FINAL REPORT

Study Title: A Dosage Range-Finding 10-Day Oral

(Drinking Water) Toxicity Study of Acetaldehyde in Rats

Study Number: WIL-876001

Study Director: Jeffrey H. Charlap, MS

Data Requirements: Not Applicable

Study Initiation Date: 10 May 2012

Study Completion Date: 20 March 2013

Performing Laboratory: WIL Research

1407 George Road

Ashland, OH 44805-8946

Sponsor: Acetaldehyde Working Group

of the Vinyl Acetate Council, Inc.

1250 Connecticut Avenue, NW

Suite 700

Washington, DC 20036

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WIL-876001 Acetaldehyde 

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc. 

This study, designated WIL-876001, was conducted in compliance with the OECD 

Principles of GLP [C(97) 186/Final], 26 November 1997; WIL Research's SOPS; and the 

protocol as approved by the Sponsor. A Certificate of Analysis for the test item was 

provided by the manufacturer (presented in Appendix B); the characterization analyses 

were not conducted according to GLP or GMP standards, but conformed to current ACS 

requirements, loth edition. An expiration date was not provided by the supplier for the lot 

of test item used on this study. However, the test item was guaranteed by the supplier for 

1 year following purchase. Therefore, the absence of an expiration date was not expected 

to have negatively impacted the outcome of the study. 

&md a13 fl -feffrey H. Charlap, MS Date 

SLToxicologist, Developmental and 

Reproductive Toxicology 

Study Director 

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TABLE OF CONTENTS

Page

Compliance Statement...............................................................................2

Table of Contents.......................................................................................3

Index of Tables...........................................................................................5

Index of Appendices...................................................................................6

1. Summary.....................................................................................................7

1.1. Objective ......................................................................................................7

1.2. Study Design................................................................................................7

1.3. Results..........................................................................................................7

1.4. Conclusion ...................................................................................................8

2. Introduction................................................................................................9

2.1. General Study Information ..........................................................................9

2.2. Key Study Dates ..........................................................................................9

2.3. Participating Scientist ..................................................................................9

2.4. WIL Research Key Study Personnel..........................................................10

3. Study Design.............................................................................................11

4. Experimental Procedures - Materials and Methods.............................12

4.1. Test Item and Vehicle ................................................................................12

4.1.1. Test Item ....................................................................................................12

4.1.2. Vehicle .......................................................................................................12

4.1.3. Preparation .................................................................................................12

4.1.4. Sampling and Analyses..............................................................................13

4.2. Test System, Animal Receipt, and Acclimation Period.............................13

4.3. Animal Housing.........................................................................................14

4.4. Diet, Drinking Water, and Maintenance ....................................................14

4.5. Environmental Conditions.........................................................................15

4.6. Assignment of Animals to Treatment Groups...........................................16

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Page

4.7. Organization of Test Groups, Dosage Levels, and Treatment 

Regimen .....................................................................................................16

5. Parameters Evaluated .............................................................................18

5.1. Clinical Observations and Survival ...........................................................18

5.2. Body Weights.............................................................................................18

5.3. Food Consumption.....................................................................................18

5.4. Water and Test Item Consumption ............................................................18

5.5. Anatomic Pathology...................................................................................19

5.5.1. Macroscopic Examinations........................................................................19

5.5.2. Microscopic Examinations.........................................................................19

5.6. Data Acquisition and Analysis...................................................................20

5.6.1. Acquisition and Reporting .........................................................................20

5.6.2. Statistical Analyses....................................................................................20

6. Results.......................................................................................................22

6.1. Clinical Observations and Survival ...........................................................22

6.2. Body Weights.............................................................................................22

6.3. Food Consumption.....................................................................................22

6.4. Water Consumption ...................................................................................23

6.5. Test Item Consumption..............................................................................24

6.6. Anatomic Pathology...................................................................................24

6.6.1. Macroscopic Examinations........................................................................24

6.6.2. Microscopic Examinations.........................................................................25

7. Conclusions...............................................................................................26

8. Report Review and Approval .................................................................27

9. Quality Assurance Statement..................................................................28

10. References.................................................................................................29

11. Data Retention..........................................................................................30

12. Abbreviations...........................................................................................31

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INDEX OF TABLES

Page

S1. Summary of Clinical Findings (Daily Examinations) ...............................................33

S2. Summary of Body Weights [g] ..................................................................................34

S3. Summary of Body Weight Changes [g].....................................................................37

S4. Summary of Food Consumption [g/animal/day] .......................................................40

S5. Summary of Food Consumption [g/kg/day] ..............................................................43

S6. Summary of Water Consumption [g/animal/day]......................................................46

S7. Summary of Water Consumption [g/kg/day].............................................................49

S8. Summary of Calculated Test Item Consumption [mg/kg/day]..................................52

S9. Summary of Macroscopic Findings...........................................................................55

S10. Summary of Microscopic Findings............................................................................56

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INDEX OF APPENDICES

Page

A. Study Protocol and Deviations...................................................................................58

B. Certificate of Analysis (Manufacturer-Provided Data)..............................................78

C. Animal Room Environmental Conditions..................................................................80

D. Pathology Report (WIL Research).............................................................................85

E. Individual Animal Data ..............................................................................................93

A1. Individual Clinical Observations (Daily Examinations)....................................94

A2. Individual Body Weights [g]............................................................................107

A3. Individual Body Weight Changes [g]...............................................................113

A4. Individual Food Consumption [g/animal/day].................................................119

A5. Individual Food Consumption [g/kg/day]........................................................125

A6. Individual Water Consumption [g/animal/day] ...............................................131

A7. Individual Water Consumption [g/kg/day] ......................................................137

A8. Individual Calculated Test Item Consumption [mg/kg/day] ...........................143

A9. Individual Macroscopic and Microscopic Findings.........................................149

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1. SUMMARY

1.1. OBJECTIVE

The objective of this study was to determine dosage levels of acetaldehyde to be 

evaluated in a potential repeated dose toxicity study combined with the 

reproduction/developmental toxicity screening test (OECD 422) in rats.

1.2. STUDY DESIGN

Acetaldehyde was offered on a continuous basis in the drinking water to 5 groups 

(Groups 2-6) of 5 female Crl:CD(SD) rats each during study days 0-10. Concentrations 

were 1, 2, 3, 4, and 5 mg/mL. A concurrent control group (Group 1) consisting of 

5 female rats was offered the vehicle (reverse osmosis-purified water) on a comparable 

regimen. Animals were approximately 9 weeks old at the initiation of test item exposure.

All animals were observed twice daily for mortality and moribundity. Clinical 

observations, body weights, food consumption, and water consumption were recorded 

daily. All animals were euthanized by carbon dioxide inhalation on study day 10. 

Complete necropsies were conducted on all animals. The oral tissues (tongue, gingiva, 

and oropharynx), esophagus, and nonglandular forestomach from all animals in the 

control and high-dose groups were examined microscopically for signs of irritation.

1.3. RESULTS

The average calculated quantities of acetaldehyde consumed during the study were 191, 

316, 394, 448, and 589 mg/kg/day for the 1, 2, 3, 4, and 5 mg/mL groups, respectively.

All animals survived to the scheduled necropsy on study day 10. There were no 

remarkable clinical findings or effects on mean body weights, body weight gains, or food 

consumption, and no macroscopic or microscopic findings that could be attributed to test 

item exposure.

Mean water consumption in the control group and at low dosage levels of acetaldehyde 

(1 and 2 mg/mL) was generally higher than expected, whereas, mean water consumption 

at higher dosage levels of acetaldehyde (3, 4, and 5 mg/mL) was generally within the 

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expected range of water consumption. Furthermore, there were no effects (e.g., increased 

or decreased urination, effects on body weight gain, etc.) that would typically correspond 

with increases or decreases in water consumption. This pattern of water consumption 

could be attributed to partial water spillage at the lower dosage levels of acetaldehyde and 

in the control group. Therefore, due to the partial water spillage there were no effects of 

acetaldehyde on water consumption under the conditions of this dose range-finding study.

1.4. CONCLUSION

Oral administration via the drinking water of acetaldehyde at dosage levels of 1, 2, 3, 4, 

and 5 mg/mL to female Crl:CD(SD) rats was well tolerated. There was no toxicity noted 

at any dosage level. Therefore, a high dosage level of 5 mg/mL was selected for a 

repeated dose toxicity study with the reproduction/developmental toxicity screening test 

(OECD 422) in Crl:CD(SD) rats. Dosage levels of 1 and 3 mg/mL were selected to 

evaluate a potential dose-response relationship.

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2. INTRODUCTION

2.1. GENERAL STUDY INFORMATION

This report presents the data from “A Dosage Range-Finding 10-Day Oral (Drinking 

Water) Toxicity Study of Acetaldehyde in Rats.” Due to software spacing constraints, the 

study title is presented as “R-F 10-Day Oral (Water) Toxicity Study of Acetaldehyde in 

Rats” on the report tables.

The study protocol and deviations from the protocol are presented in Appendix A. A list 

of abbreviations potentially used in this report is presented in Section 12.

The computer protocol reference number and type of data collected were identified as 

follows:

Computer Protocol Type of Data Collected

WIL-876001 ...........................................Main study data 

2.2. KEY STUDY DATES

Date(s) 1 Event(s)

15 May 2012...........................................Experimental starting date (animal receipt)

29 May - 08 June 2012...........................Test item administration

03 July 2012............................................Experimental completion date

(last microscopic examination)

2.3. PARTICIPATING SCIENTIST

Histopathology Catherine A. Picut, VMD, DACVP, DABT

WIL Research

 

1 Date ranges represent the first and last dates of evaluation.

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2.4. WIL RESEARCH KEY STUDY PERSONNEL

Susan C. Haley, BS Operations Manager, Pathology

Heather L. Johnson, BS, 

RQAP-GLP

Assistant Director of Quality and 

Regulatory Compliance

Sally A. Keets, AS Senior Operations Manager, Vivarium

Carol A. Kopp, BS, LAT Manager, Developmental Toxicology

Laboratory

Gwendalyn M. Maginnis, DVM Clinical Veterinarian

John S. Moore, BS, RLATG Operations Manager, Developmental, 

Reproductive, and Neurotoxicology

George A. Parker, DVM, PhD, 

DACVP, DABT

Vice President, Global Pathology

Theresa M. Rafeld, CPhT Group Manager, Formulations Laboratory

Michael A. Safron, AS, HT 

(ASCP)CM

Manager, Histology

Bennett J. Varsho, MPH, DABT Director, Nonclinical Safety Operations

Robert A. Wally, BS Operations Manager, Reporting &

Technical Support Services

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3. STUDY DESIGN

Acclimation period

Assignment of animals to treatment groups 

based on body weight

Clinical observations, body weights,

food consumption, and water consumption 

recorded daily

5 rats/group (1-6) offered the vehicle or the 

test item via the drinking water daily from 

study day 0 through study day 10

All rats euthanized on study day 10; gross 

necropsies performed; histopathological 

evaluation of selected tissues

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4. EXPERIMENTAL PROCEDURES - MATERIALS AND METHODS

4.1. TEST ITEM AND VEHICLE

4.1.1. TEST ITEM

The test item, acetaldehyde, was received from Sigma-Aldrich, Milwaukee, WI, on 

behalf of the Sponsor, on 04 October 2011, as follows:

Identification Physical Description

Acetaldehyde

Lot no. SHBB4508V

Exp. date: NAa

CAS no. 75-07-0

[WIL ID no. 110159]

Clear, colorless liquid

a

This product does not have an expiration date but was guaranteed by 

Sigma-Aldrich for 1 year following purchase.

Documentation regarding the purity of the test item is on file with the manufacturer and 

WIL Research. A Certificate of Analysis for the test item was provided by the 

manufacturer and is presented in Appendix B. The purity of the test item was 99.77%. 

The test item was stored refrigerated, under nitrogen, and was considered stable under 

these conditions. A reserve sample of the test item was collected and stored in the WIL 

Research Archives.

4.1.2. VEHICLE

The vehicle used in preparation of the test item formulations and for administration to the 

control group was reverse osmosis-purified water (prepared on-site).

4.1.3. PREPARATION

The vehicle was dispensed approximately every 2 days for administration to the control 

group (Group 1) and for preparation of the test item formulations, and transferred to 

water bottles for administration to the control group. The vehicle was mixed throughout 

preparation.

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Dosing formulations were prepared at the test item concentrations indicated in the 

following table:

Group 

Number Treatment

Test Item

Concentrationa

(mg/mL) pHb

1 Vehicle Control 0 8.89

2 Acetaldehyde 1 8.76

3 Acetaldehyde 2 8.50

4 Acetaldehyde 3 8.52

5 Acetaldehyde 4 8.61

6 Acetaldehyde 5 8.08 

a

= The dosing formulations were not adjusted for purity.

b

= pH measurement of the first dosing formulations.

The test item formulations were prepared every 2 days as single formulations for each 

dosage level and transferred to water bottles for dose administration. Any formulation 

that remained after dispensation into water bottles was stored at room temperature until 

needed, for no longer than 2 days. The test item formulations were stirred continuously 

throughout preparation.

The first dosing formulations were visually inspected by the Study Director and were 

found to be visibly homogeneous and acceptable for administration.

4.1.4. SAMPLING AND ANALYSES

In a previous analytical method validation study (Freer, 2013, WIL-876002), the test item 

in reverse osmosis-purified water at concentrations of 1 to 5 mg/mL was determined to be 

stable at room temperature for 48 hours in glass containers and 72 hours in plastic 

drinking water bottles. Furthermore, the formulations were within the acceptable range 

for concentration (Freer, 2013, WIL-876002). Therefore, no stability or concentration 

analyses were conducted as part of the current dose range-finding study.

4.2. TEST SYSTEM, ANIMAL RECEIPT, AND ACCLIMATION PERIOD

Crl:CD(SD) rats were used as the test system on this study. This species and strain is 

recognized as appropriate for reproduction studies. In addition, WIL Research has 

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reproductive historical control data in the Crl:CD(SD) rat. The number of animals 

selected for this study allowed for meaningful interpretation of the data to adequately 

assess toxicological endpoints and to determine dosage levels for subsequent studies. In 

addition, given the possibility of unexpected deaths or treatment-related morbundity 

and/or mortality, this was an appropriate number of animals to evaluate 2-3 animals per 

group at termination on this dose tolerability/dose range-finding study.

Crl:CD(SD) rats (35 females) were received in good health from Charles River 

Laboratories, Inc., Raleigh, NC, on 15 May 2012. The animals were approximately

7 weeks old upon receipt. Each animal was examined by a qualified biologist on the day 

of receipt. The day following receipt, all animals were weighed and clinical observations 

were recorded. Each rat was uniquely identified by a Monel® metal ear tag displaying the 

animal number. The animals were housed for an acclimation period of 14 days prior to

the first day of treatment. During the acclimation period, the animals were observed 

twice daily for mortality and general changes in appearance and behavior.

4.3. ANIMAL HOUSING

Upon arrival, all animals were housed individually in clean, solid-bottom cages 

containing nesting material, ground corncob bedding (Bed-O'Cobs®; The Andersons, Cob

Products Division, Maumee, OH). The nesting material is periodically analyzed by the 

manufacturer for contaminants. Analyses of the nesting material are provided by the 

manufacturer and are maintained at WIL Research. No contaminants were present in the 

bedding at concentrations sufficient to interfere with the outcome of the study. Animals

were maintained in accordance with the Guide for the Care and Use of Laboratory 

Animals (National Research Council, 1996). The animal facilities at WIL Research are 

accredited by AAALAC International. Enrichment devices (Nylabones®) were provided 

to all animals as appropriate throughout the study.

4.4. DIET, DRINKING WATER, AND MAINTENANCE

The basal diet used in this study, PMI Nutrition International, LLC Certified Rodent 

LabDiet®5002, was a certified feed with appropriate analyses performed by the 

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manufacturer and provided to WIL Research. Feed lots used during the study were 

documented in the study records. Feeders were changed and sanitized once per week. 

Reverse osmosis-treated (on-site) tap water (with acetaldehyde added during the 

treatment period for the animals assigned to Groups 2-6) was provided from standard 

plastic water bottles (approximately 400 mL) with a silicon ring around the lip and 

slip-on cap with a nozzle containing ball bearings. The plastic bottles used to administer 

the animals’ drinking water were checked daily for spillage (occurrence of spillage was 

documented) and supplemented when necessary. Filters servicing the automatic watering 

system used to prepare the water bottles were changed regularly according to WIL 

Research’s SOPs. In addition, municipal water supplying the facility was sampled for 

contaminants according to WIL Research’s SOPs. The results of the diet and water 

analyses are maintained at WIL Research. No contaminants were present in animal feed 

or water at concentrations sufficient to interfere with the objectives of this study. 

Drinking water and the basal diet were provided ad libitum throughout the acclimation 

period and during the study.

4.5. ENVIRONMENTAL CONDITIONS

All rats were housed throughout the acclimation period and during the study in an 

environmentally controlled room. The room temperature and humidity controls were set 

to maintain environmental conditions of 71°F ± 5°F (22°C ± 3°C) and 50% ± 20%,

respectively. Room temperature and relative humidity data were monitored continuously

and were scheduled for automatic collection on an hourly basis. These data are 

summarized in Appendix C. Actual mean daily temperature ranged from 69.8°F to 

70.6°F (21.0°C to 21.4°C) and mean daily relative humidity ranged from 39.7% to 51.2% 

during the study. Fluorescent lighting provided illumination for a 12-hour light 

(0600 hours to 1800 hours)/12-hour dark photoperiod. The light status (on or off) was

recorded once every 15 minutes. Air handling units were set to provide a minimum of 

10 fresh air changes per hour.

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4.6. ASSIGNMENT OF ANIMALS TO TREATMENT GROUPS

At the conclusion of the acclimation period, all available females were weighed and 

examined in detail for physical abnormalities. At the discretion of the Study Director, 

each animal judged to be in good health and meeting acceptable body weight 

requirements was selected for use in the computerized randomization procedure based on 

body weight stratification in a block design. At that time, the individual body weights 

and corresponding animal identification numbers were entered into WTDMSTM. A

printout containing the animal numbers, corresponding body weights, and individual 

group assignments was generated. The animals then were arranged into groups according 

to the printout. Animals not assigned to study were transferred to the WIL Research

stock colony.

The experimental design consisted of 1 control and 5 test item-treated groups composed 

of 5 rats each. The selected animals were approximately 9 weeks old at the initiation of 

dose administration (study day 0); individual body weights ranged from 180 g to 235 g.

4.7. ORGANIZATION OF TEST GROUPS, DOSAGE LEVELS, AND TREATMENT 

REGIMEN

The vehicle and test drinking water were offered ad libitum during study days 0-10. The 

test item was offered continuously at a constant concentration (mg/mL) in the drinking 

water.

The following table presents the study group assignment:

Group

Number Treatment

Test Item 

Concentration

(mg/mL)

Number of 

Females

1 Vehicle Control 0 5

2 Acetaldehyde 1 5

3 Acetaldehyde 2 5

4 Acetaldehyde 3 5

5 Acetaldehyde 4 5

6 Acetaldehyde 5 5

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Dosage levels were provided by the Sponsor Representative after consultation with the 

Study Director. This pilot study was designed to determine dosage levels for a future 

OECD 422 study. The range of dosage levels in this study was expected to cause no 

observable toxicity (1 mg/mL) and the possibility of some toxicity (5 mg/mL).

The selected route of administration for this study was oral (drinking water) because this 

is a potential route of human exposure.

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5. PARAMETERS EVALUATED

5.1. CLINICAL OBSERVATIONS AND SURVIVAL

All rats were observed twice daily, once in the morning and once in the afternoon, for 

moribundity and mortality. Individual clinical observations were recorded daily. The 

absence or presence of findings was recorded for all animals.

5.2. BODY WEIGHTS

Individual body weights were recorded daily, beginning on study day 0 and continuing 

until the scheduled necropsy. Mean body weights and mean body weight changes were 

calculated for the corresponding intervals. In addition, mean body weight changes were 

calculated for the overall exposure period (study days 0-10).

5.3. FOOD CONSUMPTION

Individual food consumption was recorded daily, beginning on study day 0 and 

continuing until the scheduled necropsy. Food intake was calculated as g/animal/day and 

g/kg/day for the corresponding body weight change intervals. Calculation of the 

comprehensive intervals excludes all erroneous values such as total food spillage.

When food consumption could not be determined for an animal during a given interval 

(due to a weighing error, food spillage, etc.), group mean values were calculated for that 

interval using the available data. The time periods when food consumption values were 

unavailable for a given animal were designated as “NA” on the individual report tables.

5.4. WATER AND TEST ITEM CONSUMPTION

Individual water consumption was recorded daily, beginning on study day 0 and 

continuing until the scheduled necropsy. Water intake was calculated as g/animal/day

and g/kg/day for the corresponding body weight change intervals. Calculation of the 

comprehensive intervals excludes all erroneous values, including total water spillage.

When water consumption could not be measured for an animal during a given interval 

(due to total water spillage), group mean values were calculated for that interval using the 

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available data. The time periods when water consumption values were unavailable for a 

given animal were designated as “NA” on the individual report tables.

