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TDMS Study 96007-05 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 05                                                                                     TIME: 11:38:42       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007F       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 57117-31-4      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                  FINAL #3/CONTROL VS. STOP GROUPS                                                  
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 NG/KG                                                                       
                                       INCLUDE 007    200 NG/ KG STOP                                                               
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 05                                                                                     TIME: 11:38:42       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007F       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 57117-31-4      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF       TOXIC EQUIVALENCY FACTOR EVALUATION(                                                                       
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Cortex                         Angiectasis                                                                                  
                                       Atrophy                                                                                      
                                       Degeneration Cystic                                                                          
                                       Hyperplasia                                                                                  
                                       Hypertrophy                                                                                  
                                       Necrosis                                                                                     
                                       Vacuolization Cytoplasmic                                                                    
Adrenal Medulla                        Hyperplasia                                                                                  
Bone Marrow                            Hyperplasia                                                                                  
Clitoral Gland                         Inflammation                                                                                 
Clitoral Gland: Duct                   Cyst                                                                                         
Harderian Gland                        Inflammation                                                                                 
Heart                                  Cardiomyopathy                                                                               
                                       Hemorrhage                                                                                   
Intestine Large, Colon                 Parasite Metazoan                                                                            
Intestine Large, Rectum                Parasite Metazoan                                                                            
Kidney                                 Accumulation, Hyaline Droplet                                                                
                                       Calculus Micro Observation Only                                                              
                                       Inflammation                                                                                 
                                       Mineralization                                                                               
                                       Nephropathy                                                                                  
                                       Pigmentation                                                                                 
Kidney: Transitional Epithelium        Hyperplasia                                                                                  
Liver                                  Angiectasis                                                                                  
                                       Basophilic Focus                                                                             
                                       Cholangiofibrosis                                                                            
                                       Clear Cell Focus                                                                             
                                       Eosinophilic Focus                                                                           
                                       Fatty Change Diffuse                                                                         
                                       Fatty Change Focal                                                                           
                                       Hematopoietic Cell Proliferation                                                             
                                       Hepatodiaphragmatic Nodule                                                                   
                                       Inflammation                                                                                 
                                       Mixed Cell Focus                                                                             
                                       Necrosis                                                                                     
                                       Pigmentation                                                                                 
                                       Toxic Hepatopathy                                                                            
Liver: Bile Duct                       Cyst                                                                                         
                                       Hyperplasia                                                                                  
Liver: Centrilobular                   Degeneration                                                                                 
Liver: Hepatocyte                      Hypertrophy                                                                                  
                                       Multinucleated                                                                               
Liver: Oval Cell                       Hyperplasia                                                                                  
Lung                                   Hemorrhage                                                                                   
                                       Infiltration Cellular Histiocyte                                                             
                                       Inflammation                                                                                 
Lung: Alveolar Epithelium              Hyperplasia                                                                                  
                                       Metaplasia Bronchiolar                                                                       
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 05                                                                                     TIME: 11:38:42       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007F       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 57117-31-4      
Lymph Node, Mandibular                 Hyperplasia                                                                                  
Lymph Node: Lumbar                     Ectasia                                                                                      
                                       Hemorrhage                                                                                   
Mammary Gland                          Cyst                                                                                         
                                       Hyperplasia                                                                                  
                                       Inflammation Granulomatous                                                                   
Nose                                   Inflammation                                                                                 
Nose: Respiratory Epithelium           Hyperplasia                                                                                  
Oral Mucosa: Gingival                  Hyperplasia                                                                                  
Ovary                                  Atrophy                                                                                      
                                       Cyst                                                                                         
Pancreas                               Inflammation Chronic                                                                         
Pancreas: Acinus                       Atrophy                                                                                      
                                       Vacuolization Cytoplasmic                                                                    
Pituitary Gland                        Angiectasis                                                                                  
                                       Cyst                                                                                         
                                       Cytoplasmic Alteration                                                                       
                                       Vacuolization Cytoplasmic                                                                    
Pituitary Gland: Pars Distalis         Hyperplasia                                                                                  
Skin                                   Inflammation                                                                                 
                                       Ulcer                                                                                        
Spleen                                 Hematopoietic Cell Proliferation                                                             
                                       Pigmentation                                                                                 
Spleen: Lymphoid Follicle              Atrophy                                                                                      
Spleen: Red Pulp                       Atrophy                                                                                      
Stomach, Forestomach                   Hyperplasia                                                                                  
Stomach, Glandular                     Mineralization                                                                               
Thymus                                 Atrophy                                                                                      
Thyroid Gland: C-Cell                  Hyperplasia                                                                                  
Thyroid Gland: Follicular Cell         Hypertrophy                                                                                  
Urinary Bladder                        Inflammation                                                                                 
Urinary Bladder: Transitional Epithelium                                                                                            
                                       Hyperplasia                                                                                  
Uterus                                 Inflammation                                                                                 
                                       Inflammation Chronic                                                                         
                                       Metaplasia                                                                                   
Uterus: Endometrium                    Hyperplasia Cystic                                                                           
===============================================================                                                                     
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              31/53 (58%)                                       29/48 (60%)                  | 
|POLY-3 RATE (b)    |                              31/44.10                                          29/40.00                     | 
|POLY-3 PERCENT (g) |                              70.3%                                             72.5%                        | 
|TERMINAL (d)       |                              20/25 (80%)                                       13/15 (87%)                  | 
|FIRST INCIDENCE    |                              588                                               276                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.045 *                    | 
|POLY 3             |                                                                                P=0.513                      | 
|POLY 1.5           |                                                                                P=0.518                      | 
|POLY 6             |                                                                                P=0.498                      | 
|LOGISTIC REGRESSION|                                                                                P=0.251                      | 
|COCH-ARM / FISHERS |                                                                                P=0.503                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         0/48 (0%)                    | 
|POLY-3 RATE (b)    |                              3/42.22                                           0/32.61                      | 
|POLY-3 PERCENT (g) |                              7.1%                                              0.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              619                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.207N                     | 
|POLY 3             |                                                                                P=0.194N                     | 
