### FINAL **REPORT**

Study Title : A Dosage Range

- Finding 10

- Day Oral (Drinking Water) Toxicity Study of Acetaldehy de in Rats Study Number : WI L-876001 Study Director : Jeffrey H. Charlap, MS Data Requirements : Not Applicable Study I niti ation Date : 10 May 2012 Study Completion Date : 20 March 2013 Performing Laboratory : WI L Research 1407 George Road Ashland, OH 44805

- 8946 Sponsor : Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc

. 1250 Connecticut Avenue, NW Suite 70 0 Washington, DC 20036

**Page 1 of 178**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 t he 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

Page 2 of 178

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.



### T **ABLE O**  **F** 

### C **ONTENTS**



### Page
**Compliance Statement**

**................................ ................................**  **............... 2**  **Table of Contents**

**................................ ................................**  **....................... 3**  **Index of Tables**

**................................ ................................**  **........................... 5**  **I ndex 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

I nformation

................................ ................................ .......... 9 2.2

. Key Study Dates

................................ ................................ .......................... 9 2.3

. Participating Scientist

................................ ................................ .................. 9 2.4

. WI L Research Key

Study Personnel

................................ .......................... 10 **3**

**. Study Design** 

**................................ ................................**  **............................. 11**  **4**

**. Experimental Procedures** 

**- Materials and Methods** 

**............................. 12**  4.1

. Test I tem and Vehicle

................................ ................................ ................ 12 4.1.1

. Test I tem

................................ ................................ ................................ .... 12 4.1.2

. Vehicle

................................ ................................ ................................ ....... 12 4.1.3

. Preparation

................................ ................................ ................................ . 12 4.1.4

. Sampling and Anal ys es

................................ ................................ .............. 13 4.2 . T est Sy stem, 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

**Page 3 of 178**

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc. 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

. Bod y 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 Analy sis

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

................................ ......... 20 5.6.2

. Statistical Analy ses

................................ ................................ .................... 20 **6**

**. Results** 

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

........................... 22 6.2

. Bod y Weights

................................ ................................ ............................. 22 6.3

. Food Consumption

................................ ................................ ..................... 22 6.4

. Water Consumption

................................ ................................ ................... 23 6.5

. Test I tem Consumption

................................ ................................ .............. 24 6.6

. Anatomic Pat hology

................................ ................................ ................... 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** 

**Page 4 of 178**

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.



### I **NDEX O**  **F** 

### T **AB LES** 



### 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 I

tem Consumption [mg/kg/day ]

.................................. 52
S9. Summary

of Macroscopic Findings

................................ ........................................... 55
S10. Summary

of Microscopic Findings

................................ ............................................ 56

**Page 5 of 178**

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.



### I **NDEX O**  **F** 

### A **PPENDICES**



### Page

A. Study Protocol and Deviations

................................ ................................................... 58

B. Certificate o f Analy sis ( Manufacturer

- Provided Data)

.............................................. 78
C. Animal Room Environmental Conditions

................................ .................................. 80

D. Pathology

Re port ( WIL Research )

................................ ............................................. 85

E. Individual Animal Data

................................ .............................................................. 93
A1. I ndividual Clinical Observations (Daily Examinations)

.................................... 94
A2. I ndividual Body

Weights [g ]

................................ ............................................ 107
A3. I ndividual Body

Weight Changes [g]

............................................................... 113
A4. I ndividual Food Consumption [g/animal/day ]

................................................. 119
A5. I ndividual Food Consumption [g/kg/day ]

........................................................ 125
A6. I ndividual Water Consumption [g/animal/day ]

............................................... 131
A7. I ndividual Water Consumption [g/kg/day ]

...................................................... 137
A8. I ndividual Calculated Test I tem Consumption [mg/kg/day ]

........................... 143
A9. I ndividual Macroscopic and Microscopic Findings

......................................... 149

**Page 6 of 178**

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.


### 1. S **UMMAR**

**Y** 

### 1.1. **O BJECTIVE**  

### Th e objective of this study w as to determine dos age levels of acetaldehy de to be evaluated in a potential rep eated dose toxicity s tudy combined with the reproduction/developmental toxicity screening test (OECD 422) in rats.



### 1.2. **S TUDY**  

### D **ESIGN** 

### Acetaldeh yd e was offered on a continuous basis in the drinking water to 5 groups (Groups 2- 6) of 5 female Crl:CD(SD) rats each d uring study

d ay s 0 -10. Concentrations

were 1, 2, 3, 4, and 5 mg/mL

. A concurrent control group (Group 1) consi sting 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 f or mortality

a nd moribundity

. C linical observations, body

w eights , food consumption , and water consumption were recorded daily

. All animals were euthanized by c arbon dioxide inhalation on study d ay 1 0. Complete necropsies were conducted on all animals

. The oral tissues (tongue, gingiva, and orophary

nx), esophagus, and nonglandular forestomach from all animals in the control and high

- dose groups were examined microscopicall y for signs of irritation

. 

