal general, ano-genital staining 1 1 1 1 1 1 1 1 1 1 1553 Within normal limits P P P P P P P P P P P 1554 Within normal limits P P P P P P P P P P P 1555 Within normal limits P P P P P P P P P P P 1556 Within normal limits P P P P  Dermal general, alopecia (head/neck) 2 2 2 2 2 2 2 

1557 Within normal limits P P P P P P P P P P P 1558 Within normal limits P P P P P P P P P P P Group 2 - 2,500 ppm 

2551 Within normal limits P P P P P P P P P P P P = present, 1 = slight, 2 = moderate 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Females Individual Gestation Physical Examination Findings 

Animal Phase GES Number Observations Day 17 18 19 20 21 22 23 24 25 26 2Group 2 - 2,500 ppm 2552 Within normal limits P P P P P P P P  Dermal general, alopecia (limbs) 3 3 2553 Within normal limits P P P P P P P P P P P 2554 Within normal limits P P P P P P P P P P P 2555 Within normal limits P P P P P P P P P P P 2556 Within normal limits P P P P P P P P P P P 2557 Within normal limits P P P P P P P P P P  General appearance, red exudate (limbs/tail), hind 

paw(s) 

 P 

2558 Within normal limits P P P P  Dermal general, ano-genital staining 2 2 2 2 2 2 2 P = present, 2 = moderate, 3 = extreme 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Females Individual Gestation Physical Examination Findings 

Animal Phase GES Number Observations Day 17 18 19 20 21 22 23 24 25 26 2Group 3 - 10,000 ppm 3551 Within normal limits P P P P  Dermal general, alopecia (head/neck) 3  Dermal general, alopecia (head/neck), head 2 2 3 3 3 3552 Within normal limits P P P P P P P P P P P 3553 Within normal limits P P P P P P P P P P P 3554 Within normal limits P P P P P P P P P P P 3555 Within normal limits P P P P P P P P P P P 3556 Within normal limits P P P P P P P P P P P 3557 Within normal limits P P P P P P P P P P P 3558 Within normal limits P P P P P P P P P P P  Dermal general, alopecia (limbs)  Dermal general, alopecia (torso) P = present, 2 = moderate, 3 = extreme 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Females Individual Gestation Physical Examination Findings 

Animal Phase GES Number Observations Day 17 18 19 20 21 22 23 24 25 26 2Group 4 - 15,000 ppm 4551 np Within normal limits P P P P P P P P P P P 4552 Within normal limits P P P P P  Dermal general, alopecia (head/neck) 3 3 3 3 3 

 Dermal general, ano-genital staining 2 2 2 2 4553 Within normal limits P P P P P P P P P P P 4554 Within normal limits P P P P P P P P P P P 4555 Within normal limits P P P P P P P P P P P 4556 Within normal limits P P P P P P P P P P P 4557 Within normal limits P P P P P P P P P P P 4558 Within normal limits P P P P P P P P P P P np = not pregnant, P = present, 1 = slight, 2 = moderate, 3 = extreme 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weights 

Females (grams) 

Animal Phase GES Number Day 4 6 7 8 9 10 11 12 13 14 Group 1 - 0 ppm 1551 3060.0 3114.8 3131.0 3139.5 3161.4 3170.3 3208.0 3238.6 3277.0 3314.1 1552 3143.9 3224.2 3205.5 3199.9 3233.8 3252.5 3282.7 3283.8 3306.4 3343.7 1553 3213.5 3236.1 3226.6 3260.6 3257.7 3267.2 3275.6 3314.0 3362.2 3344.4 1554 3198.5 3298.8 3371.4 3410.2 3408.5 3422.1 3430.3 3462.2 3508.0 3518.5 1555 3146.8 3148.0 3287.3 3285.8 3311.1 3309.8 3342.2 3408.0 3465.7 3548.0 1556 3416.1 3480.4 3481.7 3500.8 3491.3 3514.9 3538.4 3563.2 3573.3 3574.0 1557 3159.0 3115.8 3154.8 3193.1 3256.7 3230.1 3279.4 3313.7 3322.6 3401.0 1558 3319.1 3285.4 3334.8 3319.3 3365.0 3396.6 3380.4 3433.8 3426.4 3493.3 Mean 3207.1 3237.9 3274.1 3288.7 3310.7 3320.4 3342.1 3377.2 3405.2 3442.1 SD 112.07 121.37 118.38 119.98 106.27 114.78 105.32 108.19 105.43 103.08 N 8 8 8 8 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weights 

Females (grams) 

Animal Phase GES Number Day 4 6 7 8 9 10 11 12 13 14 Group 2 - 2,500 ppm 2551 3450.2 3533.2 3524.3 3538.1 3567.2 3590.7 3616.2 3671.7 3685.0 3731.2 2552 3443.2 3482.3 3463.8 3461.5 3468.3 3473.1 3463.4 3483.4 3398.1 3370.5 2553 3226.9 3272.9 3260.8 3274.1 3311.0 3299.3 3348.5 3368.3 3391.8 3468.2 2554 3380.4 3448.9 3430.3 3436.0 3423.7 3459.9 3459.5 3483.0 3490.9 3512.2 2555 3204.1 3235.5 3313.1 3300.3 3339.3 3289.0 3351.6 3437.8 3447.1 3548.0 2556 3285.2 3328.1 3354.6 3352.4 3372.4 3400.2 3386.7 3384.9 3378.0 3429.5 2557 3590.1 3589.6 3620.2 3622.0 3618.3 3612.1 3622.2 3621.8 3610.9 3589.5 2558 3323.9 3382.9 3456.2 3437.2 3442.9 3428.0 3480.1 3488.3 3510.4 3563.0 Mean 3363.0 3409.2 3427.9 3427.7 3442.9 3444.0 3466.0 3492.4 3489.0 3526.5 SD 129.43 125.84 116.40 117.56 107.12 118.33 107.16 106.25 110.53 110.20 N 8 8 8 8 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weights 

Females (grams) 

Animal Phase GES Number Day 4 6 7 8 9 10 11 12 13 14 Group 3 - 10,000 ppm 3551 3225.9 3356.0 3356.3 3361.2 3384.8 3302.6 3378.4 3420.6 3465.8 3480.6 3552 3175.5 3301.9 3256.0 3253.4 3226.2 3244.6 3280.1 3256.0 3276.5 3309.7 3553 3237.6 3338.4 3347.2 3337.1 3373.1 3351.7 3364.6 3385.1 3425.9 3444.2 3554 3478.7 3494.2 3530.8 3546.0 3528.2 3552.2 3559.6 3624.7 3653.8 3681.6 3555 3029.4 3027.8 3040.0 3042.5 3035.9 3109.6 3098.2 3112.3 3161.6 3208.4 3556 3169.8 3231.5 3325.0 3289.6 3323.8 3308.0 3352.5 3388.1 3411.4 3475.5 3557 3533.3 3504.4 3551.5 3572.6 3561.6 3586.4 3607.7 3639.5 3635.0 3639.1 3558 3885.2 3836.8 3913.3 3896.5 3897.1 3913.3 3911.1 3957.3 3942.9 3953.3 Mean 3341.9 3386.4 3415.0 3412.4 3416.3 3421.1 3444.0 3473.0 3496.6 3524.1 SD 275.12 236.45 257.01 257.28 255.53 252.59 246.04 261.90 244.05 232.54 N 8 8 8 8 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weights 

Females (grams) 

Animal Phase GES Number Day 4 6 7 8 9 10 11 12 13 14 Group 4 - 15,000 ppm 4551 np 3132.1x 3152.5x 3157.8x 3170.4x 3188.7x 3210.1x 3203.3x 3185.4x 3208.3x 3243.9x 4552 3324.4 3347.8 3378.3 3384.5 3413.0 3411.7 3402.8 3433.0 3438.4 3500.3 4553 3279.8 3385.2 3267.2 3375.6 3352.1 3351.2 3398.4 3438.9 3452.2 3406.7 4554 3086.7 3381.2 3439.5 3442.1 3475.9 3470.0 3524.4 3613.8 3671.2 3729.7 4555 3000.3 3021.5 3086.3 3116.1 3088.4 3079.3 3092.5 3180.8 3180.7 3230.7 4556 3084.0 3067.2 3074.2 3042.6 3048.2 3086.1 3055.9 3035.9 3047.0 3062.7 4557 3927.1 3918.5 3951.5 3942.6 3971.2 3947.9 3978.1 3991.1 3986.3 3992.9 4558 2960.2 2993.0 2991.3 2985.7 2980.4 2981.7 3013.3 3014.4 3027.6 3048.4 Mean 3237.5 3302.1 3312.6 3327.0 3332.7 3332.6 3352.2 3386.8 3400.5 3424.5 SD 332.75 322.66 327.10 326.53 341.50 329.68 340.63 347.80 349.49 349.33 N 7 7 7 7 7 7 7 7 7 7 np = not pregnant, x = excluded from calculation 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weights 

Females (grams) 

Animal Phase GES Number Day 17 18 19 20 21 22 23 24 25 26 Group 1 - 0 ppm 1551 3358.7 3330.6 3373.0 3350.9 3346.4 3372.3 3397.4 3417.9 3418.9 3535.0 1552 3423.7 3433.5 3452.5 3473.6 3504.2 3536.6 3526.0 3568.9 3587.5 3593.4 1553 3257.0 3266.7 3327.1 3357.7 3387.4 3398.5 3426.6 3453.0 3469.0 3391.3 1554 3645.3 3634.5 3666.3 3691.4 3707.7 3748.6 3751.7 3781.8 3818.9 3873.4 1555 3531.4 3578.1 3592.4 3538.0 3631.3 3625.3 3659.5 3729.4 3750.6 3804.7 1556 3614.0 3626.7 3685.9 3695.7 3697.8 3732.1 3700.6 3718.2 3711.2 3749.1 1557 3403.0 3425.8 3466.5 3480.0 3521.3 3515.6 3498.7 3569.5 3585.0 3600.8 1558 3513.1 3538.3 3565.4 3568.0 3597.9 3583.5 3614.9 3648.8 3666.2 3686.1 Mean 3468.3 3479.3 3516.1 3519.4 3549.3 3564.1 3571.9 3610.9 3625.9 3654.2 SD 131.72 136.97 132.21 131.78 134.39 138.21 129.53 131.94 137.48 156.11 N 8 8 8 8 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weights 