The mean amounts of the test item consumed (mg/kg/day) per group were calculated 

using the mean water consumed (g/kg/day) and the appropriate target concentration of the 

test item in the water (mg/mL).

5.5. ANATOMIC PATHOLOGY

5.5.1. MACROSCOPIC EXAMINATIONS

All rats were euthanized by carbon dioxide inhalation on study day 10 and subjected to a 

gross necropsy. Necropsy included examination of the external surface, all orifices, the 

external surface of the brain, and the cranial, thoracic, abdominal, and pelvic cavities, 

including viscera. The oral tissues (tongue, gingiva, and oropharynx), esophagus, and 

nonglandular forestomach were collected from all animals and placed in 

10% neutral-buffered formalin. The gingival tissues were collected using the Morgan 

method of nasal cavity trimming (Morgan, 1991).

5.5.2. MICROSCOPIC EXAMINATIONS

After fixation, protocol-specified tissues were trimmed according to WIL Research’s 

SOPs and the protocol. Trimmed tissues were processed into paraffin blocks, sectioned 

at 4 to 8 microns, mounted on glass microscope slides, and stained with hematoxylin and 

eosin.

Microscopic examination was performed on all tissues listed in Section 5.5.1. from all 

animals in the control and 5 mg/mL groups at the scheduled necropsy. The pathology 

report is presented in Appendix D.

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5.6. DATA ACQUISITION AND ANALYSIS

5.6.1. ACQUISITION AND REPORTING

Program/System Description

Archive Management System (AMS) In-house developed application for storage, 

maintenance, and retrieval of information for 

archived materials (e.g., lab books, study data, wet 

tissues, slides, etc.) 

InSight®Publisher Electronic publishing system (output is Adobe 

Acrobat, PDF)

Master Schedule Maintains the master schedule for the company. 

Metasys DDC Electronic 

Environmental Control System

Controls and monitors animal room 

environmental conditions.

Microsoft® Office 2007 Used in conjunction with the publishing software 

to generate study reports.

Provantis DispenseTM Comprehensive system (Instem LSS Limited) to 

manage test materials, including receipt, 

formulation instructions, and accountability.

WIL Metasys In-house developed system used to record and 

report animal room environmental conditions. 

WIL Toxicology Data Management 

SystemTM (WTDMSTM) 

In-house developed system used for collection and 

reporting of in-life and postmortem data.

Note: Version numbers of WTDMSTM programs used for the study are presented on the 

report data tables (reporting programs); version numbers and release dates are otherwise 

maintained in the study records and/or facility records.

5.6.2. STATISTICAL ANALYSES

All statistical tests were performed using WTDMSTM unless otherwise noted. Analyses 

were conducted using two-tailed tests (except as noted otherwise) for minimum 

significance levels of 1% and 5%, comparing each test item-treated group to the control 

group.

Each mean was presented with the standard deviation (S.D.), standard error (S.E.), and 

the number of animals (N) used to calculate the mean. Due to the use of significant 

figures and the different rounding conventions inherent in the types of software used, the 

means and standard deviations on the summary and individual tables may differ slightly. 

Therefore, the use of reported individual values to calculate subsequent parameters or 

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means will, in some instances, yield minor variations from those listed in the report data 

tables.

Mean body weights, body weight changes, food consumption, and water consumption

were subjected to a parametric one-way ANOVA (Snedecor and Cochran, 1980) to 

determine intergroup differences. If the ANOVA revealed significant (p<0.05) 

intergroup variance, Dunnett's test (Dunnett, 1964) was used to compare the test 

item-treated groups to the control group.

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6. RESULTS 

6.1. CLINICAL OBSERVATIONS AND SURVIVAL

Summary Data: Table S1

Individual Data: Table A1

All females survived to the scheduled euthanasia on study day 10. No remarkable 

clinical findings were noted at the daily examinations at any dosage level. Findings 

noted in the test item-exposed groups, including hair loss on the forelimbs, occurred 

infrequently, at a similar frequency in the control group, and in a manner that was not 

dose-related.

6.2. BODY WEIGHTS

Summary Data: Table S2, Table S3

Individual Data: Table A2, Table A3

No test item-related effects on mean body weights or body weight gains were noted in the 

1, 2, 3, 4, or 5 mg/mL groups. The values in the test item-exposed groups were similar to 

and not statistically significantly different from the control group.

6.3. FOOD CONSUMPTION

Summary Data: Table S4, Table S5

Individual Data: Table A4, Table A5

Mean food consumption, evaluated as g/animal/day and g/kg/day, in the 1, 2, 3, 4, and

5 mg/mL groups was similar to the control group throughout the exposure period. The 

values in the test item-exposed groups were similar to and not statistically significantly 

different from the control group.

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6.4. WATER CONSUMPTION 

Summary Data: Table S6, Table S7

Individual Data: Table A6, Table A7

Mean water consumption, evaluated as g/animal/day and g/kg/day, appeared to decrease 

with increasing dosage beginning at a dosage level of 2 mg/mL. During the overall 

interval (study days 0-10), when a dose-responsive pattern was most apparent, mean 

water consumption in the 2, 3, 4, and 5 mg/mL groups was 34, 30, 25, and 

26 g/animal/day, respectively, compared with 40 g/animal/day in the control group. The 

differences from the control group were significant (p<0.01) for the 3, 4, and 5 mg/mL 

groups. However, 3 of the 5 animals in the control group had water consumption values 

of 38-47 g/day during this period, which was higher than the range of expected water 

consumption for female rats of this strain and age (approximately 25-35 g/day based on 

previous water consumption studies conducted at WIL Research). Similarly, 4 of the 

5 animals in the 1 mg/mL group, in which mean water consumption was similar to the 

control group for the overall interval, had water consumption values of 38-51 g/day

during study days 0-10, which was also higher than expected. In contrast, the range of 

individual water consumption values in the 3, 4, and 5 mg/mL groups during study

days 0-10 was 21-32 g/day, which was within the expected range. At 2 mg/mL, only 

1 animal had water consumption that was slightly high (37 g/day) during study days 0-10.

When evaluated during the daily intervals, mean water consumption for the control group 

was generally higher than expected, with mean values up to 65 g/animal/day. Similarly, 

mean water consumption values at the lower dosage levels of acetaldehyde (1 and

2 mg/mL) were higher than expected (up to 79 g/animal/day). In contrast, mean water

consumption values at the higher dosage levels of acetaldehyde (3, 4, and 5 mg/mL) were 

within the expected range of water consumption and were generally characterized by low 

variability. This pattern of apparent decreasing water consumption with increasing 

dosage generally did not occur in an obvious dose-dependent manner. Furthermore, there 

were no corresponding effects in other endpoints to corroborate an increase or a decrease 

 Page 23 of 178
WIL-876001 Acetaldehyde

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc.

in water consumption at any of the dosage levels, e.g., an increase in urination at the 

lower dosage levels for which apparent increases in water consumption were noted, or 

body weight loss/decreased body weight gain at higher dosage levels for which apparent 

decreases in water consumption were noted. Based on the aforementioned findings and 

the absence of effects in all other endpoints, the high water consumption noted in the 

control group and low dosage levels of acetaldehyde could potentially be attributed to 

partial water spillage. Therefore, due to the partial water spillage there were no effects of 

acetaldehyde on water consumption under the conditions of this dose range-finding study.

6.5. TEST ITEM CONSUMPTION

Summary Data: Table S8

Individual Data: Table A8

The average quantities of acetaldehyde consumed during the study are presented below.

Theoretical 

Exposure Level (mg/mL)

Mean Calculated

Test Item Consumption (mg/kg/day)

1 191

2 316

3 394

4 448

5 589

6.6. ANATOMIC PATHOLOGY

6.6.1. MACROSCOPIC EXAMINATIONS

Summary Data: Table S9

Individual Data: Table A9

Pathology Report: Appendix D

Review of the gross necropsy observations revealed no observations that were considered 

to be associated with administration of the test item.

 Page 24 of 178
WIL-876001 Acetaldehyde

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc.

6.6.2. MICROSCOPIC EXAMINATIONS

Summary Data: Table S10

Individual Data: Table A9

Pathology Report: Appendix D

There were no test item-related microscopic findings noted in the alimentary tract tissues 

examined.

 Page 25 of 178
WIL-876001 Acetaldehyde

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc.

7. CONCLUSIONS

Oral administration via the drinking water of acetaldehyde at dosage levels of 1, 2, 3, 4, 

and 5 mg/mL to female Crl:CD(SD) rats was well tolerated. There was no toxicity noted 

at any dosage level. Therefore, a high dosage level of 5 mg/mL was selected for a 

repeated dose toxicity study with the reproduction/developmental toxicity screening test 

(OECD 422) in Crl:CD(SD) rats. Dosage levels of 1 and 3 mg/mL were selected to 

evaluate a potential dose-response relationship.

 Page 26 of 178
WIL-87600 1 Acetaldehyde 

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc. 

8. REPORT REVIEW AND APPROVAL 

Report Approved By: 

,dta&~oxicolo~ist, Developmental and 

Reproductive Toxicology 

Study Director 

Date 

Report Prepared By: 

G3.k mmsw13 

Kristin M. Risner, MS Date 

Senior Study Analyst 

Report Reviewed BY: 

CAA~YV\ b 7aTfhr 7ct 3 

/ jaime L. Mesnard, MS Date 

/ Group Supervisor, 

Reporting & Technical Support Services 

$c,hiw.&3. 

Date 

E~UM a0t5 - 

Donald G. Stump, PhD, DABT Date 

Vice President, Nonclinical Safety Science, U.S. 

o,* 

Date =I3 

Reporting & Technical Support Services 

Page 27 of 178 
WIL-87600 1 

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc. 

Date(s) of 

Inspection(s) Phase Insuected 

10-May-2012 Protocol 

Acetaldehyde 

Date(s) Findings 

Reported to Study 

Director and 

Management 

29-May-201 2 Protocol Amendment 1 29-May-20 12 

07-Jun-2012 Body Weights 07-Jun-20 12 

17-Jul-2012 Study Records (1-1) 17-Jul-2012 

17-Jul-2012 Study Records (N-1) 17-Jul-2012 

1 7-Jul-201 2 Study Records (Rx-I) 1 7-Jul-20 12 

17-JuI-2012, 

1 8-Jul-2012 Study Records (H-I) 

1 7-Jul-201 2, 

1 8-Jul-2012 Study Records (Pathology Data) 

25-Jul-2012 Pathology Report 25-Jul-201 2 

3 1 -Ju~-201 2, 

03-Aug-20 12 Draft Report (Without Pathology Report Appendix) 03-Aug-2012 

10-Aug-20 12 Audited Report (Including Pathology Report Appendix) 10-Aug-2012 

12-Mar-20 13 Final Pathology Report 12-Mar-201 3 

19-Mar-20 13 Final Report 19-Mar-20 1 3 

This study was inspected in accordance with the applicable GLP Regulations, the SOPs 

of WIL Research, and the protocol and protocol amendment, with the following 

exception. The data located in Appendix B (Certificate of Analysis) were the 

responsibility of the manufacturer. A yearly internal facility inspection is conducted by 

the WIL Research Quality Assurance Department. 

This report accurately reflects the data generated during the study. The methods and 

procedures used in the study were those specified in the protocol, its amendment, and the 

SOPs of WIL Resear&. , 

K*%. 

R. eld din ~entze!, BS, RQAP-GLP 

2 

Date 

Quality Assurance Representative 

Page 28 of 178 
WIL-876001 Acetaldehyde

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc.

10. REFERENCES

Dunnett, C.W. New tables for multiple comparisons with a control. Biometrics

1964, 20, 482-491.

Freer, S.D. An Analytical Method Validation, Compatibility, and Stability Study of 

Acetaldehyde in Deionized Water (Study No. WIL-876002). WIL Research, 

Ashland, OH, 2013.

Morgan, K.T. Approaches to the Identification and Recording of Nasal Lesions in 

Toxicology Studies. Toxicologic Pathology, 1991, Vol. 19, Number 4 (Part 1), 

pp 337-351.

National Research Council. Guide for the Care and Use of Laboratory Animals, 

Institute of Laboratory Animal Resources, Commission on Life Sciences; National 

Academy Press: Washington, DC, 1996.

Snedecor, G.W.; Cochran, W.G. One-Way Classifications; Analysis of Variance. 

In Statistical Methods, 7th ed.; The Iowa State University Press: Ames, IA, 1980; 

pp 215-237.

 Page 29 of 178
WIL-876001 Acetaldehyde

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc.

11. DATA RETENTION

The Sponsor has title to all documentation records, raw data, specimens, or other work 

product generated during the performance of the study. All work product generated by

WIL Research, including raw paper data and specimens, are retained in the WIL 

Research Archives as specified in the study protocol.

The reserve sample of the test item, pertinent electronic storage media, and the original 

final report are retained in the WIL Research Archives in compliance with regulatory

requirements.

 Page 30 of 178
WIL-876001 Acetaldehyde

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc.

12. ABBREVIATIONS

The following abbreviations may apply to this report:

μ - micro

AAALAC - Association for Assessment and Accreditation of Laboratory

Animal Care

ANOVA - analysis of variance

cm - centimeter

dB - decibels

dL - deciliter

exp. - expiration

g - gram

GLP - Good Laboratory Practices

GMP - Good Manufacturing Practices

hr - hour(s)

kg - kilogram

L - liter

M - molar

mg - milligram

mL - milliliter

mm - millimeter

ms - milliseconds

mM - millimolar

NA - not applicable

no. - number

OECD - Organisation for Economic Cooperation and Development

ppm - parts per million

SOP - standard operating procedure

WTDMSTM - WIL Toxicology Data Management System

wt. - weight

wts. - weights

 Page 31 of 178
WIL-876001 Acetaldehyde

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc.

TABLES S1 - S10

 Page 32 of 178
 TABLE S1 (DAILY EXAMINATIONS)

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 1

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF CLINICAL FINDINGS: TOTAL OCCURRENCE/NO. OF ANIMALS

 ----- F E M A L E -----

-----------------------------------------------------------------------------------------------------------------------------------

 TABLE RANGE: 05-29-12 TO 06-08-12

 GROUP: 1 2 3 4 5 6

-----------------------------------------------------------------------------------------------------------------------------------

NORMAL

-NO SIGNIFICANT CLINICAL OBSERVATIONS 54/ 5 54/ 5 51/ 5 45/ 5 55/ 5 54/ 5

DISPOSITION

-SCHEDULED EUTHANASIA 5/ 5 5/ 5 5/ 5 5/ 5 5/ 5 5/ 5

BODY/INTEGUMENT

-HAIR LOSS RIGHT FORELIMB 0/ 0 1/ 1 4/ 1 10/ 2 0/ 0 1/ 1

-HAIR LOSS LEFT FORELIMB 1/ 1 0/ 0 1/ 1 5/ 1 0/ 0 1/ 1

-----------------------------------------------------------------------------------------------------------------------------------

 1- 0 MG/ML 2- 1 MG/ML 3- 2 MG/ML 4- 3 MG/ML 5- 4 MG/ML 6- 5 MG/ML

 PCSUv4.07

Page 33 of 178

 06/22/2012
 TABLE S2

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 1

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF BODY WEIGHTS [G]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 0

 MEAN 214. 214. 208. 218. 213. 214.

 % DIFFERENCE 0.0 -2.8 1.9 -0.5 0.0

 S.D. 11.0 11.0 17.6 6.4 6.8 17.8

 S.E. 4.9 4.9 7.9 2.9 3.0 7.9

 N 5 5 5 5 5 5

 DAY 1

 MEAN 217. 214. 208. 216. 214. 215.

 % DIFFERENCE -1.4 -4.1 -0.5 -1.4 -0.9

 S.D. 12.0 12.1 14.5 6.0 5.5 20.8

 S.E. 5.4 5.4 6.5 2.7 2.5 9.3

 N 5 5 5 5 5 5

 DAY 2

 MEAN 218. 217. 212. 219. 215. 217.

 % DIFFERENCE -0.5 -2.8 0.5 -1.4 -0.5

 S.D. 7.6 12.8 14.7 4.4 9.3 22.4

 S.E. 3.4 5.7 6.6 2.0 4.1 10.0

 N 5 5 5 5 5 5

 DAY 3

 MEAN 222. 220. 216. 223. 218. 221.

 % DIFFERENCE -0.9 -2.7 0.5 -1.8 -0.5

 S.D. 11.1 12.8 16.9 7.8 9.4 20.3

 S.E. 5.0 5.7 7.6 3.5 4.2 9.1

 N 5 5 5 5 5 5

 DAY 4

 MEAN 224. 221. 215. 228. 222. 222.

 % DIFFERENCE -1.3 -4.0 1.8 -0.9 -0.9

 S.D. 9.9 12.1 17.8 8.9 11.2 19.7

 S.E. 4.4 5.4 8.0 4.0 5.0 8.8

 N 5 5 5 5 5 5

-----------------------------------------------------------------------------------------------------------------------------------

None significantly different from control group

Page 34 of 178
 TABLE S2

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 2

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF BODY WEIGHTS [G]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 5

 MEAN 227. 226. 216. 227. 222. 223.

 % DIFFERENCE -0.4 -4.8 0.0 -2.2 -1.8

 S.D. 11.5 12.2 15.2 8.0 8.4 21.4

 S.E. 5.1 5.4 6.8 3.6 3.7 9.6

 N 5 5 5 5 5 5

 DAY 6

 MEAN 229. 227. 220. 228. 223. 226.

 % DIFFERENCE -0.9 -3.9 -0.4 -2.6 -1.3

 S.D. 10.1 12.6 14.5 4.6 12.8 24.8

 S.E. 4.5 5.7 6.5 2.1 5.7 11.1

 N 5 5 5 5 5 5

 DAY 7

 MEAN 229. 229. 219. 233. 224. 227.

 % DIFFERENCE 0.0 -4.4 1.7 -2.2 -0.9

 S.D. 11.5 12.2 16.2 6.9 13.2 22.2

 S.E. 5.2 5.5 7.2 3.1 5.9 9.9

 N 5 5 5 5 5 5

 DAY 8

 MEAN 232. 229. 221. 234. 225. 229.

 % DIFFERENCE -1.3 -4.7 0.9 -3.0 -1.3

 S.D. 11.0 15.2 17.7 9.9 12.7 20.1

 S.E. 4.9 6.8 7.9 4.4 5.7 9.0

 N 5 5 5 5 5 5

 DAY 9

 MEAN 233. 228. 220. 232. 224. 230.

 % DIFFERENCE -2.1 -5.6 -0.4 -3.9 -1.3

 S.D. 10.9 15.6 16.6 12.5 10.8 21.5

 S.E. 4.9 7.0 7.4 5.6 4.8 9.6

 N 5 5 5 5 5 5

-----------------------------------------------------------------------------------------------------------------------------------

None significantly different from control group

Page 35 of 178
 TABLE S2

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 3

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF BODY WEIGHTS [G]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 10

 MEAN 234. 232. 224. 238. 227. 233.

 % DIFFERENCE -0.9 -4.3 1.7 -3.0 -0.4

 S.D. 9.7 16.1 17.7 10.3 14.2 25.5

 S.E. 4.3 7.2 7.9 4.6 6.3 11.4

 N 5 5 5 5 5 5

-----------------------------------------------------------------------------------------------------------------------------------

None significantly different from control group

 PJTBWSUv5.18

 06/22/2012

Page 36 of 178
 TABLE S3

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 1

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF BODY WEIGHT CHANGES [G]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 0- 1

 MEAN 3. 0. 0. -3. 1. 1.

 S.D. 2.6 2.8 6.4 4.7 3.0 5.8

 S.E. 1.2 1.2 2.9 2.1 1.3 2.6

 N 5 5 5 5 5 5

 DAY 1- 2

 MEAN 2. 3. 4. 3. 1. 1.

 S.D. 5.8 3.5 3.5 8.1 5.0 2.1

 S.E. 2.6 1.6 1.6 3.6 2.2 0.9

 N 5 5 5 5 5 5

 DAY 2- 3

 MEAN 4. 3. 4. 4. 3. 4.

 S.D. 5.7 6.0 3.7 5.0 2.3 3.5

 S.E. 2.6 2.7 1.7 2.2 1.0 1.6

 N 5 5 5 5 5 5

 DAY 3- 4

 MEAN 2. 1. -1. 5. 4. 2.

 S.D. 3.1 2.7 2.0 1.4 5.2 3.8

 S.E. 1.4 1.2 0.9 0.6 2.3 1.7

 N 5 5 5 5 5 5

 DAY 4- 5

 MEAN 3. 5. 1. -1. 0. 1.

 S.D. 2.8 3.2 4.8 4.9 4.2 4.1

 S.E. 1.2 1.4 2.1 2.2 1.9 1.9

 N 5 5 5 5 5 5

-----------------------------------------------------------------------------------------------------------------------------------

None significantly different from control group

MEAN DIFFERENCES CALCULATED FROM INDIVIDUAL DIFFERENCES

Page 37 of 178
 TABLE S3

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 2

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF BODY WEIGHT CHANGES [G]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 5- 6

 MEAN 2. 1. 4. 1. 1. 3.