### 1.3. **R ESULTS**  

### The average calculated quantities of acetaldeh yde consumed during the study w ere 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 o n study

d ay 1 0. T here 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 con trol group and at low dosage levels of acetaldeh yd e (1 and 2 mg /mL) was generall y higher than expected , whereas, mean water consumption
at higher dosage levels of acetaldeh yde (3, 4 , and 5 mg/mL) was generally within the **Page 7 of 178**

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc. expected range of water consumption

. Furthermore, th ere were no effects ( e.g. , increased

or decreased urination, effects on body w eight gain, etc. ) that would ty pically correspond with increases or decreases in water consumption. This pattern of water consumption could be attributed to pa rtial water spillage at the lower dosage levels of acetaldehy de and in the control group. Therefore, due to the partial water spillage there were no effects of acetaldeh yde on water consumption under the conditions of this dose range

- finding study

. 

### 1.4. **C ONCLU**  **SION** 

### Oral administration via the drinking water of acetaldehy de 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 an y dosage level. T herefore, a high dosage level of 5 mg /mL was selec ted for a repeated dose toxicity

s tudy w ith the reproduction/developmental toxicity s creening test (OECD 422) in Crl:CD(SD) rats. D osage levels of 1 and 3 mg/mL w ere selected to evaluate a potential dose -response relationship.

**Page 8 of 178**

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.


### 2. I **NTRODUCTION** 

### 2.1. **G ENERAL**  

### S **TUDY** 

### I **NFORMATION** 

### This report presents the data from “ A Dosage Range

- Finding 10

- Day O ral (Drinking Water) Toxicity

S tudy o f Acetaldeh yde in Rats

. ” D ue to software spacing constraints, t he study t itle is presented as “R- F 10

- Day O ral (Water) Toxicity

S tudy o f Ace taldeh yd e in
Rats ” on the report tables.

The study pr otocol and deviations from the protocol are presented in Appendix A

. A list of abbreviations pote ntially used in this report is presented in Section 1 2

.
The computer protocol reference number and ty pe of data collected were identified as follows:
**Computer Protocol Type of Data Collected**  WIL

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



### 2.2. **K E**  **Y** 

### S **TUDY** 

### D **ATES** 

### Date(s) **1** 

### Event(s) 15 May 2012........................................... Experimental starting date (animal receipt) 29 May - 0 8 June 2012

........................... Test item administration 0 3 July 2012............................................ Experimental completi on date (last microscopic examination)


### 2.3. **P ARTICIPATING**  

### S **CIENTIST** 

### Histopathology Catheri ne A. Picut, VMD, DACVP, DABT WI L Research

1 D ate ranges represent the first and last dates of evaluation. 

### Page 9 of 178

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.


### 2.4. **WIL R**  **ESEARCH** 

### K **EY** 

### S **TUDY** 

### P **ERSONNEL** 

### Susan C. Haley , BS Operations Manager, Pathology Heather L. Johnson, BS, RQAP

- GL P Assistant Director of Quality and Regulatory

Compliance Sally A. Keets, AS Senior Operation s Manager, Vivarium Carol A. Kopp, BS, LAT Manager, Developmental Toxicology Laboratory Gwendal yn 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 L aboratory Michael A. Safron, AS, HT (ASCP) CM 

### Manager, Histology
Bennett J. Varsho, MPH, DABT Director, Nonclinical Safety Operations Robert A. Wall y, BS Operations Manager, Reporting & Technical Support S ervices

**Page 10 of 178**

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.


### 3. S **TUDY** 

### D **ESIGN**


### Acclimation period

Assignment of animals to treatment groups

based on bod y weight
Clinical observation s , body weights , food consumption , and water consumption

recorded dail y 5 rats/group (1

- 6) offered the vehicle or the test item via the drinking water dail y from study day 0 through study

day 10 All rats euthanized on study day 10; gross necropsies performed; histopathological evaluation of sel ected tissues

**Page 11 of 178**

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.


### 4. E **XPERIMENT**

**AL** 

### P **ROCEDURES** 

### - M **AT ERIALS**  **A ND**  

### M **ETHODS** 

### 4.1. **T EST**  

### I **TEM A**  **ND** 

### V **EHICLE** 

### 4.1.1. **T EST**  

### I **TEM** 

### The test item , acetaldehy de, was received from Sigma

- Aldrich , Milwaukee, WI , on behalf of the Sponsor, on 0 4 October 2011 , as follows:

Id entification Phy sical D escription
Acetaldeh yd e Lot no. SHBB4508V Exp. date: NA a 

### CAS no. 75 -07-0 [WIL ID no. 110159] Clear, colorless liquid

a 

### This product does not have an expiration date but was guaranteed b y Sigma -Aldrich for 1 ye ar following purchase.

Documentation regar ding the purit y of the test item is on file with the manufacturer and
WI L Research

. A C ertificate of Analy sis for the test item was provided by t he manufacturer and is presented in Appendix B

. The purity o f the test item was 99.77 %. The test item was stored refrigerated , under nitrogen , and was considered stable under these conditions. A r eserve sample of the test item was collect ed and stored in the WIL Research Archives

. 