Females (grams) 

Animal Phase GES Number Day 17 18 19 20 21 22 23 24 25 26 Group 2 - 2,500 ppm 2551 3762.0 3762.3 3785.3 3791.1 3793.9 3828.1 3870.2 3865.4 3930.3 3894.7 2552 3451.9 3503.1 3534.6 3503.3 3499.2 3530.1 3558.1 3580.1 3591.0 3609.9 2553 3560.1 3544.1 3587.6 3608.6 3591.7 3613.1 3663.3 3697.9 3680.2 3633.1 2554 3589.6 3622.9 3644.1 3663.7 3673.6 3682.1 3704.9 3726.4 3765.6 3799.4 2555 3523.4 3575.2 3575.1 3571.4 3625.0 3629.1 3661.0 3675.5 3669.7 3641.0 2556 3495.4 3486.0 3517.1 3519.5 3575.2 3584.4 3552.9 3605.1 3643.0 3659.5 2557 3619.7 3638.2 3653.8 3657.6 3686.5 3749.3 3755.8 3704.2 3772.5 3766.6 2558 3605.1 3664.7 3681.8 3679.7 3726.0 3711.5 3733.2 3786.4 3783.9 3853.0 Mean 3575.9 3599.6 3622.4 3624.4 3646.4 3666.0 3687.4 3705.1 3729.5 3732.2 SD 94.46 91.52 87.64 94.28 93.06 96.24 104.60 92.05 106.30 110.25 N 8 8 8 8 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weights 

Females (grams) 

Animal Phase GES Number Day 17 18 19 20 21 22 23 24 25 26 Group 3 - 10,000 ppm 3551 3564.1 3591.0 3616.9 3640.7 3655.2 3722.6 3729.4 3738.4 3771.9 3773.1 3552 3374.7 3395.5 3399.3 3403.3 3420.8 3406.9 3433.2 3444.4 3458.1 3490.4 3553 3472.1 3473.7 3481.3 3530.1 3512.7 3556.8 3561.1 3586.3 3627.7 3641.2 3554 3774.3 3771.0 3812.2 3829.7 3848.1 3887.9 3896.4 3897.1 3922.2 3943.0 3555 3255.5 3300.1 3327.4 3323.0 3346.3 3394.0 3443.5 3473.6 3467.9 3496.2 3556 3493.8 3505.0 3533.9 3539.3 3570.2 3578.4 3620.1 3647.5 3695.0 3709.0 3557 3661.7 3686.5 3661.8 3699.9 3680.6 3666.8 3678.2 3691.9 3673.5 3724.7 3558 3975.5 3971.6 3998.8 4029.5 4058.3 4069.8 4076.4 4118.6 4106.4 4099.7 Mean 3571.5 3586.8 3604.0 3624.4 3636.5 3660.4 3679.8 3699.7 3715.3 3734.7 SD 228.98 217.20 220.75 229.31 231.59 231.75 220.70 222.93 219.14 208.45 N 8 8 8 8 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weights 

Females (grams) 

Animal Phase GES Number Day 17 18 19 20 21 22 23 24 25 26 Group 4 - 15,000 ppm 4551 np 3300.8x 3306.7x 3334.2x 3357.4x 3322.7x 3388.4x 3380.2x 3372.3x 3386.0x 3426.4x 4552 3490.5 3514.5 3519.2 3523.0 3556.1 3575.8 3573.2 3591.1 3603.4 3639.4 4553 3392.2 3406.0 3432.6 3457.6 3472.2 3518.1 3539.8 3556.3 3583.6 3601.6 4554 3788.1 3820.5 3840.3 3842.1 3870.1 3936.8 3973.6 4017.2 4098.8 4114.0 4555 3258.5 3277.1 3323.8 3334.1 3382.5 3383.8 3417.0 3471.6 3514.6 3563.3 4556 3122.5 3138.8 3163.9 3157.3 3183.3 3189.1 3202.1 3216.8 3238.3 3218.6 4557 4055.8 4064.2 4059.4 4070.1 4092.2 4098.9 4132.9 4136.4 4152.8 4175.5 4558 3100.5 3100.2 3117.6 3117.4 3144.8 3162.2 3149.3 3181.2 3199.0 3193.8 Mean 3458.3 3474.5 3493.8 3500.2 3528.7 3552.1 3569.7 3595.8 3627.2 3643.7 SD 354.00 357.19 347.28 350.17 347.87 356.09 368.88 365.69 376.03 386.30 N 7 7 7 7 7 7 7 7 7 7 np = not pregnant, x = excluded from calculation 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weights 

Females (grams) 

Animal Phase GES Number Day 29 Group 1 - 0 ppm 1551 3609.4 1552 3605.2 1553 3475.0 1554 3980.9 1555 3926.3 1556 3801.8 1557 3659.1 1558 3717.3 Mean 3721.9 SD 171.73 N 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weights 

Females (grams) 

Animal Phase GES Number Day 29 Group 2 - 2,500 ppm 2551 3998.7 2552 3655.3 2553 3746.2 2554 3854.7 2555 3691.2 2556 3771.2 2557 3792.1 2558 3904.5 Mean 3801.7 SD 113.35 N 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weights 

Females (grams) 

Animal Phase GES Number Day 29 Group 3 - 10,000 ppm 3551 3794.2 3552 3571.1 3553 3694.3 3554 4011.1 3555 3583.4 3556 3764.6 3557 3752.7 3558 4138.1 Mean 3788.7 SD 197.07 N 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weights 

Females (grams) 

Animal Phase GES Number Day 29 Group 4 - 15,000 ppm 4551 np 3455.0x 4552 3652.6 4553 3691.9 4554 4187.2 4555 3628.8 4556 3259.1 4557 4225.8 4558 3231.1 Mean 3696.6 SD 394.84 N 7 np = not pregnant, x = excluded from calculation 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weight Changes 

Females (grams) 

Animal Phase GES Number Day 4-6 6-7 7-8 8-9 9-10 10-11 11-12 12-13 13-14 14-15 Group 1 - 0 ppm 1551 54.8 16.2 8.5 21.9 8.9 37.7 30.6 38.4 37.1 52.2 1552 80.3 -18.7 -5.6 33.9 18.7 30.2 1.1 22.6 37.3 47.3 1553 22.6 -9.5 34.0 -2.9 9.5 8.4 38.4 48.2 -17.8 -27.2 1554 100.3 72.6 38.8 -1.7 13.6 8.2 31.9 45.8 10.5 104.5 1555 1.2 139.3 -1.5 25.3 -1.3 32.4 65.8 57.7 82.3 -7.3 1556 64.3 1.3 19.1 -9.5 23.6 23.5 24.8 10.1 0.7 29.8 1557 -43.2 39.0 38.3 63.6 -26.6 49.3 34.3 8.9 78.4 32.3 1558 -33.7 49.4 -15.5 45.7 31.6 -16.2 53.4 -7.4 66.9 23.0 Mean 30.8 36.2 14.5 22.0 9.7 21.7 35.0 28.0 36.9 31.8 SD 52.86 51.90 21.23 25.69 17.76 20.71 19.20 22.94 37.19 39.70 N 8 8 8 8 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weight Changes 

Females (grams) 

Animal Phase GES Number Day 4-6 6-7 7-8 8-9 9-10 10-11 11-12 12-13 13-14 14-15 Group 2 - 2,500 ppm 2551 83.0 -8.9 13.8 29.1 23.5 25.5 55.5 13.3 46.2 18.7 2552 39.1 -18.5 -2.3 6.8 4.8 -9.7 20.0 -85.3 -27.6 -29.0 2553 46.0 -12.1 13.3 36.9 -11.7 49.2 19.8 23.5 76.4 49.5 2554 68.5 -18.6 5.7 -12.3 36.2 -0.4 23.5 7.9 21.3 59.7 2555 31.4 77.6 -12.8 39.0 -50.3 62.6 86.2 9.3 100.9 37.6 2556 42.9 26.5 -2.2 20.0 27.8 -13.5 -1.8 -6.9 51.5 36.4 2557 -0.5 30.6 1.8 -3.7 -6.2 10.1 -0.4 -10.9 -21.4 -58.1 2558 59.0 73.3 -19.0 5.7 -14.9 52.1 8.2 22.1 52.6 19.2 Mean 46.2 18.7 -0.2 15.2 1.1 22.0 26.4 -3.4 37.5 16.8 SD 25.29 39.89 11.57 19.00 28.22 29.80 30.14 35.29 44.72 40.43 N 8 8 8 8 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weight Changes 

Females (grams) 

Animal Phase GES Number Day 4-6 6-7 7-8 8-9 9-10 10-11 11-12 12-13 13-14 14-15 Group 3 - 10,000 ppm 3551 130.1 0.3 4.9 23.6 -82.2 75.8 42.2 45.2 14.8 52.3 3552 126.4 -45.9 -2.6 -27.2 18.4 35.5 -24.1 20.5 33.2 27.4 3553 100.8 8.8 -10.1 36.0 -21.4 12.9 20.5 40.8 18.3 22.1 3554 15.5 36.6 15.2 -17.8 24.0 7.4 65.1 29.1 27.8 41.4 3555 -1.6 12.2 2.5 -6.6 73.7 -11.4 14.1 49.3 46.8 21.7 3556 61.7 93.5 -35.4 34.2 -15.8 44.5 35.6 23.3 64.1 37.2 3557 -28.9 47.1 21.1 -11.0 24.8 21.3 31.8 -4.5 4.1 21.4 3558 -48.4 76.5 -16.8 0.6 16.2 -2.2 46.2 -14.4 10.4 5.0 Mean 44.5 28.6 -2.7 4.0 4.7 23.0 28.9 23.7 27.4 28.6 SD 70.19 44.60 18.10 24.25 45.53 28.22 26.56 22.98 20.11 14.64 N 8 8 8 8 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weight Changes 

Females (grams) 

