National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/4905

TDMS Study 96007-01 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126)                    DATE: 10/01/03       
EXPERIMENT: 96007 TEST: 01                                                                                     TIME: 12:19:51       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007D       
PATHOLOGIST: MISSING                                                                                           CAS: 57465-28-8      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                             FINAL #3/RATS CONTROL VS. GROUPS 3, 4, & 5                                             
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25022 Accidently Killed                                                                      
                                       25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 NG/KG                                                                       
                                       INCLUDE 003    30 NG/KG                                                                      
                                       INCLUDE 004    100     NG/KG                                                                 
                                       INCLUDE 005    175     NG/KG                                                                 
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126)                    DATE: 10/01/03       
EXPERIMENT: 96007 TEST: 01                                                                                     TIME: 12:19:51       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007D       
PATHOLOGIST: MISSING                                                                                           CAS: 57465-28-8      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF      TOXIC EQUIVALENCY FACTOR EVALUATION (                                                                       
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Cortex                         Angiectasis                                                                                  
                                       Hyperplasia                                                                                  
Adrenal Medulla                        Hyperplasia                                                                                  
Blood Vessel: Aorta                    Mineralization                                                                               
Bone Marrow                            Hyperplasia                                                                                  
Clitoral Gland                         Inflammation                                                                                 
Clitoral Gland: Duct                   Cyst                                                                                         
Kidney                                 Cyst                                                                                         
                                       Mineralization                                                                               
                                       Nephropathy                                                                                  
Kidney: Pelvis                         Inflammation                                                                                 
Liver                                  Angiectasis                                                                                  
                                       Eosinophilic Focus                                                                           
                                       Fatty Change Diffuse                                                                         
                                       Fatty Change Focal                                                                           
                                       Hepatocyte, Multinucleate                                                                    
                                       Inflammation                                                                                 
                                       Mixed Cell Focus                                                                             
                                       Necrosis                                                                                     
                                       Pigmentation                                                                                 
                                       Toxic Hepatopathy                                                                            
Liver: Bile Duct                       Cyst                                                                                         
                                       Hyperplasia                                                                                  
Liver: Hepatocyte                      Degeneration                                                                                 
                                       Hypertrophy                                                                                  
Liver: Oval Cell                       Hyperplasia                                                                                  
Lung                                   Infiltration Cellular Histiocyte                                                             
                                       Inflammation Chronic                                                                         
                                       Inflammation Granulomatous                                                                   
Lung: Alveolar Epithelium              Hyperplasia                                                                                  
                                       Metaplasia Bronchiolar                                                                       
Lymph Node, Mandibular                 Hyperplasia                                                                                  
Lymph Node, Mesenteric                 Hyperplasia                                                                                  
Mammary Gland                          Cyst                                                                                         
                                       Hyperplasia                                                                                  
Ovary                                  Atrophy                                                                                      
Pancreas                               Inflammation Chronic                                                                         
Pancreas: Acinus                       Vacuolization Cytoplasmic                                                                    
Spleen                                 Hematopoietic Cell Proliferation                                                             
                                       Pigmentation                                                                                 
Spleen: Lymphoid Follicle              Atrophy                                                                                      
Spleen: Red Pulp                       Atrophy                                                                                      
Thymus                                 Atrophy                                                                                      
Thyroid Gland: Follicular Cell         Hypertrophy                                                                                  
Uterus                                 Inflammation Chronic                                                                         
===============================================================                                                                     
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  11/52 (21%)              13/55 (24%)              25/53 (47%)              19/53 (36%)     | 
|POLY-3 RATE (b)    |                  11/34.50                 13/39.17                 25/43.24                 19/38.60        | 
|POLY-3 PERCENT (g) |                  31.9%                    33.2%                    57.8%                    49.2%           | 
|TERMINAL (d)       |                  4/15 (27%)               12/25 (48%)              16/26 (62%)              14/22 (64%)     | 
|FIRST INCIDENCE    |                  541                      516                      498                      658             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.061                  P=0.327N                 P=0.148                  P=0.299         | 
|POLY 3             |                  P=0.018 *                P=0.553                  P=0.016 *                P=0.092         | 
|POLY 1.5           |                  P=0.021 *                P=0.519                  P=0.009 **               P=0.096         | 
|POLY 6             |                  P=0.013 *                P=0.594                  P=0.028 *                P=0.078         | 
|LOGISTIC REGRESSION|                  P=0.032 *                P=0.541N                 P=0.019 *                P=0.167         | 
|COCH-ARM / FISHERS |                  P=0.015 *                P=0.470                  P=0.004 **               P=0.073         | 
|ORDER RESTRICTED   |                  P=0.037 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/52 (2%)                3/55 (5%)                5/53 (9%)                3/53 (6%)       | 
|POLY-3 RATE (b)    |                  1/31.36                  3/38.64                  5/41.14                  3/38.30         | 
|POLY-3 PERCENT (g) |                  3.2%                     7.8%                     12.2%                    7.8%            | 
|TERMINAL (d)       |                  1/15 (7%)                2/25 (8%)                3/26 (12%)               0/22 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  700                      300                      592             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.312                  P=0.502                  P=0.218                  P=0.410         | 
|POLY 3             |                  P=0.322                  P=0.382                  P=0.176                  P=0.379         | 
|POLY 1.5           |                  P=0.299                  P=0.356                  P=0.148                  P=0.357         | 
|POLY 6             |                  P=0.341                  P=0.424                  P=0.214                  P=0.405         | 
|LOGISTIC REGRESSION|                  P=0.266                  P=0.486                  P=0.115                  P=0.358         | 
|COCH-ARM / FISHERS |                  P=0.236                  P=0.330                  P=0.107                  P=0.316         | 
|ORDER RESTRICTED   |                  P=0.249                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  11/52 (21%)              14/55 (25%)              10/53 (19%)              14/53 (26%)     | 
|POLY-3 RATE (b)    |                  11/34.41                 14/40.34                 10/40.23                 14/39.18        | 
|POLY-3 PERCENT (g) |                  32.0%                    34.7%                    24.9%                    35.7%           | 
|TERMINAL (d)       |                  4/15 (27%)               9/25 (36%)               7/26 (27%)               9/22 (41%)      | 
|FIRST INCIDENCE    |                  496                      516                      651                      496             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.443N                 P=0.423N                 P=0.134N                 P=0.539N        | 
|POLY 3             |                  P=0.511                  P=0.498                  P=0.334N                 P=0.462         | 
|POLY 1.5           |                  P=0.499                  P=0.446                  P=0.379N                 P=0.437         | 
|POLY 6             |                  P=0.496                  P=0.576                  P=0.290N                 P=0.474         | 
|LOGISTIC REGRESSION|                  P=0.525N                 P=0.526                  P=0.277N                 P=0.506         | 
|COCH-ARM / FISHERS |                  P=0.405                  P=0.384                  P=0.480N                 P=0.344         | 
|ORDER RESTRICTED   |                  P=0.495                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  23/52 (44%)              21/55 (38%)              27/53 (51%)              25/53 (47%)     | 
|POLY-3 RATE (b)    |                  23/38.88                 21/40.99                 27/43.02                 25/42.19        | 
|POLY-3 PERCENT (g) |                  59.2%                    51.2%                    62.8%                    59.3%           | 
|TERMINAL (d)       |                  7/15 (47%)               15/25 (60%)              16/26 (62%)              12/22 (55%)     | 
|FIRST INCIDENCE    |                  309                      434                      531                      530             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.490N                 P=0.046N*                P=0.181N                 P=0.289N        | 
|POLY 3             |                  P=0.351                  P=0.305N                 P=0.455                  P=0.590         | 
|POLY 1.5           |                  P=0.334                  P=0.312N                 P=0.410                  P=0.571         | 
|POLY 6             |                  P=0.355                  P=0.300N                 P=0.510                  P=0.594         | 
|LOGISTIC REGRESSION|                  P=0.420                  P=0.200N                 P=0.576                  P=0.508N        | 
|COCH-ARM / FISHERS |                  P=0.234                  P=0.330N                 P=0.311                  P=0.458         | 
|ORDER RESTRICTED   |                  P=0.453                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  34/52 (65%)              41/55 (75%)              40/53 (75%)              41/53 (77%)     | 
|POLY-3 RATE (b)    |                  34/39.07                 41/45.61                 40/45.30                 41/44.98        | 
|POLY-3 PERCENT (g) |                  87.0%                    89.9%                    88.3%                    91.2%           | 
|TERMINAL (d)       |                  15/15 (100%)             22/25 (88%)              24/26 (92%)              22/22 (100%)    | 
|FIRST INCIDENCE    |                  391                      356                      498                      405             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.387N                 P=0.129N                 P=0.060N                 P=0.313N        | 
|POLY 3             |                  P=0.350                  P=0.464                  P=0.575                  P=0.360         | 
|POLY 1.5           |                  P=0.307                  P=0.290                  P=0.381                  P=0.278         | 
|POLY 6             |                  P=0.303                  P=0.606N                 P=0.556N                 P=0.462         | 
|LOGISTIC REGRESSION|                  P=0.514                  P=0.369                  P=0.539N                 P=0.477         | 
|COCH-ARM / FISHERS |                  P=0.133                  P=0.205                  P=0.179                  P=0.127         | 
|ORDER RESTRICTED   |                  P=0.365                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/52 (10%)               3/55 (5%)                5/53 (9%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  5/32.65                  3/38.73                  5/40.96                  2/37.58         | 
|POLY-3 PERCENT (g) |                  15.3%                    7.8%                     12.2%                    5.3%            | 
|TERMINAL (d)       |                  3/15 (20%)               1/25 (4%)                2/26 (8%)                1/22 (5%)       | 
|FIRST INCIDENCE    |                  496                      681                      428                      658             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.169N                 P=0.169N                 P=0.369N                 P=0.118N        | 
|POLY 3             |                  P=0.212N                 P=0.263N                 P=0.483N                 P=0.159N        | 
|POLY 1.5           |                  P=0.217N                 P=0.291N                 P=0.532N                 P=0.171N        | 
|POLY 6             |                  P=0.222N                 P=0.223N                 P=0.422N                 P=0.148N        | 
|LOGISTIC REGRESSION|                  P=0.210N                 P=0.256N                 P=0.560N                 P=0.161N        | 
|COCH-ARM / FISHERS |                  P=0.256N                 P=0.327N                 P=0.617N                 P=0.211N        | 
|ORDER RESTRICTED   |                  P=0.138N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                0/55 (0%)                2/53 (4%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  0/31.36                  0/38.53                  2/39.67                  1/37.32         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     5.0%                     2.7%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                1/26 (4%)                1/22 (5%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      709                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.201                  (e)                      P=0.368                  P=0.576         | 
|POLY 3             |                  P=0.198                  (e)                      P=0.292                  P=0.535         | 
|POLY 1.5           |                  P=0.196                  (e)                      P=0.273                  P=0.526         | 
|POLY 6             |                  P=0.195                  (e)                      P=0.318                  P=0.543         | 
|LOGISTIC REGRESSION|                  P=0.189                  (e)                      P=0.341                  P=0.576         | 
|COCH-ARM / FISHERS |                  P=0.173                  (e)                      P=0.252                  P=0.505         | 
|ORDER RESTRICTED   |                  P=0.215                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  8/52 (15%)               18/55 (33%)              11/53 (21%)              11/53 (21%)     | 
|POLY-3 RATE (b)    |                  8/33.72                  18/40.38                 11/41.48                 11/39.17        | 
|POLY-3 PERCENT (g) |                  23.7%                    44.6%                    26.5%                    28.1%           | 
|TERMINAL (d)       |                  3/15 (20%)               12/25 (48%)              7/26 (27%)               7/22 (32%)      | 
|FIRST INCIDENCE    |                  496                      580                      376                      496             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.246N                 P=0.208                  P=0.511N                 P=0.566         | 
|POLY 3             |                  P=0.280N                 P=0.046 *                P=0.496                  P=0.438         | 
|POLY 1.5           |                  P=0.315N                 P=0.035 *                P=0.434                  P=0.409         | 
|POLY 6             |                  P=0.265N                 P=0.073                  P=0.566                  P=0.461         | 
|LOGISTIC REGRESSION|                  P=0.313N                 P=0.066                  P=0.445                  P=0.438         | 
|COCH-ARM / FISHERS |                  P=0.448N                 P=0.030 *                P=0.323                  P=0.323         | 
|ORDER RESTRICTED   |                  P=0.312                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Blood Vessel: Aorta                                                                                                              | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/53 (6%)                1/55 (2%)                1/53 (2%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  3/32.76                  1/39.50                  1/40.46                  0/37.32         | 