### 4.1.2. **V EHICLE**  

### 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. **P REPARATION**  

### The vehicle was dispense d approximately every 2 d ay s 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.

**Page 12 of 178**

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.
Dosin g formulations were prepared at the test item concentrations indicated in the following table:

Group Number Treatment Test I tem Concentration a 

### (mg/mL) pH b 

### 1 Vehicle Control 0 8.89 2 Acetaldeh yd e 1 8.76 3 Acetaldeh yd e 2 8.50 4 Acetaldeh yd e 3 8.52 5 Ace taldeh yd e 4 8.61 6 Acetaldeh yd e 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 d ay s as single formulations for each dosage level a nd 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 day s. The test item formulations were stirred continuously thro ughout preparation.

The first dosing formulations were visually i nspected by

t he Study

D irector and were found to be visibly

homogeneous and acceptable for administration.



### 4.1.4. **S AMPLING**  **A ND**  

### A **NALYSES** 

### I n a previous anal yt ical method validation study ( Freer, 2013 , WIL

- 876002 ), t he 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 an d 72 hours in plastic drinking water bottle s. Furthermore, the formulations were within the acceptable range for concentration ( Freer, 2013, WIL -876002 ). Th e refore, no stability o r concentration anal ys es were conducte d as part of th e current dose range

- finding st udy

. 

### 4.2. **T EST**  

### S **YSTEM** 

### , A **NIMAL** 

### R **ECEIPT** 

### , **AND** 

### A **CCLIMATION** 

### P **ERIOD** 

### Crl:CD(SD ) rats were used as the test sy stem on this study

. This species and strain is recognized as appropriate for reproduction studies. In a ddition, WIL Research has

**Page 13 of 178**

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc. reproductive historical cont rol data in the Crl:CD(SD) rat

. The number of animals selected for this stu dy

a llowed for meaningful interpretation of the data to adequatel y

assess toxicological endpoints and to determine dos age levels for subsequent studies. I n addition, given the pos sibility o f 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 tolerabil i ty /dose range

- finding stud y. Crl:CD(SD) rats (35 females) were received in good health from Charles River Laboratories, In c., Raleigh, NC , on 15 May 2 012

. T he animals were approximately
7 weeks old upon receipt. E ach animal was examined by a q ualified biologist on the day of receipt

. The day

f ollowing receipt, all animals were weighed and clinical observations were recorded. Each rat was uniquel y identified by a Monel ® 

### metal ear tag display ing the animal number. T he animals were housed for an acclimation period of 14 day s prior to the first day

o f treatment. D ur ing the acclimation period, the animals were observed twice dail y for mortalit y and general chan ges in appearance and behavior.



### 4.3. **A NIMAL**  

### H **OUSING** 

### Upon arrival, all animals were housed individually i n clean, solid

- bottom cages containing nesting material , grou nd corncob bedding (Bed

- O'Cobs ® 

### ; The Andersons, Cob Products Division, Maumee, OH ). T he nesting material is periodically a naly zed by

t he manufacturer for contaminants. A naly ses of the nesting material are provided by t he manufacturer and are maintained a t WI L Research

. N o contaminants were present in the bedding at concentrations sufficient to interfere with the outcome of the study

. A nimals

were maintained in accordance with the Guide for the Care and Use of Laboratory Animals ( National Research Council, 1996 ). The animal facilities at WI L Research are accredited by

A AALAC International. Enrichment devices (Ny labones ® 

### ) were provided to all animals as a

ppropriate throughout the study

. 

### 4.4. **D IET**  

### , D **RINKING** 

### W **ATER** 

### , **A ND**  

### M **AINTENA NCE**  

### The basal diet used in this study , PMI Nutrition In ternational, LLC Certified Rodent LabDiet ® 

### 5002, wa s a certified feed with appropriate analy ses performed by t he **Page 14 of 178**

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.
manufacturer and provided to WIL Research

. Feed lots used during the study we re documen ted in the study records. Feeders were changed and sanitized once per week.
Reverse osmosis

- treated (on

- site) tap water (with acetaldeh yd e added during the
treatment period for the animals assigned to Groups 2

- 6) was provided from standard plastic water bottles (approximately 4 00 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 dail y for spillage (occurrence of spillage was docume nted) and supplemented when necessary . Filters servicing the automati c watering
sy stem used to prepare the water bottles were changed regularly a ccording to WIL Research’s SOPs. In a ddition, m unicipal water supply ing the facility wa s sampled for contaminants according to WIL Research’s SOP s. The results of the diet and water anal ys es a re maintained at WI L Research

. N o contaminants were present in animal feed

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

. D rinking water and the basal diet were provided ad libitum throughout the acclimation period and during the study

. 

