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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: 12:20:03       
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 6, 7, & 8                                             
                                                                                                                                    
                                                                                                                                    
               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 006    300     NG/KG                                                                 
                                       INCLUDE 007    550     NG/KG                                                                 
                                       INCLUDE 008    1000    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: 12:20:03       
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                                                                                  
                                       Atrophy                                                                                      
                                       Hypertrophy                                                                                  
                                       Vacuolization Cytoplasmic                                                                    
Adrenal Medulla                        Hyperplasia                                                                                  
Blood Vessel: Aorta                    Mineralization                                                                               
Bone Marrow                            Hyperplasia                                                                                  
Clitoral Gland                         Inflammation                                                                                 
Clitoral Gland: Duct                   Cyst                                                                                         
Eye: Cornea                            Inflammation                                                                                 
Eye: Retina                            Atrophy                                                                                      
Harderian Gland                        Inflammation                                                                                 
Heart                                  Cardiomyopathy                                                                               
Heart: Epicardium                      Inflammation                                                                                 
Kidney                                 Casts Protein                                                                                
                                       Mineralization                                                                               
                                       Nephropathy                                                                                  
Kidney: Transitional Epithelium        Hyperplasia                                                                                  
Liver                                  Cholangiofibrosis                                                                            
                                       Clear Cell Focus                                                                             
                                       Degeneration Cystic                                                                          
                                       Eosinophilic Focus                                                                           
                                       Fatty Change Diffuse                                                                         
                                       Hepatocyte, Multinucleate                                                                    
                                       Hyperplasia                                                                                  
                                       Inflammation                                                                                 
                                       Mixed Cell Focus                                                                             
                                       Necrosis                                                                                     
                                       Pigmentation                                                                                 
                                       Toxic Hepatopathy                                                                            
Liver: Bile Duct                       Cyst                                                                                         
                                       Hyperplasia                                                                                  
Liver: Hepatocyte                      Degeneration                                                                                 
                                       Hypertrophy                                                                                  
Liver: Oval Cell                       Hyperplasia                                                                                  
Liver: Portal                          Fibrosis                                                                                     
Lung                                   Infiltration Cellular Histiocyte                                                             
                                       Inflammation Chronic                                                                         
                                       Inflammation Granulomatous                                                                   
                                       Metaplasia                                                                                   
Lung: Alveolar Epithelium              Hyperplasia                                                                                  
                                       Metaplasia Bronchiolar                                                                       
Lymph Node, Mandibular                 Hyperplasia                                                                                  
Lymph Node, Mesenteric                 Hyperplasia Lymphoid                                                                         
Lymph Node: Mediastinal                Ectasia                                                                                      
                                       Hemorrhage                                                                                   
Mammary Gland                          Cyst                                                                                         
                                       Hyperplasia                                                                                  
                                                                                                                                   
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: 12:20:03       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007D       
PATHOLOGIST: MISSING                                                                                           CAS: 57465-28-8      
                                       Inflammation Granulomatous                                                                   
Mesentery                              Inflammation Chronic                                                                         
Mesentery: Artery                      Inflammation Chronic                                                                         
Oral Mucosa: Gingival                  Hyperplasia                                                                                  
Ovary                                  Atrophy                                                                                      
Pancreas                               Inflammation Chronic                                                                         
Pancreas: Acinus                       Atrophy                                                                                      
                                       Vacuolization Cytoplasmic                                                                    
Pancreas: Artery                       Inflammation Chronic                                                                         
Pancreas: Duct                         Dilatation                                                                                   
Spleen                                 Hyperplasia Lymphoid                                                                         
                                       Pigmentation                                                                                 
Spleen: Lymphoid Follicle              Atrophy                                                                                      
Stomach, Forestomach                   Hyperplasia                                                                                  
Thymus                                 Atrophy                                                                                      
Thyroid Gland: C-Cell                  Hyperplasia                                                                                  
Thyroid Gland: Follicular Cell         Hypertrophy                                                                                  
Tooth: Peridontal Tissue               Inflammation                                                                                 
                                       Inflammation Chronic                                                                         
Ureter                                 Metaplasia                                                                                   
Uterus                                 Inflammation                                                                                 
                                       Metaplasia                                                                                   
Uterus: Endometrium                    Hyperplasia Cystic                                                                           
===============================================================                                                                     
                                                                                                                                   
       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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  11/52 (21%)              20/53 (38%)              8/52 (15%)               1/53 (2%)       | 
|POLY-3 RATE (b)    |                  11/34.50                 20/39.31                 8/42.81                  1/32.22         | 
|POLY-3 PERCENT (g) |                  31.9%                    50.9%                    18.7%                    3.1%            | 
|TERMINAL (d)       |                  4/15 (27%)               12/16 (75%)              6/23 (26%)               0/7 (0%)        | 
|FIRST INCIDENCE    |                  541                      301                      440                      642             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001N**               P=0.106                  P=0.078N                 P=0.010N*       | 
|POLY 3             |                  P<0.001N**               P=0.069                  P=0.140N                 P=0.002N**      | 
|POLY 1.5           |                  P<0.001N**               P=0.063                  P=0.183N                 P=0.002N**      | 
|POLY 6             |                  P<0.001N**               P=0.061                  P=0.109N                 P=0.004N**      | 
|LOGISTIC REGRESSION|                  P<0.001N**               P=0.095                  P=0.179N                 P=0.002N**      | 
|COCH-ARM / FISHERS |                  P<0.001N**               P=0.049 *                P=0.306N                 P=0.002N**      | 
|ORDER RESTRICTED   |                  P<0.001N**               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/52 (2%)                5/53 (9%)                19/52 (37%)              30/53 (57%)     | 
|POLY-3 RATE (b)    |                  1/31.36                  5/37.66                  19/43.48                 30/39.85        | 
|POLY-3 PERCENT (g) |                  3.2%                     13.3%                    43.7%                    75.3%           | 
|TERMINAL (d)       |                  1/15 (7%)                2/16 (13%)               9/23 (39%)               6/7 (86%)       | 
|FIRST INCIDENCE    |                  727 (T)                  607                      554                      243             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.150                  P<0.001 **               P<0.001 **      | 
|POLY 3             |                  P<0.001 **               P=0.146                  P<0.001 **               P<0.001 **      | 
|POLY 1.5           |                  P<0.001 **               P=0.129                  P<0.001 **               P<0.001 **      | 
|POLY 6             |                  P<0.001 **               P=0.167                  P<0.001 **               P<0.001 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.143                  P<0.001 **               P<0.001 **      | 
|COCH-ARM / FISHERS |                  P<0.001 **               P=0.107                  P<0.001 **               P<0.001 **      | 
|ORDER RESTRICTED   |                  P<0.001 **               (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  11/52 (21%)              14/53 (26%)              16/52 (31%)              10/53 (19%)     | 
|POLY-3 RATE (b)    |                  11/34.41                 14/40.61                 16/43.78                 10/35.87        | 
|POLY-3 PERCENT (g) |                  32.0%                    34.5%                    36.5%                    27.9%           | 
|TERMINAL (d)       |                  4/15 (27%)               0/16 (0%)                8/23 (35%)               0/7 (0%)        | 
|FIRST INCIDENCE    |                  496                      531                      535                      309             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.447                  P=0.548                  P=0.528N                 P=0.515         | 
|POLY 3             |                  P=0.396N                 P=0.507                  P=0.427                  P=0.454N        | 
|POLY 1.5           |                  P=0.384N                 P=0.440                  P=0.336                  P=0.448N        | 
|POLY 6             |                  P=0.452N                 P=0.581                  P=0.525                  P=0.504N        | 
|LOGISTIC REGRESSION|                  P=0.404N                 P=0.428                  P=0.391                  P=0.471N        | 
|COCH-ARM / FISHERS |                  P=0.421N                 P=0.344                  P=0.186                  P=0.480N        | 
|ORDER RESTRICTED   |                  P=0.446N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  23/52 (44%)              25/53 (47%)              31/52 (60%)              24/53 (45%)     | 
|POLY-3 RATE (b)    |                  23/38.88                 25/41.73                 31/44.16                 24/39.04        | 
|POLY-3 PERCENT (g) |                  59.2%                    59.9%                    70.2%                    61.5%           | 
|TERMINAL (d)       |                  7/15 (47%)               10/16 (63%)              18/23 (78%)              4/7 (57%)       | 
|FIRST INCIDENCE    |                  309                      331                      573                      394             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.103                  P=0.453N                 P=0.341N                 P=0.230         | 
|POLY 3             |                  P=0.370                  P=0.566                  P=0.191                  P=0.509         | 
|POLY 1.5           |                  P=0.411                  P=0.534                  P=0.155                  P=0.538         | 
|POLY 6             |                  P=0.279                  P=0.572                  P=0.219                  P=0.419         | 
|LOGISTIC REGRESSION|                  P=0.467                  P=0.565N                 P=0.363                  P=0.567         | 
|COCH-ARM / FISHERS |                  P=0.425                  P=0.458                  P=0.085                  P=0.535         | 
|ORDER RESTRICTED   |                  P=0.401                  (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  34/52 (65%)              40/53 (75%)              41/52 (79%)              41/53 (77%)     | 
|POLY-3 RATE (b)    |                  34/39.07                 40/45.32                 41/46.88                 41/44.54        | 
|POLY-3 PERCENT (g) |                  87.0%                    88.3%                    87.5%                    92.0%           | 
|TERMINAL (d)       |                  15/15 (100%)             14/16 (88%)              22/23 (96%)              7/7 (100%)      | 
|FIRST INCIDENCE    |                  391                      454                      185                      309             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.010 *                P=0.558                  P=0.095N                 P=0.013 *       | 
|POLY 3             |                  P=0.251                  P=0.575                  P=0.625                  P=0.299         | 
|POLY 1.5           |                  P=0.179                  P=0.341                  P=0.383                  P=0.188         | 
|POLY 6             |                  P=0.323                  P=0.470N                 P=0.465N                 P=0.534         | 
|LOGISTIC REGRESSION|                  P=0.158                  P=0.446                  P=0.538N                 P=0.176         | 
|COCH-ARM / FISHERS |                  P=0.106                  P=0.179                  P=0.095                  P=0.127         | 
|ORDER RESTRICTED   |                  P=0.315                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/52 (2%)                1/53 (2%)                1/52 (2%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  1/31.80                  1/36.92                  1/41.58                  2/32.55         | 
|POLY-3 PERCENT (g) |                  3.1%                     2.7%                     2.4%                     6.2%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  600                      642                      714                      574             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.311                  P=0.706N                 P=0.648N                 P=0.503         | 
|POLY 3             |                  P=0.354                  P=0.727N                 P=0.698N                 P=0.508         | 
|POLY 1.5           |                  P=0.359                  P=0.738N                 P=0.720N                 P=0.513         | 
|POLY 6             |                  P=0.341                  P=0.717N                 P=0.672N                 P=0.484         | 
|LOGISTIC REGRESSION|                  P=0.353                  P=0.750N                 P=0.731N                 P=0.509         | 
|COCH-ARM / FISHERS |                  P=0.354                  P=0.748N                 P=0.752N                 P=0.507         | 
|ORDER RESTRICTED   |                  P=0.381                  (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/52 (10%)               9/53 (17%)               4/52 (8%)                17/53 (32%)     | 
|POLY-3 RATE (b)    |                  5/32.65                  9/39.52                  4/42.52                  17/36.67        | 
|POLY-3 PERCENT (g) |                  15.3%                    22.8%                    9.4%                     46.4%           | 
|TERMINAL (d)       |                  3/15 (20%)               2/16 (13%)               1/23 (4%)                3/7 (43%)       | 
|FIRST INCIDENCE    |                  496                      163                      554                      525             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.295                  P=0.273N                 P<0.001 **      | 
|POLY 3             |                  P=0.003 **               P=0.308                  P=0.338N                 P=0.004 **      | 
|POLY 1.5           |                  P=0.003 **               P=0.268                  P=0.393N                 P=0.004 **      | 
|POLY 6             |                  P=0.002 **               P=0.358                  P=0.281N                 P=0.003 **      | 
|LOGISTIC REGRESSION|                  P=0.003 **               P=0.224                  P=0.422N                 P=0.004 **      | 
|COCH-ARM / FISHERS |                  P=0.003 **               P=0.206                  P=0.500N                 P=0.004 **      | 
|ORDER RESTRICTED   |                  P<0.001 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                2/53 (4%)                2/52 (4%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  0/31.36                  2/36.61                  2/41.53                  0/31.91         | 
|POLY-3 PERCENT (g) |                  0.0%                     5.5%                     4.8%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                2/16 (13%)               2/23 (9%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  ---                      727 (T)                  727 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.586                  P=0.250                  P=0.336                  (e)             | 
|POLY 3             |                  P=0.528N                 P=0.272                  P=0.304                  (e)             | 
|POLY 1.5           |                  P=0.525N                 P=0.260                  P=0.280                  (e)             | 
|POLY 6             |                  P=0.551N                 P=0.283                  P=0.333                  (e)             | 
