National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/4917

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: 12:23:10       
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. TREATED                                                  
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25022 Accidently Killed                                                                      
                                       25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 NG/KG                                                                       
                                       INCLUDE 003    30 NG/KG                                                                      
                                       INCLUDE 004    100     NG/KG                                                                 
                                       INCLUDE 005    175     NG/KG                                                                 
                                       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: 12:23:10       
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                                                                                      
                                       Hyperplasia                                                                                  
                                       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                                                                                 
Intestine Small, Duodenum              Erosion                                                                                      
Kidney                                 Casts Protein                                                                                
                                       Mineralization                                                                               
                                       Nephropathy                                                                                  
Kidney: Transitional Epithelium        Hyperplasia                                                                                  
Liver                                  Basophilic Focus                                                                             
                                       Cholangiofibrosis                                                                            
                                       Clear Cell Focus                                                                             
                                       Degeneration Cystic                                                                          
                                       Eosinophilic Focus                                                                           
                                       Fatty Change Diffuse                                                                         
                                       Fatty Change Focal                                                                           
                                       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                 Ectasia                                                                                      
                                       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: 12:23:10       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007D       
PATHOLOGIST: MISSING                                                                                           CAS: 57465-28-8      
Lymph Node, Mesenteric                 Hyperplasia                                                                                  
                                       Hyperplasia Lymphoid                                                                         
Lymph Node: Mediastinal                Ectasia                                                                                      
                                       Hemorrhage                                                                                   
                                       Pigmentation                                                                                 
Mammary Gland                          Cyst                                                                                         
                                       Hyperplasia                                                                                  
Mesentery                              Inflammation Chronic                                                                         
Mesentery: Artery                      Inflammation Chronic                                                                         
Nose: Turbinate                        Inflammation                                                                                 
Oral Mucosa: Gingival                  Hyperplasia                                                                                  
Ovary                                  Atrophy                                                                                      
Pancreas                               Inflammation Chronic                                                                         
Pancreas: Acinus                       Atrophy                                                                                      
                                       Vacuolization Cytoplasmic                                                                    
Pancreas: Artery                       Inflammation Chronic                                                                         
Pancreas: Duct                         Dilatation                                                                                   
Pituitary Gland: Pars Distalis         Hyperplasia                                                                                  
Spleen                                 Hematopoietic Cell Proliferation                                                             
                                       Hyperplasia Lymphoid                                                                         
                                       Pigmentation                                                                                 
Spleen: Lymphoid Follicle              Atrophy                                                                                      
Spleen: Red Pulp                       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      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     11/52 (21%)  13/55 (24%)  25/53 (47%)  19/53 (36%)  20/53 (38%)  8/52 (15%)   1/53 (2%)                 | 
|POLY-3 RATE (b)    |     11/34.50     13/39.17     25/43.24     19/38.60     20/39.31     8/42.81      1/32.22                   | 
|POLY-3 PERCENT (g) |     31.9%        33.2%        57.8%        49.2%        50.9%        18.7%        3.1%                      | 
|TERMINAL (d)       |     4/15 (27%)   12/25 (48%)  16/26 (62%)  14/22 (64%)  12/16 (75%)  6/23 (26%)   0/7 (0%)                  | 
|FIRST INCIDENCE    |     541          516          498          658          301          440          642                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001N**   P=0.327N     P=0.148      P=0.299      P=0.106      P=0.078N     P=0.010N*                 | 
|POLY 3             |     P<0.001N**   P=0.553      P=0.016 *    P=0.092      P=0.069      P=0.140N     P=0.002N**                | 
|POLY 1.5           |     P<0.001N**   P=0.519      P=0.009 **   P=0.096      P=0.063      P=0.183N     P=0.002N**                | 
|POLY 6             |     P<0.001N**   P=0.594      P=0.028 *    P=0.078      P=0.061      P=0.109N     P=0.004N**                | 
|LOGISTIC REGRESSION|     P<0.001N**   P=0.541N     P=0.019 *    P=0.167      P=0.095      P=0.179N     P=0.002N**                | 
|COCH-ARM / FISHERS |     P<0.001N**   P=0.470      P=0.004 **   P=0.073      P=0.049 *    P=0.306N     P=0.002N**                | 
|ORDER RESTRICTED   |     P<0.001N**   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     1/52 (2%)    3/55 (5%)    5/53 (9%)    3/53 (6%)    5/53 (9%)    19/52 (37%)  30/53 (57%)               | 
|POLY-3 RATE (b)    |     1/31.36      3/38.64      5/41.14      3/38.30      5/37.66      19/43.48     30/39.85                  | 
|POLY-3 PERCENT (g) |     3.2%         7.8%         12.2%        7.8%         13.3%        43.7%        75.3%                     | 
|TERMINAL (d)       |     1/15 (7%)    2/25 (8%)    3/26 (12%)   0/22 (0%)    2/16 (13%)   9/23 (39%)   6/7 (86%)                 | 
|FIRST INCIDENCE    |     727 (T)      700          300          592          607          554          243                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.502      P=0.218      P=0.410      P=0.150      P<0.001 **   P<0.001 **                | 
|POLY 3             |     P<0.001 **   P=0.382      P=0.176      P=0.379      P=0.146      P<0.001 **   P<0.001 **                | 
|POLY 1.5           |     P<0.001 **   P=0.356      P=0.148      P=0.357      P=0.129      P<0.001 **   P<0.001 **                | 
|POLY 6             |     P<0.001 **   P=0.424      P=0.214      P=0.405      P=0.167      P<0.001 **   P<0.001 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.486      P=0.115      P=0.358      P=0.143      P<0.001 **   P<0.001 **                | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.330      P=0.107      P=0.316      P=0.107      P<0.001 **   P<0.001 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     11/52 (21%)  14/55 (25%)  10/53 (19%)  14/53 (26%)  14/53 (26%)  16/52 (31%)  10/53 (19%)               | 
|POLY-3 RATE (b)    |     11/34.41     14/40.34     10/40.23     14/39.18     14/40.61     16/43.78     10/35.87                  | 
|POLY-3 PERCENT (g) |     32.0%        34.7%        24.9%        35.7%        34.5%        36.5%        27.9%                     | 
|TERMINAL (d)       |     4/15 (27%)   9/25 (36%)   7/26 (27%)   9/22 (41%)   0/16 (0%)    8/23 (35%)   0/7 (0%)                  | 
|FIRST INCIDENCE    |     496          516          651          496          531          535          309                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.127      P=0.423N     P=0.134N     P=0.539N     P=0.548      P=0.528N     P=0.515                   | 
|POLY 3             |     P=0.484N     P=0.498      P=0.334N     P=0.462      P=0.507      P=0.427      P=0.454N                  | 
|POLY 1.5           |     P=0.464N     P=0.446      P=0.379N     P=0.437      P=0.440      P=0.336      P=0.448N                  | 
|POLY 6             |     P=0.500      P=0.576      P=0.290N     P=0.474      P=0.581      P=0.525      P=0.504N                  | 
|LOGISTIC REGRESSION|     P=0.520N     P=0.526      P=0.277N     P=0.506      P=0.428      P=0.391      P=0.471N                  | 
|COCH-ARM / FISHERS |     P=0.473N     P=0.384      P=0.480N     P=0.344      P=0.344      P=0.186      P=0.480N                  | 
|ORDER RESTRICTED   |     P=0.590N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     23/52 (44%)  21/55 (38%)  27/53 (51%)  25/53 (47%)  25/53 (47%)  31/52 (60%)  24/53 (45%)               | 
|POLY-3 RATE (b)    |     23/38.88     21/40.99     27/43.02     25/42.19     25/41.73     31/44.16     24/39.04                  | 
|POLY-3 PERCENT (g) |     59.2%        51.2%        62.8%        59.3%        59.9%        70.2%        61.5%                     | 
|TERMINAL (d)       |     7/15 (47%)   15/25 (60%)  16/26 (62%)  12/22 (55%)  10/16 (63%)  18/23 (78%)  4/7 (57%)                 | 
|FIRST INCIDENCE    |     309          434          531          530          331          573          394                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.002 **   P=0.046N*    P=0.181N     P=0.289N     P=0.453N     P=0.341N     P=0.230                   | 
|POLY 3             |     P=0.189      P=0.305N     P=0.455      P=0.590      P=0.566      P=0.191      P=0.509                   | 
|POLY 1.5           |     P=0.224      P=0.312N     P=0.410      P=0.571      P=0.534      P=0.155      P=0.538                   | 
|POLY 6             |     P=0.119      P=0.300N     P=0.510      P=0.594      P=0.572      P=0.219      P=0.419                   | 
|LOGISTIC REGRESSION|     P=0.204      P=0.200N     P=0.576      P=0.508N     P=0.565N     P=0.363      P=0.567                   | 
|COCH-ARM / FISHERS |     P=0.257      P=0.330N     P=0.311      P=0.458      P=0.458      P=0.085      P=0.535                   | 
|ORDER RESTRICTED   |     P=0.279      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     34/52 (65%)  41/55 (75%)  40/53 (75%)  41/53 (77%)  40/53 (75%)  41/52 (79%)  41/53 (77%)               | 
|POLY-3 RATE (b)    |     34/39.07     41/45.61     40/45.30     41/44.98     40/45.32     41/46.88     41/44.54                  | 
|POLY-3 PERCENT (g) |     87.0%        89.9%        88.3%        91.2%        88.3%        87.5%        92.0%                     | 
|TERMINAL (d)       |     15/15 (100%) 22/25 (88%)  24/26 (92%)  22/22 (100%) 14/16 (88%)  22/23 (96%)  7/7 (100%)                | 
|FIRST INCIDENCE    |     391          356          498          405          454          185          309                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.129N     P=0.060N     P=0.313N     P=0.558      P=0.095N     P=0.013 *                 | 
|POLY 3             |     P=0.353      P=0.464      P=0.575      P=0.360      P=0.575      P=0.625      P=0.299                   | 
|POLY 1.5           |     P=0.272      P=0.290      P=0.381      P=0.278      P=0.341      P=0.383      P=0.188                   | 
|POLY 6             |     P=0.399      P=0.606N     P=0.556N     P=0.462      P=0.470N     P=0.465N     P=0.534                   | 
|LOGISTIC REGRESSION|     P=0.197      P=0.369      P=0.539N     P=0.477      P=0.446      P=0.538N     P=0.176                   | 
|COCH-ARM / FISHERS |     P=0.182      P=0.205      P=0.179      P=0.127      P=0.179      P=0.095      P=0.127                   | 
|ORDER RESTRICTED   |     P=0.366      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     1/52 (2%)    1/55 (2%)    0/53 (0%)    1/53 (2%)    1/53 (2%)    1/52 (2%)    2/53 (4%)                 | 
|POLY-3 RATE (b)    |     1/31.80      1/38.53      0/39.60      1/37.75      1/36.92      1/41.58      2/32.55                   | 
|POLY-3 PERCENT (g) |     3.1%         2.6%         0.0%         2.7%         2.7%         2.4%         6.2%                      | 
|TERMINAL (d)       |     0/15 (0%)    1/25 (4%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     600          727 (T)      ---          604          642          714          574                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.142      P=0.679N     P=0.448N     P=0.721N     P=0.706N     P=0.648N     P=0.503                   | 
|POLY 3             |     P=0.195      P=0.717N     P=0.456N     P=0.722N     P=0.727N     P=0.698N     P=0.508                   | 
|POLY 1.5           |     P=0.205      P=0.731N     P=0.471N     P=0.732N     P=0.738N     P=0.720N     P=0.513                   | 
|POLY 6             |     P=0.187      P=0.695N     P=0.440N     P=0.713N     P=0.717N     P=0.672N     P=0.484                   | 
|LOGISTIC REGRESSION|     P=0.206      P=0.724N     P=0.499N     P=0.761N     P=0.750N     P=0.731N     P=0.509                   | 
|COCH-ARM / FISHERS |     P=0.216      P=0.738N     P=0.495N     P=0.748N     P=0.748N     P=0.752N     P=0.507                   | 
|ORDER RESTRICTED   |     P=0.296      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     5/52 (10%)   3/55 (5%)    5/53 (9%)    2/53 (4%)    9/53 (17%)   4/52 (8%)    17/53 (32%)               | 
|POLY-3 RATE (b)    |     5/32.65      3/38.73      5/40.96      2/37.58      9/39.52      4/42.52      17/36.67                  | 
|POLY-3 PERCENT (g) |     15.3%        7.8%         12.2%        5.3%         22.8%        9.4%         46.4%                     | 
|TERMINAL (d)       |     3/15 (20%)   1/25 (4%)    2/26 (8%)    1/22 (5%)    2/16 (13%)   1/23 (4%)    3/7 (43%)                 | 
|FIRST INCIDENCE    |     496          681          428          658          163          554          525                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.169N     P=0.369N     P=0.118N     P=0.295      P=0.273N     P<0.001 **                | 
|POLY 3             |     P<0.001 **   P=0.263N     P=0.483N     P=0.159N     P=0.308      P=0.338N     P=0.004 **                | 
|POLY 1.5           |     P<0.001 **   P=0.291N     P=0.532N     P=0.171N     P=0.268      P=0.393N     P=0.004 **                | 
|POLY 6             |     P<0.001 **   P=0.223N     P=0.422N     P=0.148N     P=0.358      P=0.281N     P=0.003 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.256N     P=0.560N     P=0.161N     P=0.224      P=0.422N     P=0.004 **                | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.327N     P=0.617N     P=0.211N     P=0.206      P=0.500N     P=0.004 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/52 (0%)    0/55 (0%)    2/53 (4%)    1/53 (2%)    2/53 (4%)    2/52 (4%)    0/53 (0%)                 | 
|POLY-3 RATE (b)    |     0/31.36      0/38.53      2/39.67      1/37.32      2/36.61      2/41.53      0/31.91                   | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         5.0%         2.7%         5.5%         4.8%         0.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    1/26 (4%)    1/22 (5%)    2/16 (13%)   2/23 (9%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          709          727 (T)      727 (T)      727 (T)      ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.391      (e)          P=0.368      P=0.576      P=0.250      P=0.336      (e)                       | 
|POLY 3             |     P=0.561      (e)          P=0.292      P=0.535      P=0.272      P=0.304      (e)                       | 
|POLY 1.5           |     P=0.577N     (e)          P=0.273      P=0.526      P=0.260      P=0.280      (e)                       | 
|POLY 6             |     P=0.493      (e)          P=0.318      P=0.543      P=0.283      P=0.333      (e)                       | 
|LOGISTIC REGRESSION|     P=0.460      (e)          P=0.341      P=0.576      P=0.250      P=0.336      (e)                       | 
|COCH-ARM / FISHERS |     P=0.570N     (e)          P=0.252      P=0.505      P=0.252      P=0.248      (e)                       | 
|ORDER RESTRICTED   |     P=0.371      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     8/52 (15%)   18/55 (33%)  11/53 (21%)  11/53 (21%)  12/53 (23%)  6/52 (12%)   1/53 (2%)                 | 
|POLY-3 RATE (b)    |     8/33.72      18/40.38     11/41.48     11/39.17     12/37.67     6/42.16      1/32.28                   | 
|POLY-3 PERCENT (g) |     23.7%        44.6%        26.5%        28.1%        31.9%        14.2%        3.1%                      | 
|TERMINAL (d)       |     3/15 (20%)   12/25 (48%)  7/26 (27%)   7/22 (32%)   5/16 (31%)   3/23 (13%)   0/7 (0%)                  | 
|FIRST INCIDENCE    |     496          580          376          496          618          573          621                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.004N**   P=0.208      P=0.511N     P=0.566      P=0.376      P=0.143N     P=0.040N*                 | 
|POLY 3             |     P<0.001N**   P=0.046 *    P=0.496      P=0.438      P=0.305      P=0.224N     P=0.015N*                 | 
|POLY 1.5           |     P<0.001N**   P=0.035 *    P=0.434      P=0.409      P=0.283      P=0.273N     P=0.014N*                 | 
|POLY 6             |     P<0.001N**   P=0.073      P=0.566      P=0.461      P=0.320      P=0.180N     P=0.023N*                 | 
|LOGISTIC REGRESSION|     P<0.001N**   P=0.066      P=0.445      P=0.438      P=0.362      P=0.248N     P=0.016N*                 | 
|COCH-ARM / FISHERS |     P<0.001N**   P=0.030 *    P=0.323      P=0.323      P=0.243      P=0.387N     P=0.014N*                 | 
|ORDER RESTRICTED   |     P=0.002N**   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Blood Vessel: Aorta                                                                                                              | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     3/53 (6%)    1/55 (2%)    1/53 (2%)    0/53 (0%)    0/53 (0%)    2/53 (4%)    0/53 (0%)                 | 
|POLY-3 RATE (b)    |     3/32.76      1/39.50      1/40.46      0/37.32      0/36.61      2/42.83      0/31.91                   | 
|POLY-3 PERCENT (g) |     9.2%         2.5%         2.5%         0.0%         0.0%         4.7%         0.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     583          223          376          ---          ---          573          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.203N     P=0.255N     P=0.239N     P=0.097N     P=0.088N     P=0.329N     P=0.100N                  | 
|POLY 3             |     P=0.259N     P=0.240N     P=0.233N     P=0.096N     P=0.098N     P=0.380N     P=0.121N                  | 
|POLY 1.5           |     P=0.240N     P=0.259N     P=0.255N     P=0.100N     P=0.104N     P=0.418N     P=0.116N                  | 
|POLY 6             |     P=0.313N     P=0.218N     P=0.213N     P=0.093N     P=0.095N     P=0.345N     P=0.142N                  | 
|LOGISTIC REGRESSION|     P=0.224N     P=0.326N     P=0.360N     P=0.118N     P=0.118N     P=0.512N     P=0.119N                  | 
|COCH-ARM / FISHERS |     P=0.214N     P=0.295N     P=0.309N     P=0.121N     P=0.121N     P=0.500N     P=0.121N                  | 
|ORDER RESTRICTED   |     P=0.023N*    (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone                                                                                                                             | 
|     Osteopetrosis                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/53 (0%)    0/55 (0%)    1/53 (2%)    0/53 (0%)    2/53 (4%)    0/53 (0%)    0/53 (0%)                 | 
|POLY-3 RATE (b)    |     0/31.38      0/38.53      1/39.88      0/37.32      2/38.22      0/42.13      0/31.91                   | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.5%         0.0%         5.2%         0.0%         0.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          651          ---          40           ---          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.521N     (e)          P=0.595      (e)          P=0.258      (e)          (e)                       | 
|POLY 3             |     P=0.461N     (e)          P=0.547      (e)          P=0.283      (e)          (e)                       | 
|POLY 1.5           |     P=0.474N     (e)          P=0.531      (e)          P=0.267      (e)          (e)                       | 
|POLY 6             |     P=0.485N     (e)          P=0.567      (e)          P=0.299      (e)          (e)                       | 
|LOGISTIC REGRESSION|     P=0.513N     (e)          P=0.529      (e)          P=0.182      (e)          (e)                       | 
|COCH-ARM / FISHERS |     P=0.504N     (e)          P=0.500      (e)          P=0.248      (e)          (e)                       | 
|ORDER RESTRICTED   |     P=0.507      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     47/53 (89%)  37/55 (67%)  35/53 (66%)  44/53 (83%)  45/53 (85%)  46/53 (87%)  46/53 (87%)               | 
|POLY-3 RATE (b)    |     47/52.12     37/50.34     35/50.58     44/52.04     45/51.59     46/52.30     46/49.04                  | 
|POLY-3 PERCENT (g) |     90.2%        73.5%        69.2%        84.6%        87.2%        88.0%        93.8%                     | 
|TERMINAL (d)       |     10/15 (67%)  14/25 (56%)  12/26 (46%)  16/22 (73%)  12/16 (75%)  18/23 (78%)  7/7 (100%)                | 
|FIRST INCIDENCE    |     126          223          188          124          40           185          72                        | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.002 **   P=0.004N**   P=0.002N**   P=0.072N     P=0.181N     P=0.019N*    P=0.265                   | 
|POLY 3             |     P=0.006 **   P=0.022N*    P=0.006N**   P=0.282N     P=0.432N     P=0.479N     P=0.370                   | 
|POLY 1.5           |     P=0.012 *    P=0.016N*    P=0.005N**   P=0.272N     P=0.399N     P=0.476N     P=0.545                   | 
|POLY 6             |     P=0.002 **   P=0.031N*    P=0.008N**   P=0.310N     P=0.493N     P=0.494N     P=0.167                   | 
|LOGISTIC REGRESSION|     P=0.025 *    P=0.010N*    P=0.020N*    P=0.436N     P=0.504N     P=0.514      P=0.508N                  | 
|COCH-ARM / FISHERS |     P=0.025 *    P=0.007N**   P=0.005N**   P=0.289N     P=0.388N     P=0.500N     P=0.500N                  | 
|ORDER RESTRICTED   |     P=0.014 *    (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain                                                                                                                            | 
|     Hydrocephalus                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     1/53 (2%)    0/55 (0%)    2/53 (4%)    0/53 (0%)    0/53 (0%)    1/53 (2%)    0/53 (0%)                 | 
|POLY-3 RATE (b)    |     1/32.36      0/38.53      2/39.86      0/37.32      0/36.61      1/42.15      0/31.91                   | 
|POLY-3 PERCENT (g) |     3.1%         0.0%         5.0%         0.0%         0.0%         2.4%         0.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     201          ---          678          ---          ---          722          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.431N     P=0.489N     P=0.623      P=0.496N     P=0.500N     P=0.703N     P=0.500N                  | 
|POLY 3             |     P=0.349N     P=0.465N     P=0.572      P=0.472N     P=0.475N     P=0.699N     P=0.503N                  | 
|POLY 1.5           |     P=0.348N     P=0.478N     P=0.546      P=0.479N     P=0.484N     P=0.721N     P=0.498N                  | 