### 4.5. **E NVIRONMENTAL**  

### C **ONDITIONS** 

### All rats were housed throughout the acclimation period and during the study i n an environmentally

c ontrolled room. The room temperature and humidity c ontrols were set
to maintain environmental conditions of 71 ° F ± 5 ° F (22 ° C ± 3 ° C) and 50% ± 20%, respectivel y. Room temperature and relative humidity d ata were monitored continuously and were scheduled for automatic collection on an hourly b asis. T hese data are summarized in Appendix C

. Actual mean daily tempera ture ranged from 69.8 ° F to 70.6 ° F ( 21.0 ° C to 21.4 ° C) and mean daily r elative humidity

r anged 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 lig ht status (on or off) was recorded once every

1 5 minutes. Air handling units were set to provide a minimum of 10 fresh air changes per hour.

**Page 15 of 178**

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.


### 4.6. **A SSIGNMENT**  **O F**  

### A **NIMALS T**  **O** 

### T **REATMENT** 

### G **ROUPS** 

### At the conclusion of the acclimation period, all available females were weighed and examined in detail for phy sical abnormalities. A t the discretion of the Study D irector , each animal judged to be in good health and meeting acceptable body w eight requirements was selected for use in the compute rized randomization procedure ba sed on body w eight stratification in a block design. A t that time, the individual body w eights and corresponding animal identification numbers were entered into WTDMS TM

. A printout containing the animal numbers, corresponding body w eights, and individual group assignments was generated

. The animals then were arranged into groups according
to the printout

. Animals not assigned to study w ere transferred to the WI L 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. **O RGANIZATION**  **O F**  

### T **EST** 

### G **ROUPS** 

### , D **OSAGE** 

### L **EVELS** 

### , **A ND**  

### T **REATMENT** 

### R **EGI MEN**  

### The vehicle and test drinking water were offered ad libitum during study day s 0-10

. The
test item was offered continuously a t a constant concentration (mg/mL) in the dr inking
water.
The following table presents the study group assignment:

Group Nu mber Treatment Test I tem Concentration (m g/ mL ) Number of

Females 1 Vehicle Control 0 5 2 Acetaldeh yd e 1 5 3 Acetaldeh yd e 2 5 4 Acetaldeh yd e 3 5 5 Acetaldeh yd e 4 5 6 Acetaldeh yd e 5 5

**Page 16 of 178**

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc. Dosage levels were provided by t he Sponsor Representative after co nsultation with the Study D irector. T his pilot study w as designed to determine dos ag e levels for a future OECD 422 study

. T he range of dos ag e levels in this study w as 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 w as oral ( drinking water ) because this is a potential route of human exposure.

**Page 17 of 178**

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.


### 5. P **ARAMETERS** 

### E **VA LUA**  **TED** 

### 5.1. **C LINICAL**  

### O **BSERVATIONS A**  **ND** 

### S **URVIVAL** 

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

a nd mortality

. I ndividual clinical o bservations were recorded dail y. The absence or presence of findings w as recorded for all animals

. 

### 5.2. **B ODY**  

### W **EIGHTS** 

### Individual body

w eights were recorded daily , beginning on study day 0 a nd continuing until the scheduled necropsy

. Mean body w eights and mean body w eight changes were calculated for the corresponding intervals. I n addition, mean body w eight changes were calculated for the overall exposure period (stud y days 0

- 10).



### 5.3. **F OOD**  

### C **ONSUMPTION** 

### Individual food consumption was recorded daily , beginning on study d ay 0 a nd continuing until the scheduled necropsy

. Food intake was calculated as g/animal/day and g/kg/day f or the corresponding body w eight change intervals. C alculation o f 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 f or that interval using the available data. T he time periods when food consumption values were unavailable for a given animal were designated as “NA” on the individual report tables.



### 5.4. **W ATER AND**  

### T **EST** 

### I **TEM** 

### C **ONSUMPTION** 

### Individual water consumption was recorded daily , beginning on study d ay 0 a nd continuing until the scheduled necrops y. W ater intake was calculated as g/animal/day and g/kg/day

f or the corresponding body w eight change intervals. C alculation of the comprehensive intervals excludes all erroneous v alues, 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

**Page 18 of 178**

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.
available data. T he time periods when wa ter 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 appropriat e target concentration of the test item in the water (mg/mL).



