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TDMS Study 96021-01 Pathology Tables


NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                    DATE: 10/09/03       
EXPERIMENT: 96021 TEST: 01                                                                                     TIME: 11:58:02       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96021       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 35065-27-1      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                     FINAL #3 CONTROL VS. STOP                                                      
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 UG/KG                                                                       
                                       INCLUDE 007    3000 UG/KG STOP                                                               
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                    DATE: 10/09/03       
EXPERIMENT: 96021 TEST: 01                                                                                     TIME: 11:58:02       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96021       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 35065-27-1      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF      TOXIC EQUIVALENCY FACTOR EVALUATION (                                                                       
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Cortex                         Angiectasis                                                                                  
                                       Degeneration Cystic                                                                          
                                       Hematopoietic Cell Proliferation                                                             
                                       Hyperplasia                                                                                  
                                       Hypertrophy                                                                                  
                                       Vacuolization Cytoplasmic                                                                    
Adrenal Medulla                        Hyperplasia                                                                                  
Blood Vessel: Aorta                    Mineralization                                                                               
Bone Marrow                            Hyperplasia                                                                                  
Clitoral Gland                         Inflammation                                                                                 
Clitoral Gland: Duct                   Cyst                                                                                         
Esophagus: Muscularis                  Inflammation                                                                                 
Eye: Retina                            Atrophy                                                                                      
Harderian Gland                        Inflammation                                                                                 
Heart                                  Cardiomyopathy                                                                               
Intestine Large, Rectum                Parasite Metazoan                                                                            
Kidney                                 Calculus Micro Observation Only                                                              
                                       Casts Protein                                                                                
                                       Inflammation                                                                                 
                                       Inflammation Chronic                                                                         
                                       Mineralization                                                                               
                                       Nephropathy                                                                                  
Kidney: Pelvis                         Inflammation                                                                                 
Kidney: Transitional Epithelium        Hyperplasia                                                                                  
Liver                                  Angiectasis                                                                                  
                                       Basophilic Focus                                                                             
                                       Clear Cell Focus                                                                             
                                       Eosinophilic Focus                                                                           
                                       Fatty Change Diffuse                                                                         
                                       Fatty Change Focal                                                                           
                                       Hematopoietic Cell Proliferation                                                             
                                       Hepatodiaphragmatic Nodule                                                                   
                                       Hyperplasia                                                                                  
                                       Inflammation                                                                                 
                                       Mixed Cell Focus                                                                             
                                       Necrosis                                                                                     
                                       Pigmentation                                                                                 
Liver: Bile Duct                       Cyst                                                                                         
                                       Fibrosis                                                                                     
                                       Hyperplasia                                                                                  
Liver: Centrilobular                   Degeneration                                                                                 
Liver: Hepatocyte                      Hypertrophy                                                                                  
Liver: Oval Cell                       Hyperplasia                                                                                  
Lung                                   Infiltration Cellular Histiocyte                                                             
                                       Inflammation                                                                                 
Lung: Alveolar Epithelium              Hyperplasia                                                                                  
Lymph Node, Mandibular                 Hyperplasia                                                                                  
Lymph Node: Mediastinal                Congestion                                                                                   
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                    DATE: 10/09/03       
EXPERIMENT: 96021 TEST: 01                                                                                     TIME: 11:58:02       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96021       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 35065-27-1      
                                       Hyperplasia                                                                                  
Mammary Gland                          Cyst                                                                                         
                                       Hyperplasia                                                                                  
                                       Inflammation Granulomatous                                                                   
Nose                                   Inflammation                                                                                 
Nose: Nasolacrimal Duct                Inflammation                                                                                 
Nose: Septum                           Inflammation                                                                                 
Nose: Turbinate                        Inflammation                                                                                 
Ovary                                  Atrophy                                                                                      
                                       Cyst                                                                                         
Oviduct                                Inflammation Chronic                                                                         
Pancreas                               Inflammation Chronic                                                                         
Pancreas: Acinus                       Atrophy                                                                                      
                                       Hyperplasia                                                                                  
Parathyroid Gland                      Hyperplasia                                                                                  
Pituitary Gland                        Angiectasis                                                                                  
                                       Cytoplasmic Alteration                                                                       
Pituitary Gland: Pars Distalis         Hyperplasia                                                                                  
Spleen                                 Hematopoietic Cell Proliferation                                                             
                                       Pigmentation                                                                                 
Spleen: Lymphoid Follicle              Atrophy                                                                                      
Stomach, Forestomach                   Hyperkeratosis                                                                               
                                       Hyperplasia                                                                                  
                                       Inflammation                                                                                 
                                       Mineralization                                                                               
Stomach, Glandular                     Mineralization                                                                               
Thymus                                 Atrophy                                                                                      
Thyroid Gland: C-Cell                  Hyperplasia                                                                                  
Thyroid Gland: Follicular Cell         Hypertrophy                                                                                  
Tooth: Peridontal Tissue               Inflammation                                                                                 
Urinary Bladder                        Inflammation                                                                                 
Urinary Bladder: Transitional Epithelium                                                                                            
                                       Hyperplasia                                                                                  
Uterus                                 Adenomyosis                                                                                  
                                       Inflammation                                                                                 
                                       Inflammation Chronic                                                                         
                                       Metaplasia                                                                                   
Uterus: Cervix                         Hyperplasia Stromal                                                                          
Uterus: Endometrium                    Hyperplasia Cystic                                                                           
===============================================================                                                                     
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (        
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              21/53 (40%)                                       20/50 (40%)                  | 
|POLY-3 RATE (b)    |                              21/42.96                                          20/39.75                     | 
|POLY-3 PERCENT (g) |                              48.9%                                             50.3%                        | 
|TERMINAL (d)       |                              12/24 (50%)                                       13/20 (65%)                  | 
|FIRST INCIDENCE    |                              502                                               400                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.451                      | 
|POLY 3             |                                                                                P=0.540                      | 
|POLY 1.5           |                                                                                P=0.537                      | 
|POLY 6             |                                                                                P=0.543                      | 
|LOGISTIC REGRESSION|                                                                                P=0.541                      | 
|COCH-ARM / FISHERS |                                                                                P=0.564                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              9/53 (17%)                                        7/50 (14%)                   | 
|POLY-3 RATE (b)    |                              9/40.67                                           7/36.86                      | 
|POLY-3 PERCENT (g) |                              22.1%                                             19.0%                        | 
|TERMINAL (d)       |                              5/24 (21%)                                        5/20 (25%)                   | 
|FIRST INCIDENCE    |                              437                                               591                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.513N                     | 
|POLY 3             |                                                                                P=0.482N                     | 
|POLY 1.5           |                                                                                P=0.477N                     | 