|POLY-3 PERCENT (g) |                  9.2%                     2.5%                     2.5%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  583                      223                      376                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.063N                 P=0.255N                 P=0.239N                 P=0.097N        | 
|POLY 3             |                  P=0.074N                 P=0.240N                 P=0.233N                 P=0.096N        | 
|POLY 1.5           |                  P=0.073N                 P=0.259N                 P=0.255N                 P=0.100N        | 
|POLY 6             |                  P=0.081N                 P=0.218N                 P=0.213N                 P=0.093N        | 
|LOGISTIC REGRESSION|                  P=0.121N                 P=0.326N                 P=0.360N                 P=0.118N        | 
|COCH-ARM / FISHERS |                  P=0.078N                 P=0.295N                 P=0.309N                 P=0.121N        | 
|ORDER RESTRICTED   |                  P=0.027N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  47/53 (89%)              37/55 (67%)              35/53 (66%)              44/53 (83%)     | 
|POLY-3 RATE (b)    |                  47/52.12                 37/50.34                 35/50.58                 44/52.04        | 
|POLY-3 PERCENT (g) |                  90.2%                    73.5%                    69.2%                    84.6%           | 
|TERMINAL (d)       |                  10/15 (67%)              14/25 (56%)              12/26 (46%)              16/22 (73%)     | 
|FIRST INCIDENCE    |                  126                      223                      188                      124             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.175N                 P=0.004N**               P=0.002N**               P=0.072N        | 
|POLY 3             |                  P=0.376N                 P=0.022N*                P=0.006N**               P=0.282N        | 
|POLY 1.5           |                  P=0.388N                 P=0.016N*                P=0.005N**               P=0.272N        | 
|POLY 6             |                  P=0.383N                 P=0.031N*                P=0.008N**               P=0.310N        | 
|LOGISTIC REGRESSION|                  P=0.465                  P=0.010N*                P=0.020N*                P=0.436N        | 
|COCH-ARM / FISHERS |                  P=0.490N                 P=0.007N**               P=0.005N**               P=0.289N        | 
|ORDER RESTRICTED   |                  P=0.041N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain                                                                                                                            | 
|     Hydrocephalus                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/53 (2%)                0/55 (0%)                2/53 (4%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  1/32.36                  0/38.53                  2/39.86                  0/37.32         | 
|POLY-3 PERCENT (g) |                  3.1%                     0.0%                     5.0%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  201                      ---                      678                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.508N                 P=0.489N                 P=0.623                  P=0.496N        | 
|POLY 3             |                  P=0.519N                 P=0.465N                 P=0.572                  P=0.472N        | 
|POLY 1.5           |                  P=0.516N                 P=0.478N                 P=0.546                  P=0.479N        | 
|POLY 6             |                  P=0.539N                 P=0.447N                 P=0.605                  P=0.464N        | 
|LOGISTIC REGRESSION|                  P=0.588N                 P=0.524N                 P=0.434                  P=0.710N        | 
|COCH-ARM / FISHERS |                  P=0.535N                 P=0.491N                 P=0.500                  P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.299N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  28/50 (56%)              36/55 (65%)              39/52 (75%)              28/50 (56%)     | 
|POLY-3 RATE (b)    |                  28/40.18                 36/47.35                 39/48.96                 28/42.13        | 
|POLY-3 PERCENT (g) |                  69.7%                    76.0%                    79.7%                    66.5%           | 
|TERMINAL (d)       |                  9/14 (64%)               19/25 (76%)              19/26 (73%)              13/22 (59%)     | 
|FIRST INCIDENCE    |                  222                      253                      188                      436             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.130N                 P=0.325N                 P=0.406N                 P=0.134N        | 
|POLY 3             |                  P=0.371N                 P=0.326                  P=0.188                  P=0.467N        | 
|POLY 1.5           |                  P=0.381N                 P=0.274                  P=0.121                  P=0.476N        | 
|POLY 6             |                  P=0.381N                 P=0.413                  P=0.286                  P=0.464N        | 
|LOGISTIC REGRESSION|                  P=0.392N                 P=0.287                  P=0.055                  P=0.424N        | 
|COCH-ARM / FISHERS |                  P=0.526                  P=0.214                  P=0.035 *                P=0.580N        | 
|ORDER RESTRICTED   |                  P=0.275N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland: Duct                                                                                                             | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  29/50 (58%)              32/55 (58%)              34/52 (65%)              37/50 (74%)     | 
|POLY-3 RATE (b)    |                  29/40.97                 32/47.78                 34/46.12                 37/45.50        | 
|POLY-3 PERCENT (g) |                  70.8%                    67.0%                    73.7%                    81.3%           | 
|TERMINAL (d)       |                  8/14 (57%)               14/25 (56%)              17/26 (65%)              15/22 (68%)     | 
|FIRST INCIDENCE    |                  126                      202                      188                      436             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.417                  P=0.157N                 P=0.153N                 P=0.498N        | 
|POLY 3             |                  P=0.072                  P=0.435N                 P=0.472                  P=0.170         | 
|POLY 1.5           |                  P=0.052                  P=0.497N                 P=0.402                  P=0.117         | 
|POLY 6             |                  P=0.110                  P=0.377N                 P=0.557                  P=0.260         | 
|LOGISTIC REGRESSION|                  P=0.055                  P=0.562N                 P=0.383                  P=0.113         | 
|COCH-ARM / FISHERS |                  P=0.033 *                P=0.571                  P=0.287                  P=0.069         | 
|ORDER RESTRICTED   |                  P=0.135                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Esophagus: Muscularis                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/52 (4%)                1/55 (2%)                0/53 (0%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  2/30.96                  1/39.04                  0/39.60                  1/37.32         | 
|POLY-3 PERCENT (g) |                  6.5%                     2.6%                     0.0%                     2.7%            | 
|TERMINAL (d)       |                  1/14 (7%)                0/25 (0%)                0/26 (0%)                1/22 (5%)       | 
|FIRST INCIDENCE    |                  547                      574                      ---                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.266N                 P=0.400N                 P=0.157N                 P=0.378N        | 
|POLY 3             |                  P=0.313N                 P=0.420N                 P=0.186N                 P=0.435N        | 
|POLY 1.5           |                  P=0.311N                 P=0.445N                 P=0.201N                 P=0.450N        | 
|POLY 6             |                  P=0.324N                 P=0.384N                 P=0.170N                 P=0.421N        | 
|LOGISTIC REGRESSION|                  P=0.298N                 P=0.463N                 P=0.205N                 P=0.430N        | 
|COCH-ARM / FISHERS |                  P=0.321N                 P=0.479N                 P=0.243N                 P=0.493N        | 
|ORDER RESTRICTED   |                  P=0.165N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Retina                                                                                                                      | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/51 (0%)                0/55 (0%)                3/53 (6%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  0/30.21                  0/38.53                  3/39.60                  1/37.32         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     7.6%                     2.7%            | 
|TERMINAL (d)       |                  0/14 (0%)                0/25 (0%)                3/26 (12%)               1/22 (5%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.200                  (e)                      P=0.247                  P=0.590         | 
|POLY 3             |                  P=0.193                  (e)                      P=0.173                  P=0.542         | 
|POLY 1.5           |                  P=0.190                  (e)                      P=0.155                  P=0.533         | 
|POLY 6             |                  P=0.188                  (e)                      P=0.198                  P=0.551         | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      P=0.247                  P=0.590         | 
|COCH-ARM / FISHERS |                  P=0.162                  (e)                      P=0.129                  P=0.510         | 
|ORDER RESTRICTED   |                  P=0.165                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                3/53 (6%)                6/53 (11%)               6/53 (11%)      | 
|POLY-3 RATE (b)    |                  2/32.88                  3/38.60                  6/39.67                  6/37.35         | 
|POLY-3 PERCENT (g) |                  6.1%                     7.8%                     15.1%                    16.1%           | 
|TERMINAL (d)       |                  0/15 (0%)                1/25 (4%)                5/26 (19%)               5/22 (23%)      | 
|FIRST INCIDENCE    |                  321                      652                      709                      720             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.106                  P=0.643                  P=0.315                  P=0.260         | 
|POLY 3             |                  P=0.079                  P=0.573                  P=0.199                  P=0.173         | 
|POLY 1.5           |                  P=0.080                  P=0.543                  P=0.175                  P=0.165         | 
|POLY 6             |                  P=0.073                  P=0.614                  P=0.231                  P=0.178         | 
|LOGISTIC REGRESSION|                  P=0.086                  P=0.500                  P=0.180                  P=0.178         | 
|COCH-ARM / FISHERS |                  P=0.064                  P=0.500                  P=0.135                  P=0.135         | 
|ORDER RESTRICTED   |                  P=0.155                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  9/52 (17%)               16/54 (30%)              17/53 (32%)              16/53 (30%)     | 
|POLY-3 RATE (b)    |                  9/35.59                  16/38.84                 17/40.82                 16/40.33        | 
|POLY-3 PERCENT (g) |                  25.3%                    41.2%                    41.7%                    39.7%           | 
|TERMINAL (d)       |                  2/15 (13%)               10/24 (42%)              14/26 (54%)              9/22 (41%)      | 
|FIRST INCIDENCE    |                  201                      574                      376                      448             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.300                  P=0.391                  P=0.373                  P=0.286         | 
|POLY 3             |                  P=0.195                  P=0.107                  P=0.096                  P=0.132         | 
|POLY 1.5           |                  P=0.177                  P=0.096                  P=0.082                  P=0.120         | 
|POLY 6             |                  P=0.201                  P=0.139                  P=0.115                  P=0.144         | 
|LOGISTIC REGRESSION|                  P=0.202                  P=0.139                  P=0.105                  P=0.115         | 
|COCH-ARM / FISHERS |                  P=0.121                  P=0.103                  P=0.063                  P=0.093         | 
|ORDER RESTRICTED   |                  P=0.118                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart: Epicardium                                                                                                                | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/52 (4%)                0/54 (0%)                0/53 (0%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  2/32.82                  0/37.53                  0/39.60                  1/38.32         | 
|POLY-3 PERCENT (g) |                  6.1%                     0.0%                     0.0%                     2.6%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/24 (0%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  126                      ---                      ---                      124             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.434N                 P=0.216N                 P=0.213N                 P=0.480N        | 
|POLY 3             |                  P=0.448N                 P=0.207N                 P=0.197N                 P=0.446N        | 
|POLY 1.5           |                  P=0.442N                 P=0.218N                 P=0.210N                 P=0.458N        | 
|POLY 6             |                  P=0.461N                 P=0.191N                 P=0.182N                 P=0.436N        | 
|LOGISTIC REGRESSION|                  P=0.613                  P=0.245N                 P=0.351N                 P=0.737         | 
|COCH-ARM / FISHERS |                  P=0.443N                 P=0.238N                 P=0.243N                 P=0.493N        | 
|ORDER RESTRICTED   |                  P=0.097N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Colon                                                                                                           | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                1/55 (2%)                2/53 (4%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  0/31.36                  1/38.88                  2/39.67                  1/37.75         | 
|POLY-3 PERCENT (g) |                  0.0%                     2.6%                     5.0%                     2.7%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                1/26 (4%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  ---                      630                      709                      604             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.360                  P=0.573                  P=0.368                  P=0.539         | 
|POLY 3             |                  P=0.376                  P=0.543                  P=0.292                  P=0.537         | 
|POLY 1.5           |                  P=0.363                  P=0.528                  P=0.273                  P=0.527         | 
|POLY 6             |                  P=0.384                  P=0.564                  P=0.318                  P=0.547         | 
|LOGISTIC REGRESSION|                  P=0.345                  P=0.522                  P=0.341                  P=0.506         | 
|COCH-ARM / FISHERS |                  P=0.319                  P=0.514                  P=0.252                  P=0.505         | 
|ORDER RESTRICTED   |                  P=0.274                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Rectum                                                                                                          | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/52 (4%)                2/55 (4%)                3/53 (6%)                0/52 (0%)       | 
|POLY-3 RATE (b)    |                  2/30.87                  2/38.53                  3/39.60                  0/36.94         | 
|POLY-3 PERCENT (g) |                  6.5%                     5.2%                     7.6%                     0.0%            | 
|TERMINAL (d)       |                  2/15 (13%)               2/25 (8%)                3/26 (12%)               0/22 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  727 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.144N                 P=0.500N                 P=0.626N                 P=0.157N        | 
|POLY 3             |                  P=0.180N                 P=0.612N                 P=0.612                  P=0.198N        | 
|POLY 1.5           |                  P=0.187N                 P=0.638N                 P=0.577                  P=0.209N        | 
|POLY 6             |                  P=0.181N                 P=0.574N                 P=0.652                  P=0.189N        | 
|LOGISTIC REGRESSION|                  P=0.144N                 P=0.500N                 P=0.626N                 (e)             | 
|COCH-ARM / FISHERS |                  P=0.224N                 P=0.670N                 P=0.509                  P=0.248N        | 
|ORDER RESTRICTED   |                  P=0.182N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/52 (2%)                2/54 (4%)                1/53 (2%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  1/31.36                  2/39.02                  1/40.16                  1/37.75         | 
|POLY-3 PERCENT (g) |                  3.2%                     5.1%                     2.5%                     2.7%            | 
|TERMINAL (d)       |                  1/15 (7%)                1/25 (4%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  223                      555                      604             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.423N                 P=0.628                  P=0.674N                 P=0.695N        | 
|POLY 3             |                  P=0.424N                 P=0.576                  P=0.703N                 P=0.719N        | 
|POLY 1.5           |                  P=0.438N                 P=0.549                  P=0.724N                 P=0.730N        | 
|POLY 6             |                  P=0.417N                 P=0.613                  P=0.676N                 P=0.706N        | 
|LOGISTIC REGRESSION|                  P=0.508N                 P=0.501                  P=0.740N                 P=0.727N        | 
|COCH-ARM / FISHERS |                  P=0.475N                 P=0.514                  P=0.748N                 P=0.748N        | 
|ORDER RESTRICTED   |                  P=0.558N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Casts Protein                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/53 (8%)                3/55 (5%)                1/53 (2%)                6/53 (11%)      | 
|POLY-3 RATE (b)    |                  4/31.53                  3/39.63                  1/40.59                  6/38.91         | 
|POLY-3 PERCENT (g) |                  12.7%                    7.6%                     2.5%                     15.4%           | 
|TERMINAL (d)       |                  3/15 (20%)               0/25 (0%)                0/26 (0%)                2/22 (9%)       | 
|FIRST INCIDENCE    |                  688                      516                      188                      546             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.367                  P=0.282N                 P=0.077N                 P=0.563         | 