|POLY 6             |     P=0.385N     P=0.447N     P=0.605      P=0.464N     P=0.467N     P=0.673N     P=0.520N                  | 
|LOGISTIC REGRESSION|     P=0.354N     P=0.524N     P=0.434      P=0.710N     P=0.511N     P=0.650      P=0.515N                  | 
|COCH-ARM / FISHERS |     P=0.352N     P=0.491N     P=0.500      P=0.500N     P=0.500N     P=0.752N     P=0.500N                  | 
|ORDER RESTRICTED   |     P=0.323N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     28/50 (56%)  36/55 (65%)  39/52 (75%)  28/50 (56%)  30/53 (57%)  27/52 (52%)  22/51 (43%)               | 
|POLY-3 RATE (b)    |     28/40.18     36/47.35     39/48.96     28/42.13     30/44.65     27/47.18     22/42.43                  | 
|POLY-3 PERCENT (g) |     69.7%        76.0%        79.7%        66.5%        67.2%        57.2%        51.9%                     | 
|TERMINAL (d)       |     9/14 (64%)   19/25 (76%)  19/26 (73%)  13/22 (59%)  12/16 (75%)  11/23 (48%)  1/7 (14%)                 | 
|FIRST INCIDENCE    |     222          253          188          436          301          320          188                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.365N     P=0.325N     P=0.406N     P=0.134N     P=0.385N     P=0.043N*    P=0.393N                  | 
|POLY 3             |     P<0.001N**   P=0.326      P=0.188      P=0.467N     P=0.494N     P=0.155N     P=0.062N                  | 
|POLY 1.5           |     P<0.001N**   P=0.274      P=0.121      P=0.476N     P=0.527N     P=0.214N     P=0.064N                  | 
|POLY 6             |     P<0.001N**   P=0.413      P=0.286      P=0.464N     P=0.476N     P=0.110N     P=0.080N                  | 
|LOGISTIC REGRESSION|     P=0.003N**   P=0.287      P=0.055      P=0.424N     P=0.513N     P=0.321N     P=0.150N                  | 
|COCH-ARM / FISHERS |     P=0.004N**   P=0.214      P=0.035 *    P=0.580N     P=0.554      P=0.415N     P=0.137N                  | 
|ORDER RESTRICTED   |     P=0.012N*    (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland: Duct                                                                                                             | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     29/50 (58%)  32/55 (58%)  34/52 (65%)  37/50 (74%)  39/53 (74%)  42/52 (81%)  45/51 (88%)               | 
|POLY-3 RATE (b)    |     29/40.97     32/47.78     34/46.12     37/45.50     39/47.23     42/48.69     45/47.03                  | 
|POLY-3 PERCENT (g) |     70.8%        67.0%        73.7%        81.3%        82.6%        86.3%        95.7%                     | 
|TERMINAL (d)       |     8/14 (57%)   14/25 (56%)  17/26 (65%)  15/22 (68%)  11/16 (69%)  18/23 (78%)  6/7 (86%)                 | 
|FIRST INCIDENCE    |     126          202          188          436          247          320          188                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.157N     P=0.153N     P=0.498N     P=0.349      P=0.438N     P=0.004 **                | 
|POLY 3             |     P<0.001 **   P=0.435N     P=0.472      P=0.170      P=0.126      P=0.049 *    P<0.001 **                | 
|POLY 1.5           |     P<0.001 **   P=0.497N     P=0.402      P=0.117      P=0.090      P=0.025 *    P<0.001 **                | 
|POLY 6             |     P<0.001 **   P=0.377N     P=0.557      P=0.260      P=0.177      P=0.094      P<0.001 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.562N     P=0.383      P=0.113      P=0.100      P=0.033 *    P<0.001 **                | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.571      P=0.287      P=0.069      P=0.072      P=0.011 *    P<0.001 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Esophagus: Muscularis                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     2/52 (4%)    1/55 (2%)    0/53 (0%)    1/53 (2%)    1/53 (2%)    2/52 (4%)    0/52 (0%)                 | 
|POLY-3 RATE (b)    |     2/30.96      1/39.04      0/39.60      1/37.32      1/36.86      2/41.73      0/31.53                   | 
|POLY-3 PERCENT (g) |     6.5%         2.6%         0.0%         2.7%         2.7%         4.8%         0.0%                      | 
|TERMINAL (d)       |     1/14 (7%)    0/25 (0%)    0/26 (0%)    1/22 (5%)    0/16 (0%)    2/23 (9%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     547          574          ---          727 (T)      659          727 (T)      ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.478N     P=0.400N     P=0.157N     P=0.378N     P=0.439N     P=0.526N     P=0.293N                  | 
|POLY 3             |     P=0.421N     P=0.420N     P=0.186N     P=0.435N     P=0.439N     P=0.582N     P=0.231N                  | 
|POLY 1.5           |     P=0.394N     P=0.445N     P=0.201N     P=0.450N     P=0.458N     P=0.620N     P=0.229N                  | 
|POLY 6             |     P=0.494N     P=0.384N     P=0.170N     P=0.421N     P=0.421N     P=0.540N     P=0.247N                  | 
|LOGISTIC REGRESSION|     P=0.368N     P=0.463N     P=0.205N     P=0.430N     P=0.455N     P=0.574N     P=0.231N                  | 
|COCH-ARM / FISHERS |     P=0.363N     P=0.479N     P=0.243N     P=0.493N     P=0.493N     P=0.691N     P=0.248N                  | 
|ORDER RESTRICTED   |     P=0.129N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Cornea                                                                                                                      | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/51 (0%)    0/55 (0%)    0/53 (0%)    0/53 (0%)    0/53 (0%)    1/52 (2%)    2/52 (4%)                 | 
|POLY-3 RATE (b)    |     0/30.21      0/38.53      0/39.60      0/37.32      0/36.61      1/41.54      2/31.74                   | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%         0.0%         2.4%         6.3%                      | 
|TERMINAL (d)       |     0/14 (0%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          ---          ---          ---          720          663                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   (e)          (e)          (e)          (e)          P=0.610      P=0.208                   | 
|POLY 3             |     P=0.005 **   (e)          (e)          (e)          (e)          P=0.562      P=0.246                   | 
|POLY 1.5           |     P=0.006 **   (e)          (e)          (e)          (e)          P=0.543      P=0.249                   | 
|POLY 6             |     P=0.005 **   (e)          (e)          (e)          (e)          P=0.584      P=0.233                   | 
|LOGISTIC REGRESSION|     P=0.004 **   (e)          (e)          (e)          (e)          P=0.619      P=0.231                   | 
|COCH-ARM / FISHERS |     P=0.007 **   (e)          (e)          (e)          (e)          P=0.505      P=0.252                   | 
|ORDER RESTRICTED   |     P=0.023 *    (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Retina                                                                                                                      | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/51 (0%)    0/55 (0%)    3/53 (6%)    1/53 (2%)    0/53 (0%)    1/52 (2%)    4/52 (8%)                 | 
|POLY-3 RATE (b)    |     0/30.21      0/38.53      3/39.60      1/37.32      0/36.61      1/41.53      4/32.41                   | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         7.6%         2.7%         0.0%         2.4%         12.3%                     | 
|TERMINAL (d)       |     0/14 (0%)    0/25 (0%)    3/26 (12%)   1/22 (5%)    0/16 (0%)    0/23 (0%)    1/7 (14%)                 | 
|FIRST INCIDENCE    |     ---          ---          727 (T)      727 (T)      ---          722          484                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   (e)          P=0.247      P=0.590      (e)          P=0.602      P=0.031 *                 | 
|POLY 3             |     P=0.022 *    (e)          P=0.173      P=0.542      (e)          P=0.562      P=0.066                   | 
|POLY 1.5           |     P=0.020 *    (e)          P=0.155      P=0.533      (e)          P=0.543      P=0.067                   | 
|POLY 6             |     P=0.024 *    (e)          P=0.198      P=0.551      (e)          P=0.584      P=0.058                   | 
|LOGISTIC REGRESSION|     P=0.010 *    (e)          P=0.247      P=0.590      (e)          P=0.622      P=0.066                   | 
|COCH-ARM / FISHERS |     P=0.018 *    (e)          P=0.129      P=0.510      (e)          P=0.505      P=0.061                   | 
|ORDER RESTRICTED   |     P=0.009 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     2/53 (4%)    3/53 (6%)    6/53 (11%)   6/53 (11%)   3/53 (6%)    3/52 (6%)    6/52 (12%)                | 
|POLY-3 RATE (b)    |     2/32.88      3/38.60      6/39.67      6/37.35      3/37.08      3/42.38      6/33.83                   | 
|POLY-3 PERCENT (g) |     6.1%         7.8%         15.1%        16.1%        8.1%         7.1%         17.7%                     | 
|TERMINAL (d)       |     0/15 (0%)    1/25 (4%)    5/26 (19%)   5/22 (23%)   0/16 (0%)    1/23 (4%)    1/7 (14%)                 | 
|FIRST INCIDENCE    |     321          652          709          720          607          574          188                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.047 *    P=0.643      P=0.315      P=0.260      P=0.581      P=0.632      P=0.110                   | 
|POLY 3             |     P=0.265      P=0.573      P=0.199      P=0.173      P=0.555      P=0.613      P=0.135                   | 
|POLY 1.5           |     P=0.264      P=0.543      P=0.175      P=0.165      P=0.536      P=0.573      P=0.139                   | 
|POLY 6             |     P=0.255      P=0.614      P=0.231      P=0.178      P=0.573      P=0.657      P=0.116                   | 
|LOGISTIC REGRESSION|     P=0.221      P=0.500      P=0.180      P=0.178      P=0.495      P=0.398      P=0.118                   | 
|COCH-ARM / FISHERS |     P=0.239      P=0.500      P=0.135      P=0.135      P=0.500      P=0.491      P=0.129                   | 
|ORDER RESTRICTED   |     P=0.130      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     9/52 (17%)   16/54 (30%)  17/53 (32%)  16/53 (30%)  24/53 (45%)  28/51 (55%)  32/51 (63%)               | 
|POLY-3 RATE (b)    |     9/35.59      16/38.84     17/40.82     16/40.33     24/41.08     28/45.07     32/39.46                  | 
|POLY-3 PERCENT (g) |     25.3%        41.2%        41.7%        39.7%        58.4%        62.1%        81.1%                     | 
|TERMINAL (d)       |     2/15 (13%)   10/24 (42%)  14/26 (54%)  9/22 (41%)   12/16 (75%)  12/23 (52%)  7/7 (100%)                | 
|FIRST INCIDENCE    |     201          574          376          448          331          554          188                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.391      P=0.373      P=0.286      P=0.012 *    P=0.034 *    P<0.001 **                | 
|POLY 3             |     P<0.001 **   P=0.107      P=0.096      P=0.132      P=0.002 **   P<0.001 **   P<0.001 **                | 
|POLY 1.5           |     P<0.001 **   P=0.096      P=0.082      P=0.120      P<0.001 **   P<0.001 **   P<0.001 **                | 
|POLY 6             |     P<0.001 **   P=0.139      P=0.115      P=0.144      P=0.002 **   P=0.002 **   P<0.001 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.139      P=0.105      P=0.115      P=0.003 **   P<0.001 **   P<0.001 **                | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.103      P=0.063      P=0.093      P=0.002 **   P<0.001 **   P<0.001 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart: Epicardium                                                                                                                | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     2/52 (4%)    0/54 (0%)    0/53 (0%)    1/53 (2%)    0/53 (0%)    0/51 (0%)    0/51 (0%)                 | 
|POLY-3 RATE (b)    |     2/32.82      0/37.53      0/39.60      1/38.32      0/36.61      0/41.13      0/30.95                   | 
|POLY-3 PERCENT (g) |     6.1%         0.0%         0.0%         2.6%         0.0%         0.0%         0.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/24 (0%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     126          ---          ---          124          ---          ---          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.178N     P=0.218N     P=0.215N     P=0.482N     P=0.217N     P=0.204N     P=0.228N                  | 
|POLY 3             |     P=0.172N     P=0.207N     P=0.197N     P=0.446N     P=0.212N     P=0.191N     P=0.249N                  | 
|POLY 1.5           |     P=0.177N     P=0.218N     P=0.210N     P=0.458N     P=0.221N     P=0.208N     P=0.244N                  | 
|POLY 6             |     P=0.187N     P=0.191N     P=0.182N     P=0.436N     P=0.206N     P=0.173N     P=0.269N                  | 
|LOGISTIC REGRESSION|     P=0.188N     P=0.245N     P=0.351N     P=0.737      P=0.256N     P=0.431N     P=0.247N                  | 
|COCH-ARM / FISHERS |     P=0.185N     P=0.238N     P=0.243N     P=0.493N     P=0.243N     P=0.252N     P=0.252N                  | 
|ORDER RESTRICTED   |     P=0.024N*    (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Colon                                                                                                           | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/52 (0%)    1/55 (2%)    2/53 (4%)    1/53 (2%)    0/53 (0%)    0/51 (0%)    1/53 (2%)                 | 
|POLY-3 RATE (b)    |     0/31.36      1/38.88      2/39.67      1/37.75      0/36.61      0/41.43      1/32.61                   | 
|POLY-3 PERCENT (g) |     0.0%         2.6%         5.0%         2.7%         0.0%         0.0%         3.1%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    1/26 (4%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          630          709          604          ---          ---          484                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.628      P=0.573      P=0.368      P=0.539      (e)          (e)          P=0.523                   | 
|POLY 3             |     P=0.470N     P=0.543      P=0.292      P=0.537      (e)          (e)          P=0.508                   | 
|POLY 1.5           |     P=0.502N     P=0.528      P=0.273      P=0.527      (e)          (e)          P=0.509                   | 
|POLY 6             |     P=0.446N     P=0.564      P=0.318      P=0.547      (e)          (e)          P=0.495                   | 
|LOGISTIC REGRESSION|     P=0.556N     P=0.522      P=0.341      P=0.506      (e)          (e)          P=0.496                   | 
|COCH-ARM / FISHERS |     P=0.554N     P=0.514      P=0.252      P=0.505      (e)          (e)          P=0.505                   | 
|ORDER RESTRICTED   |     P=0.382      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Rectum                                                                                                          | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     2/52 (4%)    2/55 (4%)    3/53 (6%)    0/52 (0%)    1/53 (2%)    0/52 (0%)    1/53 (2%)                 | 
|POLY-3 RATE (b)    |     2/30.87      2/38.53      3/39.60      0/36.94      1/37.22      0/41.53      1/31.91                   | 
|POLY-3 PERCENT (g) |     6.5%         5.2%         7.6%         0.0%         2.7%         0.0%         3.1%                      | 
|TERMINAL (d)       |     2/15 (13%)   2/25 (8%)    3/26 (12%)   0/22 (0%)    0/16 (0%)    0/23 (0%)    1/7 (14%)                 | 
|FIRST INCIDENCE    |     727 (T)      727 (T)      727 (T)      ---          531          ---          727 (T)                   | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.341N     P=0.500N     P=0.626N     P=0.157N     P=0.465N     P=0.149N     P=0.723                   | 
|POLY 3             |     P=0.152N     P=0.612N     P=0.612      P=0.198N     P=0.435N     P=0.178N     P=0.488N                  | 
|POLY 1.5           |     P=0.165N     P=0.638N     P=0.577      P=0.209N     P=0.455N     P=0.196N     P=0.482N                  | 
|POLY 6             |     P=0.144N     P=0.574N     P=0.652      P=0.189N     P=0.416N     P=0.160N     P=0.518N                  | 
|LOGISTIC REGRESSION|     P=0.219N     P=0.500N     P=0.626N     (e)          P=0.448N     (e)          P=0.723                   | 
|COCH-ARM / FISHERS |     P=0.186N     P=0.670N     P=0.509      P=0.248N     P=0.493N     P=0.248N     P=0.493N                  | 
|ORDER RESTRICTED   |     P=0.281N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Duodenum                                                                                                        | 
|     Erosion                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     1/52 (2%)    0/55 (0%)    0/52 (0%)    0/53 (0%)    0/53 (0%)    0/51 (0%)    2/53 (4%)                 | 
|POLY-3 RATE (b)    |     1/31.84      0/38.53      0/38.67      0/37.32      0/36.61      0/41.43      2/32.17                   | 
|POLY-3 PERCENT (g) |     3.1%         0.0%         0.0%         0.0%         0.0%         0.0%         6.2%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     583          ---          ---          ---          ---          ---          694                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.040 *    P=0.471N     P=0.455N     P=0.471N     P=0.461N     P=0.436N     P=0.455                   | 
|POLY 3             |     P=0.065      P=0.462N     P=0.461N     P=0.468N     P=0.472N     P=0.448N     P=0.504                   | 
|POLY 1.5           |     P=0.065      P=0.474N     P=0.475N     P=0.476N     P=0.481N     P=0.467N     P=0.511                   | 
|POLY 6             |     P=0.079      P=0.445N     P=0.445N     P=0.462N     P=0.465N     P=0.429N     P=0.475                   | 
|LOGISTIC REGRESSION|     P=0.061      P=0.491N     P=0.510N     P=0.505N     P=0.499N     P=0.534N     P=0.499                   | 
|COCH-ARM / FISHERS |     P=0.068      P=0.486N     P=0.500N     P=0.495N     P=0.495N     P=0.505N     P=0.507                   | 
|ORDER RESTRICTED   |     P=0.033 *    (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 13      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     1/52 (2%)    2/54 (4%)    1/53 (2%)    1/53 (2%)    0/53 (0%)    1/52 (2%)    0/51 (0%)                 | 
|POLY-3 RATE (b)    |     1/31.36      2/39.02      1/40.16      1/37.75      0/36.61      1/41.53      0/30.67                   | 
|POLY-3 PERCENT (g) |     3.2%         5.1%         2.5%         2.7%         0.0%         2.4%         0.0%                      | 
|TERMINAL (d)       |     1/15 (7%)    1/25 (4%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    1/23 (4%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     727 (T)      223          555          604          ---          727 (T)      ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.227N     P=0.628      P=0.674N     P=0.695N     P=0.487N     P=0.664N     P=0.652N                  | 
|POLY 3             |     P=0.183N     P=0.576      P=0.703N     P=0.719N     P=0.469N     P=0.694N     P=0.504N                  | 
|POLY 1.5           |     P=0.184N     P=0.549      P=0.724N     P=0.730N     P=0.479N     P=0.719N     P=0.501N                  | 
|POLY 6             |     P=0.201N     P=0.613      P=0.676N     P=0.706N     P=0.460N     P=0.666N     P=0.519N                  | 
|LOGISTIC REGRESSION|     P=0.188N     P=0.501      P=0.740N     P=0.727N     (e)          P=0.664N     (e)                       | 
|COCH-ARM / FISHERS |     P=0.187N     P=0.514      P=0.748N     P=0.748N     P=0.495N     P=0.752N     P=0.505N                  | 
|ORDER RESTRICTED   |     P=0.283N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Casts Protein                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     4/53 (8%)    3/55 (5%)    1/53 (2%)    6/53 (11%)   0/53 (0%)    0/52 (0%)    2/53 (4%)                 | 
|POLY-3 RATE (b)    |     4/31.53      3/39.63      1/40.59      6/38.91      0/36.61      0/41.53      2/32.74                   | 
|POLY-3 PERCENT (g) |     12.7%        7.6%         2.5%         15.4%        0.0%         0.0%         6.1%                      | 
|TERMINAL (d)       |     3/15 (20%)   0/25 (0%)    0/26 (0%)    2/22 (9%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     688          516          188          546          ---          ---          607                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.201N     P=0.282N     P=0.077N     P=0.563      P=0.049N*    P=0.020N*    P=0.514N                  | 
|POLY 3             |     P=0.118N     P=0.376N     P=0.111N     P=0.506      P=0.042N*    P=0.033N*    P=0.316N                  | 
|POLY 1.5           |     P=0.122N     P=0.420N     P=0.131N     P=0.463      P=0.048N*    P=0.041N*    P=0.316N                  | 
|POLY 6             |     P=0.118N     P=0.317N     P=0.091N     P=0.556      P=0.037N*    P=0.025N*    P=0.338N                  | 
|LOGISTIC REGRESSION|     P=0.135N     P=0.387N     P=0.166N     P=0.487      P=0.035N*    P=0.016N*    P=0.369N                  | 
|COCH-ARM / FISHERS |     P=0.136N     P=0.479N     P=0.181N     P=0.371      P=0.059N     P=0.061N     P=0.339N                  | 
|ORDER RESTRICTED   |     P=0.070N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 14      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/53 (0%)    0/55 (0%)    0/53 (0%)    2/53 (4%)    0/53 (0%)    0/52 (0%)    0/53 (0%)                 | 
|POLY-3 RATE (b)    |     0/31.38      0/38.53      0/39.60      2/37.58      0/36.61      0/41.53      0/31.91                   | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         5.3%         0.0%         0.0%         0.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    1/22 (5%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          ---          659          ---          ---          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.556N     (e)          (e)          P=0.306      (e)          (e)          (e)                       | 
|POLY 3             |     P=0.415N     (e)          (e)          P=0.279      (e)          (e)          (e)                       | 
|POLY 1.5           |     P=0.432N     (e)          (e)          P=0.267      (e)          (e)          (e)                       | 
|POLY 6             |     P=0.436N     (e)          (e)          P=0.291      (e)          (e)          (e)                       | 
|LOGISTIC REGRESSION|     P=0.490N     (e)          (e)          P=0.285      (e)          (e)          (e)                       | 
|COCH-ARM / FISHERS |     P=0.469N     (e)          (e)          P=0.248      (e)          (e)          (e)                       | 
|ORDER RESTRICTED   |     P=0.529N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/53 (0%)    0/55 (0%)    3/53 (6%)    0/53 (0%)    0/53 (0%)    1/52 (2%)    2/53 (4%)                 | 
|POLY-3 RATE (b)    |     0/31.38      0/38.53      3/40.41      0/37.32      0/36.61      1/41.91      2/32.93                   | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         7.4%         0.0%         0.0%         2.4%         6.1%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          651          ---          ---          618          555                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.130      (e)          P=0.205      (e)          (e)          P=0.596      P=0.281                   | 
|POLY 3             |     P=0.175      (e)          P=0.170      (e)          (e)          P=0.557      P=0.246                   | 
|POLY 1.5           |     P=0.173      (e)          P=0.150      (e)          (e)          P=0.536      P=0.247                   | 
|POLY 6             |     P=0.183      (e)          P=0.198      (e)          (e)          P=0.579      P=0.234                   | 
|LOGISTIC REGRESSION|     P=0.162      (e)          P=0.145      (e)          (e)          P=0.501      P=0.237                   | 
|COCH-ARM / FISHERS |     P=0.163      (e)          P=0.121      (e)          (e)          P=0.495      P=0.248                   | 
|ORDER RESTRICTED   |     P=0.109      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 15      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     2/53 (4%)    2/55 (4%)    1/53 (2%)    1/53 (2%)    1/53 (2%)    1/52 (2%)    0/53 (0%)                 | 
|POLY-3 RATE (b)    |     2/31.89      2/39.21      1/39.60      1/37.58      1/36.86      1/41.53      0/31.91                   | 
|POLY-3 PERCENT (g) |     6.3%         5.1%         2.5%         2.7%         2.7%         2.4%         0.0%                      | 
|TERMINAL (d)       |     1/15 (7%)    1/25 (4%)    1/26 (4%)    0/22 (0%)    0/16 (0%)    1/23 (4%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     574          498          727 (T)      658          659          727 (T)      ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.182N     P=0.572N     P=0.353N     P=0.398N     P=0.446N     P=0.366N     P=0.302N                  | 
|POLY 3             |     P=0.138N     P=0.618N     P=0.425N     P=0.443N     P=0.449N     P=0.409N     P=0.235N                  | 
|POLY 1.5           |     P=0.134N     P=0.645N     P=0.450N     P=0.458N     P=0.467N     P=0.441N     P=0.231N                  | 
|POLY 6             |     P=0.159N     P=0.580N     P=0.396N     P=0.429N     P=0.434N     P=0.377N     P=0.255N                  | 
|LOGISTIC REGRESSION|     P=0.130N     P=0.658N     P=0.418N     P=0.453N     P=0.459N     P=0.408N     P=0.236N                  | 
|COCH-ARM / FISHERS |     P=0.132N     P=0.677N     P=0.500N     P=0.500N     P=0.500N     P=0.507N     P=0.248N                  | 
|ORDER RESTRICTED   |     P=0.160N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     32/53 (60%)  39/55 (71%)  44/53 (83%)  44/53 (83%)  44/53 (83%)  39/52 (75%)  37/53 (70%)               | 
|POLY-3 RATE (b)    |     32/42.76     39/47.07     44/50.44     44/49.02     44/50.35     39/47.55     37/45.03                  | 