|LOGISTIC REGRESSION|                  (e)                      P=0.250                  P=0.336                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.537N                 P=0.252                  P=0.248                  (e)             | 
|ORDER RESTRICTED   |                  P=0.322N                 (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  8/52 (15%)               12/53 (23%)              6/52 (12%)               1/53 (2%)       | 
|POLY-3 RATE (b)    |                  8/33.72                  12/37.67                 6/42.16                  1/32.28         | 
|POLY-3 PERCENT (g) |                  23.7%                    31.9%                    14.2%                    3.1%            | 
|TERMINAL (d)       |                  3/15 (20%)               5/16 (31%)               3/23 (13%)               0/7 (0%)        | 
|FIRST INCIDENCE    |                  496                      618                      573                      621             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.017N*                P=0.376                  P=0.143N                 P=0.040N*       | 
|POLY 3             |                  P=0.005N**               P=0.305                  P=0.224N                 P=0.015N*       | 
|POLY 1.5           |                  P=0.004N**               P=0.283                  P=0.273N                 P=0.014N*       | 
|POLY 6             |                  P=0.006N**               P=0.320                  P=0.180N                 P=0.023N*       | 
|LOGISTIC REGRESSION|                  P=0.004N**               P=0.362                  P=0.248N                 P=0.016N*       | 
|COCH-ARM / FISHERS |                  P=0.007N**               P=0.243                  P=0.387N                 P=0.014N*       | 
|ORDER RESTRICTED   |                  P=0.006N**               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Blood Vessel: Aorta                                                                                                              | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/53 (6%)                0/53 (0%)                2/53 (4%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  3/32.76                  0/36.61                  2/42.83                  0/31.91         | 
|POLY-3 PERCENT (g) |                  9.2%                     0.0%                     4.7%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  583                      ---                      573                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.088N                 P=0.088N                 P=0.329N                 P=0.100N        | 
|POLY 3             |                  P=0.117N                 P=0.098N                 P=0.380N                 P=0.121N        | 
|POLY 1.5           |                  P=0.113N                 P=0.104N                 P=0.418N                 P=0.116N        | 
|POLY 6             |                  P=0.124N                 P=0.095N                 P=0.345N                 P=0.142N        | 
|LOGISTIC REGRESSION|                  P=0.111N                 P=0.118N                 P=0.512N                 P=0.119N        | 
|COCH-ARM / FISHERS |                  P=0.111N                 P=0.121N                 P=0.500N                 P=0.121N        | 
|ORDER RESTRICTED   |                  P=0.038N*                (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone                                                                                                                             | 
|     Osteopetrosis                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                2/53 (4%)                0/53 (0%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  0/31.38                  2/38.22                  0/42.13                  0/31.91         | 
|POLY-3 PERCENT (g) |                  0.0%                     5.2%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  ---                      40                       ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.414N                 P=0.258                  (e)                      (e)             | 
|POLY 3             |                  P=0.362N                 P=0.283                  (e)                      (e)             | 
|POLY 1.5           |                  P=0.381N                 P=0.267                  (e)                      (e)             | 
|POLY 6             |                  P=0.340N                 P=0.299                  (e)                      (e)             | 
|LOGISTIC REGRESSION|                  P=0.476N                 P=0.182                  (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.423N                 P=0.248                  (e)                      (e)             | 
|ORDER RESTRICTED   |                  P=0.283N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  47/53 (89%)              45/53 (85%)              46/53 (87%)              46/53 (87%)     | 
|POLY-3 RATE (b)    |                  47/52.12                 45/51.59                 46/52.30                 46/49.04        | 
|POLY-3 PERCENT (g) |                  90.2%                    87.2%                    88.0%                    93.8%           | 
|TERMINAL (d)       |                  10/15 (67%)              12/16 (75%)              18/23 (78%)              7/7 (100%)      | 
|FIRST INCIDENCE    |                  126                      40                       185                      72              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.224                  P=0.181N                 P=0.019N*                P=0.265         | 
|POLY 3             |                  P=0.288                  P=0.432N                 P=0.479N                 P=0.370         | 
|POLY 1.5           |                  P=0.423                  P=0.399N                 P=0.476N                 P=0.545         | 
|POLY 6             |                  P=0.155                  P=0.493N                 P=0.494N                 P=0.167         | 
|LOGISTIC REGRESSION|                  P=0.500N                 P=0.504N                 P=0.514                  P=0.508N        | 
|COCH-ARM / FISHERS |                  P=0.483N                 P=0.388N                 P=0.500N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.281                  (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  28/50 (56%)              30/53 (57%)              27/52 (52%)              22/51 (43%)     | 
|POLY-3 RATE (b)    |                  28/40.18                 30/44.65                 27/47.18                 22/42.43        | 
|POLY-3 PERCENT (g) |                  69.7%                    67.2%                    57.2%                    51.9%           | 
|TERMINAL (d)       |                  9/14 (64%)               12/16 (75%)              11/23 (48%)              1/7 (14%)       | 
|FIRST INCIDENCE    |                  222                      301                      320                      188             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.329N                 P=0.385N                 P=0.043N*                P=0.393N        | 
|POLY 3             |                  P=0.032N*                P=0.494N                 P=0.155N                 P=0.062N        | 
|POLY 1.5           |                  P=0.034N*                P=0.527N                 P=0.214N                 P=0.064N        | 
|POLY 6             |                  P=0.041N*                P=0.476N                 P=0.110N                 P=0.080N        | 
|LOGISTIC REGRESSION|                  P=0.083N                 P=0.513N                 P=0.321N                 P=0.150N        | 
|COCH-ARM / FISHERS |                  P=0.088N                 P=0.554                  P=0.415N                 P=0.137N        | 
|ORDER RESTRICTED   |                  P=0.064N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland: Duct                                                                                                             | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  29/50 (58%)              39/53 (74%)              42/52 (81%)              45/51 (88%)     | 
|POLY-3 RATE (b)    |                  29/40.97                 39/47.23                 42/48.69                 45/47.03        | 
|POLY-3 PERCENT (g) |                  70.8%                    82.6%                    86.3%                    95.7%           | 
|TERMINAL (d)       |                  8/14 (57%)               11/16 (69%)              18/23 (78%)              6/7 (86%)       | 
|FIRST INCIDENCE    |                  126                      247                      320                      188             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.349                  P=0.438N                 P=0.004 **      | 
|POLY 3             |                  P<0.001 **               P=0.126                  P=0.049 *                P<0.001 **      | 
|POLY 1.5           |                  P<0.001 **               P=0.090                  P=0.025 *                P<0.001 **      | 
|POLY 6             |                  P<0.001 **               P=0.177                  P=0.094                  P<0.001 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.100                  P=0.033 *                P<0.001 **      | 
|COCH-ARM / FISHERS |                  P<0.001 **               P=0.072                  P=0.011 *                P<0.001 **      | 
|ORDER RESTRICTED   |                  P<0.001 **               (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Esophagus: Muscularis                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/52 (4%)                1/53 (2%)                2/52 (4%)                0/52 (0%)       | 
|POLY-3 RATE (b)    |                  2/30.96                  1/36.86                  2/41.73                  0/31.53         | 
|POLY-3 PERCENT (g) |                  6.5%                     2.7%                     4.8%                     0.0%            | 
|TERMINAL (d)       |                  1/14 (7%)                0/16 (0%)                2/23 (9%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  547                      659                      727 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.228N                 P=0.439N                 P=0.526N                 P=0.293N        | 
|POLY 3             |                  P=0.200N                 P=0.439N                 P=0.582N                 P=0.231N        | 
|POLY 1.5           |                  P=0.196N                 P=0.458N                 P=0.620N                 P=0.229N        | 
|POLY 6             |                  P=0.212N                 P=0.421N                 P=0.540N                 P=0.247N        | 
|LOGISTIC REGRESSION|                  P=0.179N                 P=0.455N                 P=0.574N                 P=0.231N        | 
|COCH-ARM / FISHERS |                  P=0.199N                 P=0.493N                 P=0.691N                 P=0.248N        | 
|ORDER RESTRICTED   |                  P=0.150N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Cornea                                                                                                                      | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/51 (0%)                0/53 (0%)                1/52 (2%)                2/52 (4%)       | 
|POLY-3 RATE (b)    |                  0/30.21                  0/36.61                  1/41.54                  2/31.74         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     2.4%                     6.3%            | 
|TERMINAL (d)       |                  0/14 (0%)                0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  ---                      ---                      720                      663             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.032 *                (e)                      P=0.610                  P=0.208         | 
|POLY 3             |                  P=0.065                  (e)                      P=0.562                  P=0.246         | 
|POLY 1.5           |                  P=0.068                  (e)                      P=0.543                  P=0.249         | 
|POLY 6             |                  P=0.060                  (e)                      P=0.584                  P=0.233         | 
|LOGISTIC REGRESSION|                  P=0.051                  (e)                      P=0.619                  P=0.231         | 
|COCH-ARM / FISHERS |                  P=0.069                  (e)                      P=0.505                  P=0.252         | 
|ORDER RESTRICTED   |                  P=0.080                  (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Retina                                                                                                                      | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/51 (0%)                0/53 (0%)                1/52 (2%)                4/52 (8%)       | 
|POLY-3 RATE (b)    |                  0/30.21                  0/36.61                  1/41.53                  4/32.41         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     2.4%                     12.3%           | 
|TERMINAL (d)       |                  0/14 (0%)                0/16 (0%)                0/23 (0%)                1/7 (14%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      722                      484             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               (e)                      P=0.602                  P=0.031 *       | 
|POLY 3             |                  P=0.006 **               (e)                      P=0.562                  P=0.066         | 
|POLY 1.5           |                  P=0.006 **               (e)                      P=0.543                  P=0.067         | 
|POLY 6             |                  P=0.005 **               (e)                      P=0.584                  P=0.058         | 
|LOGISTIC REGRESSION|                  P=0.005 **               (e)                      P=0.622                  P=0.066         | 
|COCH-ARM / FISHERS |                  P=0.006 **               (e)                      P=0.505                  P=0.061         | 
|ORDER RESTRICTED   |                  P=0.007 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                3/53 (6%)                3/52 (6%)                6/52 (12%)      | 
|POLY-3 RATE (b)    |                  2/32.88                  3/37.08                  3/42.38                  6/33.83         | 
|POLY-3 PERCENT (g) |                  6.1%                     8.1%                     7.1%                     17.7%           | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                1/23 (4%)                1/7 (14%)       | 
|FIRST INCIDENCE    |                  321                      607                      574                      188             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.048 *                P=0.581                  P=0.632                  P=0.110         | 
|POLY 3             |                  P=0.085                  P=0.555                  P=0.613                  P=0.135         | 
|POLY 1.5           |                  P=0.085                  P=0.536                  P=0.573                  P=0.139         | 
|POLY 6             |                  P=0.080                  P=0.573                  P=0.657                  P=0.116         | 
|LOGISTIC REGRESSION|                  P=0.075                  P=0.495                  P=0.398                  P=0.118         | 
|COCH-ARM / FISHERS |                  P=0.076                  P=0.500                  P=0.491                  P=0.129         | 
|ORDER RESTRICTED   |                  P=0.091                  (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  9/52 (17%)               24/53 (45%)              28/51 (55%)              32/51 (63%)     | 
|POLY-3 RATE (b)    |                  9/35.59                  24/41.08                 28/45.07                 32/39.46        | 
|POLY-3 PERCENT (g) |                  25.3%                    58.4%                    62.1%                    81.1%           | 
|TERMINAL (d)       |                  2/15 (13%)               12/16 (75%)              12/23 (52%)              7/7 (100%)      | 
|FIRST INCIDENCE    |                  201                      331                      554                      188             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.012 *                P=0.034 *                P<0.001 **      | 
|POLY 3             |                  P<0.001 **               P=0.002 **               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=0.002 **               P=0.002 **               P<0.001 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.003 **               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)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart: Epicardium                                                                                                                | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/52 (4%)                0/53 (0%)                0/51 (0%)                0/51 (0%)       | 
|POLY-3 RATE (b)    |                  2/32.82                  0/36.61                  0/41.13                  0/30.95         | 
|POLY-3 PERCENT (g) |                  6.1%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  126                      ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.080N                 P=0.217N                 P=0.204N                 P=0.228N        | 
|POLY 3             |                  P=0.080N                 P=0.212N                 P=0.191N                 P=0.249N        | 
|POLY 1.5           |                  P=0.084N                 P=0.221N                 P=0.208N                 P=0.244N        | 
|POLY 6             |                  P=0.069N                 P=0.206N                 P=0.173N                 P=0.269N        | 
|LOGISTIC REGRESSION|                  P=0.111N                 P=0.256N                 P=0.431N                 P=0.247N        | 
|COCH-ARM / FISHERS |                  P=0.089N                 P=0.243N                 P=0.252N                 P=0.252N        | 
|ORDER RESTRICTED   |                  P=0.034N*                (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Rectum                                                                                                          | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/52 (4%)                1/53 (2%)                0/52 (0%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  2/30.87                  1/37.22                  0/41.53                  1/31.91         | 
|POLY-3 PERCENT (g) |                  6.5%                     2.7%                     0.0%                     3.1%            | 
|TERMINAL (d)       |                  2/15 (13%)               0/16 (0%)                0/23 (0%)                1/7 (14%)       | 
|FIRST INCIDENCE    |                  727 (T)                  531                      ---                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.405N                 P=0.465N                 P=0.149N                 P=0.723         | 
|POLY 3             |                  P=0.304N                 P=0.435N                 P=0.178N                 P=0.488N        | 
|POLY 1.5           |                  P=0.312N                 P=0.455N                 P=0.196N                 P=0.482N        | 
|POLY 6             |                  P=0.282N                 P=0.416N                 P=0.160N                 P=0.518N        | 
|LOGISTIC REGRESSION|                  P=0.316N                 P=0.448N                 (e)                      P=0.723         | 
|COCH-ARM / FISHERS |                  P=0.324N                 P=0.493N                 P=0.248N                 P=0.493N        | 
|ORDER RESTRICTED   |                  P=0.194N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Duodenum                                                                                                        | 
|     Erosion                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/52 (2%)                0/53 (0%)                0/51 (0%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  1/31.84                  0/36.61                  0/41.43                  2/32.17         | 
|POLY-3 PERCENT (g) |                  3.1%                     0.0%                     0.0%                     6.2%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  583                      ---                      ---                      694             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.236                  P=0.461N                 P=0.436N                 P=0.455         | 
|POLY 3             |                  P=0.272                  P=0.472N                 P=0.448N                 P=0.504         | 
|POLY 1.5           |                  P=0.273                  P=0.481N                 P=0.467N                 P=0.511         | 
|POLY 6             |                  P=0.274                  P=0.465N                 P=0.429N                 P=0.475         | 
|LOGISTIC REGRESSION|                  P=0.266                  P=0.499N                 P=0.534N                 P=0.499         | 
|COCH-ARM / FISHERS |                  P=0.272                  P=0.495N                 P=0.505N                 P=0.507         | 
|ORDER RESTRICTED   |                  P=0.122                  (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Casts Protein                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/53 (8%)                0/53 (0%)                0/52 (0%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  4/31.53                  0/36.61                  0/41.53                  2/32.74         | 
|POLY-3 PERCENT (g) |                  12.7%                    0.0%                     0.0%                     6.1%            | 
|TERMINAL (d)       |                  3/15 (20%)               0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  688                      ---                      ---                      607             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.316N                 P=0.049N*                P=0.020N*                P=0.514N        | 
|POLY 3             |                  P=0.261N                 P=0.042N*                P=0.033N*                P=0.316N        | 