|POLY 3             |                  P=0.332                  P=0.376N                 P=0.111N                 P=0.506         | 
|POLY 1.5           |                  P=0.325                  P=0.420N                 P=0.131N                 P=0.463         | 
|POLY 6             |                  P=0.327                  P=0.317N                 P=0.091N                 P=0.556         | 
|LOGISTIC REGRESSION|                  P=0.301                  P=0.387N                 P=0.166N                 P=0.487         | 
|COCH-ARM / FISHERS |                  P=0.281                  P=0.479N                 P=0.181N                 P=0.371         | 
|ORDER RESTRICTED   |                  P=0.197                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                0/55 (0%)                0/53 (0%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  0/31.38                  0/38.53                  0/39.60                  2/37.58         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     5.3%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                0/26 (0%)                1/22 (5%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      659             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.049 *                (e)                      (e)                      P=0.306         | 
|POLY 3             |                  P=0.049 *                (e)                      (e)                      P=0.279         | 
|POLY 1.5           |                  P=0.048 *                (e)                      (e)                      P=0.267         | 
|POLY 6             |                  P=0.049 *                (e)                      (e)                      P=0.291         | 
|LOGISTIC REGRESSION|                  P=0.049 *                (e)                      (e)                      P=0.285         | 
|COCH-ARM / FISHERS |                  P=0.045 *                (e)                      (e)                      P=0.248         | 
|ORDER RESTRICTED   |                  P=0.047 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                0/55 (0%)                3/53 (6%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  0/31.38                  0/38.53                  3/40.41                  0/37.32         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     7.4%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      651                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.430                  (e)                      P=0.205                  (e)             | 
|POLY 3             |                  P=0.429                  (e)                      P=0.170                  (e)             | 
|POLY 1.5           |                  P=0.425                  (e)                      P=0.150                  (e)             | 
|POLY 6             |                  P=0.421                  (e)                      P=0.198                  (e)             | 
|LOGISTIC REGRESSION|                  P=0.404                  (e)                      P=0.145                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.381                  (e)                      P=0.121                  (e)             | 
|ORDER RESTRICTED   |                  P=0.215                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                2/55 (4%)                1/53 (2%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  2/31.89                  2/39.21                  1/39.60                  1/37.58         | 
|POLY-3 PERCENT (g) |                  6.3%                     5.1%                     2.5%                     2.7%            | 
|TERMINAL (d)       |                  1/15 (7%)                1/25 (4%)                1/26 (4%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  574                      498                      727 (T)                  658             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.239N                 P=0.572N                 P=0.353N                 P=0.398N        | 
|POLY 3             |                  P=0.272N                 P=0.618N                 P=0.425N                 P=0.443N        | 
|POLY 1.5           |                  P=0.278N                 P=0.645N                 P=0.450N                 P=0.458N        | 
|POLY 6             |                  P=0.275N                 P=0.580N                 P=0.396N                 P=0.429N        | 
|LOGISTIC REGRESSION|                  P=0.276N                 P=0.658N                 P=0.418N                 P=0.453N        | 
|COCH-ARM / FISHERS |                  P=0.306N                 P=0.677N                 P=0.500N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.363N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  32/53 (60%)              39/55 (71%)              44/53 (83%)              44/53 (83%)     | 
|POLY-3 RATE (b)    |                  32/42.76                 39/47.07                 44/50.44                 44/49.02        | 
|POLY-3 PERCENT (g) |                  74.8%                    82.9%                    87.2%                    89.8%           | 
|TERMINAL (d)       |                  12/15 (80%)              21/25 (84%)              22/26 (85%)              21/22 (96%)     | 
|FIRST INCIDENCE    |                  126                      328                      188                      385             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.260                  P=0.241N                 P=0.416N                 P=0.438         | 
|POLY 3             |                  P=0.027 *                P=0.230                  P=0.085                  P=0.033 *       | 
|POLY 1.5           |                  P=0.014 *                P=0.187                  P=0.037 *                P=0.021 *       | 
|POLY 6             |                  P=0.040 *                P=0.297                  P=0.181                  P=0.044 *       | 
|LOGISTIC REGRESSION|                  P=0.011 *                P=0.258                  P=0.020 *                P=0.024 *       | 
|COCH-ARM / FISHERS |                  P=0.003 **               P=0.171                  P=0.008 **               P=0.008 **      | 
|ORDER RESTRICTED   |                  P=0.024 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  32/53 (60%)              29/55 (53%)              38/53 (72%)              35/53 (66%)     | 
|POLY-3 RATE (b)    |                  32/43.26                 29/42.29                 38/44.90                 35/44.58        | 
|POLY-3 PERCENT (g) |                  74.0%                    68.6%                    84.6%                    78.5%           | 
|TERMINAL (d)       |                  11/15 (73%)              20/25 (80%)              26/26 (100%)             21/22 (96%)     | 
|FIRST INCIDENCE    |                  126                      350                      376                      385             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.507N                 P=0.013N*                P=0.111N                 P=0.218N        | 
|POLY 3             |                  P=0.134                  P=0.366N                 P=0.131                  P=0.387         | 
|POLY 1.5           |                  P=0.134                  P=0.363N                 P=0.124                  P=0.375         | 
|POLY 6             |                  P=0.093                  P=0.352N                 P=0.133                  P=0.347         | 
|LOGISTIC REGRESSION|                  P=0.260                  P=0.178N                 P=0.309                  P=0.472         | 
|COCH-ARM / FISHERS |                  P=0.105                  P=0.272N                 P=0.153                  P=0.344         | 
|ORDER RESTRICTED   |                  P=0.150                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                1/55 (2%)                0/53 (0%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  2/32.37                  1/38.53                  0/39.60                  0/37.32         | 
|POLY-3 PERCENT (g) |                  6.2%                     2.6%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                1/25 (4%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  574                      727 (T)                  ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.065N                 P=0.406N                 P=0.195N                 P=0.206N        | 
|POLY 3             |                  P=0.079N                 P=0.439N                 P=0.195N                 P=0.206N        | 
|POLY 1.5           |                  P=0.080N                 P=0.458N                 P=0.208N                 P=0.213N        | 
|POLY 6             |                  P=0.082N                 P=0.413N                 P=0.181N                 P=0.202N        | 
|LOGISTIC REGRESSION|                  P=0.078N                 P=0.465N                 P=0.245N                 P=0.243N        | 
|COCH-ARM / FISHERS |                  P=0.084N                 P=0.486N                 P=0.248N                 P=0.248N        | 
|ORDER RESTRICTED   |                  P=0.056N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                0/55 (0%)                0/53 (0%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  2/32.53                  0/38.53                  0/39.60                  0/37.32         | 
|POLY-3 PERCENT (g) |                  6.2%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  541                      ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.100N                 P=0.211N                 P=0.201N                 P=0.206N        | 
|POLY 3             |                  P=0.122N                 P=0.200N                 P=0.196N                 P=0.207N        | 
|POLY 1.5           |                  P=0.118N                 P=0.212N                 P=0.209N                 P=0.213N        | 
|POLY 6             |                  P=0.133N                 P=0.185N                 P=0.182N                 P=0.203N        | 
|LOGISTIC REGRESSION|                  P=0.127N                 P=0.239N                 P=0.263N                 P=0.260N        | 
|COCH-ARM / FISHERS |                  P=0.115N                 P=0.238N                 P=0.248N                 P=0.248N        | 
|ORDER RESTRICTED   |                  P=0.020N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                2/55 (4%)                2/53 (4%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  0/31.38                  2/39.16                  2/40.08                  2/37.84         | 
|POLY-3 PERCENT (g) |                  0.0%                     5.1%                     5.0%                     5.3%            | 
|TERMINAL (d)       |                  0/15 (0%)                1/25 (4%)                1/26 (4%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  ---                      524                      586                      658             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.298                  P=0.307                  P=0.331                  P=0.316         | 
|POLY 3             |                  P=0.305                  P=0.289                  P=0.295                  P=0.280         | 
|POLY 1.5           |                  P=0.287                  P=0.270                  P=0.274                  P=0.268         | 
|POLY 6             |                  P=0.321                  P=0.317                  P=0.322                  P=0.295         | 
|LOGISTIC REGRESSION|                  P=0.256                  P=0.257                  P=0.270                  P=0.269         | 
|COCH-ARM / FISHERS |                  P=0.235                  P=0.257                  P=0.248                  P=0.248         | 
|ORDER RESTRICTED   |                  P=0.228                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Transitional Epithelium                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/53 (8%)                2/55 (4%)                8/53 (15%)               4/53 (8%)       | 
|POLY-3 RATE (b)    |                  4/32.45                  2/39.16                  8/41.11                  4/38.52         | 
|POLY-3 PERCENT (g) |                  12.3%                    5.1%                     19.5%                    10.4%           | 
|TERMINAL (d)       |                  2/15 (13%)               1/25 (4%)                4/26 (15%)               1/22 (5%)       | 
|FIRST INCIDENCE    |                  554                      524                      498                      500             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.406                  P=0.204N                 P=0.444                  P=0.479N        | 
|POLY 3             |                  P=0.354                  P=0.253N                 P=0.308                  P=0.547N        | 
|POLY 1.5           |                  P=0.346                  P=0.279N                 P=0.258                  P=0.573N        | 
|POLY 6             |                  P=0.344                  P=0.218N                 P=0.373                  P=0.523N        | 
|LOGISTIC REGRESSION|                  P=0.332                  P=0.281N                 P=0.269                  P=0.585N        | 
|COCH-ARM / FISHERS |                  P=0.282                  P=0.322N                 P=0.179                  P=0.642N        | 
|ORDER RESTRICTED   |                  P=0.317                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/53 (6%)                8/55 (15%)               4/53 (8%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  3/31.69                  8/38.81                  4/39.86                  1/37.32         | 
|POLY-3 PERCENT (g) |                  9.5%                     20.6%                    10.0%                    2.7%            | 
|TERMINAL (d)       |                  2/15 (13%)               7/25 (28%)               3/26 (12%)               1/22 (5%)       | 
|FIRST INCIDENCE    |                  644                      652                      659                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.032N*                P=0.316                  P=0.548N                 P=0.193N        | 
|POLY 3             |                  P=0.040N*                P=0.169                  P=0.624                  P=0.247N        | 
|POLY 1.5           |                  P=0.048N*                P=0.142                  P=0.581                  P=0.262N        | 
|POLY 6             |                  P=0.035N*                P=0.216                  P=0.636N                 P=0.235N        | 
|LOGISTIC REGRESSION|                  P=0.041N*                P=0.264                  P=0.616N                 P=0.216N        | 
|COCH-ARM / FISHERS |                  P=0.082N                 P=0.113                  P=0.500                  P=0.309N        | 
|ORDER RESTRICTED   |                  P=0.069N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  7/53 (13%)               10/55 (18%)              10/53 (19%)              13/53 (25%)     | 
|POLY-3 RATE (b)    |                  7/32.51                  10/39.34                 10/40.14                 13/39.28        | 
|POLY-3 PERCENT (g) |                  21.5%                    25.4%                    24.9%                    33.1%           | 
|TERMINAL (d)       |                  3/15 (20%)               7/25 (28%)               8/26 (31%)               9/22 (41%)      | 
|FIRST INCIDENCE    |                  541                      574                      651                      454             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.217                  P=0.529N                 P=0.489N                 P=0.322         | 
|POLY 3             |                  P=0.170                  P=0.457                  P=0.476                  P=0.201         | 
|POLY 1.5           |                  P=0.153                  P=0.401                  P=0.412                  P=0.171         | 
|POLY 6             |                  P=0.171                  P=0.538                  P=0.550                  P=0.229         | 
|LOGISTIC REGRESSION|                  P=0.160                  P=0.538                  P=0.589                  P=0.207         | 
|COCH-ARM / FISHERS |                  P=0.095                  P=0.329                  P=0.299                  P=0.107         | 
|ORDER RESTRICTED   |                  P=0.217                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Clear Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                1/55 (2%)                0/53 (0%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  2/31.38                  1/39.30                  0/39.60                  0/37.32         | 
|POLY-3 PERCENT (g) |                  6.4%                     2.5%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/15 (13%)               0/25 (0%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  448                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.060N                 P=0.373N                 P=0.127N                 P=0.157N        | 
|POLY 3             |                  P=0.081N                 P=0.422N                 P=0.189N                 P=0.200N        | 
|POLY 1.5           |                  P=0.080N                 P=0.449N                 P=0.205N                 P=0.210N        | 
|POLY 6             |                  P=0.087N                 P=0.385N                 P=0.171N                 P=0.190N        | 
|LOGISTIC REGRESSION|                  P=0.077N                 P=0.461N                 (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.084N                 P=0.486N                 P=0.248N                 P=0.248N        | 
|ORDER RESTRICTED   |                  P=0.052N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  11/53 (21%)              10/55 (18%)              13/53 (25%)              21/53 (40%)     | 
|POLY-3 RATE (b)    |                  11/34.24                 10/39.49                 13/42.24                 21/43.22        | 
|POLY-3 PERCENT (g) |                  32.1%                    25.3%                    30.8%                    48.6%           | 
|TERMINAL (d)       |                  5/15 (33%)               6/25 (24%)               5/26 (19%)               7/22 (32%)      | 
|FIRST INCIDENCE    |                  405                      524                      509                      385             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.040 *                P=0.148N                 P=0.328N                 P=0.186         | 
|POLY 3             |                  P=0.023 *                P=0.347N                 P=0.548N                 P=0.103         | 
|POLY 1.5           |                  P=0.016 *                P=0.393N                 P=0.565                  P=0.068         | 
|POLY 6             |                  P=0.032 *                P=0.285N                 P=0.452N                 P=0.165         | 
|LOGISTIC REGRESSION|                  P=0.014 *                P=0.312N                 P=0.581                  P=0.056         | 
|COCH-ARM / FISHERS |                  P=0.007 **               P=0.462N                 P=0.408                  P=0.028 *       | 
|ORDER RESTRICTED   |                  P=0.044 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Diffuse                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/53 (9%)                7/55 (13%)               14/53 (26%)              22/53 (42%)     | 
|POLY-3 RATE (b)    |                  5/33.58                  7/40.50                  14/43.35                 22/41.83        | 
|POLY-3 PERCENT (g) |                  14.9%                    17.3%                    32.3%                    52.6%           | 
|TERMINAL (d)       |                  2/15 (13%)               2/25 (8%)                6/26 (23%)               11/22 (50%)     | 
|FIRST INCIDENCE    |                  126                      448                      376                      481             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.614                  P=0.142                  P=0.005 **      | 
|POLY 3             |                  P<0.001 **               P=0.515                  P=0.066                  P<0.001 **      | 
|POLY 1.5           |                  P<0.001 **               P=0.462                  P=0.042 *                P<0.001 **      | 
|POLY 6             |                  P<0.001 **               P=0.594                  P=0.111                  P<0.001 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.403                  P=0.020 *                P<0.001 **      | 