### 5.5. **A NATOMIC**  

### P **ATHOLOGY** 

### 5.5.1. **M ACROSCOPIC**  

### E **XAMINATIONS** 

### All rats were euthanized by c arbon dioxide inhalation on study d ay 1 0 and subjected to a gross necrops y. N ecropsy i ncluded examination of the externa l surface, all orifices, the external surface of the brain, and the cranial, thoracic, abdominal, and pelvic cavities, including viscera. T he oral tissues (tongue, gingiva, and orophary nx), esophagus, and nonglandular forestomach were collected from all a nimals and placed in 10% neutral

- buffered formalin. T he gingival tissues were collected using the Morgan method of nasal cavity

trimming ( Morgan, 1991 ).



### 5.5.2. **M ICROSCOPIC**  

### E **XAMINATIONS** 

### After fixation, protocol

- specified tissues were trimmed according to WIL Research’s SOPs and the protocol. T rimmed tissues were processed into paraffin blocks, sectioned
at 4 to 8 microns, mounted on glass microscope slides , and stained with hematox yl in and eosin.
Microscopic examination was perf ormed on all tissues listed in Section 5. 5 .1. from all animals in the control and 5 mg / mL groups at the scheduled necrops y. The pathology report is presented in Appendix D

.

**Page 19 of 178**

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Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.


### 5.6. **D ATA**  

### A **CQUISITION AND** 

### A **NALYSIS** 

### 5.6.1. **A CQUISITION AND**  

### R **EPORTING** Program/System Description Archive Management System (AMS) In

- house developed application for storage, maintenance, and retrieval of i nformation for archived materials ( e.g. , lab books, study data, wet tissues, slides, etc .) InSi ght ® Publisher Electronic publishing system (output is Adobe Acrobat, PDF) Master Schedule Maintains the master schedule for the company. Metasys DDC Electr onic 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 d eveloped 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 mai ntained in the study records and/or facility records.


### 5.6.2. **S TATISTICAL**  

### A **NALYS ES**  

### All statistical tests were performed using WTDMSTM unless otherwise noted. A naly ses

were conducted using two

- tailed tests (except as noted otherwise) for minimum significance lev els 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 figur es and the different rounding conventions inherent in the ty pes of software used, the

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

. Therefore, the use of reported individual values to calculate subsequent paramete rs or **Page 20 of 178**

### WI L-876001 Acetaldeh yd e

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means will, in some instances, yi eld minor variations from those listed in the report data tables.

Mean body

w eights , body

w eight changes, food consumption, and water consumption

were subjected to a parametric one
- way A NOVA ( Snedecor and Cochran, 1980 ) to determine intergroup differences. I f the ANOVA revealed significant (p<0.05) intergroup variance, Dunnett's test ( Dunnett, 1964 ) was used to compare the test item

- treate d groups to the control group.

**Page 21 of 178**

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Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.


### 6. R **ESUL**

**TS** 

### 6.1. **C LINICAL**  

### O **BSERVATIONS A**  **ND** 

### S **URVIVAL** 

### Summary Data: Table S1 Individual Data: Table A1

All females survived to the scheduled euthanasia on st udy d ay 1 0. N o remarkable clinical findings were noted at the daily e xaminations at any

d osage level. Findings noted in the test item

- exposed groups, including hair loss on the forelimbs, occurred infrequentl y, at a similar frequency i n the control group , and in a manner that was not dose -related.



### 6.2. **B ODY**  

### W **EIGHTS** 

### 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

signi ficantly

different from the control group.



### 6.3. **F OOD**  

### C **ONSUMPTION** 

### 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, an d
5 mg/ mL groups was similar to the control group throughout the exposure period. T he values in the test item

- exposed gr oups were similar to and not statistically s ignificantl y different from the control group.

**Page 22 of 178**

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Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.


### 6.4. **W ATER**  

### C **ONSUMPTION** 

### Summary Data: Table S6 , Table S7 Individual Data: Table A6 , Table A7

Mean water consumption, evaluated as g/animal/day a nd g/kg/day , appeared to decrease with increasing dosage beginning at a dosage level of 2 mg/mL

. D uri ng the overall interval (study

d ay s 0

- 10), when a dose

- responsive pattern was most apparent, mean

w ater consumption in the 2, 3, 4, and 5 mg/mL groups was 34, 30, 25 , and 26 g/animal/day , respectively , compa red with 40 g/animal/day i n the control group . T he difference s from the control group w ere 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

d uring this period, which was higher than the range of expected water consumption for female rats of this s train and age (approximately 2 5-35 g/day

b ased on previous water consumption studies conducted at WIL Research). S imilar ly , 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 3 8 -51 g/day during study

d ay s 0 -10, which was also higher than expected. In contrast, t he range of individual water consumption values in the 3, 4 , and 5 mg/mL group s during study day s 0-10 was 2 1 -3 2 g/ day , which was within the expected range . At 2 mg/mL , onl y 1 animal had water consumption that was slightly high (37 g/day ) during study day s 0-10