|POLY 1.5           |                  P=0.264N                 P=0.048N*                P=0.041N*                P=0.316N        | 
|POLY 6             |                  P=0.243N                 P=0.037N*                P=0.025N*                P=0.338N        | 
|LOGISTIC REGRESSION|                  P=0.257N                 P=0.035N*                P=0.016N*                P=0.369N        | 
|COCH-ARM / FISHERS |                  P=0.268N                 P=0.059N                 P=0.061N                 P=0.339N        | 
|ORDER RESTRICTED   |                  P=0.024N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                0/53 (0%)                1/52 (2%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  0/31.38                  0/36.61                  1/41.91                  2/32.93         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     2.4%                     6.1%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  ---                      ---                      618                      555             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.068                  (e)                      P=0.596                  P=0.281         | 
|POLY 3             |                  P=0.067                  (e)                      P=0.557                  P=0.246         | 
|POLY 1.5           |                  P=0.069                  (e)                      P=0.536                  P=0.247         | 
|POLY 6             |                  P=0.062                  (e)                      P=0.579                  P=0.234         | 
|LOGISTIC REGRESSION|                  P=0.069                  (e)                      P=0.501                  P=0.237         | 
|COCH-ARM / FISHERS |                  P=0.069                  (e)                      P=0.495                  P=0.248         | 
|ORDER RESTRICTED   |                  P=0.080                  (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                1/53 (2%)                1/52 (2%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  2/31.89                  1/36.86                  1/41.53                  0/31.91         | 
|POLY-3 PERCENT (g) |                  6.3%                     2.7%                     2.4%                     0.0%            | 
|TERMINAL (d)       |                  1/15 (7%)                0/16 (0%)                1/23 (4%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  574                      659                      727 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.155N                 P=0.446N                 P=0.366N                 P=0.302N        | 
|POLY 3             |                  P=0.140N                 P=0.449N                 P=0.409N                 P=0.235N        | 
|POLY 1.5           |                  P=0.140N                 P=0.467N                 P=0.441N                 P=0.231N        | 
|POLY 6             |                  P=0.141N                 P=0.434N                 P=0.377N                 P=0.255N        | 
|LOGISTIC REGRESSION|                  P=0.130N                 P=0.459N                 P=0.408N                 P=0.236N        | 
|COCH-ARM / FISHERS |                  P=0.144N                 P=0.500N                 P=0.507N                 P=0.248N        | 
|ORDER RESTRICTED   |                  P=0.115N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  32/53 (60%)              44/53 (83%)              39/52 (75%)              37/53 (70%)     | 
|POLY-3 RATE (b)    |                  32/42.76                 44/50.35                 39/47.55                 37/45.03        | 
|POLY-3 PERCENT (g) |                  74.8%                    87.4%                    82.0%                    82.2%           | 
|TERMINAL (d)       |                  12/15 (80%)              14/16 (88%)              20/23 (87%)              6/7 (86%)       | 
|FIRST INCIDENCE    |                  126                      40                       320                      72              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.085                  P=0.224                  P=0.183N                 P=0.068         | 
|POLY 3             |                  P=0.349                  P=0.080                  P=0.267                  P=0.258         | 
|POLY 1.5           |                  P=0.368                  P=0.037 *                P=0.186                  P=0.258         | 
|POLY 6             |                  P=0.276                  P=0.161                  P=0.366                  P=0.218         | 
|LOGISTIC REGRESSION|                  P=0.353                  P=0.013 *                P=0.250                  P=0.234         | 
|COCH-ARM / FISHERS |                  P=0.310                  P=0.008 **               P=0.082                  P=0.208         | 
|ORDER RESTRICTED   |                  P=0.182                  (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  32/53 (60%)              38/53 (72%)              42/52 (81%)              47/53 (89%)     | 
|POLY-3 RATE (b)    |                  32/43.26                 38/44.56                 42/46.08                 47/48.96        | 
|POLY-3 PERCENT (g) |                  74.0%                    85.3%                    91.1%                    96.0%           | 
|TERMINAL (d)       |                  11/15 (73%)              14/16 (88%)              22/23 (96%)              7/7 (100%)      | 
|FIRST INCIDENCE    |                  126                      331                      554                      188             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.515                  P=0.276N                 P=0.003 **      | 
|POLY 3             |                  P<0.001 **               P=0.116                  P=0.014 *                P<0.001 **      | 
|POLY 1.5           |                  P<0.001 **               P=0.096                  P=0.011 *                P<0.001 **      | 
|POLY 6             |                  P<0.001 **               P=0.163                  P=0.025 *                P<0.001 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.239                  P=0.095                  P<0.001 **      | 
|COCH-ARM / FISHERS |                  P<0.001 **               P=0.153                  P=0.018 *                P<0.001 **      | 
|ORDER RESTRICTED   |                  P<0.001 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                0/53 (0%)                1/52 (2%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  2/32.37                  0/36.61                  1/41.91                  2/33.30         | 
|POLY-3 PERCENT (g) |                  6.2%                     0.0%                     2.4%                     6.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  574                      ---                      618                      309             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.522                  P=0.201N                 P=0.374N                 P=0.650N        | 
|POLY 3             |                  P=0.488                  P=0.210N                 P=0.411N                 P=0.686N        | 
|POLY 1.5           |                  P=0.494                  P=0.218N                 P=0.442N                 P=0.680N        | 
|POLY 6             |                  P=0.477                  P=0.204N                 P=0.381N                 P=0.681         | 
|LOGISTIC REGRESSION|                  P=0.474                  P=0.239N                 P=0.534N                 P=0.681         | 
|COCH-ARM / FISHERS |                  P=0.493                  P=0.248N                 P=0.507N                 P=0.691N        | 
|ORDER RESTRICTED   |                  P=0.365N                 (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                3/53 (6%)                0/52 (0%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  2/32.53                  3/38.48                  0/41.53                  0/31.91         | 
|POLY-3 PERCENT (g) |                  6.2%                     7.8%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  541                      301                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.057N                 P=0.577                  P=0.180N                 P=0.211N        | 
|POLY 3             |                  P=0.058N                 P=0.577                  P=0.187N                 P=0.240N        | 
|POLY 1.5           |                  P=0.061N                 P=0.551                  P=0.204N                 P=0.233N        | 
|POLY 6             |                  P=0.054N                 P=0.598                  P=0.172N                 P=0.263N        | 
|LOGISTIC REGRESSION|                  P=0.088N                 P=0.454                  P=0.284N                 P=0.241N        | 
|COCH-ARM / FISHERS |                  P=0.072N                 P=0.500                  P=0.252N                 P=0.248N        | 
|ORDER RESTRICTED   |                  P=0.107N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Transitional Epithelium                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/53 (8%)                8/53 (15%)               8/52 (15%)               11/53 (21%)     | 
|POLY-3 RATE (b)    |                  4/32.45                  8/38.99                  8/42.50                  11/35.55        | 
|POLY-3 PERCENT (g) |                  12.3%                    20.5%                    18.8%                    30.9%           | 
|TERMINAL (d)       |                  2/15 (13%)               2/16 (13%)               4/23 (17%)               1/7 (14%)       | 
|FIRST INCIDENCE    |                  554                      301                      618                      309             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.011 *                P=0.272                  P=0.443                  P=0.023 *       | 
|POLY 3             |                  P=0.053                  P=0.273                  P=0.331                  P=0.054         | 
|POLY 1.5           |                  P=0.052                  P=0.237                  P=0.270                  P=0.054         | 
|POLY 6             |                  P=0.048 *                P=0.308                  P=0.404                  P=0.045 *       | 
|LOGISTIC REGRESSION|                  P=0.043 *                P=0.210                  P=0.323                  P=0.050         | 
|COCH-ARM / FISHERS |                  P=0.043 *                P=0.179                  P=0.170                  P=0.046 *       | 
|ORDER RESTRICTED   |                  P=0.047 *                (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/53 (6%)                1/53 (2%)                2/51 (4%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  3/31.69                  1/36.76                  2/41.43                  2/32.00         | 
|POLY-3 PERCENT (g) |                  9.5%                     2.7%                     4.8%                     6.3%            | 
|TERMINAL (d)       |                  2/15 (13%)               0/16 (0%)                2/23 (9%)                1/7 (14%)       | 
|FIRST INCIDENCE    |                  644                      688                      727 (T)                  704             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.557                  P=0.256N                 P=0.312N                 P=0.594         | 
|POLY 3             |                  P=0.470N                 P=0.252N                 P=0.380N                 P=0.495N        | 
|POLY 1.5           |                  P=0.467N                 P=0.270N                 P=0.425N                 P=0.487N        | 
|POLY 6             |                  P=0.473N                 P=0.237N                 P=0.337N                 P=0.535N        | 
|LOGISTIC REGRESSION|                  P=0.538N                 P=0.232N                 P=0.291N                 P=0.625N        | 
|COCH-ARM / FISHERS |                  P=0.473N                 P=0.309N                 P=0.518N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.332N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  7/53 (13%)               4/53 (8%)                5/51 (10%)               5/53 (9%)       | 
|POLY-3 RATE (b)    |                  7/32.51                  4/36.97                  5/41.49                  5/32.77         | 
|POLY-3 PERCENT (g) |                  21.5%                    10.8%                    12.1%                    15.3%           | 
|TERMINAL (d)       |                  3/15 (20%)               1/16 (6%)                4/23 (17%)               2/7 (29%)       | 
|FIRST INCIDENCE    |                  541                      658                      714                      525             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.521                  P=0.182N                 P=0.129N                 P=0.545         | 
|POLY 3             |                  P=0.357N                 P=0.184N                 P=0.219N                 P=0.367N        | 
|POLY 1.5           |                  P=0.354N                 P=0.209N                 P=0.274N                 P=0.357N        | 
|POLY 6             |                  P=0.373N                 P=0.166N                 P=0.173N                 P=0.427N        | 
|LOGISTIC REGRESSION|                  P=0.392N                 P=0.157N                 P=0.144N                 P=0.416N        | 
|COCH-ARM / FISHERS |                  P=0.373N                 P=0.263N                 P=0.408N                 P=0.380N        | 
|ORDER RESTRICTED   |                  P=0.258N                 (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Cholangiofibrosis                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                3/53 (6%)                13/51 (25%)              22/53 (42%)     | 
|POLY-3 RATE (b)    |                  0/31.38                  3/37.59                  13/41.80                 22/38.60        | 
|POLY-3 PERCENT (g) |                  0.0%                     8.0%                     31.1%                    57.0%           | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                10/23 (44%)              3/7 (43%)       | 
|FIRST INCIDENCE    |                  ---                      607                      651                      531             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.182                  P=0.002 **               P<0.001 **      | 
|POLY 3             |                  P<0.001 **               P=0.153                  P<0.001 **               P<0.001 **      | 
|POLY 1.5           |                  P<0.001 **               P=0.140                  P<0.001 **               P<0.001 **      | 
|POLY 6             |                  P<0.001 **               P=0.169                  P<0.001 **               P<0.001 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.133                  P=0.002 **               P<0.001 **      | 
|COCH-ARM / FISHERS |                  P<0.001 **               P=0.121                  P<0.001 **               P<0.001 **      | 
|ORDER RESTRICTED   |                  P<0.001 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Clear Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                0/53 (0%)                0/51 (0%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  2/31.38                  0/36.61                  0/41.43                  0/31.91         | 
|POLY-3 PERCENT (g) |                  6.4%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/15 (13%)               0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  727 (T)                  ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.087N                 P=0.222N                 P=0.149N                 P=0.416N        | 
|POLY 3             |                  P=0.084N                 P=0.203N                 P=0.182N                 P=0.232N        | 
|POLY 1.5           |                  P=0.087N                 P=0.215N                 P=0.201N                 P=0.229N        | 
|POLY 6             |                  P=0.075N                 P=0.193N                 P=0.163N                 P=0.248N        | 
|LOGISTIC REGRESSION|                  P=0.087N                 (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.089N                 P=0.248N                 P=0.257N                 P=0.248N        | 
|ORDER RESTRICTED   |                  P=0.028N*                (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                1/53 (2%)                1/51 (2%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  0/31.38                  1/36.61                  1/41.43                  2/32.00         | 
|POLY-3 PERCENT (g) |                  0.0%                     2.7%                     2.4%                     6.3%            | 
|TERMINAL (d)       |                  0/15 (0%)                1/16 (6%)                1/23 (4%)                1/7 (14%)       | 
|FIRST INCIDENCE    |                  ---                      727 (T)                  727 (T)                  704             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.045 *                P=0.513                  P=0.585                  P=0.105         | 
|POLY 3             |                  P=0.147                  P=0.531                  P=0.554                  P=0.240         | 
|POLY 1.5           |                  P=0.150                  P=0.520                  P=0.534                  P=0.243         | 
|POLY 6             |                  P=0.137                  P=0.540                  P=0.576                  P=0.222         | 
|LOGISTIC REGRESSION|                  P=0.061                  P=0.513                  P=0.585                  P=0.148         | 
|COCH-ARM / FISHERS |                  P=0.143                  P=0.500                  P=0.490                  P=0.248         | 
|ORDER RESTRICTED   |                  P=0.119                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  11/53 (21%)              17/53 (32%)              24/51 (47%)              17/53 (32%)     | 
|POLY-3 RATE (b)    |                  11/34.24                 17/39.64                 24/47.33                 17/41.05        | 
|POLY-3 PERCENT (g) |                  32.1%                    42.9%                    50.7%                    41.4%           | 
|TERMINAL (d)       |                  5/15 (33%)               5/16 (31%)               7/23 (30%)               1/7 (14%)       | 
|FIRST INCIDENCE    |                  405                      531                      440                      244             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.041 *                P=0.301                  P=0.194                  P=0.096         | 
|POLY 3             |                  P=0.278                  P=0.233                  P=0.073                  P=0.272         | 
|POLY 1.5           |                  P=0.217                  P=0.191                  P=0.028 *                P=0.226         | 
|POLY 6             |                  P=0.300                  P=0.287                  P=0.171                  P=0.291         | 
|LOGISTIC REGRESSION|                  P=0.107                  P=0.236                  P=0.013 *                P=0.135         | 
|COCH-ARM / FISHERS |                  P=0.099                  P=0.135                  P=0.004 **               P=0.135         | 
|ORDER RESTRICTED   |                  P=0.168                  (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Diffuse                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/53 (9%)                30/53 (57%)              45/51 (88%)              47/53 (89%)     | 
|POLY-3 RATE (b)    |                  5/33.58                  30/43.70                 45/48.97                 47/47.72        | 
|POLY-3 PERCENT (g) |                  14.9%                    68.7%                    91.9%                    98.5%           | 
|TERMINAL (d)       |                  2/15 (13%)               10/16 (63%)              21/23 (91%)              7/7 (100%)      | 
|FIRST INCIDENCE    |                  126                      163                      440                      309             | 
|-------------------|                                                                                                             | 
|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)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                3/53 (6%)                2/51 (4%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  2/32.02                  3/36.91                  2/42.21                  0/31.91         | 
|POLY-3 PERCENT (g) |                  6.3%                     8.1%                     4.7%                     0.0%            | 
|TERMINAL (d)       |                  1/15 (7%)                2/16 (13%)               1/23 (4%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  519                      645                      440                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.178N                 P=0.554                  P=0.576N                 P=0.302N        | 
|POLY 3             |                  P=0.135N                 P=0.565                  P=0.590N                 P=0.236N        | 
|POLY 1.5           |                  P=0.135N                 P=0.543                  P=0.630N                 P=0.232N        | 
|POLY 6             |                  P=0.143N                 P=0.585                  P=0.548N                 P=0.256N        | 
|LOGISTIC REGRESSION|                  P=0.135N                 P=0.568                  P=0.673                  P=0.234N        | 
|COCH-ARM / FISHERS |                  P=0.146N                 P=0.500                  P=0.676                  P=0.248N        | 
|ORDER RESTRICTED   |                  P=0.157N                 (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocyte, Multinucleate                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                19/53 (36%)              46/51 (90%)              49/53 (92%)     | 
|POLY-3 RATE (b)    |                  0/31.38                  19/39.58                 46/47.56                 49/50.73        | 
|POLY-3 PERCENT (g) |                  0.0%                     48.0%                    96.7%                    96.6%           | 
|TERMINAL (d)       |                  0/15 (0%)                9/16 (56%)               23/23 (100%)             7/7 (100%)      | 