|COCH-ARM / FISHERS |                  P<0.001 **               P=0.407                  P=0.020 *                P<0.001 **      | 
|ORDER RESTRICTED   |                  P<0.001 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                6/55 (11%)               8/53 (15%)               6/53 (11%)      | 
|POLY-3 RATE (b)    |                  2/32.02                  6/38.55                  8/40.14                  6/37.58         | 
|POLY-3 PERCENT (g) |                  6.3%                     15.6%                    19.9%                    16.0%           | 
|TERMINAL (d)       |                  1/15 (7%)                5/25 (20%)               5/26 (19%)               5/22 (23%)      | 
|FIRST INCIDENCE    |                  519                      722                      653                      660             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.236                  P=0.324                  P=0.189                  P=0.256         | 
|POLY 3             |                  P=0.213                  P=0.197                  P=0.091                  P=0.186         | 
|POLY 1.5           |                  P=0.197                  P=0.174                  P=0.073                  P=0.172         | 
|POLY 6             |                  P=0.218                  P=0.235                  P=0.120                  P=0.198         | 
|LOGISTIC REGRESSION|                  P=0.196                  P=0.250                  P=0.110                  P=0.209         | 
|COCH-ARM / FISHERS |                  P=0.139                  P=0.147                  P=0.046 *                P=0.135         | 
|ORDER RESTRICTED   |                  P=0.140                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocyte, Multinucleate                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                2/55 (4%)                10/53 (19%)              14/53 (26%)     | 
|POLY-3 RATE (b)    |                  0/31.38                  2/38.53                  10/40.61                 14/40.28        | 
|POLY-3 PERCENT (g) |                  0.0%                     5.2%                     24.6%                    34.8%           | 
|TERMINAL (d)       |                  0/15 (0%)                2/25 (8%)                7/26 (27%)               8/22 (36%)      | 
|FIRST INCIDENCE    |                  ---                      727 (T)                  509                      481             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.356                  P=0.012 *                P<0.001 **      | 
|POLY 3             |                  P<0.001 **               P=0.285                  P=0.003 **               P<0.001 **      | 
|POLY 1.5           |                  P<0.001 **               P=0.268                  P=0.002 **               P<0.001 **      | 
|POLY 6             |                  P<0.001 **               P=0.310                  P=0.006 **               P<0.001 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.356                  P=0.005 **               P<0.001 **      | 
|COCH-ARM / FISHERS |                  P<0.001 **               P=0.257                  P<0.001 **               P<0.001 **      | 
|ORDER RESTRICTED   |                  P<0.001 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  36/53 (68%)              40/55 (73%)              49/53 (92%)              50/53 (94%)     | 
|POLY-3 RATE (b)    |                  36/42.80                 40/46.70                 49/50.26                 50/50.96        | 
|POLY-3 PERCENT (g) |                  84.1%                    85.7%                    97.5%                    98.1%           | 
|TERMINAL (d)       |                  15/15 (100%)             21/25 (84%)              25/26 (96%)              22/22 (100%)    | 
|FIRST INCIDENCE    |                  176                      253                      188                      385             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.136                  P=0.082N                 P=0.334N                 P=0.405         | 
|POLY 3             |                  P<0.001 **               P=0.543                  P=0.008 **               P=0.004 **      | 
|POLY 1.5           |                  P<0.001 **               P=0.427                  P=0.002 **               P<0.001 **      | 
|POLY 6             |                  P=0.004 **               P=0.527N                 P=0.061                  P=0.020 *       | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.548                  P=0.009 **               P=0.003 **      | 
|COCH-ARM / FISHERS |                  P<0.001 **               P=0.369                  P<0.001 **               P<0.001 **      | 
|ORDER RESTRICTED   |                  P=0.002 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  21/53 (40%)              24/55 (44%)              32/53 (60%)              32/53 (60%)     | 
|POLY-3 RATE (b)    |                  21/34.34                 24/40.37                 32/42.94                 32/43.91        | 
|POLY-3 PERCENT (g) |                  61.2%                    59.5%                    74.5%                    72.9%           | 
|TERMINAL (d)       |                  12/15 (80%)              19/25 (76%)              22/26 (85%)              19/22 (86%)     | 
|FIRST INCIDENCE    |                  541                      546                      541                      385             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.081                  P=0.087N                 P=0.449N                 P=0.349         | 
|POLY 3             |                  P=0.057                  P=0.537N                 P=0.131                  P=0.170         | 
|POLY 1.5           |                  P=0.033 *                P=0.553                  P=0.071                  P=0.099         | 
|POLY 6             |                  P=0.073                  P=0.398N                 P=0.257                  P=0.261         | 
|LOGISTIC REGRESSION|                  P=0.024 *                P=0.313N                 P=0.257                  P=0.104         | 
|COCH-ARM / FISHERS |                  P=0.007 **               P=0.410                  P=0.026 *                P=0.026 *       | 
|ORDER RESTRICTED   |                  P=0.136                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/53 (8%)                2/55 (4%)                5/53 (9%)                8/53 (15%)      | 
|POLY-3 RATE (b)    |                  4/34.03                  2/39.44                  5/42.49                  8/41.14         | 
|POLY-3 PERCENT (g) |                  11.8%                    5.1%                     11.8%                    19.5%           | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  176                      356                      300                      481             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.078                  P=0.242N                 P=0.624                  P=0.294         | 
|POLY 3             |                  P=0.067                  P=0.269N                 P=0.637                  P=0.278         | 
|POLY 1.5           |                  P=0.060                  P=0.291N                 P=0.589                  P=0.243         | 
|POLY 6             |                  P=0.072                  P=0.240N                 P=0.583N                 P=0.320         | 
|LOGISTIC REGRESSION|                  P=0.017 *                P=0.373N                 P=0.320                  P=0.101         | 
|COCH-ARM / FISHERS |                  P=0.043 *                P=0.322N                 P=0.500                  P=0.179         | 
|ORDER RESTRICTED   |                  P=0.109                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/53 (2%)                11/55 (20%)              41/53 (77%)              39/53 (74%)     | 
|POLY-3 RATE (b)    |                  1/32.06                  11/39.46                 41/47.21                 39/44.38        | 
|POLY-3 PERCENT (g) |                  3.1%                     27.9%                    86.9%                    87.9%           | 
|TERMINAL (d)       |                  0/15 (0%)                7/25 (28%)               23/26 (89%)              21/22 (96%)     | 
|FIRST INCIDENCE    |                  496                      572                      328                      405             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.024 *                P<0.001 **               P<0.001 **      | 
|POLY 3             |                  P<0.001 **               P=0.005 **               P<0.001 **               P<0.001 **      | 
|POLY 1.5           |                  P<0.001 **               P=0.004 **               P<0.001 **               P<0.001 **      | 
|POLY 6             |                  P<0.001 **               P=0.009 **               P<0.001 **               P<0.001 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.008 **               P<0.001 **               P<0.001 **      | 
|COCH-ARM / FISHERS |                  P<0.001 **               P=0.002 **               P<0.001 **               P<0.001 **      | 
|ORDER RESTRICTED   |                  P<0.001 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Toxic Hepatopathy                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                6/55 (11%)               22/53 (42%)              27/53 (51%)     | 
|POLY-3 RATE (b)    |                  0/31.38                  6/38.95                  22/41.68                 27/41.02        | 
|POLY-3 PERCENT (g) |                  0.0%                     15.4%                    52.8%                    65.8%           | 
|TERMINAL (d)       |                  0/15 (0%)                3/25 (12%)               15/26 (58%)              18/22 (82%)     | 
|FIRST INCIDENCE    |                  ---                      652                      328                      454             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.068                  P<0.001 **               P<0.001 **      | 
|POLY 3             |                  P<0.001 **               P=0.029 *                P<0.001 **               P<0.001 **      | 
|POLY 1.5           |                  P<0.001 **               P=0.023 *                P<0.001 **               P<0.001 **      | 
|POLY 6             |                  P<0.001 **               P=0.040 *                P<0.001 **               P<0.001 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.042 *                P<0.001 **               P<0.001 **      | 
|COCH-ARM / FISHERS |                  P<0.001 **               P=0.015 *                P<0.001 **               P<0.001 **      | 
|ORDER RESTRICTED   |                  P<0.001 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/53 (6%)                6/55 (11%)               0/53 (0%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  3/31.38                  6/38.56                  0/39.60                  2/37.58         | 
|POLY-3 PERCENT (g) |                  9.6%                     15.6%                    0.0%                     5.3%            | 
|TERMINAL (d)       |                  3/15 (20%)               5/25 (20%)               0/26 (0%)                1/22 (5%)       | 
|FIRST INCIDENCE    |                  727 (T)                  720                      ---                      659             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.055N                 P=0.545                  P=0.042N*                P=0.343N        | 
|POLY 3             |                  P=0.068N                 P=0.350                  P=0.082N                 P=0.418N        | 
|POLY 1.5           |                  P=0.078N                 P=0.311                  P=0.094N                 P=0.441N        | 
|POLY 6             |                  P=0.059N                 P=0.412                  P=0.069N                 P=0.394N        | 
|LOGISTIC REGRESSION|                  P=0.063N                 P=0.568                  (e)                      P=0.373N        | 
|COCH-ARM / FISHERS |                  P=0.111N                 P=0.263                  P=0.121N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.087N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/53 (8%)                4/55 (7%)                3/53 (6%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  4/32.23                  4/38.64                  3/39.75                  2/38.02         | 
|POLY-3 PERCENT (g) |                  12.4%                    10.4%                    7.6%                     5.3%            | 
|TERMINAL (d)       |                  3/15 (20%)               3/25 (12%)               1/26 (4%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  391                      700                      709                      600             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.144N                 P=0.382N                 P=0.253N                 P=0.223N        | 
|POLY 3             |                  P=0.172N                 P=0.541N                 P=0.386N                 P=0.262N        | 
|POLY 1.5           |                  P=0.183N                 P=0.577N                 P=0.426N                 P=0.283N        | 
|POLY 6             |                  P=0.167N                 P=0.485N                 P=0.338N                 P=0.239N        | 
|LOGISTIC REGRESSION|                  P=0.168N                 P=0.512N                 P=0.378N                 P=0.289N        | 
|COCH-ARM / FISHERS |                  P=0.225N                 P=0.621N                 P=0.500N                 P=0.339N        | 
|ORDER RESTRICTED   |                  P=0.243N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/53 (6%)                7/55 (13%)               7/53 (13%)               13/53 (25%)     | 
|POLY-3 RATE (b)    |                  3/32.67                  7/39.97                  7/39.86                  13/41.26        | 
|POLY-3 PERCENT (g) |                  9.2%                     17.5%                    17.6%                    31.5%           | 
|TERMINAL (d)       |                  1/15 (7%)                4/25 (16%)               6/26 (23%)               5/22 (23%)      | 
|FIRST INCIDENCE    |                  496                      434                      659                      405             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.018 *                P=0.337                  P=0.392                  P=0.036 *       | 
|POLY 3             |                  P=0.013 *                P=0.248                  P=0.246                  P=0.019 *       | 
|POLY 1.5           |                  P=0.010 *                P=0.215                  P=0.215                  P=0.013 *       | 
|POLY 6             |                  P=0.016 *                P=0.298                  P=0.288                  P=0.027 *       | 
|LOGISTIC REGRESSION|                  P=0.008 **               P=0.205                  P=0.264                  P=0.009 **      | 
|COCH-ARM / FISHERS |                  P=0.005 **               P=0.176                  P=0.160                  P=0.006 **      | 
|ORDER RESTRICTED   |                  P=0.011 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/53 (6%)                1/55 (2%)                1/53 (2%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  3/33.04                  1/38.64                  1/40.21                  0/37.32         | 
|POLY-3 PERCENT (g) |                  9.1%                     2.6%                     2.5%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  354                      700                      533                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.061N                 P=0.210N                 P=0.233N                 P=0.094N        | 
|POLY 3             |                  P=0.072N                 P=0.250N                 P=0.238N                 P=0.097N        | 
|POLY 1.5           |                  P=0.071N                 P=0.267N                 P=0.260N                 P=0.102N        | 
|POLY 6             |                  P=0.077N                 P=0.224N                 P=0.213N                 P=0.093N        | 
|LOGISTIC REGRESSION|                  P=0.091N                 P=0.302N                 P=0.375N                 P=0.151N        | 
|COCH-ARM / FISHERS |                  P=0.078N                 P=0.295N                 P=0.309N                 P=0.121N        | 
|ORDER RESTRICTED   |                  P=0.027N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                23/55 (42%)              32/53 (60%)              36/53 (68%)     | 
|POLY-3 RATE (b)    |                  0/31.38                  23/43.50                 32/45.22                 36/46.82        | 
|POLY-3 PERCENT (g) |                  0.0%                     52.9%                    70.8%                    76.9%           | 
|TERMINAL (d)       |                  0/15 (0%)                10/25 (40%)              18/26 (69%)              17/22 (77%)     | 
|FIRST INCIDENCE    |                  ---                      448                      188                      385             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P<0.001 **               P<0.001 **               P<0.001 **      | 
|POLY 3             |                  P<0.001 **               P<0.001 **               P<0.001 **               P<0.001 **      | 
|POLY 1.5           |                  P<0.001 **               P<0.001 **               P<0.001 **               P<0.001 **      | 
|POLY 6             |                  P<0.001 **               P<0.001 **               P<0.001 **               P<0.001 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P<0.001 **               P<0.001 **               P<0.001 **      | 
|COCH-ARM / FISHERS |                  P<0.001 **               P<0.001 **               P<0.001 **               P<0.001 **      | 
|ORDER RESTRICTED   |                  P<0.001 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Oval Cell                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                1/55 (2%)                6/53 (11%)               7/53 (13%)      | 
|POLY-3 RATE (b)    |                  0/31.38                  1/38.56                  6/39.60                  7/37.32         | 
|POLY-3 PERCENT (g) |                  0.0%                     2.6%                     15.2%                    18.8%           | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                6/26 (23%)               7/22 (32%)      | 
|FIRST INCIDENCE    |                  ---                      720                      727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.624                  P=0.062                  P=0.024 *       | 
|POLY 3             |                  P<0.001 **               P=0.541                  P=0.031 *                P=0.013 *       | 
|POLY 1.5           |                  P<0.001 **               P=0.527                  P=0.025 *                P=0.012 *       | 
|POLY 6             |                  P<0.001 **               P=0.561                  P=0.041 *                P=0.015 *       | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.596                  P=0.062                  P=0.024 *       | 
|COCH-ARM / FISHERS |                  P<0.001 **               P=0.509                  P=0.013 *                P=0.006 **      | 
|ORDER RESTRICTED   |                  P=0.006 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  41/53 (77%)              49/55 (89%)              45/53 (85%)              48/53 (91%)     | 
|POLY-3 RATE (b)    |                  41/47.06                 49/51.17                 45/47.89                 48/49.78        | 
|POLY-3 PERCENT (g) |                  87.1%                    95.8%                    94.0%                    96.4%           | 
|TERMINAL (d)       |                  12/15 (80%)              23/25 (92%)              26/26 (100%)             21/22 (96%)     | 
|FIRST INCIDENCE    |                  201                      253                      328                      385             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.315N                 P=0.201N                 P=0.049N*                P=0.335N        | 
|POLY 3             |                  P=0.088                  P=0.099                  P=0.185                  P=0.069         | 
|POLY 1.5           |                  P=0.091                  P=0.062                  P=0.192                  P=0.058         | 