Animal Phase GES Number Day 4-6 6-7 7-8 8-9 9-10 10-11 11-12 12-13 13-14 14-15 Group 4 - 15,000 ppm 4551 np 20.4x 5.3x 12.6x 18.3x 21.4x -6.8x -17.9x 22.9x 35.6x 16.6x 4552 23.4 30.5 6.2 28.5 -1.3 -8.9 30.2 5.4 61.9 -9.6 4553 105.4 -118.0 108.4 -23.5 -0.9 47.2 40.5 13.3 -45.5 1.8 4554 294.5 58.3 2.6 33.8 -5.9 54.4 89.4 57.4 58.5 66.2 4555 21.2 64.8 29.8 -27.7 -9.1 13.2 88.3 -0.1 50.0 22.3 4556 -16.8 7.0 -31.6 5.6 37.9 -30.2 -20.0 11.1 15.7 41.0 4557 -8.6 33.0 -8.9 28.6 -23.3 30.2 13.0 -4.8 6.6 10.3 4558 32.8 -1.7 -5.6 -5.3 1.3 31.6 1.1 13.2 20.8 -9.6 Mean 64.6 10.6 14.4 5.7 -0.2 19.6 34.6 13.6 24.0 17.5 SD 108.85 61.66 45.35 25.57 18.71 30.45 41.85 20.49 37.67 28.03 N 7 7 7 7 7 7 7 7 7 7 np = not pregnant, x = excluded from calculation 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weight Changes 

Females (grams) 

Animal Phase GES Number Day 17-18 18-19 19-20 20-21 21-22 22-23 23-24 24-25 25-26 26-27 Group 1 - 0 ppm 1551 -28.1 42.4 -22.1 -4.5 25.9 25.1 20.5 1.0 116.1 4.0 1552 9.8 19.0 21.1 30.6 32.4 -10.6 42.9 18.6 5.9 -26.4 1553 9.7 60.4 30.6 29.7 11.1 28.1 26.4 16.0 -77.7 73.9 1554 -10.8 31.8 25.1 16.3 40.9 3.1 30.1 37.1 54.5 29.5 1555 46.7 14.3 -54.4 93.3 -6.0 34.2 69.9 21.2 54.1 26.1 1556 12.7 59.2 9.8 2.1 34.3 -31.5 17.6 -7.0 37.9 -1.5 1557 22.8 40.7 13.5 41.3 -5.7 -16.9 70.8 15.5 15.8 14.2 1558 25.2 27.1 2.6 29.9 -14.4 31.4 33.9 17.4 19.9 8.8 Mean 11.0 36.9 3.3 29.8 14.8 7.9 39.0 15.0 28.3 16.1 SD 22.76 17.10 28.43 29.98 21.43 25.30 20.86 13.24 54.93 29.13 N 8 8 8 8 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weight Changes 

Females (grams) 

Animal Phase GES Number Day 17-18 18-19 19-20 20-21 21-22 22-23 23-24 24-25 25-26 26-27 Group 2 - 2,500 ppm 2551 0.3 23.0 5.8 2.8 34.2 42.1 -4.8 64.9 -35.6 50.9 2552 51.2 31.5 -31.3 -4.1 30.9 28.0 22.0 10.9 18.9 10.6 2553 -16.0 43.5 21.0 -16.9 21.4 50.2 34.6 -17.7 -47.1 40.1 2554 33.3 21.2 19.6 9.9 8.5 22.8 21.5 39.2 33.8 16.0 2555 51.8 -0.1 -3.7 53.6 4.1 31.9 14.5 -5.8 -28.7 2.8 2556 -9.4 31.1 2.4 55.7 9.2 -31.5 52.2 37.9 16.5 36.2 2557 18.5 15.6 3.8 28.9 62.8 6.5 -51.6 68.3 -5.9 0.0 2558 59.6 17.1 -2.1 46.3 -14.5 21.7 53.2 -2.5 69.1 19.6 Mean 23.7 22.9 1.9 22.0 19.6 21.5 17.7 24.4 2.6 22.0 SD 29.70 13.01 16.24 27.98 23.44 25.17 33.99 32.86 39.34 18.47 N 8 8 8 8 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weight Changes 

Females (grams) 

Animal Phase GES Number Day 17-18 18-19 19-20 20-21 21-22 22-23 23-24 24-25 25-26 26-27 Group 3 - 10,000 ppm 3551 26.9 25.9 23.8 14.5 67.4 6.8 9.0 33.5 1.2 -15.3 3552 20.8 3.8 4.0 17.5 -13.9 26.3 11.2 13.7 32.3 27.0 3553 1.6 7.6 48.8 -17.4 44.1 4.3 25.2 41.4 13.5 6.6 3554 -3.3 41.2 17.5 18.4 39.8 8.5 0.7 25.1 20.8 6.0 3555 44.6 27.3 -4.4 23.3 47.7 49.5 30.1 -5.7 28.3 17.1 3556 11.2 28.9 5.4 30.9 8.2 41.7 27.4 47.5 14.0 28.2 3557 24.8 -24.7 38.1 -19.3 -13.8 11.4 13.7 -18.4 51.2 30.6 3558 -3.9 27.2 30.7 28.8 11.5 6.6 42.2 -12.2 -6.7 38.1 Mean 15.3 17.2 20.5 12.1 23.9 19.4 19.9 15.6 19.3 17.3 SD 17.04 20.76 18.34 19.60 30.17 17.66 13.56 25.30 18.26 17.43 N 8 8 8 8 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weight Changes 

Females (grams) 

Animal Phase GES Number Day 17-18 18-19 19-20 20-21 21-22 22-23 23-24 24-25 25-26 26-27 Group 4 - 15,000 ppm 4551 np 5.9x 27.5x 23.2x -34.7x 65.7x -8.2x -7.9x 13.7x 40.4x -7.0x 4552 24.0 4.7 3.8 33.1 19.7 -2.6 17.9 12.3 36.0 2.8 4553 13.8 26.6 25.0 14.6 45.9 21.7 16.5 27.3 18.0 9.0 4554 32.4 19.8 1.8 28.0 66.7 36.8 43.6 81.6 15.2 -23.5 4555 18.6 46.7 10.3 48.4 1.3 33.2 54.6 43.0 48.7 26.2 4556 16.3 25.1 -6.6 26.0 5.8 13.0 14.7 21.5 -19.7 12.1 4557 8.4 -4.8 10.7 22.1 6.7 34.0 3.5 16.4 22.7 26.8 4558 -0.3 17.4 -0.2 27.4 17.4 -12.9 31.9 17.8 -5.2 -9.0 Mean 16.2 19.4 6.4 28.5 23.4 17.6 26.1 31.4 16.5 6.3 SD 10.55 16.51 10.17 10.48 24.18 19.40 18.04 24.30 23.24 18.22 N 7 7 7 7 7 7 7 7 7 7 np = not pregnant, x = excluded from calculation 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weight Changes 

Females (grams) 

Animal Phase GES Number Day 6-29 Group 1 - 0 ppm 1551 494.6 1552 381.0 1553 238.9 1554 682.1 1555 778.3 1556 321.4 1557 543.3 1558 431.9 Mean 483.9 SD 181.00 N 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weight Changes 

Females (grams) 

Animal Phase GES Number Day 6-29 Group 2 - 2,500 ppm 2551 465.5 2552 173.0 2553 473.3 2554 405.8 2555 455.7 2556 443.1 2557 202.5 2558 521.6 Mean 392.6 SD 130.68 N 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weight Changes 

Females (grams) 

Animal Phase GES Number Day 6-29 Group 3 - 10,000 ppm 3551 438.2 3552 269.2 3553 355.9 3554 516.9 3555 555.6 3556 533.1 3557 248.3 3558 301.3 Mean 402.3 SD 124.68 N 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Body Weight Changes 

Females (grams) 

Animal Phase GES Number Day 6-29 Group 4 - 15,000 ppm 4551 302.5x 4552 304.8 4553 306.7 4554 806.0 4555 607.3 4556 191.9 4557 307.3 4558 238.1 Mean 394.6 SD 224.90 N 7 np = not pregnant, x = excluded from calculation 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Food Consumption Values 

Females (grams/animal/day) 

Animal Phase GES Number Day 4-5 5-6 6-7 7-8 8-9 9-10 10-11 11-12 12-13 13-14 Group 1 - 0 ppm 1551 133.9 155.8 148.2 145.2 157.4 124.8 154.1 176.1 119.2 104.2 1552 202.3 175.5 167.4 161.3 161.5 158.2 181.7 168.2 145.7 163.8 1553 188.3 183.7 145.9 146.8 149.4 137.1 153.8 136.4 134.8 83.5 1554 195.1 191.8 192.6 195.1 191.5 193.0 196.7 186.8 197.6 171.0 1555 202.3 193.6 183.6 200.7 194.9 197.3 201.1 195.4 201.1 203.4 1556 186.7 190.1 170.9 184.0 165.1 182.5 186.9 163.7 152.8 139.2 1557 195.9 196.6 194.2 193.2 186.7 189.1 190.3 189.4 190.9 199.5 1558 190.5 193.5 182.4 188.1 179.7 189.5 195.6 184.4 168.9 172.8 Mean 186.9 185.1 173.2 176.8 173.3 171.4 182.5 175.1 163.9 154.7 SD 22.19 13.61 18.59 22.34 17.11 27.84 18.63 18.96 30.64 42.95 N 8 8 8 8 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Food Consumption Values 

Females (grams/animal/day) 

Animal Phase GES Number Day 4-5 5-6 6-7 7-8 8-9 9-10 10-11 11-12 12-13 13-14 Group 2 - 2,500 ppm 2551 187.4 194.4 165.7 172.4 186.2 164.0 175.7 178.9 161.5 150.8 2552 173.0 157.8 143.9 134.9 136.8 127.8 117.4 92.9 118.5 1.8 2553 182.2 161.1 157.3 158.0 162.2 147.3 165.5 146.2 112.0 153.4 2554 190.6 189.4 169.0 161.9 165.3 154.6 152.3 137.8 139.9 141.9 2555 195.4 201.9 193.1 197.8 194.4 182.9 191.8 205.8 187.9 197.1 2556 195.0 197.0 188.5 194.2 171.6 195.1 180.8 164.2 139.3 143.7 2557 174.5 157.5 146.9 157.7 145.3 156.4 151.2 129.9 79.9 44.6 2558 187.4 196.2 187.3 191.1 187.9 192.8 200.4 193.8 191.8 193.8 Mean 185.7 181.9 169.0 171.0 168.7 165.1 166.9 156.2 141.4 128.4 SD 8.53 19.47 19.13 22.02 20.57 23.54 26.52 37.01 38.33 69.27 N 8 8 8 8 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Food Consumption Values 