|FIRST INCIDENCE    |                  ---                      331                      440                      188             | 
|-------------------|                                                                                                             | 
|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)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                3/53 (6%)                26/51 (51%)              39/53 (74%)     | 
|POLY-3 RATE (b)    |                  0/31.38                  3/36.86                  26/43.63                 39/42.89        | 
|POLY-3 PERCENT (g) |                  0.0%                     8.1%                     59.6%                    90.9%           | 
|TERMINAL (d)       |                  0/15 (0%)                1/16 (6%)                18/23 (78%)              7/7 (100%)      | 
|FIRST INCIDENCE    |                  ---                      680                      535                      484             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.163                  P<0.001 **               P<0.001 **      | 
|POLY 3             |                  P<0.001 **               P=0.148                  P<0.001 **               P<0.001 **      | 
|POLY 1.5           |                  P<0.001 **               P=0.137                  P<0.001 **               P<0.001 **      | 
|POLY 6             |                  P<0.001 **               P=0.160                  P<0.001 **               P<0.001 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.160                  P<0.001 **               P<0.001 **      | 
|COCH-ARM / FISHERS |                  P<0.001 **               P=0.121                  P<0.001 **               P<0.001 **      | 
|ORDER RESTRICTED   |                  P<0.001 **               (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  36/53 (68%)              51/53 (96%)              51/51 (100%)             51/53 (96%)     | 
|POLY-3 RATE (b)    |                  36/42.80                 51/51.40                 51/51.00                 51/52.15        | 
|POLY-3 PERCENT (g) |                  84.1%                    99.2%                    100.0%                   97.8%           | 
|TERMINAL (d)       |                  15/15 (100%)             16/16 (100%)             23/23 (100%)             7/7 (100%)      | 
|FIRST INCIDENCE    |                  176                      40                       185                      72              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.148                  P=0.428N                 P=0.002 **      | 
|POLY 3             |                  P<0.001 **               P<0.001 **               P<0.001 **               P=0.004 **      | 
|POLY 1.5           |                  P<0.001 **               P<0.001 **               P<0.001 **               P<0.001 **      | 
|POLY 6             |                  P=0.009 **               P=0.006 **               P=0.004 **               P=0.019 *       | 
|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)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  21/53 (40%)              30/53 (57%)              29/51 (57%)              9/53 (17%)      | 
|POLY-3 RATE (b)    |                  21/34.34                 30/42.01                 29/43.57                 9/34.56         | 
|POLY-3 PERCENT (g) |                  61.2%                    71.4%                    66.6%                    26.0%           | 
|TERMINAL (d)       |                  12/15 (80%)              15/16 (94%)              19/23 (83%)              3/7 (43%)       | 
|FIRST INCIDENCE    |                  541                      454                      574                      244             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.062N                 P=0.201                  P=0.343N                 P=0.137N        | 
|POLY 3             |                  P<0.001N**               P=0.219                  P=0.392                  P<0.001N**      | 
|POLY 1.5           |                  P<0.001N**               P=0.130                  P=0.230                  P=0.002N**      | 
|POLY 6             |                  P<0.001N**               P=0.351                  P=0.585                  P<0.001N**      | 
|LOGISTIC REGRESSION|                  P<0.001N**               P=0.198                  P=0.480N                 P=0.005N**      | 
|COCH-ARM / FISHERS |                  P=0.004N**               P=0.060                  P=0.059                  P=0.008N**      | 
|ORDER RESTRICTED   |                  P<0.001N**               (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/53 (8%)                11/53 (21%)              15/51 (29%)              17/53 (32%)     | 
|POLY-3 RATE (b)    |                  4/34.03                  11/39.49                 15/44.94                 17/38.49        | 
|POLY-3 PERCENT (g) |                  11.8%                    27.9%                    33.4%                    44.2%           | 
|TERMINAL (d)       |                  0/15 (0%)                3/16 (19%)               6/23 (26%)               1/7 (14%)       | 
|FIRST INCIDENCE    |                  176                      403                      185                      530             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.112                  P=0.064                  P=0.004 **      | 
|POLY 3             |                  P=0.002 **               P=0.075                  P=0.024 *                P=0.002 **      | 
|POLY 1.5           |                  P=0.002 **               P=0.061                  P=0.013 *                P<0.001 **      | 
|POLY 6             |                  P=0.003 **               P=0.093                  P=0.045 *                P=0.002 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.047 *                P=0.002 **               P=0.002 **      | 
|COCH-ARM / FISHERS |                  P<0.001 **               P=0.046 *                P=0.004 **               P<0.001 **      | 
|ORDER RESTRICTED   |                  P<0.001 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/53 (2%)                48/53 (91%)              51/51 (100%)             48/53 (91%)     | 
|POLY-3 RATE (b)    |                  1/32.06                  48/49.35                 51/51.00                 48/48.68        | 
|POLY-3 PERCENT (g) |                  3.1%                     97.3%                    100.0%                   98.6%           | 
|TERMINAL (d)       |                  0/15 (0%)                15/16 (94%)              23/23 (100%)             7/7 (100%)      | 
|FIRST INCIDENCE    |                  496                      247                      185                      244             | 
|-------------------|                                                                                                             | 
|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 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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Toxic Hepatopathy                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                39/53 (74%)              51/51 (100%)             49/53 (92%)     | 
|POLY-3 RATE (b)    |                  0/31.38                  39/43.36                 51/51.00                 49/49.10        | 
|POLY-3 PERCENT (g) |                  0.0%                     90.0%                    100.0%                   99.8%           | 
|TERMINAL (d)       |                  0/15 (0%)                15/16 (94%)              23/23 (100%)             7/7 (100%)      | 
|FIRST INCIDENCE    |                  ---                      541                      185                      243             | 
|-------------------|                                                                                                             | 
|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)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/53 (6%)                3/53 (6%)                8/51 (16%)               12/53 (23%)     | 
|POLY-3 RATE (b)    |                  3/31.38                  3/36.99                  8/41.43                  12/35.10        | 
|POLY-3 PERCENT (g) |                  9.6%                     8.1%                     19.3%                    34.2%           | 
|TERMINAL (d)       |                  3/15 (20%)               2/16 (13%)               8/23 (35%)               3/7 (43%)       | 
|FIRST INCIDENCE    |                  727 (T)                  618                      727 (T)                  244             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.618N                 P=0.272                  P<0.001 **      | 
|POLY 3             |                  P=0.002 **               P=0.586N                 P=0.209                  P=0.014 *       | 
|POLY 1.5           |                  P=0.002 **               P=0.614N                 P=0.160                  P=0.014 *       | 
|POLY 6             |                  P<0.001 **               P=0.557N                 P=0.270                  P=0.010 *       | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.556N                 P=0.272                  P=0.012 *       | 
|COCH-ARM / FISHERS |                  P=0.002 **               P=0.661N                 P=0.089                  P=0.012 *       | 
|ORDER RESTRICTED   |                  P=0.005 **               (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/53 (8%)                1/53 (2%)                4/51 (8%)                5/53 (9%)       | 
|POLY-3 RATE (b)    |                  4/32.23                  1/36.86                  4/42.20                  5/33.91         | 
|POLY-3 PERCENT (g) |                  12.4%                    2.7%                     9.5%                     14.8%           | 
|TERMINAL (d)       |                  3/15 (20%)               0/16 (0%)                1/23 (4%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  391                      658                      535                      525             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.174                  P=0.148N                 P=0.408N                 P=0.359         | 
|POLY 3             |                  P=0.274                  P=0.137N                 P=0.489N                 P=0.533         | 
|POLY 1.5           |                  P=0.278                  P=0.152N                 P=0.550N                 P=0.528         | 
|POLY 6             |                  P=0.262                  P=0.124N                 P=0.423N                 P=0.516         | 
|LOGISTIC REGRESSION|                  P=0.276                  P=0.149N                 P=0.564N                 P=0.512         | 
|COCH-ARM / FISHERS |                  P=0.271                  P=0.181N                 P=0.620                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.254                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/53 (6%)                14/53 (26%)              45/51 (88%)              45/53 (85%)     | 
|POLY-3 RATE (b)    |                  3/32.67                  14/39.77                 45/47.42                 45/45.98        | 
|POLY-3 PERCENT (g) |                  9.2%                     35.2%                    94.9%                    97.9%           | 
|TERMINAL (d)       |                  1/15 (7%)                5/16 (31%)               22/23 (96%)              7/7 (100%)      | 
|FIRST INCIDENCE    |                  496                      328                      535                      394             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.015 *                P<0.001 **               P<0.001 **      | 
|POLY 3             |                  P<0.001 **               P=0.008 **               P<0.001 **               P<0.001 **      | 
|POLY 1.5           |                  P<0.001 **               P=0.006 **               P<0.001 **               P<0.001 **      | 
|POLY 6             |                  P<0.001 **               P=0.011 *                P<0.001 **               P<0.001 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.006 **               P<0.001 **               P<0.001 **      | 
|COCH-ARM / FISHERS |                  P<0.001 **               P=0.003 **               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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/53 (6%)                1/53 (2%)                1/51 (2%)                7/53 (13%)      | 
|POLY-3 RATE (b)    |                  3/33.04                  1/36.68                  1/41.62                  7/34.41         | 
|POLY-3 PERCENT (g) |                  9.1%                     2.7%                     2.4%                     20.3%           | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  354                      709                      678                      484             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.028 *                P=0.256N                 P=0.191N                 P=0.129         | 
|POLY 3             |                  P=0.046 *                P=0.267N                 P=0.228N                 P=0.165         | 
|POLY 1.5           |                  P=0.046 *                P=0.279N                 P=0.256N                 P=0.169         | 
|POLY 6             |                  P=0.046 *                P=0.257N                 P=0.201N                 P=0.145         | 
|LOGISTIC REGRESSION|                  P=0.046 *                P=0.316N                 P=0.396N                 P=0.162         | 
|COCH-ARM / FISHERS |                  P=0.046 *                P=0.309N                 P=0.324N                 P=0.160         | 
|ORDER RESTRICTED   |                  P=0.013 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                42/53 (79%)              50/51 (98%)              49/53 (92%)     | 
|POLY-3 RATE (b)    |                  0/31.38                  42/46.52                 50/50.61                 49/49.44        | 
|POLY-3 PERCENT (g) |                  0.0%                     90.3%                    98.8%                    99.1%           | 
|TERMINAL (d)       |                  0/15 (0%)                15/16 (94%)              23/23 (100%)             7/7 (100%)      | 
|FIRST INCIDENCE    |                  ---                      328                      185                      243             | 
|-------------------|                                                                                                             | 
|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 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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Oval Cell                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                10/53 (19%)              38/51 (75%)              40/53 (75%)     | 
|POLY-3 RATE (b)    |                  0/31.38                  10/37.11                 38/44.37                 40/43.32        | 
|POLY-3 PERCENT (g) |                  0.0%                     27.0%                    85.6%                    92.3%           | 
|TERMINAL (d)       |                  0/15 (0%)                6/16 (38%)               23/23 (100%)             7/7 (100%)      | 
|FIRST INCIDENCE    |                  ---                      630                      535                      484             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.003 **               P<0.001 **               P<0.001 **      | 
|POLY 3             |                  P<0.001 **               P=0.002 **               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=0.002 **               P<0.001 **               P<0.001 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.003 **               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)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Portal                                                                                                                    | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                2/53 (4%)                1/51 (2%)                10/53 (19%)     | 
|POLY-3 RATE (b)    |                  0/31.38                  2/37.17                  1/41.55                  10/34.71        | 
|POLY-3 PERCENT (g) |                  0.0%                     5.4%                     2.4%                     28.8%           | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                0/23 (0%)                1/7 (14%)       | 
|FIRST INCIDENCE    |                  ---                      618                      699                      574             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.306                  P=0.626                  P<0.001 **      | 
|POLY 3             |                  P<0.001 **               P=0.276                  P=0.555                  P<0.001 **      | 
|POLY 1.5           |                  P<0.001 **               P=0.261                  P=0.534                  P<0.001 **      | 
|POLY 6             |                  P<0.001 **               P=0.291                  P=0.577                  P<0.001 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.260                  P=0.579                  P<0.001 **      | 
|COCH-ARM / FISHERS |                  P<0.001 **               P=0.248                  P=0.490                  P<0.001 **      | 
|ORDER RESTRICTED   |                  P<0.001 **               (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  41/53 (77%)              45/53 (85%)              49/51 (96%)              42/51 (82%)     | 
|POLY-3 RATE (b)    |                  41/47.06                 45/46.48                 49/49.11                 42/44.15        | 
|POLY-3 PERCENT (g) |                  87.1%                    96.8%                    99.8%                    95.1%           | 
|TERMINAL (d)       |                  12/15 (80%)              15/16 (94%)              23/23 (100%)             7/7 (100%)      | 
|FIRST INCIDENCE    |                  201                      454                      320                      394             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.102                  P=0.406N                 P=0.119N                 P=0.164         | 
|POLY 3             |                  P=0.041 *                P=0.064                  P=0.007 **               P=0.133         | 
|POLY 1.5           |                  P=0.053                  P=0.070                  P=0.004 **               P=0.156         | 
|POLY 6             |                  P=0.039 *                P=0.100                  P=0.019 *                P=0.128         | 
|LOGISTIC REGRESSION|                  P=0.382                  P=0.410                  P=0.037 *                P=0.445         | 
|COCH-ARM / FISHERS |                  P=0.224                  P=0.229                  P=0.005 **               P=0.349         | 
|ORDER RESTRICTED   |                  P=0.006 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/53 (9%)                1/53 (2%)                0/51 (0%)                2/51 (4%)       | 
|POLY-3 RATE (b)    |                  5/32.66                  1/37.61                  0/41.13                  2/31.84         | 
|POLY-3 PERCENT (g) |                  15.3%                    2.7%                     0.0%                     6.3%            | 
|TERMINAL (d)       |                  2/15 (13%)               0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  309                      40                       ---                      484             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.146N                 P=0.086N                 P=0.011N*                P=0.375N        | 
|POLY 3             |                  P=0.119N                 P=0.069N                 P=0.015N*                P=0.220N        | 
|POLY 1.5           |                  P=0.125N                 P=0.079N                 P=0.020N*                P=0.219N        | 
|POLY 6             |                  P=0.105N                 P=0.062N                 P=0.011N*                P=0.244N        | 
|LOGISTIC REGRESSION|                  P=0.152N                 P=0.121N                 P=0.027N*                P=0.225N        | 
|COCH-ARM / FISHERS |                  P=0.133N                 P=0.103N                 P=0.031N*                P=0.235N        | 
|ORDER RESTRICTED   |                  P=0.022N*                (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/53 (6%)                0/53 (0%)                0/51 (0%)                0/51 (0%)       | 
|POLY-3 RATE (b)    |                  3/32.04                  0/36.61                  0/41.13                  0/30.95         | 
|POLY-3 PERCENT (g) |                  9.4%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  1/15 (7%)                0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  611                      ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.026N*                P=0.097N                 P=0.057N                 P=0.179N        | 
|POLY 3             |                  P=0.030N*                P=0.095N                 P=0.080N                 P=0.122N        | 
|POLY 1.5           |                  P=0.032N*                P=0.102N                 P=0.094N                 P=0.120N        | 
|POLY 6             |                  P=0.026N*                P=0.090N                 P=0.069N                 P=0.137N        | 
|LOGISTIC REGRESSION|                  P=0.027N*                P=0.095N                 P=0.082N                 P=0.127N        | 
|COCH-ARM / FISHERS |                  P=0.034N*                P=0.121N                 P=0.129N                 P=0.129N        | 
|ORDER RESTRICTED   |                  P=0.009N**               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/53 (2%)                3/53 (6%)                9/51 (18%)               4/51 (8%)       | 
|POLY-3 RATE (b)    |                  1/31.53                  3/37.05                  9/42.85                  4/31.72         | 
|POLY-3 PERCENT (g) |                  3.2%                     8.1%                     21.0%                    12.6%           | 
|TERMINAL (d)       |                  0/15 (0%)                2/16 (13%)               2/23 (9%)                2/7 (29%)       | 
|FIRST INCIDENCE    |                  688                      599                      573                      607             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.039 *                P=0.365                  P=0.066                  P=0.092         | 