|POLY 1.5           |                                                                                P=0.171N                     | 
|POLY 6             |                                                                                P=0.223N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.166N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.141N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/53 (8%)                                         12/48 (25%)                  | 
|POLY-3 RATE (b)    |                              4/42.40                                           12/35.26                     | 
|POLY-3 PERCENT (g) |                              9.4%                                              34.0%                        | 
|TERMINAL (d)       |                              2/25 (8%)                                         7/15 (47%)                   | 
|FIRST INCIDENCE    |                              603                                               240                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.003 **                   | 
|POLY 3             |                                                                                P=0.007 **                   | 
|POLY 1.5           |                                                                                P=0.010 *                    | 
|POLY 6             |                                                                                P=0.004 **                   | 
|LOGISTIC REGRESSION|                                                                                P=0.013 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.016 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              8/53 (15%)                                        7/48 (15%)                   | 
|POLY-3 RATE (b)    |                              8/42.51                                           7/35.22                      | 
|POLY-3 PERCENT (g) |                              18.8%                                             19.9%                        | 
|TERMINAL (d)       |                              6/25 (24%)                                        2/15 (13%)                   | 
|FIRST INCIDENCE    |                              588                                               370                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.393                      | 
|POLY 3             |                                                                                P=0.580                      | 
|POLY 1.5           |                                                                                P=0.604                      | 
|POLY 6             |                                                                                P=0.555                      | 
|LOGISTIC REGRESSION|                                                                                P=0.598                      | 
|COCH-ARM / FISHERS |                                                                                P=0.583N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              42/53 (79%)                                       36/48 (75%)                  | 
|POLY-3 RATE (b)    |                              42/48.81                                          36/41.10                     | 
|POLY-3 PERCENT (g) |                              86.1%                                             87.6%                        | 
|TERMINAL (d)       |                              23/25 (92%)                                       14/15 (93%)                  | 
|FIRST INCIDENCE    |                              377                                               240                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.095                      | 
|POLY 3             |                                                                                P=0.557                      | 
|POLY 1.5           |                                                                                P=0.577N                     | 
|POLY 6             |                                                                                P=0.396                      | 
|LOGISTIC REGRESSION|                                                                                P=0.571                      | 
|COCH-ARM / FISHERS |                                                                                P=0.393N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/53 (8%)                                         3/48 (6%)                    | 
|POLY-3 RATE (b)    |                              4/43.02                                           3/33.19                      | 
|POLY-3 PERCENT (g) |                              9.3%                                              9.0%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              500                                               605                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.608                      | 
|POLY 3             |                                                                                P=0.661N                     | 
|POLY 1.5           |                                                                                P=0.622N                     | 
|POLY 6             |                                                                                P=0.663                      | 
|LOGISTIC REGRESSION|                                                                                P=0.575N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.556N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              9/53 (17%)                                        10/48 (21%)                  | 
|POLY-3 RATE (b)    |                              9/42.91                                           10/33.82                     | 
|POLY-3 PERCENT (g) |                              21.0%                                             29.6%                        | 
|TERMINAL (d)       |                              5/25 (20%)                                        6/15 (40%)                   | 
|FIRST INCIDENCE    |                              536                                               525                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.147                      | 
|POLY 3             |                                                                                P=0.286                      | 
|POLY 1.5           |                                                                                P=0.334                      | 
|POLY 6             |                                                                                P=0.237                      | 
|LOGISTIC REGRESSION|                                                                                P=0.252                      | 
|COCH-ARM / FISHERS |                                                                                P=0.405                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              11/53 (21%)                                       7/48 (15%)                   | 
|POLY-3 RATE (b)    |                              11/42.90                                          7/35.03                      | 
|POLY-3 PERCENT (g) |                              25.6%                                             20.0%                        | 
|TERMINAL (d)       |                              7/25 (28%)                                        3/15 (20%)                   | 
|FIRST INCIDENCE    |                              500                                               370                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.570N                     | 
|POLY 3             |                                                                                P=0.386N                     | 
|POLY 1.5           |                                                                                P=0.348N                     | 
|POLY 6             |                                                                                P=0.430N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.344N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.293N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              38/53 (72%)                                       43/50 (86%)                  | 
|POLY-3 RATE (b)    |                              38/52.51                                          43/49.89                     | 
|POLY-3 PERCENT (g) |                              72.4%                                             86.2%                        | 
|TERMINAL (d)       |                              12/25 (48%)                                       9/15 (60%)                   | 
|FIRST INCIDENCE    |                              289                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.017 *                    | 
|POLY 3             |                                                                                P=0.068                      | 
|POLY 1.5           |                                                                                P=0.065                      | 
|POLY 6             |                                                                                P=0.072                      | 
|LOGISTIC REGRESSION|                                                                                P=0.223                      | 
|COCH-ARM / FISHERS |                                                                                P=0.062                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              52/53 (98%)                                       48/50 (96%)                  | 
|POLY-3 RATE (b)    |                              52/52.72                                          48/49.33                     | 
|POLY-3 PERCENT (g) |                              98.6%                                             97.3%                        | 
|TERMINAL (d)       |                              25/25 (100%)                                      14/15 (93%)                  | 
|FIRST INCIDENCE    |                              289                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.043 *                    | 
|POLY 3             |                                                                                P=0.609N                     | 
|POLY 1.5           |                                                                                P=0.563N                     | 
|POLY 6             |                                                                                P=0.634N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.482N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.478N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland: Duct                                                                                                             | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              40/53 (75%)                                       39/50 (78%)                  | 
|POLY-3 RATE (b)    |                              40/50.78                                          39/44.51                     | 
|POLY-3 PERCENT (g) |                              78.8%                                             87.6%                        | 
|TERMINAL (d)       |                              18/25 (72%)                                       12/15 (80%)                  | 
|FIRST INCIDENCE    |                              289                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.045 *                    | 
|POLY 3             |                                                                                P=0.183                      | 
|POLY 1.5           |                                                                                P=0.264                      | 
|POLY 6             |                                                                                P=0.134                      | 
|LOGISTIC REGRESSION|                                                                                P=0.401                      | 
|COCH-ARM / FISHERS |                                                                                P=0.473                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              16/53 (30%)                                       6/49 (12%)                   | 
|POLY-3 RATE (b)    |                              16/42.80                                          6/34.36                      | 
|POLY-3 PERCENT (g) |                              37.4%                                             17.5%                        | 
|TERMINAL (d)       |                              11/25 (44%)                                       2/15 (13%)                   | 
|FIRST INCIDENCE    |                              610                                               500                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.154N                     | 
|POLY 3             |                                                                                P=0.046N*                    | 
|POLY 1.5           |                                                                                P=0.036N*                    | 
|POLY 6             |                                                                                P=0.060N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.061N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.024N*                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              15/53 (28%)                                       13/50 (26%)                  | 
|POLY-3 RATE (b)    |                              15/43.14                                          13/35.36                     | 
|POLY-3 PERCENT (g) |                              34.8%                                             36.8%                        | 
|TERMINAL (d)       |                              9/25 (36%)                                        5/15 (33%)                   | 
|FIRST INCIDENCE    |                              500                                               503                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.261                      | 
|POLY 3             |                                                                                P=0.533                      | 
|POLY 1.5           |                                                                                P=0.591                      | 
|POLY 6             |                                                                                P=0.478                      | 
|LOGISTIC REGRESSION|                                                                                P=0.465                      | 
|COCH-ARM / FISHERS |                                                                                P=0.484N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/43.24                                           0/32.95                      | 