|POLY-3 PERCENT (g) |     74.8%        82.9%        87.2%        89.8%        87.4%        82.0%        82.2%                     | 
|TERMINAL (d)       |     12/15 (80%)  21/25 (84%)  22/26 (85%)  21/22 (96%)  14/16 (88%)  20/23 (87%)  6/7 (86%)                 | 
|FIRST INCIDENCE    |     126          328          188          385          40           320          72                        | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.014 *    P=0.241N     P=0.416N     P=0.438      P=0.224      P=0.183N     P=0.068                   | 
|POLY 3             |     P=0.479N     P=0.230      P=0.085      P=0.033 *    P=0.080      P=0.267      P=0.258                   | 
|POLY 1.5           |     P=0.425N     P=0.187      P=0.037 *    P=0.021 *    P=0.037 *    P=0.186      P=0.258                   | 
|POLY 6             |     P=0.486      P=0.297      P=0.181      P=0.044 *    P=0.161      P=0.366      P=0.218                   | 
|LOGISTIC REGRESSION|     P=0.469N     P=0.258      P=0.020 *    P=0.024 *    P=0.013 *    P=0.250      P=0.234                   | 
|COCH-ARM / FISHERS |     P=0.479N     P=0.171      P=0.008 **   P=0.008 **   P=0.008 **   P=0.082      P=0.208                   | 
|ORDER RESTRICTED   |     P=0.118      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 16      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     32/53 (60%)  29/55 (53%)  38/53 (72%)  35/53 (66%)  38/53 (72%)  42/52 (81%)  47/53 (89%)               | 
|POLY-3 RATE (b)    |     32/43.26     29/42.29     38/44.90     35/44.58     38/44.56     42/46.08     47/48.96                  | 
|POLY-3 PERCENT (g) |     74.0%        68.6%        84.6%        78.5%        85.3%        91.1%        96.0%                     | 
|TERMINAL (d)       |     11/15 (73%)  20/25 (80%)  26/26 (100%) 21/22 (96%)  14/16 (88%)  22/23 (96%)  7/7 (100%)                | 
|FIRST INCIDENCE    |     126          350          376          385          331          554          188                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.013N*    P=0.111N     P=0.218N     P=0.515      P=0.276N     P=0.003 **                | 
|POLY 3             |     P<0.001 **   P=0.366N     P=0.131      P=0.387      P=0.116      P=0.014 *    P<0.001 **                | 
|POLY 1.5           |     P<0.001 **   P=0.363N     P=0.124      P=0.375      P=0.096      P=0.011 *    P<0.001 **                | 
|POLY 6             |     P<0.001 **   P=0.352N     P=0.133      P=0.347      P=0.163      P=0.025 *    P<0.001 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.178N     P=0.309      P=0.472      P=0.239      P=0.095      P<0.001 **                | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.272N     P=0.153      P=0.344      P=0.153      P=0.018 *    P<0.001 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     2/53 (4%)    1/55 (2%)    0/53 (0%)    0/53 (0%)    0/53 (0%)    1/52 (2%)    2/53 (4%)                 | 
|POLY-3 RATE (b)    |     2/32.37      1/38.53      0/39.60      0/37.32      0/36.61      1/41.91      2/33.30                   | 
|POLY-3 PERCENT (g) |     6.2%         2.6%         0.0%         0.0%         0.0%         2.4%         6.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    1/25 (4%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     574          727 (T)      ---          ---          ---          618          309                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.233      P=0.406N     P=0.195N     P=0.206N     P=0.201N     P=0.374N     P=0.650N                  | 
|POLY 3             |     P=0.229      P=0.439N     P=0.195N     P=0.206N     P=0.210N     P=0.411N     P=0.686N                  | 
|POLY 1.5           |     P=0.241      P=0.458N     P=0.208N     P=0.213N     P=0.218N     P=0.442N     P=0.680N                  | 
|POLY 6             |     P=0.224      P=0.413N     P=0.181N     P=0.202N     P=0.204N     P=0.381N     P=0.681                   | 
|LOGISTIC REGRESSION|     P=0.261      P=0.465N     P=0.245N     P=0.243N     P=0.239N     P=0.534N     P=0.681                   | 
|COCH-ARM / FISHERS |     P=0.259      P=0.486N     P=0.248N     P=0.248N     P=0.248N     P=0.507N     P=0.691N                  | 
|ORDER RESTRICTED   |     P=0.221N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 17      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     2/53 (4%)    0/55 (0%)    0/53 (0%)    0/53 (0%)    3/53 (6%)    0/52 (0%)    0/53 (0%)                 | 
|POLY-3 RATE (b)    |     2/32.53      0/38.53      0/39.60      0/37.32      3/38.48      0/41.53      0/31.91                   | 
|POLY-3 PERCENT (g) |     6.2%         0.0%         0.0%         0.0%         7.8%         0.0%         0.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     541          ---          ---          ---          301          ---          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.276N     P=0.211N     P=0.201N     P=0.206N     P=0.577      P=0.180N     P=0.211N                  | 
|POLY 3             |     P=0.300N     P=0.200N     P=0.196N     P=0.207N     P=0.577      P=0.187N     P=0.240N                  | 
|POLY 1.5           |     P=0.295N     P=0.212N     P=0.209N     P=0.213N     P=0.551      P=0.204N     P=0.233N                  | 
|POLY 6             |     P=0.338N     P=0.185N     P=0.182N     P=0.203N     P=0.598      P=0.172N     P=0.263N                  | 
|LOGISTIC REGRESSION|     P=0.302N     P=0.239N     P=0.263N     P=0.260N     P=0.454      P=0.284N     P=0.241N                  | 
|COCH-ARM / FISHERS |     P=0.292N     P=0.238N     P=0.248N     P=0.248N     P=0.500      P=0.252N     P=0.248N                  | 
|ORDER RESTRICTED   |     P=0.073N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/53 (0%)    2/55 (4%)    2/53 (4%)    2/53 (4%)    0/53 (0%)    0/52 (0%)    1/53 (2%)                 | 
|POLY-3 RATE (b)    |     0/31.38      2/39.16      2/40.08      2/37.84      0/36.61      0/41.53      1/32.16                   | 
|POLY-3 PERCENT (g) |     0.0%         5.1%         5.0%         5.3%         0.0%         0.0%         3.1%                      | 
|TERMINAL (d)       |     0/15 (0%)    1/25 (4%)    1/26 (4%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          524          586          658          ---          ---          660                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.438N     P=0.307      P=0.331      P=0.316      (e)          (e)          P=0.460                   | 
|POLY 3             |     P=0.288N     P=0.289      P=0.295      P=0.280      (e)          (e)          P=0.505                   | 
|POLY 1.5           |     P=0.314N     P=0.270      P=0.274      P=0.268      (e)          (e)          P=0.507                   | 
|POLY 6             |     P=0.269N     P=0.317      P=0.322      P=0.295      (e)          (e)          P=0.492                   | 
|LOGISTIC REGRESSION|     P=0.365N     P=0.257      P=0.270      P=0.269      (e)          (e)          P=0.497                   | 
|COCH-ARM / FISHERS |     P=0.363N     P=0.257      P=0.248      P=0.248      (e)          (e)          P=0.500                   | 
|ORDER RESTRICTED   |     P=0.449N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 18      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Transitional Epithelium                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     4/53 (8%)    2/55 (4%)    8/53 (15%)   4/53 (8%)    8/53 (15%)   8/52 (15%)   11/53 (21%)               | 
|POLY-3 RATE (b)    |     4/32.45      2/39.16      8/41.11      4/38.52      8/38.99      8/42.50      11/35.55                  | 
|POLY-3 PERCENT (g) |     12.3%        5.1%         19.5%        10.4%        20.5%        18.8%        30.9%                     | 
|TERMINAL (d)       |     2/15 (13%)   1/25 (4%)    4/26 (15%)   1/22 (5%)    2/16 (13%)   4/23 (17%)   1/7 (14%)                 | 
|FIRST INCIDENCE    |     554          524          498          500          301          618          309                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.204N     P=0.444      P=0.479N     P=0.272      P=0.443      P=0.023 *                 | 
|POLY 3             |     P=0.004 **   P=0.253N     P=0.308      P=0.547N     P=0.273      P=0.331      P=0.054                   | 
|POLY 1.5           |     P=0.005 **   P=0.279N     P=0.258      P=0.573N     P=0.237      P=0.270      P=0.054                   | 
|POLY 6             |     P=0.003 **   P=0.218N     P=0.373      P=0.523N     P=0.308      P=0.404      P=0.045 *                 | 
|LOGISTIC REGRESSION|     P=0.004 **   P=0.281N     P=0.269      P=0.585N     P=0.210      P=0.323      P=0.050                   | 
|COCH-ARM / FISHERS |     P=0.005 **   P=0.322N     P=0.179      P=0.642N     P=0.179      P=0.170      P=0.046 *                 | 
|ORDER RESTRICTED   |     P=0.011 *    (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     3/53 (6%)    8/55 (15%)   4/53 (8%)    1/53 (2%)    1/53 (2%)    2/51 (4%)    2/53 (4%)                 | 
|POLY-3 RATE (b)    |     3/31.69      8/38.81      4/39.86      1/37.32      1/36.76      2/41.43      2/32.00                   | 
|POLY-3 PERCENT (g) |     9.5%         20.6%        10.0%        2.7%         2.7%         4.8%         6.3%                      | 
|TERMINAL (d)       |     2/15 (13%)   7/25 (28%)   3/26 (12%)   1/22 (5%)    0/16 (0%)    2/23 (9%)    1/7 (14%)                 | 
|FIRST INCIDENCE    |     644          652          659          727 (T)      688          727 (T)      704                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.273N     P=0.316      P=0.548N     P=0.193N     P=0.256N     P=0.312N     P=0.594                   | 
|POLY 3             |     P=0.071N     P=0.169      P=0.624      P=0.247N     P=0.252N     P=0.380N     P=0.495N                  | 
|POLY 1.5           |     P=0.078N     P=0.142      P=0.581      P=0.262N     P=0.270N     P=0.425N     P=0.487N                  | 
|POLY 6             |     P=0.068N     P=0.216      P=0.636N     P=0.235N     P=0.237N     P=0.337N     P=0.535N                  | 
|LOGISTIC REGRESSION|     P=0.141N     P=0.264      P=0.616N     P=0.216N     P=0.232N     P=0.291N     P=0.625N                  | 
|COCH-ARM / FISHERS |     P=0.092N     P=0.113      P=0.500      P=0.309N     P=0.309N     P=0.518N     P=0.500N                  | 
|ORDER RESTRICTED   |     P=0.093N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 19      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     7/53 (13%)   10/55 (18%)  10/53 (19%)  13/53 (25%)  4/53 (8%)    5/51 (10%)   5/53 (9%)                 | 
|POLY-3 RATE (b)    |     7/32.51      10/39.34     10/40.14     13/39.28     4/36.97      5/41.49      5/32.77                   | 
|POLY-3 PERCENT (g) |     21.5%        25.4%        24.9%        33.1%        10.8%        12.1%        15.3%                     | 
|TERMINAL (d)       |     3/15 (20%)   7/25 (28%)   8/26 (31%)   9/22 (41%)   1/16 (6%)    4/23 (17%)   2/7 (29%)                 | 
|FIRST INCIDENCE    |     541          574          651          454          658          714          525                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.316N     P=0.529N     P=0.489N     P=0.322      P=0.182N     P=0.129N     P=0.545                   | 
|POLY 3             |     P=0.036N*    P=0.457      P=0.476      P=0.201      P=0.184N     P=0.219N     P=0.367N                  | 
|POLY 1.5           |     P=0.037N*    P=0.401      P=0.412      P=0.171      P=0.209N     P=0.274N     P=0.357N                  | 
|POLY 6             |     P=0.045N*    P=0.538      P=0.550      P=0.229      P=0.166N     P=0.173N     P=0.427N                  | 
|LOGISTIC REGRESSION|     P=0.067N     P=0.538      P=0.589      P=0.207      P=0.157N     P=0.144N     P=0.416N                  | 
|COCH-ARM / FISHERS |     P=0.049N*    P=0.329      P=0.299      P=0.107      P=0.263N     P=0.408N     P=0.380N                  | 
|ORDER RESTRICTED   |     P=0.165N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Cholangiofibrosis                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/53 (0%)    1/55 (2%)    1/53 (2%)    1/53 (2%)    3/53 (6%)    13/51 (25%)  22/53 (42%)               | 
|POLY-3 RATE (b)    |     0/31.38      1/38.53      1/39.60      1/37.32      3/37.59      13/41.80     22/38.60                  | 
|POLY-3 PERCENT (g) |     0.0%         2.6%         2.5%         2.7%         8.0%         31.1%        57.0%                     | 
|TERMINAL (d)       |     0/15 (0%)    1/25 (4%)    1/26 (4%)    1/22 (5%)    0/16 (0%)    10/23 (44%)  3/7 (43%)                 | 
|FIRST INCIDENCE    |     ---          727 (T)      727 (T)      727 (T)      607          651          531                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.602      P=0.610      P=0.576      P=0.182      P=0.002 **   P<0.001 **                | 
|POLY 3             |     P<0.001 **   P=0.541      P=0.546      P=0.534      P=0.153      P<0.001 **   P<0.001 **                | 
|POLY 1.5           |     P<0.001 **   P=0.527      P=0.530      P=0.525      P=0.140      P<0.001 **   P<0.001 **                | 
|POLY 6             |     P<0.001 **   P=0.561      P=0.565      P=0.543      P=0.169      P<0.001 **   P<0.001 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.602      P=0.610      P=0.576      P=0.133      P=0.002 **   P<0.001 **                | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.509      P=0.500      P=0.500      P=0.121      P<0.001 **   P<0.001 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 20      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Clear Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     2/53 (4%)    1/55 (2%)    0/53 (0%)    0/53 (0%)    0/53 (0%)    0/51 (0%)    0/53 (0%)                 | 
|POLY-3 RATE (b)    |     2/31.38      1/39.30      0/39.60      0/37.32      0/36.61      0/41.43      0/31.91                   | 
|POLY-3 PERCENT (g) |     6.4%         2.5%         0.0%         0.0%         0.0%         0.0%         0.0%                      | 
|TERMINAL (d)       |     2/15 (13%)   0/25 (0%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     727 (T)      448          ---          ---          ---          ---          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.139N     P=0.373N     P=0.127N     P=0.157N     P=0.222N     P=0.149N     P=0.416N                  | 
|POLY 3             |     P=0.117N     P=0.422N     P=0.189N     P=0.200N     P=0.203N     P=0.182N     P=0.232N                  | 
|POLY 1.5           |     P=0.122N     P=0.449N     P=0.205N     P=0.210N     P=0.215N     P=0.201N     P=0.229N                  | 
|POLY 6             |     P=0.125N     P=0.385N     P=0.171N     P=0.190N     P=0.193N     P=0.163N     P=0.248N                  | 
|LOGISTIC REGRESSION|     P=0.122N     P=0.461N     (e)          (e)          (e)          (e)          (e)                       | 
|COCH-ARM / FISHERS |     P=0.124N     P=0.486N     P=0.248N     P=0.248N     P=0.248N     P=0.257N     P=0.248N                  | 
|ORDER RESTRICTED   |     P=0.019N*    (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/53 (0%)    0/55 (0%)    0/53 (0%)    0/53 (0%)    1/53 (2%)    1/51 (2%)    2/53 (4%)                 | 
|POLY-3 RATE (b)    |     0/31.38      0/38.53      0/39.60      0/37.32      1/36.61      1/41.43      2/32.00                   | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%         2.7%         2.4%         6.3%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    1/16 (6%)    1/23 (4%)    1/7 (14%)                 | 
|FIRST INCIDENCE    |     ---          ---          ---          ---          727 (T)      727 (T)      704                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   (e)          (e)          (e)          P=0.513      P=0.585      P=0.105                   | 
|POLY 3             |     P=0.013 *    (e)          (e)          (e)          P=0.531      P=0.554      P=0.240                   | 
|POLY 1.5           |     P=0.015 *    (e)          (e)          (e)          P=0.520      P=0.534      P=0.243                   | 
|POLY 6             |     P=0.013 *    (e)          (e)          (e)          P=0.540      P=0.576      P=0.222                   | 
|LOGISTIC REGRESSION|     P=0.002 **   (e)          (e)          (e)          P=0.513      P=0.585      P=0.148                   | 
|COCH-ARM / FISHERS |     P=0.017 *    (e)          (e)          (e)          P=0.500      P=0.490      P=0.248                   | 
|ORDER RESTRICTED   |     P=0.048 *    (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 21      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     11/53 (21%)  10/55 (18%)  13/53 (25%)  21/53 (40%)  17/53 (32%)  24/51 (47%)  17/53 (32%)               | 
|POLY-3 RATE (b)    |     11/34.24     10/39.49     13/42.24     21/43.22     17/39.64     24/47.33     17/41.05                  | 
|POLY-3 PERCENT (g) |     32.1%        25.3%        30.8%        48.6%        42.9%        50.7%        41.4%                     | 
|TERMINAL (d)       |     5/15 (33%)   6/25 (24%)   5/26 (19%)   7/22 (32%)   5/16 (31%)   7/23 (30%)   1/7 (14%)                 | 
|FIRST INCIDENCE    |     405          524          509          385          531          440          244                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.148N     P=0.328N     P=0.186      P=0.301      P=0.194      P=0.096                   | 
|POLY 3             |     P=0.057      P=0.347N     P=0.548N     P=0.103      P=0.233      P=0.073      P=0.272                   | 
|POLY 1.5           |     P=0.046 *    P=0.393N     P=0.565      P=0.068      P=0.191      P=0.028 *    P=0.226                   | 
|POLY 6             |     P=0.050      P=0.285N     P=0.452N     P=0.165      P=0.287      P=0.171      P=0.291                   | 
|LOGISTIC REGRESSION|     P=0.021 *    P=0.312N     P=0.581      P=0.056      P=0.236      P=0.013 *    P=0.135                   | 
|COCH-ARM / FISHERS |     P=0.023 *    P=0.462N     P=0.408      P=0.028 *    P=0.135      P=0.004 **   P=0.135                   | 
|ORDER RESTRICTED   |     P=0.100      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Diffuse                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     5/53 (9%)    7/55 (13%)   14/53 (26%)  22/53 (42%)  30/53 (57%)  45/51 (88%)  47/53 (89%)               | 
|POLY-3 RATE (b)    |     5/33.58      7/40.50      14/43.35     22/41.83     30/43.70     45/48.97     47/47.72                  | 
|POLY-3 PERCENT (g) |     14.9%        17.3%        32.3%        52.6%        68.7%        91.9%        98.5%                     | 
|TERMINAL (d)       |     2/15 (13%)   2/25 (8%)    6/26 (23%)   11/22 (50%)  10/16 (63%)  21/23 (91%)  7/7 (100%)                | 
|FIRST INCIDENCE    |     126          448          376          481          163          440          309                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.614      P=0.142      P=0.005 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|POLY 3             |     P<0.001 **   P=0.515      P=0.066      P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|POLY 1.5           |     P<0.001 **   P=0.462      P=0.042 *    P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|POLY 6             |     P<0.001 **   P=0.594      P=0.111      P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.403      P=0.020 *    P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.407      P=0.020 *    P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 22      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     2/53 (4%)    6/55 (11%)   8/53 (15%)   6/53 (11%)   3/53 (6%)    2/51 (4%)    0/53 (0%)                 | 
|POLY-3 RATE (b)    |     2/32.02      6/38.55      8/40.14      6/37.58      3/36.91      2/42.21      0/31.91                   | 
|POLY-3 PERCENT (g) |     6.3%         15.6%        19.9%        16.0%        8.1%         4.7%         0.0%                      | 
|TERMINAL (d)       |     1/15 (7%)    5/25 (20%)   5/26 (19%)   5/22 (23%)   2/16 (13%)   1/23 (4%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     519          722          653          660          645          440          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.032N*    P=0.324      P=0.189      P=0.256      P=0.554      P=0.576N     P=0.302N                  | 
|POLY 3             |     P=0.005N**   P=0.197      P=0.091      P=0.186      P=0.565      P=0.590N     P=0.236N                  | 
|POLY 1.5           |     P=0.005N**   P=0.174      P=0.073      P=0.172      P=0.543      P=0.630N     P=0.232N                  | 
|POLY 6             |     P=0.006N**   P=0.235      P=0.120      P=0.198      P=0.585      P=0.548N     P=0.256N                  | 
|LOGISTIC REGRESSION|     P=0.009N**   P=0.250      P=0.110      P=0.209      P=0.568      P=0.673      P=0.234N                  | 
|COCH-ARM / FISHERS |     P=0.008N**   P=0.147      P=0.046 *    P=0.135      P=0.500      P=0.676      P=0.248N                  | 
|ORDER RESTRICTED   |     P=0.053N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocyte, Multinucleate                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/53 (0%)    2/55 (4%)    10/53 (19%)  14/53 (26%)  19/53 (36%)  46/51 (90%)  49/53 (92%)               | 
|POLY-3 RATE (b)    |     0/31.38      2/38.53      10/40.61     14/40.28     19/39.58     46/47.56     49/50.73                  | 
|POLY-3 PERCENT (g) |     0.0%         5.2%         24.6%        34.8%        48.0%        96.7%        96.6%                     | 
|TERMINAL (d)       |     0/15 (0%)    2/25 (8%)    7/26 (27%)   8/22 (36%)   9/16 (56%)   23/23 (100%) 7/7 (100%)                | 
|FIRST INCIDENCE    |     ---          727 (T)      509          481          331          440          188                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.356      P=0.012 *    P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|POLY 3             |     P<0.001 **   P=0.285      P=0.003 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|POLY 1.5           |     P<0.001 **   P=0.268      P=0.002 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|POLY 6             |     P<0.001 **   P=0.310      P=0.006 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.356      P=0.005 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.257      P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 23      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/53 (0%)    0/55 (0%)    0/53 (0%)    1/53 (2%)    3/53 (6%)    26/51 (51%)  39/53 (74%)               | 
|POLY-3 RATE (b)    |     0/31.38      0/38.53      0/39.60      1/37.32      3/36.86      26/43.63     39/42.89                  | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         2.7%         8.1%         59.6%        90.9%                     | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    1/22 (5%)    1/16 (6%)    18/23 (78%)  7/7 (100%)                | 
|FIRST INCIDENCE    |     ---          ---          ---          727 (T)      680          535          484                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   (e)          (e)          P=0.576      P=0.163      P<0.001 **   P<0.001 **                | 
|POLY 3             |     P<0.001 **   (e)          (e)          P=0.534      P=0.148      P<0.001 **   P<0.001 **                | 
|POLY 1.5           |     P<0.001 **   (e)          (e)          P=0.525      P=0.137      P<0.001 **   P<0.001 **                | 
|POLY 6             |     P<0.001 **   (e)          (e)          P=0.543      P=0.160      P<0.001 **   P<0.001 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   (e)          (e)          P=0.576      P=0.160      P<0.001 **   P<0.001 **                | 
|COCH-ARM / FISHERS |     P<0.001 **   (e)          (e)          P=0.500      P=0.121      P<0.001 **   P<0.001 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     36/53 (68%)  40/55 (73%)  49/53 (92%)  50/53 (94%)  51/53 (96%)  51/51 (100%) 51/53 (96%)               | 
|POLY-3 RATE (b)    |     36/42.80     40/46.70     49/50.26     50/50.96     51/51.40     51/51.00     51/52.15                  | 
|POLY-3 PERCENT (g) |     84.1%        85.7%        97.5%        98.1%        99.2%        100.0%       97.8%                     | 
|TERMINAL (d)       |     15/15 (100%) 21/25 (84%)  25/26 (96%)  22/22 (100%) 16/16 (100%) 23/23 (100%) 7/7 (100%)                | 
|FIRST INCIDENCE    |     176          253          188          385          40           185          72                        | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.082N     P=0.334N     P=0.405      P=0.148      P=0.428N     P=0.002 **                | 
|POLY 3             |     P<0.001 **   P=0.543      P=0.008 **   P=0.004 **   P<0.001 **   P<0.001 **   P=0.004 **                | 
|POLY 1.5           |     P<0.001 **   P=0.427      P=0.002 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|POLY 6             |     P=0.006 **   P=0.527N     P=0.061      P=0.020 *    P=0.006 **   P=0.004 **   P=0.019 *                 | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.548      P=0.009 **   P=0.003 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.369      P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 24      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     21/53 (40%)  24/55 (44%)  32/53 (60%)  32/53 (60%)  30/53 (57%)  29/51 (57%)  9/53 (17%)                | 
|POLY-3 RATE (b)    |     21/34.34     24/40.37     32/42.94     32/43.91     30/42.01     29/43.57     9/34.56                   | 
|POLY-3 PERCENT (g) |     61.2%        59.5%        74.5%        72.9%        71.4%        66.6%        26.0%                     | 
|TERMINAL (d)       |     12/15 (80%)  19/25 (76%)  22/26 (85%)  19/22 (86%)  15/16 (94%)  19/23 (83%)  3/7 (43%)                 | 
|FIRST INCIDENCE    |     541          546          541          385          454          574          244                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.255N     P=0.087N     P=0.449N     P=0.349      P=0.201      P=0.343N     P=0.137N                  | 