|POLY 3             |                  P=0.093                  P=0.364                  P=0.030 *                P=0.175         | 
|POLY 1.5           |                  P=0.099                  P=0.343                  P=0.018 *                P=0.177         | 
|POLY 6             |                  P=0.072                  P=0.384                  P=0.051                  P=0.157         | 
|LOGISTIC REGRESSION|                  P=0.090                  P=0.372                  P=0.021 *                P=0.153         | 
|COCH-ARM / FISHERS |                  P=0.099                  P=0.309                  P=0.007 **               P=0.170         | 
|ORDER RESTRICTED   |                  P=0.069                  (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  12/53 (23%)              2/53 (4%)                0/51 (0%)                0/51 (0%)       | 
|POLY-3 RATE (b)    |                  12/32.58                 2/37.28                  0/41.13                  0/30.95         | 
|POLY-3 PERCENT (g) |                  36.8%                    5.4%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  7/15 (47%)               0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  600                      607                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001N**               P=0.002N**               P<0.001N**               P=0.005N**      | 
|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=0.004N**               P<0.001N**               P<0.001N**      | 
|ORDER RESTRICTED   |                  P<0.001N**               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Metaplasia Bronchiolar                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                39/53 (74%)              47/51 (92%)              40/51 (78%)     | 
|POLY-3 RATE (b)    |                  0/31.38                  39/44.76                 47/48.24                 40/43.59        | 
|POLY-3 PERCENT (g) |                  0.0%                     87.1%                    97.4%                    91.8%           | 
|TERMINAL (d)       |                  0/15 (0%)                15/16 (94%)              23/23 (100%)             6/7 (86%)       | 
|FIRST INCIDENCE    |                  ---                      454                      320                      394             | 
|-------------------|                                                                                                             | 
|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 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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Serosa                                                                                                                     | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                1/53 (2%)                0/51 (0%)                0/51 (0%)       | 
|POLY-3 RATE (b)    |                  2/32.84                  1/37.59                  0/41.13                  0/30.95         | 
|POLY-3 PERCENT (g) |                  6.1%                     2.7%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  126                      163                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.081N                 P=0.476N                 P=0.204N                 P=0.228N        | 
|POLY 3             |                  P=0.080N                 P=0.453N                 P=0.191N                 P=0.249N        | 
|POLY 1.5           |                  P=0.084N                 P=0.468N                 P=0.209N                 P=0.244N        | 
|POLY 6             |                  P=0.071N                 P=0.441N                 P=0.174N                 P=0.268N        | 
|LOGISTIC REGRESSION|                  P=0.125N                 P=0.584N                 P=0.449N                 P=0.270N        | 
|COCH-ARM / FISHERS |                  P=0.090N                 P=0.500N                 P=0.257N                 P=0.257N        | 
|ORDER RESTRICTED   |                  P=0.081N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/52 (2%)                4/52 (8%)                4/51 (8%)                3/51 (6%)       | 
|POLY-3 RATE (b)    |                  1/31.47                  4/35.81                  4/41.14                  3/30.95         | 
|POLY-3 PERCENT (g) |                  3.2%                     11.2%                    9.7%                     9.7%            | 
|TERMINAL (d)       |                  0/15 (0%)                3/16 (19%)               3/23 (13%)               3/7 (43%)       | 
|FIRST INCIDENCE    |                  660                      722                      722                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.093                  P=0.215                  P=0.339                  P=0.115         | 
|POLY 3             |                  P=0.300                  P=0.217                  P=0.270                  P=0.296         | 
|POLY 1.5           |                  P=0.309                  P=0.204                  P=0.235                  P=0.304         | 
|POLY 6             |                  P=0.266                  P=0.228                  P=0.311                  P=0.265         | 
|LOGISTIC REGRESSION|                  P=0.146                  P=0.243                  P=0.345                  P=0.188         | 
|COCH-ARM / FISHERS |                  P=0.296                  P=0.181                  P=0.175                  P=0.301         | 
|ORDER RESTRICTED   |                  P=0.277                  (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  18/52 (35%)              29/52 (56%)              11/51 (22%)              15/51 (29%)     | 
|POLY-3 RATE (b)    |                  18/36.75                 29/42.17                 11/42.99                 15/36.60        | 
|POLY-3 PERCENT (g) |                  49.0%                    68.8%                    25.6%                    41.0%           | 
|TERMINAL (d)       |                  8/15 (53%)               12/16 (75%)              5/23 (22%)               1/7 (14%)       | 
|FIRST INCIDENCE    |                  222                      163                      320                      484             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.236N                 P=0.127                  P=0.009N**               P=0.552         | 
|POLY 3             |                  P=0.032N*                P=0.046 *                P=0.023N*                P=0.318N        | 
|POLY 1.5           |                  P=0.041N*                P=0.035 *                P=0.038N*                P=0.327N        | 
|POLY 6             |                  P=0.027N*                P=0.065                  P=0.013N*                P=0.329N        | 
|LOGISTIC REGRESSION|                  P=0.064N                 P=0.043 *                P=0.059N                 P=0.338N        | 
|COCH-ARM / FISHERS |                  P=0.078N                 P=0.024 *                P=0.105N                 P=0.362N        | 
|ORDER RESTRICTED   |                  P=0.010N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                2/52 (4%)                0/51 (0%)                1/51 (2%)       | 
|POLY-3 RATE (b)    |                  0/31.21                  2/36.75                  0/41.11                  1/30.95         | 
|POLY-3 PERCENT (g) |                  0.0%                     5.4%                     0.0%                     3.2%            | 
|TERMINAL (d)       |                  0/15 (0%)                1/16 (6%)                0/23 (0%)                1/7 (14%)       | 
|FIRST INCIDENCE    |                  ---                      247                      ---                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.423                  P=0.254                  (e)                      P=0.348         | 
|POLY 3             |                  P=0.535                  P=0.274                  (e)                      P=0.498         | 
|POLY 1.5           |                  P=0.528                  P=0.262                  (e)                      P=0.501         | 
|POLY 6             |                  P=0.533                  P=0.287                  (e)                      P=0.484         | 
|LOGISTIC REGRESSION|                  P=0.495                  P=0.211                  (e)                      P=0.348         | 
|COCH-ARM / FISHERS |                  P=0.502                  P=0.248                  (e)                      P=0.495         | 
|ORDER RESTRICTED   |                  P=0.322                  (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/52 (4%)                1/53 (2%)                0/51 (0%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  2/31.83                  1/36.68                  0/41.43                  2/33.24         | 
|POLY-3 PERCENT (g) |                  6.3%                     2.7%                     0.0%                     6.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  618                      709                      ---                      484             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.584                  P=0.411N                 P=0.137N                 P=0.653         | 
|POLY 3             |                  P=0.576N                 P=0.450N                 P=0.184N                 P=0.681N        | 
|POLY 1.5           |                  P=0.585N                 P=0.466N                 P=0.202N                 P=0.677N        | 
|POLY 6             |                  P=0.556N                 P=0.438N                 P=0.167N                 P=0.692         | 
|LOGISTIC REGRESSION|                  P=0.600N                 P=0.441N                 P=0.192N                 P=0.688N        | 
|COCH-ARM / FISHERS |                  P=0.600N                 P=0.493N                 P=0.252N                 P=0.684N        | 
|ORDER RESTRICTED   |                  P=0.358N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/52 (6%)                1/53 (2%)                1/51 (2%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  3/33.26                  1/36.61                  1/41.46                  1/32.33         | 
|POLY-3 PERCENT (g) |                  9.0%                     2.7%                     2.4%                     3.1%            | 
|TERMINAL (d)       |                  0/15 (0%)                1/16 (6%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  222                      727 (T)                  720                      607             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.218N                 P=0.259N                 P=0.199N                 P=0.269N        | 
|POLY 3             |                  P=0.205N                 P=0.270N                 P=0.231N                 P=0.313N        | 
|POLY 1.5           |                  P=0.208N                 P=0.280N                 P=0.257N                 P=0.302N        | 
|POLY 6             |                  P=0.198N                 P=0.263N                 P=0.206N                 P=0.348N        | 
|LOGISTIC REGRESSION|                  P=0.220N                 P=0.322N                 P=0.433N                 P=0.309N        | 
|COCH-ARM / FISHERS |                  P=0.212N                 P=0.302N                 P=0.316N                 P=0.302N        | 
|ORDER RESTRICTED   |                  P=0.172N                 (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                0/53 (0%)                0/51 (0%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  0/31.36                  0/36.61                  0/41.43                  2/32.53         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     6.2%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                0/23 (0%)                1/7 (14%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      525             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.028 *                (e)                      (e)                      P=0.172         | 
|POLY 3             |                  P=0.050                  (e)                      (e)                      P=0.244         | 
|POLY 1.5           |                  P=0.050                  (e)                      (e)                      P=0.246         | 
|POLY 6             |                  P=0.050                  (e)                      (e)                      P=0.228         | 
|LOGISTIC REGRESSION|                  P=0.049 *                (e)                      (e)                      P=0.243         | 
|COCH-ARM / FISHERS |                  P=0.051                  (e)                      (e)                      P=0.252         | 
|ORDER RESTRICTED   |                  P=0.032 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/2 (0%)                 0/4 (0%)                 2/7 (29%)                0/12 (0%)       | 
|POLY-3 RATE (b)    |                  0/0.63                   0/2.47                   2/6.05                   0/7.43          | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     33.1%                    0.0%            | 
|TERMINAL (d)       |                  0/0 (0%)                 0/1 (0%)                 0/2 (0%)                 0/1 (0%)        | 
|FIRST INCIDENCE    |                  ---                      ---                      651                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.495                  (e)                      P=0.391                  (e)             | 
|POLY 3             |                  P=0.369N                 (e)                      P=0.710                  (e)             | 
|POLY 1.5           |                  P=0.366N                 (e)                      P=0.673                  (e)             | 
|POLY 6             |                  P=0.413N                 (e)                      P=0.747                  (e)             | 
|LOGISTIC REGRESSION|                  P=0.454N                 (e)                      P=0.800                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.466N                 (e)                      P=0.583                  (e)             | 
|ORDER RESTRICTED   |                  P=0.642N                 (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/2 (0%)                 0/4 (0%)                 0/7 (0%)                 5/12 (42%)      | 
|POLY-3 RATE (b)    |                  0/0.63                   0/2.47                   0/5.66                   5/9.34          | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     53.5%           | 
|TERMINAL (d)       |                  0/0 (0%)                 0/1 (0%)                 0/2 (0%)                 1/1 (100%)      | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      525             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               (e)                      (e)                      P=0.066         | 
|POLY 3             |                  P=0.013 *                (e)                      (e)                      P=0.630         | 
|POLY 1.5           |                  P=0.016 *                (e)                      (e)                      P=0.567         | 
|POLY 6             |                  P=0.010 *                (e)                      (e)                      P=0.714         | 
|LOGISTIC REGRESSION|                  P=0.019 *                (e)                      (e)                      P=0.494         | 
|COCH-ARM / FISHERS |                  P=0.022 *                (e)                      (e)                      P=0.396         | 
|ORDER RESTRICTED   |                  P=0.544                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/2 (0%)                 1/4 (25%)                0/7 (0%)                 6/12 (50%)      | 
|POLY-3 RATE (b)    |                  0/0.63                   1/2.86                   0/5.66                   6/10.24         | 
|POLY-3 PERCENT (g) |                  0.0%                     35.0%                    0.0%                     58.6%           | 
|TERMINAL (d)       |                  0/0 (0%)                 0/1 (0%)                 0/2 (0%)                 0/1 (0%)        | 
|FIRST INCIDENCE    |                  ---                      618                      ---                      484             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.543                  (e)                      P=0.019 *       | 
|POLY 3             |                  P=0.053                  P=0.744                  (e)                      P=0.604         | 
|POLY 1.5           |                  P=0.051                  P=0.715                  (e)                      P=0.529         | 
|POLY 6             |                  P=0.052                  P=0.778                  (e)                      P=0.695         | 
|LOGISTIC REGRESSION|                  P=0.026 *                P=0.765                  (e)                      P=0.243         | 
|COCH-ARM / FISHERS |                  P=0.043 *                P=0.667                  (e)                      P=0.308         | 
|ORDER RESTRICTED   |                  P=0.550                  (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/2 (0%)                 0/4 (0%)                 0/7 (0%)                 2/12 (17%)      | 
|POLY-3 RATE (b)    |                  0/0.63                   0/2.47                   0/5.66                   2/8.62          | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     23.2%           | 
|TERMINAL (d)       |                  0/0 (0%)                 0/1 (0%)                 0/2 (0%)                 0/1 (0%)        | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      531             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.056                  (e)                      (e)                      P=0.285         | 
|POLY 3             |                  P=0.216                  (e)                      (e)                      P=0.782         | 
|POLY 1.5           |                  P=0.217                  (e)                      (e)                      P=0.757         | 
|POLY 6             |                  P=0.207                  (e)                      (e)                      P=0.812         | 
|LOGISTIC REGRESSION|                  P=0.108                  (e)                      (e)                      P=0.590         | 
|COCH-ARM / FISHERS |                  P=0.185                  (e)                      (e)                      P=0.725         | 
|ORDER RESTRICTED   |                  P=0.640                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  8/52 (15%)               5/53 (9%)                1/52 (2%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  8/33.57                  5/37.22                  1/41.88                  1/32.31         | 
|POLY-3 PERCENT (g) |                  23.8%                    13.4%                    2.4%                     3.1%            | 
|TERMINAL (d)       |                  3/15 (20%)               4/16 (25%)               0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  405                      531                      628                      611             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.004N**               P=0.205N                 P=0.004N**               P=0.051N        | 
|POLY 3             |                  P=0.002N**               P=0.203N                 P=0.005N**               P=0.015N*       | 
|POLY 1.5           |                  P=0.002N**               P=0.223N                 P=0.008N**               P=0.014N*       | 
|POLY 6             |                  P=0.002N**               P=0.190N                 P=0.003N**               P=0.021N*       | 
|LOGISTIC REGRESSION|                  P=0.003N**               P=0.200N                 P=0.011N*                P=0.016N*       | 
|COCH-ARM / FISHERS |                  P=0.004N**               P=0.265N                 P=0.016N*                P=0.014N*       | 
|ORDER RESTRICTED   |                  P=0.003N**               (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  32/52 (62%)              21/53 (40%)              23/52 (44%)              9/53 (17%)      | 
|POLY-3 RATE (b)    |                  32/43.06                 21/40.32                 23/45.33                 9/34.10         | 
|POLY-3 PERCENT (g) |                  74.3%                    52.1%                    50.7%                    26.4%           | 
|TERMINAL (d)       |                  11/15 (73%)              7/16 (44%)               10/23 (44%)              4/7 (57%)       | 
|FIRST INCIDENCE    |                  126                      531                      185                      484             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001N**               P=0.016N*                P=0.002N**               P=0.002N**      | 
|POLY 3             |                  P<0.001N**               P=0.020N*                P=0.013N*                P<0.001N**      | 
|POLY 1.5           |                  P<0.001N**               P=0.022N*                P=0.023N*                P<0.001N**      | 
|POLY 6             |                  P<0.001N**               P=0.019N*                P=0.007N**               P<0.001N**      | 
|LOGISTIC REGRESSION|                  P<0.001N**               P=0.011N*                P=0.045N*                P<0.001N**      | 
|COCH-ARM / FISHERS |                  P<0.001N**               P=0.020N*                P=0.058N                 P<0.001N**      | 
|ORDER RESTRICTED   |                  P<0.001N**               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/52 (2%)                2/53 (4%)                0/52 (0%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  1/31.36                  2/36.61                  0/41.53                  0/31.91         | 
|POLY-3 PERCENT (g) |                  3.2%                     5.5%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  1/15 (7%)                2/16 (13%)               0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.232N                 P=0.523                  P=0.415N                 P=0.652N        | 
|POLY 3             |                  P=0.158N                 P=0.554                  P=0.445N                 P=0.497N        | 
|POLY 1.5           |                  P=0.167N                 P=0.536                  P=0.464N                 P=0.493N        | 