|POLY-3 PERCENT (g) |                              4.6%                                              0.0%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              377                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.283N                     | 
|POLY 3             |                                                                                P=0.345N                     | 
|POLY 1.5           |                                                                                P=0.308N                     | 
|POLY 6             |                                                                                P=0.388N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.149N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.262N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Colon                                                                                                           | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/49 (0%)                    | 
|POLY-3 RATE (b)    |                              2/42.66                                           0/32.31                      | 
|POLY-3 PERCENT (g) |                              4.7%                                              0.0%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              536                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.320N                     | 
|POLY 3             |                                                                                P=0.346N                     | 
|POLY 1.5           |                                                                                P=0.312N                     | 
|POLY 6             |                                                                                P=0.388N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.227N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.268N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Rectum                                                                                                          | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/53 (8%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              4/41.97                                           2/32.95                      | 
|POLY-3 PERCENT (g) |                              9.5%                                              6.1%                         | 
|TERMINAL (d)       |                              3/25 (12%)                                        2/15 (13%)                   | 
|FIRST INCIDENCE    |                              678                                               728 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.574N                     | 
|POLY 3             |                                                                                P=0.478N                     | 
|POLY 1.5           |                                                                                P=0.434N                     | 
|POLY 6             |                                                                                P=0.528N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.527N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.367N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Accumulation, Hyaline Droplet                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         3/48 (6%)                    | 
|POLY-3 RATE (b)    |                              0/41.78                                           3/33.51                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              9.0%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/15 (7%)                    | 
|FIRST INCIDENCE    |                              ---                                               384                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.072                      | 
|POLY 3             |                                                                                P=0.094                      | 
|POLY 1.5           |                                                                                P=0.099                      | 
|POLY 6             |                                                                                P=0.090                      | 
|LOGISTIC REGRESSION|                                                                                P=0.111                      | 
|COCH-ARM / FISHERS |                                                                                P=0.104                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Calculus Micro Observation Only                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         1/48 (2%)                    | 
|POLY-3 RATE (b)    |                              5/41.89                                           1/33.46                      | 
|POLY-3 PERCENT (g) |                              11.9%                                             3.0%                         | 
|TERMINAL (d)       |                              4/25 (16%)                                        0/15 (0%)                    | 
|FIRST INCIDENCE    |                              699                                               384                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.221N                     | 
|POLY 3             |                                                                                P=0.173N                     | 
|POLY 1.5           |                                                                                P=0.154N                     | 
|POLY 6             |                                                                                P=0.198N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.146N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.127N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         3/48 (6%)                    | 
|POLY-3 RATE (b)    |                              2/42.16                                           3/32.66                      | 
|POLY-3 PERCENT (g) |                              4.7%                                              9.2%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         2/15 (13%)                   | 
|FIRST INCIDENCE    |                              619                                               715                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.302                      | 
|POLY 3             |                                                                                P=0.411                      | 
|POLY 1.5           |                                                                                P=0.432                      | 
|POLY 6             |                                                                                P=0.389                      | 
|LOGISTIC REGRESSION|                                                                                P=0.357                      | 
|COCH-ARM / FISHERS |                                                                                P=0.453                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              37/53 (70%)                                       41/48 (85%)                  | 
|POLY-3 RATE (b)    |                              37/49.64                                          41/44.94                     | 
|POLY-3 PERCENT (g) |                              74.5%                                             91.2%                        | 
|TERMINAL (d)       |                              20/25 (80%)                                       13/15 (87%)                  | 
|FIRST INCIDENCE    |                              289                                               276                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.006 **                   | 
|POLY 3             |                                                                                P=0.023 *                    | 
|POLY 1.5           |                                                                                P=0.027 *                    | 
|POLY 6             |                                                                                P=0.026 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.045 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.051                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              34/53 (64%)                                       35/48 (73%)                  | 
|POLY-3 RATE (b)    |                              34/45.99                                          35/41.66                     | 
|POLY-3 PERCENT (g) |                              73.9%                                             84.0%                        | 
|TERMINAL (d)       |                              20/25 (80%)                                       15/15 (100%)                 | 
|FIRST INCIDENCE    |                              377                                               240                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.011 *                    | 
|POLY 3             |                                                                                P=0.164                      | 
|POLY 1.5           |                                                                                P=0.204                      | 
|POLY 6             |                                                                                P=0.118                      | 
|LOGISTIC REGRESSION|                                                                                P=0.101                      | 
|COCH-ARM / FISHERS |                                                                                P=0.233                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/48 (0%)                    | 
|POLY-3 RATE (b)    |                              2/42.16                                           0/32.61                      | 
|POLY-3 PERCENT (g) |                              4.7%                                              0.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              619                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.334N                     | 
|POLY 3             |                                                                                P=0.336N                     | 
|POLY 1.5           |                                                                                P=0.308N                     | 
|POLY 6             |                                                                                P=0.371N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.282N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.273N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Transitional Epithelium                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         3/48 (6%)                    | 
|POLY-3 RATE (b)    |                              2/41.78                                           3/33.23                      | 
|POLY-3 PERCENT (g) |                              4.8%                                              9.0%                         | 
|TERMINAL (d)       |                              2/25 (8%)                                         2/15 (13%)                   | 
|FIRST INCIDENCE    |                              728 (T)                                           525                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.295                      | 
|POLY 3             |                                                                                P=0.420                      | 
|POLY 1.5           |                                                                                P=0.437                      | 
|POLY 6             |                                                                                P=0.402                      | 
|LOGISTIC REGRESSION|                                                                                P=0.384                      | 
|COCH-ARM / FISHERS |                                                                                P=0.453                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              6/53 (11%)                                        1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              6/42.92                                           1/33.52                      | 
|POLY-3 PERCENT (g) |                              14.0%                                             3.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              610                                               547                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.149N                     | 
|POLY 3             |                                                                                P=0.117N                     | 
|POLY 1.5           |                                                                                P=0.095N                     | 
|POLY 6             |                                                                                P=0.148N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.081N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.066N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 13      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              22/53 (42%)                                       13/50 (26%)                  | 
|POLY-3 RATE (b)    |                              22/44.73                                          13/36.12                     | 
|POLY-3 PERCENT (g) |                              49.2%                                             36.0%                        | 
|TERMINAL (d)       |                              10/25 (40%)                                       5/15 (33%)                   | 
|FIRST INCIDENCE    |                              513                                               451                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.431N                     | 
|POLY 3             |                                                                                P=0.169N                     | 
|POLY 1.5           |                                                                                P=0.122N                     | 
|POLY 6             |                                                                                P=0.242N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.158N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.073N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Cholangiofibrosis                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              0/41.78                                           3/33.14                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              9.1%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/15 (7%)                    | 