|POLY 6             |                                                                                P=0.484N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.449N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.443N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/39.01                                           2/37.02                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.4%                         | 
|TERMINAL (d)       |                              0/24 (0%)                                         0/20 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               611                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.229                      | 
|POLY 3             |                                                                                P=0.230                      | 
|POLY 1.5           |                                                                                P=0.229                      | 
|POLY 6             |                                                                                P=0.233                      | 
|LOGISTIC REGRESSION|                                                                                P=0.224                      | 
|COCH-ARM / FISHERS |                                                                                P=0.233                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              18/53 (34%)                                       18/50 (36%)                  | 
|POLY-3 RATE (b)    |                              18/42.09                                          18/38.69                     | 
|POLY-3 PERCENT (g) |                              42.8%                                             46.5%                        | 
|TERMINAL (d)       |                              11/24 (46%)                                       11/20 (55%)                  | 
|FIRST INCIDENCE    |                              418                                               528                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.392                      | 
|POLY 3             |                                                                                P=0.457                      | 
|POLY 1.5           |                                                                                P=0.455                      | 
|POLY 6             |                                                                                P=0.472                      | 
|LOGISTIC REGRESSION|                                                                                P=0.478                      | 
|COCH-ARM / FISHERS |                                                                                P=0.496                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              48/53 (91%)                                       35/50 (70%)                  | 
|POLY-3 RATE (b)    |                              48/49.83                                          35/41.93                     | 
|POLY-3 PERCENT (g) |                              96.3%                                             83.5%                        | 
|TERMINAL (d)       |                              24/24 (100%)                                      19/20 (95%)                  | 
|FIRST INCIDENCE    |                              211                                               400                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.137N                     | 
|POLY 3             |                                                                                P=0.020N*                    | 
|POLY 1.5           |                                                                                P=0.015N*                    | 
|POLY 6             |                                                                                P=0.026N*                    | 
|LOGISTIC REGRESSION|                                                                                P=0.008N**                   | 
|COCH-ARM / FISHERS |                                                                                P=0.008N**                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              10/53 (19%)                                       12/50 (24%)                  | 
|POLY-3 RATE (b)    |                              10/39.40                                          12/39.05                     | 
|POLY-3 PERCENT (g) |                              25.4%                                             30.7%                        | 
|TERMINAL (d)       |                              8/24 (33%)                                        6/20 (30%)                   | 
|FIRST INCIDENCE    |                              656                                               400                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.284                      | 
|POLY 3             |                                                                                P=0.390                      | 
|POLY 1.5           |                                                                                P=0.360                      | 
|POLY 6             |                                                                                P=0.439                      | 
|LOGISTIC REGRESSION|                                                                                P=0.334                      | 
|COCH-ARM / FISHERS |                                                                                P=0.346                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              18/53 (34%)                                       19/50 (38%)                  | 
|POLY-3 RATE (b)    |                              18/41.52                                          19/39.68                     | 
|POLY-3 PERCENT (g) |                              43.4%                                             47.9%                        | 
|TERMINAL (d)       |                              11/24 (46%)                                       10/20 (50%)                  | 
|FIRST INCIDENCE    |                              502                                               437                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.331                      | 
|POLY 3             |                                                                                P=0.426                      | 
|POLY 1.5           |                                                                                P=0.403                      | 
|POLY 6             |                                                                                P=0.464                      | 
|LOGISTIC REGRESSION|                                                                                P=0.390                      | 
|COCH-ARM / FISHERS |                                                                                P=0.412                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Blood Vessel: Aorta                                                                                                              | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/52 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/39.69                                           0/36.38                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              0.0%                         | 
|TERMINAL (d)       |                              0/24 (0%)                                         0/20 (0%)                    | 
|FIRST INCIDENCE    |                              551                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.260N                     | 
|POLY 3             |                                                                                P=0.267N                     | 
|POLY 1.5           |                                                                                P=0.264N                     | 
|POLY 6             |                                                                                P=0.269N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.234N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.257N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              34/53 (64%)                                       40/50 (80%)                  | 
|POLY-3 RATE (b)    |                              34/49.96                                          40/48.69                     | 
|POLY-3 PERCENT (g) |                              68.1%                                             82.2%                        | 
|TERMINAL (d)       |                              11/24 (46%)                                       13/20 (65%)                  | 
|FIRST INCIDENCE    |                              399                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.135                      | 
|POLY 3             |                                                                                P=0.077                      | 
|POLY 1.5           |                                                                                P=0.070                      | 
|POLY 6             |                                                                                P=0.094                      | 
|LOGISTIC REGRESSION|                                                                                P=0.060                      | 
|COCH-ARM / FISHERS |                                                                                P=0.058                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              52/53 (98%)                                       44/48 (92%)                  | 
|POLY-3 RATE (b)    |                              52/52.22                                          44/46.77                     | 
|POLY-3 PERCENT (g) |                              99.6%                                             94.1%                        | 
|TERMINAL (d)       |                              24/24 (100%)                                      19/20 (95%)                  | 
|FIRST INCIDENCE    |                              211                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.414N                     | 
|POLY 3             |                                                                                P=0.136N                     | 
|POLY 1.5           |                                                                                P=0.135N                     | 
|POLY 6             |                                                                                P=0.156N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.164N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.152N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland: Duct                                                                                                             | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              49/53 (92%)                                       41/48 (85%)                  | 
|POLY-3 RATE (b)    |                              49/52.16                                          41/46.08                     | 
|POLY-3 PERCENT (g) |                              93.9%                                             89.0%                        | 
|TERMINAL (d)       |                              22/24 (92%)                                       18/20 (90%)                  | 
|FIRST INCIDENCE    |                              211                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.396N                     | 
|POLY 3             |                                                                                P=0.295N                     | 
|POLY 1.5           |                                                                                P=0.252N                     | 
|POLY 6             |                                                                                P=0.374N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.199N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.208N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Esophagus: Muscularis                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         3/49 (6%)                    | 
|POLY-3 RATE (b)    |                              0/39.01                                           3/37.96                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              7.9%                         | 
|TERMINAL (d)       |                              0/24 (0%)                                         0/20 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               191                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.114                      | 
|POLY 3             |                                                                                P=0.114                      | 
|POLY 1.5           |                                                                                P=0.111                      | 
|POLY 6             |                                                                                P=0.119                      | 
|LOGISTIC REGRESSION|                                                                                P=0.161                      | 
|COCH-ARM / FISHERS |                                                                                P=0.107                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Retina                                                                                                                      | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              2/39.23                                           2/36.61                      | 
|POLY-3 PERCENT (g) |                              5.1%                                              5.5%                         | 
|TERMINAL (d)       |                              1/24 (4%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              672                                               668                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.653                      | 
|POLY 3             |                                                                                P=0.677                      | 
|POLY 1.5           |                                                                                P=0.674                      | 
|POLY 6             |                                                                                P=0.682                      | 
|LOGISTIC REGRESSION|                                                                                P=0.675                      | 
|COCH-ARM / FISHERS |                                                                                P=0.669                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              20/53 (38%)                                       15/50 (30%)                  | 
|POLY-3 RATE (b)    |                              20/42.61                                          15/38.36                     | 
|POLY-3 PERCENT (g) |                              46.9%                                             39.1%                        | 
|TERMINAL (d)       |                              11/24 (46%)                                       8/20 (40%)                   | 
|FIRST INCIDENCE    |                              211                                               575                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.357N                     | 
|POLY 3             |                                                                                P=0.313N                     | 
|POLY 1.5           |                                                                                P=0.317N                     | 
|POLY 6             |                                                                                P=0.296N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.279N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.268N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              22/52 (42%)                                       15/50 (30%)                  | 
|POLY-3 RATE (b)    |                              22/42.16                                          15/37.84                     | 