Females (grams/animal/day) 

Animal Phase GES Number Day 4-5 5-6 6-7 7-8 8-9 9-10 10-11 11-12 12-13 13-14 Group 3 - 10,000 ppm 3551 193.3 188.8 180.9 172.0 191.1 nw 181.6 163.0 160.7 170.8 3552 184.5 161.0 129.1 112.9 96.7 115.5 111.8 82.1 111.9 111.9 3553 154.9 153.9 166.7 181.0 177.5 156.3 161.6 163.8 164.2 151.2 3554 196.4 199.5 195.1 198.5 196.0 195.9 199.5 196.5 189.4 180.8 3555 183.0 188.1 174.1 181.9 154.9 167.6 174.1 169.1 157.3 162.8 3556 197.3 200.2 201.4 201.7 199.0 197.6 202.5 198.9 198.6 195.1 3557 190.7 193.9 184.6 185.9 180.4 178.2 177.2 172.6 155.7 138.0 3558 191.5 196.7 195.9 190.7 189.7 189.1 178.7 166.0 141.2 109.9 Mean 186.5 185.3 178.5 178.1 173.2 171.5 173.4 164.0 159.9 152.6 SD 13.72 17.82 23.13 28.04 33.88 28.91 28.21 36.03 26.90 31.01 N 8 8 8 8 8 7 8 8 8 8 nw = not weighed 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Food Consumption Values 

Females (grams/animal/day) 

Animal Phase GES Number Day 4-5 5-6 6-7 7-8 8-9 9-10 10-11 11-12 12-13 13-14 Group 4 - 15,000 ppm 4551 np 197.2x 195.9x 197.0x 195.9x 201.0x 192.2x 195.3x 185.3x 187.8x 195.2x 4552 192.8 188.1 181.9 180.5 181.8 169.0 156.9 165.5 161.2 145.7 4553 182.1 180.1 116.6 167.9 149.1 133.5 146.3 118.6 125.7 70.4 4554 195.9 188.9 194.4 189.7 192.7 190.3 193.7 195.8 184.8 192.9 4555 200.6 201.7 193.7 198.6 196.2 197.2 189.2 197.3 193.3 206.5 4556 154.7 157.3 138.6 134.5 123.6 136.9 117.5 104.9 86.9 79.6 4557 132.3 148.4 136.9 138.9 139.5 142.8 143.9 127.8 104.5 100.4 4558 177.7 173.6 143.9 138.4 123.7 133.4 137.5 141.8 134.2 133.2 Mean 176.6 176.9 158.0 164.1 158.1 157.6 155.0 150.2 141.5 132.7 SD 24.78 18.72 31.37 26.77 31.65 27.63 27.64 36.87 40.00 53.20 N 7 7 7 7 7 7 7 7 7 7 np = not pregnant, x = excluded from calculation 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Food Consumption Values 

Females (grams/animal/day) 

Animal Phase GES Number Day 16-17 17-18 18-19 19-20 20-21 21-22 22-23 23-24 24-25 25-26 Group 1 - 0 ppm 1551 130.3 200.4 192.2 187.1 nw 192.3 nw nw nw 177.9 1552 174.8 181.6 179.9 184.0 183.0 171.1 148.3 165.2 147.8 140.6 1553 7.8 72.4 160.7 170.8 173.1 165.6 156.4 155.0 105.2 25.8 1554 202.2 197.5 191.8 197.6 195.3 195.9 193.7 180.7 187.6 181.2 1555 194.7 186.9 202.4 195.2 193.9 188.9 201.4 194.3 185.6 173.9 1556 169.5 174.1 183.4 184.1 164.5 175.1 150.7 126.7 120.3 96.9 1557 195.3 194.9 198.8 199.8 195.1 189.5 187.8 187.7 181.2 188.6 1558 185.8 188.0 168.9 187.6 182.2 183.7 182.2 173.5 153.8 119.4 Mean 157.6 174.5 184.8 188.3 183.9 182.8 174.4 169.0 154.5 138.0 SD 64.59 42.13 14.49 9.34 11.92 10.93 22.02 22.90 32.71 55.98 N 8 8 8 8 7 8 7 7 7 8 nw = not weighed 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Food Consumption Values 

Females (grams/animal/day) 

Animal Phase GES Number Day 16-17 17-18 18-19 19-20 20-21 21-22 22-23 23-24 24-25 25-26 Group 2 - 2,500 ppm 2551 150.0 153.4 157.3 160.9 161.7 149.1 175.7 178.2 147.7 109.6 2552 70.1 95.3 89.4 84.0 87.8 107.6 107.2 108.8 83.2 80.5 2553 177.9 164.5 159.9 145.6 155.4 144.8 147.3 154.2 167.2 153.2 2554 177.9 181.8 178.2 160.8 159.7 148.5 162.5 163.8 144.1 139.1 2555 181.2 200.1 191.7 196.7 192.0 193.3 195.3 174.4 158.6 133.4 2556 189.3 192.9 196.8 193.1 188.3 192.0 174.8 171.0 175.5 172.2 2557 109.5 131.1 139.3 144.3 146.2 166.6 165.8 58.0 123.6 103.9 2558 180.3 191.8 194.7 193.5 195.7 191.8 194.5 184.3 191.2 183.7 Mean 154.5 163.9 163.4 159.9 160.9 161.7 165.4 149.1 148.9 134.5 SD 42.85 36.14 36.30 37.41 34.89 30.22 28.43 43.71 33.61 35.23 N 8 8 8 8 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Food Consumption Values 

Females (grams/animal/day) 

Animal Phase GES Number Day 16-17 17-18 18-19 19-20 20-21 21-22 22-23 23-24 24-25 25-26 Group 3 - 10,000 ppm 3551 186.5 198.9 186.3 191.1 190.3 194.2 194.6 172.6 160.3 146.5 3552 149.3 156.6 140.2 132.8 122.3 93.4 97.9 99.4 94.4 108.0 3553 145.6 136.1 146.0 156.0 155.3 146.1 144.8 139.0 139.8 140.2 3554 184.1 199.7 198.6 196.3 194.8 191.6 196.9 188.5 162.9 142.3 3555 203.0 187.3 189.4 199.2 196.9 195.7 191.6 183.5 153.6 148.7 3556 195.2 189.9 194.8 189.5 194.8 190.5 191.5 194.6 192.5 181.1 3557 172.0 164.1 159.5 174.5 155.5 193.6 134.4 162.6 119.0 119.7 3558 181.8 177.6 174.9 188.3 177.9 146.6 134.6 109.9 79.9 55.5 Mean 177.2 176.3 173.7 178.5 173.5 169.0 160.8 156.3 137.8 130.3 SD 20.52 22.42 22.56 23.09 26.81 37.16 37.67 36.33 37.74 37.09 N 8 8 8 8 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Food Consumption Values 

Females (grams/animal/day) 

Animal Phase GES Number Day 16-17 17-18 18-19 19-20 20-21 21-22 22-23 23-24 24-25 25-26 Group 4 - 15,000 ppm 4551 np 184.1x 184.5x 199.8x 187.1x 188.0x 195.1x 194.2x 191.6x 191.4x 199.4x 4552 135.0 153.9 165.0 161.7 187.0 169.2 174.3 159.2 145.2 140.2 4553 91.6 99.3 101.8 117.0 126.3 131.9 126.8 125.2 107.9 105.6 4554 194.8 189.1 189.4 194.4 191.9 191.8 185.7 187.6 194.8 189.9 4555 195.9 189.6 189.7 195.1 196.9 189.6 200.6 197.3 193.4 195.2 4556 119.5 113.6 121.3 125.3 122.5 132.6 121.0 117.9 89.5 84.8 4557 134.8 129.7 137.5 142.8 131.7 135.9 134.3 131.7 115.5 101.5 4558 161.1 153.1 145.7 157.3 160.4 155.1 173.9 153.4 147.2 144.2 Mean 147.5 146.9 150.1 156.2 159.5 158.0 159.5 153.2 141.9 137.3 SD 38.71 35.03 33.35 30.75 32.79 26.11 31.59 30.70 41.00 43.24 N 7 7 7 7 7 7 7 7 7 7 np = not pregnant, x = excluded from calculation 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Food Consumption Values 

Females (grams/animal/day) 

Animal Phase GES Number Day 28-29 6-29 Group 1 - 0 ppm 1551 151.5 159.6 1552 127.1 160.2 1553 114.2 118.3 1554 186.4 190.2 1555 190.8 192.0 1556 129.5 154.5 1557 190.8 192.0 1558 112.8 166.8 Mean 150.4 166.7 SD 34.36 25.10 N 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Food Consumption Values 

Females (grams/animal/day) 

Animal Phase GES Number Day 28-29 6-29 Group 2 - 2,500 ppm 2551 129.4 156.8 2552 90.4 90.9 2553 158.7 154.4 2554 137.0 156.1 2555 146.0 180.3 2556 186.7 178.1 2557 97.8 115.2 2558 154.5 187.2 Mean 137.6 152.4 SD 31.83 33.49 N 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Food Consumption Values 

Females (grams/animal/day) 

Animal Phase GES Number Day 28-29 6-29 Group 3 - 10,000 ppm 3551 125.5 172.5 3552 149.8 119.8 3553 151.9 153.0 3554 162.2 184.9 3555 156.2 175.3 3556 174.0 191.8 3557 114.9 154.2 3558 74.8 145.6 Mean 138.7 162.1 SD 32.13 23.58 N 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Gestation Food Consumption Values 

Females (grams/animal/day) 

Animal Phase GES Number Day 28-29 6-29 Group 4 - 15,000 ppm 4551 np 190.7x 192.4x 4552 142.4 157.1 4553 124.6 115.0 4554 131.7 186.2 4555 190.9 195.7 4556 121.3 110.2 4557 119.4 124.1 4558 146.8 144.8 Mean 139.6 147.6 SD 24.91 33.96 N 7 7 np = not pregnant, x = excluded from calculation 