 S.D. 3.1 3.8 3.6 5.6 6.7 4.3

 S.E. 1.4 1.7 1.6 2.5 3.0 1.9

 N 5 5 5 5 5 5

 DAY 6- 7

 MEAN 1. 2. -1. 5. 1. 1.

 S.D. 5.6 2.8 3.0 3.5 3.3 4.4

 S.E. 2.5 1.2 1.3 1.5 1.5 2.0

 N 5 5 5 5 5 5

 DAY 7- 8

 MEAN 2. 0. 2. 1. 1. 2.

 S.D. 0.9 4.2 4.7 3.4 3.1 4.4

 S.E. 0.4 1.9 2.1 1.5 1.4 1.9

 N 5 5 5 5 5 5

 DAY 8- 9

 MEAN 1. -1. -1. -2. -1. 1.

 S.D. 3.3 3.4 3.3 3.9 2.3 4.2

 S.E. 1.5 1.5 1.5 1.7 1.0 1.9

 N 5 5 5 5 5 5

 DAY 9- 10

 MEAN 1. 4. 4. 6. 3. 3.

 S.D. 6.2 4.7 5.5 5.9 4.6 5.5

 S.E. 2.8 2.1 2.5 2.6 2.0 2.5

 N 5 5 5 5 5 5

-----------------------------------------------------------------------------------------------------------------------------------

None significantly different from control group

MEAN DIFFERENCES CALCULATED FROM INDIVIDUAL DIFFERENCES

Page 38 of 178
 TABLE S3

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 3

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF BODY WEIGHT CHANGES [G]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 0- 10

 MEAN 20. 18. 16. 20. 14. 19.

 S.D. 6.6 5.6 9.4 8.3 7.7 9.0

 S.E. 2.9 2.5 4.2 3.7 3.4 4.0

 N 5 5 5 5 5 5

-----------------------------------------------------------------------------------------------------------------------------------

None significantly different from control group

MEAN DIFFERENCES CALCULATED FROM INDIVIDUAL DIFFERENCES

 PJTBWSUv5.18

 06/22/2012

Page 39 of 178
 TABLE S4

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 1

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF FOOD CONSUMPTION [G/ANIMAL/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 0- 1

 MEAN 16. 17. 14. 14. 15. 16.

 S.D. 8.9 3.3 2.2 2.6 1.1 3.4

 S.E. 4.0 1.5 1.0 1.1 0.5 1.5

 N 5 5 5 5 5 5

 DAY 1- 2

 MEAN 18. 17. 18. 17. 17. 15.

 S.D. 1.5 1.1 2.0 2.6 2.4 3.8

 S.E. 0.7 0.5 0.9 1.2 1.1 1.7

 N 5 5 5 5 5 5

 DAY 2- 3

 MEAN 18. 16. 17. 17. 17. 18.

 S.D. 4.0 2.3 2.3 2.0 2.0 2.5

 S.E. 1.8 1.0 1.1 0.9 0.9 1.1

 N 5 5 5 5 5 5

 DAY 3- 4

 MEAN 18. 16. 17. 18. 17. 17.

 S.D. 1.9 2.4 2.9 1.9 2.8 2.3

 S.E. 0.9 1.1 1.3 0.8 1.3 1.0

 N 5 5 5 5 5 5

 DAY 4- 5

 MEAN 19. 19. 17. 17. 16. 18.

 S.D. 2.6 1.6 1.1 2.1 1.6 1.9

 S.E. 1.2 0.7 0.5 0.9 0.7 0.9

 N 5 5 5 5 5 5

-----------------------------------------------------------------------------------------------------------------------------------

None significantly different from control group

Page 40 of 178
 TABLE S4

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 2

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF FOOD CONSUMPTION [G/ANIMAL/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 5- 6

 MEAN 19. 19. 18. 18. 17. 18.

 S.D. 1.5 2.7 2.9 1.9 2.7 4.7

 S.E. 0.7 1.2 1.3 0.8 1.2 2.1

 N 5 5 5 5 5 5

 DAY 6- 7

 MEAN 17. 17. 16. 19. 16. 17.

 S.D. 3.2 2.2 2.3 2.0 2.5 1.9

 S.E. 1.5 1.0 1.0 0.9 1.1 0.8

 N 5 5 5 5 5 5

 DAY 7- 8

 MEAN 21. 18. 18. 20. 18. 18.

 S.D. 2.7 1.8 3.0 3.0 2.2 1.5

 S.E. 1.2 0.8 1.3 1.3 1.0 0.7

 N 5 5 5 5 5 5

 DAY 8- 9

 MEAN 19. 15. 15. 15. 15. 16.

 S.D. 2.3 2.7 1.5 3.0 1.2 2.0

 S.E. 1.0 1.2 0.7 1.4 0.6 0.9

 N 5 5 5 5 5 5

 DAY 9- 10

 MEAN 20. 17. 18. 21. 22. 22.

 S.D. 3.9 3.0 3.4 1.7 8.2 2.4

 S.E. 1.7 1.3 1.5 0.8 3.7 1.2

 N 5 5 5 5 5 4

-----------------------------------------------------------------------------------------------------------------------------------

None significantly different from control group

Page 41 of 178
 TABLE S4

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 3

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF FOOD CONSUMPTION [G/ANIMAL/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 0- 10

 MEAN 19. 17. 17. 17. 17. 17.

 S.D. 1.6 1.5 1.7 0.8 1.4 1.7

 S.E. 0.7 0.7 0.7 0.3 0.6 0.8

 N 5 5 5 5 5 5

-----------------------------------------------------------------------------------------------------------------------------------

None significantly different from control group

 PJTFWSUv5.22

 06/22/2012

Page 42 of 178
 TABLE S5

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 1

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF FOOD CONSUMPTION [G/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 0- 1

 MEAN 74. 78. 66. 63. 70. 75.

 S.D. 41.2 12.1 9.9 11.5 6.5 11.0

 S.E. 18.4 5.4 4.4 5.1 2.9 4.9

 N 5 5 5 5 5 5

 DAY 1- 2

 MEAN 82. 78. 85. 77. 77. 68.

 S.D. 9.7 4.7 8.9 12.3 10.0 13.0

 S.E. 4.3 2.1 4.0 5.5 4.5 5.8

 N 5 5 5 5 5 5

 DAY 2- 3

 MEAN 80. 74. 81. 78. 77. 81.

 S.D. 16.6 10.3 6.8 7.5 6.6 11.8

 S.E. 7.4 4.6 3.1 3.4 3.0 5.3

 N 5 5 5 5 5 5

 DAY 3- 4

 MEAN 82. 74. 76. 79. 79. 77.

 S.D. 5.3 10.4 8.2 6.5 12.1 11.2

 S.E. 2.4 4.6 3.7 2.9 5.4 5.0

 N 5 5 5 5 5 5

 DAY 4- 5

 MEAN 83. 84. 77. 76. 72. 79.

 S.D. 8.5 5.4 7.8 9.6 9.5 5.7

 S.E. 3.8 2.4 3.5 4.3 4.3 2.6

 N 5 5 5 5 5 5

-----------------------------------------------------------------------------------------------------------------------------------

None significantly different from control group

Page 43 of 178
 TABLE S5

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 2

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF FOOD CONSUMPTION [G/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 5- 6

 MEAN 83. 82. 84. 80. 76. 81.

 S.D. 6.3 10.8 16.2 10.0 9.9 15.8

 S.E. 2.8 4.8 7.2 4.5 4.4 7.1

 N 5 5 5 5 5 5

 DAY 6- 7

 MEAN 75. 73. 75. 80. 74. 73.

 S.D. 13.5 8.9 6.5 7.9 9.9 10.6

 S.E. 6.1 4.0 2.9 3.5 4.4 4.7

 N 5 5 5 5 5 5

 DAY 7- 8

 MEAN 91. 79. 82. 84. 82. 80.

 S.D. 7.9 4.7 9.1 10.8 6.7 10.8

 S.E. 3.5 2.1 4.1 4.8 3.0 4.8

 N 5 5 5 5 5 5

 DAY 8- 9

 MEAN 80. 67. 69. 65. 66. 70.

 S.D. 8.6 9.2 7.4 11.2 7.8 8.1

 S.E. 3.9 4.1 3.3 5.0 3.5 3.6

 N 5 5 5 5 5 5

 DAY 9- 10

 MEAN 86. 75. 81. 88. 95. 91.

 S.D. 15.6 9.5 15.5 8.9 31.3 5.3

 S.E. 7.0 4.2 6.9 4.0 14.0 2.7

 N 5 5 5 5 5 4

-----------------------------------------------------------------------------------------------------------------------------------

None significantly different from control group

Page 44 of 178
 TABLE S5

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 3

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF FOOD CONSUMPTION [G/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 0- 10

 MEAN 82. 76. 78. 77. 77. 77.

 S.D. 3.8 3.8 5.7 1.6 3.4 1.2

 S.E. 1.7 1.7 2.6 0.7 1.5 0.5

 N 5 5 5 5 5 5

-----------------------------------------------------------------------------------------------------------------------------------

None significantly different from control group

 PJTFWSUv5.22

 06/22/2012

Page 45 of 178
 TABLE S6

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 1

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF WATER CONSUMPTION [G/ANIMAL/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 0- 1

 MEAN 24. 36.* 26. 21. 20. 22.

 S.D. 7.8 4.4 4.2 3.6 3.7 6.4

 S.E. 3.5 2.2 1.9 1.6 1.6 2.8

 N 5 4 5 5 5 5

 DAY 1- 2

 MEAN 33. 58. 53.* 40. 30. 29.

 S.D. 4.0 9.3 15.5 10.4 3.2 5.2

 S.E. 1.8 6.6 7.7 4.6 1.4 2.3

 N 5 2 4 5 5 5

 DAY 2- 3

 MEAN 30. 40. 28. 27. 21. 25.

 S.D. 6.5 14.1 6.3 1.5 2.0 4.5

 S.E. 2.9 6.3 2.8 0.7 0.9 2.0

 N 5 5 5 5 5 5

 DAY 3- 4

 MEAN 48. 79.* 46. 42. 29. 33.

 S.D. 8.5 30.2 15.8 7.8 4.4 7.1

 S.E. 3.8 15.1 7.1 3.5 2.2 3.2

 N 5 4 5 5 4 5

 DAY 4- 5

 MEAN 36. 48.* 32. 25. 23.* 24.*

 S.D. 6.3 11.7 3.2 5.9 3.9 4.4

 S.E. 2.8 5.2 1.4 2.6 1.8 2.0

 N 5 5 5 5 5 5

-----------------------------------------------------------------------------------------------------------------------------------

* = Significantly different from the control group at 0.05 using Dunnett's test

Page 46 of 178
 TABLE S6

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 2

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF WATER CONSUMPTION [G/ANIMAL/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 5- 6

 MEAN 47. 51. 47. 34. 30.** 31.*

 S.D. 8.6 7.4 8.1 7.9 5.5 5.5

 S.E. 4.3 4.3 3.6 3.5 2.5 2.5

 N 4 3 5 5 5 5

 DAY 6- 7

 MEAN 33. 25.* 22.** 27. 19.** 21.**

 S.D. 4.8 3.9 4.4 4.3 3.5 4.4

 S.E. 2.1 1.7 2.0 1.9 1.6 2.0

 N 5 5 5 5 5 5

 DAY 7- 8

 MEAN 65. 36.** 33.** 35.** 26.** 29.**

 S.D. 15.7 10.0 5.1 7.1 6.1 3.6

 S.E. 7.0 4.5 2.3 3.2 2.7 1.8

 N 5 5 5 5 5 4

 DAY 8- 9

 MEAN 35. 29. 26. 20.** 17.** 23.**

 S.D. 6.5 5.8 2.6 2.5 2.4 7.6

 S.E. 2.9 2.9 1.2 1.1 1.2 3.4

 N 5 4 5 5 4 5

 DAY 9- 10

 MEAN 46. 36. 31. 27.* 29.* 27.*

 S.D. 10.5 13.2 2.6 2.9 13.8 7.0

 S.E. 4.7 6.6 1.2 1.3 6.2 3.2

 N 5 4 5 5 5 5

-----------------------------------------------------------------------------------------------------------------------------------

* = Significantly different from the control group at 0.05 using Dunnett's test

** = Significantly different from the control group at 0.01 using Dunnett's test

Page 47 of 178
 TABLE S6

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 3

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF WATER CONSUMPTION [G/ANIMAL/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 0- 10

 MEAN 40. 42. 34. 30.** 25.** 26.**

 S.D. 5.3 6.8 2.4 2.0 4.1 4.4

 S.E. 2.4 3.1 1.1 0.9 1.8 2.0

 N 5 5 5 5 5 5

-----------------------------------------------------------------------------------------------------------------------------------

** = Significantly different from the control group at 0.01 using Dunnett's test

 PJTFWSUv5.22

 06/22/2012

Page 48 of 178
 TABLE S7

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 1

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF WATER CONSUMPTION [G/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 0- 1

 MEAN 112. 164.* 124. 95. 94. 100.

 S.D. 30.2 19.8 26.2 17.4 18.1 23.1

 S.E. 13.5 9.9 11.7 7.8 8.1 10.3

 N 5 4 5 5 5 5

 DAY 1- 2

 MEAN 152. 267. 244.** 185. 139. 135.

 S.D. 12.9 28.1 72.6 49.8 13.4 13.5

 S.E. 5.8 19.9 36.3 22.3 6.0 6.0

 N 5 2 4 5 5 5

 DAY 2- 3

 MEAN 137. 182. 131. 124. 95. 114.

 S.D. 24.7 66.2 24.9 7.6 8.7 13.5

 S.E. 11.0 29.6 11.2 3.4 3.9 6.1

 N 5 5 5 5 5 5

 DAY 3- 4

 MEAN 213. 365.* 216. 186. 133. 149.

 S.D. 30.5 149.7 91.7 40.8 15.7 20.7

 S.E. 13.6 74.9 41.0 18.2 7.8 9.2

 N 5 4 5 5 4 5

 DAY 4- 5

 MEAN 157. 215.* 149. 111. 103.* 106.*

 S.D. 23.5 52.0 22.5 25.1 19.8 10.9

 S.E. 10.5 23.3 10.1 11.2 8.8 4.9

 N 5 5 5 5 5 5

-----------------------------------------------------------------------------------------------------------------------------------

* = Significantly different from the control group at 0.05 using Dunnett's test

** = Significantly different from the control group at 0.01 using Dunnett's test

Page 49 of 178
 TABLE S7

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 2

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF WATER CONSUMPTION [G/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 5- 6

 MEAN 207. 230. 218. 151. 134.* 138.*

 S.D. 28.3 43.9 51.0 35.3 20.3 15.2

 S.E. 14.1 25.4 22.8 15.8 9.1 6.8

 N 4 3 5 5 5 5

 DAY 6- 7

 MEAN 144. 108.** 102.** 115.* 87.** 94.**

 S.D. 18.9 16.1 13.8 17.1 15.8 14.0

 S.E. 8.4 7.2 6.2 7.7 7.1 6.3

 N 5 5 5 5 5 5

 DAY 7- 8

 MEAN 282. 155.** 148.** 151.** 116.** 132.**

 S.D. 71.2 40.0 19.2 27.0 27.9 17.7

 S.E. 31.8 17.9 8.6 12.1 12.5 8.8

 N 5 5 5 5 5 4

 DAY 8- 9

 MEAN 150. 123. 120. 85.** 76.** 97.**

 S.D. 29.3 27.9 10.8 9.4 10.4 28.6

 S.E. 13.1 14.0 4.8 4.2 5.2 12.8

 N 5 4 5 5 4 5

 DAY 9- 10

 MEAN 196. 155. 142. 114.* 128. 116.*

 S.D. 44.0 58.4 19.2 16.0 61.9 23.9

 S.E. 19.7 29.2 8.6 7.1 27.7 10.7

 N 5 4 5 5 5 5

-----------------------------------------------------------------------------------------------------------------------------------

* = Significantly different from the control group at 0.05 using Dunnett's test

** = Significantly different from the control group at 0.01 using Dunnett's test

Page 50 of 178
 TABLE S7

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 3

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF WATER CONSUMPTION [G/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 0- 10

 MEAN 175. 191. 158. 131.* 112.** 118.**

 S.D. 19.3 37.5 17.6 11.3 18.2 9.6

 S.E. 8.6 16.8 7.9 5.1 8.1 4.3

 N 5 5 5 5 5 5

-----------------------------------------------------------------------------------------------------------------------------------

* = Significantly different from the control group at 0.05 using Dunnett's test

** = Significantly different from the control group at 0.01 using Dunnett's test

 PJTFWSUv5.22

 06/22/2012

Page 51 of 178
 TABLE S8

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 1

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF CALCULATED TEST ITEM CONSUMPTION [MG/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 0- 1

 MEAN 0. 164. 248. 286. 378. 499.

 S.D. 0.0 19.8 52.3 52.1 72.3 115.3

 S.E. 0.0 9.9 23.4 23.3 32.3 51.6

 N 5 4 5 5 5 5

 DAY 1- 2

 MEAN 0. 267. 488. 556. 557. 676.

 S.D. 0.0 28.1 145.3 149.4 53.7 67.4

 S.E. 0.0 19.9 72.6 66.8 24.0 30.2

 N 5 2 4 5 5 5

 DAY 2- 3

 MEAN 0. 182. 262. 373. 382. 569.

 S.D. 0.0 66.2 49.9 22.8 34.7 67.7

 S.E. 0.0 29.6 22.3 10.2 15.5 30.3

 N 5 5 5 5 5 5

 DAY 3- 4

 MEAN 0. 365. 432. 558. 534. 745.

 S.D. 0.0 149.7 183.4 122.3 62.7 103.4

 S.E. 0.0 74.9 82.0 54.7 31.4 46.2

 N 5 4 5 5 4 5

 DAY 4- 5

 MEAN 0. 215. 297. 332. 411. 529.

 S.D. 0.0 52.0 45.0 75.4 79.1 54.3

 S.E. 0.0 23.3 20.1 33.7 35.4 24.3

 N 5 5 5 5 5 5

-----------------------------------------------------------------------------------------------------------------------------------

Page 52 of 178
 TABLE S8

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 2

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF CALCULATED TEST ITEM CONSUMPTION [MG/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 5- 6

 MEAN 0. 230. 437. 453. 535. 688.

 S.D. 0.0 43.9 102.0 106.0 81.0 76.0

 S.E. 0.0 25.4 45.6 47.4 36.2 34.0

 N 4 3 5 5 5 5

 DAY 6- 7

 MEAN 0. 108. 203. 345. 348. 471.

 S.D. 0.0 16.1 27.6 51.4 63.3 70.1

 S.E. 0.0 7.2 12.3 23.0 28.3 31.3

 N 5 5 5 5 5 5

 DAY 7- 8

 MEAN 0. 155. 296. 452. 463. 659.

 S.D. 0.0 40.0 38.5 80.9 111.7 88.4

 S.E. 0.0 17.9 17.2 36.2 49.9 44.2

 N 5 5 5 5 5 4

 DAY 8- 9

 MEAN 0. 123. 239. 255. 305. 487.

 S.D. 0.0 27.9 21.6 28.3 41.6 142.8

 S.E. 0.0 14.0 9.7 12.7 20.8 63.8

 N 5 4 5 5 4 5

 DAY 9- 10

 MEAN 0. 155. 284. 341. 513. 579.

 S.D. 0.0 58.4 38.4 47.9 247.8 119.3

 S.E. 0.0 29.2 17.2 21.4 110.8 53.3

 N 5 4 5 5 5 5

-----------------------------------------------------------------------------------------------------------------------------------

Page 53 of 178
 TABLE S8

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 3

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF CALCULATED TEST ITEM CONSUMPTION [MG/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 GROUP: 0 MG/ML 1 MG/ML 2 MG/ML 3 MG/ML 4 MG/ML 5 MG/ML

-----------------------------------------------------------------------------------------------------------------------------------

 DAY 0- 10

 MEAN 0. 191. 316. 394. 448. 589.