|POLY-3 PERCENT (g) |                              52.2%                                             39.6%                        | 
|TERMINAL (d)       |                              14/24 (58%)                                       8/20 (40%)                   | 
|FIRST INCIDENCE    |                              399                                               590                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.235N                     | 
|POLY 3             |                                                                                P=0.179N                     | 
|POLY 1.5           |                                                                                P=0.172N                     | 
|POLY 6             |                                                                                P=0.182N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.144N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.139N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Rectum                                                                                                          | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              1/39.01                                           3/36.38                      | 
|POLY-3 PERCENT (g) |                              2.6%                                              8.3%                         | 
|TERMINAL (d)       |                              1/24 (4%)                                         2/20 (10%)                   | 
|FIRST INCIDENCE    |                              731 (T)                                           730                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.247                      | 
|POLY 3             |                                                                                P=0.285                      | 
|POLY 1.5           |                                                                                P=0.284                      | 
|POLY 6             |                                                                                P=0.288                      | 
|LOGISTIC REGRESSION|                                                                                P=0.268                      | 
|COCH-ARM / FISHERS |                                                                                P=0.287                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Calculus Micro Observation Only                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              3/39.32                                           0/36.38                      | 
|POLY-3 PERCENT (g) |                              7.6%                                              0.0%                         | 
|TERMINAL (d)       |                              2/24 (8%)                                         0/20 (0%)                    | 
|FIRST INCIDENCE    |                              644                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.146N                     | 
|POLY 3             |                                                                                P=0.137N                     | 
|POLY 1.5           |                                                                                P=0.139N                     | 
|POLY 6             |                                                                                P=0.134N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.130N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.132N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Casts Protein                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              3/39.60                                           4/38.31                      | 
|POLY-3 PERCENT (g) |                              7.6%                                              10.4%                        | 
|TERMINAL (d)       |                              1/24 (4%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              590                                               400                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.451                      | 
|POLY 3             |                                                                                P=0.484                      | 
|POLY 1.5           |                                                                                P=0.474                      | 
|POLY 6             |                                                                                P=0.497                      | 
|LOGISTIC REGRESSION|                                                                                P=0.480                      | 
|COCH-ARM / FISHERS |                                                                                P=0.467                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              1/39.01                                           2/36.38                      | 
|POLY-3 PERCENT (g) |                              2.6%                                              5.5%                         | 
|TERMINAL (d)       |                              1/24 (4%)                                         2/20 (10%)                   | 
|FIRST INCIDENCE    |                              731 (T)                                           731 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.436                      | 
|POLY 3             |                                                                                P=0.484                      | 
|POLY 1.5           |                                                                                P=0.482                      | 
|POLY 6             |                                                                                P=0.487                      | 
|LOGISTIC REGRESSION|                                                                                P=0.436                      | 
|COCH-ARM / FISHERS |                                                                                P=0.478                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              0/39.01                                           3/37.26                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              8.1%                         | 
|TERMINAL (d)       |                              0/24 (0%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              ---                                               360                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.101                      | 
|POLY 3             |                                                                                P=0.112                      | 
|POLY 1.5           |                                                                                P=0.111                      | 
|POLY 6             |                                                                                P=0.114                      | 
|LOGISTIC REGRESSION|                                                                                P=0.114                      | 
|COCH-ARM / FISHERS |                                                                                P=0.111                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              40/53 (75%)                                       38/50 (76%)                  | 
|POLY-3 RATE (b)    |                              40/47.84                                          38/44.00                     | 
|POLY-3 PERCENT (g) |                              83.6%                                             86.4%                        | 
|TERMINAL (d)       |                              21/24 (88%)                                       19/20 (95%)                  | 
|FIRST INCIDENCE    |                              399                                               245                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.395                      | 
|POLY 3             |                                                                                P=0.472                      | 
|POLY 1.5           |                                                                                P=0.476                      | 
|POLY 6             |                                                                                P=0.497                      | 
|LOGISTIC REGRESSION|                                                                                P=0.494                      | 
|COCH-ARM / FISHERS |                                                                                P=0.567                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              34/53 (64%)                                       22/50 (44%)                  | 
|POLY-3 RATE (b)    |                              34/46.35                                          22/38.29                     | 
|POLY-3 PERCENT (g) |                              73.4%                                             57.5%                        | 
|TERMINAL (d)       |                              18/24 (75%)                                       16/20 (80%)                  | 
|FIRST INCIDENCE    |                              211                                               590                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.087N                     | 
|POLY 3             |                                                                                P=0.084N                     | 
|POLY 1.5           |                                                                                P=0.063N                     | 
|POLY 6             |                                                                                P=0.119N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.030N*                    | 
|COCH-ARM / FISHERS |                                                                                P=0.032N*                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              1/39.13                                           3/37.73                      | 
|POLY-3 PERCENT (g) |                              2.6%                                              8.0%                         | 
|TERMINAL (d)       |                              0/24 (0%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              701                                               360                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.278                      | 
|POLY 3             |                                                                                P=0.294                      | 
|POLY 1.5           |                                                                                P=0.290                      | 
|POLY 6             |                                                                                P=0.301                      | 
|LOGISTIC REGRESSION|                                                                                P=0.297                      | 
|COCH-ARM / FISHERS |                                                                                P=0.287                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Transitional Epithelium                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              1/39.13                                           4/37.49                      | 
|POLY-3 PERCENT (g) |                              2.6%                                              10.7%                        | 
|TERMINAL (d)       |                              0/24 (0%)                                         2/20 (10%)                   | 
|FIRST INCIDENCE    |                              701                                               360                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.155                      | 
|POLY 3             |                                                                                P=0.166                      | 
|POLY 1.5           |                                                                                P=0.163                      | 
|POLY 6             |                                                                                P=0.170                      | 
|LOGISTIC REGRESSION|                                                                                P=0.162                      | 
|COCH-ARM / FISHERS |                                                                                P=0.164                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 13      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         8/50 (16%)                   | 
|POLY-3 RATE (b)    |                              5/40.04                                           8/37.12                      | 
|POLY-3 PERCENT (g) |                              12.5%                                             21.6%                        | 
|TERMINAL (d)       |                              2/24 (8%)                                         6/20 (30%)                   | 
|FIRST INCIDENCE    |                              442                                               528                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.196                      | 
|POLY 3             |                                                                                P=0.226                      | 
|POLY 1.5           |                                                                                P=0.226                      | 
|POLY 6             |                                                                                P=0.229                      | 
|LOGISTIC REGRESSION|                                                                                P=0.232                      | 
|COCH-ARM / FISHERS |                                                                                P=0.240                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              16/53 (30%)                                       10/50 (20%)                  | 
|POLY-3 RATE (b)    |                              16/42.46                                          10/37.74                     | 
|POLY-3 PERCENT (g) |                              37.7%                                             26.5%                        | 
|TERMINAL (d)       |                              7/24 (29%)                                        5/20 (25%)                   | 
|FIRST INCIDENCE    |                              502                                               528                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.230N                     | 
|POLY 3             |                                                                                P=0.204N                     | 
|POLY 1.5           |                                                                                P=0.196N                     | 
|POLY 6             |                                                                                P=0.213N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.174N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.168N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 14      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Clear Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              6/53 (11%)                                        1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              6/39.13                                           1/36.85                      | 
|POLY-3 PERCENT (g) |                              15.3%                                             2.7%                         | 
|TERMINAL (d)       |                              5/24 (21%)                                        0/20 (0%)                    | 
|FIRST INCIDENCE    |                              701                                               591                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.084N                     | 
|POLY 3             |                                                                                P=0.065N                     | 