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Huntingdon Life Sciences 09-4347 Page 113 

 MA-252E-93-23 Final Report

 Raw Data Listing of 

Gross Observations with Modifiers 

Preface Appendix H 

Corresponding dose levels for each group were as follows: 

Group 1 - 0 ppm 

Group 2 - 2,500 ppm 

Group 3 - 10,000 ppm 

Group 4 - 15,000 ppm 

SANITIZED
SANITIZED
SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Females Individual Cesarean Section Data 

Animal Corpora Implant- Resorptions Dead Live Fetuses Sex Rat

Number Lutea ations Early Late Total Fetuses Male Female Total (% Mal

Group 1 - 0 ppm 1551 14 12 2 0 2 0 4 6 10 40 1552 10 10 0 0 0 0 3 7 10 30 1553 9 9 0 0 0 0 4 5 9 44 1554 8 8 0 0 0 0 2 6 8 25 1555 7 7 0 0 0 0 2 5 7 29 1556 10 10 1 0 1 0 4 5 9 44 1557 13 13 0 3 3 0 2 8 10 20 1558 10 10 0 0 0 0 4 6 10 40 Mean 10.1 9.9 0.4 0.4 0.8 0.0 3.1 6.0 9.1 34.1 SD 2.36 1.96 0.74 1.06 1.16 0.00 0.99 1.07 1.13 9.3N 8 8 8 8 8 8 8 8 8 8 Impl. = Implantation 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Females Individual Cesarean Section Data 

Animal Corpora Implant- Resorptions Dead Live Fetuses Sex Rat

Number Lutea ations Early Late Total Fetuses Male Female Total (% Mal

Group 2 - 2,500 ppm 

2551 10 10 0 0 0 0 4 6 10 40 2552 11 11 0 0 0 0 3 8 11 27 2553 11 11 0 0 0 0 4 7 11 36 2554 9 9 0 0 0 0 6 3 9 67 2555 7 7 0 0 0 0 4 3 7 57 2556 11 10 1 0 1 0 3 6 9 33 2557 8 8 0 0 0 0 4 4 8 50 2558 9 9 0 0 0 0 3 6 9 33 Mean 9.5 9.4 0.1 0.0 0.1 0.0 3.9 5.4 9.3 43.0 SD 1.51 1.41 0.35 0.00 0.35 0.00 0.99 1.85 1.39 13.6N 8 8 8 8 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Females Individual Cesarean Section Data 

Animal Corpora Implant- Resorptions Dead Live Fetuses Sex Rat

Number Lutea ations Early Late Total Fetuses Male Female Total (% Mal

Group 3 - 10,000 ppm 

3551 8 7 0 0 0 0 3 4 7 43 3552 10 10 0 0 0 0 4 6 10 40 3553 9 9 0 0 0 0 5 4 9 56 3554 8 8 1 0 1 0 2 5 7 29 3555 11 10 0 0 0 0 3 7 10 30 3556 10 10 0 0 0 0 3 7 10 30 3557 9 9 1 0 1 0 4 4 8 50 3558 12 11 0 0 0 0 5 6 11 45 Mean 9.6 9.3 0.3 0.0 0.3 0.0 3.6 5.4 9.0 40.3 SD 1.41 1.28 0.46 0.00 0.46 0.00 1.06 1.30 1.51 10.0N 8 8 8 8 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

Females Individual Cesarean Section Data 

Animal Corpora Implant- Resorptions Dead Live Fetuses Sex Rat

Number Lutea ations Early Late Total Fetuses Male Female Total (% Mal

Group 4 - 15,000 ppm 

4551np - - - - - - - - - - 4552 8 8 1 0 1 0 5 2 7 71 4553 10 10 0 0 0 0 4 6 10 40 4554 10 10 0 0 0 0 4 6 10 40 4555 10 10 0 0 0 0 5 5 10 50 4556 9 9 0 1 1 0 5 3 8 63 4557 9 9 1 0 1 0 5 3 8 63 4558 7 6 0 0 0 0 1 5 6 17 Mean 9.0 8.9 0.3 0.1 0.4 0.0 4.1 4.3 8.4 49.0 SD 1.15 1.46 0.49 0.38 0.53 0.00 1.46 1.60 1.62 18.6N 7 7 7 7 7 7 7 7 7 7 np = not pregnant 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 Bwt = body weight, Adj bwt = Adjusted body weight Adjusted body weight = Body weight on Day 29 – Gravid Uterine Weight 

 Individual Gravid Uterine Adjusted Body Weights 

Females (grams) 

Animal Bodyweight on Bodyweight on Bwt change Gravid Uterine Adj Bwt Adj bwt 

Number Day 6 Day 29 Days 6-29 Weight Day 29 Days 

Group 1 - 0 ppm 

1551 3114.8 3609.4 494.6 562.2 3047.2 -671552 3224.2 3605.2 381.0 526.0 3079.2 -141553 3236.1 3475.0 238.9 496.5 2978.5 -251554 3298.8 3980.9 682.1 507.9 3473.0 1741555 3148.0 3926.3 778.3 456.2 3470.1 3221556 3480.4 3801.8 321.4 496.7 3305.1 -171557 3115.8 3659.1 543.3 564.4 3094.7 -211558 3285.4 3717.3 431.9 603.3 3114.0 -17

Mean 3237.9 3721.9 483.9 526.7 3195.2 -42S.D. 121.37 171.73 181.00 47.34 194.14 197N 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 Bwt = body weight, Adj bwt = Adjusted body weight Adjusted body weight = Body weight on Day 29 – Gravid Uterine Weight 

 Individual Gravid Uterine Adjusted Body Weights 

Females (grams) 

Animal Bodyweight on Bodyweight on Bwt change Gravid Uterine Adj Bwt Adj bwt 

Number Day 6 Day 29 Days 6-29 Weight Day 29 Days 

Group 2 - 2,500 ppm 

2551 3533.2 3998.7 465.5 596.6 3402.1 -132552 3482.3 3655.3 173.0 579.5 3075.8 -402553 3272.9 3746.2 473.3 610.7 3135.5 -132554 3448.9 3854.7 405.8 578.8 3275.9 -172555 3235.5 3691.2 455.7 478.6 3212.6 -222556 3328.1 3771.2 443.1 554.1 3217.1 -112557 3589.6 3792.1 202.5 439.5 3352.6 -232558 3382.9 3904.5 521.6 547.4 3357.1 -25

Mean 3409.2 3801.7 392.6 548.2 3253.6 -15S.D. 125.84 113.35 130.68 59.59 114.42 123N 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 Bwt = body weight, Adj bwt = Adjusted body weight Adjusted body weight = Body weight on Day 29 – Gravid Uterine Weight 

 Individual Gravid Uterine Adjusted Body Weights 

Females (grams) 

Animal Bodyweight on Bodyweight on Bwt change Gravid Uterine Adj Bwt Adj bwt 

Number Day 6 Day 29 Days 6-29 Weight Day 29 Days 

Group 3 - 10,000 ppm 

3551 3356.0 3794.2 438.2 424 3370.2 14.3552 3301.9 3571.1 269.2 541.1 3030.0 -271.3553 3338.4 3694.3 355.9 510.3 3184.0 -154.3554 3494.2 4011.1 516.9 481.6 3529.5 35.3555 3027.8 3583.4 555.6 553.4 3030.0 2.3556 3231.5 3764.6 533.1 565.3 3199.3 -32.3557 3504.4 3752.7 248.3 422.6 3330.1 -174.3558 3836.8 4138.1 301.3 642.9 3495.2 -341.

Mean 3386.4 3788.7 402.3 517.7 3271.0 -115.S.D. 236.45 197.07 124.68 74.59 192.46 141.N 8 8 8 8 8 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 Bwt = body weight, Adj bwt = Adjusted body weight Adjusted body weight = Body weight on Day 29 – Gravid Uterine Weight 

 Individual Gravid Uterine Adjusted Body Weights 

Females (grams) 

Animal Bodyweight on Bodyweight on Bwt change Gravid Uterine Adj Bwt Adj bwt 

Number Day 6 Day 29 Days 6-29 Weight Day 29 Days 

Group 4 - 15,000 ppm 

4551 np 

4552 3347.8 3652.6 304.8 406.2 3246.4 -104553 3385.2 3691.9 306.7 527.7 3164.2 -224554 3381.2 4187.2 806.0 722.7 3464.5 834555 3021.5 3628.8 607.3 622.3 3006.5 -154556 3067.2 3259.1 191.9 412.8 2846.3 -224557 3918.5 4225.8 307.3 610 3615.8 -304558 2993.0 3231.1 238.1 291.7 2939.4 -53

Mean 3302.1 3696.6 394.6 513.3 3183.3 -11S.D. 322.66 394.84 224.90 150.54 281.30 135N 7 7 7 7 7 7 

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Huntingdon Life Sciences 09-4347 Page 124 

 MA-252E-93-23 Final Report

Litter Weight Data 

Preface Appendix K 

Individual Fetal Weights..................................................................................................125

Individual Placental Weights ...........................................................................................129

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 Individual Fetal Weights 

Females (grams) 

Animal Litter Fetus 

Number Mean 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Group 1 – 0 ppm  1551 39.6 46.8 38.4 53.2 53.6 28.8 35.3 32.0 34.9 33.2 40.3  1552 37.3 34.1 27.9 30.6 34.3 39.2 44.0 35.8 36.1 43.0 48.0  1553 39.4 44.9 44.1 38.3 34.8 34.1 32.4 38.3 40.3 47.9  1554 46.2 52.8 42.5 46.8 46.5 43.6 39.6 48.1 49.7  1555 46.8 45.4 43.3 44.1 45.5 46.8 49.7 52.5  1556 40.0 44.2 41.6 44.9 37.7 38.3 38.2 31.1 38.3 45.6  1557 36.7 51.3 43.0 45.4 21.3 27.8 27.3 34.1 36.0 38.0 43.1  1558 43.4 46.0 43.0 42.2 44.6 39.1 36.6 44.7 47.7 43.4 46.6 Mean 41.2 SD 3.84 N 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Fetal Weights 

Females (grams) 