|FIRST INCIDENCE    |                              ---                                               692                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.060                      | 
|POLY 3             |                                                                                P=0.095                      | 
|POLY 1.5           |                                                                                P=0.100                      | 
|POLY 6             |                                                                                P=0.090                      | 
|LOGISTIC REGRESSION|                                                                                P=0.065                      | 
|COCH-ARM / FISHERS |                                                                                P=0.111                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 14      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Clear Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              13/53 (25%)                                       6/50 (12%)                   | 
|POLY-3 RATE (b)    |                              13/43.13                                          6/32.95                      | 
|POLY-3 PERCENT (g) |                              30.1%                                             18.2%                        | 
|TERMINAL (d)       |                              9/25 (36%)                                        6/15 (40%)                   | 
|FIRST INCIDENCE    |                              321                                               728 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.322N                     | 
|POLY 3             |                                                                                P=0.188N                     | 
|POLY 1.5           |                                                                                P=0.140N                     | 
|POLY 6             |                                                                                P=0.257N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.196N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.082N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              15/53 (28%)                                       22/50 (44%)                  | 
|POLY-3 RATE (b)    |                              15/45.03                                          22/38.92                     | 
|POLY-3 PERCENT (g) |                              33.3%                                             56.5%                        | 
|TERMINAL (d)       |                              6/25 (24%)                                        6/15 (40%)                   | 
|FIRST INCIDENCE    |                              289                                               370                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.013 *                    | 
|POLY 3             |                                                                                P=0.024 *                    | 
|POLY 1.5           |                                                                                P=0.034 *                    | 
|POLY 6             |                                                                                P=0.019 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.048 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.073                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 15      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Diffuse                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         6/50 (12%)                   | 
|POLY-3 RATE (b)    |                              1/41.78                                           6/34.86                      | 
|POLY-3 PERCENT (g) |                              2.4%                                              17.2%                        | 
|TERMINAL (d)       |                              1/25 (4%)                                         3/15 (20%)                   | 
|FIRST INCIDENCE    |                              728 (T)                                           413                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.019 *                    | 
|POLY 3             |                                                                                P=0.033 *                    | 
|POLY 1.5           |                                                                                P=0.038 *                    | 
|POLY 6             |                                                                                P=0.029 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.046 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.048 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         7/50 (14%)                   | 
|POLY-3 RATE (b)    |                              5/42.06                                           7/34.54                      | 
|POLY-3 PERCENT (g) |                              11.9%                                             20.3%                        | 
|TERMINAL (d)       |                              4/25 (16%)                                        2/15 (13%)                   | 
|FIRST INCIDENCE    |                              651                                               476                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.140                      | 
|POLY 3             |                                                                                P=0.257                      | 
|POLY 1.5           |                                                                                P=0.287                      | 
|POLY 6             |                                                                                P=0.231                      | 
|LOGISTIC REGRESSION|                                                                                P=0.233                      | 
|COCH-ARM / FISHERS |                                                                                P=0.339                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 16      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              24/53 (45%)                                       31/50 (62%)                  | 
|POLY-3 RATE (b)    |                              24/48.52                                          31/42.24                     | 
|POLY-3 PERCENT (g) |                              49.5%                                             73.4%                        | 
|TERMINAL (d)       |                              10/25 (40%)                                       10/15 (67%)                  | 
|FIRST INCIDENCE    |                              289                                               240                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.008 **                   | 
|POLY 3             |                                                                                P=0.014 *                    | 
|POLY 1.5           |                                                                                P=0.024 *                    | 
|POLY 6             |                                                                                P=0.008 **                   | 
|LOGISTIC REGRESSION|                                                                                P=0.072                      | 
|COCH-ARM / FISHERS |                                                                                P=0.066                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatodiaphragmatic Nodule                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              3/41.97                                           1/32.95                      | 
|POLY-3 PERCENT (g) |                              7.2%                                              3.0%                         | 
|TERMINAL (d)       |                              2/25 (8%)                                         1/15 (7%)                    | 
|FIRST INCIDENCE    |                              678                                               728 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.484N                     | 
|POLY 3             |                                                                                P=0.425N                     | 
|POLY 1.5           |                                                                                P=0.387N                     | 
|POLY 6             |                                                                                P=0.469N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.443N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.331N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 17      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              47/53 (89%)                                       48/50 (96%)                  | 
|POLY-3 RATE (b)    |                              47/51.32                                          48/48.98                     | 
|POLY-3 PERCENT (g) |                              91.6%                                             98.0%                        | 
|TERMINAL (d)       |                              23/25 (92%)                                       15/15 (100%)                 | 
|FIRST INCIDENCE    |                              289                                               240                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.010 *                    | 
|POLY 3             |                                                                                P=0.145                      | 
|POLY 1.5           |                                                                                P=0.123                      | 
|POLY 6             |                                                                                P=0.194                      | 
|LOGISTIC REGRESSION|                                                                                P=0.112                      | 
|COCH-ARM / FISHERS |                                                                                P=0.154                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              33/53 (62%)                                       24/50 (48%)                  | 
|POLY-3 RATE (b)    |                              33/45.39                                          24/36.74                     | 
|POLY-3 PERCENT (g) |                              72.7%                                             65.3%                        | 
|TERMINAL (d)       |                              21/25 (84%)                                       11/15 (73%)                  | 
|FIRST INCIDENCE    |                              500                                               451                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.352                      | 
|POLY 3             |                                                                                P=0.312N                     | 
|POLY 1.5           |                                                                                P=0.206N                     | 
|POLY 6             |                                                                                P=0.457N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.406N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.104N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 18      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/53 (8%)                                         11/50 (22%)                  | 
|POLY-3 RATE (b)    |                              4/44.47                                           11/39.94                     | 
|POLY-3 PERCENT (g) |                              9.0%                                              27.5%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              377                                               240                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.027 *                    | 
|POLY 3             |                                                                                P=0.024 *                    | 
|POLY 1.5           |                                                                                P=0.028 *                    | 
|POLY 6             |                                                                                P=0.021 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.120                      | 
|COCH-ARM / FISHERS |                                                                                P=0.035 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              13/53 (25%)                                       48/50 (96%)                  | 
|POLY-3 RATE (b)    |                              13/43.77                                          48/48.40                     | 
|POLY-3 PERCENT (g) |                              29.7%                                             99.2%                        | 
|TERMINAL (d)       |                              7/25 (28%)                                        15/15 (100%)                 | 
|FIRST INCIDENCE    |                              321                                               240                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 19      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Toxic Hepatopathy                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         9/50 (18%)                   | 
|POLY-3 RATE (b)    |                              0/41.78                                           9/33.65                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              26.7%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         5/15 (33%)                   | 
|FIRST INCIDENCE    |                              ---                                               610                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              7/53 (13%)                                        2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              7/42.31                                           2/33.05                      | 
|POLY-3 PERCENT (g) |                              16.6%                                             6.1%                         | 
|TERMINAL (d)       |                              4/25 (16%)                                        1/15 (7%)                    | 
|FIRST INCIDENCE    |                              651                                               701                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.242N                     | 
|POLY 3             |                                                                                P=0.164N                     | 
|POLY 1.5           |                                                                                P=0.134N                     | 