|POLY 1.5           |                                                                                P=0.069N                     | 
|POLY 6             |                                                                                P=0.059N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.065N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.066N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              12/53 (23%)                                       14/50 (28%)                  | 
|POLY-3 RATE (b)    |                              12/40.39                                          14/40.54                     | 
|POLY-3 PERCENT (g) |                              29.7%                                             34.5%                        | 
|TERMINAL (d)       |                              8/24 (33%)                                        4/20 (20%)                   | 
|FIRST INCIDENCE    |                              507                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.299                      | 
|POLY 3             |                                                                                P=0.409                      | 
|POLY 1.5           |                                                                                P=0.375                      | 
|POLY 6             |                                                                                P=0.459                      | 
|LOGISTIC REGRESSION|                                                                                P=0.334                      | 
|COCH-ARM / FISHERS |                                                                                P=0.345                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 15      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Diffuse                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         15/50 (30%)                  | 
|POLY-3 RATE (b)    |                              3/39.88                                           15/38.34                     | 
|POLY-3 PERCENT (g) |                              7.5%                                              39.1%                        | 
|TERMINAL (d)       |                              0/24 (0%)                                         8/20 (40%)                   | 
|FIRST INCIDENCE    |                              608                                               575                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.002 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/53 (8%)                                         6/50 (12%)                   | 
|POLY-3 RATE (b)    |                              4/39.26                                           6/37.79                      | 
|POLY-3 PERCENT (g) |                              10.2%                                             15.9%                        | 
|TERMINAL (d)       |                              2/24 (8%)                                         2/20 (10%)                   | 
|FIRST INCIDENCE    |                              696                                               452                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.315                      | 
|POLY 3             |                                                                                P=0.345                      | 
|POLY 1.5           |                                                                                P=0.335                      | 
|POLY 6             |                                                                                P=0.362                      | 
|LOGISTIC REGRESSION|                                                                                P=0.326                      | 
|COCH-ARM / FISHERS |                                                                                P=0.334                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 16      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              20/53 (38%)                                       17/50 (34%)                  | 
|POLY-3 RATE (b)    |                              20/46.75                                          17/42.49                     | 
|POLY-3 PERCENT (g) |                              42.8%                                             40.0%                        | 
|TERMINAL (d)       |                              5/24 (21%)                                        5/20 (25%)                   | 
|FIRST INCIDENCE    |                              399                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.484N                     | 
|POLY 3             |                                                                                P=0.484N                     | 
|POLY 1.5           |                                                                                P=0.468N                     | 
|POLY 6             |                                                                                P=0.493N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.381N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.425N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatodiaphragmatic Nodule                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/39.01                                           2/36.50                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.5%                         | 
|TERMINAL (d)       |                              0/24 (0%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              ---                                               701                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.216                      | 
|POLY 3             |                                                                                P=0.229                      | 
|POLY 1.5           |                                                                                P=0.228                      | 
|POLY 6             |                                                                                P=0.230                      | 
|LOGISTIC REGRESSION|                                                                                P=0.225                      | 
|COCH-ARM / FISHERS |                                                                                P=0.233                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 17      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/39.01                                           2/37.36                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.4%                         | 
|TERMINAL (d)       |                              0/24 (0%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              ---                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.214                      | 
|POLY 3             |                                                                                P=0.231                      | 
|POLY 1.5           |                                                                                P=0.230                      | 
|POLY 6             |                                                                                P=0.233                      | 
|LOGISTIC REGRESSION|                                                                                P=0.280                      | 
|COCH-ARM / FISHERS |                                                                                P=0.233                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              44/53 (83%)                                       44/50 (88%)                  | 
|POLY-3 RATE (b)    |                              44/49.23                                          44/47.40                     | 
|POLY-3 PERCENT (g) |                              89.4%                                             92.8%                        | 
|TERMINAL (d)       |                              20/24 (83%)                                       20/20 (100%)                 | 
|FIRST INCIDENCE    |                              399                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.287                      | 
|POLY 3             |                                                                                P=0.397                      | 
|POLY 1.5           |                                                                                P=0.411                      | 
|POLY 6             |                                                                                P=0.307                      | 
|LOGISTIC REGRESSION|                                                                                P=0.286                      | 
|COCH-ARM / FISHERS |                                                                                P=0.332                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 18      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              29/53 (55%)                                       20/50 (40%)                  | 
|POLY-3 RATE (b)    |                              29/42.75                                          20/39.11                     | 
|POLY-3 PERCENT (g) |                              67.8%                                             51.1%                        | 
|TERMINAL (d)       |                              20/24 (83%)                                       13/20 (65%)                  | 
|FIRST INCIDENCE    |                              418                                               514                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.178N                     | 
|POLY 3             |                                                                                P=0.080N                     | 
|POLY 1.5           |                                                                                P=0.096N                     | 
|POLY 6             |                                                                                P=0.059N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.085N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.097N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              7/53 (13%)                                        9/50 (18%)                   | 
|POLY-3 RATE (b)    |                              7/42.63                                           9/40.31                      | 
|POLY-3 PERCENT (g) |                              16.4%                                             22.3%                        | 
|TERMINAL (d)       |                              0/24 (0%)                                         0/20 (0%)                    | 
|FIRST INCIDENCE    |                              442                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.346                      | 
|POLY 3             |                                                                                P=0.346                      | 
|POLY 1.5           |                                                                                P=0.345                      | 
|POLY 6             |                                                                                P=0.349                      | 
|LOGISTIC REGRESSION|                                                                                P=0.407                      | 
|COCH-ARM / FISHERS |                                                                                P=0.345                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 19      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              1/39.56                                           3/36.61                      | 
|POLY-3 PERCENT (g) |                              2.5%                                              8.2%                         | 
|TERMINAL (d)       |                              0/24 (0%)                                         2/20 (10%)                   | 
|FIRST INCIDENCE    |                              557                                               670                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.269                      | 
|POLY 3             |                                                                                P=0.283                      | 
|POLY 1.5           |                                                                                P=0.283                      | 
|POLY 6             |                                                                                P=0.285                      | 
|LOGISTIC REGRESSION|                                                                                P=0.280                      | 
|COCH-ARM / FISHERS |                                                                                P=0.287                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              3/39.38                                           3/36.50                      | 
|POLY-3 PERCENT (g) |                              7.6%                                              8.2%                         | 
|TERMINAL (d)       |                              1/24 (4%)                                         2/20 (10%)                   | 
|FIRST INCIDENCE    |                              664                                               701                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.612                      | 
|POLY 3             |                                                                                P=0.634                      | 
|POLY 1.5           |                                                                                P=0.632                      | 
|POLY 6             |                                                                                P=0.639                      | 
|LOGISTIC REGRESSION|                                                                                P=0.640                      | 
|COCH-ARM / FISHERS |                                                                                P=0.633                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 20      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         5/50 (10%)                   | 
|POLY-3 RATE (b)    |                              2/39.48                                           5/37.75                      | 
|POLY-3 PERCENT (g) |                              5.1%                                              13.2%                        | 
|TERMINAL (d)       |                              1/24 (4%)                                         2/20 (10%)                   | 
|FIRST INCIDENCE    |                              590                                               437                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.183                      | 
|POLY 3             |                                                                                P=0.198                      | 
|POLY 1.5           |                                                                                P=0.194                      | 
|POLY 6             |                                                                                P=0.205                      | 
|LOGISTIC REGRESSION|                                                                                P=0.192                      | 
|COCH-ARM / FISHERS |                                                                                P=0.195                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         12/50 (24%)                  | 
|POLY-3 RATE (b)    |                              5/39.38                                           12/37.83                     | 
|POLY-3 PERCENT (g) |                              12.7%                                             31.7%                        | 
|TERMINAL (d)       |                              3/24 (13%)                                        9/20 (45%)                   | 
|FIRST INCIDENCE    |                              664                                               575                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.027 *                    | 