|POLY 3             |     P<0.001N**   P=0.537N     P=0.131      P=0.170      P=0.219      P=0.392      P<0.001N**                | 
|POLY 1.5           |     P<0.001N**   P=0.553      P=0.071      P=0.099      P=0.130      P=0.230      P=0.002N**                | 
|POLY 6             |     P<0.001N**   P=0.398N     P=0.257      P=0.261      P=0.351      P=0.585      P<0.001N**                | 
|LOGISTIC REGRESSION|     P<0.001N**   P=0.313N     P=0.257      P=0.104      P=0.198      P=0.480N     P=0.005N**                | 
|COCH-ARM / FISHERS |     P<0.001N**   P=0.410      P=0.026 *    P=0.026 *    P=0.060      P=0.059      P=0.008N**                | 
|ORDER RESTRICTED   |     P<0.001N**   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     4/53 (8%)    2/55 (4%)    5/53 (9%)    8/53 (15%)   11/53 (21%)  15/51 (29%)  17/53 (32%)               | 
|POLY-3 RATE (b)    |     4/34.03      2/39.44      5/42.49      8/41.14      11/39.49     15/44.94     17/38.49                  | 
|POLY-3 PERCENT (g) |     11.8%        5.1%         11.8%        19.5%        27.9%        33.4%        44.2%                     | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    3/16 (19%)   6/23 (26%)   1/7 (14%)                 | 
|FIRST INCIDENCE    |     176          356          300          481          403          185          530                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.242N     P=0.624      P=0.294      P=0.112      P=0.064      P=0.004 **                | 
|POLY 3             |     P<0.001 **   P=0.269N     P=0.637      P=0.278      P=0.075      P=0.024 *    P=0.002 **                | 
|POLY 1.5           |     P<0.001 **   P=0.291N     P=0.589      P=0.243      P=0.061      P=0.013 *    P<0.001 **                | 
|POLY 6             |     P<0.001 **   P=0.240N     P=0.583N     P=0.320      P=0.093      P=0.045 *    P=0.002 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.373N     P=0.320      P=0.101      P=0.047 *    P=0.002 **   P=0.002 **                | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.322N     P=0.500      P=0.179      P=0.046 *    P=0.004 **   P<0.001 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 25      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     1/53 (2%)    11/55 (20%)  41/53 (77%)  39/53 (74%)  48/53 (91%)  51/51 (100%) 48/53 (91%)               | 
|POLY-3 RATE (b)    |     1/32.06      11/39.46     41/47.21     39/44.38     48/49.35     51/51.00     48/48.68                  | 
|POLY-3 PERCENT (g) |     3.1%         27.9%        86.9%        87.9%        97.3%        100.0%       98.6%                     | 
|TERMINAL (d)       |     0/15 (0%)    7/25 (28%)   23/26 (89%)  21/22 (96%)  15/16 (94%)  23/23 (100%) 7/7 (100%)                | 
|FIRST INCIDENCE    |     496          572          328          405          247          185          244                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.024 *    P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|POLY 3             |     P<0.001 **   P=0.005 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|POLY 1.5           |     P<0.001 **   P=0.004 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|POLY 6             |     P<0.001 **   P=0.009 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.008 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.002 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Toxic Hepatopathy                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/53 (0%)    6/55 (11%)   22/53 (42%)  27/53 (51%)  39/53 (74%)  51/51 (100%) 49/53 (92%)               | 
|POLY-3 RATE (b)    |     0/31.38      6/38.95      22/41.68     27/41.02     39/43.36     51/51.00     49/49.10                  | 
|POLY-3 PERCENT (g) |     0.0%         15.4%        52.8%        65.8%        90.0%        100.0%       99.8%                     | 
|TERMINAL (d)       |     0/15 (0%)    3/25 (12%)   15/26 (58%)  18/22 (82%)  15/16 (94%)  23/23 (100%) 7/7 (100%)                | 
|FIRST INCIDENCE    |     ---          652          328          454          541          185          243                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.068      P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|POLY 3             |     P<0.001 **   P=0.029 *    P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|POLY 1.5           |     P<0.001 **   P=0.023 *    P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|POLY 6             |     P<0.001 **   P=0.040 *    P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.042 *    P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.015 *    P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 26      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     3/53 (6%)    6/55 (11%)   0/53 (0%)    2/53 (4%)    3/53 (6%)    8/51 (16%)   12/53 (23%)               | 
|POLY-3 RATE (b)    |     3/31.38      6/38.56      0/39.60      2/37.58      3/36.99      8/41.43      12/35.10                  | 
|POLY-3 PERCENT (g) |     9.6%         15.6%        0.0%         5.3%         8.1%         19.3%        34.2%                     | 
|TERMINAL (d)       |     3/15 (20%)   5/25 (20%)   0/26 (0%)    1/22 (5%)    2/16 (13%)   8/23 (35%)   3/7 (43%)                 | 
|FIRST INCIDENCE    |     727 (T)      720          ---          659          618          727 (T)      244                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.545      P=0.042N*    P=0.343N     P=0.618N     P=0.272      P<0.001 **                | 
|POLY 3             |     P<0.001 **   P=0.350      P=0.082N     P=0.418N     P=0.586N     P=0.209      P=0.014 *                 | 
|POLY 1.5           |     P<0.001 **   P=0.311      P=0.094N     P=0.441N     P=0.614N     P=0.160      P=0.014 *                 | 
|POLY 6             |     P<0.001 **   P=0.412      P=0.069N     P=0.394N     P=0.557N     P=0.270      P=0.010 *                 | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.568      (e)          P=0.373N     P=0.556N     P=0.272      P=0.012 *                 | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.263      P=0.121N     P=0.500N     P=0.661N     P=0.089      P=0.012 *                 | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     4/53 (8%)    4/55 (7%)    3/53 (6%)    2/53 (4%)    1/53 (2%)    4/51 (8%)    5/53 (9%)                 | 
|POLY-3 RATE (b)    |     4/32.23      4/38.64      3/39.75      2/38.02      1/36.86      4/42.20      5/33.91                   | 
|POLY-3 PERCENT (g) |     12.4%        10.4%        7.6%         5.3%         2.7%         9.5%         14.8%                     | 
|TERMINAL (d)       |     3/15 (20%)   3/25 (12%)   1/26 (4%)    0/22 (0%)    0/16 (0%)    1/23 (4%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     391          700          709          600          658          535          525                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.082      P=0.382N     P=0.253N     P=0.223N     P=0.148N     P=0.408N     P=0.359                   | 
|POLY 3             |     P=0.240      P=0.541N     P=0.386N     P=0.262N     P=0.137N     P=0.489N     P=0.533                   | 
|POLY 1.5           |     P=0.248      P=0.577N     P=0.426N     P=0.283N     P=0.152N     P=0.550N     P=0.528                   | 
|POLY 6             |     P=0.226      P=0.485N     P=0.338N     P=0.239N     P=0.124N     P=0.423N     P=0.516                   | 
|LOGISTIC REGRESSION|     P=0.234      P=0.512N     P=0.378N     P=0.289N     P=0.149N     P=0.564N     P=0.512                   | 
|COCH-ARM / FISHERS |     P=0.252      P=0.621N     P=0.500N     P=0.339N     P=0.181N     P=0.620      P=0.500                   | 
|ORDER RESTRICTED   |     P=0.305      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 27      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     3/53 (6%)    7/55 (13%)   7/53 (13%)   13/53 (25%)  14/53 (26%)  45/51 (88%)  45/53 (85%)               | 
|POLY-3 RATE (b)    |     3/32.67      7/39.97      7/39.86      13/41.26     14/39.77     45/47.42     45/45.98                  | 
|POLY-3 PERCENT (g) |     9.2%         17.5%        17.6%        31.5%        35.2%        94.9%        97.9%                     | 
|TERMINAL (d)       |     1/15 (7%)    4/25 (16%)   6/26 (23%)   5/22 (23%)   5/16 (31%)   22/23 (96%)  7/7 (100%)                | 
|FIRST INCIDENCE    |     496          434          659          405          328          535          394                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.337      P=0.392      P=0.036 *    P=0.015 *    P<0.001 **   P<0.001 **                | 
|POLY 3             |     P<0.001 **   P=0.248      P=0.246      P=0.019 *    P=0.008 **   P<0.001 **   P<0.001 **                | 
|POLY 1.5           |     P<0.001 **   P=0.215      P=0.215      P=0.013 *    P=0.006 **   P<0.001 **   P<0.001 **                | 
|POLY 6             |     P<0.001 **   P=0.298      P=0.288      P=0.027 *    P=0.011 *    P<0.001 **   P<0.001 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.205      P=0.264      P=0.009 **   P=0.006 **   P<0.001 **   P<0.001 **                | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.176      P=0.160      P=0.006 **   P=0.003 **   P<0.001 **   P<0.001 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     3/53 (6%)    1/55 (2%)    1/53 (2%)    0/53 (0%)    1/53 (2%)    1/51 (2%)    7/53 (13%)                | 
|POLY-3 RATE (b)    |     3/33.04      1/38.64      1/40.21      0/37.32      1/36.68      1/41.62      7/34.41                   | 
|POLY-3 PERCENT (g) |     9.1%         2.6%         2.5%         0.0%         2.7%         2.4%         20.3%                     | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     354          700          533          ---          709          678          484                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.210N     P=0.233N     P=0.094N     P=0.256N     P=0.191N     P=0.129                   | 
|POLY 3             |     P=0.002 **   P=0.250N     P=0.238N     P=0.097N     P=0.267N     P=0.228N     P=0.165                   | 
|POLY 1.5           |     P=0.002 **   P=0.267N     P=0.260N     P=0.102N     P=0.279N     P=0.256N     P=0.169                   | 
|POLY 6             |     P=0.002 **   P=0.224N     P=0.213N     P=0.093N     P=0.257N     P=0.201N     P=0.145                   | 
|LOGISTIC REGRESSION|     P=0.002 **   P=0.302N     P=0.375N     P=0.151N     P=0.316N     P=0.396N     P=0.162                   | 
|COCH-ARM / FISHERS |     P=0.002 **   P=0.295N     P=0.309N     P=0.121N     P=0.309N     P=0.324N     P=0.160                   | 
|ORDER RESTRICTED   |     P=0.002 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 28      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/53 (0%)    23/55 (42%)  32/53 (60%)  36/53 (68%)  42/53 (79%)  50/51 (98%)  49/53 (92%)               | 
|POLY-3 RATE (b)    |     0/31.38      23/43.50     32/45.22     36/46.82     42/46.52     50/50.61     49/49.44                  | 
|POLY-3 PERCENT (g) |     0.0%         52.9%        70.8%        76.9%        90.3%        98.8%        99.1%                     | 
|TERMINAL (d)       |     0/15 (0%)    10/25 (40%)  18/26 (69%)  17/22 (77%)  15/16 (94%)  23/23 (100%) 7/7 (100%)                | 
|FIRST INCIDENCE    |     ---          448          188          385          328          185          243                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P<0.001 **   P<0.001 **   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 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|POLY 1.5           |     P<0.001 **   P<0.001 **   P<0.001 **   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 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   P<0.001 **   P<0.001 **   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 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Oval Cell                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/53 (0%)    1/55 (2%)    6/53 (11%)   7/53 (13%)   10/53 (19%)  38/51 (75%)  40/53 (75%)               | 
|POLY-3 RATE (b)    |     0/31.38      1/38.56      6/39.60      7/37.32      10/37.11     38/44.37     40/43.32                  | 
|POLY-3 PERCENT (g) |     0.0%         2.6%         15.2%        18.8%        27.0%        85.6%        92.3%                     | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    6/26 (23%)   7/22 (32%)   6/16 (38%)   23/23 (100%) 7/7 (100%)                | 
|FIRST INCIDENCE    |     ---          720          727 (T)      727 (T)      630          535          484                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.624      P=0.062      P=0.024 *    P=0.003 **   P<0.001 **   P<0.001 **                | 
|POLY 3             |     P<0.001 **   P=0.541      P=0.031 *    P=0.013 *    P=0.002 **   P<0.001 **   P<0.001 **                | 
|POLY 1.5           |     P<0.001 **   P=0.527      P=0.025 *    P=0.012 *    P<0.001 **   P<0.001 **   P<0.001 **                | 
|POLY 6             |     P<0.001 **   P=0.561      P=0.041 *    P=0.015 *    P=0.002 **   P<0.001 **   P<0.001 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.596      P=0.062      P=0.024 *    P=0.003 **   P<0.001 **   P<0.001 **                | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.509      P=0.013 *    P=0.006 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 29      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Portal                                                                                                                    | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/53 (0%)    0/55 (0%)    0/53 (0%)    0/53 (0%)    2/53 (4%)    1/51 (2%)    10/53 (19%)               | 
|POLY-3 RATE (b)    |     0/31.38      0/38.53      0/39.60      0/37.32      2/37.17      1/41.55      10/34.71                  | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%         5.4%         2.4%         28.8%                     | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    1/7 (14%)                 | 
|FIRST INCIDENCE    |     ---          ---          ---          ---          618          699          574                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   (e)          (e)          (e)          P=0.306      P=0.626      P<0.001 **                | 
|POLY 3             |     P<0.001 **   (e)          (e)          (e)          P=0.276      P=0.555      P<0.001 **                | 
|POLY 1.5           |     P<0.001 **   (e)          (e)          (e)          P=0.261      P=0.534      P<0.001 **                | 
|POLY 6             |     P<0.001 **   (e)          (e)          (e)          P=0.291      P=0.577      P<0.001 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   (e)          (e)          (e)          P=0.260      P=0.579      P<0.001 **                | 
|COCH-ARM / FISHERS |     P<0.001 **   (e)          (e)          (e)          P=0.248      P=0.490      P<0.001 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     41/53 (77%)  49/55 (89%)  45/53 (85%)  48/53 (91%)  45/53 (85%)  49/51 (96%)  42/51 (82%)               | 
|POLY-3 RATE (b)    |     41/47.06     49/51.17     45/47.89     48/49.78     45/46.48     49/49.11     42/44.15                  | 
|POLY-3 PERCENT (g) |     87.1%        95.8%        94.0%        96.4%        96.8%        99.8%        95.1%                     | 
|TERMINAL (d)       |     12/15 (80%)  23/25 (92%)  26/26 (100%) 21/22 (96%)  15/16 (94%)  23/23 (100%) 7/7 (100%)                | 
|FIRST INCIDENCE    |     201          253          328          385          454          320          394                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.009 **   P=0.201N     P=0.049N*    P=0.335N     P=0.406N     P=0.118N     P=0.164                   | 
|POLY 3             |     P=0.093      P=0.099      P=0.185      P=0.069      P=0.064      P=0.007 **   P=0.133                   | 
|POLY 1.5           |     P=0.132      P=0.062      P=0.192      P=0.058      P=0.070      P=0.004 **   P=0.156                   | 
|POLY 6             |     P=0.077      P=0.182      P=0.187      P=0.097      P=0.100      P=0.019 *    P=0.128                   | 
|LOGISTIC REGRESSION|     P=0.504      P=0.128      P=0.479      P=0.144      P=0.410      P=0.037 *    P=0.445                   | 
|COCH-ARM / FISHERS |     P=0.411      P=0.084      P=0.229      P=0.055      P=0.229      P=0.005 **   P=0.349                   | 
|ORDER RESTRICTED   |     P=0.006 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 30      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     5/53 (9%)    3/55 (5%)    0/53 (0%)    1/53 (2%)    1/53 (2%)    0/51 (0%)    2/51 (4%)                 | 
|POLY-3 RATE (b)    |     5/32.66      3/39.74      0/39.60      1/37.78      1/37.61      0/41.13      2/31.84                   | 
|POLY-3 PERCENT (g) |     15.3%        7.6%         0.0%         2.7%         2.7%         0.0%         6.3%                      | 
|TERMINAL (d)       |     2/15 (13%)   0/25 (0%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     309          356          ---          592          40           ---          484                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.289N     P=0.179N     P=0.010N*    P=0.057N     P=0.086N     P=0.011N*    P=0.375N                  | 
|POLY 3             |     P=0.215N     P=0.252N     P=0.017N*    P=0.069N     P=0.069N     P=0.015N*    P=0.220N                  | 
|POLY 1.5           |     P=0.223N     P=0.286N     P=0.021N*    P=0.077N     P=0.079N     P=0.020N*    P=0.219N                  | 
|POLY 6             |     P=0.207N     P=0.207N     P=0.013N*    P=0.061N     P=0.062N     P=0.011N*    P=0.244N                  | 
|LOGISTIC REGRESSION|     P=0.238N     P=0.321N     P=0.026N*    P=0.088N     P=0.121N     P=0.027N*    P=0.225N                  | 
|COCH-ARM / FISHERS |     P=0.231N     P=0.337N     P=0.028N*    P=0.103N     P=0.103N     P=0.031N*    P=0.235N                  | 
|ORDER RESTRICTED   |     P=0.011N*    (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     3/53 (6%)    0/55 (0%)    2/53 (4%)    0/53 (0%)    0/53 (0%)    0/51 (0%)    0/51 (0%)                 | 
|POLY-3 RATE (b)    |     3/32.04      0/38.53      2/39.67      0/37.32      0/36.61      0/41.13      0/30.95                   | 
|POLY-3 PERCENT (g) |     9.4%         0.0%         5.0%         0.0%         0.0%         0.0%         0.0%                      | 
|TERMINAL (d)       |     1/15 (7%)    0/25 (0%)    1/26 (4%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     611          ---          709          ---          ---          ---          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.078N     P=0.066N     P=0.300N     P=0.085N     P=0.097N     P=0.057N     P=0.179N                  | 
|POLY 3             |     P=0.061N     P=0.088N     P=0.403N     P=0.092N     P=0.095N     P=0.080N     P=0.122N                  | 
|POLY 1.5           |     P=0.064N     P=0.097N     P=0.435N     P=0.098N     P=0.102N     P=0.094N     P=0.120N                  | 
|POLY 6             |     P=0.065N     P=0.076N     P=0.368N     P=0.088N     P=0.090N     P=0.069N     P=0.137N                  | 
|LOGISTIC REGRESSION|     P=0.065N     P=0.088N     P=0.374N     P=0.092N     P=0.095N     P=0.082N     P=0.127N                  | 
|COCH-ARM / FISHERS |     P=0.069N     P=0.115N     P=0.500N     P=0.121N     P=0.121N     P=0.129N     P=0.129N                  | 
|ORDER RESTRICTED   |     P=0.007N**   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 31      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     1/53 (2%)    0/55 (0%)    1/53 (2%)    2/53 (4%)    3/53 (6%)    9/51 (18%)   4/51 (8%)                 | 
|POLY-3 RATE (b)    |     1/31.53      0/38.53      1/39.60      2/37.32      3/37.05      9/42.85      4/31.72                   | 
|POLY-3 PERCENT (g) |     3.2%         0.0%         2.5%         5.4%         8.1%         21.0%        12.6%                     | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    1/26 (4%)    2/22 (9%)    2/16 (13%)   2/23 (9%)    2/7 (29%)                 | 
|FIRST INCIDENCE    |     688          ---          727 (T)      727 (T)      599          573          607                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.405N     P=0.642N     P=0.616      P=0.365      P=0.066      P=0.092                   | 
|POLY 3             |     P<0.001 **   P=0.460N     P=0.708N     P=0.559      P=0.364      P=0.030 *    P=0.175                   | 
|POLY 1.5           |     P<0.001 **   P=0.474N     P=0.727N     P=0.543      P=0.343      P=0.018 *    P=0.177                   | 
|POLY 6             |     P<0.001 **   P=0.441N     P=0.685N     P=0.572      P=0.384      P=0.051      P=0.157                   | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.448N     P=0.677N     P=0.598      P=0.372      P=0.021 *    P=0.153                   | 
|COCH-ARM / FISHERS |     P=0.002 **   P=0.491N     P=0.752N     P=0.500      P=0.309      P=0.007 **   P=0.170                   | 
|ORDER RESTRICTED   |     P=0.016 *    (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Thrombosis                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/53 (0%)    2/55 (4%)    0/53 (0%)    0/53 (0%)    0/53 (0%)    1/51 (2%)    0/51 (0%)                 | 
|POLY-3 RATE (b)    |     0/31.38      2/38.67      0/39.60      0/37.32      0/36.61      1/41.64      0/30.95                   | 
|POLY-3 PERCENT (g) |     0.0%         5.2%         0.0%         0.0%         0.0%         2.4%         0.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          700          ---          ---          ---          573          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.509N     P=0.374      (e)          (e)          (e)          P=0.566      (e)                       | 
|POLY 3             |     P=0.435N     P=0.286      (e)          (e)          (e)          P=0.555      (e)                       | 
|POLY 1.5           |     P=0.444N     P=0.268      (e)          (e)          (e)          P=0.534      (e)                       | 
|POLY 6             |     P=0.460N     P=0.312      (e)          (e)          (e)          P=0.578      (e)                       | 
|LOGISTIC REGRESSION|     P=0.455N     P=0.322      (e)          (e)          (e)          P=0.461      (e)                       | 
|COCH-ARM / FISHERS |     P=0.452N     P=0.257      (e)          (e)          (e)          P=0.490      (e)                       | 
|ORDER RESTRICTED   |     P=0.307N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 32      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     12/53 (23%)  1/55 (2%)    0/53 (0%)    1/53 (2%)    2/53 (4%)    0/51 (0%)    0/51 (0%)                 | 
|POLY-3 RATE (b)    |     12/32.58     1/38.75      0/39.60      1/37.32      2/37.28      0/41.13      0/30.95                   | 
|POLY-3 PERCENT (g) |     36.8%        2.6%         0.0%         2.7%         5.4%         0.0%         0.0%                      | 
|TERMINAL (d)       |     7/15 (47%)   0/25 (0%)    0/26 (0%)    1/22 (5%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     600          671          ---          727 (T)      607          ---          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.002N**   P<0.001N**   P<0.001N**   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**   P<0.001N**   P<0.001N**   P<0.001N**                | 
|POLY 1.5           |     P<0.001N**   P<0.001N**   P<0.001N**   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**   P<0.001N**   P<0.001N**   P<0.001N**                | 
|LOGISTIC REGRESSION|     P<0.001N**   P<0.001N**   P<0.001N**   P<0.001N**   P<0.001N**   P<0.001N**   P<0.001N**                | 
|COCH-ARM / FISHERS |     P=0.002N**   P<0.001N**   P<0.001N**   P<0.001N**   P=0.004N**   P<0.001N**   P<0.001N**                | 
|ORDER RESTRICTED   |     P<0.001N**   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Metaplasia Bronchiolar                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/53 (0%)    29/55 (53%)  34/53 (64%)  41/53 (77%)  39/53 (74%)  47/51 (92%)  40/51 (78%)               | 
|POLY-3 RATE (b)    |     0/31.38      29/41.27     34/43.69     41/45.19     39/44.76     47/48.24     40/43.59                  | 
|POLY-3 PERCENT (g) |     0.0%         70.3%        77.8%        90.7%        87.1%        97.4%        91.8%                     | 
|TERMINAL (d)       |     0/15 (0%)    19/25 (76%)  22/26 (85%)  21/22 (96%)  15/16 (94%)  23/23 (100%) 6/7 (86%)                 | 
|FIRST INCIDENCE    |     ---          516          541          405          454          320          394                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P<0.001 **   P<0.001 **   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 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|POLY 1.5           |     P<0.001 **   P<0.001 **   P<0.001 **   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 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   P<0.001 **   P<0.001 **   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 **   P<0.001 **   P<0.001 **   P<0.001 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 33      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Serosa                                                                                                                     | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/53 (0%)    0/55 (0%)    2/53 (4%)    0/53 (0%)    0/53 (0%)    0/51 (0%)    0/51 (0%)                 | 
|POLY-3 RATE (b)    |     0/31.38      0/38.53      2/39.88      0/37.32      0/36.61      0/41.13      0/30.95                   | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         5.0%         0.0%         0.0%         0.0%         0.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    1/26 (4%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          651          ---          ---          ---          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.413N     (e)          P=0.358      (e)          (e)          (e)          (e)                       | 