Animal Litter Fetus 

Number Mean 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Group 2 – 2,500 ppm  2551 41.9 46.9 42.9 45.8 40.9 40.5 43.7 40.6 34.4 41.1 42.5  2552 36.9 44.8 36.7 32.2 29.2 34.9 32.8 35.5 38.5 41.4 38.1 41.6  2553 39.4 47.9 46.4 41.9 39.0 35.8 26.9 32.7 33.6 37.2 46.6 45.4  2554 45.2 52.7 46.5 46.7 46.6 43.2 43.1 40.5 38.6 49.2  2555 46.1 49.1 44.7 46.0 41.9 42.6 48.0 50.5  2556 43.7 48.6 42.1 41.0 34.9 34.3 38.8 47.5 52.0 54.6  2557 40.0 46.2 39.9 37.2 41.4 34.3 36.0 40.3 44.6  2558 43.9 46.9 45.9 41.5 44.7 39.4 39.9 43.9 45.9 46.6 Mean 42.1 SD 3.18 N 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Fetal Weights 

Females (grams) 

Animal Litter Fetus 

Number Mean 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Group 3 – 10,000 ppm  3551 42.6 46.7 45.8 39.7 36.6 39.5 46.2 43.8  3552 39.0 41.4 42.2 42.7 37.5 32.0 37.9 36.5 42.0 37.3 40.6  3553 41.7 41.7 42.5 44.1 38.8 37.8 41.5 40.9 39.9 47.9  3554 49.2 52.4 48.5 42.3 51.2 46.2 49.3 54.7  3555 39.8 39.4 40.5 41.9 39.8 37.4 37.8 38.8 40.8 36.3 45.4  3556 39.8 42.9 41.0 43.6 37.1 37.3 33.2 35.0 39.8 44.2 44.0  3557 37.7 38.8 38.0 42.3 38.7 35.4 27.8 38.1 42.5  3558 43.3 47.2 45.3 40.6 46.2 40.6 39.6 35.6 39.9 44.4 48.5 48.0 Mean 41.6 SD 3.60 N 8 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Fetal Weights 

Females (grams) 

Animal Litter Fetus 

Number Mean 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Group 4 – 15,000 ppm  4552 41.3 44.7 41.8 41.5 36.8 35.5 42.5 46.3  4553 38.6 43.2 40.2 38.0 38.0 40.4 32.8 29.6 37.8 42.1 43.8  4554 48.7 58.0 57.2 47.9 50.0 38.2 39.2 35.3 46.8 54.0 60.1  4555 43.5 51.1 44.7 45.5 44.5 41.0 43.0 40.1 36.3 43.2 45.9  4556 36.5 40.1 33.7 36.8 36.6 31.3 33.6 38.5 41.2  4557 54.2 45.2 55.7 58.6 49.2 61.0 52.1 53.3 58.5  4558 34.8 16.1 43.9 36.1 37.0 34.7 41.0 Mean 42.5 SD 6.93 N 7 

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Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Placental Weights 

Females (grams) 

Animal Litter Fetus 

Number Mean 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 

Group 1 – 0 ppm  1551 3.8 5.2 3.8 6.3 6.0 2.2 3.7 2.2 3.6 2.4 3.0  1552 4.0 3.2 3.3 3.2 3.6 4.1 4.9 4.1 3.7 4.5 5.3  1553 4.8 5.3 5.2 4.9 4.2 4.0 4.4 4.7 5.2 4.9  1554 4.8 5.9 4.4 5.0 4.4 4.1 4.1 4.5 5.7  1555 4.8 4.3 4.6 4.3 4.4 4.9 5.0 6.0  1556 4.3 4.9 4.2 4.5 4.1 4.2 4.2 3.2 4.7 4.8  1557 4.1 6.1 4.8 4.1 2.5 3.1 3.1 3.9 4.0 4.4 4.7  1558 4.6 4.9 4.7 4.4 5.4 4.0 3.9 4.7 5.0 4.5 4.9 Mean 4.4 SD 0.39 N 8 

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Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Placental Weights 

Females (grams) 

Animal Litter Fetus 

Number Mean 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 

Group 2 – 2,500 ppm  2551 5.8 7.0 6.3 6.1 4.7 5.4 5.7 5.5 4.6 6.8 5.6  2552 4.0 4.0 4.5 3.3 3.6 3.8 3.8 3.7 4.7 4.5 4.3 4.2  2553 4.8 5.9 4.9 5.2 5.0 3.7 3.5 4.1 3.8 5.0 5.4 5.8  2554 5.5 6.5 5.7 5.3 5.6 5.4 4.8 6.0 4.9 5.6  2555 5.4 6.7 4.7 5.0 5.3 4.6 6.3 5.5  2556 4.6 4.8 4.4 5.8 3.8 4.2 3.4 3.1 5.0 6.5  2557 4.8 5.4 4.9 4.8 4.1 4.0 4.4 4.7 5.7  2558 5.1 5.0 4.9 4.5 4.8 4.8 5.1 5.4 5.9 5.3 Mean 5.0 SD 0.58 N 8 

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Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Placental Weights 

Females (grams) 

Animal Litter Fetus 

Number Mean 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 

Group 3 – 10,000 ppm  3551 5.1 5.4 4.5 4.8 4.2 5.3 5.5 5.7  3552 4.9 4.8 4.8 5.6 5.4 3.7 4.7 5.2 5.2 5.2 4.6  3553 4.6 4.5 4.8 5.0 4.2 4.2 4.4 4.7 4.6 5.0  3554 5.4 6.0 5.5 4.8 6.1 4.4 5.6 5.5  3555 4.0 4.6 4.2 4.5 3.4 4.0 3.7 3.3 4.1 3.6 5.0  3556 4.7 4.5 4.4 5.7 4.0 4.3 4.4 4.8 4.4 5.0 5.7  3557 4.7 5.4 4.9 5.7 5.2 4.1 3.3 4.6  3558 4.6 4.6 5.4 3.9 5.6 4.6 3.7 3.5 4.6 4.3 5.2 5.7 Mean 4.8 SD 0.40 N 8 

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Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Placental Weights 

Females (grams) 

Animal Litter Fetus 

Number Mean 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 

Group 4 – 15,000 ppm  4552 5.4 6.0 5.8 5.5 4.8 4.7 5.0 6.1  4553 4.6 6.2 4.7 4.1 4.7 4.6 2.4 4.2 4.4 5.2 5.3  4554 6.1 7.7 7.5 5.9 5.5 4.4 4.8 5.1 5.5 7.9 6.5  4555 5.4 6.6 5.3 5.5 5.3 5.4 5.7 4.9 4.9 5.1 5.7  4556 5.2 6.0 5.2 5.4 5.2 4.6 4.6 5.1 5.5  4557 6.0 4.7 6.4 6.8 5.7 6.8 5.1 6.4 5.9  4558 4.3 2.1 5.6 4.7 4.2 4.7 4.4 Mean 5.3 SD 0.67 N 7 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Fetal Observations 

 (External) 

Animal Weight Abnormalities (only fetuses with abnormalities are listed) 

Number Exams Fetus Sex (g) Major in CAPITALS 

Group 1 - 0 ppm  1551 10 1 M 46.8 No abnormality detected 

 2 F 38.4 No abnormality detected  3 M 53.2 No abnormality detected  4 F 53.6 No abnormality detected  5 F 28.8 No abnormality detected  6 F 35.3 No abnormality detected  7 F 32.0 No abnormality detected  8 M 34.9 No abnormality detected  9 M 33.2 No abnormality detected  10 F 40.3 No abnormality detected 

 1552 10 1 F 34.1 No abnormality detected 

 2 M 27.9 No abnormality detected  3 F 30.6 No abnormality detected  4 F 34.3 No abnormality detected  5 M 39.2 No abnormality detected  6 M 44.0 No abnormality detected  7 F 35.8 No abnormality detected  8 F 36.1 No abnormality detected  9 F 43.0 No abnormality detected  10 F 48.0 No abnormality detected 

 1553 9 1 F 44.9 No abnormality detected 

 2 F 44.1 No abnormality detected 

F = Female, M = Male, U = Unknown 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Fetal Observations 

 (External) 

Animal Weight Abnormalities (only fetuses with abnormalities are listed) 

Number Exams Fetus Sex (g) Major in CAPITALS 

Group 1 - 0 ppm  1553 9 3 M 38.3 No abnormality detected 

 4 M 34.8 No abnormality detected  5 M 34.1 No abnormality detected  6 M 32.4 No abnormality detected  7 F 38.3 No abnormality detected  8 F 40.3 No abnormality detected  9 F 47.9 No abnormality detected 

 1554 8 1 F 52.8 No abnormality detected 

 2 F 42.5 No abnormality detected  3 M 46.8 No abnormality detected  4 M 46.5 No abnormality detected  5 F 43.6 No abnormality detected  6 F 39.6 No abnormality detected  7 F 48.1 No abnormality detected  8 F 49.7 No abnormality detected 

 1555 7 1 M 45.4 No abnormality detected 

 2 F 43.3 No abnormality detected  3 F 44.1 No abnormality detected  4 F 45.5 No abnormality detected  5 F 46.8 No abnormality detected  6 F 49.7 No abnormality detected  7 M 52.5 No abnormality detected 

F = Female, M = Male, U = Unknown 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Fetal Observations 

 (External) 

Animal Weight Abnormalities (only fetuses with abnormalities are listed) 

Number Exams Fetus Sex (g) Major in CAPITALS 

Group 1 - 0 ppm  1556 9 1 F 44.2 No abnormality detected 

 2 F 41.6 No abnormality detected  3 M 44.9 No abnormality detected  4 M 37.7 No abnormality detected  5 M 38.3 No abnormality detected  6 M 38.2 No abnormality detected  7 F 31.1 No abnormality detected  8 F 38.3 No abnormality detected  9 F 45.6 No abnormality detected 

 1557 10 0 U 0.0 No abnormality detected  No abnormality detected  No abnormality detected 

 1 M 51.3 No abnormality detected  2 F 43.0 No abnormality detected  3 F 45.4 No abnormality detected  4 F 21.3 No abnormality detected  5 F 27.8 No abnormality detected  6 F 27.3 No abnormality detected  7 F 34.1 No abnormality detected  8 F 36.0 No abnormality detected  9 M 38.0 No abnormality detected  10 F 43.1 No abnormality detected 