|POLY 6             |                  P=0.088                  P=0.182                  P=0.187                  P=0.097         | 
|LOGISTIC REGRESSION|                  P=0.308                  P=0.128                  P=0.479                  P=0.144         | 
|COCH-ARM / FISHERS |                  P=0.094                  P=0.084                  P=0.229                  P=0.055         | 
|ORDER RESTRICTED   |                  P=0.026 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/53 (9%)                3/55 (5%)                0/53 (0%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  5/32.66                  3/39.74                  0/39.60                  1/37.78         | 
|POLY-3 PERCENT (g) |                  15.3%                    7.6%                     0.0%                     2.7%            | 
|TERMINAL (d)       |                  2/15 (13%)               0/25 (0%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  309                      356                      ---                      592             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.017N*                P=0.179N                 P=0.010N*                P=0.057N        | 
|POLY 3             |                  P=0.022N*                P=0.252N                 P=0.017N*                P=0.069N        | 
|POLY 1.5           |                  P=0.022N*                P=0.286N                 P=0.021N*                P=0.077N        | 
|POLY 6             |                  P=0.023N*                P=0.207N                 P=0.013N*                P=0.061N        | 
|LOGISTIC REGRESSION|                  P=0.027N*                P=0.321N                 P=0.026N*                P=0.088N        | 
|COCH-ARM / FISHERS |                  P=0.027N*                P=0.337N                 P=0.028N*                P=0.103N        | 
|ORDER RESTRICTED   |                  P=0.010N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/53 (6%)                0/55 (0%)                2/53 (4%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  3/32.04                  0/38.53                  2/39.67                  0/37.32         | 
|POLY-3 PERCENT (g) |                  9.4%                     0.0%                     5.0%                     0.0%            | 
|TERMINAL (d)       |                  1/15 (7%)                0/25 (0%)                1/26 (4%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  611                      ---                      709                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.129N                 P=0.066N                 P=0.300N                 P=0.085N        | 
|POLY 3             |                  P=0.168N                 P=0.088N                 P=0.403N                 P=0.092N        | 
|POLY 1.5           |                  P=0.162N                 P=0.097N                 P=0.435N                 P=0.098N        | 
|POLY 6             |                  P=0.185N                 P=0.076N                 P=0.368N                 P=0.088N        | 
|LOGISTIC REGRESSION|                  P=0.138N                 P=0.088N                 P=0.374N                 P=0.092N        | 
|COCH-ARM / FISHERS |                  P=0.171N                 P=0.115N                 P=0.500N                 P=0.121N        | 
|ORDER RESTRICTED   |                  P=0.025N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/53 (2%)                0/55 (0%)                1/53 (2%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  1/31.53                  0/38.53                  1/39.60                  2/37.32         | 
|POLY-3 PERCENT (g) |                  3.2%                     0.0%                     2.5%                     5.4%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                1/26 (4%)                2/22 (9%)       | 
|FIRST INCIDENCE    |                  688                      ---                      727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.245                  P=0.405N                 P=0.642N                 P=0.616         | 
|POLY 3             |                  P=0.221                  P=0.460N                 P=0.708N                 P=0.559         | 
|POLY 1.5           |                  P=0.223                  P=0.474N                 P=0.727N                 P=0.543         | 
|POLY 6             |                  P=0.213                  P=0.441N                 P=0.685N                 P=0.572         | 
|LOGISTIC REGRESSION|                  P=0.232                  P=0.448N                 P=0.677N                 P=0.598         | 
|COCH-ARM / FISHERS |                  P=0.207                  P=0.491N                 P=0.752N                 P=0.500         | 
|ORDER RESTRICTED   |                  P=0.268                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Thrombosis                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                2/55 (4%)                0/53 (0%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  0/31.38                  2/38.67                  0/39.60                  0/37.32         | 
|POLY-3 PERCENT (g) |                  0.0%                     5.2%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  ---                      700                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.245N                 P=0.374                  (e)                      (e)             | 
|POLY 3             |                  P=0.225N                 P=0.286                  (e)                      (e)             | 
|POLY 1.5           |                  P=0.245N                 P=0.268                  (e)                      (e)             | 
|POLY 6             |                  P=0.205N                 P=0.312                  (e)                      (e)             | 
|LOGISTIC REGRESSION|                  P=0.250N                 P=0.322                  (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.284N                 P=0.257                  (e)                      (e)             | 
|ORDER RESTRICTED   |                  P=0.258N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  12/53 (23%)              1/55 (2%)                0/53 (0%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  12/32.58                 1/38.75                  0/39.60                  1/37.32         | 
|POLY-3 PERCENT (g) |                  36.8%                    2.6%                     0.0%                     2.7%            | 
|TERMINAL (d)       |                  7/15 (47%)               0/25 (0%)                0/26 (0%)                1/22 (5%)       | 
|FIRST INCIDENCE    |                  600                      671                      ---                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001N**               P<0.001N**               P<0.001N**               P<0.001N**      | 
|POLY 3             |                  P<0.001N**               P<0.001N**               P<0.001N**               P<0.001N**      | 
|POLY 1.5           |                  P<0.001N**               P<0.001N**               P<0.001N**               P<0.001N**      | 
|POLY 6             |                  P<0.001N**               P<0.001N**               P<0.001N**               P<0.001N**      | 
|LOGISTIC REGRESSION|                  P<0.001N**               P<0.001N**               P<0.001N**               P<0.001N**      | 
|COCH-ARM / FISHERS |                  P<0.001N**               P<0.001N**               P<0.001N**               P<0.001N**      | 
|ORDER RESTRICTED   |                  P<0.001N**               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Metaplasia Bronchiolar                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                29/55 (53%)              34/53 (64%)              41/53 (77%)     | 
|POLY-3 RATE (b)    |                  0/31.38                  29/41.27                 34/43.69                 41/45.19        | 
|POLY-3 PERCENT (g) |                  0.0%                     70.3%                    77.8%                    90.7%           | 
|TERMINAL (d)       |                  0/15 (0%)                19/25 (76%)              22/26 (85%)              21/22 (96%)     | 
|FIRST INCIDENCE    |                  ---                      516                      541                      405             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P<0.001 **               P<0.001 **               P<0.001 **      | 
|POLY 3             |                  P<0.001 **               P<0.001 **               P<0.001 **               P<0.001 **      | 
|POLY 1.5           |                  P<0.001 **               P<0.001 **               P<0.001 **               P<0.001 **      | 
|POLY 6             |                  P<0.001 **               P<0.001 **               P<0.001 **               P<0.001 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P<0.001 **               P<0.001 **               P<0.001 **      | 
|COCH-ARM / FISHERS |                  P<0.001 **               P<0.001 **               P<0.001 **               P<0.001 **      | 
|ORDER RESTRICTED   |                  P<0.001 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Serosa                                                                                                                     | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                0/55 (0%)                2/53 (4%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  0/31.38                  0/38.53                  2/39.88                  0/37.32         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     5.0%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                1/26 (4%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      651                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.502                  (e)                      P=0.358                  (e)             | 
|POLY 3             |                  P=0.498                  (e)                      P=0.294                  (e)             | 
|POLY 1.5           |                  P=0.495                  (e)                      P=0.273                  (e)             | 
|POLY 6             |                  P=0.493                  (e)                      P=0.320                  (e)             | 
|LOGISTIC REGRESSION|                  P=0.483                  (e)                      P=0.300                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.454                  (e)                      P=0.248                  (e)             | 
|ORDER RESTRICTED   |                  P=0.296                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Serosa                                                                                                                     | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                0/55 (0%)                0/53 (0%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  2/32.84                  0/38.53                  0/39.60                  1/38.32         | 
|POLY-3 PERCENT (g) |                  6.1%                     0.0%                     0.0%                     2.6%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  126                      ---                      ---                      124             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.436N                 P=0.218N                 P=0.215N                 P=0.482N        | 
|POLY 3             |                  P=0.459N                 P=0.202N                 P=0.197N                 P=0.446N        | 
|POLY 1.5           |                  P=0.451N                 P=0.214N                 P=0.211N                 P=0.459N        | 
|POLY 6             |                  P=0.473N                 P=0.186N                 P=0.182N                 P=0.436N        | 
|LOGISTIC REGRESSION|                  P=0.583                  P=0.267N                 P=0.371N                 P=0.703         | 
|COCH-ARM / FISHERS |                  P=0.449N                 P=0.238N                 P=0.248N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.097N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/52 (2%)                1/53 (2%)                4/51 (8%)                4/51 (8%)       | 
|POLY-3 RATE (b)    |                  1/31.47                  1/37.64                  4/38.08                  4/36.51         | 
|POLY-3 PERCENT (g) |                  3.2%                     2.7%                     10.5%                    11.0%           | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                4/25 (16%)               4/22 (18%)      | 
|FIRST INCIDENCE    |                  660                      722                      727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.079                  P=0.658N                 P=0.344                  P=0.293         | 
|POLY 3             |                  P=0.068                  P=0.720N                 P=0.240                  P=0.224         | 
|POLY 1.5           |                  P=0.067                  P=0.736N                 P=0.215                  P=0.210         | 
|POLY 6             |                  P=0.065                  P=0.695N                 P=0.272                  P=0.237         | 
|LOGISTIC REGRESSION|                  P=0.066                  P=0.709N                 P=0.309                  P=0.264         | 
|COCH-ARM / FISHERS |                  P=0.052                  P=0.748N                 P=0.175                  P=0.175         | 
|ORDER RESTRICTED   |                  P=0.158                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  18/52 (35%)              24/53 (45%)              31/51 (61%)              21/51 (41%)     | 
|POLY-3 RATE (b)    |                  18/36.75                 24/45.45                 31/41.45                 21/38.38        | 
|POLY-3 PERCENT (g) |                  49.0%                    52.8%                    74.8%                    54.7%           | 
|TERMINAL (d)       |                  8/15 (53%)               9/25 (36%)               21/25 (84%)              16/22 (73%)     | 
|FIRST INCIDENCE    |                  222                      202                      531                      496             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.457N                 P=0.485N                 P=0.366                  P=0.347N        | 
|POLY 3             |                  P=0.170                  P=0.450                  P=0.010 *                P=0.388         | 
|POLY 1.5           |                  P=0.228                  P=0.328                  P=0.007 **               P=0.389         | 
|POLY 6             |                  P=0.096                  P=0.571N                 P=0.017 *                P=0.369         | 
|LOGISTIC REGRESSION|                  P=0.391                  P=0.205                  P=0.034 *                P=0.544         | 
|COCH-ARM / FISHERS |                  P=0.224                  P=0.180                  P=0.007 **               P=0.315         | 
|ORDER RESTRICTED   |                  P=0.108                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/52 (4%)                3/54 (6%)                0/52 (0%)                1/52 (2%)       | 
|POLY-3 RATE (b)    |                  2/31.83                  3/39.51                  0/38.60                  1/36.90         | 
|POLY-3 PERCENT (g) |                  6.3%                     7.6%                     0.0%                     2.7%            | 
|TERMINAL (d)       |                  0/15 (0%)                1/25 (4%)                0/25 (0%)                0/21 (0%)       | 
|FIRST INCIDENCE    |                  618                      498                      ---                      546             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.140N                 P=0.642                  P=0.150N                 P=0.427N        | 
|POLY 3             |                  P=0.146N                 P=0.598                  P=0.196N                 P=0.448N        | 
|POLY 1.5           |                  P=0.153N                 P=0.562                  P=0.210N                 P=0.462N        | 
|POLY 6             |                  P=0.144N                 P=0.644                  P=0.181N                 P=0.437N        | 
|LOGISTIC REGRESSION|                  P=0.173N                 P=0.539                  P=0.200N                 P=0.481N        | 
|COCH-ARM / FISHERS |                  P=0.175N                 P=0.518                  P=0.248N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.197N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/52 (6%)                0/54 (0%)                0/52 (0%)                0/52 (0%)       | 
|POLY-3 RATE (b)    |                  3/33.26                  0/38.32                  0/38.60                  0/36.32         | 
|POLY-3 PERCENT (g) |                  9.0%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                0/25 (0%)                0/21 (0%)       | 
|FIRST INCIDENCE    |                  222                      ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.043N*                P=0.095N                 P=0.093N                 P=0.102N        | 
|POLY 3             |                  P=0.052N                 P=0.094N                 P=0.093N                 P=0.102N        | 
|POLY 1.5           |                  P=0.049N*                P=0.102N                 P=0.102N                 P=0.106N        | 
|POLY 6             |                  P=0.059N                 P=0.083N                 P=0.084N                 P=0.100N        | 
|LOGISTIC REGRESSION|                  P=0.070N                 P=0.130N                 P=0.171N                 P=0.172N        | 
|COCH-ARM / FISHERS |                  P=0.051N                 P=0.115N                 P=0.121N                 P=0.121N        | 
|ORDER RESTRICTED   |                  P=0.006N**               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/2 (0%)                 0/6 (0%)                 0/6 (0%)                 2/6 (33%)       | 
|POLY-3 RATE (b)    |                  0/0.63                   0/3.24                   0/3.60                   2/4.37          | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     45.8%           | 
|TERMINAL (d)       |                  0/0 (0%)                 0/1 (0%)                 0/2 (0%)                 0/1 (0%)        | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      496             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.056                  (e)                      (e)                      P=0.309         | 
|POLY 3             |                  P=0.080                  (e)                      (e)                      P=0.682         | 
|POLY 1.5           |                  P=0.074                  (e)                      (e)                      P=0.636         | 
|POLY 6             |                  P=0.099                  (e)                      (e)                      P=0.740         | 
|LOGISTIC REGRESSION|                  P=0.067                  (e)                      (e)                      P=0.581         | 
|COCH-ARM / FISHERS |                  P=0.066                  (e)                      (e)                      P=0.536         | 
|ORDER RESTRICTED   |                  P=0.501                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/2 (0%)                 2/6 (33%)                3/6 (50%)                0/6 (0%)        | 
|POLY-3 RATE (b)    |                  0/0.63                   2/3.86                   3/4.04                   0/3.43          | 
|POLY-3 PERCENT (g) |                  0.0%                     51.8%                    74.3%                    0.0%            | 
|TERMINAL (d)       |                  0/0 (0%)                 0/1 (0%)                 2/2 (100%)               0/1 (0%)        | 
|FIRST INCIDENCE    |                  ---                      630                      602                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.360N                 P=0.331                  P=0.581                  (e)             | 
|POLY 3             |                  P=0.191N                 P=0.673                  P=0.593                  (e)             | 
|POLY 1.5           |                  P=0.177N                 P=0.618                  P=0.510                  (e)             | 
|POLY 6             |                  P=0.281N                 P=0.742                  P=0.784                  (e)             | 