. When evaluated during the dail y intervals, mean water consumption for the control gr oup

was generall y higher than expected, with mean values up to 65 g/animal/day

. S imilarly ,
mean water consumption values at the lower dosage levels of acetaldehy de (1 and 2 mg/mL) were higher than expected (up to 79 g/animal/day ). I n contrast, mean water consumption values at the higher dosage levels of acetaldehy de (3, 4 , and 5 mg/mL) were within the expected range of water consumption and were generally c haracterized by

l ow variability . Th is pattern of apparent decreasing water consumption with incre as ing 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**

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Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.
in water consumption at any o f the dosage levels, e.g. , an increase in uri nation at the lower dosage levels for which apparent increases in water consumption were noted, or body w eight loss/ decreased body w eight gain at higher dosage levels for which apparent decreases in water consumption were noted. B ased on the aforementione d findings and the absence of effects in all other endpoints, the high water consumption noted in the control group and low dosage levels of acetaldehy de could potentially be attributed to partial water spillage

. Therefore, due to the partial water spilla ge there were no effects of acetaldeh yde on water consumption under the conditions of this dose range

- finding stud y.


### 6.5. **T EST**  

### I **TEM** 

### C **ONSUMPTION** 

### Summary Data: Table S8 Individual Data: Table A8
The average quantities of acetaldehy de consumed during the study are presented below.

Theoretical Exposure L evel (mg/mL) Mean Calculated Test I tem Consumption (m g/kg/day ) 1 191 2 316 3 394 4 448 5 589


### 6.6. **A NATOMIC**  

### P **ATHOLOGY** 

### 6.6.1. **M A**  **CROSCOPIC** 

### E **XAMINATIONS** 

### 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**

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.


### 6.6.2. **M ICROSCOPIC**  

### E **XAMINATIONS** 

### Summary Data: Table S10 Individual Data: Table A9 Pathology

Report: Appendix D

There were no te st item -related microscopic findings noted in the alimentary tract tissues examined.

**Page 25 of 178**

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Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.


### 7. C **ONCLUSIONS** 

### Oral administration via the drinking water of acetaldehy de 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 an y dosage level. T herefore, a high dosage level of 5 mg /mL was selected for a repeated dose toxicity

s tudy w ith the reproduction/developmental toxicity s creening test (OECD 422) in Crl:CD(SD) rats. D osage levels of 1 and 3 mg/mL w e re 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 178WIL-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

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.


### 10. **R EFERENCES** 



### Dunnett, C.W. N ew tables for multiple comparisons with a control. Biometrics **1964** , 20 , 482

- 491.
Freer, S.D. A n Analy

tical Me thod Validation, Compatibility , and Stability S tudy o f Acetaldehy

de in Deionized Water (Study N o. WIL

- 876002). W IL Research, Ashland, OH, **2013**

. Morgan, K.T. A

pproaches to the Id entification and Recording of Nasal Le sions i n Toxicology Studies. Toxicol ogic 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 Li fe Sciences; National Academy Press: Washington, DC, **199 6** 

. Snedecor, G.W.; Cochran, W.G. O ne
- Way C lassifications; Analy sis of Variance. In Statistical Methods , 7th ed.; The Io wa State University P ress: A

mes, IA , **1980** ; pp 215

- 237.

**Page 29 of 178**

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Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.


### 11. **D ATA**  

### R **ETENTION** 

### The Sponsor has title to all documentation records, raw data, specimens, or other work product generated during the performance of the study . A ll work product generated by WI L Research , including raw paper data and spe cimens, are retained in the WI L Research Archives as specified in t he study protocol.

The r eserve sample of the test item , pertinent electronic storage media, and the original f inal report are retained in the WIL Research Archives in compliance with regulatory requirements.

**Page 30 of 178**

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Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.


### 12. **A BBREVIA** 

**TIONS** 

### The following abbreviations may apply to this report:

μ - micro AAALAC

- Association for Assessment and Accreditation of Laboratory

Animal Care ANOVA

- anal ys is of variance
cm
- centimeter dB

- decibels dL

- deciliter exp.
- expiration g
- gram GL P

- Good Laboratory Practices GMP

- Good Manufacturing Pra ctices 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 pe r million SOP

- standard operating procedure WTDMSTM

- WI L Toxicology Data Management S ys tem wt.

- weight wts.

- weights

**Page 31 of 178**

### WI L

- 876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc

.



### 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 06/22/2012**Page 33 of 178**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**

### WI L

- 876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc

.



### APPENDIX **A**

Study Protocol and Deviations

**Page 58 of 178**

### WI L-876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.


### D **EVIATIONS F**  **ROM T**  **HE** 

### P **ROTOCOL**



### This study

w as 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 f rom 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 o f animal receipt (15 May 2 012) through 17 May 20 12, the ty

pe of water bottle used to provide drinking water was not documented. T herefore, 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

.

Th i s deviation did not negativel y impact the quality o r i ntegrit y of the data or the outcome of the stud y.