|POLY 6             |                                                                                P=0.203N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.182N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.095N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 20      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              3/42.17                                           1/32.95                      | 
|POLY-3 PERCENT (g) |                              7.1%                                              3.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         1/15 (7%)                    | 
|FIRST INCIDENCE    |                              619                                               728 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.484N                     | 
|POLY 3             |                                                                                P=0.427N                     | 
|POLY 1.5           |                                                                                P=0.388N                     | 
|POLY 6             |                                                                                P=0.473N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.416N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.331N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Centrilobular                                                                                                             | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/53 (8%)                                         7/50 (14%)                   | 
|POLY-3 RATE (b)    |                              4/43.64                                           7/36.67                      | 
|POLY-3 PERCENT (g) |                              9.2%                                              19.1%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         2/15 (13%)                   | 
|FIRST INCIDENCE    |                              310                                               240                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.145                      | 
|POLY 3             |                                                                                P=0.175                      | 
|POLY 1.5           |                                                                                P=0.196                      | 
|POLY 6             |                                                                                P=0.154                      | 
|LOGISTIC REGRESSION|                                                                                P=0.388                      | 
|COCH-ARM / FISHERS |                                                                                P=0.230                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 21      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         14/50 (28%)                  | 
|POLY-3 RATE (b)    |                              2/42.11                                           14/38.76                     | 
|POLY-3 PERCENT (g) |                              4.8%                                              36.1%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         3/15 (20%)                   | 
|FIRST INCIDENCE    |                              651                                               240                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Multinucleated                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         25/50 (50%)                  | 
|POLY-3 RATE (b)    |                              0/41.78                                           25/42.04                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              59.5%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         7/15 (47%)                   | 
|FIRST INCIDENCE    |                              ---                                               276                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 22      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Oval Cell                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              1/41.78                                           3/33.20                      | 
|POLY-3 PERCENT (g) |                              2.4%                                              9.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         1/15 (7%)                    | 
|FIRST INCIDENCE    |                              728 (T)                                           689                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.175                      | 
|POLY 3             |                                                                                P=0.249                      | 
|POLY 1.5           |                                                                                P=0.263                      | 
|POLY 6             |                                                                                P=0.236                      | 
|LOGISTIC REGRESSION|                                                                                P=0.188                      | 
|COCH-ARM / FISHERS |                                                                                P=0.287                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/41.78                                           2/34.31                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.8%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               495                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.194                      | 
|POLY 3             |                                                                                P=0.218                      | 
|POLY 1.5           |                                                                                P=0.222                      | 
|POLY 6             |                                                                                P=0.215                      | 
|LOGISTIC REGRESSION|                                                                                P=0.297                      | 
|COCH-ARM / FISHERS |                                                                                P=0.233                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 23      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              44/53 (83%)                                       30/50 (60%)                  | 
|POLY-3 RATE (b)    |                              44/49.96                                          30/41.31                     | 
|POLY-3 PERCENT (g) |                              88.1%                                             72.6%                        | 
|TERMINAL (d)       |                              22/25 (88%)                                       10/15 (67%)                  | 
|FIRST INCIDENCE    |                              310                                               276                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.534                      | 
|POLY 3             |                                                                                P=0.044N*                    | 
|POLY 1.5           |                                                                                P=0.022N*                    | 
|POLY 6             |                                                                                P=0.078N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.026N*                    | 
|COCH-ARM / FISHERS |                                                                                P=0.008N**                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         5/50 (10%)                   | 
|POLY-3 RATE (b)    |                              5/43.26                                           5/33.26                      | 
|POLY-3 PERCENT (g) |                              11.6%                                             15.0%                        | 
|TERMINAL (d)       |                              1/25 (4%)                                         2/15 (13%)                   | 
|FIRST INCIDENCE    |                              377                                               689                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.378                      | 
|POLY 3             |                                                                                P=0.480                      | 
|POLY 1.5           |                                                                                P=0.524                      | 
|POLY 6             |                                                                                P=0.436                      | 
|LOGISTIC REGRESSION|                                                                                P=0.517                      | 
|COCH-ARM / FISHERS |                                                                                P=0.592                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 24      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              14/53 (26%)                                       6/50 (12%)                   | 
|POLY-3 RATE (b)    |                              14/42.58                                          6/33.73                      | 
|POLY-3 PERCENT (g) |                              32.9%                                             17.8%                        | 
|TERMINAL (d)       |                              11/25 (44%)                                       3/15 (20%)                   | 
|FIRST INCIDENCE    |                              610                                               547                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.259N                     | 
|POLY 3             |                                                                                P=0.114N                     | 
|POLY 1.5           |                                                                                P=0.086N                     | 
|POLY 6             |                                                                                P=0.151N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.152N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.054N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Metaplasia Bronchiolar                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         7/50 (14%)                   | 
|POLY-3 RATE (b)    |                              5/41.78                                           7/33.80                      | 
|POLY-3 PERCENT (g) |                              12.0%                                             20.7%                        | 
|TERMINAL (d)       |                              5/25 (20%)                                        4/15 (27%)                   | 
|FIRST INCIDENCE    |                              728 (T)                                           512                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.115                      | 
|POLY 3             |                                                                                P=0.249                      | 
|POLY 1.5           |                                                                                P=0.282                      | 
|POLY 6             |                                                                                P=0.218                      | 
|LOGISTIC REGRESSION|                                                                                P=0.175                      | 
|COCH-ARM / FISHERS |                                                                                P=0.339                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 25      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              38/53 (72%)                                       29/49 (59%)                  | 
|POLY-3 RATE (b)    |                              38/46.17                                          29/40.93                     | 
|POLY-3 PERCENT (g) |                              82.3%                                             70.9%                        | 
|TERMINAL (d)       |                              24/25 (96%)                                       10/15 (67%)                  | 
|FIRST INCIDENCE    |                              321                                               240                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.284                      | 
|POLY 3             |                                                                                P=0.136N                     | 
|POLY 1.5           |                                                                                P=0.130N                     | 
|POLY 6             |                                                                                P=0.144N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.284N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.131N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/5 (40%)                                         1/3 (33%)                    | 
|POLY-3 RATE (b)    |                              2/4.62                                            1/2.95                       | 
|POLY-3 PERCENT (g) |                              43.3%                                             33.9%                        | 
|TERMINAL (d)       |                              1/3 (33%)                                         1/2 (50%)                    | 
|FIRST INCIDENCE    |                              678                                               728 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.662N                     | 
|POLY 3             |                                                                                P=0.720N                     | 
|POLY 1.5           |                                                                                P=0.731N                     | 
|POLY 6             |                                                                                P=0.705N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.689N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.714N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 26      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/5 (40%)                                         0/3 (0%)                     | 
|POLY-3 RATE (b)    |                              2/4.42                                            0/2.95                       | 
|POLY-3 PERCENT (g) |                              45.2%                                             0.0%                         | 
|TERMINAL (d)       |                              2/3 (67%)                                         0/2 (0%)                     | 
|FIRST INCIDENCE    |                              728 (T)                                           ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.309N                     | 