 S.D. 0.0 37.5 35.2 34.0 72.9 47.9

 S.E. 0.0 16.8 15.7 15.2 32.6 21.4

 N 5 5 5 5 5 5

-----------------------------------------------------------------------------------------------------------------------------------

 PJTFWSUv5.22

 06/22/2012

 R:06/22/2012

Page 54 of 178
 TABLE S9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 1

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF MACROSCOPIC FINDINGS

 SCHEDULED NECROPSY

-----------------------------------------------------------------------------------------------------------------------------------

 ----- F E M A L E -----

 GROUP: 1 2 3 4 5 6

-----------------------------------------------------------------------------------------------------------------------------------

NUMBER OF ANIMALS EXAMINED 5 5 5 5 5 5

UTERUS

-CONTENTS, CLEAR FLUID 1 0 1 0 1 0

NO SIGNIFICANT CHANGES OBSERVED - ALL EXAMINED TISSUES 4 5 4 5 4 5

-----------------------------------------------------------------------------------------------------------------------------------

 1- 0 MG/ML 2- 1 MG/ML 3- 2 MG/ML 4- 3 MG/ML 5- 4 MG/ML 6- 5 MG/ML

 PGRSI2v4.10

 08/09/2012

Page 55 of 178
 TABLE S10

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 1

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF MICROSCOPIC FINDINGS

 ----- FEMALE -----

-----------------------------------------------------------------------------------------------------------------------------------

 GROUP: 1 2 3 4 5 6

-----------------------------------------------------------------------------------------------------------------------------------

NUMBER OF ANIMALS EXAMINED 5 0 0 0 0 5

ESOPHAGUS

 TOTAL NUMBER EXAMINED 5 NA NA NA NA 5

 EXAMINED, UNREMARKABLE 5 NA NA NA NA 5

GINGIVA

 TOTAL NUMBER EXAMINED 5 NA NA NA NA 5

 EXAMINED, UNREMARKABLE 5 NA NA NA NA 5

OROPHARYNX

 TOTAL NUMBER EXAMINED 5 NA NA NA NA 5

 EXAMINED, UNREMARKABLE 4 NA NA NA NA 4

-HEMORRHAGE 0 NA NA NA NA 1

 MILD NONE NA NA NA NA 1

-INFLAMMATION, CHRONIC 1 NA NA NA NA 0

 MINIMAL 1 NA NA NA NA NONE

STOMACH, NONGL

 TOTAL NUMBER EXAMINED 5 NA NA NA NA 5

 EXAMINED, UNREMARKABLE 4 NA NA NA NA 5

-ULCERATION 1 NA NA NA NA 0

 MINIMAL 1 NA NA NA NA NONE

-----------------------------------------------------------------------------------------------------------------------------------

 1- 0 MG/ML 2- 1 MG/ML 3- 2 MG/ML 4- 3 MG/ML 5- 4 MG/ML 6- 5 MG/ML

NA = NOT APPLICABLE

Page 56 of 178
 TABLE S10

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 2

SPONSOR:ACETALDEHYDE GROUP SUMMARY OF MICROSCOPIC FINDINGS

 ----- FEMALE -----

-----------------------------------------------------------------------------------------------------------------------------------

 GROUP: 1 2 3 4 5 6

-----------------------------------------------------------------------------------------------------------------------------------

NUMBER OF ANIMALS EXAMINED 5 NA NA NA NA 5

TONGUE

 TOTAL NUMBER EXAMINED 5 NA NA NA NA 5

 EXAMINED, UNREMARKABLE 5 NA NA NA NA 5

-----------------------------------------------------------------------------------------------------------------------------------

 1- 0 MG/ML 2- 1 MG/ML 3- 2 MG/ML 4- 3 MG/ML 5- 4 MG/ML 6- 5 MG/ML

NA = NOT APPLICABLE

 PHSI2v4.36

 08/09/2012

Page 57 of 178
WIL-876001 Acetaldehyde

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc.

APPENDIX A

Study Protocol and Deviations

 Page 58 of 178
WIL-876001 Acetaldehyde

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc.

DEVIATIONS FROM THE PROTOCOL

This study was conducted in accordance with the protocol and protocol amendment, 

except for the following.

• Protocol Section 6.3 states that reverse osmosis-treated tap water would be provided 

from standard plastic water bottles with a silicon ring around the lip and slip on cap 

with a nozzle containing ball bearings. Beginning on the day of animal receipt 

(15 May 2012) through 17 May 2012, the type of water bottle used to provide 

drinking water was not documented. Therefore, it could not be determined if the

drinking water was provided from the protocol-specified water bottles during this 

period.

Reason for Deviation: Technician error.

This deviation did not negatively impact the quality or integrity of the data or the 

outcome of the study.

 Page 59 of 178
PROTOCOL AMENDMENT 1

Study Number: WIL-876001 

Sponsor: Acetaldehyde Working Group of the Vinyl Acetate Council, Inc 

Title of Study: 

A Dosage Range-Finding 10-Day Oral (Drinking Water) Toxicity Study of Acetaldehyde 

in Rats 

Protocol Modifications: 

1) 4.6 Storage Conditions: 

As per Study Director Notification on 28 May 2012, this section is revised as follows: 

Refrigerated, protected from light under nitrogen 

Reasons for Protocol Modification: 

1) To correct storage conditions of the Test Item. 

 

 Page 60 of 178
Page 2 of 2 

WIL-87600 1 

Protocol An~endment 1 

. . 

Spol~sor's approval was obtained via 

WIL Research 

Acetaldehyde Working Group 

of the Vinyl Acetate Council, Inc n 

fpo nsor Representative 

 Page 61 of 178
Departmentallstudy Director Notification 

Study Director: Jeff Charlap 

Study No.: WIL-876001 

Please note the following: 

Section 4.6 Storage Conditions is modified to: 

Refrigerated, under nitrogen. The test item does not need to be protected from 

light. 

Reason for change: 

Correction of storage conditions for the test item. 

Sponsor approval on: iador 

Protocol amendment forthcoming 

Clarification of procedure, no protocol amendment required 

Date: 

Original: QAU 

Copies as per protocol distribution 

 Page 62 of 178
 WIL-876001 

 Page 1 of 15 May 10, 2012 

PROTOCOL 

A DOSAGE RANGE-FINDING 10-DAY ORAL 

(DRINKING WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS 

WIL Study Number: WIL-876001 

Submitted To: 

Acetaldehyde Working Group 

of the Vinyl Acetate Council, Inc 

1250 Connecticut Ave, NW 

Suite 700 

Washington, DC, 20036 

WIL Research 

1407 George Road 

Ashland, OH 44805-8946 

 Page 63 of 178
WIL-876001 

Page 2 of 15 May 10,2012 

To determine dose levels of acetaldehyde to be evaluated in a potential combined 

repeated dose toxicity study with the reproduction/developmental toxicity screening 

test (OECD 422) in rats. 

This study will be conducted in compliance with the OECD [C(97) 186/Final] Good 

Laboratory Practice Regulations. 

2 PERSONNEL INVOLVED IN THE STUDY: 

2.1 Sponsor Representative: 

Robert Fensterheim, MPH 

Acetaldehyde Working Group 

1250 Connecticut Ave., NW 

Suite 700 

Washington, DC 20036 

202.419.1500 

Email: rfensterheirn@regnet.com 

2.2 Study Monitor: 

Willem Faber, PhD, DABT 

WFTC, LLC 

1338 Strong Rd., Victor, NY 14564 

Phone:585-742-1568 

Email: wfaber@msn.com 

2.3 WIL Study Director: 

Jeffrey H. Charlap, MS 

Staff Toxicologist, Developmental 

and Reproductive Toxicology 

Tel: (419) 289-8700 

Fax: (419) 289-3650 

Email: jcharlap@wilresearch.com 

2.4 Study Pathologist: 

Catherine Picut, VMD, DACVP, DABT 

Senior Pathologist 

 Page 64 of 178
WIL-876001 

Page3 of15 May 10,2012 

2.5 WIL Departmental Res~onsibilities: 

Donald G. Stump, PhD, DABT 

Senior Director, Developmental 

and Reproductive Toxicology 

Emergency Contact 

Tel: (419) 289-8700 

Fax: (419) 289-3650 

E-mail: dstump@wilresearch.com 

Steven D. Barkyoumb, DVM, PhD, DACVP 

Senior Vice President Global Operations - Safety Assessment 

Eddie D. Sloter, PhD 

Assistant Director, Developmental and 

Reproductive Toxicology 

Melissa J. Beck, PhD 

Assistant Director, Neurosciences 

and Head of Juvenile Toxicology 

Bennett J. Varsho, MPH, DABT 

Director, Operations 

Gwendalyn M. Maginnis, DVM 

Clinical Veterinarian 

Carol A. Kopp, BS, LAT 

Manager, Gross Pathology and 

Developmental Toxicology Laboratory 

George A. Parker, DVM, PhD, DACVP, DABT 

Vice President, Pathology 

Eric S. Bodle, PhD 

Assistant Director, Analytical Chemistry 

Ronald E. Wilson, BS 

Director, Informational Systems 

Heather L. Johnson, BS RQAP-GLP 

Manager, Quality Assurance 

 Page 65 of 178
WIL-876001 

Page 4 of 15 May 10,2012 

Robert A. Wally, BS 

Operations Manager, Reporting and 

Technical Support Services 

3 STUDY SCHEDULE: 

Proposed Experimental Starting 

(Animal Receipt) Date: 15 May 2012 

Proposed Experimental Start 

(First Day of Dosing) Date: 29 May 20 12 

Proposed Experimental 

Completion/Terrnination Date: 8 June 2012 

Proposed DraR Report Date: 10 August 2012 

4 TEST ITEM DATA: 

4.1 Test Item Shipment: 

Test item and applicable documentation, including a Certificate of Analysis, 

was ordered by the Testing Facility and shipped to: 

Formulations Laboratory (WIL-876001; Jeffkey H. Charlap) 

Attn: Terri Rafeld, Manager 

WIL Research 

1407 George Road 

Ashland, Ohio 44805-8946 

Tel: (419) 289-8700 

Fax: (419) 289-3650 

Email: trafeld@wilresearch.com 

4.2 Identification: 

Acetaldehyde 

4.3 Lot Number: 

4.4 ExpirationIRetest Date: 

To be documented in the study records 

 Page 66 of 178
WIL-876001 

Page 5 of 15 May 10,2012 

4.5 Puritv: 

To be documented in the study records 

4.6 Storage Conditions: 

Refrigerated, protected from light 

4.7 Stabilitv: 

The test item is considered to be stable under the storage conditions provided by 

the supplier. 

4.8 Phvsical Description: 

To be documented by WIL Research. 

4.9 Reserve Samples: 

Reserve samples of the test item will be taken in accordance with WIL Standard 

Operating Procedures and stored in the Archives at WIL Research indefinitely, 

unless otherwise specified. 

4.10 Personnel Safetv Data: 

A Material Safety Data Sheet WSDS) is on file at the Testing Facility, and 

appropriate safety precautions will be followed based on the MSDS. 

4.11 Test Item Disposition: 

The test item will be retained for subsequent studies. 

5 TEST SYSTEM: 

5.1 Species: 

Rat 

5.2 BreedIStrain: 

Sprague Dawley Crl:CD(SD) 

5.3 Source: 

Charles River Laboratories, Inc. 

(Facility to be documented in the study records) 

 Page 67 of 178
WIL-876001 

Page 6 of 15 May 10,2012 

5.4 Number of Animals: 

30 Females (maximum of 35 Females purchased). Non-litter mates will be 

purchased. Animals not assigned to study will be transferred to the stock 

animal colony or will be euthanized by carbon dioxide inhalation and the 

carcasses discarded. 

Given the possibility of unexpected deaths, or treatment-related moribundity 

andlor mortality, this is an appropriate number of animals to evaluate 2-3 

animals per group at termination on this dose tolerabilityldose range-finding 

study. This number of animals will allow for meaningful interpretation of the 

data to adequately assess toxicological endpoints and to determine dose levels 

for subsequent studies. 

5.5 Body Weight Range: 

At randomization: Females 170-250 g 

5.6 Approximate Age: 

Age at randomization: Females 61-70 days 

5.7 Identification System: 

The animals will be uniquely identified by a on el@ metal ear tag displaying 

the animal number. Individual cage cards will be affixed to each cage and will 

display the animal number, group number, study number, dosage level and sex 

of the animal. 

5.8 Justification for Selection: 

This species and strain of animal is recognized as appropriate for tolerability 

studies. WIL Research has reproductive historical control data in the 

Crl:CD(SD) rat. 

6 SPECIFIC MAINTENANCE SCHEDULE: 

6.1 Animal Housing: 

The animals will be individually housed in clean solid bottom cages containing 

nesting material (B ed-0 ' cobsB) in an environmentally controlled room. 

 lab one@ (or a similar enrichment device) will be provided to cach animal for 

environmental enrichment and to aid in maintaining the animal's oral health, 

beginning during acclimation and continuing throughout the course of the study. 

The cages will be subjected to routine cleaning at a frequency consistent with 

maintaining good animal health and WIL Standard Operating Procedures. The 

 Page 68 of 178
WIL-876001 

Page 7 of IS May 10,2012 

facilities at WIL Research are accredited by the Association for Assessment and 

Accreditation of Laboratory Animal Care International (AAALAC 

International). 

6.2 Environmental Conditions: 

Controls will be set to maintain temperature at 71 + 5°F (22 + 3°C) and relative 

humidity at 50 + 20%. Temperature and relative humidity will be monitored 

continuously. Data for these two parameters will be scheduled for automatic 

collection on an hourly basis. Fluorescent lighting controlled by light timers 

will provide illumination for a 12-hour lightldark photoperiod. The ventilation 

rate will be set at a minimum of 10 room air changes per hour, 100% fiesh air. 

6.3 Drinking Water: 

Cage banks will not be connected to the automatic watering system. Reverse 

osmosis-treated tap water (with test substance added during the treatment 

period for the animals assigned to Groups 2-6) will be available ad libitum to 

all animals and will be provided fiom standard plastic water bottles 

(approximately 400 ml) with a silicon ring around the lip and slip on cap with a 

nozzle containing ball bearings. Bottles will be checked daily for spillage 

(occurrence of spillage will be documented) and supplemented as necessary. 

Filters servicing the automatic watering system used to prepare water bottles 

will be changed regularly according to WIL SOPs. Municipal water supplying 

the laboratory will be analyzed for contaminants according to WE SOPs to 

ascertain that none are present at concentrations that would be expected to 

affect the outcome of the study. 

6.4 Basal Diet: 

PMI Nutrition International LLC Certified Rodent ~ab~iet@ 5002 will be 

offered ad libitum during the study. Periodic analyses of the certified feed are 

performed by the manufacturer to ensure that heavy metals and pesticides are 

not present at concentrations that would be expected to affect the outcome of 

the study. Results of the analyses are provided to WIL Research by the 

manufacturer. Feeders will be changed and sanitized once per week. 

7 EXPERIMENTAL DESIGN: 

7.1 Animal Receipt and Quarantine: 

Each animal will be inspected by a qualified technician upon receipt. Rats 

judged to be in good health and suitable as test animals will be immediately 

placed in quarantine for a minimum of 10 days. All rats will be initially 

weighed, permanently identified with a metal ear tag and receive a clinical 

 Page 69 of 178
WIL-876001 

Page 8 of 15 May 10,2012 

observation. During the quarantine period, each rat will be observed twice daily 

for changes in general appearance and behavior. Prior to the start of the in-life 

phase, those animals judged to be suitable test subjects will be identified. 

7.2 Randomization: 

At the conclusion of the quarantine period, animals judged to be suitable test 

subjects and meeting acceptable body weight requirements will be assigned to 

the study at random using a computer program. At that time, the animal 

numbers and corresponding body weights will be entered into the 

WIL Toxicology Data Management System (WTDMS~). A printout containing 

the animal numbers and individual group assignments will be generated based 

on body weight stratification into a block design. The animals will then be 

arranged into the groups according to the printout. The control group and five 

test item groups will consist of 5 females each. 

Any animal assigned to the study that is found dead, euthanized in extvemis or 

exhibits abnormal clinical signs, reduced food consumption or body weight 

losses prior to the start of dosing may be replaced by an animal of appropriate 

age, when possible. Replacement animals will be arbitrarily assigned 

(not computer randomized) to the study based on comparable body weights 

(if possible) with respect to the animal that was replaced. 

7.3 Route and Rationale of Test Item Administration: 

The route of administration will be oral (drinking water) since this is a potential 

route of exposure for humans. 

7.4 Organization of Test Groups, Dosage Levels and Treatment Regimen: 

7.4.1 Organization of Test Groups: 

The dosage levels were provided by the Sponsor Representative after 

consultation with the WIL Study Director. This pilot study was 

designed to determine dose levels for a future OECD 422. The range of 

dose levels in this study are expected to cause no observable toxicity 

(1 mg/mL) and the possibility of some toxicity (5 mg/mL). 

 Page 70 of 178
WIL-876001 

Page9 of 15 May 10,2012 

The following table presents the study group arrangement. 

7.4.2 Vehicle Control Item: 

Reverse osmosis-purified water. 

7.4.3 Treatment Regimen: 

The test item will be administered as a constant concentration (mg1mL) 

in drinking water provided ad libitum and supplied as per section 7.5.1 

fiom study day 0 until the day of euthanasia on study day 10. 

7.4.4 Adjustment of Doses: 

The test item will be administered as a constant concentration in the 

drinking water. 

7.5 Preparation and Analysis of Test Item Formulations: 

7.5.1 Method and Frequency of Preparation: 

A prior stability study (WIL-876002) determined that the stability of 

acetaldehyde in the concentration range to be used in this probe study 

was 48 hours in glass formulation containers and 72 hours in plastic 

drinking water bottles. Therefore, formulations of test item will be 

prepared and drinking water bottles replaced every 48 hours 

(+I-2 hours). The formulations of the test item will not be stored in glass 

for more than 48 hours. The test item and vehicle formulations will be 

stirred continuously during preparation of the dose formulations within 

the glass containers. 

The Study Director or designee will visually inspect the test item 

formulations prior to initiation of dosing. This visual inspection will be 

performed to ensure that the formulations are visibly homogeneous and 

acceptable for dosing. Any special procedures required for formulation 

will be documented according to Good Laboratory Practices and 

presented in the final report of this study. 

 Page 71 of 178
WIL-876001 

Page 10 of 15 May 10,2012 

7.5.2 Concentration of Test Item Formulations: 

A prior stability study (WIL-876002) has demonstrated the ability of the 

laboratory to prepare dosing formulations at appropriate concentrations. 

No analytical analysis of the dosing formulations will be conducted as 

part of this probe study. 

7.6 General Observations During the Experimental Period: 

7.6.1 Appearance and Behavior: 

Each animal will be observed twice daily for moribundity and mortality, 

once in the morning and once in the afternoon, for the duration of the 

study. Additional observations may be necessary and will be 

documented in the study records. Clinical observations will be recorded 

daily. Mortality and all signs of overt toxicity will be recorded on the 

day observed. The observations shall include, but are not limited to, 

evaluation for changes in appearance of skin and fur, eyes, mucous 

membranes, respiratory and circulatory systems, autonomic and central 

nervous systems, somatomotor activity and behavior. All animals will 

also be observed on the day of necropsy and any findings will be 

recorded. 

7.6.2 Body Weights, Water Consumption and Food Consumption: 

Individual body weights, water and food consumption will be recorded 

daily. 

7.6.3 Deaths and Animals Euthanized in Extremis: 

Animals not surviving until the scheduled euthanasia will be necropsied, 

and the cause of death will be recorded, if possible. Animals not 

expected to survive to the next observation period (moribund) will be 

euthanized by carbon dioxide inhalation. The animals will be examined 

as described in section 7.8. 

7.7 Euthanasia: 

On study day 10, all surviving animals will be euthanized by carbon dioxide 

inhalation and subjected to necropsy as described in section 7.8. 

 Page 72 of 178
WIL-876001 

Page 11 of 15 May 10,2012 

7.8 Anatomic Patholow: 

7.8.1 Macroscopic Examination: 

A necropsy will be conducted on animals dying spontaneously, 

euthanized in extremis (by carbon dioxide inhalation) or at scheduled 

termination. 

At the time of necropsy, the following tissues and organs will be 

collected and placed in 10% neutral-buffered formalin: 

Oral tissues (tongue, gingiva and oropharynx), esophagus and 

nonglandular forestomach will be collected fiom all animals. Gingival 

tissues will be collected using the Morgan method of nasal cavity 

trimming (Morgan, 1991). 

7.8.2 Microscopic Examination: 

Microscopic examination of hematoxylin-eosin stained paraffin sections 

will be performed on the tissues listed in Section 7.8.1 fiom all animals 

in the control and high-dose groups (euthanized at the primary necropsy) 

and fiom all animals that die or are euthanized in extremis. 

8 DURATION OF STUDY: 

The acclimation and in-life phases of this study will require approximately 3 weeks. 

9 STATISTICAL METHODS: 

All analyses will be two-tailed for minimum significance levels of 5% and 1%. All 

means will be presented with standard deviations. All statistical tests will be 

performed using a computer with appropriate programming as referenced below. 

9.1 In-Life Data: 

Continuous data variables, [mean body weights, body weight gains, water 

consumption and food consumption of each interval] will be subjected to a 

parametric one-way analysis of variance (ANOVA) (Snedecor and Cochran, 

1980) to determine intergroup difference. If the results of the ANOVA are 

significant (p<0.05), Dunnett's test (Dunnett, 1964) will be applied to the data to 

compare the treated groups to the control group. 

10 QUALITY ASSURANCE: 

The study will be audited by the WIL Quality Assurance Department while in 

progress to assure compliance with the study protocol and protocol amendments, WIL 

 Page 73 of 178
WIL-876001 

Page 12 of 15 May 10,2012 

Standard Operating Procedures and the appropriate provisions of the OECD Good 

Laboratory Practice Regulations [C(97) 186 Final]. The protocol, protocol 

amendments, raw data, draR report and final report will be audited by the WIL 

Quality Assurance Department prior to submission to the Sponsor to assure that the 

final report accurately describes the conduct and the findings of the study. 

11 RECORDS TO BE MAINTAINED: 

All original raw data records, as defined by WIL SOPs and the applicable GLPs, will 

be stored as described in Section 12 in the Archives at WIL Research. 