|POLY 6             |                  P=0.146N                 P=0.571                  P=0.424N                 P=0.512N        | 
|LOGISTIC REGRESSION|                  P=0.232N                 P=0.523                  (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.184N                 P=0.507                  P=0.500N                 P=0.495N        | 
|ORDER RESTRICTED   |                  P=0.193N                 (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/52 (4%)                0/53 (0%)                0/52 (0%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  2/31.43                  0/36.61                  0/41.53                  0/31.91         | 
|POLY-3 PERCENT (g) |                  6.4%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  1/15 (7%)                0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  709                      ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.082N                 P=0.203N                 P=0.137N                 P=0.410N        | 
|POLY 3             |                  P=0.081N                 P=0.204N                 P=0.181N                 P=0.232N        | 
|POLY 1.5           |                  P=0.084N                 P=0.214N                 P=0.199N                 P=0.229N        | 
|POLY 6             |                  P=0.072N                 P=0.194N                 P=0.163N                 P=0.249N        | 
|LOGISTIC REGRESSION|                  P=0.071N                 P=0.186N                 P=0.130N                 P=0.330N        | 
|COCH-ARM / FISHERS |                  P=0.086N                 P=0.243N                 P=0.248N                 P=0.243N        | 
|ORDER RESTRICTED   |                  P=0.028N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery                                                                                                                        | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/1 (100%)               0/7 (0%)                 0/13 (0%)                3/11 (27%)      | 
|POLY-3 RATE (b)    |                  1/1.00                   0/6.22                   0/10.00                  3/8.85          | 
|POLY-3 PERCENT (g) |                  100.0%                   0.0%                     0.0%                     33.9%           | 
|TERMINAL (d)       |                  0/0 (0%)                 0/4 (0%)                 0/3 (0%)                 1/2 (50%)       | 
|FIRST INCIDENCE    |                  391                      ---                      ---                      562             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.113                  P=0.473N                 P=0.440N                 P=0.544         | 
|POLY 3             |                  P=0.345                  P<0.001N**               P<0.001N**               P=0.408N        | 
|POLY 1.5           |                  P=0.328                  P<0.001N**               P<0.001N**               P=0.379N        | 
|POLY 6             |                  P=0.403                  P<0.001N**               P<0.001N**               P=0.472N        | 
|LOGISTIC REGRESSION|                  P=0.270                  (e)                      P=0.168N                 P=0.983N        | 
|COCH-ARM / FISHERS |                  P=0.328                  P=0.125N                 P=0.071N                 P=0.333N        | 
|ORDER RESTRICTED   |                  P=0.249N                 (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Artery                                                                                                                | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/1 (0%)                 6/7 (86%)                10/13 (77%)              7/11 (64%)      | 
|POLY-3 RATE (b)    |                  0/0.16                   6/6.85                   10/11.50                 7/9.70          | 
|POLY-3 PERCENT (g) |                  0.0%                     87.6%                    87.0%                    72.2%           | 
|TERMINAL (d)       |                  0/0 (0%)                 4/4 (100%)               3/3 (100%)               1/2 (50%)       | 
|FIRST INCIDENCE    |                  ---                      618                      573                      607             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.008 **               P=0.310                  P=0.050                  P=0.014 *       | 
|POLY 3             |                  P=0.289N                 P=0.873                  P=0.899                  P=0.840         | 
|POLY 1.5           |                  P=0.288N                 P=0.699                  P=0.708                  P=0.711         | 
|POLY 6             |                  P=0.362N                 P=0.955                  P=0.983                  P=0.922         | 
|LOGISTIC REGRESSION|                  P=0.417N                 (e)                      P=0.978                  P=0.991         | 
|COCH-ARM / FISHERS |                  P=0.484N                 P=0.250                  P=0.286                  P=0.417         | 
|ORDER RESTRICTED   |                  P=0.682                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Respiratory Epithelium                                                                                                     | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                2/52 (4%)                2/53 (4%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  2/32.23                  2/36.06                  2/42.16                  1/32.29         | 
|POLY-3 PERCENT (g) |                  6.2%                     5.6%                     4.7%                     3.1%            | 
|TERMINAL (d)       |                  1/15 (7%)                1/16 (6%)                1/23 (4%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  391                      607                      720                      618             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.453N                 P=0.648N                 P=0.550N                 P=0.577N        | 
|POLY 3             |                  P=0.360N                 P=0.654N                 P=0.593N                 P=0.499N        | 
|POLY 1.5           |                  P=0.358N                 P=0.671N                 P=0.628N                 P=0.493N        | 
|POLY 6             |                  P=0.369N                 P=0.639N                 P=0.555N                 P=0.526N        | 
|LOGISTIC REGRESSION|                  P=0.358N                 P=0.689N                 P=0.658N                 P=0.499N        | 
|COCH-ARM / FISHERS |                  P=0.370N                 P=0.684                  P=0.691N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.461N                 (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Turbinate                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                2/52 (4%)                0/53 (0%)                4/53 (8%)       | 
|POLY-3 RATE (b)    |                  2/31.81                  2/36.29                  0/42.13                  4/32.97         | 
|POLY-3 PERCENT (g) |                  6.3%                     5.5%                     0.0%                     12.1%           | 
|TERMINAL (d)       |                  1/15 (7%)                0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  603                      607                      ---                      611             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.201                  P=0.608N                 P=0.155N                 P=0.251         | 
|POLY 3             |                  P=0.275                  P=0.647N                 P=0.181N                 P=0.350         | 
|POLY 1.5           |                  P=0.271                  P=0.666N                 P=0.198N                 P=0.354         | 
|POLY 6             |                  P=0.280                  P=0.629N                 P=0.164N                 P=0.323         | 
|LOGISTIC REGRESSION|                  P=0.256                  P=0.665N                 P=0.184N                 P=0.333         | 
|COCH-ARM / FISHERS |                  P=0.256                  P=0.684                  P=0.248N                 P=0.339         | 
|ORDER RESTRICTED   |                  P=0.116                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Mucosa: Gingival                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/1 (100%)               0/2 (0%)                 4/6 (67%)                3/11 (27%)      | 
|POLY-3 RATE (b)    |                  1/1.00                   0/1.61                   4/5.29                   3/8.09          | 
|POLY-3 PERCENT (g) |                  100.0%                   0.0%                     75.6%                    37.1%           | 
|TERMINAL (d)       |                  1/1 (100%)               0/1 (0%)                 3/3 (100%)               1/1 (100%)      | 
|FIRST INCIDENCE    |                  727 (T)                  ---                      651                      531             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.043 *                P=0.500N                 P=0.627                  P=0.247         | 
|POLY 3             |                  P=0.249N                 P=0.085N                 P=0.783N                 P=0.438N        | 
|POLY 1.5           |                  P=0.217N                 P<0.001N**               P=0.741N                 P=0.392N        | 
|POLY 6             |                  P=0.375N                 P=0.303N                 P=0.822N                 P=0.546N        | 
|LOGISTIC REGRESSION|                  P=0.471N                 (e)                      P=0.872N                 P=0.529N        | 
|COCH-ARM / FISHERS |                  P=0.214N                 P=0.333N                 P=0.714N                 P=0.333N        | 
|ORDER RESTRICTED   |                  P=0.396N                 (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  45/52 (87%)              47/52 (90%)              46/52 (88%)              33/53 (62%)     | 
|POLY-3 RATE (b)    |                  45/46.65                 47/49.76                 46/50.55                 33/43.43        | 
|POLY-3 PERCENT (g) |                  96.5%                    94.5%                    91.0%                    76.0%           | 
|TERMINAL (d)       |                  14/15 (93%)              15/16 (94%)              22/23 (96%)              5/7 (71%)       | 
|FIRST INCIDENCE    |                  126                      163                      320                      243             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.254N                 P=0.310N                 P=0.016N*                P=0.336N        | 
|POLY 3             |                  P<0.001N**               P=0.508N                 P=0.232N                 P<0.001N**      | 
|POLY 1.5           |                  P<0.001N**               P=0.619N                 P=0.360N                 P<0.001N**      | 
|POLY 6             |                  P<0.001N**               P=0.539N                 P=0.195N                 P=0.005N**      | 
|LOGISTIC REGRESSION|                  P<0.001N**               P=0.492                  P=0.388N                 P=0.002N**      | 
|COCH-ARM / FISHERS |                  P<0.001N**               P=0.380                  P=0.500                  P=0.004N**      | 
|ORDER RESTRICTED   |                  P<0.001N**               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  12/52 (23%)              16/52 (31%)              18/52 (35%)              11/53 (21%)     | 
|POLY-3 RATE (b)    |                  12/33.36                 16/40.40                 18/44.23                 11/35.26        | 
|POLY-3 PERCENT (g) |                  36.0%                    39.6%                    40.7%                    31.2%           | 
|TERMINAL (d)       |                  7/15 (47%)               6/16 (38%)               9/23 (39%)               1/7 (14%)       | 
|FIRST INCIDENCE    |                  547                      331                      498                      525             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.366                  P=0.419                  P=0.552N                 P=0.380         | 
|POLY 3             |                  P=0.361N                 P=0.468                  P=0.425                  P=0.433N        | 
|POLY 1.5           |                  P=0.361N                 P=0.378                  P=0.304                  P=0.440N        | 
|POLY 6             |                  P=0.397N                 P=0.567                  P=0.569                  P=0.465N        | 
|LOGISTIC REGRESSION|                  P=0.382N                 P=0.348                  P=0.415                  P=0.492N        | 
|COCH-ARM / FISHERS |                  P=0.402N                 P=0.254                  P=0.140                  P=0.479N        | 
|ORDER RESTRICTED   |                  P=0.408N                 (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                0/52 (0%)                2/52 (4%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  0/31.36                  0/35.84                  2/41.53                  0/31.91         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     4.8%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                2/23 (9%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  ---                      ---                      727 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.431                  (e)                      P=0.336                  (e)             | 
|POLY 3             |                  P=0.494                  (e)                      P=0.304                  (e)             | 
|POLY 1.5           |                  P=0.523                  (e)                      P=0.280                  (e)             | 
|POLY 6             |                  P=0.422                  (e)                      P=0.333                  (e)             | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      P=0.336                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.542                  (e)                      P=0.248                  (e)             | 
|ORDER RESTRICTED   |                  P=0.303                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oviduct                                                                                                                          | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/1 (100%)               0/1 (0%)                 2/3 (67%)                1/1 (100%)      | 
|POLY-3 RATE (b)    |                  1/1.00                   0/0.98                   2/2.72                   1/1.00          | 
|POLY-3 PERCENT (g) |                  100.0%                   0.0%                     73.6%                    100.0%          | 
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)                 2/2 (100%)               1/1 (100%)      | 
|FIRST INCIDENCE    |                  709                      ---                      727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.282N                 P=0.477N                 P=0.411N                 (e)             | 
|POLY 3             |                  P=0.603                  P=1.000N                 P=0.786N                 (e)             | 
|POLY 1.5           |                  P=0.593                  P=1.000N                 P=0.737N                 (e)             | 
|POLY 6             |                  P=0.627                  P=1.000N                 P=0.885N                 (e)             | 
|LOGISTIC REGRESSION|                  P=0.714                  (e)                      P=0.411N                 (e)             | 
|COCH-ARM / FISHERS |                  P=0.604                  P=0.500N                 P=0.750N                 (e)             | 
|ORDER RESTRICTED   |                  P=0.426                  (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/51 (10%)               4/53 (8%)                6/52 (12%)               13/51 (25%)     | 
|POLY-3 RATE (b)    |                  5/32.80                  4/37.40                  6/43.08                  13/35.71        | 
|POLY-3 PERCENT (g) |                  15.2%                    10.7%                    13.9%                    36.4%           | 
|TERMINAL (d)       |                  3/15 (20%)               0/16 (0%)                1/23 (4%)                2/7 (29%)       | 
|FIRST INCIDENCE    |                  391                      618                      573                      531             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.003 **               P=0.405N                 P=0.478N                 P=0.019 *       | 
|POLY 3             |                  P=0.008 **               P=0.416N                 P=0.566N                 P=0.037 *       | 
|POLY 1.5           |                  P=0.007 **               P=0.442N                 P=0.623                  P=0.034 *       | 
|POLY 6             |                  P=0.008 **               P=0.387N                 P=0.486N                 P=0.040 *       | 
|LOGISTIC REGRESSION|                  P=0.007 **               P=0.435N                 P=0.563                  P=0.034 *       | 
|COCH-ARM / FISHERS |                  P=0.008 **               P=0.475N                 P=0.514                  P=0.034 *       | 
|ORDER RESTRICTED   |                  P=0.009 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/51 (10%)               2/53 (4%)                11/52 (21%)              18/51 (35%)     | 
|POLY-3 RATE (b)    |                  5/31.43                  2/37.14                  11/43.58                 18/37.39        | 
|POLY-3 PERCENT (g) |                  15.9%                    5.4%                     25.2%                    48.1%           | 
|TERMINAL (d)       |                  4/15 (27%)               0/16 (0%)                2/23 (9%)                2/7 (29%)       | 
|FIRST INCIDENCE    |                  705                      618                      573                      531             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.164N                 P=0.382                  P<0.001 **      | 
|POLY 3             |                  P<0.001 **               P=0.149N                 P=0.248                  P=0.003 **      | 
|POLY 1.5           |                  P<0.001 **               P=0.170N                 P=0.175                  P=0.002 **      | 
|POLY 6             |                  P<0.001 **               P=0.128N                 P=0.359                  P=0.005 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.132N                 P=0.244                  P=0.002 **      | 
|COCH-ARM / FISHERS |                  P<0.001 **               P=0.203N                 P=0.093                  P=0.002 **      | 
|ORDER RESTRICTED   |                  P<0.001 **               (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/51 (0%)                9/53 (17%)               20/52 (38%)              23/51 (45%)     | 
|POLY-3 RATE (b)    |                  0/31.35                  9/37.20                  20/42.74                 23/36.28        | 
|POLY-3 PERCENT (g) |                  0.0%                     24.2%                    46.8%                    63.4%           | 
|TERMINAL (d)       |                  0/15 (0%)                6/16 (38%)               14/23 (61%)              6/7 (86%)       | 
|FIRST INCIDENCE    |                  ---                      607                      618                      525             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.004 **               P<0.001 **               P<0.001 **      | 
|POLY 3             |                  P<0.001 **               P=0.003 **               P<0.001 **               P<0.001 **      | 
|POLY 1.5           |                  P<0.001 **               P=0.003 **               P<0.001 **               P<0.001 **      | 
|POLY 6             |                  P<0.001 **               P=0.004 **               P<0.001 **               P<0.001 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.005 **               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)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Artery                                                                                                                 | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/51 (0%)                8/53 (15%)               15/52 (29%)              11/51 (22%)     | 
|POLY-3 RATE (b)    |                  0/31.35                  8/37.31                  15/42.61                 11/35.04        | 
|POLY-3 PERCENT (g) |                  0.0%                     21.4%                    35.2%                    31.4%           | 
|TERMINAL (d)       |                  0/15 (0%)                5/16 (31%)               8/23 (35%)               2/7 (29%)       | 
|FIRST INCIDENCE    |                  ---                      618                      588                      188             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.009 **               P=0.002 **               P<0.001 **      | 
|POLY 3             |                  P=0.002 **               P=0.007 **               P<0.001 **               P<0.001 **      | 
|POLY 1.5           |                  P=0.002 **               P=0.006 **               P<0.001 **               P<0.001 **      | 
|POLY 6             |                  P=0.002 **               P=0.008 **               P<0.001 **               P<0.001 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.010 *                P<0.001 **               P<0.001 **      | 
|COCH-ARM / FISHERS |                  P=0.002 **               P=0.003 **               P<0.001 **               P<0.001 **      | 
|ORDER RESTRICTED   |                  P<0.001 **               (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Duct                                                                                                                   | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/51 (0%)                0/53 (0%)                0/52 (0%)                2/51 (4%)       | 
|POLY-3 RATE (b)    |                  0/31.35                  0/36.61                  0/41.53                  2/31.51         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     6.4%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      603             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.035 *                (e)                      (e)                      P=0.230         | 