|POLY 3             |                                                                                P=0.357N                     | 
|POLY 1.5           |                                                                                P=0.386N                     | 
|POLY 6             |                                                                                P=0.313N                     | 
|LOGISTIC REGRESSION|                                                                                (e)                          | 
|COCH-ARM / FISHERS |                                                                                P=0.357N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              1/41.81                                           3/33.91                      | 
|POLY-3 PERCENT (g) |                              2.4%                                              8.9%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/15 (7%)                    | 
|FIRST INCIDENCE    |                              720                                               384                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.185                      | 
|POLY 3             |                                                                                P=0.253                      | 
|POLY 1.5           |                                                                                P=0.266                      | 
|POLY 6             |                                                                                P=0.240                      | 
|LOGISTIC REGRESSION|                                                                                P=0.278                      | 
|COCH-ARM / FISHERS |                                                                                P=0.287                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 27      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              33/53 (62%)                                       19/50 (38%)                  | 
|POLY-3 RATE (b)    |                              33/46.61                                          19/36.27                     | 
|POLY-3 PERCENT (g) |                              70.8%                                             52.4%                        | 
|TERMINAL (d)       |                              19/25 (76%)                                       7/15 (47%)                   | 
|FIRST INCIDENCE    |                              289                                               413                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.350N                     | 
|POLY 3             |                                                                                P=0.060N                     | 
|POLY 1.5           |                                                                                P=0.033N*                    | 
|POLY 6             |                                                                                P=0.099N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.046N*                    | 
|COCH-ARM / FISHERS |                                                                                P=0.012N*                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              2/41.97                                           1/33.80                      | 
|POLY-3 PERCENT (g) |                              4.8%                                              3.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              678                                               384                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.605N                     | 
|POLY 3             |                                                                                P=0.604N                     | 
|POLY 1.5           |                                                                                P=0.574N                     | 
|POLY 6             |                                                                                P=0.638N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.487N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.522N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 28      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              8/53 (15%)                                        7/50 (14%)                   | 
|POLY-3 RATE (b)    |                              8/44.12                                           7/34.45                      | 
|POLY-3 PERCENT (g) |                              18.1%                                             20.3%                        | 
|TERMINAL (d)       |                              2/25 (8%)                                         1/15 (7%)                    | 
|FIRST INCIDENCE    |                              321                                               370                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.437                      | 
|POLY 3             |                                                                                P=0.535                      | 
|POLY 1.5           |                                                                                P=0.587                      | 
|POLY 6             |                                                                                P=0.478                      | 
|LOGISTIC REGRESSION|                                                                                P=0.571N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.549N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Respiratory Epithelium                                                                                                     | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              1/42.34                                           2/33.05                      | 
|POLY-3 PERCENT (g) |                              2.4%                                              6.1%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/15 (7%)                    | 
|FIRST INCIDENCE    |                              554                                               701                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.365                      | 
|POLY 3             |                                                                                P=0.449                      | 
|POLY 1.5           |                                                                                P=0.462                      | 
|POLY 6             |                                                                                P=0.437                      | 
|LOGISTIC REGRESSION|                                                                                P=0.446                      | 
|COCH-ARM / FISHERS |                                                                                P=0.478                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 29      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Mucosa: Gingival                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              15/52 (29%)                                       14/50 (28%)                  | 
|POLY-3 RATE (b)    |                              15/42.71                                          14/36.02                     | 
|POLY-3 PERCENT (g) |                              35.1%                                             38.9%                        | 
|TERMINAL (d)       |                              9/24 (38%)                                        5/15 (33%)                   | 
|FIRST INCIDENCE    |                              500                                               491                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.225                      | 
|POLY 3             |                                                                                P=0.465                      | 
|POLY 1.5           |                                                                                P=0.523                      | 
|POLY 6             |                                                                                P=0.414                      | 
|LOGISTIC REGRESSION|                                                                                P=0.445                      | 
|COCH-ARM / FISHERS |                                                                                P=0.550N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              43/53 (81%)                                       39/47 (83%)                  | 
|POLY-3 RATE (b)    |                              43/50.40                                          39/43.66                     | 
|POLY-3 PERCENT (g) |                              85.3%                                             89.3%                        | 
|TERMINAL (d)       |                              21/25 (84%)                                       13/15 (87%)                  | 
|FIRST INCIDENCE    |                              310                                               276                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.072                      | 
|POLY 3             |                                                                                P=0.396                      | 
|POLY 1.5           |                                                                                P=0.422                      | 
|POLY 6             |                                                                                P=0.395                      | 
|LOGISTIC REGRESSION|                                                                                P=0.427                      | 
|COCH-ARM / FISHERS |                                                                                P=0.510                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 30      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              11/53 (21%)                                       12/47 (26%)                  | 
|POLY-3 RATE (b)    |                              11/42.65                                          12/36.25                     | 
|POLY-3 PERCENT (g) |                              25.8%                                             33.1%                        | 
|TERMINAL (d)       |                              8/25 (32%)                                        4/15 (27%)                   | 
|FIRST INCIDENCE    |                              554                                               384                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.148                      | 
|POLY 3             |                                                                                P=0.327                      | 
|POLY 1.5           |                                                                                P=0.345                      | 
|POLY 6             |                                                                                P=0.309                      | 
|LOGISTIC REGRESSION|                                                                                P=0.327                      | 
|COCH-ARM / FISHERS |                                                                                P=0.371                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/49 (0%)                    | 
|POLY-3 RATE (b)    |                              2/42.25                                           0/32.92                      | 
|POLY-3 PERCENT (g) |                              4.7%                                              0.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              588                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.331N                     | 
|POLY 3             |                                                                                P=0.333N                     | 
|POLY 1.5           |                                                                                P=0.303N                     | 
|POLY 6             |                                                                                P=0.372N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.268N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.268N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 31      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         0/49 (0%)                    | 
|POLY-3 RATE (b)    |                              3/42.64                                           0/32.92                      | 
|POLY-3 PERCENT (g) |                              7.0%                                              0.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              588                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.197N                     | 
|POLY 3             |                                                                                P=0.195N                     | 
|POLY 1.5           |                                                                                P=0.169N                     | 
|POLY 6             |                                                                                P=0.230N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.137N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.136N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/49 (4%)                    | 
|POLY-3 RATE (b)    |                              0/41.78                                           2/34.20                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.9%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               370                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.204                      | 
|POLY 3             |                                                                                P=0.217                      | 
|POLY 1.5           |                                                                                P=0.221                      | 
|POLY 6             |                                                                                P=0.214                      | 
|LOGISTIC REGRESSION|                                                                                P=0.281                      | 
|COCH-ARM / FISHERS |                                                                                P=0.228                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 32      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              20/53 (38%)                                       13/49 (27%)                  | 
|POLY-3 RATE (b)    |                              20/42.80                                          13/34.10                     | 
|POLY-3 PERCENT (g) |                              46.7%                                             38.1%                        | 