|POLY 3             |     P=0.267N     (e)          P=0.294      (e)          (e)          (e)          (e)                       | 
|POLY 1.5           |     P=0.298N     (e)          P=0.273      (e)          (e)          (e)          (e)                       | 
|POLY 6             |     P=0.261N     (e)          P=0.320      (e)          (e)          (e)          (e)                       | 
|LOGISTIC REGRESSION|     P=0.356N     (e)          P=0.300      (e)          (e)          (e)          (e)                       | 
|COCH-ARM / FISHERS |     P=0.351N     (e)          P=0.248      (e)          (e)          (e)          (e)                       | 
|ORDER RESTRICTED   |     P=0.421N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Serosa                                                                                                                     | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     2/53 (4%)    0/55 (0%)    0/53 (0%)    1/53 (2%)    1/53 (2%)    0/51 (0%)    0/51 (0%)                 | 
|POLY-3 RATE (b)    |     2/32.84      0/38.53      0/39.60      1/38.32      1/37.59      0/41.13      0/30.95                   | 
|POLY-3 PERCENT (g) |     6.1%         0.0%         0.0%         2.6%         2.7%         0.0%         0.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     126          ---          ---          124          163          ---          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.210N     P=0.218N     P=0.215N     P=0.482N     P=0.476N     P=0.204N     P=0.228N                  | 
|POLY 3             |     P=0.216N     P=0.202N     P=0.197N     P=0.446N     P=0.453N     P=0.191N     P=0.249N                  | 
|POLY 1.5           |     P=0.216N     P=0.214N     P=0.211N     P=0.459N     P=0.468N     P=0.209N     P=0.244N                  | 
|POLY 6             |     P=0.238N     P=0.186N     P=0.182N     P=0.436N     P=0.441N     P=0.174N     P=0.268N                  | 
|LOGISTIC REGRESSION|     P=0.225N     P=0.267N     P=0.371N     P=0.703      P=0.584N     P=0.449N     P=0.270N                  | 
|COCH-ARM / FISHERS |     P=0.220N     P=0.238N     P=0.248N     P=0.500N     P=0.500N     P=0.257N     P=0.257N                  | 
|ORDER RESTRICTED   |     P=0.053N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 34      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     1/52 (2%)    1/53 (2%)    4/51 (8%)    4/51 (8%)    4/52 (8%)    4/51 (8%)    3/51 (6%)                 | 
|POLY-3 RATE (b)    |     1/31.47      1/37.64      4/38.08      4/36.51      4/35.81      4/41.14      3/30.95                   | 
|POLY-3 PERCENT (g) |     3.2%         2.7%         10.5%        11.0%        11.2%        9.7%         9.7%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    4/25 (16%)   4/22 (18%)   3/16 (19%)   3/23 (13%)   3/7 (43%)                 | 
|FIRST INCIDENCE    |     660          722          727 (T)      727 (T)      722          722          727 (T)                   | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.022 *    P=0.658N     P=0.344      P=0.293      P=0.215      P=0.339      P=0.115                   | 
|POLY 3             |     P=0.234      P=0.720N     P=0.240      P=0.224      P=0.217      P=0.270      P=0.296                   | 
|POLY 1.5           |     P=0.261      P=0.736N     P=0.215      P=0.210      P=0.204      P=0.235      P=0.304                   | 
|POLY 6             |     P=0.188      P=0.695N     P=0.272      P=0.237      P=0.228      P=0.311      P=0.265                   | 
|LOGISTIC REGRESSION|     P=0.057      P=0.709N     P=0.309      P=0.264      P=0.243      P=0.345      P=0.188                   | 
|COCH-ARM / FISHERS |     P=0.273      P=0.748N     P=0.175      P=0.175      P=0.181      P=0.175      P=0.301                   | 
|ORDER RESTRICTED   |     P=0.291      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     18/52 (35%)  24/53 (45%)  31/51 (61%)  21/51 (41%)  29/52 (56%)  11/51 (22%)  15/51 (29%)               | 
|POLY-3 RATE (b)    |     18/36.75     24/45.45     31/41.45     21/38.38     29/42.17     11/42.99     15/36.60                  | 
|POLY-3 PERCENT (g) |     49.0%        52.8%        74.8%        54.7%        68.8%        25.6%        41.0%                     | 
|TERMINAL (d)       |     8/15 (53%)   9/25 (36%)   21/25 (84%)  16/22 (73%)  12/16 (75%)  5/23 (22%)   1/7 (14%)                 | 
|FIRST INCIDENCE    |     222          202          531          496          163          320          484                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.249N     P=0.485N     P=0.365      P=0.348N     P=0.127      P=0.009N**   P=0.552                   | 
|POLY 3             |     P<0.001N**   P=0.450      P=0.010 *    P=0.388      P=0.046 *    P=0.023N*    P=0.318N                  | 
|POLY 1.5           |     P=0.002N**   P=0.328      P=0.007 **   P=0.389      P=0.035 *    P=0.038N*    P=0.327N                  | 
|POLY 6             |     P=0.002N**   P=0.571N     P=0.017 *    P=0.369      P=0.065      P=0.013N*    P=0.329N                  | 
|LOGISTIC REGRESSION|     P=0.004N**   P=0.205      P=0.034 *    P=0.544      P=0.043 *    P=0.059N     P=0.338N                  | 
|COCH-ARM / FISHERS |     P=0.005N**   P=0.180      P=0.007 **   P=0.315      P=0.024 *    P=0.105N     P=0.362N                  | 
|ORDER RESTRICTED   |     P=0.009N**   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 35      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/52 (0%)    1/53 (2%)    1/51 (2%)    1/51 (2%)    2/52 (4%)    0/51 (0%)    1/51 (2%)                 | 
|POLY-3 RATE (b)    |     0/31.21      1/37.90      1/38.68      1/37.34      2/36.75      0/41.11      1/30.95                   | 
|POLY-3 PERCENT (g) |     0.0%         2.6%         2.6%         2.7%         5.4%         0.0%         3.2%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/25 (0%)    0/22 (0%)    1/16 (6%)    0/23 (0%)    1/7 (14%)                 | 
|FIRST INCIDENCE    |     ---          652          533          405          247          ---          727 (T)                   | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.500      P=0.578      P=0.535      P=0.539      P=0.254      (e)          P=0.348                   | 
|POLY 3             |     P=0.579      P=0.538      P=0.542      P=0.536      P=0.274      (e)          P=0.498                   | 
|POLY 1.5           |     P=0.584      P=0.523      P=0.526      P=0.524      P=0.262      (e)          P=0.501                   | 
|POLY 6             |     P=0.585      P=0.561      P=0.562      P=0.547      P=0.287      (e)          P=0.484                   | 
|LOGISTIC REGRESSION|     P=0.571      P=0.525      P=0.462      P=0.388      P=0.211      (e)          P=0.348                   | 
|COCH-ARM / FISHERS |     P=0.575      P=0.505      P=0.495      P=0.495      P=0.248      (e)          P=0.495                   | 
|ORDER RESTRICTED   |     P=0.412      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     2/52 (4%)    3/54 (6%)    0/52 (0%)    1/52 (2%)    1/53 (2%)    0/51 (0%)    2/53 (4%)                 | 
|POLY-3 RATE (b)    |     2/31.83      3/39.51      0/38.60      1/36.90      1/36.68      0/41.43      2/33.24                   | 
|POLY-3 PERCENT (g) |     6.3%         7.6%         0.0%         2.7%         2.7%         0.0%         6.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    1/25 (4%)    0/25 (0%)    0/21 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     618          498          ---          546          709          ---          484                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.575N     P=0.642      P=0.150N     P=0.427N     P=0.411N     P=0.137N     P=0.653                   | 
|POLY 3             |     P=0.460N     P=0.598      P=0.196N     P=0.448N     P=0.450N     P=0.184N     P=0.681N                  | 
|POLY 1.5           |     P=0.481N     P=0.562      P=0.210N     P=0.462N     P=0.466N     P=0.202N     P=0.677N                  | 
|POLY 6             |     P=0.438N     P=0.644      P=0.181N     P=0.437N     P=0.438N     P=0.167N     P=0.692                   | 
|LOGISTIC REGRESSION|     P=0.508N     P=0.539      P=0.200N     P=0.481N     P=0.441N     P=0.192N     P=0.688N                  | 
|COCH-ARM / FISHERS |     P=0.509N     P=0.518      P=0.248N     P=0.500N     P=0.493N     P=0.252N     P=0.684N                  | 
|ORDER RESTRICTED   |     P=0.289N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 36      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     3/52 (6%)    0/54 (0%)    0/52 (0%)    0/52 (0%)    1/53 (2%)    1/51 (2%)    1/53 (2%)                 | 
|POLY-3 RATE (b)    |     3/33.26      0/38.32      0/38.60      0/36.32      1/36.61      1/41.46      1/32.33                   | 
|POLY-3 PERCENT (g) |     9.0%         0.0%         0.0%         0.0%         2.7%         2.4%         3.1%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/25 (0%)    0/21 (0%)    1/16 (6%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     222          ---          ---          ---          727 (T)      720          607                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.556      P=0.095N     P=0.093N     P=0.102N     P=0.259N     P=0.199N     P=0.269N                  | 
|POLY 3             |     P=0.537      P=0.094N     P=0.093N     P=0.102N     P=0.270N     P=0.231N     P=0.313N                  | 
|POLY 1.5           |     P=0.568      P=0.102N     P=0.102N     P=0.106N     P=0.280N     P=0.257N     P=0.302N                  | 
|POLY 6             |     P=0.508      P=0.083N     P=0.084N     P=0.100N     P=0.263N     P=0.206N     P=0.348N                  | 
|LOGISTIC REGRESSION|     P=0.606      P=0.130N     P=0.171N     P=0.172N     P=0.322N     P=0.433N     P=0.309N                  | 
|COCH-ARM / FISHERS |     P=0.607      P=0.115N     P=0.121N     P=0.121N     P=0.302N     P=0.316N     P=0.302N                  | 
|ORDER RESTRICTED   |     P=0.038N*    (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/52 (0%)    0/54 (0%)    0/52 (0%)    0/52 (0%)    0/53 (0%)    0/51 (0%)    2/53 (4%)                 | 
|POLY-3 RATE (b)    |     0/31.36      0/38.32      0/38.60      0/36.32      0/36.61      0/41.43      2/32.53                   | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%         0.0%         0.0%         6.2%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/25 (0%)    0/21 (0%)    0/16 (0%)    0/23 (0%)    1/7 (14%)                 | 
|FIRST INCIDENCE    |     ---          ---          ---          ---          ---          ---          525                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.002 **   (e)          (e)          (e)          (e)          (e)          P=0.172                   | 
|POLY 3             |     P=0.007 **   (e)          (e)          (e)          (e)          (e)          P=0.244                   | 
|POLY 1.5           |     P=0.007 **   (e)          (e)          (e)          (e)          (e)          P=0.246                   | 
|POLY 6             |     P=0.010 *    (e)          (e)          (e)          (e)          (e)          P=0.228                   | 
|LOGISTIC REGRESSION|     P=0.006 **   (e)          (e)          (e)          (e)          (e)          P=0.243                   | 
|COCH-ARM / FISHERS |     P=0.007 **   (e)          (e)          (e)          (e)          (e)          P=0.252                   | 
|ORDER RESTRICTED   |     P=0.005 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 37      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/2 (0%)     0/6 (0%)     0/6 (0%)     0/6 (0%)     0/4 (0%)     2/7 (29%)    0/12 (0%)                 | 
|POLY-3 RATE (b)    |     0/0.63       0/3.24       0/3.60       0/3.43       0/2.47       2/6.05       0/7.43                    | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%         0.0%         33.1%        0.0%                      | 
|TERMINAL (d)       |     0/0 (0%)     0/1 (0%)     0/2 (0%)     0/1 (0%)     0/1 (0%)     0/2 (0%)     0/1 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          ---          ---          ---          651          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.192      (e)          (e)          (e)          (e)          P=0.367      (e)                       | 
|POLY 3             |     P=0.540      (e)          (e)          (e)          (e)          P=0.710      (e)                       | 
|POLY 1.5           |     P=0.555      (e)          (e)          (e)          (e)          P=0.673      (e)                       | 
|POLY 6             |     P=0.481      (e)          (e)          (e)          (e)          P=0.747      (e)                       | 
|LOGISTIC REGRESSION|     P=0.542      (e)          (e)          (e)          (e)          P=0.800      (e)                       | 
|COCH-ARM / FISHERS |     P=0.502      (e)          (e)          (e)          (e)          P=0.583      (e)                       | 
|ORDER RESTRICTED   |     P=0.760      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/2 (0%)     0/6 (0%)     0/6 (0%)     2/6 (33%)    1/4 (25%)    1/7 (14%)    0/12 (0%)                 | 
|POLY-3 RATE (b)    |     0/0.63       0/3.24       0/3.60       2/4.37       1/3.38       1/6.05       0/7.43                    | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         45.8%        29.6%        16.5%        0.0%                      | 
|TERMINAL (d)       |     0/0 (0%)     0/1 (0%)     0/2 (0%)     0/1 (0%)     0/1 (0%)     0/2 (0%)     0/1 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          ---          496          331          618          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.637      (e)          (e)          P=0.287      P=0.522      P=0.581      (e)                       | 
|POLY 3             |     P=0.212N     (e)          (e)          P=0.682      P=0.749      P=0.817      (e)                       | 
|POLY 1.5           |     P=0.229N     (e)          (e)          P=0.636      P=0.723      P=0.802      (e)                       | 
|POLY 6             |     P=0.208N     (e)          (e)          P=0.740      P=0.778      P=0.833      (e)                       | 
|LOGISTIC REGRESSION|     P=0.410N     (e)          (e)          P=0.581      P=0.439      P=0.851      (e)                       | 
|COCH-ARM / FISHERS |     P=0.327N     (e)          (e)          P=0.536      P=0.667      P=0.778      (e)                       | 
|ORDER RESTRICTED   |     P=0.764N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 38      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/2 (0%)     2/6 (33%)    3/6 (50%)    0/6 (0%)     0/4 (0%)     0/7 (0%)     5/12 (42%)                | 
|POLY-3 RATE (b)    |     0/0.63       2/3.86       3/4.04       0/3.43       0/2.47       0/5.66       5/9.34                    | 
|POLY-3 PERCENT (g) |     0.0%         51.8%        74.3%        0.0%         0.0%         0.0%         53.5%                     | 
|TERMINAL (d)       |     0/0 (0%)     0/1 (0%)     2/2 (100%)   0/1 (0%)     0/1 (0%)     0/2 (0%)     1/1 (100%)                | 
|FIRST INCIDENCE    |     ---          630          602          ---          ---          ---          525                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.016 *    P=0.326      P=0.573      (e)          (e)          (e)          P=0.068                   | 
|POLY 3             |     P=0.395      P=0.673      P=0.593      (e)          (e)          (e)          P=0.630                   | 
|POLY 1.5           |     P=0.340      P=0.618      P=0.510      (e)          (e)          (e)          P=0.567                   | 
|POLY 6             |     P=0.467      P=0.742      P=0.784      (e)          (e)          (e)          P=0.714                   | 
|LOGISTIC REGRESSION|     P=0.311      P=0.662      P=0.527      (e)          (e)          (e)          P=0.494                   | 
|COCH-ARM / FISHERS |     P=0.244      P=0.536      P=0.357      (e)          (e)          (e)          P=0.396                   | 
|ORDER RESTRICTED   |     P=0.654      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/2 (0%)     0/6 (0%)     2/6 (33%)    1/6 (17%)    1/4 (25%)    0/7 (0%)     6/12 (50%)                | 
|POLY-3 RATE (b)    |     0/0.63       0/3.24       2/4.04       1/3.97       1/2.86       0/5.66       6/10.24                   | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         49.6%        25.2%        35.0%        0.0%         58.6%                     | 
|TERMINAL (d)       |     0/0 (0%)     0/1 (0%)     1/2 (50%)    0/1 (0%)     0/1 (0%)     0/2 (0%)     0/1 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          602          559          618          ---          484                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   (e)          P=0.573      P=0.543      P=0.554      (e)          P=0.018 *                 | 
|POLY 3             |     P=0.066      (e)          P=0.677      P=0.796      P=0.744      (e)          P=0.604                   | 
|POLY 1.5           |     P=0.051      (e)          P=0.629      P=0.775      P=0.715      (e)          P=0.529                   | 
|POLY 6             |     P=0.089      (e)          P=0.743      P=0.824      P=0.778      (e)          P=0.695                   | 
|LOGISTIC REGRESSION|     P=0.027 *    (e)          P=0.709      P=0.783      P=0.765      (e)          P=0.243                   | 
|COCH-ARM / FISHERS |     P=0.027 *    (e)          P=0.536      P=0.750      P=0.667      (e)          P=0.308                   | 
|ORDER RESTRICTED   |     P=0.637      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 39      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/2 (0%)     0/6 (0%)     0/6 (0%)     0/6 (0%)     0/4 (0%)     0/7 (0%)     2/12 (17%)                | 
|POLY-3 RATE (b)    |     0/0.63       0/3.24       0/3.60       0/3.43       0/2.47       0/5.66       2/8.62                    | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%         0.0%         0.0%         23.2%                     | 
|TERMINAL (d)       |     0/0 (0%)     0/1 (0%)     0/2 (0%)     0/1 (0%)     0/1 (0%)     0/2 (0%)     0/1 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          ---          ---          ---          ---          531                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.008 **   (e)          (e)          (e)          (e)          (e)          P=0.281                   | 
|POLY 3             |     P=0.066      (e)          (e)          (e)          (e)          (e)          P=0.782                   | 
|POLY 1.5           |     P=0.062      (e)          (e)          (e)          (e)          (e)          P=0.757                   | 
|POLY 6             |     P=0.070      (e)          (e)          (e)          (e)          (e)          P=0.812                   | 
|LOGISTIC REGRESSION|     P=0.027 *    (e)          (e)          (e)          (e)          (e)          P=0.590                   | 
|COCH-ARM / FISHERS |     P=0.047 *    (e)          (e)          (e)          (e)          (e)          P=0.725                   | 
|ORDER RESTRICTED   |     P=0.706      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     8/52 (15%)   3/55 (5%)    1/53 (2%)    4/53 (8%)    5/53 (9%)    1/52 (2%)    1/53 (2%)                 | 
|POLY-3 RATE (b)    |     8/33.57      3/39.34      1/40.40      4/37.83      5/37.22      1/41.88      1/32.31                   | 
|POLY-3 PERCENT (g) |     23.8%        7.6%         2.5%         10.6%        13.4%        2.4%         3.1%                      | 
|TERMINAL (d)       |     3/15 (20%)   1/25 (4%)    0/26 (0%)    3/22 (14%)   4/16 (25%)   0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     405          524          428          576          531          628          611                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.067N     P=0.031N*    P=0.005N**   P=0.077N     P=0.205N     P=0.004N**   P=0.051N                  | 
|POLY 3             |     P=0.034N*    P=0.052N     P=0.006N**   P=0.116N     P=0.203N     P=0.005N**   P=0.015N*                 | 
|POLY 1.5           |     P=0.031N*    P=0.064N     P=0.008N**   P=0.128N     P=0.223N     P=0.008N**   P=0.014N*                 | 
|POLY 6             |     P=0.043N*    P=0.038N*    P=0.004N**   P=0.108N     P=0.190N     P=0.003N**   P=0.021N*                 | 
|LOGISTIC REGRESSION|     P=0.030N*    P=0.066N     P=0.014N*    P=0.117N     P=0.200N     P=0.011N*    P=0.016N*                 | 
|COCH-ARM / FISHERS |     P=0.031N*    P=0.084N     P=0.014N*    P=0.170N     P=0.265N     P=0.016N*    P=0.014N*                 | 
|ORDER RESTRICTED   |     P=0.002N**   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 40      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     32/52 (62%)  33/55 (60%)  30/53 (57%)  29/53 (55%)  21/53 (40%)  23/52 (44%)  9/53 (17%)                | 
|POLY-3 RATE (b)    |     32/43.06     33/45.84     30/46.24     29/43.63     21/40.32     23/45.33     9/34.10                   | 
|POLY-3 PERCENT (g) |     74.3%        72.0%        64.9%        66.5%        52.1%        50.7%        26.4%                     | 
|TERMINAL (d)       |     11/15 (73%)  15/25 (60%)  13/26 (50%)  15/22 (68%)  7/16 (44%)   10/23 (44%)  4/7 (57%)                 | 
|FIRST INCIDENCE    |     126          82           328          405          531          185          484                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001N**   P=0.082N     P=0.031N*    P=0.063N     P=0.016N*    P=0.002N**   P=0.002N**                | 
|POLY 3             |     P<0.001N**   P=0.497N     P=0.219N     P=0.269N     P=0.020N*    P=0.013N*    P<0.001N**                | 
|POLY 1.5           |     P<0.001N**   P=0.540N     P=0.295N     P=0.277N     P=0.022N*    P=0.023N*    P<0.001N**                | 
|POLY 6             |     P<0.001N**   P=0.374N     P=0.127N     P=0.267N     P=0.019N*    P=0.007N**   P<0.001N**                | 
|LOGISTIC REGRESSION|     P<0.001N**   P=0.450N     P=0.294N     P=0.216N     P=0.011N*    P=0.045N*    P<0.001N**                | 
|COCH-ARM / FISHERS |     P<0.001N**   P=0.514N     P=0.376N     P=0.305N     P=0.020N*    P=0.058N     P<0.001N**                | 
|ORDER RESTRICTED   |     P<0.001N**   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     1/52 (2%)    0/55 (0%)    0/53 (0%)    2/53 (4%)    2/53 (4%)    0/52 (0%)    0/53 (0%)                 | 
|POLY-3 RATE (b)    |     1/31.36      0/38.53      0/39.60      2/37.74      2/36.61      0/41.53      0/31.91                   | 
|POLY-3 PERCENT (g) |     3.2%         0.0%         0.0%         5.3%         5.5%         0.0%         0.0%                      | 
|TERMINAL (d)       |     1/15 (7%)    0/25 (0%)    0/26 (0%)    1/22 (5%)    2/16 (13%)   0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     727 (T)      ---          ---          607          727 (T)      ---          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.446N     P=0.398N     P=0.390N     P=0.607      P=0.523      P=0.415N     P=0.652N                  | 
|POLY 3             |     P=0.305N     P=0.459N     P=0.454N     P=0.564      P=0.554      P=0.445N     P=0.497N                  | 
|POLY 1.5           |     P=0.304N     P=0.472N     P=0.469N     P=0.547      P=0.536      P=0.464N     P=0.493N                  | 
|POLY 6             |     P=0.341N     P=0.439N     P=0.435N     P=0.583      P=0.571      P=0.424N     P=0.512N                  | 
|LOGISTIC REGRESSION|     P=0.349N     (e)          (e)          P=0.572      P=0.523      (e)          (e)                       | 
|COCH-ARM / FISHERS |     P=0.314N     P=0.486N     P=0.495N     P=0.507      P=0.507      P=0.500N     P=0.495N                  | 
|ORDER RESTRICTED   |     P=0.369N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 41      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     2/52 (4%)    2/55 (4%)    0/53 (0%)    1/53 (2%)    0/53 (0%)    0/52 (0%)    0/53 (0%)                 | 
|POLY-3 RATE (b)    |     2/31.43      2/39.32      0/39.60      1/37.83      0/36.61      0/41.53      0/31.91                   | 
|POLY-3 PERCENT (g) |     6.4%         5.1%         0.0%         2.6%         0.0%         0.0%         0.0%                      | 
|TERMINAL (d)       |     1/15 (7%)    1/25 (4%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     709          434          ---          576          ---          ---          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.083N     P=0.535N     P=0.129N     P=0.395N     P=0.203N     P=0.137N     P=0.410N                  | 
|POLY 3             |     P=0.065N     P=0.611N     P=0.189N     P=0.435N     P=0.204N     P=0.181N     P=0.232N                  | 
|POLY 1.5           |     P=0.069N     P=0.640N     P=0.204N     P=0.453N     P=0.214N     P=0.199N     P=0.229N                  | 
|POLY 6             |     P=0.067N     P=0.570N     P=0.172N     P=0.418N     P=0.194N     P=0.163N     P=0.249N                  | 
|LOGISTIC REGRESSION|     P=0.071N     P=0.643N     P=0.141N     P=0.439N     P=0.186N     P=0.130N     P=0.330N                  | 
|COCH-ARM / FISHERS |     P=0.073N     P=0.670N     P=0.243N     P=0.493N     P=0.243N     P=0.248N     P=0.243N                  | 
|ORDER RESTRICTED   |     P=0.071N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery                                                                                                                        | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     1/1 (100%)   0/0 (0%)     0/4 (0%)     0/2 (0%)     0/7 (0%)     0/13 (0%)    3/11 (27%)                | 
|POLY-3 RATE (b)    |     1/1.00       0/0.00       0/3.52       0/2.00       0/6.22       0/10.00      3/8.85                    | 