|POLY 3             |                                                                                P=0.037 *                    | 
|POLY 1.5           |                                                                                P=0.036 *                    | 
|POLY 6             |                                                                                P=0.040 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.038 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.042 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 21      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Centrilobular                                                                                                             | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         5/50 (10%)                   | 
|POLY-3 RATE (b)    |                              2/39.58                                           5/39.06                      | 
|POLY-3 PERCENT (g) |                              5.1%                                              12.8%                        | 
|TERMINAL (d)       |                              1/24 (4%)                                         0/20 (0%)                    | 
|FIRST INCIDENCE    |                              551                                               191                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.194                      | 
|POLY 3             |                                                                                P=0.209                      | 
|POLY 1.5           |                                                                                P=0.203                      | 
|POLY 6             |                                                                                P=0.218                      | 
|LOGISTIC REGRESSION|                                                                                P=0.239                      | 
|COCH-ARM / FISHERS |                                                                                P=0.195                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         32/50 (64%)                  | 
|POLY-3 RATE (b)    |                              0/39.01                                           32/41.91                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              76.4%                        | 
|TERMINAL (d)       |                              0/24 (0%)                                         19/20 (95%)                  | 
|FIRST INCIDENCE    |                              ---                                               400                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 22      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Oval Cell                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/39.01                                           2/36.38                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.5%                         | 
|TERMINAL (d)       |                              0/24 (0%)                                         2/20 (10%)                   | 
|FIRST INCIDENCE    |                              ---                                               731 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.198                      | 
|POLY 3             |                                                                                P=0.228                      | 
|POLY 1.5           |                                                                                P=0.228                      | 
|POLY 6             |                                                                                P=0.229                      | 
|LOGISTIC REGRESSION|                                                                                P=0.198                      | 
|COCH-ARM / FISHERS |                                                                                P=0.233                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              45/52 (87%)                                       37/50 (74%)                  | 
|POLY-3 RATE (b)    |                              45/48.19                                          37/44.85                     | 
|POLY-3 PERCENT (g) |                              93.4%                                             82.5%                        | 
|TERMINAL (d)       |                              23/24 (96%)                                       16/20 (80%)                  | 
|FIRST INCIDENCE    |                              410                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.371N                     | 
|POLY 3             |                                                                                P=0.073N                     | 
|POLY 1.5           |                                                                                P=0.071N                     | 
|POLY 6             |                                                                                P=0.088N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.119N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.089N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 23      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              6/52 (12%)                                        9/50 (18%)                   | 
|POLY-3 RATE (b)    |                              6/40.63                                           9/37.34                      | 
|POLY-3 PERCENT (g) |                              14.8%                                             24.1%                        | 
|TERMINAL (d)       |                              3/24 (13%)                                        6/20 (30%)                   | 
|FIRST INCIDENCE    |                              410                                               590                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.201                      | 
|POLY 3             |                                                                                P=0.226                      | 
|POLY 1.5           |                                                                                P=0.233                      | 
|POLY 6             |                                                                                P=0.225                      | 
|LOGISTIC REGRESSION|                                                                                P=0.245                      | 
|COCH-ARM / FISHERS |                                                                                P=0.261                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              20/52 (38%)                                       4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              20/41.45                                          4/36.53                      | 
|POLY-3 PERCENT (g) |                              48.3%                                             11.0%                        | 
|TERMINAL (d)       |                              13/24 (54%)                                       3/20 (15%)                   | 
|FIRST INCIDENCE    |                              555                                               691                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001N**                   | 
|POLY 3             |                                                                                P<0.001N**                   | 
|POLY 1.5           |                                                                                P<0.001N**                   | 
|POLY 6             |                                                                                P<0.001N**                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001N**                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001N**                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 24      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              37/51 (73%)                                       37/48 (77%)                  | 
|POLY-3 RATE (b)    |                              37/46.48                                          37/43.23                     | 
|POLY-3 PERCENT (g) |                              79.6%                                             85.6%                        | 
|TERMINAL (d)       |                              18/24 (75%)                                       17/20 (85%)                  | 
|FIRST INCIDENCE    |                              211                                               191                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.313                      | 
|POLY 3             |                                                                                P=0.311                      | 
|POLY 1.5           |                                                                                P=0.313                      | 
|POLY 6             |                                                                                P=0.315                      | 
|LOGISTIC REGRESSION|                                                                                P=0.331                      | 
|COCH-ARM / FISHERS |                                                                                P=0.387                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Congestion                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/3 (100%)                                        0/1 (0%)                     | 
|POLY-3 RATE (b)    |                              3/3.00                                            0/1.00                       | 
|POLY-3 PERCENT (g) |                              100.0%                                            0.0%                         | 
|TERMINAL (d)       |                              0/0 (0%)                                          0/1 (0%)                     | 
|FIRST INCIDENCE    |                              399                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.154N                     | 
|POLY 3             |                                                                                P=0.250                      | 
|POLY 1.5           |                                                                                P=0.250                      | 
|POLY 6             |                                                                                P=0.250                      | 
|LOGISTIC REGRESSION|                                                                                (e)                          | 
|COCH-ARM / FISHERS |                                                                                P=0.250N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 25      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/3 (67%)                                         0/1 (0%)                     | 
|POLY-3 RATE (b)    |                              2/2.43                                            0/1.00                       | 
|POLY-3 PERCENT (g) |                              82.4%                                             0.0%                         | 
|TERMINAL (d)       |                              0/0 (0%)                                          0/1 (0%)                     | 
|FIRST INCIDENCE    |                              399                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.269N                     | 
|POLY 3             |                                                                                P=0.577N                     | 
|POLY 1.5           |                                                                                P=0.635N                     | 
|POLY 6             |                                                                                P=0.470N                     | 
|LOGISTIC REGRESSION|                                                                                (e)                          | 
|COCH-ARM / FISHERS |                                                                                P=0.500N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              2/39.84                                           4/37.45                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              10.7%                        | 
|TERMINAL (d)       |                              1/24 (4%)                                         0/20 (0%)                    | 
|FIRST INCIDENCE    |                              399                                               611                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.313                      | 
|POLY 3             |                                                                                P=0.312                      | 
|POLY 1.5           |                                                                                P=0.307                      | 
|POLY 6             |                                                                                P=0.323                      | 
|LOGISTIC REGRESSION|                                                                                P=0.313                      | 
|COCH-ARM / FISHERS |                                                                                P=0.312                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 26      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              22/53 (42%)                                       27/50 (54%)                  | 
|POLY-3 RATE (b)    |                              22/43.38                                          27/41.08                     | 
|POLY-3 PERCENT (g) |                              50.7%                                             65.7%                        | 
|TERMINAL (d)       |                              12/24 (50%)                                       15/20 (75%)                  | 
|FIRST INCIDENCE    |                              211                                               437                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.107                      | 
|POLY 3             |                                                                                P=0.108                      | 
|POLY 1.5           |                                                                                P=0.105                      | 
|POLY 6             |                                                                                P=0.116                      | 
|LOGISTIC REGRESSION|                                                                                P=0.118                      | 
|COCH-ARM / FISHERS |                                                                                P=0.142                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/39.01                                           2/36.53                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.5%                         | 
|TERMINAL (d)       |                              0/24 (0%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              ---                                               691                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.212                      | 
|POLY 3             |                                                                                P=0.229                      | 
|POLY 1.5           |                                                                                P=0.228                      | 
|POLY 6             |                                                                                P=0.230                      | 
|LOGISTIC REGRESSION|                                                                                P=0.225                      | 
|COCH-ARM / FISHERS |                                                                                P=0.233                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 27      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              1/39.01                                           2/36.75                      | 