|TERMINAL (d)       |                              14/25 (56%)                                       6/15 (40%)                   | 
|FIRST INCIDENCE    |                              651                                               500                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.550                      | 
|POLY 3             |                                                                                P=0.305N                     | 
|POLY 1.5           |                                                                                P=0.243N                     | 
|POLY 6             |                                                                                P=0.381N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.435N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.159N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         1/49 (2%)                    | 
|POLY-3 RATE (b)    |                              2/41.83                                           1/32.63                      | 
|POLY-3 PERCENT (g) |                              4.8%                                              3.1%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         1/15 (7%)                    | 
|FIRST INCIDENCE    |                              715                                               728 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.664N                     | 
|POLY 3             |                                                                                P=0.619N                     | 
|POLY 1.5           |                                                                                P=0.587N                     | 
|POLY 6             |                                                                                P=0.654N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.648N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.530N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 33      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         2/49 (4%)                    | 
|POLY-3 RATE (b)    |                              1/41.78                                           2/32.96                      | 
|POLY-3 PERCENT (g) |                              2.4%                                              6.1%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         1/15 (7%)                    | 
|FIRST INCIDENCE    |                              728 (T)                                           638                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.342                      | 
|POLY 3             |                                                                                P=0.450                      | 
|POLY 1.5           |                                                                                P=0.461                      | 
|POLY 6             |                                                                                P=0.440                      | 
|LOGISTIC REGRESSION|                                                                                P=0.397                      | 
|COCH-ARM / FISHERS |                                                                                P=0.470                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         2/49 (4%)                    | 
|POLY-3 RATE (b)    |                              2/42.16                                           2/32.63                      | 
|POLY-3 PERCENT (g) |                              4.7%                                              6.1%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         2/15 (13%)                   | 
|FIRST INCIDENCE    |                              619                                               728 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.520                      | 
|POLY 3             |                                                                                P=0.628                      | 
|POLY 1.5           |                                                                                P=0.645                      | 
|POLY 6             |                                                                                P=0.611                      | 
|LOGISTIC REGRESSION|                                                                                P=0.582                      | 
|COCH-ARM / FISHERS |                                                                                P=0.661                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 34      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              22/53 (42%)                                       19/49 (39%)                  | 
|POLY-3 RATE (b)    |                              22/43.51                                          19/37.38                     | 
|POLY-3 PERCENT (g) |                              50.6%                                             50.8%                        | 
|TERMINAL (d)       |                              16/25 (64%)                                       8/15 (53%)                   | 
|FIRST INCIDENCE    |                              610                                               384                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.187                      | 
|POLY 3             |                                                                                P=0.589                      | 
|POLY 1.5           |                                                                                P=0.563N                     | 
|POLY 6             |                                                                                P=0.562                      | 
|LOGISTIC REGRESSION|                                                                                P=0.460                      | 
|COCH-ARM / FISHERS |                                                                                P=0.469N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/42.17                                           0/32.95                      | 
|POLY-3 PERCENT (g) |                              4.7%                                              0.0%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              619                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.338N                     | 
|POLY 3             |                                                                                P=0.333N                     | 
|POLY 1.5           |                                                                                P=0.301N                     | 
|POLY 6             |                                                                                P=0.372N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.278N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.262N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 35      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/42.17                                           0/32.95                      | 
|POLY-3 PERCENT (g) |                              4.7%                                              0.0%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              619                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.338N                     | 
|POLY 3             |                                                                                P=0.333N                     | 
|POLY 1.5           |                                                                                P=0.301N                     | 
|POLY 6             |                                                                                P=0.372N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.278N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.262N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              49/53 (92%)                                       49/49 (100%)                 | 
|POLY-3 RATE (b)    |                              49/51.40                                          49/49.00                     | 
|POLY-3 PERCENT (g) |                              95.3%                                             100.0%                       | 
|TERMINAL (d)       |                              25/25 (100%)                                      15/15 (100%)                 | 
|FIRST INCIDENCE    |                              289                                               240                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.011 *                    | 
|POLY 3             |                                                                                P=0.164                      | 
|POLY 1.5           |                                                                                P=0.119                      | 
|POLY 6             |                                                                                P=0.237                      | 
|LOGISTIC REGRESSION|                                                                                P=0.053                      | 
|COCH-ARM / FISHERS |                                                                                P=0.069                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 36      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              52/53 (98%)                                       48/49 (98%)                  | 
|POLY-3 RATE (b)    |                              52/53.00                                          48/48.57                     | 
|POLY-3 PERCENT (g) |                              98.1%                                             98.8%                        | 
|TERMINAL (d)       |                              24/25 (96%)                                       15/15 (100%)                 | 
|FIRST INCIDENCE    |                              289                                               240                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.041 *                    | 
|POLY 3             |                                                                                P=0.724                      | 
|POLY 1.5           |                                                                                P=0.756                      | 
|POLY 6             |                                                                                P=0.661                      | 
|LOGISTIC REGRESSION|                                                                                P=0.726N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.732N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              7/53 (13%)                                        2/49 (4%)                    | 
|POLY-3 RATE (b)    |                              7/44.55                                           2/33.47                      | 
|POLY-3 PERCENT (g) |                              15.7%                                             6.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              310                                               625                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.189N                     | 
|POLY 3             |                                                                                P=0.183N                     | 
|POLY 1.5           |                                                                                P=0.147N                     | 
|POLY 6             |                                                                                P=0.231N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.077N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.100N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 37      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Red Pulp                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/49 (0%)                    | 
|POLY-3 RATE (b)    |                              2/42.70                                           0/32.92                      | 
|POLY-3 PERCENT (g) |                              4.7%                                              0.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              310                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.308N                     | 
|POLY 3             |                                                                                P=0.338N                     | 
|POLY 1.5           |                                                                                P=0.307N                     | 
|POLY 6             |                                                                                P=0.376N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.197N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.268N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/53 (8%)                                         5/50 (10%)                   | 
|POLY-3 RATE (b)    |                              4/42.72                                           5/35.15                      | 
|POLY-3 PERCENT (g) |                              9.4%                                              14.2%                        | 
|TERMINAL (d)       |                              2/25 (8%)                                         2/15 (13%)                   | 
|FIRST INCIDENCE    |                              289                                               370                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.296                      | 
|POLY 3             |                                                                                P=0.394                      | 
|POLY 1.5           |                                                                                P=0.419                      | 
|POLY 6             |                                                                                P=0.368                      | 
|LOGISTIC REGRESSION|                                                                                P=0.538                      | 
|COCH-ARM / FISHERS |                                                                                P=0.463                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 38      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              2/41.98                                           3/34.03                      | 
|POLY-3 PERCENT (g) |                              4.8%                                              8.8%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         1/15 (7%)                    | 
|FIRST INCIDENCE    |                              675                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.340                      | 
|POLY 3             |                                                                                P=0.427                      | 
|POLY 1.5           |                                                                                P=0.447                      | 