**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 (Drinki ng Water) Toxicity Study of Acetaldehyde in Rats

Protocol Modifications : 1) 4.6 Storage Conditions: As per Study Director Notification on 28 Ma y 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 178WIL-876001 Page 1 of 15 May 10, 2012



### PROTOCOL

A DOSAGE RANGE-FINDI NG 10-DAY ORAL (DRINKING WATER) TOXICITY STU DY 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 178WIL-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 178WIL-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 178WIL-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 178WIL-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 178WIL-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 178WIL-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 178WIL-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 178WIL-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 178WIL-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 178WIL-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 178WIL-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 178WIL-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 178WIL-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 H. Charlap, 

### MS 

# *

/ / Study Director



### Page 77 of 178

### WI L

- 876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc

.



### APPENDIX **B**

Certificate of Analy sis ( 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

### WI L

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.



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

HIGH TEMPERATURE °C: LOW TEMPERATURE °C: 18.9 24.4 876001

B ROOM 115

DATE SECONDARY TEMP PRIMARY HUM SECONDARY HUM PRIMARY TEMP MEAN (°F) MEAN (°C) MEAN (°F) MEAN (°C) MEAN (%RH) MEAN (%RH) 05/15/12 70.3 43.4 70.3 43.3 21.3 21.3 05/16/12 70.5 45.8 70.6 45.6 21.4 21.4 05/17/12 70.5 39.7 70.6 39.5 21.4 21.4 05/18/12 70.5 40.6 70.6 40.5 21.4 21.4 05/19/12 70.1 45.2 70.2 45.0 21.2 21.2 05/20/12 70.6 48.5 70.7 48.3 21.4 21.5 05/21/12 70.1 49.0 70.2 48.7 21.2 21.2 05/22/12 70.2 47.5 70.3 47.4 21.2 21.3 05/23/12 70.3 47.9 70.4 47.7 21.3 21.3 05/24/12 70.1 47.9 70.2 47.7 21.2 21.2 05/25/12 70.4 50.2 70.5 49.8 21.3 21.4 05/26/12 70.3 47.4 70.4 47.1 21.3 21.3 05/27/12 70.1 50.0 70.2 49.7 21.2 21.2 05/28/12 70.3 51.2 70.4 50.8 21.3 21.3 05/29/12 70.6 49.0 70.7 48.7 21.4 21.5 05/30/12 70.4 46.6 70.5 46.3 21.3 21.4 05/31/12 70.3 47.1 70.4 46.9 21.3 21.3 06/01/12 70.4 47.9 70.4 47.7 21.3 21.3 06/02/12 70.2 42.1 70.3 42.0 21.2 21.3 R-F 10-DAY ORAL (WATER) TOXICITY STUDY OF ACETALDEHYDE IN RATS 876001 876 - ACETALDEHYDE GROUP Page 1 of 4 TEMPERATURE/HUMIDITY - STUDY SUMMARY REPORT PROJECT NO.:WIL-
SPONSOR:**Page 81 of 178**DATE SECONDARY TEMP PRIMARY HUM SECONDARY HUM PRIMARY TEMP MEAN (°F) MEAN (°C) MEAN (°F) MEAN (°C) MEAN (%RH) MEAN (%RH) 06/03/12 70.2 43.9 70.3 43.7 21.2 21.3 06/04/12 70.4 46.4 70.6 46.1 21.3 21.4 06/05/12 70.2 47.1 70.3 46.9 21.2 21.3 06/06/12 70.3 45.7 70.4 45.6 21.3 21.3 06/07/12 70.3 45.8 70.4 45.6 21.3 21.3 06/08/12 69.8 49.6 69.8 49.6 21.0 21.0

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 69.8 70.7 SECONDARY TEMP °F:
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 TEMPERATURE/HUMIDITY - STUDY SUMMARY REPORT PROJECT NO.:WIL-
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

0.08 0.21 0.09 0.21 SE 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 TEMPERATURE/HUMIDITY - STUDY SUMMARY REPORT PROJECT NO.:WIL-
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

0.08 0.21 0.09 0.21 SE 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 TEMPERATURE/HUMIDITY - STUDY SUMMARY REPORT PROJECT NO.:WIL-
SPONSOR:

WIL METASYS VERSION 2.27 11:35 25-Jun-12**Page 84 of 178**

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.



### APPENDIX **D**

Pathology Report (WIL Research)

**Page 85 of 178**

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- A Dosage Range

- Finding 10

- Day Oral ( Drinking Water) Toxicity Study of Acetaldehy de i n Rats

Pathology

Report

WI L Research Pathology Department

**Page 86 of 178**

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-2

- 

### T **ABLE O F**  

### C **ONTENTS** 

### 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** 

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- 3

- 

### 1. **I NTRODUCTION**  

### T he o bjective of this study w as to determine dose levels of acetaldeh yd e to be evaluated i n a potential repeated dose toxicity study combined with the reproduction/developmental toxicity s creening test (OECD 422) in rats. This pathology r eport addresses the

ana tomical endpoints of the study

. 