|POLY-3 PERCENT (g) |                              2.6%                                              5.4%                         | 
|TERMINAL (d)       |                              1/24 (4%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              731 (T)                                           627                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.461                      | 
|POLY 3             |                                                                                P=0.486                      | 
|POLY 1.5           |                                                                                P=0.483                      | 
|POLY 6             |                                                                                P=0.491                      | 
|LOGISTIC REGRESSION|                                                                                P=0.478                      | 
|COCH-ARM / FISHERS |                                                                                P=0.478                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Nasolacrimal Duct                                                                                                          | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/39.01                                           0/36.38                      | 
|POLY-3 PERCENT (g) |                              5.1%                                              0.0%                         | 
|TERMINAL (d)       |                              2/24 (8%)                                         0/20 (0%)                    | 
|FIRST INCIDENCE    |                              731 (T)                                           ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.278N                     | 
|POLY 3             |                                                                                P=0.260N                     | 
|POLY 1.5           |                                                                                P=0.263N                     | 
|POLY 6             |                                                                                P=0.254N                     | 
|LOGISTIC REGRESSION|                                                                                (e)                          | 
|COCH-ARM / FISHERS |                                                                                P=0.262N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 28      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Septum                                                                                                                     | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/53 (8%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              4/40.77                                           4/37.52                      | 
|POLY-3 PERCENT (g) |                              9.8%                                              10.7%                        | 
|TERMINAL (d)       |                              1/24 (4%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              211                                               452                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.585                      | 
|POLY 3             |                                                                                P=0.604                      | 
|POLY 1.5           |                                                                                P=0.601                      | 
|POLY 6             |                                                                                P=0.612                      | 
|LOGISTIC REGRESSION|                                                                                P=0.638                      | 
|COCH-ARM / FISHERS |                                                                                P=0.609                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Turbinate                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              8/53 (15%)                                        5/50 (10%)                   | 
|POLY-3 RATE (b)    |                              8/42.11                                           5/38.15                      | 
|POLY-3 PERCENT (g) |                              19.0%                                             13.1%                        | 
|TERMINAL (d)       |                              2/24 (8%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              211                                               452                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.350N                     | 
|POLY 3             |                                                                                P=0.346N                     | 
|POLY 1.5           |                                                                                P=0.347N                     | 
|POLY 6             |                                                                                P=0.341N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.286N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.317N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 29      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Mucosa: Gingival                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              21/21 (100%)                                      15/15 (100%)                 | 
|POLY-3 RATE (b)    |                              21/21.00                                          15/15.00                     | 
|POLY-3 PERCENT (g) |                              100.0%                                            100.0%                       | 
|TERMINAL (d)       |                              10/10 (100%)                                      7/7 (100%)                   | 
|FIRST INCIDENCE    |                              211                                               360                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                (e)                          | 
|POLY 3             |                                                                                (e)                          | 
|POLY 1.5           |                                                                                (e)                          | 
|POLY 6             |                                                                                (e)                          | 
|LOGISTIC REGRESSION|                                                                                (e)                          | 
|COCH-ARM / FISHERS |                                                                                (e)                          | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              47/53 (89%)                                       41/49 (84%)                  | 
|POLY-3 RATE (b)    |                              47/51.19                                          41/45.06                     | 
|POLY-3 PERCENT (g) |                              91.8%                                             91.0%                        | 
|TERMINAL (d)       |                              22/24 (92%)                                       20/20 (100%)                 | 
|FIRST INCIDENCE    |                              211                                               191                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.507N                     | 
|POLY 3             |                                                                                P=0.609N                     | 
|POLY 1.5           |                                                                                P=0.514N                     | 
|POLY 6             |                                                                                P=0.678                      | 
|LOGISTIC REGRESSION|                                                                                P=0.366N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.328N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 30      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              14/53 (26%)                                       16/49 (33%)                  | 
|POLY-3 RATE (b)    |                              14/41.40                                          16/36.86                     | 
|POLY-3 PERCENT (g) |                              33.8%                                             43.4%                        | 
|TERMINAL (d)       |                              6/24 (25%)                                        10/20 (50%)                  | 
|FIRST INCIDENCE    |                              557                                               591                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.285                      | 
|POLY 3             |                                                                                P=0.261                      | 
|POLY 1.5           |                                                                                P=0.273                      | 
|POLY 6             |                                                                                P=0.249                      | 
|LOGISTIC REGRESSION|                                                                                P=0.293                      | 
|COCH-ARM / FISHERS |                                                                                P=0.318                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oviduct                                                                                                                          | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/50 (2%)                                         2/46 (4%)                    | 
|POLY-3 RATE (b)    |                              1/37.44                                           2/32.91                      | 
|POLY-3 PERCENT (g) |                              2.7%                                              6.1%                         | 
|TERMINAL (d)       |                              1/24 (4%)                                         1/19 (5%)                    | 
|FIRST INCIDENCE    |                              731 (T)                                           730                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.431                      | 
|POLY 3             |                                                                                P=0.471                      | 
|POLY 1.5           |                                                                                P=0.472                      | 
|POLY 6             |                                                                                P=0.471                      | 
|LOGISTIC REGRESSION|                                                                                P=0.441                      | 
|COCH-ARM / FISHERS |                                                                                P=0.468                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 31      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              2/39.01                                           2/36.60                      | 
|POLY-3 PERCENT (g) |                              5.1%                                              5.5%                         | 
|TERMINAL (d)       |                              2/24 (8%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              731 (T)                                           671                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.638                      | 
|POLY 3             |                                                                                P=0.678                      | 
|POLY 1.5           |                                                                                P=0.675                      | 
|POLY 6             |                                                                                P=0.685                      | 
|LOGISTIC REGRESSION|                                                                                P=0.679                      | 
|COCH-ARM / FISHERS |                                                                                P=0.669                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              1/39.01                                           3/37.37                      | 
|POLY-3 PERCENT (g) |                              2.6%                                              8.0%                         | 
|TERMINAL (d)       |                              1/24 (4%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              731 (T)                                           452                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.264                      | 
|POLY 3             |                                                                                P=0.292                      | 
|POLY 1.5           |                                                                                P=0.288                      | 
|POLY 6             |                                                                                P=0.299                      | 
|LOGISTIC REGRESSION|                                                                                P=0.282                      | 
|COCH-ARM / FISHERS |                                                                                P=0.287                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 32      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              3/39.01                                           2/36.38                      | 
|POLY-3 PERCENT (g) |                              7.7%                                              5.5%                         | 
|TERMINAL (d)       |                              3/24 (13%)                                        2/20 (10%)                   | 
|FIRST INCIDENCE    |                              731 (T)                                           731 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.585N                     | 
|POLY 3             |                                                                                P=0.539N                     | 
|POLY 1.5           |                                                                                P=0.542N                     | 
|POLY 6             |                                                                                P=0.530N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.585N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.528N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Parathyroid Gland                                                                                                                | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/49 (4%)                                         1/45 (2%)                    | 
|POLY-3 RATE (b)    |                              2/36.68                                           1/34.50                      | 
|POLY-3 PERCENT (g) |                              5.5%                                              2.9%                         | 
|TERMINAL (d)       |                              2/23 (9%)                                         0/20 (0%)                    | 
|FIRST INCIDENCE    |                              731 (T)                                           467                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.543N                     | 
|POLY 3             |                                                                                P=0.528N                     | 
|POLY 1.5           |                                                                                P=0.536N                     | 