|POLY-3 PERCENT (g) |     100.0%       0.0%         0.0%         0.0%         0.0%         0.0%         33.9%                     | 
|TERMINAL (d)       |     0/0 (0%)     0/0 (0%)     0/3 (0%)     0/2 (0%)     0/4 (0%)     0/3 (0%)     1/2 (50%)                 | 
|FIRST INCIDENCE    |     391          ---          ---          ---          ---          ---          562                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.011 *    (e)          P=0.468N     P=0.468N     P=0.473N     P=0.440N     P=0.544                   | 
|POLY 3             |     (e)          (e)          P<0.001N**   P=0.333      P<0.001N**   P<0.001N**   P=0.408N                  | 
|POLY 1.5           |     (e)          (e)          P<0.001N**   P=0.333      P<0.001N**   P<0.001N**   P=0.379N                  | 
|POLY 6             |     (e)          (e)          P<0.001N**   P=0.333      P<0.001N**   P<0.001N**   P=0.472N                  | 
|LOGISTIC REGRESSION|     P=0.170      (e)          (e)          (e)          (e)          P=0.168N     P=0.983N                  | 
|COCH-ARM / FISHERS |     P=0.181      (e)          P=0.200N     P=0.333N     P=0.125N     P=0.071N     P=0.333N                  | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 42      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Artery                                                                                                                | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/1 (0%)     0/0 (0%)     2/4 (50%)    2/2 (100%)   6/7 (86%)    10/13 (77%)  7/11 (64%)                | 
|POLY-3 RATE (b)    |     0/0.16       0/0.00       2/3.52       2/2.00       6/6.85       10/11.50     7/9.70                    | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         56.8%        100.0%       87.6%        87.0%        72.2%                     | 
|TERMINAL (d)       |     0/0 (0%)     0/0 (0%)     2/3 (67%)    2/2 (100%)   4/4 (100%)   3/3 (100%)   1/2 (50%)                 | 
|FIRST INCIDENCE    |     ---          ---          727 (T)      727 (T)      618          573          607                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   (e)          P=1.000      P=1.000      P=0.310      P=0.050      P=0.014 *                 | 
|POLY 3             |     (e)          (e)          P=0.800      P=0.333      P=0.873      P=0.899      P=0.840                   | 
|POLY 1.5           |     (e)          (e)          P=0.731      P=0.333      P=0.699      P=0.708      P=0.711                   | 
|POLY 6             |     (e)          (e)          P=0.843      P=0.333      P=0.955      P=0.983      P=0.922                   | 
|LOGISTIC REGRESSION|     P=0.537      (e)          P=1.000      P=1.000      (e)          P=0.978      P=0.991                   | 
|COCH-ARM / FISHERS |     P=0.567N     (e)          P=0.600      P=0.333      P=0.250      P=0.286      P=0.417                   | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Respiratory Epithelium                                                                                                     | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     2/53 (4%)    0/54 (0%)    1/52 (2%)    1/53 (2%)    2/52 (4%)    2/53 (4%)    1/53 (2%)                 | 
|POLY-3 RATE (b)    |     2/32.23      0/37.53      1/39.58      1/37.32      2/36.06      2/42.16      1/32.29                   | 
|POLY-3 PERCENT (g) |     6.2%         0.0%         2.5%         2.7%         5.6%         4.7%         3.1%                      | 
|TERMINAL (d)       |     1/15 (7%)    0/24 (0%)    0/26 (0%)    1/22 (5%)    1/16 (6%)    1/23 (4%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     391          ---          709          727 (T)      607          720          618                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.323      P=0.185N     P=0.365N     P=0.395N     P=0.648N     P=0.550N     P=0.577N                  | 
|POLY 3             |     P=0.432      P=0.204N     P=0.429N     P=0.449N     P=0.654N     P=0.593N     P=0.499N                  | 
|POLY 1.5           |     P=0.470      P=0.216N     P=0.455N     P=0.461N     P=0.671N     P=0.628N     P=0.493N                  | 
|POLY 6             |     P=0.376      P=0.186N     P=0.398N     P=0.437N     P=0.639N     P=0.555N     P=0.526N                  | 
|LOGISTIC REGRESSION|     P=0.497      P=0.240N     P=0.501N     P=0.484N     P=0.689N     P=0.658N     P=0.499N                  | 
|COCH-ARM / FISHERS |     P=0.508      P=0.243N     P=0.507N     P=0.500N     P=0.684      P=0.691N     P=0.500N                  | 
|ORDER RESTRICTED   |     P=0.495N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 43      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Turbinate                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     2/53 (4%)    0/54 (0%)    1/52 (2%)    1/53 (2%)    2/52 (4%)    0/53 (0%)    4/53 (8%)                 | 
|POLY-3 RATE (b)    |     2/31.81      0/37.53      1/39.51      1/37.32      2/36.29      0/42.13      4/32.97                   | 
|POLY-3 PERCENT (g) |     6.3%         0.0%         2.5%         2.7%         5.5%         0.0%         12.1%                     | 
|TERMINAL (d)       |     1/15 (7%)    0/24 (0%)    1/26 (4%)    1/22 (5%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     603          ---          727 (T)      727 (T)      607          ---          611                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.020 *    P=0.165N     P=0.344N     P=0.393N     P=0.608N     P=0.155N     P=0.251                   | 
|POLY 3             |     P=0.067      P=0.201N     P=0.425N     P=0.444N     P=0.647N     P=0.181N     P=0.350                   | 
|POLY 1.5           |     P=0.067      P=0.214N     P=0.452N     P=0.458N     P=0.666N     P=0.198N     P=0.354                   | 
|POLY 6             |     P=0.070      P=0.184N     P=0.396N     P=0.433N     P=0.629N     P=0.164N     P=0.323                   | 
|LOGISTIC REGRESSION|     P=0.053      P=0.201N     P=0.405N     P=0.429N     P=0.665N     P=0.184N     P=0.333                   | 
|COCH-ARM / FISHERS |     P=0.065      P=0.243N     P=0.507N     P=0.500N     P=0.684      P=0.248N     P=0.339                   | 
|ORDER RESTRICTED   |     P=0.049 *    (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Mucosa: Gingival                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     1/1 (100%)   0/1 (0%)     2/3 (67%)    2/4 (50%)    0/2 (0%)     4/6 (67%)    3/11 (27%)                | 
|POLY-3 RATE (b)    |     1/1.00       0/0.82       2/2.72       2/4.00       0/1.61       4/5.29       3/8.09                    | 
|POLY-3 PERCENT (g) |     100.0%       0.0%         73.6%        50.0%        0.0%         75.6%        37.1%                     | 
|TERMINAL (d)       |     1/1 (100%)   0/0 (0%)     0/0 (0%)     1/3 (33%)    0/1 (0%)     3/3 (100%)   1/1 (100%)                | 
|FIRST INCIDENCE    |     727 (T)      ---          688          658          ---          651          531                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.034 *    P=1.000      P=0.369      P=0.735N     P=0.500N     P=0.598      P=0.247                   | 
|POLY 3             |     P=0.313N     P=1.000      P=0.786N     P=0.577N     P=0.085N     P=0.783N     P=0.438N                  | 
|POLY 1.5           |     P=0.251N     P=1.000      P=0.737N     P=0.577N     P<0.001N**   P=0.741N     P=0.392N                  | 
|POLY 6             |     P=0.436N     P=1.000      P=0.885N     P=0.577N     P=0.303N     P=0.822N     P=0.546N                  | 
|LOGISTIC REGRESSION|     P=0.478N     (e)          (e)          (e)          (e)          P=0.872N     P=0.529N                  | 
|COCH-ARM / FISHERS |     P=0.197N     P=0.500N     P=0.750N     P=0.600N     P=0.333N     P=0.714N     P=0.333N                  | 
|ORDER RESTRICTED   |     P=0.448N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 44      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     45/52 (87%)  49/54 (91%)  46/53 (87%)  45/52 (87%)  47/52 (90%)  46/52 (88%)  33/53 (62%)               | 
|POLY-3 RATE (b)    |     45/46.65     49/52.02     46/50.50     45/49.66     47/49.76     46/50.55     33/43.43                  | 
|POLY-3 PERCENT (g) |     96.5%        94.2%        91.1%        90.6%        94.5%        91.0%        76.0%                     | 
|TERMINAL (d)       |     14/15 (93%)  22/25 (88%)  23/26 (89%)  19/22 (86%)  15/16 (94%)  22/23 (96%)  5/7 (71%)                 | 
|FIRST INCIDENCE    |     126          223          188          124          163          320          243                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.383      P=0.075N     P=0.020N*    P=0.090N     P=0.310N     P=0.016N*    P=0.336N                  | 
|POLY 3             |     P<0.001N**   P=0.477N     P=0.234N     P=0.204N     P=0.508N     P=0.232N     P<0.001N**                | 
|POLY 1.5           |     P<0.001N**   P=0.654N     P=0.314N     P=0.271N     P=0.619N     P=0.360N     P<0.001N**                | 
|POLY 6             |     P=0.005N**   P=0.376N     P=0.217N     P=0.218N     P=0.539N     P=0.195N     P=0.005N**                | 
|LOGISTIC REGRESSION|     P<0.001N**   P=0.447      P=0.394N     P=0.388N     P=0.492      P=0.388N     P=0.002N**                | 
|COCH-ARM / FISHERS |     P<0.001N**   P=0.354      P=0.598      P=0.613N     P=0.380      P=0.500      P=0.004N**                | 
|ORDER RESTRICTED   |     P<0.001N**   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     12/52 (23%)  17/54 (31%)  17/53 (32%)  15/52 (29%)  16/52 (31%)  18/52 (35%)  11/53 (21%)               | 
|POLY-3 RATE (b)    |     12/33.36     17/41.28     17/40.57     15/38.87     16/40.40     18/44.23     11/35.26                  | 
|POLY-3 PERCENT (g) |     36.0%        41.2%        41.9%        38.6%        39.6%        40.7%        31.2%                     | 
|TERMINAL (d)       |     7/15 (47%)   10/25 (40%)  15/26 (58%)  10/22 (46%)  6/16 (38%)   9/23 (39%)   1/7 (14%)                 | 
|FIRST INCIDENCE    |     547          356          541          496          331          498          525                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.164      P=0.505N     P=0.411N     P=0.481N     P=0.419      P=0.552N     P=0.380                   | 
|POLY 3             |     P=0.263N     P=0.411      P=0.387      P=0.506      P=0.468      P=0.425      P=0.433N                  | 
|POLY 1.5           |     P=0.251N     P=0.321      P=0.318      P=0.453      P=0.378      P=0.304      P=0.440N                  | 
|POLY 6             |     P=0.317N     P=0.545      P=0.469      P=0.553      P=0.567      P=0.569      P=0.465N                  | 
|LOGISTIC REGRESSION|     P=0.310N     P=0.379      P=0.549      P=0.547      P=0.348      P=0.415      P=0.492N                  | 
|COCH-ARM / FISHERS |     P=0.261N     P=0.226      P=0.208      P=0.328      P=0.254      P=0.140      P=0.479N                  | 
|ORDER RESTRICTED   |     P=0.449N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 45      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/52 (0%)    1/54 (2%)    0/53 (0%)    0/52 (0%)    0/52 (0%)    2/52 (4%)    0/53 (0%)                 | 
|POLY-3 RATE (b)    |     0/31.36      1/38.90      0/39.60      0/36.94      0/35.84      2/41.53      0/31.91                   | 
|POLY-3 PERCENT (g) |     0.0%         2.6%         0.0%         0.0%         0.0%         4.8%         0.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    2/23 (9%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          546          ---          ---          ---          727 (T)      ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.407      P=0.526      (e)          (e)          (e)          P=0.336      (e)                       | 
|POLY 3             |     P=0.389      P=0.543      (e)          (e)          (e)          P=0.304      (e)                       | 
|POLY 1.5           |     P=0.445      P=0.527      (e)          (e)          (e)          P=0.280      (e)                       | 
|POLY 6             |     P=0.323      P=0.565      (e)          (e)          (e)          P=0.333      (e)                       | 
|LOGISTIC REGRESSION|     P=0.503      P=0.497      (e)          (e)          (e)          P=0.336      (e)                       | 
|COCH-ARM / FISHERS |     P=0.513      P=0.509      (e)          (e)          (e)          P=0.248      (e)                       | 
|ORDER RESTRICTED   |     P=0.322      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oviduct                                                                                                                          | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     1/1 (100%)   1/1 (100%)   0/0 (0%)     0/0 (0%)     0/1 (0%)     2/3 (67%)    1/1 (100%)                | 
|POLY-3 RATE (b)    |     1/1.00       1/1.00       0/0.00       0/0.00       0/0.98       2/2.72       1/1.00                    | 
|POLY-3 PERCENT (g) |     100.0%       100.0%       0.0%         0.0%         0.0%         73.6%        100.0%                    | 
|TERMINAL (d)       |     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     2/2 (100%)   1/1 (100%)                | 
|FIRST INCIDENCE    |     709          546          ---          ---          ---          727 (T)      727 (T)                   | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.253N     (e)          (e)          (e)          P=0.477N     P=0.411N     (e)                       | 
|POLY 3             |     (e)          (e)          (e)          (e)          P=1.000      P=0.786N     (e)                       | 
|POLY 1.5           |     (e)          (e)          (e)          (e)          P=1.000      P=0.737N     (e)                       | 
|POLY 6             |     (e)          (e)          (e)          (e)          P=1.000      P=0.885N     (e)                       | 
|LOGISTIC REGRESSION|     P=0.748N     (e)          (e)          (e)          (e)          P=0.411N     (e)                       | 
|COCH-ARM / FISHERS |     P=0.719      (e)          (e)          (e)          P=0.500N     P=0.750N     (e)                       | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 46      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     5/51 (10%)   1/55 (2%)    3/53 (6%)    4/53 (8%)    4/53 (8%)    6/52 (12%)   13/51 (25%)               | 
|POLY-3 RATE (b)    |     5/32.80      1/38.53      3/40.81      4/38.15      4/37.40      6/43.08      13/35.71                  | 
|POLY-3 PERCENT (g) |     15.2%        2.6%         7.4%         10.5%        10.7%        13.9%        36.4%                     | 
|TERMINAL (d)       |     3/15 (20%)   1/25 (4%)    1/26 (4%)    3/22 (14%)   0/16 (0%)    1/23 (4%)    2/7 (29%)                 | 
|FIRST INCIDENCE    |     391          727 (T)      300          405          618          573          531                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.041N*    P=0.182N     P=0.315N     P=0.405N     P=0.478N     P=0.019 *                 | 
|POLY 3             |     P<0.001 **   P=0.066N     P=0.242N     P=0.404N     P=0.416N     P=0.566N     P=0.037 *                 | 
|POLY 1.5           |     P<0.001 **   P=0.075N     P=0.275N     P=0.424N     P=0.442N     P=0.623      P=0.034 *                 | 
|POLY 6             |     P<0.001 **   P=0.053N     P=0.203N     P=0.385N     P=0.387N     P=0.486N     P=0.040 *                 | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.075N     P=0.347N     P=0.439N     P=0.435N     P=0.563      P=0.034 *                 | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.086N     P=0.336N     P=0.475N     P=0.475N     P=0.514      P=0.034 *                 | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     5/51 (10%)   3/55 (5%)    2/53 (4%)    7/53 (13%)   2/53 (4%)    11/52 (21%)  18/51 (35%)               | 
|POLY-3 RATE (b)    |     5/31.43      3/38.53      2/40.53      7/38.15      2/37.14      11/43.58     18/37.39                  | 
|POLY-3 PERCENT (g) |     15.9%        7.8%         4.9%         18.4%        5.4%         25.2%        48.1%                     | 
|TERMINAL (d)       |     4/15 (27%)   3/25 (12%)   1/26 (4%)    6/22 (27%)   0/16 (0%)    2/23 (9%)    2/7 (29%)                 | 
|FIRST INCIDENCE    |     705          727 (T)      300          405          618          573          531                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.120N     P=0.072N     P=0.612N     P=0.164N     P=0.382      P<0.001 **                | 
|POLY 3             |     P<0.001 **   P=0.247N     P=0.124N     P=0.520      P=0.149N     P=0.248      P=0.003 **                | 
|POLY 1.5           |     P<0.001 **   P=0.280N     P=0.151N     P=0.484      P=0.170N     P=0.175      P=0.002 **                | 
|POLY 6             |     P<0.001 **   P=0.201N     P=0.097N     P=0.558      P=0.128N     P=0.359      P=0.005 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.109N     P=0.145N     P=0.546      P=0.132N     P=0.244      P=0.002 **                | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.316N     P=0.203N     P=0.408      P=0.203N     P=0.093      P=0.002 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 47      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/51 (0%)    0/55 (0%)    1/53 (2%)    4/53 (8%)    9/53 (17%)   20/52 (38%)  23/51 (45%)               | 
|POLY-3 RATE (b)    |     0/31.35      0/38.53      1/39.60      4/39.05      9/37.20      20/42.74     23/36.28                  | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.5%         10.2%        24.2%        46.8%        63.4%                     | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    1/26 (4%)    0/22 (0%)    6/16 (38%)   14/23 (61%)  6/7 (86%)                 | 
|FIRST INCIDENCE    |     ---          ---          727 (T)      595          607          618          525                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   (e)          P=0.610      P=0.092      P=0.004 **   P<0.001 **   P<0.001 **                | 
|POLY 3             |     P<0.001 **   (e)          P=0.546      P=0.092      P=0.003 **   P<0.001 **   P<0.001 **                | 
|POLY 1.5           |     P<0.001 **   (e)          P=0.531      P=0.082      P=0.003 **   P<0.001 **   P<0.001 **                | 
|POLY 6             |     P<0.001 **   (e)          P=0.565      P=0.106      P=0.004 **   P<0.001 **   P<0.001 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   (e)          P=0.610      P=0.065      P=0.005 **   P<0.001 **   P<0.001 **                | 
|COCH-ARM / FISHERS |     P<0.001 **   (e)          P=0.510      P=0.064      P=0.002 **   P<0.001 **   P<0.001 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Artery                                                                                                                 | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/51 (0%)    4/55 (7%)    2/53 (4%)    4/53 (8%)    8/53 (15%)   15/52 (29%)  11/51 (22%)               | 
|POLY-3 RATE (b)    |     0/31.35      4/39.52      2/39.60      4/38.50      8/37.31      15/42.61     11/35.04                  | 
|POLY-3 PERCENT (g) |     0.0%         10.1%        5.1%         10.4%        21.4%        35.2%        31.4%                     | 
|TERMINAL (d)       |     0/15 (0%)    2/25 (8%)    2/26 (8%)    2/22 (9%)    5/16 (31%)   8/23 (35%)   2/7 (29%)                 | 
|FIRST INCIDENCE    |     ---          253          727 (T)      448          618          588          188                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.132      P=0.365      P=0.106      P=0.009 **   P=0.002 **   P<0.001 **                | 
|POLY 3             |     P<0.001 **   P=0.094      P=0.292      P=0.089      P=0.007 **   P<0.001 **   P<0.001 **                | 
|POLY 1.5           |     P<0.001 **   P=0.082      P=0.273      P=0.081      P=0.006 **   P<0.001 **   P<0.001 **                | 
|POLY 6             |     P<0.001 **   P=0.114      P=0.316      P=0.099      P=0.008 **   P<0.001 **   P<0.001 **                | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.074      P=0.365      P=0.073      P=0.010 *    P<0.001 **   P<0.001 **                | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.069      P=0.257      P=0.064      P=0.003 **   P<0.001 **   P<0.001 **                | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 48      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Duct                                                                                                                   | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/51 (0%)    0/55 (0%)    0/53 (0%)    0/53 (0%)    0/53 (0%)    0/52 (0%)    2/51 (4%)                 | 
|POLY-3 RATE (b)    |     0/31.35      0/38.53      0/39.60      0/37.32      0/36.61      0/41.53      2/31.51                   | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%         0.0%         0.0%         6.4%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          ---          ---          ---          ---          603                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.003 **   (e)          (e)          (e)          (e)          (e)          P=0.230                   | 
|POLY 3             |     P=0.006 **   (e)          (e)          (e)          (e)          (e)          P=0.236                   | 
|POLY 1.5           |     P=0.006 **   (e)          (e)          (e)          (e)          (e)          P=0.239                   | 
|POLY 6             |     P=0.008 **   (e)          (e)          (e)          (e)          (e)          P=0.225                   | 
|LOGISTIC REGRESSION|     P=0.005 **   (e)          (e)          (e)          (e)          (e)          P=0.233                   | 
|COCH-ARM / FISHERS |     P=0.006 **   (e)          (e)          (e)          (e)          (e)          P=0.248                   | 
|ORDER RESTRICTED   |     P=0.005 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Duct                                                                                                                   | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/51 (0%)    0/55 (0%)    0/53 (0%)    0/53 (0%)    0/53 (0%)    2/52 (4%)    0/51 (0%)                 | 
|POLY-3 RATE (b)    |     0/31.35      0/38.53      0/39.60      0/37.32      0/36.61      2/41.71      0/30.95                   | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%         0.0%         4.8%         0.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    1/23 (4%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          ---          ---          ---          678          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.178      (e)          (e)          (e)          (e)          P=0.362      (e)                       | 
|POLY 3             |     P=0.159      (e)          (e)          (e)          (e)          P=0.305      (e)                       | 
|POLY 1.5           |     P=0.208      (e)          (e)          (e)          (e)          P=0.281      (e)                       | 
|POLY 6             |     P=0.108      (e)          (e)          (e)          (e)          P=0.335      (e)                       | 
|LOGISTIC REGRESSION|     P=0.236      (e)          (e)          (e)          (e)          P=0.329      (e)                       | 
|COCH-ARM / FISHERS |     P=0.282      (e)          (e)          (e)          (e)          P=0.252      (e)                       | 
|ORDER RESTRICTED   |     P=0.228      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 49      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Parathyroid Gland                                                                                                                | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/47 (0%)    1/50 (2%)    1/48 (2%)    2/46 (4%)    1/49 (2%)    1/47 (2%)    0/46 (0%)                 | 
|POLY-3 RATE (b)    |     0/27.62      1/35.62      1/37.40      2/34.68      1/33.12      1/38.40      0/28.20                   | 
|POLY-3 PERCENT (g) |     0.0%         2.8%         2.7%         5.8%         3.0%         2.6%         0.0%                      | 
|TERMINAL (d)       |     0/13 (0%)    1/24 (4%)    0/24 (0%)    0/21 (0%)    1/15 (7%)    0/20 (0%)    0/5 (0%)                  | 
|FIRST INCIDENCE    |     ---          727 (T)      376          559          727 (T)      573          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.425N     P=0.622      P=0.521      P=0.283      P=0.529      P=0.566      (e)                       | 
|POLY 3             |     P=0.353N     P=0.550      P=0.559      P=0.291      P=0.536      P=0.564      (e)                       | 
|POLY 1.5           |     P=0.351N     P=0.535      P=0.541      P=0.271      P=0.527      P=0.543      (e)                       | 
|POLY 6             |     P=0.396N     P=0.571      P=0.580      P=0.313      P=0.545      P=0.586      (e)                       | 
|LOGISTIC REGRESSION|     P=0.374N     P=0.622      P=0.376      P=0.217      P=0.529      P=0.469      (e)                       | 
|COCH-ARM / FISHERS |     P=0.371N     P=0.515      P=0.505      P=0.242      P=0.510      P=0.500      (e)                       | 
|ORDER RESTRICTED   |     P=0.493      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     14/51 (27%)  15/54 (28%)  22/53 (42%)  12/53 (23%)  16/53 (30%)  19/53 (36%)  9/53 (17%)                | 
|POLY-3 RATE (b)    |     14/33.32     15/40.05     22/44.01     12/38.05     16/38.31     19/44.06     9/33.36                   | 
|POLY-3 PERCENT (g) |     42.0%        37.5%        50.0%        31.5%        41.8%        43.1%        27.0%                     | 
|TERMINAL (d)       |     7/15 (47%)   7/25 (28%)   13/26 (50%)  10/22 (46%)  8/16 (50%)   12/23 (52%)  3/7 (43%)                 | 
|FIRST INCIDENCE    |     546          434          328          487          607          588          588                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.299      P=0.194N     P=0.572      P=0.108N     P=0.557N     P=0.410N     P=0.573N                  | 