12 WORK PRODUCT: 

The Sponsor will have title to all documentation records, raw data, specimens and 

other work product generated during the performance of the study. All work product, 

including raw paper data, pertinent electronic storage media and specimens, will be 

retained at no charge for six months following issuance of the final report in the 

Archives at WIL Research. ThereaRer, WIL Research will charge a monthly 

archiving fee for retention of all work product. All work product will be stored in 

compliance with regulatory requirements. 

Any work product, including documents, specimens, and samples, that are required 

by this protocol, its amendments, or other written instructions of the Sponsor, to be 

shipped by WIL Research to another location will be appropriately packaged and 

labeled as defined by WIL's SOPs and delivered to a common carrier for shipment. 

WIL Research will not be responsible for shipment following delivery to the common 

carrier. 

13 REPORTS: 

The final report will contain a summary, test item information, methods and 

procedures, appropriate individual animal and summary data tables, supporting subreports, a copy of the protocol and amendment(s), if any, and an interpretation and 

discussion of the study results. The final report will be comprehensive and shall 

define level(s) inducing toxic effects under the condition of this investigation. 

WIL Research will submit an electronic copy (PDF and MS Word copy of the report 

text for editing and comments) of the audited draR report in a timely manner upon 

completion of data collection prior to issuance of the final report. It is expected that 

the Sponsor will review the draft report and provide comments to WIL Research 

within a two-month time frame following submission. WIL Research shall provide a 

revised draft report that incorporates the Sponsor's reasonable revisions and 

suggestions. One revision will be permitted as part of the cost of the study; additional 

changes or revisions may be made, at extra cost. WIL Research shall submit the final 

report within two weeks of receiving authorization to finalize the report from the 

 Page 74 of 178
WIL-876001 

Page 13 of 15 May 10,2012 

Sponsor. If the Sponsor's comments andlor authorization to finalize the report have 

not been received at WIL Research within one year following submission of the draft 

report, WIL Research may elect to finalize the report following appropriate written 

notification to the Sponsor. Two electronic copies (PDF) of the final report on CD-R 

will be provided; requests for paper copies of the final report may result in additional 

charges. 

14 ANIMAL WELFARE ACT COMPLIANCE: 

This study will comply with all applicable sections of the Final Rules of the Animal 

Welfare Act (AWA) regulations (9 CFR Parts 1,2 and 3). The Sponsor should make 

particular note of the following: 

The Sponsor Representative's signature on this protocol documents for the Study 

Director the Sponsor's assurance that the study described in this protocol does not 

unnecessarily duplicate previous experiments. 

Whenever possible, procedures used in this study have been designed to avoid or 

minimize discomfort, distress or pain to animals. All methods are described in this 

study protocol or in written laboratory Standard Operating Procedures. 

Animals that experience severe or chronic pain or distress that cannot be relieved 

will be painlessly euthanized as deemed appropriate by the veterinary staff and 

Study Director. The Sponsor will be advised by the Study Director of all 

circumstances which could lead to this action in as timely a manner as possible. 

Methods of euthanasia used during this study are in conformance with the 

above-referenced regulation. 

The SponsorIStudy Director has considered alternatives to procedures that may 

cause more than momentary or slight pain or distress to the animals and has 

provided a written narrative description (AWA covered species only) of the methods 

and sources used to determine that alternatives are not available. 

15 PROTOCOL MODIFICATION: 

Modification of the protocol may be accomplished during the course of this 

investigation. However, no changes will be made in the study design without the 

verbal or written permission of the Sponsor. In the event that the Sponsor verbally 

requests or approves a change in the protocol such changes will be made by 

appropriate documentation in the form of a protocol amendment. All alterations of 

the protocol and reasons for the modification(s) will be signed by the Study Director 

and the Sponsor Representative. 

 Page 75 of 178
WIL-876001 

Page 14 of 15 May 10,2012 

16 REFERENCES: 

Morgan, K.T. Approaches to the Identification and Recording of Nasal Lesions In 

Toxicology Studies. Toxicologic Pathology 1991, Vol 19, Number 4 (Part l), pp 337- 

351. 

Dunnett, C.W. New tables for multiple comparisons with a control Biometrics 1964, 

20, pp. 482-491. 

Snedecor, G.W.; Cochran, W.G. One Way Classifications; Analysis of Variance. In 

Statistical Methods, 7th ed.; The Iowa State University Press: Ames, IA, 1980; pp. 21 5- 

237. 

 Page 76 of 178
WIL-876001 

Page IS of IS May 10.2012 

17 PROTOCOL APPROVAL: 

Sponsor approval received via 1 on (%'fi~.&l* . @ate 

Acetaldehyde Working Group 

of the Vinyl Acetate Coancil, Inc 

(/ Robert Fensterheim, MPH 

Sponsor Representative 

WIL Research 

%r2 

/ 

/T 

/ 

JefEey 

Study 

H. Charlap, 

Director 

MS * 

 Page 77 of 178
WIL-876001 Acetaldehyde

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc.

APPENDIX B

Certificate of Analysis (Manufacturer-Provided Data)

 Page 78 of 178
3050 Spruce Street, Saint Louis, MO 63103, USA 

C-C 

Website: www.sigmaaldrich.com 

Email USA: techserv@sial.com YbR 

Outside USA: eurtechserv@sial.com 

ACc 

Product Name: 

Acet aldehycle - ACS reagent, 299.5% 

Product Number: 

Lot Number: 

Brand: 

CAS Number: 

MDL Number: 

Formula: 

Formula Weight: 

Storage Temperature: 

Quality Release Date: 

402788 

SHBB4508V 

SlAL 

75-07-0 

MFCDO0006991 

C2 H4 0 

44.05 glmol 

Store at 2 - 8 9= 

03 AUG 2011 

Certificate . of Analysis 

0 

Test Specification Result 

-- -- - 

Appearance (Color) Colorless Colorless 

Appearance (Form) Liquid Liquid 

Infrared spectrum Conforms to Structure Conforms 

Purity (GC) - > 99.50 % 99.77 % 

Residue on Evaporation - <0.005 % 0.001 % 

Titratable acid - <0.008 meq 0.004 meq 

Meets ACS Requirements Current ACS Specification Conforms 

10th Edition 

Jennifer Baughman, Manager 

Quality Control 

Sheboygan Falls, WI US 

BY: --... ------ "- 

~a-Aldrich warrants, that at the time of the quality release or subsequent retest date this product conformed to the information 

rained in this publication. The current Specification sheet may be available at Sigma-Aldrich.com. For fur!her inquiries, please contact 

Technical Service. Purchaser must determine the suitability of the product for its particular use. See reverse side of invoice or packing 

slip for additional terms and conditions of sale. 

Version Number: 1 Page 1 of 1 

 Page 79 of 178
WIL-876001 Acetaldehyde

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc.

APPENDIX C

Animal Room Environmental Conditions

 Page 80 of 178
TEST SYSTEM:

DATE IN TIME IN

DATE OUT TIME OUT

05/15/12 08:00

06/08/12 14:00

RAT HIGH HUMIDITY %RH:

ROOM SPECIFICATIONS: LOW TEMPERATURE °F: 66.0 HIGH TEMPERATURE °F: 76.0 LOW HUMIDITY %RH: 30.0

70.0

STUDY SPECIFICATIONS:

LOW TEMPERATURE °C: 18.9 HIGH TEMPERATURE °C: 24.4

876001

B ROOM 115

DATE

PRIMARY TEMP SECONDARY TEMP PRIMARY HUM SECONDARY HUM

MEAN (°F) MEAN (°C) MEAN (°F) MEAN (°C) MEAN (%RH) MEAN (%RH)

05/15/12 70.3 21.3 70.3 21.3 43.4 43.3

05/16/12 70.5 21.4 70.6 21.4 45.8 45.6

05/17/12 70.5 21.4 70.6 21.4 39.7 39.5

05/18/12 70.5 21.4 70.6 21.4 40.6 40.5

05/19/12 70.1 21.2 70.2 21.2 45.2 45.0

05/20/12 70.6 21.4 70.7 21.5 48.5 48.3

05/21/12 70.1 21.2 70.2 21.2 49.0 48.7

05/22/12 70.2 21.2 70.3 21.3 47.5 47.4

05/23/12 70.3 21.3 70.4 21.3 47.9 47.7

05/24/12 70.1 21.2 70.2 21.2 47.9 47.7

05/25/12 70.4 21.3 70.5 21.4 50.2 49.8

05/26/12 70.3 21.3 70.4 21.3 47.4 47.1

05/27/12 70.1 21.2 70.2 21.2 50.0 49.7

05/28/12 70.3 21.3 70.4 21.3 51.2 50.8

05/29/12 70.6 21.4 70.7 21.5 49.0 48.7

05/30/12 70.4 21.3 70.5 21.4 46.6 46.3

05/31/12 70.3 21.3 70.4 21.3 47.1 46.9

06/01/12 70.4 21.3 70.4 21.3 47.9 47.7

06/02/12 70.2 21.2 70.3 21.3 42.1 42.0

R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS

876001

876 - ACETALDEHYDE GROUP Page 1 of 4

PROJECT NO.:WIL- TEMPERATURE/HUMIDITY - STUDY SUMMARY REPORT

SPONSOR:

Page 81 of 178
DATE

PRIMARY TEMP SECONDARY TEMP PRIMARY HUM SECONDARY HUM

MEAN (°F) MEAN (°C) MEAN (°F) MEAN (°C) MEAN (%RH) MEAN (%RH)

06/03/12 70.2 21.2 70.3 21.3 43.9 43.7

06/04/12 70.4 21.3 70.6 21.4 46.4 46.1

06/05/12 70.2 21.2 70.3 21.3 47.1 46.9

06/06/12 70.3 21.3 70.4 21.3 45.7 45.6

06/07/12 70.3 21.3 70.4 21.3 45.8 45.6

06/08/12 69.8 21.0 69.8 21.0 49.6 49.6

SUMMARY OF DAILY MEANS

70.3 69.8 70.6

MEAN MIN MAX

PRIMARY TEMP °F:

PRIMARY TEMP °C:

PRIMARY HUM %RH:

N DAYS

21.3 21.0 21.4

46.6 39.7 51.2

70.4

25

SECONDARY TEMP °F: 69.8 70.7

SECONDARY TEMP °C:

SECONDARY HUM %RH:

21.3 21.0 21.5

46.4 39.5 50.8

R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS

876001

876 - ACETALDEHYDE GROUP Page 2 of 4

PROJECT NO.:WIL- TEMPERATURE/HUMIDITY - STUDY SUMMARY REPORT

SPONSOR:

Page 82 of 178
N DAYS

LAST DAY

FIRST DAY

MEAN

N SAMPLES

SD

MAX

MIN

B ROOM 115 SUMMARY OF HOURLY VALUES

70.3 46.6

66.8

73.7

579

33.4

70.6

579

2.01 4.97

PRIMARY TEMP PRIMARY HUM

05/15/12

06/08/12

25

70.4

67.0

73.8

579

2.14

46.4

33.1

71.6

579

5.08

°F

°F

°F

°F

°F

°F

SECONDARY TEMP SECONDARY HUM

%RH

%RH

%RH

%RH

%RH

%RH

SE 0.08 0.09 0.21 0.21

21.3

19.3

23.2

1.12

°C

°C

°C

0.05

21.3

19.4

23.2

1.19

°C

°C

°C

0.05

R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS

876001

876 - ACETALDEHYDE GROUP Page 3 of 4

PROJECT NO.:WIL- TEMPERATURE/HUMIDITY - STUDY SUMMARY REPORT

SPONSOR:

Page 83 of 178
STUDY 876001 SUMMARY OF HOURLY VALUES

PRIMARY TEMP

LAST DAY

FIRST DAY

MEAN

N SAMPLES

SD

MAX

MIN

70.3 46.6

66.8

73.7

579

33.4

70.6

579

2.01 4.97

°F

PRIMARY HUM

05/15/12

06/08/12

25

70.4

67.0

73.8

579

2.14

46.4

33.1

71.6

579

5.08

°F

°F

°F

°F

°F

N DAYS

SECONDARY TEMP SECONDARY HUM

%RH

%RH

%RH

%RH

%RH

%RH

SE 0.08 0.09 0.21 0.21

21.3

19.3

23.2

1.12

°C

°C

°C

0.05

°C

21.3

19.4

23.2

1.19

°C

°C

0.05

R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS

876001

876 - ACETALDEHYDE GROUP Page 4 of 4

PROJECT NO.:WIL- TEMPERATURE/HUMIDITY - STUDY SUMMARY REPORT

SPONSOR:

11:35 25-Jun-12 WIL METASYS VERSION 2.27

Page 84 of 178
WIL-876001 Acetaldehyde

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc.

APPENDIX D

Pathology Report (WIL Research)

 Page 85 of 178
WIL-876001 Acetaldehyde

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc.

-1-

A Dosage Range-Finding 10-Day Oral 

(Drinking Water) Toxicity Study of Acetaldehyde in Rats

Pathology Report

WIL Research Pathology Department

 Page 86 of 178
WIL-876001 Acetaldehyde

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc.

-2-

TABLE OF CONTENTS

Page

Table of Contents.......................................................................................2

1. Introduction................................................................................................3

2. Study Design...............................................................................................3

3. Methods.......................................................................................................3

3.1. Anatomic Pathology.....................................................................................3

3.1.1. Macroscopic Examination ...........................................................................3

3.1.2. Microscopic Examination ............................................................................4

4. Results.........................................................................................................6

4.1. Survival........................................................................................................6

4.2. Gross Observations ......................................................................................6

4.3. Histologic Changes......................................................................................6

5. Conclusions.................................................................................................6

6. Reference ....................................................................................................6

7. Report Submission.....................................................................................7

 Page 87 of 178
WIL-876001 Acetaldehyde

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc.

-3-

1. INTRODUCTION

The objective of this study was to determine dose levels of acetaldehyde to be evaluated 

in a potential repeated dose toxicity study combined with the reproduction/developmental 

toxicity screening test (OECD 422) in rats. This pathology report addresses the 

anatomical endpoints of the study.

2. STUDY DESIGN

Female Crl:CD(SD) rats, an average of 9 weeks of age on study day 0, were offered 

drinking water or drinking water containing acetaldehyde ad libitum for 10 consecutive 

days as indicated in the following table.

Group 

Number Treatment

Test Item

Concentration

(mg/mL)

Number of 

Females

1 Vehicle Control a0 5

2 Acetaldehyde 1 5

3 Acetaldehyde 2 5

4 Acetaldehyde 3 5

5 Acetaldehyde 4 5

6 Acetaldehyde 5 5

a

- The vehicle control was reverse osmosis-purified water.

3. METHODS

3.1. ANATOMIC PATHOLOGY

3.1.1. MACROSCOPIC EXAMINATION

Complete postmortem examinations were performed on all animals at the scheduled 

necropsy. Animals were euthanized by carbon dioxide inhalation and exsanguinated. At 

the time of necropsy, the following tissues and organs were collected and placed in 

10% neutral-buffered formalin fixative unless otherwise noted:

 Page 88 of 178
WIL-876001 Acetaldehyde

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc.

-4-

Oral tissues

Tongue

Gingiva a

Oropharynx

Esophagus

Nonglandular forestomach

a

- Collected using the Morgan method of nasal cavity trimming (Morgan, 1991).

3.1.2. MICROSCOPIC EXAMINATION

Microscopic examination of routinely prepared hematoxylin-eosin stained paraffin 

sections was performed on all tissues collected at necropsy from all animals in the control 

and high-dose groups. Stained histologic sections were examined by light microscopy 

and observations were entered in the WIL Toxicology Data Management System 

(WTDMSTM) by the pathologist. Histologic sections were of adequate size and quality 

for detailed evaluation, and the number of tissues examined from each treatment group 

was sufficient to allow detection of test item-related histologic alterations.

Severity grades were assigned to non-neoplastic histopathologic diagnoses in compliance 

with the following general guidelines, as presented in the following table. Severity 

grades were assigned based on the severity of alterations in the examined histologic 

sections and may not reflect the overall severity of the pathologic process in the entire 

tissue, organ, or animal. The WTDMSTM histopathology tables contain all of the 

recorded data and serve as the basis for this narrative report. 

 Page 89 of 178
WIL-876001 Acetaldehyde

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc.

-5-

Unremarkable Tissue considered to be within normal limits, under the conditions 

of the study and considering the age, sex, and strain of the animal 

concerned. 

Present A non-gradable histologic change for which no additional 

information would be gained by assigning a severity grade

(e.g. cyst).

Grade 1 

(Minimal)

A histologic change that barely exceeds that which is considered 

to be within normal limits. This change is unlikely to produce any 

functional impairment.

Grade 2 

(Mild)

A histologic change that is easily identified but of limited severity. 

This change probably does not produce any functional 

impairment.

Grade 3 

(Moderate)

A histologic change that is a prominent feature of the tissue but 

not of maximal severity. Limited tissue or organ dysfunction is 

possible.

Grade 4 

(Severe)

A histologic change that is an overwhelming feature of the tissue 

and that may cause significant tissue or organ dysfunction.

 Page 90 of 178
WIL-876001 Acetaldehyde

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc.

-6-

4. RESULTS

4.1. SURVIVAL

All animals survived until the scheduled necropsy. 

4.2. GROSS OBSERVATIONS

Review of the gross necropsy observations revealed no observations that were considered 

to be associated with administration of the test item.

4.3. HISTOLOGIC CHANGES

There were no test item-related findings in the tissues examined.

5. CONCLUSIONS

Administration of acetaldehyde in ad libitum drinking water to female Crl:CD(SD) rats, 

for 10 consecutive days, at concentrations of 0, 1, 2, 3, 4, and 5 mg/mL, was associated 

with no early deaths, no gross pathology findings, and no histopathologic findings.

6. REFERENCE

Morgan, K.T. Approaches to the Identification and Recording of Nasal Lesions in 

Toxicology Studies. Toxicologic Pathology 1991, 19(4, Part 1), pp 337-351.

 Page 91 of 178
WIL-87600 I 

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc. 

Acetaldehyde 

W IL-87600 1 Pathology Report 

Repod Submitted BY: 

,a Nbaol3 

Date 

Study Pathologist 

 Page 92 of 178
WIL-876001 Acetaldehyde

Acetaldehyde Working Group of the Vinyl Acetate Council, Inc.