F = Female, M = Male, U = Unknown 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Fetal Observations 

 (External) 

Animal Weight Abnormalities (only fetuses with abnormalities are listed) 

Number Exams Fetus Sex (g) Major in CAPITALS 

Group 1 - 0 ppm  1558 10 1 F 46.0 No abnormality detected 

 2 F 43.0 No abnormality detected  3 F 42.2 No abnormality detected  4 M 44.6 No abnormality detected  5 F 39.1 No abnormality detected  6 F 36.6 No abnormality detected  7 F 44.7 No abnormality detected  8 M 47.7 No abnormality detected  9 M 43.4 No abnormality detected  10 M 46.6 No abnormality detected 

F = Female, M = Male, U = Unknown 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Fetal Observations 

 (External) 

Animal Weight Abnormalities (only fetuses with abnormalities are listed) 

Number Exams Fetus Sex (g) Major in CAPITALS 

Group 2 - 2,500 ppm  2551 10 1 F 46.9 No abnormality detected 

 2 F 42.9 No abnormality detected  3 M 45.8 No abnormality detected  4 M 40.9 No abnormality detected  5 M 40.5 No abnormality detected  6 M 43.7 No abnormality detected  7 F 40.6 No abnormality detected  8 F 34.4 No abnormality detected  9 F 41.1 No abnormality detected  10 F 42.5 No abnormality detected 

 2552 11 1 F 44.8 No abnormality detected 

 2 M 36.7 No abnormality detected  3 F 32.2 Skin/subcutis: forepaw(s), left, subcutaneous hemorrhage

 4 F 29.2 No abnormality detected  5 F 34.9 No abnormality detected  6 M 32.8 No abnormality detected  7 F 35.5 Skin/subcutis: hindpaw(s), right, subcutaneous hemorrhage

 8 F 38.5 No abnormality detected  9 F 41.4 No abnormality detected  10 M 38.1 No abnormality detected  11 F 41.6 No abnormality detected  2553 11 1 M 47.9 No abnormality detected F = Female, M = Male, U = Unknown 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Fetal Observations 

 (External) 

Animal Weight Abnormalities (only fetuses with abnormalities are listed) 

Number Exams Fetus Sex (g) Major in CAPITALS 

Group 2 - 2,500 ppm  2553 11 2 F 46.4 No abnormality detected 

 3 F 41.9 No abnormality detected  4 F 39.0 No abnormality detected  5 F 35.8 No abnormality detected  6 F 26.9 No abnormality detected  7 F 32.7 No abnormality detected  8 F 33.6 No abnormality detected  9 M 37.2 No abnormality detected  10 M 46.6 No abnormality detected  11 M 45.4 No abnormality detected 

 2554 9 1 M 52.7 No abnormality detected 

 2 M 46.5 No abnormality detected  3 M 46.7 No abnormality detected  4 M 46.6 No abnormality detected  5 F 43.2 No abnormality detected  6 F 43.1 No abnormality detected  7 M 40.5 No abnormality detected  8 F 38.6 No abnormality detected  9 M 49.2 No abnormality detected 

 2555 7 1 F 49.1 No abnormality detected 

 2 M 44.7 No abnormality detected  3 M 46.0 No abnormality detected 

F = Female, M = Male, U = Unknown 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Fetal Observations 

 (External) 

Animal Weight Abnormalities (only fetuses with abnormalities are listed) 

Number Exams Fetus Sex (g) Major in CAPITALS 

Group 2 - 2,500 ppm  2555 7 4 M 41.9 No abnormality detected 

 5 F 42.6 No abnormality detected  6 F 48.0 No abnormality detected  7 M 50.5 No abnormality detected 

 2556 9 1 F 48.6 No abnormality detected 

 2 F 42.1 No abnormality detected  3 F 41.0 No abnormality detected  4 F 34.9 No abnormality detected  5 M 34.3 No abnormality detected  6 F 38.8 No abnormality detected  7 F 47.5 No abnormality detected  8 M 52.0 No abnormality detected  9 M 54.6 No abnormality detected 

 2557 8 1 F 46.2 No abnormality detected 

 2 F 39.9 No abnormality detected  3 M 37.2 No abnormality detected  4 F 41.4 No abnormality detected  5 F 34.3 No abnormality detected  6 M 36.0 No abnormality detected  7 M 40.3 No abnormality detected  8 M 44.6 No abnormality detected 

F = Female, M = Male, U = Unknown 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Fetal Observations 

 (External) 

Animal Weight Abnormalities (only fetuses with abnormalities are listed) 

Number Exams Fetus Sex (g) Major in CAPITALS 

Group 2 - 2,500 ppm  2558 9 1 F 46.9 No abnormality detected 

 2 F 45.9 No abnormality detected  3 M 41.5 No abnormality detected  4 F 44.7 No abnormality detected  5 F 39.4 No abnormality detected  6 F 39.9 No abnormality detected  7 F 43.9 No abnormality detected  8 M 45.9 No abnormality detected  9 M 46.6 No abnormality detected 

F = Female, M = Male, U = Unknown 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Fetal Observations 

 (External) 

Animal Weight Abnormalities (only fetuses with abnormalities are listed) 

Number Exams Fetus Sex (g) Major in CAPITALS 

Group 3 - 10,000 ppm  3551 7 1 F 46.7 No abnormality detected 

 2 M 45.8 No abnormality detected  3 M 39.7 No abnormality detected  4 F 36.6 No abnormality detected  5 F 39.5 No abnormality detected  6 F 46.2 No abnormality detected  7 M 43.8 No abnormality detected 

 3552 10 1 F 41.4 No abnormality detected 

 2 M 42.2 No abnormality detected  3 M 42.7 No abnormality detected  4 F 37.5 No abnormality detected  5 F 32.0 No abnormality detected  6 F 37.9 No abnormality detected  7 M 36.5 No abnormality detected  8 F 42.0 No abnormality detected  9 M 37.3 No abnormality detected  10 F 40.6 No abnormality detected 

 3553 9 1 M 41.7 No abnormality detected 

 2 F 42.5 No abnormality detected  3 M 44.1 No abnormality detected  4 F 38.8 No abnormality detected  5 M 37.8 No abnormality detected 

F = Female, M = Male, U = Unknown 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Fetal Observations 

 (External) 

Animal Weight Abnormalities (only fetuses with abnormalities are listed) 

Number Exams Fetus Sex (g) Major in CAPITALS 

Group 3 - 10,000 ppm  3553 9 6 F 41.5 No abnormality detected 

 7 F 40.9 No abnormality detected  8 M 39.9 No abnormality detected  9 M 47.9 No abnormality detected 

 3554 7 1 F 52.4 No abnormality detected 

 2 F 48.5 No abnormality detected  3 F 42.3 No abnormality detected  4 M 51.2 No abnormality detected  5 F 46.2 No abnormality detected  6 F 49.3 No abnormality detected  7 M 54.7 No abnormality detected 

 3555 10 1 F 39.4 No abnormality detected 

 2 F 40.5 No abnormality detected  3 F 41.9 No abnormality detected  4 M 39.8 No abnormality detected  5 M 37.4 No abnormality detected  6 F 37.8 No abnormality detected  7 F 38.8 No abnormality detected  8 F 40.8 No abnormality detected  9 M 36.3 No abnormality detected  10 F 45.4 No abnormality detected 

F = Female, M = Male, U = Unknown 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Fetal Observations 

 (External) 

Animal Weight Abnormalities (only fetuses with abnormalities are listed) 

Number Exams Fetus Sex (g) Major in CAPITALS 

Group 3 - 10,000 ppm  3556 10 1 F 42.9 No abnormality detected 

 2 F 41.0 No abnormality detected  3 F 43.6 No abnormality detected  4 F 37.1 No abnormality detected  5 F 37.3 No abnormality detected  6 F 33.2 No abnormality detected  7 M 35.0 No abnormality detected  8 M 39.8 No abnormality detected  9 M 44.2 No abnormality detected  10 F 44.0 No abnormality detected 

 3557 8 1 F 38.8 No abnormality detected 

 2 M 38.0 No abnormality detected  3 M 42.3 No abnormality detected  4 F 38.7 No abnormality detected  5 F 35.4 No abnormality detected  6 F 27.8 No abnormality detected  7 M 38.1 No abnormality detected  8 M 42.5 No abnormality detected 

 3558 11 1 F 47.2 No abnormality detected 

 2 M 45.3 No abnormality detected  3 F 40.6 No abnormality detected  4 M 46.2 No abnormality detected 

F = Female, M = Male, U = Unknown 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Fetal Observations 

 (External) 

Animal Weight Abnormalities (only fetuses with abnormalities are listed) 

Number Exams Fetus Sex (g) Major in CAPITALS 

Group 3 - 10,000 ppm  3558 11 5 M 40.6 No abnormality detected 

 6 F 39.6 No abnormality detected  7 F 35.6 No abnormality detected  8 M 39.9 No abnormality detected  9 F 44.4 No abnormality detected  10 M 48.5 No abnormality detected  11 F 48.0 No abnormality detected 

F = Female, M = Male, U = Unknown 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Fetal Observations 

 (External) 

Animal Weight Abnormalities (only fetuses with abnormalities are listed) 

Number Exams Fetus Sex (g) Major in CAPITALS 

Group 4 - 15,000 ppm  4552 7 1 F 44.7 No abnormality detected 

 2 M 41.8 No abnormality detected  3 M 41.5 No abnormality detected  4 F 36.8 No abnormality detected  5 M 35.5 No abnormality detected  6 M 42.5 No abnormality detected  7 M 46.3 No abnormality detected 

 4553 10 1 M 43.2 No abnormality detected 

 2 F 40.2 No abnormality detected  3 F 38.0 No abnormality detected  4 M 38.0 No abnormality detected  5 M 40.4 No abnormality detected  6 F 32.8 No abnormality detected  7 F 29.6 No abnormality detected  8 F 37.8 No abnormality detected  9 M 42.1 No abnormality detected  10 F 43.8 No abnormality detected 

 4554 10 1 M 58.0 No abnormality detected 

 2 F 57.2 No abnormality detected  3 M 47.9 No abnormality detected  4 F 50.0 No abnormality detected  5 F 38.2 No abnormality detected 