|LOGISTIC REGRESSION|                  P=0.199N                 P=0.662                  P=0.527                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.314N                 P=0.536                  P=0.357                  (e)             | 
|ORDER RESTRICTED   |                  P=0.493N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/2 (0%)                 0/6 (0%)                 2/6 (33%)                1/6 (17%)       | 
|POLY-3 RATE (b)    |                  0/0.63                   0/3.24                   2/4.04                   1/3.97          | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     49.6%                    25.2%           | 
|TERMINAL (d)       |                  0/0 (0%)                 0/1 (0%)                 1/2 (50%)                0/1 (0%)        | 
|FIRST INCIDENCE    |                  ---                      ---                      602                      559             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.235                  (e)                      P=0.581                  P=0.543         | 
|POLY 3             |                  P=0.429                  (e)                      P=0.677                  P=0.796         | 
|POLY 1.5           |                  P=0.393                  (e)                      P=0.629                  P=0.775         | 
|POLY 6             |                  P=0.519                  (e)                      P=0.743                  P=0.824         | 
|LOGISTIC REGRESSION|                  P=0.311                  (e)                      P=0.709                  P=0.783         | 
|COCH-ARM / FISHERS |                  P=0.269                  (e)                      P=0.536                  P=0.750         | 
|ORDER RESTRICTED   |                  P=0.587                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  8/52 (15%)               3/55 (5%)                1/53 (2%)                4/53 (8%)       | 
|POLY-3 RATE (b)    |                  8/33.57                  3/39.34                  1/40.40                  4/37.83         | 
|POLY-3 PERCENT (g) |                  23.8%                    7.6%                     2.5%                     10.6%           | 
|TERMINAL (d)       |                  3/15 (20%)               1/25 (4%)                0/26 (0%)                3/22 (14%)      | 
|FIRST INCIDENCE    |                  405                      524                      428                      576             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.082N                 P=0.031N*                P=0.005N**               P=0.077N        | 
|POLY 3             |                  P=0.111N                 P=0.052N                 P=0.006N**               P=0.116N        | 
|POLY 1.5           |                  P=0.111N                 P=0.064N                 P=0.008N**               P=0.128N        | 
|POLY 6             |                  P=0.118N                 P=0.038N*                P=0.004N**               P=0.108N        | 
|LOGISTIC REGRESSION|                  P=0.112N                 P=0.066N                 P=0.014N*                P=0.117N        | 
|COCH-ARM / FISHERS |                  P=0.131N                 P=0.084N                 P=0.014N*                P=0.170N        | 
|ORDER RESTRICTED   |                  P=0.012N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  32/52 (62%)              33/55 (60%)              30/53 (57%)              29/53 (55%)     | 
|POLY-3 RATE (b)    |                  32/43.06                 33/45.84                 30/46.24                 29/43.63        | 
|POLY-3 PERCENT (g) |                  74.3%                    72.0%                    64.9%                    66.5%           | 
|TERMINAL (d)       |                  11/15 (73%)              15/25 (60%)              13/26 (50%)              15/22 (68%)     | 
|FIRST INCIDENCE    |                  126                      82                       328                      405             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.082N                 P=0.082N                 P=0.031N*                P=0.063N        | 
|POLY 3             |                  P=0.181N                 P=0.497N                 P=0.219N                 P=0.269N        | 
|POLY 1.5           |                  P=0.189N                 P=0.540N                 P=0.295N                 P=0.277N        | 
|POLY 6             |                  P=0.195N                 P=0.374N                 P=0.127N                 P=0.267N        | 
|LOGISTIC REGRESSION|                  P=0.146N                 P=0.450N                 P=0.294N                 P=0.216N        | 
|COCH-ARM / FISHERS |                  P=0.240N                 P=0.514N                 P=0.376N                 P=0.305N        | 
|ORDER RESTRICTED   |                  P=0.287N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/52 (2%)                0/55 (0%)                0/53 (0%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  1/31.36                  0/38.53                  0/39.60                  2/37.74         | 
|POLY-3 PERCENT (g) |                  3.2%                     0.0%                     0.0%                     5.3%            | 
|TERMINAL (d)       |                  1/15 (7%)                0/25 (0%)                0/26 (0%)                1/22 (5%)       | 
|FIRST INCIDENCE    |                  727 (T)                  ---                      ---                      607             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.265                  P=0.398N                 P=0.390N                 P=0.607         | 
|POLY 3             |                  P=0.240                  P=0.459N                 P=0.454N                 P=0.564         | 
|POLY 1.5           |                  P=0.242                  P=0.472N                 P=0.469N                 P=0.547         | 
|POLY 6             |                  P=0.231                  P=0.439N                 P=0.435N                 P=0.583         | 
|LOGISTIC REGRESSION|                  P=0.256                  (e)                      (e)                      P=0.572         | 
|COCH-ARM / FISHERS |                  P=0.234                  P=0.486N                 P=0.495N                 P=0.507         | 
|ORDER RESTRICTED   |                  P=0.167                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/52 (4%)                2/55 (4%)                0/53 (0%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  2/31.43                  2/39.32                  0/39.60                  1/37.83         | 
|POLY-3 PERCENT (g) |                  6.4%                     5.1%                     0.0%                     2.6%            | 
|TERMINAL (d)       |                  1/15 (7%)                1/25 (4%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  709                      434                      ---                      576             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.183N                 P=0.535N                 P=0.129N                 P=0.395N        | 
|POLY 3             |                  P=0.210N                 P=0.611N                 P=0.189N                 P=0.435N        | 
|POLY 1.5           |                  P=0.215N                 P=0.640N                 P=0.204N                 P=0.453N        | 
|POLY 6             |                  P=0.208N                 P=0.570N                 P=0.172N                 P=0.418N        | 
|LOGISTIC REGRESSION|                  P=0.219N                 P=0.643N                 P=0.141N                 P=0.439N        | 
|COCH-ARM / FISHERS |                  P=0.233N                 P=0.670N                 P=0.243N                 P=0.493N        | 
|ORDER RESTRICTED   |                  P=0.208N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Artery                                                                                                                | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/1 (0%)                 0/0 (0%)                 2/4 (50%)                2/2 (100%)      | 
|POLY-3 RATE (b)    |                  0/0.16                   0/0.00                   2/3.52                   2/2.00          | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     56.8%                    100.0%          | 
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)                 2/3 (67%)                2/2 (100%)      | 
|FIRST INCIDENCE    |                  ---                      ---                      727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.581                  (e)                      P=1.000                  P=1.000         | 
|POLY 3             |                  (e)                      (e)                      P=0.800                  P=0.333         | 
|POLY 1.5           |                  (e)                      (e)                      P=0.731                  P=0.333         | 
|POLY 6             |                  (e)                      (e)                      P=0.843                  P=0.333         | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      P=1.000                  P=1.000         | 
|COCH-ARM / FISHERS |                  P=0.120                  (e)                      P=0.600                  P=0.333         | 
|ORDER RESTRICTED   |                  (e)                      (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Respiratory Epithelium                                                                                                     | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                0/54 (0%)                1/52 (2%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  2/32.23                  0/37.53                  1/39.58                  1/37.32         | 
|POLY-3 PERCENT (g) |                  6.2%                     0.0%                     2.5%                     2.7%            | 
|TERMINAL (d)       |                  1/15 (7%)                0/24 (0%)                0/26 (0%)                1/22 (5%)       | 
|FIRST INCIDENCE    |                  391                      ---                      709                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.461N                 P=0.185N                 P=0.365N                 P=0.395N        | 
|POLY 3             |                  P=0.521N                 P=0.204N                 P=0.429N                 P=0.449N        | 
|POLY 1.5           |                  P=0.516N                 P=0.216N                 P=0.455N                 P=0.461N        | 
|POLY 6             |                  P=0.540N                 P=0.186N                 P=0.398N                 P=0.437N        | 
|LOGISTIC REGRESSION|                  P=0.506N                 P=0.240N                 P=0.501N                 P=0.484N        | 
|COCH-ARM / FISHERS |                  P=0.526N                 P=0.243N                 P=0.507N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.212N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Turbinate                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                0/54 (0%)                1/52 (2%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  2/31.81                  0/37.53                  1/39.51                  1/37.32         | 
|POLY-3 PERCENT (g) |                  6.3%                     0.0%                     2.5%                     2.7%            | 
|TERMINAL (d)       |                  1/15 (7%)                0/24 (0%)                1/26 (4%)                1/22 (5%)       | 
|FIRST INCIDENCE    |                  603                      ---                      727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.458N                 P=0.165N                 P=0.344N                 P=0.393N        | 
|POLY 3             |                  P=0.522N                 P=0.201N                 P=0.425N                 P=0.444N        | 
|POLY 1.5           |                  P=0.517N                 P=0.214N                 P=0.452N                 P=0.458N        | 
|POLY 6             |                  P=0.542N                 P=0.184N                 P=0.396N                 P=0.433N        | 
|LOGISTIC REGRESSION|                  P=0.479N                 P=0.201N                 P=0.405N                 P=0.429N        | 
|COCH-ARM / FISHERS |                  P=0.526N                 P=0.243N                 P=0.507N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.209N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Mucosa: Gingival                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/1 (100%)               0/1 (0%)                 2/3 (67%)                2/4 (50%)       | 
|POLY-3 RATE (b)    |                  1/1.00                   0/0.82                   2/2.72                   2/4.00          | 
|POLY-3 PERCENT (g) |                  100.0%                   0.0%                     73.6%                    50.0%           | 
|TERMINAL (d)       |                  1/1 (100%)               0/0 (0%)                 0/0 (0%)                 1/3 (33%)       | 
|FIRST INCIDENCE    |                  727 (T)                  ---                      688                      658             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.478                  P=1.000                  P=0.377                  P=0.729N        | 
|POLY 3             |                  P=0.485N                 P=1.000                  P=0.786N                 P=0.577N        | 
|POLY 1.5           |                  P=0.520N                 P=1.000                  P=0.737N                 P=0.577N        | 
|POLY 6             |                  P=0.421N                 P=1.000                  P=0.885N                 P=0.577N        | 
|LOGISTIC REGRESSION|                  P=0.555N                 (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.565N                 P=0.500N                 P=0.750N                 P=0.600N        | 
|ORDER RESTRICTED   |                  P=0.419N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  45/52 (87%)              49/54 (91%)              46/53 (87%)              45/52 (87%)     | 
|POLY-3 RATE (b)    |                  45/46.65                 49/52.02                 46/50.50                 45/49.66        | 
|POLY-3 PERCENT (g) |                  96.5%                    94.2%                    91.1%                    90.6%           | 
|TERMINAL (d)       |                  14/15 (93%)              22/25 (88%)              23/26 (89%)              19/22 (86%)     | 
|FIRST INCIDENCE    |                  126                      223                      188                      124             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.104N                 P=0.075N                 P=0.020N*                P=0.090N        | 
|POLY 3             |                  P=0.134N                 P=0.477N                 P=0.234N                 P=0.204N        | 
|POLY 1.5           |                  P=0.145N                 P=0.654N                 P=0.314N                 P=0.271N        | 
|POLY 6             |                  P=0.174N                 P=0.376N                 P=0.217N                 P=0.218N        | 
|LOGISTIC REGRESSION|                  P=0.249N                 P=0.447                  P=0.394N                 P=0.388N        | 
|COCH-ARM / FISHERS |                  P=0.422N                 P=0.354                  P=0.598                  P=0.613N        | 
|ORDER RESTRICTED   |                  P=0.186N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  12/52 (23%)              17/54 (31%)              17/53 (32%)              15/52 (29%)     | 
|POLY-3 RATE (b)    |                  12/33.36                 17/41.28                 17/40.57                 15/38.87        | 
|POLY-3 PERCENT (g) |                  36.0%                    41.2%                    41.9%                    38.6%           | 
|TERMINAL (d)       |                  7/15 (47%)               10/25 (40%)              15/26 (58%)              10/22 (46%)     | 
|FIRST INCIDENCE    |                  547                      356                      541                      496             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.433N                 P=0.505N                 P=0.411N                 P=0.481N        | 
|POLY 3             |                  P=0.506                  P=0.411                  P=0.387                  P=0.506         | 
|POLY 1.5           |                  P=0.483                  P=0.321                  P=0.318                  P=0.453         | 
|POLY 6             |                  P=0.490                  P=0.545                  P=0.469                  P=0.553         | 
|LOGISTIC REGRESSION|                  P=0.531                  P=0.379                  P=0.549                  P=0.547         | 
|COCH-ARM / FISHERS |                  P=0.354                  P=0.226                  P=0.208                  P=0.328         | 
|ORDER RESTRICTED   |                  P=0.542                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/51 (10%)               1/55 (2%)                3/53 (6%)                4/53 (8%)       | 
|POLY-3 RATE (b)    |                  5/32.80                  1/38.53                  3/40.81                  4/38.15         | 
|POLY-3 PERCENT (g) |                  15.2%                    2.6%                     7.4%                     10.5%           | 
|TERMINAL (d)       |                  3/15 (20%)               1/25 (4%)                1/26 (4%)                3/22 (14%)      | 
|FIRST INCIDENCE    |                  391                      727 (T)                  300                      405             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.525N                 P=0.041N*                P=0.182N                 P=0.315N        | 
|POLY 3             |                  P=0.540                  P=0.066N                 P=0.242N                 P=0.404N        | 
|POLY 1.5           |                  P=0.540                  P=0.075N                 P=0.275N                 P=0.424N        | 
|POLY 6             |                  P=0.524                  P=0.053N                 P=0.203N                 P=0.385N        | 
|LOGISTIC REGRESSION|                  P=0.515                  P=0.075N                 P=0.347N                 P=0.439N        | 
|COCH-ARM / FISHERS |                  P=0.504                  P=0.086N                 P=0.336N                 P=0.475N        | 
|ORDER RESTRICTED   |                  P=0.170N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/51 (10%)               3/55 (5%)                2/53 (4%)                7/53 (13%)      | 
|POLY-3 RATE (b)    |                  5/31.43                  3/38.53                  2/40.53                  7/38.15         | 
|POLY-3 PERCENT (g) |                  15.9%                    7.8%                     4.9%                     18.4%           | 
|TERMINAL (d)       |                  4/15 (27%)               3/25 (12%)               1/26 (4%)                6/22 (27%)      | 
|FIRST INCIDENCE    |                  705                      727 (T)                  300                      405             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.355                  P=0.120N                 P=0.072N                 P=0.612N        | 
|POLY 3             |                  P=0.297                  P=0.247N                 P=0.124N                 P=0.520         | 
|POLY 1.5           |                  P=0.291                  P=0.280N                 P=0.151N                 P=0.484         | 
|POLY 6             |                  P=0.289                  P=0.201N                 P=0.097N                 P=0.558         | 
|LOGISTIC REGRESSION|                  P=0.307                  P=0.109N                 P=0.145N                 P=0.546         | 
|COCH-ARM / FISHERS |                  P=0.254                  P=0.316N                 P=0.203N                 P=0.408         | 
|ORDER RESTRICTED   |                  P=0.186                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/51 (0%)                0/55 (0%)                1/53 (2%)                4/53 (8%)       | 