APPENDIX E

Individual Animal Data

 Page 93 of 178
 TABLE A1 (DAILY EXAMINATIONS)

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 1

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL CLINICAL OBSERVATIONS

 TABLE RANGE: 05-29-12 TO 06-08-12

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMAL SEX GROUP CATEGORY DATE TIME GRADE OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

 52050 F 0 MG/ML NORMAL 05-29-12 7:27 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:20 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:44 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:18 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:14 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:34 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:34 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:24 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:08 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 7:58 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:28 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52050 F 0 MG/ML DISPOSITION 06-08-12 8:13 P SCHEDULED EUTHANASIA

 52054 F 0 MG/ML NORMAL 05-29-12 7:28 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:21 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:44 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:18 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:14 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:34 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:34 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:25 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:09 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 7:58 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52054 F 0 MG/ML DISPOSITION 06-08-12 8:16 P SCHEDULED EUTHANASIA

 52054 F 0 MG/ML BODY/INTEGUMENT 06-08-12 7:29 1 HAIR LOSS LEFT FORELIMB

 52059 F 0 MG/ML NORMAL 05-29-12 7:28 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:22 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:44 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:19 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:15 P NO SIGNIFICANT CLINICAL OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

GRADE CODE: 1 - SLIGHT 2 - MODERATE 3 - SEVERE P - PRESENT

Page 94 of 178
 TABLE A1 (DAILY EXAMINATIONS)

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 2

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL CLINICAL OBSERVATIONS

 TABLE RANGE: 05-29-12 TO 06-08-12

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMAL SEX GROUP CATEGORY DATE TIME GRADE OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

 52059 F 0 MG/ML NORMAL 06-03-12 6:35 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:35 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:26 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:09 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 7:58 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:30 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52059 F 0 MG/ML DISPOSITION 06-08-12 8:14 P SCHEDULED EUTHANASIA

 52063 F 0 MG/ML NORMAL 05-29-12 7:28 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:23 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:45 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:20 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:15 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:35 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:35 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:26 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:09 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 7:59 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:30 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52063 F 0 MG/ML DISPOSITION 06-08-12 8:13 P SCHEDULED EUTHANASIA

 52071 F 0 MG/ML NORMAL 05-29-12 7:29 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:24 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:45 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:20 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:16 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:36 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:35 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:27 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:10 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 7:59 P NO SIGNIFICANT CLINICAL OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

GRADE CODE: 1 - SLIGHT 2 - MODERATE 3 - SEVERE P - PRESENT

Page 95 of 178
 TABLE A1 (DAILY EXAMINATIONS)

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 3

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL CLINICAL OBSERVATIONS

 TABLE RANGE: 05-29-12 TO 06-08-12

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMAL SEX GROUP CATEGORY DATE TIME GRADE OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

 52071 F 0 MG/ML NORMAL 06-08-12 7:31 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52071 F 0 MG/ML DISPOSITION 06-08-12 8:13 P SCHEDULED EUTHANASIA

 52042 F 1 MG/ML NORMAL 05-29-12 7:29 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:25 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:46 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:21 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:17 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:37 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:36 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:29 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:10 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:00 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:32 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52042 F 1 MG/ML DISPOSITION 06-08-12 8:12 P SCHEDULED EUTHANASIA

 52048 F 1 MG/ML NORMAL 05-29-12 7:30 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:26 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:47 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:22 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:17 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:38 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:37 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:30 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:00 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:32 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52048 F 1 MG/ML DISPOSITION 06-08-12 8:13 P SCHEDULED EUTHANASIA

 52048 F 1 MG/ML BODY/INTEGUMENT 06-06-12 8:11 1 HAIR LOSS RIGHT FORELIMB

 52055 F 1 MG/ML NORMAL 05-29-12 7:30 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:27 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:47 P NO SIGNIFICANT CLINICAL OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

GRADE CODE: 1 - SLIGHT 2 - MODERATE 3 - SEVERE P - PRESENT

Page 96 of 178
 TABLE A1 (DAILY EXAMINATIONS)

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 4

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL CLINICAL OBSERVATIONS

 TABLE RANGE: 05-29-12 TO 06-08-12

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMAL SEX GROUP CATEGORY DATE TIME GRADE OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

 52055 F 1 MG/ML NORMAL 06-01-12 7:23 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:18 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:38 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:37 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:30 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:11 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:01 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:33 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52055 F 1 MG/ML DISPOSITION 06-08-12 8:13 P SCHEDULED EUTHANASIA

 52057 F 1 MG/ML NORMAL 05-29-12 7:30 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:28 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:47 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:24 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:18 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:39 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:38 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:31 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:11 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:01 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:34 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52057 F 1 MG/ML DISPOSITION 06-08-12 8:13 P SCHEDULED EUTHANASIA

 52061 F 1 MG/ML NORMAL 05-29-12 7:31 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:29 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:48 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:25 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:18 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:40 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:38 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:32 P NO SIGNIFICANT CLINICAL OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

GRADE CODE: 1 - SLIGHT 2 - MODERATE 3 - SEVERE P - PRESENT

Page 97 of 178
 TABLE A1 (DAILY EXAMINATIONS)

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 5

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL CLINICAL OBSERVATIONS

 TABLE RANGE: 05-29-12 TO 06-08-12

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMAL SEX GROUP CATEGORY DATE TIME GRADE OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

 52061 F 1 MG/ML NORMAL 06-06-12 8:12 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:01 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:34 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52061 F 1 MG/ML DISPOSITION 06-08-12 8:12 P SCHEDULED EUTHANASIA

 52038 F 2 MG/ML NORMAL 05-29-12 7:31 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:30 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:48 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:27 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:19 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:41 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:39 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:33 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:12 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:02 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:35 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52038 F 2 MG/ML DISPOSITION 06-08-12 8:16 P SCHEDULED EUTHANASIA

 52047 F 2 MG/ML NORMAL 05-29-12 7:32 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:31 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:42 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:39 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:34 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:13 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:02 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52047 F 2 MG/ML DISPOSITION 06-08-12 8:14 P SCHEDULED EUTHANASIA

 52047 F 2 MG/ML BODY/INTEGUMENT 05-31-12 7:49 1 HAIR LOSS RIGHT FORELIMB

 06-01-12 7:27 1 HAIR LOSS RIGHT FORELIMB

 06-02-12 7:20 1 HAIR LOSS RIGHT FORELIMB

 06-08-12 7:36 1 HAIR LOSS RIGHT FORELIMB

 06-08-12 7:36 1 HAIR LOSS LEFT FORELIMB

-----------------------------------------------------------------------------------------------------------------------------------

GRADE CODE: 1 - SLIGHT 2 - MODERATE 3 - SEVERE P - PRESENT

Page 98 of 178
 TABLE A1 (DAILY EXAMINATIONS)

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 6

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL CLINICAL OBSERVATIONS

 TABLE RANGE: 05-29-12 TO 06-08-12

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMAL SEX GROUP CATEGORY DATE TIME GRADE OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

 52051 F 2 MG/ML NORMAL 05-29-12 7:32 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:33 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:49 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:28 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:20 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:42 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:39 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:35 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:13 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:02 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:36 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52051 F 2 MG/ML DISPOSITION 06-08-12 8:16 P SCHEDULED EUTHANASIA

 52053 F 2 MG/ML NORMAL 05-29-12 7:32 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:34 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:50 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:29 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:20 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:43 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:40 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:35 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:13 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:03 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:37 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52053 F 2 MG/ML DISPOSITION 06-08-12 8:16 P SCHEDULED EUTHANASIA

 52066 F 2 MG/ML NORMAL 05-29-12 7:33 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:34 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:50 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:30 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:21 P NO SIGNIFICANT CLINICAL OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

GRADE CODE: 1 - SLIGHT 2 - MODERATE 3 - SEVERE P - PRESENT

Page 99 of 178
 TABLE A1 (DAILY EXAMINATIONS)

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 7

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL CLINICAL OBSERVATIONS

 TABLE RANGE: 05-29-12 TO 06-08-12

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMAL SEX GROUP CATEGORY DATE TIME GRADE OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

 52066 F 2 MG/ML NORMAL 06-03-12 6:44 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:40 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:36 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:14 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:03 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:38 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52066 F 2 MG/ML DISPOSITION 06-08-12 8:14 P SCHEDULED EUTHANASIA

 52039 F 3 MG/ML NORMAL 05-29-12 7:34 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:36 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:51 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:31 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:21 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:45 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52039 F 3 MG/ML DISPOSITION 06-08-12 8:12 P SCHEDULED EUTHANASIA

 52039 F 3 MG/ML BODY/INTEGUMENT 06-04-12 7:41 1 HAIR LOSS RIGHT FORELIMB

 06-04-12 7:41 1 HAIR LOSS LEFT FORELIMB

 06-05-12 7:37 1 HAIR LOSS RIGHT FORELIMB

 06-05-12 7:37 1 HAIR LOSS LEFT FORELIMB

 06-06-12 8:14 1 HAIR LOSS RIGHT FORELIMB

 06-06-12 8:15 1 HAIR LOSS LEFT FORELIMB

 06-07-12 8:03 1 HAIR LOSS RIGHT FORELIMB

 06-07-12 8:03 1 HAIR LOSS LEFT FORELIMB

 06-08-12 7:38 1 HAIR LOSS RIGHT FORELIMB

 06-08-12 7:38 1 HAIR LOSS LEFT FORELIMB

 52046 F 3 MG/ML NORMAL 05-29-12 7:34 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:37 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:51 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:31 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:22 P NO SIGNIFICANT CLINICAL OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

GRADE CODE: 1 - SLIGHT 2 - MODERATE 3 - SEVERE P - PRESENT

Page 100 of 178
 TABLE A1 (DAILY EXAMINATIONS)

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 8

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL CLINICAL OBSERVATIONS

 TABLE RANGE: 05-29-12 TO 06-08-12

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMAL SEX GROUP CATEGORY DATE TIME GRADE OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

 52046 F 3 MG/ML NORMAL 06-03-12 6:45 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:42 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:38 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:15 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:04 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:39 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52046 F 3 MG/ML DISPOSITION 06-08-12 8:16 P SCHEDULED EUTHANASIA

 52056 F 3 MG/ML NORMAL 05-29-12 7:34 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:38 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:52 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:32 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:22 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:46 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:42 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:39 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:15 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:04 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:40 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52056 F 3 MG/ML DISPOSITION 06-08-12 8:14 P SCHEDULED EUTHANASIA

 52070 F 3 MG/ML NORMAL 05-29-12 7:35 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:39 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:52 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:33 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:23 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:47 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52070 F 3 MG/ML DISPOSITION 06-08-12 8:14 P SCHEDULED EUTHANASIA

 52070 F 3 MG/ML BODY/INTEGUMENT 06-04-12 7:42 1 HAIR LOSS RIGHT FORELIMB

 06-05-12 7:40 1 HAIR LOSS RIGHT FORELIMB

 06-06-12 8:16 1 HAIR LOSS RIGHT FORELIMB

-----------------------------------------------------------------------------------------------------------------------------------

GRADE CODE: 1 - SLIGHT 2 - MODERATE 3 - SEVERE P - PRESENT

Page 101 of 178
 TABLE A1 (DAILY EXAMINATIONS)

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 9

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL CLINICAL OBSERVATIONS

 TABLE RANGE: 05-29-12 TO 06-08-12

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMAL SEX GROUP CATEGORY DATE TIME GRADE OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

 52070 F 3 MG/ML BODY/INTEGUMENT 06-07-12 8:04 1 HAIR LOSS RIGHT FORELIMB

 06-08-12 7:40 1 HAIR LOSS RIGHT FORELIMB

 52072 F 3 MG/ML NORMAL 05-29-12 7:35 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:40 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:53 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:34 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:23 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:48 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:43 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:40 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:16 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:05 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:41 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52072 F 3 MG/ML DISPOSITION 06-08-12 8:12 P SCHEDULED EUTHANASIA

 52043 F 4 MG/ML NORMAL 05-29-12 7:36 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:41 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:53 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:34 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:23 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:48 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:43 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:42 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:17 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:05 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:42 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52043 F 4 MG/ML DISPOSITION 06-08-12 8:14 P SCHEDULED EUTHANASIA

 52044 F 4 MG/ML NORMAL 05-29-12 7:36 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:42 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:54 P NO SIGNIFICANT CLINICAL OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

GRADE CODE: 1 - SLIGHT 2 - MODERATE 3 - SEVERE P - PRESENT

Page 102 of 178
 TABLE A1 (DAILY EXAMINATIONS)

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 10

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL CLINICAL OBSERVATIONS

 TABLE RANGE: 05-29-12 TO 06-08-12

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMAL SEX GROUP CATEGORY DATE TIME GRADE OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

 52044 F 4 MG/ML NORMAL 06-01-12 7:35 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:24 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:49 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:44 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:43 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:17 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:05 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:42 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52044 F 4 MG/ML DISPOSITION 06-08-12 8:12 P SCHEDULED EUTHANASIA

 52052 F 4 MG/ML NORMAL 05-29-12 7:36 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:43 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:54 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:36 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:24 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:50 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:44 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:43 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:17 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:06 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:43 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52052 F 4 MG/ML DISPOSITION 06-08-12 8:14 P SCHEDULED EUTHANASIA

 52062 F 4 MG/ML NORMAL 05-29-12 7:37 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:43 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:55 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:37 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:25 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:51 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:45 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:44 P NO SIGNIFICANT CLINICAL OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

GRADE CODE: 1 - SLIGHT 2 - MODERATE 3 - SEVERE P - PRESENT

Page 103 of 178
 TABLE A1 (DAILY EXAMINATIONS)

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 11

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL CLINICAL OBSERVATIONS

 TABLE RANGE: 05-29-12 TO 06-08-12

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMAL SEX GROUP CATEGORY DATE TIME GRADE OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

 52062 F 4 MG/ML NORMAL 06-06-12 8:18 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:06 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:44 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52062 F 4 MG/ML DISPOSITION 06-08-12 8:14 P SCHEDULED EUTHANASIA

 52064 F 4 MG/ML NORMAL 05-29-12 7:37 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:44 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:55 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:37 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:25 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:51 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:45 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:45 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:18 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:06 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:44 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52064 F 4 MG/ML DISPOSITION 06-08-12 8:16 P SCHEDULED EUTHANASIA

 52040 F 5 MG/ML NORMAL 05-29-12 7:38 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:45 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:56 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:38 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:26 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:52 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:46 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:46 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:19 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:07 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52040 F 5 MG/ML DISPOSITION 06-08-12 8:13 P SCHEDULED EUTHANASIA

 52040 F 5 MG/ML BODY/INTEGUMENT 06-08-12 7:45 1 HAIR LOSS RIGHT FORELIMB

 06-08-12 7:45 1 HAIR LOSS LEFT FORELIMB

-----------------------------------------------------------------------------------------------------------------------------------

GRADE CODE: 1 - SLIGHT 2 - MODERATE 3 - SEVERE P - PRESENT

Page 104 of 178
 TABLE A1 (DAILY EXAMINATIONS)

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 12

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL CLINICAL OBSERVATIONS

 TABLE RANGE: 05-29-12 TO 06-08-12

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMAL SEX GROUP CATEGORY DATE TIME GRADE OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

 52041 F 5 MG/ML NORMAL 05-29-12 7:38 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:46 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:56 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:39 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:26 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:53 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:46 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:46 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:19 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:07 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:46 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52041 F 5 MG/ML DISPOSITION 06-08-12 8:14 P SCHEDULED EUTHANASIA

 52060 F 5 MG/ML NORMAL 05-29-12 7:39 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:47 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:57 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:40 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:27 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:53 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:47 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:47 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:19 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:07 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:46 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52060 F 5 MG/ML DISPOSITION 06-08-12 8:13 P SCHEDULED EUTHANASIA

 52065 F 5 MG/ML NORMAL 05-29-12 7:39 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:48 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:57 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:40 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:27 P NO SIGNIFICANT CLINICAL OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

GRADE CODE: 1 - SLIGHT 2 - MODERATE 3 - SEVERE P - PRESENT

Page 105 of 178
 TABLE A1 (DAILY EXAMINATIONS)

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 13

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL CLINICAL OBSERVATIONS

 TABLE RANGE: 05-29-12 TO 06-08-12

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMAL SEX GROUP CATEGORY DATE TIME GRADE OBSERVATIONS

-----------------------------------------------------------------------------------------------------------------------------------

 52065 F 5 MG/ML NORMAL 06-03-12 6:54 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:47 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:48 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:20 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:07 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:47 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52065 F 5 MG/ML DISPOSITION 06-08-12 8:13 P SCHEDULED EUTHANASIA

 52069 F 5 MG/ML NORMAL 05-29-12 7:40 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-30-12 7:48 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 05-31-12 7:58 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-01-12 7:41 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-02-12 7:28 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-03-12 6:55 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-04-12 7:48 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-05-12 7:48 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-06-12 8:20 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-07-12 8:08 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 06-08-12 7:48 P NO SIGNIFICANT CLINICAL OBSERVATIONS

 52069 F 5 MG/ML DISPOSITION 06-08-12 8:12 P SCHEDULED EUTHANASIA

-----------------------------------------------------------------------------------------------------------------------------------

GRADE CODE: 1 - SLIGHT 2 - MODERATE 3 - SEVERE P - PRESENT

 PCRDv4.18

 06/22/2012

Page 106 of 178
 TABLE A2

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 1

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL BODY WEIGHTS [G]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0 1 2 3 4 5 6 7 8 9 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 1: 0 MG/ML

-------------------------------------------

 52050 228. 230. 224. 234. 234. 239. 236. 243. 243. 247. 241.

 52054 207. 206. 213. 220. 218. 217. 222. 228. 230. 228. 223.

 52059 222. 228. 226. 227. 231. 237. 239. 233. 235. 239. 242.

 52063 202. 205. 208. 205. 210. 213. 215. 211. 214. 218. 224.

 52071 210. 214. 221. 226. 228. 229. 233. 232. 235. 233. 240.

 MEAN 214. 217. 218. 222. 224. 227. 229. 229. 232. 233. 234.

 S.D. 11.0 12.0 7.6 11.1 9.9 11.5 10.1 11.5 11.0 10.9 9.7

 S.E. 4.9 5.4 3.4 5.0 4.4 5.1 4.5 5.2 4.9 4.9 4.3

 N 5 5 5 5 5 5 5 5 5 5 5

Page 107 of 178
 TABLE A2

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 2

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL BODY WEIGHTS [G]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0 1 2 3 4 5 6 7 8 9 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 2: 1 MG/ML

-------------------------------------------

 52042 214. 212. 217. 223. 223. 224. 226. 230. 226. 229. 235.

 52048 197. 197. 200. 198. 200. 207. 210. 209. 205. 203. 207.

 52055 212. 210. 210. 221. 225. 228. 223. 228. 232. 231. 228.

 52057 220. 225. 232. 228. 225. 234. 235. 237. 239. 234. 243.

 52061 227. 227. 226. 229. 231. 238. 243. 241. 243. 245. 248.

 MEAN 214. 214. 217. 220. 221. 226. 227. 229. 229. 228. 232.

 S.D. 11.0 12.1 12.8 12.8 12.1 12.2 12.6 12.2 15.2 15.6 16.1

 S.E. 4.9 5.4 5.7 5.7 5.4 5.4 5.7 5.5 6.8 7.0 7.2

 N 5 5 5 5 5 5 5 5 5 5 5

Page 108 of 178
 TABLE A2

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 3

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL BODY WEIGHTS [G]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0 1 2 3 4 5 6 7 8 9 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 3: 2 MG/ML

-------------------------------------------

 52038 180. 187. 192. 192. 189. 197. 202. 198. 194. 197. 205.

 52047 202. 208. 209. 213. 212. 214. 215. 218. 222. 217. 218.

 52051 212. 203. 212. 213. 214. 210. 218. 214. 218. 214. 216.

 52053 218. 215. 216. 225. 222. 224. 224. 223. 230. 230. 228.

 52066 226. 226. 233. 238. 238. 237. 242. 243. 242. 241. 252.

 MEAN 208. 208. 212. 216. 215. 216. 220. 219. 221. 220. 224.

 S.D. 17.6 14.5 14.7 16.9 17.8 15.2 14.5 16.2 17.7 16.6 17.7

 S.E. 7.9 6.5 6.6 7.6 8.0 6.8 6.5 7.2 7.9 7.4 7.9

 N 5 5 5 5 5 5 5 5 5 5 5

Page 109 of 178
 TABLE A2

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 4

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL BODY WEIGHTS [G]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0 1 2 3 4 5 6 7 8 9 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 4: 3 MG/ML

-------------------------------------------

 52039 220. 210. 221. 226. 232. 225. 231. 233. 237. 231. 244.

 52046 212. 214. 212. 210. 213. 218. 220. 222. 218. 215. 221.

 52056 214. 212. 219. 222. 226. 221. 227. 233. 231. 226. 236.

 52070 217. 216. 224. 228. 232. 234. 229. 238. 242. 246. 247.

 52072 229. 225. 217. 229. 236. 237. 232. 239. 242. 243. 242.

 MEAN 218. 216. 219. 223. 228. 227. 228. 233. 234. 232. 238.

 S.D. 6.4 6.0 4.4 7.8 8.9 8.0 4.6 6.9 9.9 12.5 10.3

 S.E. 2.9 2.7 2.0 3.5 4.0 3.6 2.1 3.1 4.4 5.6 4.6

 N 5 5 5 5 5 5 5 5 5 5 5

Page 110 of 178
 TABLE A2

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 5

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL BODY WEIGHTS [G]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0 1 2 3 4 5 6 7 8 9 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 5: 4 MG/ML

-------------------------------------------

 52043 205. 208. 210. 209. 205. 209. 211. 210. 209. 210. 213.

 52044 217. 221. 222. 226. 228. 229. 236. 234. 234. 233. 239.

 52052 209. 210. 203. 209. 216. 220. 210. 215. 216. 219. 215.

 52062 222. 218. 225. 229. 234. 229. 236. 241. 240. 237. 245.

 52064 213. 212. 213. 216. 225. 221. 222. 220. 226. 223. 224.

 MEAN 213. 214. 215. 218. 222. 222. 223. 224. 225. 224. 227.

 S.D. 6.8 5.5 9.3 9.4 11.2 8.4 12.8 13.2 12.7 10.8 14.2

 S.E. 3.0 2.5 4.1 4.2 5.0 3.7 5.7 5.9 5.7 4.8 6.3

 N 5 5 5 5 5 5 5 5 5 5 5

Page 111 of 178
 TABLE A2

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 6

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL BODY WEIGHTS [G]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0 1 2 3 4 5 6 7 8 9 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 6: 5 MG/ML

-------------------------------------------

 52040 235. 237. 241. 245. 248. 249. 255. 256. 256. 257. 265.

 52041 213. 207. 209. 215. 218. 213. 219. 218. 221. 216. 224.

 52060 217. 220. 220. 219. 223. 226. 229. 224. 232. 232. 234.

 52065 186. 184. 183. 192. 194. 193. 189. 197. 201. 202. 197.

 52069 220. 229. 231. 234. 229. 235. 239. 239. 235. 242. 246.

 MEAN 214. 215. 217. 221. 222. 223. 226. 227. 229. 230. 233.

 S.D. 17.8 20.8 22.4 20.3 19.7 21.4 24.8 22.2 20.1 21.5 25.5

 S.E. 7.9 9.3 10.0 9.1 8.8 9.6 11.1 9.9 9.0 9.6 11.4

 N 5 5 5 5 5 5 5 5 5 5 5

 PJTBWv4.25

Page 112 of 178

 06/22/2012
 TABLE A3

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 1

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL BODY WEIGHT CHANGES [G]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 1: 0 MG/ML

-------------------------------------------

 52050 2. -7. 11. 0. 4. -3. 7. 1. 3. -6. 13.

 52054 -1. 7. 8. -2. -1. 5. 6. 2. -3. -5. 16.

 52059 6. -2. 1. 4. 7. 2. -6. 2. 3. 3. 20.

 52063 4. 3. -4. 6. 3. 1. -3. 3. 4. 6. 22.

 52071 4. 7. 5. 2. 2. 3. 0. 3. -3. 7. 30.