F = Female, M = Male, U = Unknown 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Fetal Observations 

 (External) 

Animal Weight Abnormalities (only fetuses with abnormalities are listed) 

Number Exams Fetus Sex (g) Major in CAPITALS 

Group 4 - 15,000 ppm  4554 10 6 F 39.2 No abnormality detected 

 7 F 35.3 No abnormality detected  8 F 46.8 No abnormality detected  9 M 54.0 No abnormality detected  10 M 60.1 No abnormality detected 

 4555 10 1 M 51.1 No abnormality detected 

 2 F 44.7 No abnormality detected  3 M 45.5 No abnormality detected  4 M 44.5 No abnormality detected  5 F 41.0 No abnormality detected  6 F 43.0 No abnormality detected  7 M 40.1 No abnormality detected  8 M 36.3 No abnormality detected  9 F 43.2 No abnormality detected  10 F 45.9 No abnormality detected 

 4556 8 0 U 0.0 No abnormality detected 

 1 M 40.1 No abnormality detected  2 M 33.7 No abnormality detected  3 F 36.8 No abnormality detected  4 F 36.6 No abnormality detected  5 M 31.3 No abnormality detected  6 M 33.6 No abnormality detected 

F = Female, M = Male, U = Unknown 

SANITIZED
Huntingdon Life Sciences 09-4347 

 MA-252E-93-23 

 Individual Fetal Observations 

 (External) 

Animal Weight Abnormalities (only fetuses with abnormalities are listed) 

Number Exams Fetus Sex (g) Major in CAPITALS 

Group 4 - 15,000 ppm  4556 8 7 F 38.5 No abnormality detected 

 8 M 41.2 No abnormality detected 

 4557 8 1 F 45.2 No abnormality detected 

 2 M 55.7 No abnormality detected  3 M 58.6 No abnormality detected  4 F 49.2 No abnormality detected  5 M 61.0 No abnormality detected  6 M 52.1 No abnormality detected  7 F 53.3 No abnormality detected  8 M 58.5 No abnormality detected 

 4558 6 1 F 16.1 No abnormality detected 

 2 M 43.9 No abnormality detected  3 F 36.1 No abnormality detected  4 F 37.0 No abnormality detected  5 F 34.7 No abnormality detected  6 F 41.0 No abnormality detected 

F = Female, M = Male, U = Unknown 

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Equipment List Appendix M 

Exposure Chamber 

1000 liter glass and stainless steel chamber (Wahmann) 

Compound Generator 

Counter-Current Volatilization Unit, coiled glass rod insert heated by a nichrome wire 

(Crown Glass Co., Inc.) 

Compound Reservoir

Sponsor Container 

Variable Auto Transformer

Variable Autotransformer, Type 3PN 1010 (Staco Energy Products Company) 

Flowmeters 

Liquid flowmeter, size 0-65 mm, Model G603-R3, G604-R3 (Key Instruments) 

Flowmeter, size 0 – 5, 0 – 10, 0 – 20, 0 - 30 or 0 - 40 Lpm (Dwyer®) 

Pressure/Vacuum Gauge(s)

Union Carbide backpressure gauge, P/N SG 3800 

Regulator(s)

U.S. Gauge backpressure gauge, P/N 12672-1 

Norgreen, P/N R07-219-RGKA 

Valves

Metering Valve, Model SS-4L Series (Nupro® Co.) 

Tubing

Size 1/4”, 1/2”, 3/8” plastic (Norton or Baxter) 

Teflon®/Tygon®, size 1/8”, 1/4” 

1/2” stainless steel 

T-Tube, stainless steel 

Filters

Balston® Microfibre Disposable Filter Units (Grade DQ) 

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Equipment List Appendix M 

Vacuum Pumps

Thomas Industries Inc., Model 707CM50 

Balance(s)

Pelouse 4040 

Air Analyzer

MIRAN® 1A Ambient Air Analyzer (Wilks) with a Cole Parmer strip chart recorder, 

Model 201, and a Micronta® LCD Benchtop Digital Multimeter No. 22-195 

Particle Sizer/Analyzer

TSI Aerodynamic Particle Sizer, Model 331001, with a TSI Diluter, Model 330201, and a 

DELL computer, Model 486P25, equipped with an Epson LQ-570+ Dot matrix printer, 

Model P630B 

Environmental Monitoring

Springfield® Apollo or Sunbeam Temperature and Humidity Gauge, calibrated prestudy 

with a Digital Hygrometer and Thermometer, Model 72680251 (Control Company) 

Chamber Air-flow Gauge(s)

Dwyer® magnahelic gauge, calibrated prestudy with Dry Gas Meter, Model 2M (Singer) 

Chamber Static Pressure

Dwyer® Magnehelic® gauge, calibrated prestudy with Dwyer Mark II Manometer, 

Model 25 (Dwyer

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 Instruments Inc.)
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Pre-Study Chamber Distribution Samples Appendix N 

Group 

(target ppm) Date Port 

Concentration 

(ppm) Ratio to H-1 

 

2 (2,500) 18 Aug 09 H-1 2500 

 H-2 2400 0.96 

 H-7 2400 0.96 

 H-1 2800 

 H-8 2800 1.00 

 

3 (10,000) 19 Aug 09 H-1 10000 - 

 H-2 9700 0.97 

 H-7 9900 0.99 

 H-1 9300 - 

 H-8 9200 0.99 

 20 Aug 09 H-1 11000 - 

 H-2 11000 1.00 

 H-7 10000 0.91 

 H-1 11000 - 

 H-8 10000 0.91 

 

4 (15,000) 19 Aug 09 H-1 15000 - 

 H-2 13000 0.87 

 H-7 14000 0.93 

 H-1 15000 

 H-8 15000 1.00 

 20 Aug 09 H-1 16000 - 

 H-2 15000 0.94 

 H-7 15000 0.94 

 H-1 16000 - 

 H-8 15000 0.94 

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Miran Calibration Appendix O 

Methodology for 

Settings: The instrument settings for the unit are summarized below: 

 wavelength, microns 3.24 

 pathlength, dial setting 1.74 

 slit width, mm 1 

 range, absorbance 1 

 response, seconds 1 

 gain high 

 chart speed, cm/min 1 

 chart volts 1 

Calibrations: The Miran® was turned on and allowed to warm up for approximately 

10 minutes. The cell was flushed with room air for approximately one minute. The loop 

was closed, the unit was zeroed and the calibration series was performed as shown below. 

The resultant data were plotted to obtain a calibration curve. Each observer used a 

separate syringe for calibration. 

Injection Calculated Absorbance 

Volume Concentration1

 Operator 1 Operator 2 Average 

(μL) (ppm) (volts) (volts) (volts) 

Liquid 

60 2,506 0.2317 0.2179 0.2248 

240 10,024 0.728 0.753 0.741 

360 15,036 0.943 0.975 0.959 

Vapor 

11,000 1,950 0.1580 0.1596 0.1588 

14,000 2,482 0.2030 0.2062 0.2046 

56,600 10,018 0.679 0.686 0.683 

84,500 14,982 0.907 0.925 0.916 

100,000 17,730 0.981 0.998 0.990 

1

Calculated Conc. (ppm) 

Liquid: Injection volume (μL) x Density (mg/μL) x 1000 (μg/mg) / 5.64L / Molecular weight of 

 test material (μg/μmole) x (22.4 μL/μmole) x (295K/273K) 

Vapor: Volume injected (μL)/5.64 L 

 where: 5.64 L = volume of Miran closed loop 

Molecular weight of test material = 130.5 

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Miran Calibration Appendix O 

Calibration Checks: A three-point calibration check of the Miran® was performed for 

each exposure prior to sampling the chambers. The parameters are shown below: 

Liquid Expected Acceptable 

Injection Calculated Absorbance Absorbance 

Volume Concentration Reading Range 

(μL) (ppm) (volts) (volts) 

 

60 2,506 0.2248 0.1911 – 0.2585 

240 10,024 0.741 0.630 – 0.852 

360 15,036 0.959 0.815 – 1.103 

The absorbance was recorded after each injection. The absorbance was considered 

satisfactory if it was within 15% of the original calibration series. If any of the 

absorbance values fell outside the 15% range, the injection was rechecked as follows. 

The volume for the value that was out of range was reinjected twice. The closer pair of 

the three injections were averaged and the results were compared to the original curve. If 

the average of the pair was within the 15% range, the original was accepted. If the value 

of the average was outside the 15% range, the Study Director decided if a new graph was 

to be prepared. 

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Miran Calibration Appendix O 

Calibration Curve for 

y = -13986x3 + 19899x2 + 11241x

R2

 = 0.9065

0

2000

4000

6000

8000

10000

12000

14000

16000

18000

20000

0.050 0.150 0.250 0.350 0.450 0.550 0.650 0.750 0.850 0.950

Absorbance (Volts)

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Protocol and Protocol Amendments

Appendix P Page 154

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Scientists and Supervising Personnel Appendix Q 

TITLE/DEPARTMENT NAME/DEGREE 

SENIOR VICE PRESIDENT, 

 SAFETY ASSESSMENT 

Sylvie J Gosselin, DVM, PhD, 

 Diplomate ACVP 

 

DIRECTOR, DEVELOPMENTAL AND 

 REPRODUCTIVE TOXICOLOGY 

Robert M Parker, PhD, DABT 

 

DIRECTOR, ANALYTICAL SERVICES Barbara A Litzenberger, BS, MT 

(ASCP) 

 

DIRECTOR, TOXICOLOGY 

 OPERATIONS Ian Vanterpool, FIAT 

 

STUDY DIRECTOR Gary M Hoffman, BA, DABT 

REPORT WRITER Suzanne U Mullen, AALAS LATG 

VETERINARIAN Teresa S Kusznir, VMD 

MANAGER/SUPERVISOR 

 Rodent Toxicology 

 Inhalation Toxicology 

 Pharmacy 

 Necropsy and Fetal Pathology 

Christina Savidge, BS, 

 AALAS RLATG 

Stuart Cracknell, CBiol, MIBiol 

Michael S McCarthy 

Donna G Chuddley, BS, 

 CLA (ASCP) HT 

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