|POLY 3             |     P=0.139N     P=0.436N     P=0.317      P=0.243N     P=0.590N     P=0.554      P=0.139N                  | 
|POLY 1.5           |     P=0.105N     P=0.507N     P=0.223      P=0.262N     P=0.561      P=0.444      P=0.127N                  | 
|POLY 6             |     P=0.251N     P=0.337N     P=0.433      P=0.252N     P=0.569N     P=0.531N     P=0.202N                  | 
|LOGISTIC REGRESSION|     P=0.126N     P=0.422N     P=0.225      P=0.176N     P=0.500N     P=0.536N     P=0.176N                  | 
|COCH-ARM / FISHERS |     P=0.094N     P=0.572      P=0.097      P=0.367N     P=0.464      P=0.239      P=0.147N                  | 
|ORDER RESTRICTED   |     P=0.164N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 50      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/51 (0%)    3/54 (6%)    1/53 (2%)    1/53 (2%)    0/53 (0%)    2/53 (4%)    1/53 (2%)                 | 
|POLY-3 RATE (b)    |     0/30.88      3/38.75      1/39.60      1/37.76      0/36.61      2/42.60      1/32.52                   | 
|POLY-3 PERCENT (g) |     0.0%         7.7%         2.5%         2.7%         0.0%         4.7%         3.1%                      | 
|TERMINAL (d)       |     0/15 (0%)    1/25 (4%)    1/26 (4%)    0/22 (0%)    0/16 (0%)    1/23 (4%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          448          727 (T)      600          ---          588          530                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.504      P=0.187      P=0.610      P=0.531      (e)          P=0.329      P=0.525                   | 
|POLY 3             |     P=0.571      P=0.163      P=0.549      P=0.540      (e)          P=0.314      P=0.510                   | 
|POLY 1.5           |     P=0.584N     P=0.148      P=0.535      P=0.531      (e)          P=0.290      P=0.513                   | 
|POLY 6             |     P=0.553      P=0.189      P=0.566      P=0.549      (e)          P=0.342      P=0.496                   | 
|LOGISTIC REGRESSION|     P=0.595N     P=0.134      P=0.610      P=0.508      (e)          P=0.278      P=0.503                   | 
|COCH-ARM / FISHERS |     P=0.594N     P=0.132      P=0.510      P=0.510      (e)          P=0.257      P=0.510                   | 
|ORDER RESTRICTED   |     P=0.370      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/51 (0%)    1/54 (2%)    1/53 (2%)    1/53 (2%)    3/53 (6%)    1/53 (2%)    0/53 (0%)                 | 
|POLY-3 RATE (b)    |     0/30.88      1/37.71      1/39.60      1/37.32      3/36.91      1/42.13      0/31.91                   | 
|POLY-3 PERCENT (g) |     0.0%         2.7%         2.5%         2.7%         8.1%         2.4%         0.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    1/25 (4%)    1/26 (4%)    1/22 (5%)    2/16 (13%)   1/23 (4%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          727 (T)      727 (T)      727 (T)      645          727 (T)      ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.596      P=0.602      P=0.610      P=0.576      P=0.145      P=0.585      (e)                       | 
|POLY 3             |     P=0.419N     P=0.540      P=0.549      P=0.538      P=0.152      P=0.561      (e)                       | 
|POLY 1.5           |     P=0.411N     P=0.527      P=0.535      P=0.530      P=0.142      P=0.543      (e)                       | 
|POLY 6             |     P=0.469N     P=0.558      P=0.566      P=0.545      P=0.161      P=0.579      (e)                       | 
|LOGISTIC REGRESSION|     P=0.534N     P=0.602      P=0.610      P=0.576      P=0.159      P=0.585      (e)                       | 
|COCH-ARM / FISHERS |     P=0.417N     P=0.514      P=0.510      P=0.510      P=0.129      P=0.510      (e)                       | 
|ORDER RESTRICTED   |     P=0.390      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 51      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     18/51 (35%)  20/54 (37%)  23/53 (43%)  17/53 (32%)  21/53 (40%)  26/53 (49%)  17/53 (32%)               | 
|POLY-3 RATE (b)    |     18/36.64     20/40.01     23/42.91     17/41.61     21/40.94     26/43.52     17/36.71                  | 
|POLY-3 PERCENT (g) |     49.1%        50.0%        53.6%        40.9%        51.3%        59.7%        46.3%                     | 
|TERMINAL (d)       |     4/15 (27%)   13/25 (52%)  15/26 (58%)  8/22 (36%)   7/16 (44%)   18/23 (78%)  3/7 (43%)                 | 
|FIRST INCIDENCE    |     400          546          498          436          541          637          531                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.029 *    P=0.215N     P=0.328N     P=0.208N     P=0.532N     P=0.469N     P=0.396                   | 
|POLY 3             |     P=0.444      P=0.562      P=0.429      P=0.301N     P=0.515      P=0.224      P=0.497N                  | 
|POLY 1.5           |     P=0.524      P=0.545      P=0.382      P=0.317N     P=0.483      P=0.200      P=0.445N                  | 
|POLY 6             |     P=0.286      P=0.593      P=0.465      P=0.318N     P=0.531      P=0.219      P=0.582                   | 
|LOGISTIC REGRESSION|     P=0.515      P=0.501N     P=0.475      P=0.326N     P=0.538      P=0.434      P=0.425N                  | 
|COCH-ARM / FISHERS |     P=0.481N     P=0.507      P=0.260      P=0.444N     P=0.400      P=0.111      P=0.444N                  | 
|ORDER RESTRICTED   |     P=0.614      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     39/52 (75%)  43/55 (78%)  46/52 (88%)  45/53 (85%)  41/53 (77%)  42/52 (81%)  37/52 (71%)               | 
|POLY-3 RATE (b)    |     39/47.51     43/47.53     46/48.28     45/49.58     41/47.65     42/47.95     37/44.38                  | 
|POLY-3 PERCENT (g) |     82.1%        90.5%        95.3%        90.8%        86.1%        87.6%        83.4%                     | 
|TERMINAL (d)       |     8/15 (53%)   23/25 (92%)  24/25 (96%)  21/22 (96%)  15/16 (94%)  22/23 (96%)  6/7 (86%)                 | 
|FIRST INCIDENCE    |     126          223          188          385          40           320          72                        | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.062      P=0.112N     P=0.174N     P=0.336N     P=0.353N     P=0.056N     P=0.344                   | 
|POLY 3             |     P=0.177N     P=0.170      P=0.033 *    P=0.155      P=0.395      P=0.313      P=0.550                   | 
|POLY 1.5           |     P=0.111N     P=0.251      P=0.039 *    P=0.168      P=0.472      P=0.337      P=0.534N                  | 
|POLY 6             |     P=0.391N     P=0.114      P=0.032 *    P=0.119      P=0.258      P=0.260      P=0.327                   | 
|LOGISTIC REGRESSION|     P=0.115N     P=0.522      P=0.115      P=0.202      P=0.514      P=0.491      P=0.404N                  | 
|COCH-ARM / FISHERS |     P=0.118N     P=0.436      P=0.063      P=0.153      P=0.478      P=0.319      P=0.413N                  | 
|ORDER RESTRICTED   |     P=0.236      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 52      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/52 (0%)    0/55 (0%)    1/52 (2%)    0/53 (0%)    1/53 (2%)    1/52 (2%)    3/52 (6%)                 | 
|POLY-3 RATE (b)    |     0/31.36      0/38.53      1/38.98      0/37.32      1/36.86      1/41.53      3/32.34                   | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.6%         0.0%         2.7%         2.4%         9.3%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/25 (0%)    0/22 (0%)    0/16 (0%)    1/23 (4%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          621          ---          659          727 (T)      603                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.004 **   (e)          P=0.584      (e)          P=0.548      P=0.585      P=0.146                   | 
|POLY 3             |     P=0.009 **   (e)          P=0.543      (e)          P=0.532      P=0.555      P=0.121                   | 
|POLY 1.5           |     P=0.009 **   (e)          P=0.527      (e)          P=0.521      P=0.536      P=0.123                   | 
|POLY 6             |     P=0.009 **   (e)          P=0.563      (e)          P=0.543      P=0.576      P=0.112                   | 
|LOGISTIC REGRESSION|     P=0.008 **   (e)          P=0.509      (e)          P=0.526      P=0.585      P=0.121                   | 
|COCH-ARM / FISHERS |     P=0.009 **   (e)          P=0.500      (e)          P=0.505      P=0.500      P=0.121                   | 
|ORDER RESTRICTED   |     P=0.014 *    (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     49/52 (94%)  50/55 (91%)  51/52 (98%)  51/53 (96%)  52/53 (98%)  52/52 (100%) 50/52 (96%)               | 
|POLY-3 RATE (b)    |     49/49.42     50/52.81     51/51.32     51/52.28     52/52.75     52/52.00     50/50.58                  | 
|POLY-3 PERCENT (g) |     99.2%        94.7%        99.4%        97.6%        98.6%        100.0%       98.9%                     | 
|TERMINAL (d)       |     15/15 (100%) 24/25 (96%)  25/25 (100%) 22/22 (100%) 16/16 (100%) 23/23 (100%) 7/7 (100%)                | 
|FIRST INCIDENCE    |     126          202          188          124          40           185          188                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.004 **   P=0.030N*    P=0.026N*    P=0.114N     P=0.338N     P=0.023N*    P=0.149                   | 
|POLY 3             |     P=0.224      P=0.209N     P=0.972      P=0.575N     P=0.807N     P=0.958      P=0.895N                  | 
|POLY 1.5           |     P=0.179      P=0.266N     P=0.743      P=0.634N     P=0.779      P=0.503      P=0.787                   | 
|POLY 6             |     P=0.239      P=0.189N     P=1.000      P=0.678N     P=0.845N     P=1.000      P=0.985N                  | 
|LOGISTIC REGRESSION|     P=0.179      P=0.320N     P=0.493      P=0.672      P=0.347      P=0.303      P=0.541                   | 
|COCH-ARM / FISHERS |     P=0.172      P=0.390N     P=0.309      P=0.491      P=0.302      P=0.121      P=0.500                   | 
|ORDER RESTRICTED   |     P=0.223      (e)          (e)          (e)          (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      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/52 (0%)    5/55 (9%)    3/52 (6%)    2/53 (4%)    5/53 (9%)    3/52 (6%)    6/52 (12%)                | 
|POLY-3 RATE (b)    |     0/31.36      5/42.56      3/40.37      2/38.51      5/39.29      3/42.88      6/33.93                   | 
|POLY-3 PERCENT (g) |     0.0%         11.8%        7.4%         5.2%         12.7%        7.0%         17.7%                     | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    1/25 (4%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          202          328          500          163          440          531                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.058      P=0.049 *    P=0.167      P=0.272      P=0.056      P=0.210      P=0.028 *                 | 
|POLY 3             |     P=0.071      P=0.065      P=0.170      P=0.285      P=0.053      P=0.185      P=0.018 *                 | 
|POLY 1.5           |     P=0.068      P=0.052      P=0.150      P=0.271      P=0.045 *    P=0.159      P=0.017 *                 | 
|POLY 6             |     P=0.072      P=0.088      P=0.195      P=0.300      P=0.064      P=0.218      P=0.016 *                 | 
|LOGISTIC REGRESSION|     P=0.065      P=0.022 *    P=0.070      P=0.202      P=0.026 *    P=0.088      P=0.018 *                 | 
|COCH-ARM / FISHERS |     P=0.063      P=0.033 *    P=0.121      P=0.252      P=0.030 *    P=0.121      P=0.013 *                 | 
|ORDER RESTRICTED   |     P=0.013 *    (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Red Pulp                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/52 (0%)    0/55 (0%)    4/52 (8%)    1/53 (2%)    1/53 (2%)    0/52 (0%)    2/52 (4%)                 | 
|POLY-3 RATE (b)    |     0/31.36      0/38.53      4/40.50      1/38.00      1/36.99      0/41.53      2/32.44                   | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         9.9%         2.6%         2.7%         0.0%         6.2%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    1/25 (4%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          328          500          618          ---          309                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.378      (e)          P=0.113      P=0.524      P=0.559      (e)          P=0.260                   | 
|POLY 3             |     P=0.467      (e)          P=0.099      P=0.538      P=0.533      (e)          P=0.243                   | 
|POLY 1.5           |     P=0.452      (e)          P=0.083      P=0.528      P=0.522      (e)          P=0.244                   | 
|POLY 6             |     P=0.489      (e)          P=0.122      P=0.549      P=0.544      (e)          P=0.230                   | 
|LOGISTIC REGRESSION|     P=0.413      (e)          P=0.042 *    P=0.453      P=0.511      (e)          P=0.227                   | 
|COCH-ARM / FISHERS |     P=0.411      (e)          P=0.059      P=0.505      P=0.505      (e)          P=0.248                   | 
|ORDER RESTRICTED   |     P=0.162      (e)          (e)          (e)          (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      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Hyperkeratosis                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/52 (0%)    3/55 (5%)    1/53 (2%)    1/53 (2%)    3/53 (6%)    1/51 (2%)    2/53 (4%)                 | 
|POLY-3 RATE (b)    |     0/31.36      3/38.71      1/39.75      1/37.58      3/37.14      1/41.62      2/32.22                   | 
|POLY-3 PERCENT (g) |     0.0%         7.8%         2.5%         2.7%         8.1%         2.4%         6.2%                      | 
|TERMINAL (d)       |     0/15 (0%)    2/25 (8%)    0/26 (0%)    0/22 (0%)    1/16 (6%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          681          688          658          618          678          681                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.248      P=0.226      P=0.595      P=0.568      P=0.162      P=0.627      P=0.192                   | 
|POLY 3             |     P=0.420      P=0.159      P=0.547      P=0.536      P=0.150      P=0.555      P=0.241                   | 
|POLY 1.5           |     P=0.423      P=0.145      P=0.531      P=0.527      P=0.139      P=0.535      P=0.245                   | 
|POLY 6             |     P=0.424      P=0.184      P=0.566      P=0.546      P=0.163      P=0.577      P=0.226                   | 
|LOGISTIC REGRESSION|     P=0.370      P=0.193      P=0.557      P=0.530      P=0.150      P=0.553      P=0.207                   | 
|COCH-ARM / FISHERS |     P=0.418      P=0.132      P=0.505      P=0.505      P=0.125      P=0.495      P=0.252                   | 
|ORDER RESTRICTED   |     P=0.231      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     3/52 (6%)    4/55 (7%)    6/53 (11%)   2/53 (4%)    5/53 (9%)    6/51 (12%)   8/53 (15%)                | 
|POLY-3 RATE (b)    |     3/32.29      4/38.74      6/41.70      2/38.13      5/38.68      6/42.62      8/34.42                   | 
|POLY-3 PERCENT (g) |     9.3%         10.3%        14.4%        5.3%         12.9%        14.1%        23.2%                     | 
|TERMINAL (d)       |     1/15 (7%)    2/25 (8%)    2/26 (8%)    0/22 (0%)    1/16 (6%)    2/23 (9%)    1/7 (14%)                 | 
|FIRST INCIDENCE    |     391          681          328          559          301          320          244                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.005 **   P=0.567N     P=0.446      P=0.377N     P=0.440      P=0.484      P=0.046 *                 | 
|POLY 3             |     P=0.037 *    P=0.600      P=0.381      P=0.424N     P=0.458      P=0.395      P=0.109                   | 
|POLY 1.5           |     P=0.040 *    P=0.567      P=0.331      P=0.444N     P=0.423      P=0.336      P=0.113                   | 
|POLY 6             |     P=0.030 *    P=0.649      P=0.446      P=0.403N     P=0.496      P=0.462      P=0.093                   | 
|LOGISTIC REGRESSION|     P=0.038 *    P=0.605      P=0.246      P=0.483N     P=0.362      P=0.257      P=0.109                   | 
|COCH-ARM / FISHERS |     P=0.039 *    P=0.532      P=0.254      P=0.491N     P=0.369      P=0.234      P=0.107                   | 
|ORDER RESTRICTED   |     P=0.088      (e)          (e)          (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      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/52 (0%)    1/55 (2%)    2/53 (4%)    1/53 (2%)    1/53 (2%)    0/51 (0%)    0/53 (0%)                 | 
|POLY-3 RATE (b)    |     0/31.36      1/38.56      2/40.19      1/37.58      1/36.61      0/41.43      0/31.91                   | 
|POLY-3 PERCENT (g) |     0.0%         2.6%         5.0%         2.7%         2.7%         0.0%         0.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    1/16 (6%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          720          602          658          727 (T)      ---          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.253N     P=0.624      P=0.328      P=0.568      P=0.513      (e)          (e)                       | 
|POLY 3             |     P=0.165N     P=0.541      P=0.296      P=0.536      P=0.531      (e)          (e)                       | 
|POLY 1.5           |     P=0.179N     P=0.528      P=0.275      P=0.527      P=0.521      (e)          (e)                       | 
|POLY 6             |     P=0.168N     P=0.561      P=0.324      P=0.546      P=0.540      (e)          (e)                       | 
|LOGISTIC REGRESSION|     P=0.210N     P=0.596      P=0.263      P=0.530      P=0.513      (e)          (e)                       | 
|COCH-ARM / FISHERS |     P=0.208N     P=0.514      P=0.252      P=0.505      P=0.505      (e)          (e)                       | 
|ORDER RESTRICTED   |     P=0.441N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     1/52 (2%)    0/55 (0%)    1/53 (2%)    1/53 (2%)    0/53 (0%)    1/51 (2%)    2/53 (4%)                 | 
|POLY-3 RATE (b)    |     1/32.34      0/38.53      1/40.46      1/37.32      0/36.61      1/41.94      2/33.34                   | 
|POLY-3 PERCENT (g) |     3.1%         0.0%         2.5%         2.7%         0.0%         2.4%         6.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    1/22 (5%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     201          ---          376          727 (T)      ---          573          72                        | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.151      P=0.485N     P=0.744N     P=0.714N     P=0.496N     P=0.719N     P=0.524                   | 
|POLY 3             |     P=0.160      P=0.465N     P=0.709N     P=0.729N     P=0.475N     P=0.699N     P=0.511                   | 
|POLY 1.5           |     P=0.169      P=0.477N     P=0.727N     P=0.737N     P=0.484N     P=0.724N     P=0.515                   | 
|POLY 6             |     P=0.156      P=0.447N     P=0.685N     P=0.721N     P=0.467N     P=0.670N     P=0.489                   | 
|LOGISTIC REGRESSION|     P=0.176      P=0.496N     P=0.609      P=0.697      P=0.484N     P=0.567      P=0.476                   | 
|COCH-ARM / FISHERS |     P=0.172      P=0.486N     P=0.748N     P=0.748N     P=0.495N     P=0.748      P=0.507                   | 
|ORDER RESTRICTED   |     P=0.223      (e)          (e)          (e)          (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      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     3/52 (6%)    1/55 (2%)    0/53 (0%)    1/53 (2%)    3/53 (6%)    2/51 (4%)    2/53 (4%)                 | 
|POLY-3 RATE (b)    |     3/32.17      1/38.56      0/39.60      1/37.58      3/37.14      2/42.54      2/32.69                   | 
|POLY-3 PERCENT (g) |     9.3%         2.6%         0.0%         2.7%         8.1%         4.7%         6.1%                      | 
|TERMINAL (d)       |     1/15 (7%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    1/16 (6%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     574          720          ---          658          618          320          603                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.270      P=0.180N     P=0.066N     P=0.217N     P=0.578N     P=0.338N     P=0.568N                  | 
|POLY 3             |     P=0.335      P=0.242N     P=0.085N     P=0.250N     P=0.596N     P=0.376N     P=0.493N                  | 
|POLY 1.5           |     P=0.362      P=0.260N     P=0.095N     P=0.262N     P=0.617N     P=0.419N     P=0.485N                  | 
|POLY 6             |     P=0.302      P=0.216N     P=0.075N     P=0.240N     P=0.577N     P=0.334N     P=0.528N                  | 
|LOGISTIC REGRESSION|     P=0.389      P=0.239N     P=0.094N     P=0.258N     P=0.599N     P=0.567N     P=0.490N                  | 
|COCH-ARM / FISHERS |     P=0.392      P=0.288N     P=0.118N     P=0.302N     P=0.652N     P=0.509N     P=0.491N                  | 
|ORDER RESTRICTED   |     P=0.309N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     37/50 (74%)  34/52 (65%)  41/46 (89%)  45/48 (94%)  36/41 (88%)  47/49 (96%)  41/44 (93%)               | 
|POLY-3 RATE (b)    |     37/45.02     34/44.40     41/43.90     45/45.61     36/36.59     47/48.09     41/41.71                  | 
|POLY-3 PERCENT (g) |     82.2%        76.6%        93.4%        98.7%        98.4%        97.7%        98.3%                     | 
|TERMINAL (d)       |     9/15 (60%)   15/22 (68%)  19/21 (91%)  19/19 (100%) 14/14 (100%) 22/23 (96%)  7/7 (100%)                | 
|FIRST INCIDENCE    |     126          202          300          385          531          185          72                        | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.052N     P=0.203N     P=0.543N     P=0.292N     P=0.232N     P=0.115                   | 
|POLY 3             |     P<0.001 **   P=0.340N     P=0.088      P=0.005 **   P=0.014 *    P=0.010 *    P=0.010 *                 | 
|POLY 1.5           |     P<0.001 **   P=0.297N     P=0.063      P=0.005 **   P=0.018 *    P=0.005 **   P=0.008 **                | 
|POLY 6             |     P<0.001 **   P=0.376N     P=0.117      P=0.006 **   P=0.013 *    P=0.017 *    P=0.012 *                 | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.196N     P=0.081      P=0.018 *    P=0.168      P=0.009 **   P=0.016 *                 | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.233N     P=0.050      P=0.008 **   P=0.082      P=0.002 **   P=0.012 *                 | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)          (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      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland                                                                                                                    | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/52 (0%)    1/55 (2%)    4/52 (8%)    0/51 (0%)    0/52 (0%)    0/50 (0%)    0/48 (0%)                 | 
|POLY-3 RATE (b)    |     0/31.37      1/38.53      4/39.64      0/36.51      0/35.79      0/41.02      0/29.95                   | 
|POLY-3 PERCENT (g) |     0.0%         2.6%         10.1%        0.0%         0.0%         0.0%         0.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    1/25 (4%)    3/26 (12%)   0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          727 (T)      709          ---          ---          ---          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.173N     P=0.602      P=0.154      (e)          (e)          (e)          (e)                       | 
|POLY 3             |     P=0.076N     P=0.541      P=0.095      (e)          (e)          (e)          (e)                       | 
|POLY 1.5           |     P=0.091N     P=0.527      P=0.081      (e)          (e)          (e)          (e)                       | 
|POLY 6             |     P=0.068N     P=0.561      P=0.114      (e)          (e)          (e)          (e)                       | 
|LOGISTIC REGRESSION|     P=0.145N     P=0.602      P=0.137      (e)          (e)          (e)          (e)                       | 
|COCH-ARM / FISHERS |     P=0.126N     P=0.514      P=0.059      (e)          (e)          (e)          (e)                       | 
|ORDER RESTRICTED   |     P=0.207N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     12/52 (23%)  21/55 (38%)  17/52 (33%)  19/51 (37%)  18/52 (35%)  16/50 (32%)  19/48 (40%)               | 
|POLY-3 RATE (b)    |     12/33.93     21/40.89     17/42.41     19/40.46     18/39.59     16/42.33     19/35.88                  | 
|POLY-3 PERCENT (g) |     35.4%        51.4%        40.1%        47.0%        45.5%        37.8%        53.0%                     | 
|TERMINAL (d)       |     5/15 (33%)   14/25 (56%)  10/26 (39%)  11/22 (50%)  6/16 (38%)   12/23 (52%)  2/7 (29%)                 | 
|FIRST INCIDENCE    |     541          356          428          436          531          554          484                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.011 *    P=0.427      P=0.463N     P=0.384      P=0.321      P=0.412N     P=0.036 *                 | 
|POLY 3             |     P=0.288      P=0.115      P=0.426      P=0.212      P=0.255      P=0.508      P=0.096                   | 
|POLY 1.5           |     P=0.261      P=0.088      P=0.334      P=0.165      P=0.201      P=0.401      P=0.078                   | 
|POLY 6             |     P=0.285      P=0.169      P=0.532      P=0.260      P=0.320      P=0.586N     P=0.108                   | 
|LOGISTIC REGRESSION|     P=0.195      P=0.152      P=0.399      P=0.180      P=0.229      P=0.591N     P=0.066                   | 
|COCH-ARM / FISHERS |     P=0.205      P=0.069      P=0.191      P=0.088      P=0.140      P=0.216      P=0.058                   | 
|ORDER RESTRICTED   |     P=0.129      (e)          (e)          (e)          (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      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     9/52 (17%)   13/55 (24%)  13/52 (25%)  17/51 (33%)  28/52 (54%)  26/50 (52%)  16/48 (33%)               | 