|POLY-3 RATE (b)    |                  0/31.35                  0/38.53                  1/39.60                  4/39.05         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     2.5%                     10.2%           | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                1/26 (4%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      727 (T)                  595             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.007 **               (e)                      P=0.610                  P=0.092         | 
|POLY 3             |                  P=0.006 **               (e)                      P=0.546                  P=0.092         | 
|POLY 1.5           |                  P=0.006 **               (e)                      P=0.531                  P=0.082         | 
|POLY 6             |                  P=0.007 **               (e)                      P=0.565                  P=0.106         | 
|LOGISTIC REGRESSION|                  P=0.005 **               (e)                      P=0.610                  P=0.065         | 
|COCH-ARM / FISHERS |                  P=0.005 **               (e)                      P=0.510                  P=0.064         | 
|ORDER RESTRICTED   |                  P=0.013 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Artery                                                                                                                 | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/51 (0%)                4/55 (7%)                2/53 (4%)                4/53 (8%)       | 
|POLY-3 RATE (b)    |                  0/31.35                  4/39.52                  2/39.60                  4/38.50         | 
|POLY-3 PERCENT (g) |                  0.0%                     10.1%                    5.1%                     10.4%           | 
|TERMINAL (d)       |                  0/15 (0%)                2/25 (8%)                2/26 (8%)                2/22 (9%)       | 
|FIRST INCIDENCE    |                  ---                      253                      727 (T)                  448             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.196                  P=0.132                  P=0.365                  P=0.106         | 
|POLY 3             |                  P=0.207                  P=0.094                  P=0.292                  P=0.089         | 
|POLY 1.5           |                  P=0.187                  P=0.082                  P=0.273                  P=0.081         | 
|POLY 6             |                  P=0.228                  P=0.114                  P=0.316                  P=0.099         | 
|LOGISTIC REGRESSION|                  P=0.160                  P=0.074                  P=0.365                  P=0.073         | 
|COCH-ARM / FISHERS |                  P=0.148                  P=0.069                  P=0.257                  P=0.064         | 
|ORDER RESTRICTED   |                  P=0.072                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Parathyroid Gland                                                                                                                | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/47 (0%)                1/50 (2%)                1/48 (2%)                2/46 (4%)       | 
|POLY-3 RATE (b)    |                  0/27.62                  1/35.62                  1/37.40                  2/34.68         | 
|POLY-3 PERCENT (g) |                  0.0%                     2.8%                     2.7%                     5.8%            | 
|TERMINAL (d)       |                  0/13 (0%)                1/24 (4%)                0/24 (0%)                0/21 (0%)       | 
|FIRST INCIDENCE    |                  ---                      727 (T)                  376                      559             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.183                  P=0.622                  P=0.521                  P=0.283         | 
|POLY 3             |                  P=0.193                  P=0.550                  P=0.559                  P=0.291         | 
|POLY 1.5           |                  P=0.178                  P=0.535                  P=0.541                  P=0.271         | 
|POLY 6             |                  P=0.207                  P=0.571                  P=0.580                  P=0.313         | 
|LOGISTIC REGRESSION|                  P=0.117                  P=0.622                  P=0.376                  P=0.217         | 
|COCH-ARM / FISHERS |                  P=0.142                  P=0.515                  P=0.505                  P=0.242         | 
|ORDER RESTRICTED   |                  P=0.160                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  14/51 (27%)              15/54 (28%)              22/53 (42%)              12/53 (23%)     | 
|POLY-3 RATE (b)    |                  14/33.32                 15/40.05                 22/44.01                 12/38.05        | 
|POLY-3 PERCENT (g) |                  42.0%                    37.5%                    50.0%                    31.5%           | 
|TERMINAL (d)       |                  7/15 (47%)               7/25 (28%)               13/26 (50%)              10/22 (46%)     | 
|FIRST INCIDENCE    |                  546                      434                      328                      487             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.238N                 P=0.194N                 P=0.572                  P=0.108N        | 
|POLY 3             |                  P=0.337N                 P=0.436N                 P=0.317                  P=0.243N        | 
|POLY 1.5           |                  P=0.331N                 P=0.507N                 P=0.223                  P=0.262N        | 
|POLY 6             |                  P=0.410N                 P=0.337N                 P=0.433                  P=0.252N        | 
|LOGISTIC REGRESSION|                  P=0.295N                 P=0.422N                 P=0.225                  P=0.176N        | 
|COCH-ARM / FISHERS |                  P=0.457N                 P=0.572                  P=0.097                  P=0.367N        | 
|ORDER RESTRICTED   |                  P=0.247N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/51 (0%)                3/54 (6%)                1/53 (2%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  0/30.88                  3/38.75                  1/39.60                  1/37.76         | 
|POLY-3 PERCENT (g) |                  0.0%                     7.7%                     2.5%                     2.7%            | 
|TERMINAL (d)       |                  0/15 (0%)                1/25 (4%)                1/26 (4%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  ---                      448                      727 (T)                  600             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.497N                 P=0.187                  P=0.610                  P=0.531         | 
|POLY 3             |                  P=0.469N                 P=0.163                  P=0.549                  P=0.540         | 
|POLY 1.5           |                  P=0.494N                 P=0.148                  P=0.535                  P=0.531         | 
|POLY 6             |                  P=0.446N                 P=0.189                  P=0.566                  P=0.549         | 
|LOGISTIC REGRESSION|                  P=0.536N                 P=0.134                  P=0.610                  P=0.508         | 
|COCH-ARM / FISHERS |                  P=0.550N                 P=0.132                  P=0.510                  P=0.510         | 
|ORDER RESTRICTED   |                  P=0.276                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  18/51 (35%)              20/54 (37%)              23/53 (43%)              17/53 (32%)     | 
|POLY-3 RATE (b)    |                  18/36.64                 20/40.01                 23/42.91                 17/41.61        | 
|POLY-3 PERCENT (g) |                  49.1%                    50.0%                    53.6%                    40.9%           | 
|TERMINAL (d)       |                  4/15 (27%)               13/25 (52%)              15/26 (58%)              8/22 (36%)      | 
|FIRST INCIDENCE    |                  400                      546                      498                      436             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.222N                 P=0.215N                 P=0.328N                 P=0.208N        | 
|POLY 3             |                  P=0.254N                 P=0.562                  P=0.429                  P=0.301N        | 
|POLY 1.5           |                  P=0.273N                 P=0.545                  P=0.382                  P=0.317N        | 
|POLY 6             |                  P=0.279N                 P=0.593                  P=0.465                  P=0.318N        | 
|LOGISTIC REGRESSION|                  P=0.270N                 P=0.501N                 P=0.475                  P=0.326N        | 
|COCH-ARM / FISHERS |                  P=0.438N                 P=0.507                  P=0.260                  P=0.444N        | 
|ORDER RESTRICTED   |                  P=0.286N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  39/52 (75%)              43/55 (78%)              46/52 (88%)              45/53 (85%)     | 
|POLY-3 RATE (b)    |                  39/47.51                 43/47.53                 46/48.28                 45/49.58        | 
|POLY-3 PERCENT (g) |                  82.1%                    90.5%                    95.3%                    90.8%           | 
|TERMINAL (d)       |                  8/15 (53%)               23/25 (92%)              24/25 (96%)              21/22 (96%)     | 
|FIRST INCIDENCE    |                  126                      223                      188                      385             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.442N                 P=0.112N                 P=0.174N                 P=0.336N        | 
|POLY 3             |                  P=0.096                  P=0.170                  P=0.033 *                P=0.155         | 
|POLY 1.5           |                  P=0.093                  P=0.251                  P=0.039 *                P=0.168         | 
|POLY 6             |                  P=0.078                  P=0.114                  P=0.032 *                P=0.119         | 
|LOGISTIC REGRESSION|                  P=0.162                  P=0.522                  P=0.115                  P=0.202         | 
|COCH-ARM / FISHERS |                  P=0.068                  P=0.436                  P=0.063                  P=0.153         | 
|ORDER RESTRICTED   |                  P=0.035 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            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                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  49/52 (94%)              50/55 (91%)              51/52 (98%)              51/53 (96%)     | 
|POLY-3 RATE (b)    |                  49/49.42                 50/52.81                 51/51.32                 51/52.28        | 
|POLY-3 PERCENT (g) |                  99.2%                    94.7%                    99.4%                    97.6%           | 
|TERMINAL (d)       |                  15/15 (100%)             24/25 (96%)              25/25 (100%)             22/22 (100%)    | 
|FIRST INCIDENCE    |                  126                      202                      188                      124             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.208N                 P=0.030N*                P=0.026N*                P=0.114N        | 
|POLY 3             |                  P=0.518                  P=0.209N                 P=0.972                  P=0.575N        | 
|POLY 1.5           |                  P=0.449                  P=0.266N                 P=0.743                  P=0.634N        | 
|POLY 6             |                  P=0.489                  P=0.189N                 P=1.000                  P=0.678N        | 
|LOGISTIC REGRESSION|                  P=0.295                  P=0.320N                 P=0.493                  P=0.672         | 
|COCH-ARM / FISHERS |                  P=0.180                  P=0.390N                 P=0.309                  P=0.491         | 
|ORDER RESTRICTED   |                  P=0.355N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                5/55 (9%)                3/52 (6%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  0/31.36                  5/42.56                  3/40.37                  2/38.51         | 
|POLY-3 PERCENT (g) |                  0.0%                     11.8%                    7.4%                     5.2%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                1/25 (4%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  ---                      202                      328                      500             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.560                  P=0.049 *                P=0.167                  P=0.272         | 
|POLY 3             |                  P=0.527N                 P=0.065                  P=0.170                  P=0.285         | 
|POLY 1.5           |                  P=0.562N                 P=0.052                  P=0.150                  P=0.271         | 
|POLY 6             |                  P=0.500N                 P=0.088                  P=0.195                  P=0.300         | 
|LOGISTIC REGRESSION|                  P=0.291                  P=0.022 *                P=0.070                  P=0.202         | 
|COCH-ARM / FISHERS |                  P=0.496                  P=0.033 *                P=0.121                  P=0.252         | 
|ORDER RESTRICTED   |                  P=0.146                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 44      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Red Pulp                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                0/55 (0%)                4/52 (8%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  0/31.36                  0/38.53                  4/40.50                  1/38.00         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     9.9%                     2.6%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                1/25 (4%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      328                      500             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.174                  (e)                      P=0.113                  P=0.524         | 
|POLY 3             |                  P=0.180                  (e)                      P=0.099                  P=0.538         | 
|POLY 1.5           |                  P=0.174                  (e)                      P=0.083                  P=0.528         | 
|POLY 6             |                  P=0.178                  (e)                      P=0.122                  P=0.549         | 
|LOGISTIC REGRESSION|                  P=0.109                  (e)                      P=0.042 *                P=0.453         | 
|COCH-ARM / FISHERS |                  P=0.146                  (e)                      P=0.059                  P=0.505         | 
|ORDER RESTRICTED   |                  P=0.119                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Hyperkeratosis                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                3/55 (5%)                1/53 (2%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  0/31.36                  3/38.71                  1/39.75                  1/37.58         | 
|POLY-3 PERCENT (g) |                  0.0%                     7.8%                     2.5%                     2.7%            | 
|TERMINAL (d)       |                  0/15 (0%)                2/25 (8%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  ---                      681                      688                      658             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.499N                 P=0.226                  P=0.595                  P=0.568         | 
|POLY 3             |                  P=0.477N                 P=0.159                  P=0.547                  P=0.536         | 
|POLY 1.5           |                  P=0.503N                 P=0.145                  P=0.531                  P=0.527         | 
|POLY 6             |                  P=0.450N                 P=0.184                  P=0.566                  P=0.546         | 
|LOGISTIC REGRESSION|                  P=0.514N                 P=0.193                  P=0.557                  P=0.530         | 
|COCH-ARM / FISHERS |                  P=0.558N                 P=0.132                  P=0.505                  P=0.505         | 
|ORDER RESTRICTED   |                  P=0.273                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 45      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/52 (6%)                4/55 (7%)                6/53 (11%)               2/53 (4%)       | 
|POLY-3 RATE (b)    |                  3/32.29                  4/38.74                  6/41.70                  2/38.13         | 
|POLY-3 PERCENT (g) |                  9.3%                     10.3%                    14.4%                    5.3%            | 
|TERMINAL (d)       |                  1/15 (7%)                2/25 (8%)                2/26 (8%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  391                      681                      328                      559             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.348N                 P=0.567N                 P=0.446                  P=0.377N        | 
|POLY 3             |                  P=0.357N                 P=0.600                  P=0.381                  P=0.424N        | 
|POLY 1.5           |                  P=0.376N                 P=0.567                  P=0.331                  P=0.444N        | 
|POLY 6             |                  P=0.350N                 P=0.649                  P=0.446                  P=0.403N        | 
|LOGISTIC REGRESSION|                  P=0.417N                 P=0.605                  P=0.246                  P=0.483N        | 
|COCH-ARM / FISHERS |                  P=0.445N                 P=0.532                  P=0.254                  P=0.491N        | 
|ORDER RESTRICTED   |                  P=0.315N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                1/55 (2%)                2/53 (4%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  0/31.36                  1/38.56                  2/40.19                  1/37.58         | 
|POLY-3 PERCENT (g) |                  0.0%                     2.6%                     5.0%                     2.7%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  ---                      720                      602                      658             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.361                  P=0.624                  P=0.328                  P=0.568         | 
|POLY 3             |                  P=0.375                  P=0.541                  P=0.296                  P=0.536         | 
|POLY 1.5           |                  P=0.363                  P=0.528                  P=0.275                  P=0.527         | 
|POLY 6             |                  P=0.385                  P=0.561                  P=0.324                  P=0.546         | 
|LOGISTIC REGRESSION|                  P=0.345                  P=0.596                  P=0.263                  P=0.530         | 
|COCH-ARM / FISHERS |                  P=0.319                  P=0.514                  P=0.252                  P=0.505         | 
|ORDER RESTRICTED   |                  P=0.276                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 46      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/52 (6%)                1/55 (2%)                0/53 (0%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  3/32.17                  1/38.56                  0/39.60                  1/37.58         | 
|POLY-3 PERCENT (g) |                  9.3%                     2.6%                     0.0%                     2.7%            | 
|TERMINAL (d)       |                  1/15 (7%)                0/25 (0%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  574                      720                      ---                      658             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.135N                 P=0.180N                 P=0.066N                 P=0.217N        | 
|POLY 3             |                  P=0.170N                 P=0.242N                 P=0.085N                 P=0.250N        | 
|POLY 1.5           |                  P=0.169N                 P=0.260N                 P=0.095N                 P=0.262N        | 