 MEAN 3. 2. 4. 2. 3. 2. 1. 2. 1. 1. 20.

 S.D. 2.6 5.8 5.7 3.1 2.8 3.1 5.6 0.9 3.3 6.2 6.6

 S.E. 1.2 2.6 2.6 1.4 1.2 1.4 2.5 0.4 1.5 2.8 2.9

 N 5 5 5 5 5 5 5 5 5 5 5

Page 113 of 178
 TABLE A3

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 2

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL BODY WEIGHT CHANGES [G]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 2: 1 MG/ML

-------------------------------------------

 52042 -2. 5. 6. 0. 1. 2. 4. -5. 3. 7. 22.

 52048 0. 2. -2. 2. 7. 3. 0. -5. -2. 4. 9.

 52055 -2. 0. 11. 4. 3. -5. 5. 4. -1. -3. 16.

 52057 5. 7. -4. -3. 9. 2. 2. 2. -6. 9. 23.

 52061 0. -1. 4. 1. 7. 5. -2. 2. 2. 2. 21.

 MEAN 0. 3. 3. 1. 5. 1. 2. 0. -1. 4. 18.

 S.D. 2.8 3.5 6.0 2.7 3.2 3.8 2.8 4.2 3.4 4.7 5.6

 S.E. 1.2 1.6 2.7 1.2 1.4 1.7 1.2 1.9 1.5 2.1 2.5

 N 5 5 5 5 5 5 5 5 5 5 5

Page 114 of 178
 TABLE A3

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 3

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL BODY WEIGHT CHANGES [G]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 3: 2 MG/ML

-------------------------------------------

 52038 7. 5. 0. -3. 8. 5. -4. -4. 3. 8. 25.

 52047 6. 1. 4. -1. 3. 1. 3. 4. -5. 1. 16.

 52051 -8. 9. 2. 1. -5. 9. -4. 4. -4. 2. 4.

 52053 -4. 1. 10. -3. 2. 0. -1. 7. 0. -2. 10.

 52066 1. 7. 4. 1. -1. 5. 1. -1. -1. 11. 26.

 MEAN 0. 4. 4. -1. 1. 4. -1. 2. -1. 4. 16.

 S.D. 6.4 3.5 3.7 2.0 4.8 3.6 3.0 4.7 3.3 5.5 9.4

 S.E. 2.9 1.6 1.7 0.9 2.1 1.6 1.3 2.1 1.5 2.5 4.2

 N 5 5 5 5 5 5 5 5 5 5 5

Page 115 of 178
 TABLE A3

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 4

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL BODY WEIGHT CHANGES [G]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 4: 3 MG/ML

-------------------------------------------

 52039 -11. 12. 5. 6. -6. 6. 2. 3. -5. 13. 24.

 52046 2. -2. -2. 3. 5. 2. 1. -3. -3. 6. 9.

 52056 -2. 7. 3. 4. -5. 6. 6. -2. -4. 10. 22.

 52070 -1. 8. 4. 4. 2. -5. 10. 4. 4. 1. 30.

 52072 -3. -8. 12. 7. 1. -5. 7. 3. 1. -1. 14.

 MEAN -3. 3. 4. 5. -1. 1. 5. 1. -2. 6. 20.

 S.D. 4.7 8.1 5.0 1.4 4.9 5.6 3.5 3.4 3.9 5.9 8.3

 S.E. 2.1 3.6 2.2 0.6 2.2 2.5 1.5 1.5 1.7 2.6 3.7

 N 5 5 5 5 5 5 5 5 5 5 5

Page 116 of 178
 TABLE A3

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 5

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL BODY WEIGHT CHANGES [G]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 5: 4 MG/ML

-------------------------------------------

 52043 3. 2. -1. -4. 4. 2. -1. -1. 2. 3. 9.

 52044 3. 2. 4. 1. 2. 7. -2. 0. -1. 5. 21.

 52052 1. -7. 6. 8. 4. -10. 4. 2. 2. -4. 6.

 52062 -3. 7. 3. 5. -5. 7. 4. -1. -3. 9. 23.

 52064 -1. 2. 3. 9. -4. 1. -2. 6. -3. 1. 11.

 MEAN 1. 1. 3. 4. 0. 1. 1. 1. -1. 3. 14.

 S.D. 3.0 5.0 2.3 5.2 4.2 6.7 3.3 3.1 2.3 4.6 7.7

 S.E. 1.3 2.2 1.0 2.3 1.9 3.0 1.5 1.4 1.0 2.0 3.4

 N 5 5 5 5 5 5 5 5 5 5 5

Page 117 of 178
 TABLE A3

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 6

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL BODY WEIGHT CHANGES [G]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 6: 5 MG/ML

-------------------------------------------

 52040 2. 4. 4. 3. 1. 7. 0. 0. 1. 8. 30.

 52041 -7. 2. 5. 4. -5. 6. -1. 2. -5. 8. 10.

 52060 2. 0. -1. 4. 3. 2. -4. 8. 0. 2. 16.

 52065 -2. -1. 9. 2. -1. -4. 8. 5. 1. -6. 11.

 52069 9. 2. 3. -5. 6. 4. 0. -4. 7. 4. 26.

 MEAN 1. 1. 4. 2. 1. 3. 1. 2. 1. 3. 19.

 S.D. 5.8 2.1 3.5 3.8 4.1 4.3 4.4 4.4 4.2 5.5 9.0

 S.E. 2.6 0.9 1.6 1.7 1.9 1.9 2.0 1.9 1.9 2.5 4.0

 N 5 5 5 5 5 5 5 5 5 5 5

 PJTBWv4.25

Page 118 of 178

 06/22/2012
 TABLE A4

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 1

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL FOOD CONSUMPTION [G/ANIMAL/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 1: 0 MG/ML

-------------------------------------------

 52050 20. 16. 22. 21. 22. 20. 20. 23. 21. 17. 20.

 52054 1. 20. 21. 18. 18. 21. 21. 21. 17. 16. 17.

 52059 19. 18. 15. 18. 21. 19. 14. 24. 21. 25. 19.

 52063 16. 18. 12. 16. 17. 17. 14. 17. 18. 20. 16.

 52071 25. 18. 19. 19. 17. 19. 17. 21. 16. 24. 20.

 MEAN 16. 18. 18. 18. 19. 19. 17. 21. 19. 20. 19.

 S.D. 8.9 1.5 4.0 1.9 2.6 1.5 3.2 2.7 2.3 3.9 1.6

 S.E. 4.0 0.7 1.8 0.9 1.2 0.7 1.5 1.2 1.0 1.7 0.7

 N 5 5 5 5 5 5 5 5 5 5 5

Page 119 of 178
 TABLE A4

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 2

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL FOOD CONSUMPTION [G/ANIMAL/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 2: 1 MG/ML

-------------------------------------------

 52042 13. 17. 18. 19. 17. 22. 20. 18. 16. 20. 18.

 52048 15. 16. 13. 15. 18. 17. 14. 15. 12. 13. 15.

 52055 15. 16. 19. 18. 19. 16. 17. 20. 17. 15. 17.

 52057 20. 19. 14. 13. 19. 18. 15. 18. 13. 19. 17.

 52061 21. 16. 17. 17. 21. 21. 17. 20. 18. 19. 19.

 MEAN 17. 17. 16. 16. 19. 19. 17. 18. 15. 17. 17.

 S.D. 3.3 1.1 2.3 2.4 1.6 2.7 2.2 1.8 2.7 3.0 1.5

 S.E. 1.5 0.5 1.0 1.1 0.7 1.2 1.0 0.8 1.2 1.3 0.7

 N 5 5 5 5 5 5 5 5 5 5 5

Page 120 of 178
 TABLE A4

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 3

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL FOOD CONSUMPTION [G/ANIMAL/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 3: 2 MG/ML

-------------------------------------------

 52038 14. 18. 15. 13. 17. 22. 15. 13. 16. 21. 17.

 52047 13. 15. 16. 15. 16. 15. 16. 18. 14. 14. 15.

 52051 12. 18. 16. 18. 15. 18. 14. 20. 13. 17. 16.

 52053 13. 17. 20. 16. 18. 16. 16. 19. 16. 16. 17.

 52066 17. 21. 20. 21. 17. 20. 20. 21. 17. 22. 20.

 MEAN 14. 18. 17. 17. 17. 18. 16. 18. 15. 18. 17.

 S.D. 2.2 2.0 2.3 2.9 1.1 2.9 2.3 3.0 1.5 3.4 1.7

 S.E. 1.0 0.9 1.1 1.3 0.5 1.3 1.0 1.3 0.7 1.5 0.7

 N 5 5 5 5 5 5 5 5 5 5 5

Page 121 of 178
 TABLE A4

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 4

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL FOOD CONSUMPTION [G/ANIMAL/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 4: 3 MG/ML

-------------------------------------------

 52039 12. 20. 18. 17. 15. 19. 17. 19. 13. 23. 17.

 52046 16. 15. 14. 15. 19. 20. 16. 17. 15. 21. 17.

 52056 10. 18. 18. 20. 15. 19. 21. 17. 12. 20. 17.

 52070 15. 18. 18. 18. 19. 15. 19. 20. 18. 19. 18.

 52072 15. 13. 19. 19. 19. 17. 20. 25. 19. 20. 19.

 MEAN 14. 17. 17. 18. 17. 18. 19. 20. 15. 21. 17.

 S.D. 2.6 2.6 2.0 1.9 2.1 1.9 2.0 3.0 3.0 1.7 0.8

 S.E. 1.1 1.2 0.9 0.8 0.9 0.8 0.9 1.3 1.4 0.8 0.3

 N 5 5 5 5 5 5 5 5 5 5 5

Page 122 of 178
 TABLE A4

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 5

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL FOOD CONSUMPTION [G/ANIMAL/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 5: 4 MG/ML

-------------------------------------------

 52043 17. 18. 15. 13. 17. 17. 16. 15. 15. 17. 16.

 52044 16. 17. 18. 16. 17. 20. 15. 19. 13. 32. 18.

 52052 15. 13. 16. 20. 18. 13. 17. 17. 17. 13. 16.

 52062 14. 19. 19. 20. 14. 19. 20. 21. 14. 29. 19.

 52064 14. 15. 15. 18. 15. 15. 14. 20. 15. 18. 16.

 MEAN 15. 17. 17. 17. 16. 17. 16. 18. 15. 22. 17.

 S.D. 1.1 2.4 2.0 2.8 1.6 2.7 2.5 2.2 1.2 8.2 1.4

 S.E. 0.5 1.1 0.9 1.3 0.7 1.2 1.1 1.0 0.6 3.7 0.6

 N 5 5 5 5 5 5 5 5 5 5 5

Page 123 of 178
 TABLE A4

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 6

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL FOOD CONSUMPTION [G/ANIMAL/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 6: 5 MG/ML

-------------------------------------------

 52040 18. 19. 20. 19. 18. 21. 19. 20. 16. 25. 20.

 52041 14. 16. 19. 19. 16. 17. 17. 18. 14. 20. 17.

 52060 18. 11. 14. 17. 19. 23. 14. 18. 19. 22. 17.

 52065 12. 11. 17. 16. 15. 11. 17. 19. 15. NA 15.

 52069 20. 17. 18. 14. 20. 19. 15. 16. 17. 21. 18.

 MEAN 16. 15. 18. 17. 18. 18. 17. 18. 16. 22. 17.

 S.D. 3.4 3.8 2.5 2.3 1.9 4.7 1.9 1.5 2.0 2.4 1.7

 S.E. 1.5 1.7 1.1 1.0 0.9 2.1 0.8 0.7 0.9 1.2 0.8

 N 5 5 5 5 5 5 5 5 5 4 5

NA = NOT APPLICABLE

 PJTFWv4.25

 06/22/2012

Page 124 of 178
 TABLE A5

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 1

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL FOOD CONSUMPTION [G/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 1: 0 MG/ML

-------------------------------------------

 52050 87. 70. 94. 90. 94. 84. 85. 95. 87. 70. 86.

 52054 6. 96. 95. 81. 81. 93. 92. 90. 74. 70. 79.

 52059 83. 78. 67. 78. 90. 79. 58. 101. 87. 102. 83.

 52063 78. 86. 58. 77. 79. 77. 68. 80. 85. 89. 78.

 52071 118. 82. 87. 84. 73. 84. 73. 91. 68. 101. 86.

 MEAN 74. 82. 80. 82. 83. 83. 75. 91. 80. 86. 82.

 S.D. 41.2 9.7 16.6 5.3 8.5 6.3 13.5 7.9 8.6 15.6 3.8

 S.E. 18.4 4.3 7.4 2.4 3.8 2.8 6.1 3.5 3.9 7.0 1.7

 N 5 5 5 5 5 5 5 5 5 5 5

Page 125 of 178
 TABLE A5

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 2

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL FOOD CONSUMPTION [G/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 2: 1 MG/ML

-------------------------------------------

 52042 63. 80. 81. 85. 76. 97. 87. 80. 72. 87. 81.

 52048 78. 81. 67. 74. 87. 82. 67. 73. 57. 65. 73.

 52055 72. 76. 88. 79. 82. 70. 75. 86. 75. 66. 77.

 52057 89. 81. 63. 57. 84. 75. 65. 76. 57. 80. 72.

 52061 92. 70. 74. 74. 91. 88. 69. 81. 73. 78. 79.

 MEAN 78. 78. 74. 74. 84. 82. 73. 79. 67. 75. 76.

 S.D. 12.1 4.7 10.3 10.4 5.4 10.8 8.9 4.7 9.2 9.5 3.8

 S.E. 5.4 2.1 4.6 4.6 2.4 4.8 4.0 2.1 4.1 4.2 1.7

 N 5 5 5 5 5 5 5 5 5 5 5

Page 126 of 178
 TABLE A5

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 3

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL FOOD CONSUMPTION [G/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 3: 2 MG/ML

-------------------------------------------

 52038 77. 95. 80. 69. 90. 110. 77. 67. 81. 103. 85.

 52047 63. 73. 76. 69. 73. 69. 74. 83. 64. 66. 71.

 52051 57. 88. 73. 83. 72. 85. 66. 91. 62. 77. 76.

 52053 58. 79. 90. 73. 79. 72. 73. 86. 69. 69. 75.

 52066 77. 91. 85. 87. 72. 84. 84. 85. 71. 91. 82.

 MEAN 66. 85. 81. 76. 77. 84. 75. 82. 69. 81. 78.

 S.D. 9.9 8.9 6.8 8.2 7.8 16.2 6.5 9.1 7.4 15.5 5.7

 S.E. 4.4 4.0 3.1 3.7 3.5 7.2 2.9 4.1 3.3 6.9 2.6

 N 5 5 5 5 5 5 5 5 5 5 5

Page 127 of 178
 TABLE A5

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 4

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL FOOD CONSUMPTION [G/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 4: 3 MG/ML

-------------------------------------------

 52039 57. 91. 79. 76. 66. 84. 75. 80. 55. 98. 76.

 52046 76. 70. 65. 70. 89. 92. 72. 79. 68. 94. 77.

 52056 47. 82. 81. 88. 68. 84. 91. 75. 52. 87. 75.

 52070 71. 82. 81. 80. 79. 67. 81. 84. 73. 77. 78.

 52072 66. 60. 84. 81. 80. 73. 84. 102. 78. 81. 79.

 MEAN 63. 77. 78. 79. 76. 80. 80. 84. 65. 88. 77.

 S.D. 11.5 12.3 7.5 6.5 9.6 10.0 7.9 10.8 11.2 8.9 1.6

 S.E. 5.1 5.5 3.4 2.9 4.3 4.5 3.5 4.8 5.0 4.0 0.7

 N 5 5 5 5 5 5 5 5 5 5 5

Page 128 of 178
 TABLE A5

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 5

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL FOOD CONSUMPTION [G/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 5: 4 MG/ML

-------------------------------------------

 52043 80. 88. 71. 64. 82. 81. 76. 74. 70. 82. 77.

 52044 71. 77. 82. 70. 72. 84. 66. 80. 57. 135. 79.

 52052 72. 64. 80. 94. 81. 61. 80. 80. 77. 59. 75.

 52062 63. 86. 85. 85. 60. 83. 85. 87. 61. 120. 81.

 52064 66. 73. 70. 82. 67. 69. 61. 91. 67. 82. 73.

 MEAN 70. 77. 77. 79. 72. 76. 74. 82. 66. 95. 77.

 S.D. 6.5 10.0 6.6 12.1 9.5 9.9 9.9 6.7 7.8 31.3 3.4

 S.E. 2.9 4.5 3.0 5.4 4.3 4.4 4.4 3.0 3.5 14.0 1.5

 N 5 5 5 5 5 5 5 5 5 5 5

Page 129 of 178
 TABLE A5

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 6

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL FOOD CONSUMPTION [G/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 6: 5 MG/ML

-------------------------------------------

 52040 76. 80. 83. 78. 73. 85. 75. 76. 62. 96. 79.

 52041 64. 75. 88. 89. 74. 81. 75. 82. 62. 90. 78.

 52060 82. 49. 62. 75. 85. 102. 63. 81. 80. 94. 77.

 52065 65. 60. 93. 85. 79. 58. 89. 97. 74. NA 78.

 52069 90. 75. 78. 60. 85. 81. 64. 67. 73. 84. 76.

 MEAN 75. 68. 81. 77. 79. 81. 73. 80. 70. 91. 77.

 S.D. 11.0 13.0 11.8 11.2 5.7 15.8 10.6 10.8 8.1 5.3 1.2

 S.E. 4.9 5.8 5.3 5.0 2.6 7.1 4.7 4.8 3.6 2.7 0.5

 N 5 5 5 5 5 5 5 5 5 4 5

NA = NOT APPLICABLE

 PJTFWv4.25

 06/22/2012

Page 130 of 178
 TABLE A6

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 1

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL WATER CONSUMPTION [G/ANIMAL/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 1: 0 MG/ML

-------------------------------------------

 52050 34. 35. 41. 61. 43. NA 37. 51. 39. 44. 43.

 52054 15. 33. 28. 40. 26. 40. 28. 70. 30. 36. 35.

 52059 31. 38. 31. 51. 36. 58. 38. 88. 39. 61. 47.

 52063 21. 28. 23. 43. 34. 41. 33. 67. 39. 51. 38.

 52071 21. 32. 29. 43. 40. 49. 28. 49. 26. 37. 35.

 MEAN 24. 33. 30. 48. 36. 47. 33. 65. 35. 46. 40.

 S.D. 7.8 4.0 6.5 8.5 6.3 8.6 4.8 15.7 6.5 10.5 5.3

 S.E. 3.5 1.8 2.9 3.8 2.8 4.3 2.1 7.0 2.9 4.7 2.4

 N 5 5 5 5 5 4 5 5 5 5 5

Page 131 of 178

NA = NOT APPLICABLE
 TABLE A6

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 2

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL WATER CONSUMPTION [G/ANIMAL/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 2: 1 MG/ML

-------------------------------------------

 52042 40. NA 58. 91. 62. NA 23. 39. 37. 55. 51.

 52048 NA NA 35. 96. 42. 53. 22. 21. NA NA 45.

 52055 30. 52. 50. 95. 49. 58. 27. 45. 25. 28. 46.

 52057 38. NA 30. NA 55. NA 30. 44. 30. 37. 38.

 52061 35. 65. 24. 33. 32. 43. 21. 30. 24. 26. 33.

 MEAN 36. 58. 40. 79. 48. 51. 25. 36. 29. 36. 42.

 S.D. 4.4 9.3 14.1 30.2 11.7 7.4 3.9 10.0 5.8 13.2 6.8

 S.E. 2.2 6.6 6.3 15.1 5.2 4.3 1.7 4.5 2.9 6.6 3.1

 N 4 2 5 4 5 3 5 5 4 4 5

Page 132 of 178

NA = NOT APPLICABLE
 TABLE A6

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 3

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL WATER CONSUMPTION [G/ANIMAL/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 3: 2 MG/ML

-------------------------------------------

 52038 30. NA 29. 69. 33. 56. 16. 25. 24. 33. 35.

 52047 24. 40. 24. 27. 35. 53. 23. 33. 24. 29. 31.

 52051 25. 70. 24. 52. 29. 49. 22. 35. 27. 35. 37.

 52053 20. 39. 26. 38. 34. 40. 23. 39. 31. 29. 32.

 52066 29. 61. 39. 42. 28. 37. 28. 32. 26. 31. 35.

 MEAN 26. 53. 28. 46. 32. 47. 22. 33. 26. 31. 34.

 S.D. 4.2 15.5 6.3 15.8 3.2 8.1 4.4 5.1 2.6 2.6 2.4

 S.E. 1.9 7.7 2.8 7.1 1.4 3.6 2.0 2.3 1.2 1.2 1.1

 N 5 4 5 5 5 5 5 5 5 5 5

Page 133 of 178

NA = NOT APPLICABLE
 TABLE A6

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 4

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL WATER CONSUMPTION [G/ANIMAL/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 4: 3 MG/ML

-------------------------------------------

 52039 18. 47. 27. 47. 34. 48. 24. 29. 17. 28. 32.

 52046 26. 52. 27. 52. 24. 34. 21. 31. 20. 27. 31.