### 2. **S TUDY**  

### D **ESIGN** 

### F emale Crl:CD(SD) ra ts , an average of 9 weeks of age on study d ay 0 , were offered drinking water or drinking water containing a cetaldehy de ad libitum for 10 consecutive day s as indicated in the following table.

Group Number Treatment Test I tem Concentration (mg/ mL ) Number of

Females 1 Vehicle Control a 

### 0 5 2 Acetaldeh yd e 1 5 3 Acetaldeh yd e 2 5 4 Acetaldeh yd e 3 5 5 Acetaldeh yd e 4 5 6 Acetaldeh yd e 5 5

a



### - The vehicle control was reverse osmosis

- purified water

.



### 3. **M ETHODS**  

### 3.1. **A NATOMIC**  

### P **ATHOLOGY** 

### 3.1.1. **M ACROSCOPIC**  

### E **XAMINATION** 

### Com plete postmortem examinations were performed on all animals at the scheduled
necrops y

. Animals were euthanized by carbon dioxide inhalation and exsanguinated. A t the time of necrops y, the following tissues and organs were collected and placed in 10% neut ral

- buffered formalin fixative unless otherwise noted:

**Page 88 of 178**

### WI L-876001 A cetal deh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc.

-4

- Oral tissues Tongue Gingiva a 

### Orophary nx Esophagus Nonglandular forestomach

a 

### - Collected using the Morgan method of nasal cavity trimming ( Morgan, 1991 ).



### 3.1.2. **M ICRO**  **SCOPIC** 

### E **XAMINATION** 

### Microscopic examination of routinely p repared hematox yl in

- eosin stained paraffin sections was performed on all tissues collected at necrops y from all animals in the control and high

- dose groups . S tained histologic s ections were examined by l ight microscop y and obser

vations were entered in the WIL Toxicology D ata Management Sy stem (WTDMS TM) by

t he pathologist

. H istologic se ctions were of adequate size and quality for detailed evaluation , and the number of tissues examined from each treatm ent 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

. S everity grades were assigned based on the severity o f alterations in the examined histologic sections and may

n ot reflect the overall severity o f the pathologic process in the entire tissue, organ, or animal. The WTDMSTM histopathology t ables contain a ll of the recorded data and serve as the ba sis for this narrative report.

**Page 89 of 178**

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- 5

- Unremarkable Tissue considered to be within normal limits, under the conditions

of the study

and considering the age, sex, and strain o f the animal concerned. Present A non

- gradable histologic change for which no additional

information would be gained by a ssigning a severity grade ( e.g

. cy st). Grade 1 (Minimal) A histologic change that barel y exceeds that which is considered

to be w ithin normal limits. This change is unlikely to produce an y 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 . L imited tissue or organ dy sfunction is possible. Grade 4 (Severe) A histologic change that is an overwhelming feature of the tissue

and that may

cause signific ant tissue or organ d ys function.

**Page 90 of 178**

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- 6

- 

### 4. **R ESUL** 

**TS** 

### 4.1. **S URVIVAL**  

### All animals survived until the scheduled necrops y

. 

### 4.2. **G ROSS**  

### O **BSERVATIONS** 

### Review of the gross necropsy observations revealed no observations that were considered to be associated with administration of t he test item

. 

### 4.3. **H ISTOLOGIC**  

### C **HANGES** 

### There were no test item

- related fin dings in the tissues examined.



### 5. **C ONCLUSIONS**  

### Administration of acetaldehyde in ad libitum drinking water to f emale Crl:CD(SD) rats, f or 10 consecutive day s , at concentrations of 0, 1, 2, 3, 4, and 5 mg/mL , was associated with no earl y deaths, no gross pathology findings, and no histopathologic findings.



### 6. **R EFERENCE**  

### Morgan, K.T. A

pproaches to the Id entification and Recording of Nasal Le sions i n 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**

### WI L

- 876001 Acetaldeh yd e

Acetaldeh yd e Working Group of the Vin yl Acetate Council, I nc

.



### 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 06/22/2012**Page 112 of 178**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 06/22/2012**Page 118 of 178**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

NA = NOT APPLICABLE**Page 131 of 178**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

NA = NOT APPLICABLE**Page 132 of 178**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

NA = NOT APPLICABLE**Page 133 of 178**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

NA = NOT APPLICABLE**Page 135 of 178**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

NA = NOT APPLICABLE**Page 137 of 178**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

NA = NOT APPLICABLE**Page 138 of 178**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

NA = NOT APPLICABLE**Page 139 of 178**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

NA = NOT APPLICABLE**Page 141 of 178**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

NA = NOT APPLICABLE**Page 143 of 178**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

NA = NOT APPLICABLE**Page 144 of 178**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

NA = NOT APPLICABLE**Page 145 of 178**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

NA = NOT APPLICABLE**Page 147 of 178**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**