|POLY 3             |                  P=0.047 *                (e)                      (e)                      P=0.236         | 
|POLY 1.5           |                  P=0.048 *                (e)                      (e)                      P=0.239         | 
|POLY 6             |                  P=0.047 *                (e)                      (e)                      P=0.225         | 
|LOGISTIC REGRESSION|                  P=0.044 *                (e)                      (e)                      P=0.233         | 
|COCH-ARM / FISHERS |                  P=0.048 *                (e)                      (e)                      P=0.248         | 
|ORDER RESTRICTED   |                  P=0.029 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Duct                                                                                                                   | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/51 (0%)                0/53 (0%)                2/52 (4%)                0/51 (0%)       | 
|POLY-3 RATE (b)    |                  0/31.35                  0/36.61                  2/41.71                  0/30.95         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     4.8%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                1/23 (4%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  ---                      ---                      678                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.477                  (e)                      P=0.362                  (e)             | 
|POLY 3             |                  P=0.484                  (e)                      P=0.305                  (e)             | 
|POLY 1.5           |                  P=0.512                  (e)                      P=0.281                  (e)             | 
|POLY 6             |                  P=0.419                  (e)                      P=0.335                  (e)             | 
|LOGISTIC REGRESSION|                  P=0.517                  (e)                      P=0.329                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.537                  (e)                      P=0.252                  (e)             | 
|ORDER RESTRICTED   |                  P=0.305                  (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  14/51 (27%)              16/53 (30%)              19/53 (36%)              9/53 (17%)      | 
|POLY-3 RATE (b)    |                  14/33.32                 16/38.31                 19/44.06                 9/33.36         | 
|POLY-3 PERCENT (g) |                  42.0%                    41.8%                    43.1%                    27.0%           | 
|TERMINAL (d)       |                  7/15 (47%)               8/16 (50%)               12/23 (52%)              3/7 (43%)       | 
|FIRST INCIDENCE    |                  546                      607                      588                      588             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.498N                 P=0.557N                 P=0.410N                 P=0.573N        | 
|POLY 3             |                  P=0.130N                 P=0.590N                 P=0.554                  P=0.139N        | 
|POLY 1.5           |                  P=0.116N                 P=0.561                  P=0.444                  P=0.127N        | 
|POLY 6             |                  P=0.185N                 P=0.569N                 P=0.531N                 P=0.202N        | 
|LOGISTIC REGRESSION|                  P=0.141N                 P=0.500N                 P=0.536N                 P=0.176N        | 
|COCH-ARM / FISHERS |                  P=0.135N                 P=0.464                  P=0.239                  P=0.147N        | 
|ORDER RESTRICTED   |                  P=0.157N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/51 (0%)                0/53 (0%)                2/53 (4%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  0/30.88                  0/36.61                  2/42.60                  1/32.52         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     4.7%                     3.1%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                1/23 (4%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  ---                      ---                      588                      530             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.189                  (e)                      P=0.329                  P=0.525         | 
|POLY 3             |                  P=0.205                  (e)                      P=0.314                  P=0.510         | 
|POLY 1.5           |                  P=0.219                  (e)                      P=0.290                  P=0.513         | 
|POLY 6             |                  P=0.174                  (e)                      P=0.342                  P=0.496         | 
|LOGISTIC REGRESSION|                  P=0.225                  (e)                      P=0.278                  P=0.503         | 
|COCH-ARM / FISHERS |                  P=0.225                  (e)                      P=0.257                  P=0.510         | 
|ORDER RESTRICTED   |                  P=0.236                  (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/51 (0%)                3/53 (6%)                1/53 (2%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  0/30.88                  3/36.91                  1/42.13                  0/31.91         | 
|POLY-3 PERCENT (g) |                  0.0%                     8.1%                     2.4%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                2/16 (13%)               1/23 (4%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  ---                      645                      727 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.519N                 P=0.145                  P=0.585                  (e)             | 
|POLY 3             |                  P=0.361N                 P=0.152                  P=0.561                  (e)             | 
|POLY 1.5           |                  P=0.367N                 P=0.142                  P=0.543                  (e)             | 
|POLY 6             |                  P=0.368N                 P=0.161                  P=0.579                  (e)             | 
|LOGISTIC REGRESSION|                  P=0.433N                 P=0.159                  P=0.585                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.395N                 P=0.129                  P=0.510                  (e)             | 
|ORDER RESTRICTED   |                  P=0.250N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  18/51 (35%)              21/53 (40%)              26/53 (49%)              17/53 (32%)     | 
|POLY-3 RATE (b)    |                  18/36.64                 21/40.94                 26/43.52                 17/36.71        | 
|POLY-3 PERCENT (g) |                  49.1%                    51.3%                    59.7%                    46.3%           | 
|TERMINAL (d)       |                  4/15 (27%)               7/16 (44%)               18/23 (78%)              3/7 (43%)       | 
|FIRST INCIDENCE    |                  400                      541                      637                      531             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.225                  P=0.532N                 P=0.469N                 P=0.396         | 
|POLY 3             |                  P=0.501N                 P=0.515                  P=0.224                  P=0.497N        | 
|POLY 1.5           |                  P=0.435N                 P=0.483                  P=0.200                  P=0.445N        | 
|POLY 6             |                  P=0.425                  P=0.531                  P=0.219                  P=0.582         | 
|LOGISTIC REGRESSION|                  P=0.406N                 P=0.538                  P=0.434                  P=0.425N        | 
|COCH-ARM / FISHERS |                  P=0.429N                 P=0.400                  P=0.111                  P=0.444N        | 
|ORDER RESTRICTED   |                  P=0.413N                 (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  39/52 (75%)              41/53 (77%)              42/52 (81%)              37/52 (71%)     | 
|POLY-3 RATE (b)    |                  39/47.51                 41/47.65                 42/47.95                 37/44.38        | 
|POLY-3 PERCENT (g) |                  82.1%                    86.1%                    87.6%                    83.4%           | 
|TERMINAL (d)       |                  8/15 (53%)               15/16 (94%)              22/23 (96%)              6/7 (86%)       | 
|FIRST INCIDENCE    |                  126                      40                       320                      72              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.248                  P=0.353N                 P=0.056N                 P=0.344         | 
|POLY 3             |                  P=0.477                  P=0.395                  P=0.313                  P=0.550         | 
|POLY 1.5           |                  P=0.480N                 P=0.472                  P=0.337                  P=0.534N        | 
|POLY 6             |                  P=0.256                  P=0.258                  P=0.260                  P=0.327         | 
|LOGISTIC REGRESSION|                  P=0.338N                 P=0.514                  P=0.491                  P=0.404N        | 
|COCH-ARM / FISHERS |                  P=0.363N                 P=0.478                  P=0.319                  P=0.413N        | 
|ORDER RESTRICTED   |                  P=0.470                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                1/53 (2%)                1/52 (2%)                3/52 (6%)       | 
|POLY-3 RATE (b)    |                  0/31.36                  1/36.86                  1/41.53                  3/32.34         | 
|POLY-3 PERCENT (g) |                  0.0%                     2.7%                     2.4%                     9.3%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                1/23 (4%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  ---                      659                      727 (T)                  603             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.034 *                P=0.548                  P=0.585                  P=0.146         | 
|POLY 3             |                  P=0.054                  P=0.532                  P=0.555                  P=0.121         | 
|POLY 1.5           |                  P=0.054                  P=0.521                  P=0.536                  P=0.123         | 
|POLY 6             |                  P=0.052                  P=0.543                  P=0.576                  P=0.112         | 
|LOGISTIC REGRESSION|                  P=0.048 *                P=0.526                  P=0.585                  P=0.121         | 
|COCH-ARM / FISHERS |                  P=0.052                  P=0.505                  P=0.500                  P=0.121         | 
|ORDER RESTRICTED   |                  P=0.038 *                (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  49/52 (94%)              52/53 (98%)              52/52 (100%)             50/52 (96%)     | 
|POLY-3 RATE (b)    |                  49/49.42                 52/52.75                 52/52.00                 50/50.58        | 
|POLY-3 PERCENT (g) |                  99.2%                    98.6%                    100.0%                   98.9%           | 
|TERMINAL (d)       |                  15/15 (100%)             16/16 (100%)             23/23 (100%)             7/7 (100%)      | 
|FIRST INCIDENCE    |                  126                      40                       185                      188             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.127                  P=0.338N                 P=0.023N*                P=0.149         | 
|POLY 3             |                  P=0.725                  P=0.807N                 P=0.958                  P=0.895N        | 
|POLY 1.5           |                  P=0.548                  P=0.779                  P=0.503                  P=0.787         | 
|POLY 6             |                  P=0.782N                 P=0.845N                 P=1.000                  P=0.985N        | 
|LOGISTIC REGRESSION|                  P=0.435                  P=0.347                  P=0.303                  P=0.541         | 
|COCH-ARM / FISHERS |                  P=0.391                  P=0.302                  P=0.121                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.540                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                5/53 (9%)                3/52 (6%)                6/52 (12%)      | 
|POLY-3 RATE (b)    |                  0/31.36                  5/39.29                  3/42.88                  6/33.93         | 
|POLY-3 PERCENT (g) |                  0.0%                     12.7%                    7.0%                     17.7%           | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  ---                      163                      440                      531             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.030 *                P=0.056                  P=0.210                  P=0.028 *       | 
|POLY 3             |                  P=0.041 *                P=0.053                  P=0.185                  P=0.018 *       | 
|POLY 1.5           |                  P=0.037 *                P=0.045 *                P=0.159                  P=0.017 *       | 
|POLY 6             |                  P=0.042 *                P=0.064                  P=0.218                  P=0.016 *       | 
|LOGISTIC REGRESSION|                  P=0.031 *                P=0.026 *                P=0.088                  P=0.018 *       | 
|COCH-ARM / FISHERS |                  P=0.031 *                P=0.030 *                P=0.121                  P=0.013 *       | 
|ORDER RESTRICTED   |                  P=0.013 *                (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Red Pulp                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                1/53 (2%)                0/52 (0%)                2/52 (4%)       | 
|POLY-3 RATE (b)    |                  0/31.36                  1/36.99                  0/41.53                  2/32.44         | 
|POLY-3 PERCENT (g) |                  0.0%                     2.7%                     0.0%                     6.2%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  ---                      618                      ---                      309             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.134                  P=0.559                  (e)                      P=0.260         | 
|POLY 3             |                  P=0.148                  P=0.533                  (e)                      P=0.243         | 
|POLY 1.5           |                  P=0.145                  P=0.522                  (e)                      P=0.244         | 
|POLY 6             |                  P=0.148                  P=0.544                  (e)                      P=0.230         | 
|LOGISTIC REGRESSION|                  P=0.137                  P=0.511                  (e)                      P=0.227         | 
|COCH-ARM / FISHERS |                  P=0.136                  P=0.505                  (e)                      P=0.248         | 
|ORDER RESTRICTED   |                  P=0.078                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Hyperkeratosis                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                3/53 (6%)                1/51 (2%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  0/31.36                  3/37.14                  1/41.62                  2/32.22         | 
|POLY-3 PERCENT (g) |                  0.0%                     8.1%                     2.4%                     6.2%            | 
|TERMINAL (d)       |                  0/15 (0%)                1/16 (6%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  ---                      618                      678                      681             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.229                  P=0.162                  P=0.627                  P=0.192         | 
|POLY 3             |                  P=0.333                  P=0.150                  P=0.555                  P=0.241         | 
|POLY 1.5           |                  P=0.329                  P=0.139                  P=0.535                  P=0.245         | 
|POLY 6             |                  P=0.325                  P=0.163                  P=0.577                  P=0.226         | 
|LOGISTIC REGRESSION|                  P=0.289                  P=0.150                  P=0.553                  P=0.207         | 
|COCH-ARM / FISHERS |                  P=0.309                  P=0.125                  P=0.495                  P=0.252         | 
|ORDER RESTRICTED   |                  P=0.190                  (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/52 (6%)                5/53 (9%)                6/51 (12%)               8/53 (15%)      | 
|POLY-3 RATE (b)    |                  3/32.29                  5/38.68                  6/42.62                  8/34.42         | 
|POLY-3 PERCENT (g) |                  9.3%                     12.9%                    14.1%                    23.2%           | 
|TERMINAL (d)       |                  1/15 (7%)                1/16 (6%)                2/23 (9%)                1/7 (14%)       | 
|FIRST INCIDENCE    |                  391                      301                      320                      244             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.026 *                P=0.440                  P=0.484                  P=0.046 *       | 
|POLY 3             |                  P=0.077                  P=0.458                  P=0.395                  P=0.109         | 
|POLY 1.5           |                  P=0.079                  P=0.423                  P=0.336                  P=0.113         | 
|POLY 6             |                  P=0.068                  P=0.496                  P=0.462                  P=0.093         | 
|LOGISTIC REGRESSION|                  P=0.073                  P=0.362                  P=0.257                  P=0.109         | 
|COCH-ARM / FISHERS |                  P=0.073                  P=0.369                  P=0.234                  P=0.107         | 
|ORDER RESTRICTED   |                  P=0.094                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/52 (2%)                0/53 (0%)                1/51 (2%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  1/32.34                  0/36.61                  1/41.94                  2/33.34         | 
|POLY-3 PERCENT (g) |                  3.1%                     0.0%                     2.4%                     6.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  201                      ---                      573                      72              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.273                  P=0.496N                 P=0.719N                 P=0.524         | 
|POLY 3             |                  P=0.255                  P=0.475N                 P=0.699N                 P=0.511         | 
|POLY 1.5           |                  P=0.261                  P=0.484N                 P=0.724N                 P=0.515         | 
|POLY 6             |                  P=0.243                  P=0.467N                 P=0.670N                 P=0.489         | 
|LOGISTIC REGRESSION|                  P=0.234                  P=0.484N                 P=0.567                  P=0.476         | 
|COCH-ARM / FISHERS |                  P=0.259                  P=0.495N                 P=0.748                  P=0.507         | 
|ORDER RESTRICTED   |                  P=0.224                  (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/52 (6%)                3/53 (6%)                2/51 (4%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  3/32.17                  3/37.14                  2/42.54                  2/32.69         | 
|POLY-3 PERCENT (g) |                  9.3%                     8.1%                     4.7%                     6.1%            | 
|TERMINAL (d)       |                  1/15 (7%)                1/16 (6%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  574                      618                      320                      603             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.407N                 P=0.578N                 P=0.338N                 P=0.568N        | 
|POLY 3             |                  P=0.337N                 P=0.596N                 P=0.376N                 P=0.493N        | 
|POLY 1.5           |                  P=0.341N                 P=0.617N                 P=0.419N                 P=0.485N        | 
|POLY 6             |                  P=0.338N                 P=0.577N                 P=0.334N                 P=0.528N        | 
|LOGISTIC REGRESSION|                  P=0.354N                 P=0.599N                 P=0.567N                 P=0.490N        | 
|COCH-ARM / FISHERS |                  P=0.358N                 P=0.652N                 P=0.509N                 P=0.491N        | 
|ORDER RESTRICTED   |                  P=0.433N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  37/50 (74%)              36/41 (88%)              47/49 (96%)              41/44 (93%)     | 
|POLY-3 RATE (b)    |                  37/45.02                 36/36.59                 47/48.09                 41/41.71        | 
|POLY-3 PERCENT (g) |                  82.2%                    98.4%                    97.7%                    98.3%           | 
|TERMINAL (d)       |                  9/15 (60%)               14/14 (100%)             22/23 (96%)              7/7 (100%)      | 
|FIRST INCIDENCE    |                  126                      531                      185                      72              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.029 *                P=0.293N                 P=0.233N                 P=0.115         | 
|POLY 3             |                  P<0.001 **               P=0.014 *                P=0.010 *                P=0.010 *       | 