|POLY 6             |                                                                                P=0.517N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.530N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.532N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 33      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              15/53 (28%)                                       24/50 (48%)                  | 
|POLY-3 RATE (b)    |                              15/41.30                                          24/39.27                     | 
|POLY-3 PERCENT (g) |                              36.3%                                             61.1%                        | 
|TERMINAL (d)       |                              8/24 (33%)                                        15/20 (75%)                  | 
|FIRST INCIDENCE    |                              211                                               452                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.023 *                    | 
|POLY 3             |                                                                                P=0.017 *                    | 
|POLY 1.5           |                                                                                P=0.017 *                    | 
|POLY 6             |                                                                                P=0.018 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.023 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.031 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/39.01                                           0/36.38                      | 
|POLY-3 PERCENT (g) |                              5.1%                                              0.0%                         | 
|TERMINAL (d)       |                              2/24 (8%)                                         0/20 (0%)                    | 
|FIRST INCIDENCE    |                              731 (T)                                           ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.278N                     | 
|POLY 3             |                                                                                P=0.260N                     | 
|POLY 1.5           |                                                                                P=0.263N                     | 
|POLY 6             |                                                                                P=0.254N                     | 
|LOGISTIC REGRESSION|                                                                                (e)                          | 
|COCH-ARM / FISHERS |                                                                                P=0.262N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 34      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              23/53 (43%)                                       18/50 (36%)                  | 
|POLY-3 RATE (b)    |                              23/43.52                                          18/40.30                     | 
|POLY-3 PERCENT (g) |                              52.9%                                             44.7%                        | 
|TERMINAL (d)       |                              13/24 (54%)                                       7/20 (35%)                   | 
|FIRST INCIDENCE    |                              507                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.384N                     | 
|POLY 3             |                                                                                P=0.295N                     | 
|POLY 1.5           |                                                                                P=0.299N                     | 
|POLY 6             |                                                                                P=0.286N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.303N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.286N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              46/53 (87%)                                       44/50 (88%)                  | 
|POLY-3 RATE (b)    |                              46/50.02                                          44/47.81                     | 
|POLY-3 PERCENT (g) |                              92.0%                                             92.0%                        | 
|TERMINAL (d)       |                              23/24 (96%)                                       20/20 (100%)                 | 
|FIRST INCIDENCE    |                              399                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.363                      | 
|POLY 3             |                                                                                P=0.663                      | 
|POLY 1.5           |                                                                                P=0.632                      | 
|POLY 6             |                                                                                P=0.703N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.515                      | 
|COCH-ARM / FISHERS |                                                                                P=0.545                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 35      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              47/53 (89%)                                       50/50 (100%)                 | 
|POLY-3 RATE (b)    |                              47/51.94                                          50/50.00                     | 
|POLY-3 PERCENT (g) |                              90.5%                                             100.0%                       | 
|TERMINAL (d)       |                              22/24 (92%)                                       20/20 (100%)                 | 
|FIRST INCIDENCE    |                              211                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.162                      | 
|POLY 3             |                                                                                P=0.027 *                    | 
|POLY 1.5           |                                                                                P=0.023 *                    | 
|POLY 6             |                                                                                P=0.038 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.021 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.016 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              1/39.45                                           4/37.18                      | 
|POLY-3 PERCENT (g) |                              2.5%                                              10.8%                        | 
|TERMINAL (d)       |                              0/24 (0%)                                         0/20 (0%)                    | 
|FIRST INCIDENCE    |                              603                                               575                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.175                      | 
|POLY 3             |                                                                                P=0.162                      | 
|POLY 1.5           |                                                                                P=0.161                      | 
|POLY 6             |                                                                                P=0.166                      | 
|LOGISTIC REGRESSION|                                                                                P=0.159                      | 
|COCH-ARM / FISHERS |                                                                                P=0.164                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 36      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Hyperkeratosis                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/39.01                                           2/37.78                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.3%                         | 
|TERMINAL (d)       |                              0/24 (0%)                                         0/20 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               191                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.228                      | 
|POLY 3             |                                                                                P=0.233                      | 
|POLY 1.5           |                                                                                P=0.231                      | 
|POLY 6             |                                                                                P=0.235                      | 
|LOGISTIC REGRESSION|                                                                                P=0.308                      | 
|COCH-ARM / FISHERS |                                                                                P=0.233                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         5/50 (10%)                   | 
|POLY-3 RATE (b)    |                              3/39.67                                           5/39.10                      | 
|POLY-3 PERCENT (g) |                              7.6%                                              12.8%                        | 
|TERMINAL (d)       |                              2/24 (8%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              507                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.308                      | 
|POLY 3             |                                                                                P=0.347                      | 
|POLY 1.5           |                                                                                P=0.339                      | 
|POLY 6             |                                                                                P=0.361                      | 
|LOGISTIC REGRESSION|                                                                                P=0.382                      | 
|COCH-ARM / FISHERS |                                                                                P=0.325                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 37      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              0/39.01                                           4/39.10                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              10.2%                        | 
|TERMINAL (d)       |                              0/24 (0%)                                         0/20 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.062                      | 
|POLY 3             |                                                                                P=0.059                      | 
|POLY 1.5           |                                                                                P=0.057                      | 
|POLY 6             |                                                                                P=0.063                      | 
|LOGISTIC REGRESSION|                                                                                P=0.089                      | 
|COCH-ARM / FISHERS |                                                                                P=0.052                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              0/39.01                                           3/38.25                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              7.8%                         | 
|TERMINAL (d)       |                              0/24 (0%)                                         0/20 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               191                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.110                      | 
|POLY 3             |                                                                                P=0.115                      | 
|POLY 1.5           |                                                                                P=0.113                      | 
|POLY 6             |                                                                                P=0.118                      | 
|LOGISTIC REGRESSION|                                                                                P=0.151                      | 
|COCH-ARM / FISHERS |                                                                                P=0.111                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 38      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              5/40.87                                           3/38.28                      | 
|POLY-3 PERCENT (g) |                              12.2%                                             7.8%                         | 
|TERMINAL (d)       |                              1/24 (4%)                                         0/20 (0%)                    | 
|FIRST INCIDENCE    |                              551                                               191                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.406N                     | 
|POLY 3             |                                                                                P=0.396N                     | 
|POLY 1.5           |                                                                                P=0.398N                     | 
|POLY 6             |                                                                                P=0.398N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.335N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.391N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              38/48 (79%)                                       29/49 (59%)                  | 
|POLY-3 RATE (b)    |                              38/45.92                                          29/44.08                     | 
|POLY-3 PERCENT (g) |                              82.8%                                             65.8%                        | 
|TERMINAL (d)       |                              19/23 (83%)                                       11/20 (55%)                  | 
|FIRST INCIDENCE    |                              211                                               191                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.244N                     | 
|POLY 3             |                                                                                P=0.046N*                    | 
|POLY 1.5           |                                                                                P=0.039N*                    | 
|POLY 6             |                                                                                P=0.051N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.026N*                    | 
|COCH-ARM / FISHERS |                                                                                P=0.028N*                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 39      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              19/51 (37%)                                       13/49 (27%)                  | 
|POLY-3 RATE (b)    |                              19/40.16                                          13/36.92                     | 
|POLY-3 PERCENT (g) |                              47.3%                                             35.2%                        | 
|TERMINAL (d)       |                              12/24 (50%)                                       10/20 (50%)                  | 
|FIRST INCIDENCE    |                              555                                               591                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.276N                     | 
|POLY 3             |                                                                                P=0.194N                     | 
|POLY 1.5           |                                                                                P=0.196N                     | 