|POLY 6             |                                                                                P=0.405                      | 
|LOGISTIC REGRESSION|                                                                                P=0.501                      | 
|COCH-ARM / FISHERS |                                                                                P=0.472                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              43/53 (81%)                                       44/49 (90%)                  | 
|POLY-3 RATE (b)    |                              43/48.07                                          44/45.76                     | 
|POLY-3 PERCENT (g) |                              89.5%                                             96.2%                        | 
|TERMINAL (d)       |                              23/25 (92%)                                       14/15 (93%)                  | 
|FIRST INCIDENCE    |                              377                                               240                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.009 **                   | 
|POLY 3             |                                                                                P=0.166                      | 
|POLY 1.5           |                                                                                P=0.152                      | 
|POLY 6             |                                                                                P=0.218                      | 
|LOGISTIC REGRESSION|                                                                                P=0.036 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.170                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 39      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              15/53 (28%)                                       15/48 (31%)                  | 
|POLY-3 RATE (b)    |                              15/43.91                                          15/35.37                     | 
|POLY-3 PERCENT (g) |                              34.2%                                             42.4%                        | 
|TERMINAL (d)       |                              10/25 (40%)                                       5/15 (33%)                   | 
|FIRST INCIDENCE    |                              513                                               384                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.148                      | 
|POLY 3             |                                                                                P=0.309                      | 
|POLY 1.5           |                                                                                P=0.367                      | 
|POLY 6             |                                                                                P=0.260                      | 
|LOGISTIC REGRESSION|                                                                                P=0.305                      | 
|COCH-ARM / FISHERS |                                                                                P=0.457                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              7/53 (13%)                                        23/48 (48%)                  | 
|POLY-3 RATE (b)    |                              7/42.51                                           23/41.15                     | 
|POLY-3 PERCENT (g) |                              16.5%                                             55.9%                        | 
|TERMINAL (d)       |                              3/25 (12%)                                        6/15 (40%)                   | 
|FIRST INCIDENCE    |                              651                                               276                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 40      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth: Peridontal Tissue                                                                                                         | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              33/33 (100%)                                      24/24 (100%)                 | 
|POLY-3 RATE (b)    |                              33/33.00                                          24/24.00                     | 
|POLY-3 PERCENT (g) |                              100.0%                                            100.0%                       | 
|TERMINAL (d)       |                              19/19 (100%)                                      9/9 (100%)                   | 
|FIRST INCIDENCE    |                              289                                               276                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                (e)                          | 
|POLY 3             |                                                                                (e)                          | 
|POLY 1.5           |                                                                                (e)                          | 
|POLY 6             |                                                                                (e)                          | 
|LOGISTIC REGRESSION|                                                                                (e)                          | 
|COCH-ARM / FISHERS |                                                                                (e)                          | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              2/41.83                                           2/33.62                      | 
|POLY-3 PERCENT (g) |                              4.8%                                              6.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         1/15 (7%)                    | 
|FIRST INCIDENCE    |                              715                                               500                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.537                      | 
|POLY 3             |                                                                                P=0.638                      | 
|POLY 1.5           |                                                                                P=0.652                      | 
|POLY 6             |                                                                                P=0.623                      | 
|LOGISTIC REGRESSION|                                                                                P=0.632                      | 
|COCH-ARM / FISHERS |                                                                                P=0.669                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 41      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder: Transitional Epithelium                                                                                         | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              0/41.78                                           3/33.67                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              8.9%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/15 (7%)                    | 
|FIRST INCIDENCE    |                              ---                                               500                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.065                      | 
|POLY 3             |                                                                                P=0.096                      | 
|POLY 1.5           |                                                                                P=0.101                      | 
|POLY 6             |                                                                                P=0.091                      | 
|LOGISTIC REGRESSION|                                                                                P=0.098                      | 
|COCH-ARM / FISHERS |                                                                                P=0.111                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         3/49 (6%)                    | 
|POLY-3 RATE (b)    |                              3/42.38                                           3/33.17                      | 
|POLY-3 PERCENT (g) |                              7.1%                                              9.1%                         | 
|TERMINAL (d)       |                              2/25 (8%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              536                                               491                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.478                      | 
|POLY 3             |                                                                                P=0.569                      | 
|POLY 1.5           |                                                                                P=0.592                      | 
|POLY 6             |                                                                                P=0.548                      | 
|LOGISTIC REGRESSION|                                                                                P=0.600                      | 
|COCH-ARM / FISHERS |                                                                                P=0.623                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 42      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         7/49 (14%)                   | 
|POLY-3 RATE (b)    |                              0/41.78                                           7/34.56                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              20.3%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         2/15 (13%)                   | 
|FIRST INCIDENCE    |                              ---                                               276                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.003 **                   | 
|POLY 3             |                                                                                P=0.003 **                   | 
|POLY 1.5           |                                                                                P=0.004 **                   | 
|POLY 6             |                                                                                P=0.003 **                   | 
|LOGISTIC REGRESSION|                                                                                P=0.008 **                   | 
|COCH-ARM / FISHERS |                                                                                P=0.005 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              17/53 (32%)                                       28/49 (57%)                  | 
|POLY-3 RATE (b)    |                              17/45.44                                          28/39.23                     | 
|POLY-3 PERCENT (g) |                              37.4%                                             71.4%                        | 
|TERMINAL (d)       |                              8/25 (32%)                                        12/15 (80%)                  | 
|FIRST INCIDENCE    |                              321                                               451                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P=0.002 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P=0.003 **                   | 
|COCH-ARM / FISHERS |                                                                                P=0.009 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 43      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              31/53 (58%)                                       35/49 (71%)                  | 
|POLY-3 RATE (b)    |                              31/47.62                                          35/43.22                     | 
|POLY-3 PERCENT (g) |                              65.1%                                             81.0%                        | 
|TERMINAL (d)       |                              16/25 (64%)                                       12/15 (80%)                  | 
|FIRST INCIDENCE    |                              310                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.011 *                    | 
|POLY 3             |                                                                                P=0.062                      | 
|POLY 1.5           |                                                                                P=0.080                      | 
|POLY 6             |                                                                                P=0.049 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.084                      | 
|COCH-ARM / FISHERS |                                                                                P=0.123                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
(d)  Observed incidence at terminal kill.                                                                                           
(f)  Beneath the control incidence are the P-values associated with the trend                                                       
test.  Beneath the dosed group incidence are the P-values corresponding to                                                          
pairwise comparisons between the controls and that dosed group.  The life                                                           
table analysis regards tumors in animals dying prior to  terminal kill as                                                           
 being (directly or indirectly) the cause of death.                                                                                 
Logistic regression is an alternative                                                                                               
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage                                                       
and Fishers exact tests compare directly the overall incidence rates                                                                
For all tests a negative trend is indicated by N                                                                                    
(e)  Value of Statistic cannot be computed.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(I)  Interim sacrifice                                                                                                              
(T)  Terminal sacrifice                                                                                                             
#   Tumor rates based on number of animals necropsied.                                                                              
*   To the right of any statistical result, indicates significance at (P<=0.05).                                                    
**  To the right of any statistical result, indicates significance at (P<=0.01).