|POLY 6             |                  P=0.176N                 P=0.216N                 P=0.075N                 P=0.240N        | 
|LOGISTIC REGRESSION|                  P=0.153N                 P=0.239N                 P=0.094N                 P=0.258N        | 
|COCH-ARM / FISHERS |                  P=0.176N                 P=0.288N                 P=0.118N                 P=0.302N        | 
|ORDER RESTRICTED   |                  P=0.052N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  37/50 (74%)              34/52 (65%)              41/46 (89%)              45/48 (94%)     | 
|POLY-3 RATE (b)    |                  37/45.02                 34/44.40                 41/43.90                 45/45.61        | 
|POLY-3 PERCENT (g) |                  82.2%                    76.6%                    93.4%                    98.7%           | 
|TERMINAL (d)       |                  9/15 (60%)               15/22 (68%)              19/21 (91%)              19/19 (100%)    | 
|FIRST INCIDENCE    |                  126                      202                      300                      385             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.230                  P=0.052N                 P=0.203N                 P=0.543N        | 
|POLY 3             |                  P<0.001 **               P=0.340N                 P=0.088                  P=0.005 **      | 
|POLY 1.5           |                  P<0.001 **               P=0.297N                 P=0.063                  P=0.005 **      | 
|POLY 6             |                  P<0.001 **               P=0.376N                 P=0.117                  P=0.006 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.196N                 P=0.081                  P=0.018 *       | 
|COCH-ARM / FISHERS |                  P<0.001 **               P=0.233N                 P=0.050                  P=0.008 **      | 
|ORDER RESTRICTED   |                  P<0.001 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 47      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland                                                                                                                    | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                1/55 (2%)                4/52 (8%)                0/51 (0%)       | 
|POLY-3 RATE (b)    |                  0/31.37                  1/38.53                  4/39.64                  0/36.51         | 
|POLY-3 PERCENT (g) |                  0.0%                     2.6%                     10.1%                    0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                1/25 (4%)                3/26 (12%)               0/22 (0%)       | 
|FIRST INCIDENCE    |                  ---                      727 (T)                  709                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.543                  P=0.602                  P=0.154                  (e)             | 
|POLY 3             |                  P=0.535                  P=0.541                  P=0.095                  (e)             | 
|POLY 1.5           |                  P=0.517                  P=0.527                  P=0.081                  (e)             | 
|POLY 6             |                  P=0.542                  P=0.561                  P=0.114                  (e)             | 
|LOGISTIC REGRESSION|                  P=0.524                  P=0.602                  P=0.137                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.455                  P=0.514                  P=0.059                  (e)             | 
|ORDER RESTRICTED   |                  P=0.194                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  12/52 (23%)              21/55 (38%)              17/52 (33%)              19/51 (37%)     | 
|POLY-3 RATE (b)    |                  12/33.93                 21/40.89                 17/42.41                 19/40.46        | 
|POLY-3 PERCENT (g) |                  35.4%                    51.4%                    40.1%                    47.0%           | 
|TERMINAL (d)       |                  5/15 (33%)               14/25 (56%)              10/26 (39%)              11/22 (50%)     | 
|FIRST INCIDENCE    |                  541                      356                      428                      436             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.478                  P=0.427                  P=0.463N                 P=0.384         | 
|POLY 3             |                  P=0.401                  P=0.115                  P=0.426                  P=0.212         | 
|POLY 1.5           |                  P=0.328                  P=0.088                  P=0.334                  P=0.165         | 
|POLY 6             |                  P=0.451                  P=0.169                  P=0.532                  P=0.260         | 
|LOGISTIC REGRESSION|                  P=0.315                  P=0.152                  P=0.399                  P=0.180         | 
|COCH-ARM / FISHERS |                  P=0.171                  P=0.069                  P=0.191                  P=0.088         | 
|ORDER RESTRICTED   |                  P=0.250                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 48      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  9/52 (17%)               13/55 (24%)              13/52 (25%)              17/51 (33%)     | 
|POLY-3 RATE (b)    |                  9/37.19                  13/42.20                 13/42.54                 17/40.34        | 
|POLY-3 PERCENT (g) |                  24.2%                    30.8%                    30.6%                    42.2%           | 
|TERMINAL (d)       |                  2/15 (13%)               5/25 (20%)               6/26 (23%)               9/22 (41%)      | 
|FIRST INCIDENCE    |                  201                      448                      498                      405             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.159                  P=0.517                  P=0.549                  P=0.210         | 
|POLY 3             |                  P=0.065                  P=0.341                  P=0.350                  P=0.069         | 
|POLY 1.5           |                  P=0.057                  P=0.292                  P=0.294                  P=0.059         | 
|POLY 6             |                  P=0.072                  P=0.444                  P=0.445                  P=0.091         | 
|LOGISTIC REGRESSION|                  P=0.040 *                P=0.246                  P=0.135                  P=0.030 *       | 
|COCH-ARM / FISHERS |                  P=0.043 *                P=0.285                  P=0.236                  P=0.050         | 
|ORDER RESTRICTED   |                  P=0.067                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth: Peridontal Tissue                                                                                                         | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  10/12 (83%)              12/12 (100%)             10/10 (100%)             9/9 (100%)      | 
|POLY-3 RATE (b)    |                  10/12.00                 12/12.00                 10/10.00                 9/9.00          | 
|POLY-3 PERCENT (g) |                  83.3%                    100.0%                   100.0%                   100.0%          | 
|TERMINAL (d)       |                  5/7 (71%)                9/9 (100%)               5/5 (100%)               4/4 (100%)      | 
|FIRST INCIDENCE    |                  405                      253                      300                      436             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.361                  P=0.515N                 P=0.610                  P=0.574         | 
|POLY 3             |                  P=0.133                  P=0.229                  P=0.272                  P=0.297         | 
|POLY 1.5           |                  P=0.133                  P=0.229                  P=0.272                  P=0.297         | 
|POLY 6             |                  P=0.133                  P=0.229                  P=0.272                  P=0.297         | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.138                  P=0.239                  P=0.286                  P=0.314         | 
|ORDER RESTRICTED   |                  P=0.054                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 49      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth: Peridontal Tissue                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/12 (17%)               0/12 (0%)                0/10 (0%)                0/9 (0%)        | 
|POLY-3 RATE (b)    |                  2/9.81                   0/10.52                  0/7.71                   0/6.56          | 
|POLY-3 PERCENT (g) |                  20.4%                    0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/7 (29%)                0/9 (0%)                 0/5 (0%)                 0/4 (0%)        | 
|FIRST INCIDENCE    |                  727 (T)                  ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.173N                 P=0.178N                 P=0.308N                 P=0.362N        | 
|POLY 3             |                  P=0.147N                 P=0.210N                 P=0.283N                 P=0.324N        | 
|POLY 1.5           |                  P=0.138N                 P=0.221N                 P=0.284N                 P=0.310N        | 
|POLY 6             |                  P=0.162N                 P=0.196N                 P=0.277N                 P=0.346N        | 
|LOGISTIC REGRESSION|                  P=0.173N                 (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.138N                 P=0.239N                 P=0.286N                 P=0.314N        | 
|ORDER RESTRICTED   |                  P=0.072N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/51 (8%)                6/54 (11%)               10/53 (19%)              6/52 (12%)      | 
|POLY-3 RATE (b)    |                  4/32.86                  6/41.99                  10/43.51                 6/38.88         | 
|POLY-3 PERCENT (g) |                  12.2%                    14.3%                    23.0%                    15.4%           | 
|TERMINAL (d)       |                  0/15 (0%)                1/25 (4%)                5/26 (19%)               1/22 (5%)       | 
|FIRST INCIDENCE    |                  391                      350                      188                      448             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.375                  P=0.496                  P=0.216                  P=0.526         | 
|POLY 3             |                  P=0.331                  P=0.530                  P=0.183                  P=0.478         | 
|POLY 1.5           |                  P=0.321                  P=0.479                  P=0.146                  P=0.451         | 
|POLY 6             |                  P=0.330                  P=0.592                  P=0.227                  P=0.507         | 
|LOGISTIC REGRESSION|                  P=0.182                  P=0.356                  P=0.052                  P=0.374         | 
|COCH-ARM / FISHERS |                  P=0.257                  P=0.408                  P=0.086                  P=0.383         | 
|ORDER RESTRICTED   |                  P=0.343                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 50      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder: Transitional Epithelium                                                                                         | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/51 (2%)                1/54 (2%)                1/53 (2%)                2/52 (4%)       | 
|POLY-3 RATE (b)    |                  1/31.35                  1/38.94                  1/40.46                  2/37.45         | 
|POLY-3 PERCENT (g) |                  3.2%                     2.6%                     2.5%                     5.3%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  574                      524                      376                      658             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.396                  P=0.730N                 P=0.727N                 P=0.598         | 
|POLY 3             |                  P=0.376                  P=0.711N                 P=0.701N                 P=0.562         | 
|POLY 1.5           |                  P=0.371                  P=0.728N                 P=0.720N                 P=0.546         | 
|POLY 6             |                  P=0.376                  P=0.687N                 P=0.680N                 P=0.577         | 
|LOGISTIC REGRESSION|                  P=0.300                  P=0.761N                 P=0.709                  P=0.531         | 
|COCH-ARM / FISHERS |                  P=0.340                  P=0.738N                 P=0.743N                 P=0.507         | 
|ORDER RESTRICTED   |                  P=0.448                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  12/52 (23%)              12/55 (22%)              11/53 (21%)              16/52 (31%)     | 
|POLY-3 RATE (b)    |                  12/35.65                 12/42.38                 11/42.96                 16/40.30        | 
|POLY-3 PERCENT (g) |                  33.7%                    28.3%                    25.6%                    39.7%           | 
|TERMINAL (d)       |                  2/15 (13%)               4/25 (16%)               4/26 (15%)               9/22 (41%)      | 
|FIRST INCIDENCE    |                  391                      328                      188                      448             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.386                  P=0.257N                 P=0.194N                 P=0.558         | 
|POLY 3             |                  P=0.264                  P=0.395N                 P=0.296N                 P=0.377         | 
|POLY 1.5           |                  P=0.256                  P=0.445N                 P=0.350N                 P=0.348         | 
|POLY 6             |                  P=0.258                  P=0.341N                 P=0.244N                 P=0.391         | 
|LOGISTIC REGRESSION|                  P=0.220                  P=0.507N                 P=0.452N                 P=0.351         | 
|COCH-ARM / FISHERS |                  P=0.194                  P=0.530N                 P=0.479N                 P=0.254         | 
|ORDER RESTRICTED   |                  P=0.254                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 51      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                0/55 (0%)                0/53 (0%)                2/52 (4%)       | 
|POLY-3 RATE (b)    |                  0/31.36                  0/38.53                  0/39.60                  2/36.94         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     5.4%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                0/26 (0%)                2/22 (9%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.051                  (e)                      (e)                      P=0.325         | 
|POLY 3             |                  P=0.048 *                (e)                      (e)                      P=0.274         | 
|POLY 1.5           |                  P=0.047 *                (e)                      (e)                      P=0.263         | 
|POLY 6             |                  P=0.048 *                (e)                      (e)                      P=0.286         | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      (e)                      P=0.325         | 
|COCH-ARM / FISHERS |                  P=0.044 *                (e)                      (e)                      P=0.248         | 
|ORDER RESTRICTED   |                  P=0.045 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  26/52 (50%)              33/55 (60%)              25/53 (47%)              28/52 (54%)     | 
|POLY-3 RATE (b)    |                  26/41.07                 33/47.72                 25/45.60                 28/45.56        | 
|POLY-3 PERCENT (g) |                  63.3%                    69.2%                    54.8%                    61.5%           | 
|TERMINAL (d)       |                  7/15 (47%)               16/25 (64%)              11/26 (42%)              12/22 (55%)     | 
|FIRST INCIDENCE    |                  321                      253                      188                      385             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.170N                 P=0.391N                 P=0.073N                 P=0.291N        | 
|POLY 3             |                  P=0.263N                 P=0.356                  P=0.275N                 P=0.518N        | 
|POLY 1.5           |                  P=0.291N                 P=0.306                  P=0.313N                 P=0.557N        | 
|POLY 6             |                  P=0.263N                 P=0.379                  P=0.246N                 P=0.523N        | 
|LOGISTIC REGRESSION|                  P=0.394N                 P=0.240                  P=0.362N                 P=0.494         | 
|COCH-ARM / FISHERS |                  P=0.458N                 P=0.199                  P=0.462N                 P=0.422         | 
|ORDER RESTRICTED   |                  P=0.330N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 52      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                0/55 (0%)                2/53 (4%)                0/52 (0%)       | 
|POLY-3 RATE (b)    |                  0/31.36                  0/38.53                  2/39.98                  0/36.94         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     5.0%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                1/26 (4%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      621                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.494                  (e)                      P=0.351                  (e)             | 
|POLY 3             |                  P=0.497                  (e)                      P=0.294                  (e)             | 
|POLY 1.5           |                  P=0.492                  (e)                      P=0.274                  (e)             | 
|POLY 6             |                  P=0.493                  (e)                      P=0.321                  (e)             | 
|LOGISTIC REGRESSION|                  P=0.478                  (e)                      P=0.285                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.453                  (e)                      P=0.252                  (e)             | 
|ORDER RESTRICTED   |                  P=0.296                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  23/52 (44%)              33/55 (60%)              28/53 (53%)              24/52 (46%)     | 
|POLY-3 RATE (b)    |                  23/35.31                 33/43.07                 28/43.94                 24/42.67        | 
|POLY-3 PERCENT (g) |                  65.1%                    76.6%                    63.7%                    56.3%           | 
|TERMINAL (d)       |                  12/15 (80%)              22/25 (88%)              16/26 (62%)              11/22 (50%)     | 
|FIRST INCIDENCE    |                  496                      350                      188                      385             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.090N                 P=0.438N                 P=0.161N                 P=0.194N        | 
|POLY 3             |                  P=0.053N                 P=0.165                  P=0.545N                 P=0.273N        | 
|POLY 1.5           |                  P=0.109N                 P=0.107                  P=0.497                  P=0.391N        | 
|POLY 6             |                  P=0.029N*                P=0.288                  P=0.371N                 P=0.181N        | 
|LOGISTIC REGRESSION|                  P=0.144N                 P=0.187                  P=0.556N                 P=0.389N        | 
|COCH-ARM / FISHERS |                  P=0.380N                 P=0.075                  P=0.246                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.107N                 (e)                      (e)                      (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).                                                    
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.