|POLY 6             |                                                                                P=0.192N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.170N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.175N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/51 (10%)                                        12/49 (24%)                  | 
|POLY-3 RATE (b)    |                              5/39.16                                           12/39.43                     | 
|POLY-3 PERCENT (g) |                              12.8%                                             30.4%                        | 
|TERMINAL (d)       |                              3/24 (13%)                                        6/20 (30%)                   | 
|FIRST INCIDENCE    |                              507                                               191                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.036 *                    | 
|POLY 3             |                                                                                P=0.048 *                    | 
|POLY 1.5           |                                                                                P=0.045 *                    | 
|POLY 6             |                                                                                P=0.052                      | 
|LOGISTIC REGRESSION|                                                                                P=0.049 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.045 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 40      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth: Peridontal Tissue                                                                                                         | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              33/34 (97%)                                       27/27 (100%)                 | 
|POLY-3 RATE (b)    |                              33/33.44                                          27/27.00                     | 
|POLY-3 PERCENT (g) |                              98.7%                                             100.0%                       | 
|TERMINAL (d)       |                              14/14 (100%)                                      11/11 (100%)                 | 
|FIRST INCIDENCE    |                              211                                               360                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.440N                     | 
|POLY 3             |                                                                                P=0.945                      | 
|POLY 1.5           |                                                                                P=0.781                      | 
|POLY 6             |                                                                                P=1.000                      | 
|LOGISTIC REGRESSION|                                                                                P=0.554                      | 
|COCH-ARM / FISHERS |                                                                                P=0.557                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              8/53 (15%)                                        10/49 (20%)                  | 
|POLY-3 RATE (b)    |                              8/41.11                                           10/38.89                     | 
|POLY-3 PERCENT (g) |                              19.5%                                             25.7%                        | 
|TERMINAL (d)       |                              3/24 (13%)                                        3/20 (15%)                   | 
|FIRST INCIDENCE    |                              442                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.336                      | 
|POLY 3             |                                                                                P=0.346                      | 
|POLY 1.5           |                                                                                P=0.335                      | 
|POLY 6             |                                                                                P=0.363                      | 
|LOGISTIC REGRESSION|                                                                                P=0.341                      | 
|COCH-ARM / FISHERS |                                                                                P=0.329                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 41      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder: Transitional Epithelium                                                                                         | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         3/49 (6%)                    | 
|POLY-3 RATE (b)    |                              0/39.01                                           3/35.85                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              8.4%                         | 
|TERMINAL (d)       |                              0/24 (0%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              ---                                               669                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.111                      | 
|POLY 3             |                                                                                P=0.107                      | 
|POLY 1.5           |                                                                                P=0.107                      | 
|POLY 6             |                                                                                P=0.109                      | 
|LOGISTIC REGRESSION|                                                                                P=0.104                      | 
|COCH-ARM / FISHERS |                                                                                P=0.107                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Adenomyosis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/49 (0%)                    | 
|POLY-3 RATE (b)    |                              2/39.39                                           0/35.39                      | 
|POLY-3 PERCENT (g) |                              5.1%                                              0.0%                         | 
|TERMINAL (d)       |                              1/24 (4%)                                         0/20 (0%)                    | 
|FIRST INCIDENCE    |                              621                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.256N                     | 
|POLY 3             |                                                                                P=0.274N                     | 
|POLY 1.5           |                                                                                P=0.274N                     | 
|POLY 6             |                                                                                P=0.272N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.259N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.268N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 42      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         9/49 (18%)                   | 
|POLY-3 RATE (b)    |                              5/40.20                                           9/38.88                      | 
|POLY-3 PERCENT (g) |                              12.4%                                             23.2%                        | 
|TERMINAL (d)       |                              3/24 (13%)                                        2/20 (10%)                   | 
|FIRST INCIDENCE    |                              442                                               191                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.157                      | 
|POLY 3             |                                                                                P=0.169                      | 
|POLY 1.5           |                                                                                P=0.160                      | 
|POLY 6             |                                                                                P=0.185                      | 
|LOGISTIC REGRESSION|                                                                                P=0.166                      | 
|COCH-ARM / FISHERS |                                                                                P=0.153                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         1/49 (2%)                    | 
|POLY-3 RATE (b)    |                              2/39.39                                           1/35.39                      | 
|POLY-3 PERCENT (g) |                              5.1%                                              2.8%                         | 
|TERMINAL (d)       |                              1/24 (4%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              621                                               731 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.539N                     | 
|POLY 3             |                                                                                P=0.550N                     | 
|POLY 1.5           |                                                                                P=0.550N                     | 
|POLY 6             |                                                                                P=0.549N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.532N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.530N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 43      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              23/53 (43%)                                       24/49 (49%)                  | 
|POLY-3 RATE (b)    |                              23/45.42                                          24/39.43                     | 
|POLY-3 PERCENT (g) |                              50.6%                                             60.9%                        | 
|TERMINAL (d)       |                              11/24 (46%)                                       16/20 (80%)                  | 
|FIRST INCIDENCE    |                              399                                               400                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.289                      | 
|POLY 3             |                                                                                P=0.230                      | 
|POLY 1.5           |                                                                                P=0.264                      | 
|POLY 6             |                                                                                P=0.191                      | 
|LOGISTIC REGRESSION|                                                                                P=0.329                      | 
|COCH-ARM / FISHERS |                                                                                P=0.357                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Cervix                                                                                                                   | 
|     Hyperplasia Stromal                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         2/49 (4%)                    | 
|POLY-3 RATE (b)    |                              1/39.28                                           2/35.39                      | 
|POLY-3 PERCENT (g) |                              2.6%                                              5.7%                         | 
|TERMINAL (d)       |                              0/24 (0%)                                         2/20 (10%)                   | 
|FIRST INCIDENCE    |                              656                                               731 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.458                      | 
|POLY 3             |                                                                                P=0.476                      | 
|POLY 1.5           |                                                                                P=0.476                      | 
|POLY 6             |                                                                                P=0.477                      | 
|LOGISTIC REGRESSION|                                                                                P=0.469                      | 
|COCH-ARM / FISHERS |                                                                                P=0.470                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 44      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              37/53 (70%)                                       23/49 (47%)                  | 
|POLY-3 RATE (b)    |                              37/47.57                                          23/40.48                     | 
|POLY-3 PERCENT (g) |                              77.8%                                             56.8%                        | 
|TERMINAL (d)       |                              18/24 (75%)                                       13/20 (65%)                  | 
|FIRST INCIDENCE    |                              410                                               191                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.066N                     | 
|POLY 3             |                                                                                P=0.023N*                    | 
|POLY 1.5           |                                                                                P=0.019N*                    | 
|POLY 6             |                                                                                P=0.029N*                    | 
|LOGISTIC REGRESSION|                                                                                P=0.018N*                    | 
|COCH-ARM / FISHERS |                                                                                P=0.016N*                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
(d)  Observed incidence at terminal kill.                                                                                           
(f)  Beneath the control incidence are the P-values associated with the trend                                                       
test.  Beneath the dosed group incidence are the P-values corresponding to                                                          
pairwise comparisons between the controls and that dosed group.  The life                                                           
table analysis regards tumors in animals dying prior to  terminal kill as                                                           
 being (directly or indirectly) the cause of death.                                                                                 
Logistic regression is an alternative                                                                                               
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage                                                       
and Fishers exact tests compare directly the overall incidence rates                                                                
For all tests a negative trend is indicated by N                                                                                    
(e)  Value of Statistic cannot be computed.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(I)  Interim sacrifice                                                                                                              
(T)  Terminal sacrifice                                                                                                             
#   Tumor rates based on number of animals necropsied.                                                                              
*   To the right of any statistical result, indicates significance at (P<=0.05).                                                    
**  To the right of any statistical result, indicates significance at (P<=0.01).