|POLY 1.5           |                  P<0.001 **               P=0.018 *                P=0.005 **               P=0.008 **      | 
|POLY 6             |                  P=0.002 **               P=0.013 *                P=0.017 *                P=0.012 *       | 
|LOGISTIC REGRESSION|                  P=0.005 **               P=0.168                  P=0.009 **               P=0.016 *       | 
|COCH-ARM / FISHERS |                  P=0.003 **               P=0.082                  P=0.002 **               P=0.012 *       | 
|ORDER RESTRICTED   |                  P<0.001 **               (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                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  12/52 (23%)              18/52 (35%)              16/50 (32%)              19/48 (40%)     | 
|POLY-3 RATE (b)    |                  12/33.93                 18/39.59                 16/42.33                 19/35.88        | 
|POLY-3 PERCENT (g) |                  35.4%                    45.5%                    37.8%                    53.0%           | 
|TERMINAL (d)       |                  5/15 (33%)               6/16 (38%)               12/23 (52%)              2/7 (29%)       | 
|FIRST INCIDENCE    |                  541                      531                      554                      484             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.023 *                P=0.321                  P=0.412N                 P=0.036 *       | 
|POLY 3             |                  P=0.122                  P=0.255                  P=0.508                  P=0.096         | 
|POLY 1.5           |                  P=0.100                  P=0.201                  P=0.401                  P=0.078         | 
|POLY 6             |                  P=0.133                  P=0.320                  P=0.586N                 P=0.108         | 
|LOGISTIC REGRESSION|                  P=0.078                  P=0.229                  P=0.591N                 P=0.066         | 
|COCH-ARM / FISHERS |                  P=0.065                  P=0.140                  P=0.216                  P=0.058         | 
|ORDER RESTRICTED   |                  P=0.106                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  9/52 (17%)               28/52 (54%)              26/50 (52%)              16/48 (33%)     | 
|POLY-3 RATE (b)    |                  9/37.19                  28/42.67                 26/45.46                 16/37.59        | 
|POLY-3 PERCENT (g) |                  24.2%                    65.6%                    57.2%                    42.6%           | 
|TERMINAL (d)       |                  2/15 (13%)               12/16 (75%)              15/23 (65%)              2/7 (29%)       | 
|FIRST INCIDENCE    |                  201                      247                      320                      72              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.059                  P=0.002 **               P=0.030 *                P=0.053         | 
|POLY 3             |                  P=0.229                  P<0.001 **               P<0.001 **               P=0.066         | 
|POLY 1.5           |                  P=0.198                  P<0.001 **               P<0.001 **               P=0.064         | 
|POLY 6             |                  P=0.236                  P<0.001 **               P=0.005 **               P=0.060         | 
|LOGISTIC REGRESSION|                  P=0.122                  P<0.001 **               P<0.001 **               P=0.025 *       | 
|COCH-ARM / FISHERS |                  P=0.130                  P<0.001 **               P<0.001 **               P=0.053         | 
|ORDER RESTRICTED   |                  P=0.003 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 53      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth: Peridontal Tissue                                                                                                         | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  10/12 (83%)              10/10 (100%)             8/9 (89%)                18/19 (95%)     | 
|POLY-3 RATE (b)    |                  10/12.00                 10/10.00                 8/9.00                   18/18.62        | 
|POLY-3 PERCENT (g) |                  83.3%                    100.0%                   88.9%                    96.7%           | 
|TERMINAL (d)       |                  5/7 (71%)                4/4 (100%)               5/6 (83%)                4/4 (100%)      | 
|FIRST INCIDENCE    |                  405                      531                      573                      188             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.003 **               P=0.480                  P=0.285N                 P=0.011 *       | 
|POLY 3             |                  P=0.225                  P=0.272                  P=0.602                  P=0.258         | 
|POLY 1.5           |                  P=0.263                  P=0.272                  P=0.602                  P=0.294         | 
|POLY 6             |                  P=0.175                  P=0.272                  P=0.602                  P=0.208         | 
|LOGISTIC REGRESSION|                  P=0.412                  (e)                      (e)                      P=0.450         | 
|COCH-ARM / FISHERS |                  P=0.311                  P=0.286                  P=0.612                  P=0.328         | 
|ORDER RESTRICTED   |                  P=0.100                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth: Peridontal Tissue                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/12 (17%)               0/10 (0%)                1/9 (11%)                0/19 (0%)       | 
|POLY-3 RATE (b)    |                  2/9.81                   0/8.18                   1/8.19                   0/12.13         | 
|POLY-3 PERCENT (g) |                  20.4%                    0.0%                     12.2%                    0.0%            | 
|TERMINAL (d)       |                  2/7 (29%)                0/4 (0%)                 1/6 (17%)                0/4 (0%)        | 
|FIRST INCIDENCE    |                  727 (T)                  ---                      727 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.229N                 P=0.362N                 P=0.558N                 P=0.362N        | 
|POLY 3             |                  P=0.126N                 P=0.268N                 P=0.566N                 P=0.174N        | 
|POLY 1.5           |                  P=0.120N                 P=0.267N                 P=0.579N                 P=0.158N        | 
|POLY 6             |                  P=0.141N                 P=0.277N                 P=0.553N                 P=0.202N        | 
|LOGISTIC REGRESSION|                  P=0.229N                 (e)                      P=0.558N                 (e)             | 
|COCH-ARM / FISHERS |                  P=0.106N                 P=0.286N                 P=0.612N                 P=0.142N        | 
|ORDER RESTRICTED   |                  P=0.041N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 54      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ureter                                                                                                                           | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/0 (0%)                 0/0 (0%)                 0/0 (0%)                 2/3 (67%)       | 
|POLY-3 RATE (b)    |                  0/0.00                   0/0.00                   0/0.00                   2/2.75          | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     72.8%           | 
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)                 0/0 (0%)                 0/0 (0%)        | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      309             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.042 *                (e)                      (e)                      P=0.245         | 
|POLY 3             |                  (e)                      (e)                      (e)                      (e)             | 
|POLY 1.5           |                  (e)                      (e)                      (e)                      (e)             | 
|POLY 6             |                  (e)                      (e)                      (e)                      (e)             | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=1.000N                 (e)                      (e)                      P=1.000         | 
|ORDER RESTRICTED   |                  (e)                      (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ureter                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/0 (0%)                 0/0 (0%)                 0/0 (0%)                 2/3 (67%)       | 
|POLY-3 RATE (b)    |                  0/0.00                   0/0.00                   0/0.00                   2/2.08          | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     96.3%           | 
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)                 0/0 (0%)                 0/0 (0%)        | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      588             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.164                  (e)                      (e)                      P=0.471         | 
|POLY 3             |                  (e)                      (e)                      (e)                      (e)             | 
|POLY 1.5           |                  (e)                      (e)                      (e)                      (e)             | 
|POLY 6             |                  (e)                      (e)                      (e)                      (e)             | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=1.000N                 (e)                      (e)                      P=1.000         | 
|ORDER RESTRICTED   |                  (e)                      (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 55      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ureter: Transitional Epithelium                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/0 (0%)                 0/0 (0%)                 0/0 (0%)                 3/3 (100%)      | 
|POLY-3 RATE (b)    |                  0/0.00                   0/0.00                   0/0.00                   3/3.00          | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     100.0%          | 
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)                 0/0 (0%)                 0/0 (0%)        | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      309             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  (e)                      (e)                      (e)                      (e)             | 
|POLY 3             |                  (e)                      (e)                      (e)                      (e)             | 
|POLY 1.5           |                  (e)                      (e)                      (e)                      (e)             | 
|POLY 6             |                  (e)                      (e)                      (e)                      (e)             | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  (e)                      (e)                      (e)                      (e)             | 
|ORDER RESTRICTED   |                  (e)                      (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/51 (8%)                7/52 (13%)               4/52 (8%)                6/53 (11%)      | 
|POLY-3 RATE (b)    |                  4/32.86                  7/39.11                  4/42.47                  6/34.02         | 
|POLY-3 PERCENT (g) |                  12.2%                    17.9%                    9.4%                     17.6%           | 
|TERMINAL (d)       |                  0/15 (0%)                2/16 (13%)               1/23 (4%)                1/7 (14%)       | 
|FIRST INCIDENCE    |                  391                      301                      573                      309             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.338                  P=0.358                  P=0.421N                 P=0.276         | 
|POLY 3             |                  P=0.443                  P=0.366                  P=0.497N                 P=0.387         | 
|POLY 1.5           |                  P=0.452                  P=0.331                  P=0.543N                 P=0.402         | 
|POLY 6             |                  P=0.417                  P=0.398                  P=0.448N                 P=0.337         | 
|LOGISTIC REGRESSION|                  P=0.429                  P=0.247                  P=0.639                  P=0.395         | 
|COCH-ARM / FISHERS |                  P=0.435                  P=0.274                  P=0.631N                 P=0.395         | 
|ORDER RESTRICTED   |                  P=0.427                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 56      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder: Transitional Epithelium                                                                                         | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/51 (2%)                1/52 (2%)                2/52 (4%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  1/31.35                  1/36.79                  2/41.91                  2/32.25         | 
|POLY-3 PERCENT (g) |                  3.2%                     2.7%                     4.8%                     6.2%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                1/23 (4%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  574                      301                      618                      660             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.265                  P=0.734N                 P=0.642                  P=0.425         | 
|POLY 3             |                  P=0.322                  P=0.725N                 P=0.599                  P=0.510         | 
|POLY 1.5           |                  P=0.335                  P=0.736N                 P=0.568                  P=0.518         | 
|POLY 6             |                  P=0.296                  P=0.716N                 P=0.631                  P=0.481         | 
|LOGISTIC REGRESSION|                  P=0.337                  P=0.741                  P=0.540                  P=0.510         | 
|COCH-ARM / FISHERS |                  P=0.338                  P=0.748N                 P=0.507                  P=0.515         | 
|ORDER RESTRICTED   |                  P=0.428                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Adenomyosis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                0/53 (0%)                2/52 (4%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  0/31.36                  0/36.61                  2/41.91                  0/31.91         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     4.8%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/16 (0%)                1/23 (4%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  ---                      ---                      618                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.489                  (e)                      P=0.344                  (e)             | 
|POLY 3             |                  P=0.491                  (e)                      P=0.307                  (e)             | 
|POLY 1.5           |                  P=0.521                  (e)                      P=0.281                  (e)             | 
|POLY 6             |                  P=0.419                  (e)                      P=0.338                  (e)             | 
|LOGISTIC REGRESSION|                  P=0.541                  (e)                      P=0.286                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.541                  (e)                      P=0.248                  (e)             | 
|ORDER RESTRICTED   |                  P=0.305                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 57      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                2/53 (4%)                1/52 (2%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  0/31.36                  2/36.91                  1/42.13                  1/32.01         | 
|POLY-3 PERCENT (g) |                  0.0%                     5.4%                     2.4%                     3.1%            | 
|TERMINAL (d)       |                  0/15 (0%)                1/16 (6%)                0/23 (0%)                0/7 (0%)        | 
|FIRST INCIDENCE    |                  ---                      645                      535                      700             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.393                  P=0.275                  P=0.552                  P=0.413         | 
|POLY 3             |                  P=0.474                  P=0.274                  P=0.558                  P=0.504         | 
|POLY 1.5           |                  P=0.476                  P=0.261                  P=0.537                  P=0.507         | 
|POLY 6             |                  P=0.454                  P=0.288                  P=0.580                  P=0.490         | 
|LOGISTIC REGRESSION|                  P=0.464                  P=0.278                  P=0.442                  P=0.456         | 
|COCH-ARM / FISHERS |                  P=0.463                  P=0.252                  P=0.500                  P=0.505         | 
|ORDER RESTRICTED   |                  P=0.329                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  12/52 (23%)              10/53 (19%)              6/52 (12%)               4/53 (8%)       | 
|POLY-3 RATE (b)    |                  12/35.65                 10/39.29                 6/42.51                  4/33.98         | 
|POLY-3 PERCENT (g) |                  33.7%                    25.5%                    14.1%                    11.8%           | 
|TERMINAL (d)       |                  2/15 (13%)               3/16 (19%)               4/23 (17%)               0/7 (0%)        | 
|FIRST INCIDENCE    |                  391                      331                      535                      244             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.025N*                P=0.264N                 P=0.018N*                P=0.065N        | 
|POLY 3             |                  P=0.010N*                P=0.296N                 P=0.035N*                P=0.025N*       | 
|POLY 1.5           |                  P=0.009N**               P=0.319N                 P=0.049N*                P=0.021N*       | 
|POLY 6             |                  P=0.012N*                P=0.298N                 P=0.027N*                P=0.042N*       | 
|LOGISTIC REGRESSION|                  P=0.011N*                P=0.344N                 P=0.064N                 P=0.025N*       | 
|COCH-ARM / FISHERS |                  P=0.012N*                P=0.386N                 P=0.097N                 P=0.025N*       | 
|ORDER RESTRICTED   |                  P=0.018N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 58      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  26/52 (50%)              29/53 (55%)              27/52 (52%)              11/53 (21%)     | 
|POLY-3 RATE (b)    |                  26/41.07                 29/45.96                 27/46.70                 11/35.60        | 
|POLY-3 PERCENT (g) |                  63.3%                    63.1%                    57.8%                    30.9%           | 
|TERMINAL (d)       |                  7/15 (47%)               8/16 (50%)               12/23 (52%)              2/7 (29%)       | 
|FIRST INCIDENCE    |                  321                      247                      440                      555             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.016N*                P=0.476N                 P=0.098N                 P=0.023N*       | 
|POLY 3             |                  P=0.002N**               P=0.583N                 P=0.377N                 P=0.002N**      | 
|POLY 1.5           |                  P<0.001N**               P=0.545                  P=0.449N                 P<0.001N**      | 
|POLY 6             |                  P=0.011N*                P=0.582N                 P=0.329N                 P=0.010N*       | 
|LOGISTIC REGRESSION|                  P<0.001N**               P=0.433                  P=0.490N                 P<0.001N**      | 
|COCH-ARM / FISHERS |                  P<0.001N**               P=0.387                  P=0.500                  P=0.002N**      | 
|ORDER RESTRICTED   |                  P=0.002N**               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  300                      550                      1000            | 
|                   |                                           NG/KG                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  23/52 (44%)              26/53 (49%)              32/52 (62%)              9/53 (17%)      | 
|POLY-3 RATE (b)    |                  23/35.31                 26/41.15                 32/45.02                 9/34.37         | 
|POLY-3 PERCENT (g) |                  65.1%                    63.2%                    71.1%                    26.2%           | 
|TERMINAL (d)       |                  12/15 (80%)              12/16 (75%)              21/23 (91%)              3/7 (43%)       | 
|FIRST INCIDENCE    |                  496                      403                      327                      244             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.063N                 P=0.537N                 P=0.369N                 P=0.065N        | 
|POLY 3             |                  P<0.001N**               P=0.527N                 P=0.361                  P<0.001N**      | 
|POLY 1.5           |                  P<0.001N**               P=0.560                  P=0.213                  P<0.001N**      | 
|POLY 6             |                  P=0.002N**               P=0.434N                 P=0.543                  P<0.001N**      | 
|LOGISTIC REGRESSION|                  P<0.001N**               P=0.504N                 P=0.493                  P<0.001N**      | 
|COCH-ARM / FISHERS |                  P=0.003N**               P=0.382                  P=0.058                  P=0.002N**      | 
|ORDER RESTRICTED   |                  P<0.001N**               (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).