 52056 17. 33. 30. 39. 19. 33. 29. 33. 17. 30. 28.

 52070 22. 42. 28. 32. 22. 28. 32. 47. 23. 22. 30.

 52072 19. 27. 25. 38. 28. 30. 27. 37. 22. 26. 28.

 MEAN 21. 40. 27. 42. 25. 34. 27. 35. 20. 27. 30.

 S.D. 3.6 10.4 1.5 7.8 5.9 7.9 4.3 7.1 2.5 2.9 2.0

 S.E. 1.6 4.6 0.7 3.5 2.6 3.5 1.9 3.2 1.1 1.3 0.9

 N 5 5 5 5 5 5 5 5 5 5 5

Page 134 of 178
 TABLE A6

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 5

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL WATER CONSUMPTION [G/ANIMAL/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 5: 4 MG/ML

-------------------------------------------

 52043 21. 28. 18. 23. 24. 26. 19. 23. 17. 23. 22.

 52044 23. 33. 24. 31. 24. 38. 19. 21. 20. 25. 26.

 52052 20. 27. 20. 31. 23. 23. 16. 24. 17. 19. 22.

 52062 14. 29. 19. 33. 16. 31. 19. 25. 15. 25. 23.

 52064 23. 34. 22. NA 26. 32. 25. 37. NA 53. 31.

 MEAN 20. 30. 21. 29. 23. 30. 19. 26. 17. 29. 25.

 S.D. 3.7 3.2 2.0 4.4 3.9 5.5 3.5 6.1 2.4 13.8 4.1

 S.E. 1.6 1.4 0.9 2.2 1.8 2.5 1.6 2.7 1.2 6.2 1.8

 N 5 5 5 4 5 5 5 5 4 5 5

Page 135 of 178

NA = NOT APPLICABLE
 TABLE A6

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 6

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL WATER CONSUMPTION [G/ANIMAL/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 6: 5 MG/ML

-------------------------------------------

 52040 29. 36. 29. 44. 30. 36. 28. NA 26. 29. 32.

 52041 14. 29. 22. 35. 20. 33. 17. 30. 13. 25. 24.

 52060 21. 26. 21. 33. 24. 30. 19. 34. 22. 22. 25.

 52065 17. 23. 22. 24. 19. 22. 20. 27. 19. 21. 21.

 52069 27. 34. 31. 31. 26. 35. 22. 25. 33. 38. 30.

 MEAN 22. 29. 25. 33. 24. 31. 21. 29. 23. 27. 26.

 S.D. 6.4 5.2 4.5 7.1 4.4 5.5 4.4 3.6 7.6 7.0 4.4

 S.E. 2.8 2.3 2.0 3.2 2.0 2.5 2.0 1.8 3.4 3.2 2.0

 N 5 5 5 5 5 5 5 4 5 5 5

NA = NOT APPLICABLE

 PJTFWv4.25

 06/22/2012

Page 136 of 178
 TABLE A7

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 1

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL WATER CONSUMPTION [G/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 1: 0 MG/ML

-------------------------------------------

 52050 149. 156. 178. 260. 181. NA 156. 211. 160. 179. 181.

 52054 74. 157. 128. 184. 120. 180. 126. 305. 131. 159. 158.

 52059 136. 168. 135. 223. 154. 244. 161. 374. 165. 255. 203.

 52063 101. 133. 113. 205. 159. 191. 155. 313. 183. 229. 179.

 52071 100. 147. 128. 191. 173. 212. 121. 209. 109. 157. 155.

 MEAN 112. 152. 137. 213. 157. 207. 144. 282. 150. 196. 175.

 S.D. 30.2 12.9 24.7 30.5 23.5 28.3 18.9 71.2 29.3 44.0 19.3

 S.E. 13.5 5.8 11.0 13.6 10.5 14.1 8.4 31.8 13.1 19.7 8.6

 N 5 5 5 5 5 4 5 5 5 5 5

Page 137 of 178

NA = NOT APPLICABLE
 TABLE A7

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 2

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL WATER CONSUMPTION [G/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 2: 1 MG/ML

-------------------------------------------

 52042 188. NA 265. 408. 278. NA 101. 169. 162. 237. 227.

 52048 NA NA 177. 481. 205. 256. 103. 101. NA NA 220.

 52055 142. 247. 230. 425. 218. 256. 119. 194. 108. 123. 206.

 52057 172. NA 132. NA 240. NA 128. 184. 125. 153. 162.

 52061 155. 287. 106. 145. 137. 180. 88. 124. 98. 105. 142.

 MEAN 164. 267. 182. 365. 215. 230. 108. 155. 123. 155. 191.

 S.D. 19.8 28.1 66.2 149.7 52.0 43.9 16.1 40.0 27.9 58.4 37.5

 S.E. 9.9 19.9 29.6 74.9 23.3 25.4 7.2 17.9 14.0 29.2 16.8

 N 4 2 5 4 5 3 5 5 4 4 5

Page 138 of 178

NA = NOT APPLICABLE
 TABLE A7

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 3

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL WATER CONSUMPTION [G/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 3: 2 MG/ML

-------------------------------------------

 52038 163. NA 152. 363. 173. 283. 80. 127. 124. 162. 181.

 52047 117. 192. 111. 129. 166. 244. 108. 148. 111. 135. 146.

 52051 123. 337. 111. 243. 138. 230. 100. 163. 123. 163. 173.

 52053 90. 181. 118. 172. 150. 179. 103. 171. 133. 125. 142.

 52066 129. 267. 164. 175. 117. 156. 117. 130. 107. 125. 148.

 MEAN 124. 244. 131. 216. 149. 218. 102. 148. 120. 142. 158.

 S.D. 26.2 72.6 24.9 91.7 22.5 51.0 13.8 19.2 10.8 19.2 17.6

 S.E. 11.7 36.3 11.2 41.0 10.1 22.8 6.2 8.6 4.8 8.6 7.9

 N 5 4 5 5 5 5 5 5 5 5 5

Page 139 of 178

NA = NOT APPLICABLE
 TABLE A7

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 4

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL WATER CONSUMPTION [G/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 4: 3 MG/ML

-------------------------------------------

 52039 86. 219. 122. 205. 148. 209. 105. 125. 74. 119. 141.

 52046 122. 243. 128. 246. 112. 155. 94. 139. 93. 126. 145.

 52056 80. 153. 134. 175. 83. 147. 125. 141. 75. 129. 124.

 52070 103. 193. 123. 141. 92. 119. 138. 196. 93. 90. 128.

 52072 86. 120. 114. 163. 118. 126. 114. 152. 90. 106. 119.

 MEAN 95. 185. 124. 186. 111. 151. 115. 151. 85. 114. 131.

 S.D. 17.4 49.8 7.6 40.8 25.1 35.3 17.1 27.0 9.4 16.0 11.3

 S.E. 7.8 22.3 3.4 18.2 11.2 15.8 7.7 12.1 4.2 7.1 5.1

 N 5 5 5 5 5 5 5 5 5 5 5

Page 140 of 178
 TABLE A7

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 5

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL WATER CONSUMPTION [G/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 5: 4 MG/ML

-------------------------------------------

 52043 102. 132. 88. 111. 116. 125. 88. 108. 79. 108. 106.

 52044 103. 148. 105. 136. 105. 162. 82. 91. 87. 105. 112.

 52052 95. 129. 98. 145. 105. 107. 73. 111. 77. 86. 103.

 52062 63. 130. 85. 142. 69. 132. 78. 105. 62. 105. 97.

 52064 108. 159. 102. NA 119. 143. 114. 164. NA 238. 143.

 MEAN 94. 139. 95. 133. 103. 134. 87. 116. 76. 128. 112.

 S.D. 18.1 13.4 8.7 15.7 19.8 20.3 15.8 27.9 10.4 61.9 18.2

 S.E. 8.1 6.0 3.9 7.8 8.8 9.1 7.1 12.5 5.2 27.7 8.1

 N 5 5 5 4 5 5 5 5 4 5 5

Page 141 of 178

NA = NOT APPLICABLE
 TABLE A7

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 6

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL WATER CONSUMPTION [G/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 6: 5 MG/ML

-------------------------------------------

 52040 122. 149. 119. 177. 121. 141. 111. NA 103. 112. 128.

 52041 66. 138. 105. 161. 92. 155. 79. 134. 57. 114. 110.

 52060 97. 116. 97. 147. 106. 131. 82. 148. 95. 93. 111.

 52065 93. 127. 115. 125. 100. 115. 105. 138. 94. 104. 111.

 52069 121. 146. 133. 135. 110. 147. 94. 107. 138. 156. 129.

 MEAN 100. 135. 114. 149. 106. 138. 94. 132. 97. 116. 118.

 S.D. 23.1 13.5 13.5 20.7 10.9 15.2 14.0 17.7 28.6 23.9 9.6

 S.E. 10.3 6.0 6.1 9.2 4.9 6.8 6.3 8.8 12.8 10.7 4.3

 N 5 5 5 5 5 5 5 4 5 5 5

NA = NOT APPLICABLE

 PJTFWv4.25

 06/22/2012

Page 142 of 178
 TABLE A8

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 1

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL CALCULATED TEST ITEM CONSUMPTION [MG/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 1: 0 MG/ML

-------------------------------------------

 52050 0. 0. 0. 0. 0. NA 0. 0. 0. 0. 0.

 52054 0. 0. 0. 0. 0. 0. 0. 0. 0. 0. 0.

 52059 0. 0. 0. 0. 0. 0. 0. 0. 0. 0. 0.

 52063 0. 0. 0. 0. 0. 0. 0. 0. 0. 0. 0.

 52071 0. 0. 0. 0. 0. 0. 0. 0. 0. 0. 0.

 MEAN 0. 0. 0. 0. 0. 0. 0. 0. 0. 0. 0.

 S.D. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

 S.E. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

 N 5 5 5 5 5 4 5 5 5 5 5

Page 143 of 178

NA = NOT APPLICABLE
 TABLE A8

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 2

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL CALCULATED TEST ITEM CONSUMPTION [MG/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 2: 1 MG/ML

-------------------------------------------

 52042 188. NA 265. 408. 278. NA 101. 169. 162. 237. 227.

 52048 NA NA 177. 481. 205. 256. 103. 101. NA NA 220.

 52055 142. 247. 230. 425. 218. 256. 119. 194. 108. 123. 206.

 52057 172. NA 132. NA 240. NA 128. 184. 125. 153. 162.

 52061 155. 287. 106. 145. 137. 180. 88. 124. 98. 105. 142.

 MEAN 164. 267. 182. 365. 215. 230. 108. 155. 123. 155. 191.

 S.D. 19.8 28.1 66.2 149.7 52.0 43.9 16.1 40.0 27.9 58.4 37.5

 S.E. 9.9 19.9 29.6 74.9 23.3 25.4 7.2 17.9 14.0 29.2 16.8

 N 4 2 5 4 5 3 5 5 4 4 5

Page 144 of 178

NA = NOT APPLICABLE
 TABLE A8

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 3

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL CALCULATED TEST ITEM CONSUMPTION [MG/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 3: 2 MG/ML

-------------------------------------------

 52038 326. NA 304. 726. 345. 565. 159. 254. 249. 323. 362.

 52047 234. 383. 223. 257. 332. 489. 216. 296. 222. 269. 292.

 52051 245. 673. 222. 486. 276. 460. 201. 326. 246. 326. 345.

 52053 180. 362. 236. 343. 301. 357. 206. 341. 267. 250. 284.

 52066 258. 534. 328. 350. 233. 312. 233. 261. 213. 249. 296.

 MEAN 248. 488. 262. 432. 297. 437. 203. 296. 239. 284. 316.

 S.D. 52.3 145.3 49.9 183.4 45.0 102.0 27.6 38.5 21.6 38.4 35.2

 S.E. 23.4 72.6 22.3 82.0 20.1 45.6 12.3 17.2 9.7 17.2 15.7

 N 5 4 5 5 5 5 5 5 5 5 5

Page 145 of 178

NA = NOT APPLICABLE
 TABLE A8

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 4

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL CALCULATED TEST ITEM CONSUMPTION [MG/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 4: 3 MG/ML

-------------------------------------------

 52039 257. 658. 366. 616. 444. 627. 314. 376. 223. 357. 422.

 52046 367. 729. 385. 738. 337. 464. 281. 418. 279. 377. 436.

 52056 241. 458. 402. 524. 250. 440. 376. 422. 226. 386. 372.

 52070 308. 578. 368. 423. 277. 358. 413. 587. 279. 269. 385.

 52072 257. 359. 341. 488. 353. 379. 342. 455. 269. 319. 356.

 MEAN 286. 556. 373. 558. 332. 453. 345. 452. 255. 341. 394.

 S.D. 52.1 149.4 22.8 122.3 75.4 106.0 51.4 80.9 28.3 47.9 34.0

 S.E. 23.3 66.8 10.2 54.7 33.7 47.4 23.0 36.2 12.7 21.4 15.2

 N 5 5 5 5 5 5 5 5 5 5 5

Page 146 of 178
 TABLE A8

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 5

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL CALCULATED TEST ITEM CONSUMPTION [MG/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 5: 4 MG/ML

-------------------------------------------

 52043 409. 526. 351. 442. 464. 499. 352. 430. 315. 432. 423.

 52044 413. 592. 419. 545. 420. 647. 327. 366. 349. 419. 449.

 52052 381. 514. 393. 580. 420. 430. 294. 444. 307. 345. 410.

 52062 253. 519. 340. 567. 276. 529. 314. 418. 249. 418. 387.

 52064 433. 635. 406. NA 474. 572. 455. 655. NA 952. 572.

 MEAN 378. 557. 382. 534. 411. 535. 348. 463. 305. 513. 448.

 S.D. 72.3 53.7 34.7 62.7 79.1 81.0 63.3 111.7 41.6 247.8 72.9

 S.E. 32.3 24.0 15.5 31.4 35.4 36.2 28.3 49.9 20.8 110.8 32.6

 N 5 5 5 4 5 5 5 5 4 5 5

Page 147 of 178

NA = NOT APPLICABLE
 TABLE A8

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 6

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL CALCULATED TEST ITEM CONSUMPTION [MG/KG/DAY]

-----------------------------------------------------------------------------------------------------------------------------------

 FEMALES

 DAY 0- 1 1- 2 2- 3 3- 4 4- 5 5- 6 6- 7 7- 8 8- 9 9- 10 0- 10

-----------------------------------------------------------------------------------------------------------------------------------

 ANIMALS FROM GROUP 6: 5 MG/ML

-------------------------------------------

 52040 609. 745. 595. 885. 604. 704. 556. NA 513. 562. 638.

 52041 331. 690. 527. 805. 460. 773. 393. 672. 287. 571. 550.

 52060 485. 582. 485. 737. 532. 653. 411. 741. 477. 465. 556.

 52065 463. 636. 575. 624. 500. 577. 524. 689. 469. 519. 557.

 52069 606. 729. 663. 676. 552. 733. 469. 534. 688. 779. 644.

 MEAN 499. 676. 569. 745. 529. 688. 471. 659. 487. 579. 589.

 S.D. 115.3 67.4 67.7 103.4 54.3 76.0 70.1 88.4 142.8 119.3 47.9

 S.E. 51.6 30.2 30.3 46.2 24.3 34.0 31.3 44.2 63.8 53.3 21.4

 N 5 5 5 5 5 5 5 4 5 5 5

NA = NOT APPLICABLE

 PJTFWv4.25

 06/22/2012

 R:06/22/2012

Page 148 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 1

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52050 GROUP 1: 0 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 MICRO:ESOPHAGUS TONGUE GINGIVA OROPHARYNX

 STOMACH, NONGL

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 149 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 2

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52054 GROUP 1: 0 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 MICRO:ESOPHAGUS TONGUE GINGIVA OROPHARYNX

 STOMACH, NONGL

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 150 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 3

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52059 GROUP 1: 0 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 GENERAL COMMENT MICRO: GROSS LESION(S) NOT EXAMINED PER WIL SOP P

 UTERUS GROSS: CONTENTS, CLEAR FLUID P

 BOTH HORNS

 ^==> GENERAL COMMENT: GROSS LESION(S) NOT EXAMINED PER WIL SOP

 OROPHARYNX MICRO: INFLAMMATION, CHRONIC 1

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 CERVIX VAGINA DIAPHRAGM TONGUE

 GINGIVA NASAL CAVITY

 MICRO:ESOPHAGUS TONGUE GINGIVA STOMACH, NONGL

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

 ^==> INDICATES MICRO CONFIRMATION OF ABOVE GROSS FINDING

Page 151 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 4

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52063 GROUP 1: 0 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 GINGIVA MICRO: NO SIGNIFICANT CHANGES OBSERVED

 MILD TO MODERATE HEMORRHAGE IN NASAL II-VI IN SECTION

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 MICRO:ESOPHAGUS TONGUE GINGIVA OROPHARYNX

 STOMACH, NONGL

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 152 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 5

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52071 GROUP 1: 0 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 STOMACH, NONGL MICRO: ULCERATION 1

 PINPOINT

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 MICRO:ESOPHAGUS TONGUE GINGIVA OROPHARYNX

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 153 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 6

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52042 GROUP 2: 1 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 154 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 7

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52048 GROUP 2: 1 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 155 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 8

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52055 GROUP 2: 1 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 156 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 9

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52057 GROUP 2: 1 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 157 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 10

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52061 GROUP 2: 1 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 158 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 11

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52038 GROUP 3: 2 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 159 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 12

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52047 GROUP 3: 2 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 160 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 13

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52051 GROUP 3: 2 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 161 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 14

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52053 GROUP 3: 2 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 UTERUS GROSS: CONTENTS, CLEAR FLUID P

 BOTH HORNS

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 CERVIX VAGINA DIAPHRAGM TONGUE

 GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 162 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 15

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52066 GROUP 3: 2 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 163 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 16

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52039 GROUP 4: 3 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 164 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 17

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52046 GROUP 4: 3 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 165 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 18

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52056 GROUP 4: 3 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 166 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 19

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52070 GROUP 4: 3 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 167 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 20

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52072 GROUP 4: 3 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 168 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 21

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52043 GROUP 5: 4 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 169 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 22

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52044 GROUP 5: 4 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 170 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 23

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52052 GROUP 5: 4 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 171 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 24

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52062 GROUP 5: 4 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 172 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 25

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52064 GROUP 5: 4 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 UTERUS GROSS: CONTENTS, CLEAR FLUID P

 BOTH HORNS

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 CERVIX VAGINA DIAPHRAGM TONGUE

 GINGIVA NASAL CAVITY

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 173 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 26

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52040 GROUP 6: 5 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 GENERAL COMMENT GROSS: ORGAN DAMAGED AT NECROPSY P

 TONGUE

 GINGIVA MICRO: NO SIGNIFICANT CHANGES OBSERVED

 HEMORRHAGE WITHIN NASAL VI IN SECTION

 OROPHARYNX MICRO: HEMORRHAGE 2

 SLIDE 29

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 MICRO:ESOPHAGUS TONGUE GINGIVA STOMACH, NONGL

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 174 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 27

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52041 GROUP 6: 5 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 MICRO:ESOPHAGUS TONGUE GINGIVA OROPHARYNX

 STOMACH, NONGL

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 175 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 28

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52060 GROUP 6: 5 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 GINGIVA MICRO: NO SIGNIFICANT CHANGES OBSERVED

 HEMORRHAGE WITHIN NASAL III, IV, AND V IN SECTION

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 MICRO:ESOPHAGUS TONGUE GINGIVA OROPHARYNX

 STOMACH, NONGL

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 176 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 29

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52065 GROUP 6: 5 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 MICRO:ESOPHAGUS TONGUE GINGIVA OROPHARYNX

 STOMACH, NONGL

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

Page 177 of 178
 TABLE A9

PROJECT NO.:WIL-876001 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS PAGE 30

SPONSOR:ACETALDEHYDE GROUP INDIVIDUAL MACROSCOPIC AND MICROSCOPIC FINDINGS

ANIMAL NO. 52069 GROUP 6: 5 MG/ML FEMALE SCHEDULED EUTH 06/08/12 DATE OF DEATH: 06/08/12

 GRADE

-----------------------------------------------------------------------------------------------------------------------------------

 NO SIGNIFICANT

 CHANGES OBSERVED GROSS:ADRENAL GLANDS BRAIN ESOPHAGUS EYES

 HEART INTESTINE KIDNEYS LIVER

 LN, MESENTERIC LUNGS MAMMARY GLAND OVIDUCTS

 OVARIES PANCREAS PITUITARY SPINAL CORD

 SAL. GLAND MAND SKIN SPLEEN STOMACH

 THYMUS THYROID GLANDS TRACHEA URINARY BLADDER

 UTERUS CERVIX VAGINA DIAPHRAGM

 TONGUE GINGIVA NASAL CAVITY

 MICRO:ESOPHAGUS TONGUE GINGIVA OROPHARYNX

 STOMACH, NONGL

 GROSS GRADE CODE: 1-SLIGHT, 2-MODERATE, 3-MARKED, P-PRESENT

 MICRO GRADE CODE: 1-MINIMAL; 2-MILD; 3-MODERATE; 4-SEVERE; P-PRESENT

 PGRHv4.67

 08/09/2012

Page 178 of 178