|POLY-3 RATE (b)    |     9/37.19      13/42.20     13/42.54     17/40.34     28/42.67     26/45.46     16/37.59                  | 
|POLY-3 PERCENT (g) |     24.2%        30.8%        30.6%        42.2%        65.6%        57.2%        42.6%                     | 
|TERMINAL (d)       |     2/15 (13%)   5/25 (20%)   6/26 (23%)   9/22 (41%)   12/16 (75%)  15/23 (65%)  2/7 (29%)                 | 
|FIRST INCIDENCE    |     201          448          498          405          247          320          72                        | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.517      P=0.549      P=0.210      P=0.002 **   P=0.030 *    P=0.053                   | 
|POLY 3             |     P=0.010 *    P=0.341      P=0.350      P=0.069      P<0.001 **   P<0.001 **   P=0.066                   | 
|POLY 1.5           |     P=0.012 *    P=0.292      P=0.294      P=0.059      P<0.001 **   P<0.001 **   P=0.064                   | 
|POLY 6             |     P=0.005 **   P=0.444      P=0.445      P=0.091      P<0.001 **   P=0.005 **   P=0.060                   | 
|LOGISTIC REGRESSION|     P=0.009 **   P=0.246      P=0.135      P=0.030 *    P<0.001 **   P<0.001 **   P=0.025 *                 | 
|COCH-ARM / FISHERS |     P=0.009 **   P=0.285      P=0.236      P=0.050      P<0.001 **   P<0.001 **   P=0.053                   | 
|ORDER RESTRICTED   |     P=0.003 **   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth: Peridontal Tissue                                                                                                         | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     10/12 (83%)  12/12 (100%) 10/10 (100%) 9/9 (100%)   10/10 (100%) 8/9 (89%)    18/19 (95%)               | 
|POLY-3 RATE (b)    |     10/12.00     12/12.00     10/10.00     9/9.00       10/10.00     8/9.00       18/18.62                  | 
|POLY-3 PERCENT (g) |     83.3%        100.0%       100.0%       100.0%       100.0%       88.9%        96.7%                     | 
|TERMINAL (d)       |     5/7 (71%)    9/9 (100%)   5/5 (100%)   4/4 (100%)   4/4 (100%)   5/6 (83%)    4/4 (100%)                | 
|FIRST INCIDENCE    |     405          253          300          436          531          573          188                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P<0.001 **   P=0.513N     P=0.613      P=0.564      P=0.479      P=0.284N     P=0.011 *                 | 
|POLY 3             |     P=0.540      P=0.229      P=0.272      P=0.297      P=0.272      P=0.602      P=0.258                   | 
|POLY 1.5           |     P=0.594      P=0.229      P=0.272      P=0.297      P=0.272      P=0.602      P=0.294                   | 
|POLY 6             |     P=0.455      P=0.229      P=0.272      P=0.297      P=0.272      P=0.602      P=0.208                   | 
|LOGISTIC REGRESSION|     P=0.494N     (e)          (e)          (e)          (e)          (e)          P=0.450                   | 
|COCH-ARM / FISHERS |     P=0.580N     P=0.239      P=0.286      P=0.314      P=0.286      P=0.612      P=0.328                   | 
|ORDER RESTRICTED   |     P=0.024 *    (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 59      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth: Peridontal Tissue                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     2/12 (17%)   0/12 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)    1/9 (11%)    0/19 (0%)                 | 
|POLY-3 RATE (b)    |     2/9.81       0/10.52      0/7.71       0/6.56       0/8.18       1/8.19       0/12.13                   | 
|POLY-3 PERCENT (g) |     20.4%        0.0%         0.0%         0.0%         0.0%         12.2%        0.0%                      | 
|TERMINAL (d)       |     2/7 (29%)    0/9 (0%)     0/5 (0%)     0/4 (0%)     0/4 (0%)     1/6 (17%)    0/4 (0%)                  | 
|FIRST INCIDENCE    |     727 (T)      ---          ---          ---          ---          727 (T)      ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.506N     P=0.178N     P=0.308N     P=0.362N     P=0.362N     P=0.558N     P=0.362N                  | 
|POLY 3             |     P=0.345N     P=0.210N     P=0.283N     P=0.324N     P=0.268N     P=0.566N     P=0.174N                  | 
|POLY 1.5           |     P=0.325N     P=0.221N     P=0.284N     P=0.310N     P=0.267N     P=0.579N     P=0.158N                  | 
|POLY 6             |     P=0.410N     P=0.196N     P=0.277N     P=0.346N     P=0.277N     P=0.553N     P=0.202N                  | 
|LOGISTIC REGRESSION|     P=0.506N     (e)          (e)          (e)          (e)          P=0.558N     (e)                       | 
|COCH-ARM / FISHERS |     P=0.306N     P=0.239N     P=0.286N     P=0.314N     P=0.286N     P=0.612N     P=0.142N                  | 
|ORDER RESTRICTED   |     P=0.009N**   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ureter                                                                                                                           | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/0 (0%)     0/0 (0%)     0/1 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     2/3 (67%)                 | 
|POLY-3 RATE (b)    |     0/0.00       0/0.00       0/0.14       0/0.00       0/0.00       0/0.00       2/2.75                    | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%         0.0%         0.0%         72.8%                     | 
|TERMINAL (d)       |     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          ---          ---          ---          ---          309                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.004 **   (e)          (e)          (e)          (e)          (e)          P=0.233                   | 
|POLY 3             |     (e)          (e)          (e)          (e)          (e)          (e)          (e)                       | 
|POLY 1.5           |     (e)          (e)          (e)          (e)          (e)          (e)          (e)                       | 
|POLY 6             |     (e)          (e)          (e)          (e)          (e)          (e)          (e)                       | 
|LOGISTIC REGRESSION|     P=0.187      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|COCH-ARM / FISHERS |     P=0.282      (e)          (e)          (e)          (e)          (e)          P=1.000                   | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 60      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ureter                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/0 (0%)     0/0 (0%)     1/1 (100%)   0/0 (0%)     0/0 (0%)     0/0 (0%)     2/3 (67%)                 | 
|POLY-3 RATE (b)    |     0/0.00       0/0.00       1/1.00       0/0.00       0/0.00       0/0.00       2/2.08                    | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         100.0%       0.0%         0.0%         0.0%         96.3%                     | 
|TERMINAL (d)       |     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          376          ---          ---          ---          588                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.274      (e)          (e)          (e)          (e)          (e)          P=0.471                   | 
|POLY 3             |     (e)          (e)          (e)          (e)          (e)          (e)          (e)                       | 
|POLY 1.5           |     (e)          (e)          (e)          (e)          (e)          (e)          (e)                       | 
|POLY 6             |     (e)          (e)          (e)          (e)          (e)          (e)          (e)                       | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)          (e)          (e)          (e)                       | 
|COCH-ARM / FISHERS |     P=0.500N     (e)          (e)          (e)          (e)          (e)          P=1.000                   | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ureter: Transitional Epithelium                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/0 (0%)     0/0 (0%)     1/1 (100%)   0/0 (0%)     0/0 (0%)     0/0 (0%)     3/3 (100%)                | 
|POLY-3 RATE (b)    |     0/0.00       0/0.00       1/1.00       0/0.00       0/0.00       0/0.00       3/3.00                    | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         100.0%       0.0%         0.0%         0.0%         100.0%                    | 
|TERMINAL (d)       |     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          376          ---          ---          ---          309                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)          (e)          (e)          (e)                       | 
|POLY 3             |     (e)          (e)          (e)          (e)          (e)          (e)          (e)                       | 
|POLY 1.5           |     (e)          (e)          (e)          (e)          (e)          (e)          (e)                       | 
|POLY 6             |     (e)          (e)          (e)          (e)          (e)          (e)          (e)                       | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)          (e)          (e)          (e)                       | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)          (e)          (e)          (e)                       | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 61      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     4/51 (8%)    6/54 (11%)   10/53 (19%)  6/52 (12%)   7/52 (13%)   4/52 (8%)    6/53 (11%)                | 
|POLY-3 RATE (b)    |     4/32.86      6/41.99      10/43.51     6/38.88      7/39.11      4/42.47      6/34.02                   | 
|POLY-3 PERCENT (g) |     12.2%        14.3%        23.0%        15.4%        17.9%        9.4%         17.6%                     | 
|TERMINAL (d)       |     0/15 (0%)    1/25 (4%)    5/26 (19%)   1/22 (5%)    2/16 (13%)   1/23 (4%)    1/7 (14%)                 | 
|FIRST INCIDENCE    |     391          350          188          448          301          573          309                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.491      P=0.496      P=0.216      P=0.526      P=0.356      P=0.423N     P=0.274                   | 
|POLY 3             |     P=0.416N     P=0.530      P=0.183      P=0.478      P=0.366      P=0.497N     P=0.387                   | 
|POLY 1.5           |     P=0.400N     P=0.479      P=0.146      P=0.451      P=0.331      P=0.543N     P=0.402                   | 
|POLY 6             |     P=0.459N     P=0.592      P=0.227      P=0.507      P=0.398      P=0.448N     P=0.337                   | 
|LOGISTIC REGRESSION|     P=0.398N     P=0.356      P=0.052      P=0.374      P=0.247      P=0.639      P=0.395                   | 
|COCH-ARM / FISHERS |     P=0.402N     P=0.408      P=0.086      P=0.383      P=0.274      P=0.631N     P=0.395                   | 
|ORDER RESTRICTED   |     P=0.532      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder: Transitional Epithelium                                                                                         | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     1/51 (2%)    1/54 (2%)    1/53 (2%)    2/52 (4%)    1/52 (2%)    2/52 (4%)    2/53 (4%)                 | 
|POLY-3 RATE (b)    |     1/31.35      1/38.94      1/40.46      2/37.45      1/36.79      2/41.91      2/32.25                   | 
|POLY-3 PERCENT (g) |     3.2%         2.6%         2.5%         5.3%         2.7%         4.8%         6.2%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    1/23 (4%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     574          524          376          658          301          618          660                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.211      P=0.730N     P=0.727N     P=0.598      P=0.737N     P=0.638      P=0.421                   | 
|POLY 3             |     P=0.248      P=0.711N     P=0.701N     P=0.562      P=0.725N     P=0.599      P=0.510                   | 
|POLY 1.5           |     P=0.271      P=0.728N     P=0.720N     P=0.546      P=0.736N     P=0.568      P=0.518                   | 
|POLY 6             |     P=0.222      P=0.687N     P=0.680N     P=0.577      P=0.716N     P=0.631      P=0.481                   | 
|LOGISTIC REGRESSION|     P=0.295      P=0.761N     P=0.709      P=0.531      P=0.741      P=0.540      P=0.510                   | 
|COCH-ARM / FISHERS |     P=0.291      P=0.738N     P=0.743N     P=0.507      P=0.748N     P=0.507      P=0.515                   | 
|ORDER RESTRICTED   |     P=0.477      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 62      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Adenomyosis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/52 (0%)    1/55 (2%)    0/53 (0%)    1/52 (2%)    0/53 (0%)    2/52 (4%)    0/53 (0%)                 | 
|POLY-3 RATE (b)    |     0/31.36      1/38.53      0/39.60      1/37.40      0/36.61      2/41.91      0/31.91                   | 
|POLY-3 PERCENT (g) |     0.0%         2.6%         0.0%         2.7%         0.0%         4.8%         0.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    1/25 (4%)    0/26 (0%)    0/22 (0%)    0/16 (0%)    1/23 (4%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          727 (T)      ---          592          ---          618          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.503      P=0.602      (e)          P=0.535      (e)          P=0.344      (e)                       | 
|POLY 3             |     P=0.481      P=0.541      (e)          P=0.535      (e)          P=0.307      (e)                       | 
|POLY 1.5           |     P=0.533      P=0.527      (e)          P=0.524      (e)          P=0.281      (e)                       | 
|POLY 6             |     P=0.416      P=0.561      (e)          P=0.547      (e)          P=0.338      (e)                       | 
|LOGISTIC REGRESSION|     P=0.581      P=0.602      (e)          P=0.496      (e)          P=0.286      (e)                       | 
|COCH-ARM / FISHERS |     P=0.588      P=0.514      (e)          P=0.500      (e)          P=0.248      (e)                       | 
|ORDER RESTRICTED   |     P=0.392      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/52 (0%)    0/55 (0%)    0/53 (0%)    1/52 (2%)    2/53 (4%)    1/52 (2%)    1/53 (2%)                 | 
|POLY-3 RATE (b)    |     0/31.36      0/38.53      0/39.60      1/37.44      2/36.91      1/42.13      1/32.01                   | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         2.7%         5.4%         2.4%         3.1%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    0/22 (0%)    1/16 (6%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          ---          576          645          535          700                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.150      (e)          (e)          P=0.534      P=0.275      P=0.552      P=0.413                   | 
|POLY 3             |     P=0.183      (e)          (e)          P=0.535      P=0.274      P=0.558      P=0.504                   | 
|POLY 1.5           |     P=0.203      (e)          (e)          P=0.524      P=0.261      P=0.537      P=0.507                   | 
|POLY 6             |     P=0.163      (e)          (e)          P=0.547      P=0.288      P=0.580      P=0.490                   | 
|LOGISTIC REGRESSION|     P=0.217      (e)          (e)          P=0.487      P=0.278      P=0.442      P=0.456                   | 
|COCH-ARM / FISHERS |     P=0.222      (e)          (e)          P=0.500      P=0.252      P=0.500      P=0.505                   | 
|ORDER RESTRICTED   |     P=0.311      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 63      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     12/52 (23%)  12/55 (22%)  11/53 (21%)  16/52 (31%)  10/53 (19%)  6/52 (12%)   4/53 (8%)                 | 
|POLY-3 RATE (b)    |     12/35.65     12/42.38     11/42.96     16/40.30     10/39.29     6/42.51      4/33.98                   | 
|POLY-3 PERCENT (g) |     33.7%        28.3%        25.6%        39.7%        25.5%        14.1%        11.8%                     | 
|TERMINAL (d)       |     2/15 (13%)   4/25 (16%)   4/26 (15%)   9/22 (41%)   3/16 (19%)   4/23 (17%)   0/7 (0%)                  | 
|FIRST INCIDENCE    |     391          328          188          448          331          535          244                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.026N*    P=0.257N     P=0.194N     P=0.558      P=0.264N     P=0.018N*    P=0.065N                  | 
|POLY 3             |     P=0.003N**   P=0.395N     P=0.296N     P=0.377      P=0.296N     P=0.035N*    P=0.025N*                 | 
|POLY 1.5           |     P=0.003N**   P=0.445N     P=0.350N     P=0.348      P=0.319N     P=0.049N*    P=0.021N*                 | 
|POLY 6             |     P=0.007N**   P=0.341N     P=0.244N     P=0.391      P=0.298N     P=0.027N*    P=0.042N*                 | 
|LOGISTIC REGRESSION|     P=0.003N**   P=0.507N     P=0.452N     P=0.351      P=0.344N     P=0.064N     P=0.025N*                 | 
|COCH-ARM / FISHERS |     P=0.003N**   P=0.530N     P=0.479N     P=0.254      P=0.386N     P=0.097N     P=0.025N*                 | 
|ORDER RESTRICTED   |     P=0.033N*    (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/52 (0%)    0/55 (0%)    0/53 (0%)    2/52 (4%)    1/53 (2%)    1/52 (2%)    0/53 (0%)                 | 
|POLY-3 RATE (b)    |     0/31.36      0/38.53      0/39.60      2/36.94      1/36.84      1/41.58      0/31.91                   | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         5.4%         2.7%         2.4%         0.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    0/26 (0%)    2/22 (9%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          ---          727 (T)      665          714          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.519      (e)          (e)          P=0.325      P=0.555      P=0.624      (e)                       | 
|POLY 3             |     P=0.577      (e)          (e)          P=0.274      P=0.532      P=0.555      (e)                       | 
|POLY 1.5           |     P=0.617      (e)          (e)          P=0.263      P=0.521      P=0.536      (e)                       | 
|POLY 6             |     P=0.521      (e)          (e)          P=0.286      P=0.543      P=0.576      (e)                       | 
|LOGISTIC REGRESSION|     P=0.602      (e)          (e)          P=0.325      P=0.528      P=0.599      (e)                       | 
|COCH-ARM / FISHERS |     P=0.617N     (e)          (e)          P=0.248      P=0.505      P=0.500      (e)                       | 
|ORDER RESTRICTED   |     P=0.391      (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 64      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     26/52 (50%)  33/55 (60%)  25/53 (47%)  28/52 (54%)  29/53 (55%)  27/52 (52%)  11/53 (21%)               | 
|POLY-3 RATE (b)    |     26/41.07     33/47.72     25/45.60     28/45.56     29/45.96     27/46.70     11/35.60                  | 
|POLY-3 PERCENT (g) |     63.3%        69.2%        54.8%        61.5%        63.1%        57.8%        30.9%                     | 
|TERMINAL (d)       |     7/15 (47%)   16/25 (64%)  11/26 (42%)  12/22 (55%)  8/16 (50%)   12/23 (52%)  2/7 (29%)                 | 
|FIRST INCIDENCE    |     321          253          188          385          247          440          555                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.050N     P=0.391N     P=0.073N     P=0.291N     P=0.476N     P=0.098N     P=0.023N*                 | 
|POLY 3             |     P<0.001N**   P=0.356      P=0.275N     P=0.518N     P=0.583N     P=0.377N     P=0.002N**                | 
|POLY 1.5           |     P<0.001N**   P=0.306      P=0.313N     P=0.557N     P=0.545      P=0.449N     P<0.001N**                | 
|POLY 6             |     P=0.008N**   P=0.379      P=0.246N     P=0.523N     P=0.582N     P=0.329N     P=0.010N*                 | 
|LOGISTIC REGRESSION|     P<0.001N**   P=0.240      P=0.362N     P=0.494      P=0.433      P=0.490N     P<0.001N**                | 
|COCH-ARM / FISHERS |     P<0.001N**   P=0.199      P=0.462N     P=0.422      P=0.387      P=0.500      P=0.002N**                | 
|ORDER RESTRICTED   |     P<0.001N**   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     0/52 (0%)    0/55 (0%)    2/53 (4%)    0/52 (0%)    0/53 (0%)    0/52 (0%)    0/53 (0%)                 | 
|POLY-3 RATE (b)    |     0/31.36      0/38.53      2/39.98      0/36.94      0/36.61      0/41.53      0/31.91                   | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         5.0%         0.0%         0.0%         0.0%         0.0%                      | 
|TERMINAL (d)       |     0/15 (0%)    0/25 (0%)    1/26 (4%)    0/22 (0%)    0/16 (0%)    0/23 (0%)    0/7 (0%)                  | 
|FIRST INCIDENCE    |     ---          ---          621          ---          ---          ---          ---                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.397N     (e)          P=0.351      (e)          (e)          (e)          (e)                       | 
|POLY 3             |     P=0.265N     (e)          P=0.294      (e)          (e)          (e)          (e)                       | 
|POLY 1.5           |     P=0.295N     (e)          P=0.274      (e)          (e)          (e)          (e)                       | 
|POLY 6             |     P=0.260N     (e)          P=0.321      (e)          (e)          (e)          (e)                       | 
|LOGISTIC REGRESSION|     P=0.347N     (e)          P=0.285      (e)          (e)          (e)          (e)                       | 
|COCH-ARM / FISHERS |     P=0.343N     (e)          P=0.252      (e)          (e)          (e)          (e)                       | 
|ORDER RESTRICTED   |     P=0.414N     (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 65      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |     0 NG/KG      30 NG/KG     100          175          300          550          1000                      | 
|                   |                               NG/KG        NG/KG        NG/KG        NG/KG        NG/KG                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |     23/52 (44%)  33/55 (60%)  28/53 (53%)  24/52 (46%)  26/53 (49%)  32/52 (62%)  9/53 (17%)                | 
|POLY-3 RATE (b)    |     23/35.31     33/43.07     28/43.94     24/42.67     26/41.15     32/45.02     9/34.37                   | 
|POLY-3 PERCENT (g) |     65.1%        76.6%        63.7%        56.3%        63.2%        71.1%        26.2%                     | 
|TERMINAL (d)       |     12/15 (80%)  22/25 (88%)  16/26 (62%)  11/22 (50%)  12/16 (75%)  21/23 (91%)  3/7 (43%)                 | 
|FIRST INCIDENCE    |     496          350          188          385          403          327          244                       | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |     P=0.169N     P=0.438N     P=0.161N     P=0.194N     P=0.537N     P=0.369N     P=0.065N                  | 
|POLY 3             |     P<0.001N**   P=0.165      P=0.545N     P=0.273N     P=0.527N     P=0.361      P<0.001N**                | 
|POLY 1.5           |     P<0.001N**   P=0.107      P=0.497      P=0.391N     P=0.560      P=0.213      P<0.001N**                | 
|POLY 6             |     P=0.003N**   P=0.288      P=0.371N     P=0.181N     P=0.434N     P=0.543      P<0.001N**                | 
|LOGISTIC REGRESSION|     P<0.001N**   P=0.187      P=0.556N     P=0.389N     P=0.504N     P=0.493      P<0.001N**                | 
|COCH-ARM / FISHERS |     P<0.001N**   P=0.075      P=0.246      P=0.500      P=0.382      P=0.058      P=0.002N**                | 
|ORDER RESTRICTED   |     P<0.001N**   (e)          (e)          (e)          (e)          (e)          (e)                       | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
(d)  Observed incidence at terminal kill.                                                                                           
(f)  Beneath the control incidence are the P-values associated with the trend                                                       
test.  Beneath the dosed group incidence are the P-values corresponding to                                                          
pairwise comparisons between the controls and that dosed group.  The life                                                           
table analysis regards tumors in animals dying prior to  terminal kill as                                                           
 being (directly or indirectly) the cause of death.                                                                                 
Logistic regression is an alternative                                                                                               
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage                                                       
and Fishers exact tests compare directly the overall incidence rates                                                                
For all tests a negative trend is indicated by N                                                                                    
(e)  Value of Statistic cannot be computed.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(I)  Interim sacrifice                                                                                                              
(T)  Terminal sacrifice                                                                                                             
#   Tumor rates based on number of animals necropsied.                                                                              
*   To the right of any statistical result, indicates significance at (P<=0.05).                                                    
**  To the right of any statistical result, indicates significance at (P<=0.01).                                                    
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.