National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/5296

TDMS Study 96007-03 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD)                      DATE: 11/25/02       
EXPERIMENT: 96007 TEST: 03                                                                                     TIME: 12:43:22       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007G       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 1746-01-6       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                 CONTROL VS HIGH DOSE AND STOP GRP.                                                 
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 NG/KG                                                                       
                                       INCLUDE 006    100     NG/KG                                                                 
                                       INCLUDE 007    100 NG/ KG/STOP                                                               
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD)                      DATE: 11/25/02       
EXPERIMENT: 96007 TEST: 03                                                                                     TIME: 12:43:22       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007G       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 1746-01-6       
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF       TOXIC EQUIVALENCY FACTOR EVALUATION                                                                        
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Cortex                         Angiectasis                                                                                  
                                       Atrophy                                                                                      
                                       Degeneration Cystic                                                                          
                                       Hyperplasia                                                                                  
                                       Hypertrophy                                                                                  
                                       Necrosis                                                                                     
                                       Vacuolization Cytoplasmic                                                                    
Adrenal Medulla                        Hyperplasia                                                                                  
Bone Marrow                            Hyperplasia                                                                                  
Brain                                  Mineralization                                                                               
Clitoral Gland                         Inflammation                                                                                 
Clitoral Gland: Duct                   Cyst                                                                                         
Eye: Retina                            Atrophy                                                                                      
Harderian Gland                        Inflammation                                                                                 
Heart                                  Cardiomyopathy                                                                               
Heart: Atrium                          Thrombosis                                                                                   
Intestine Large, Colon                 Parasite Metazoan                                                                            
Intestine Large, Rectum                Parasite Metazoan                                                                            
Kidney                                 Accumulation, Hyaline Droplet                                                                
                                       Casts Protein                                                                                
                                       Cyst                                                                                         
                                       Inflammation                                                                                 
                                       Inflammation Chronic                                                                         
                                       Mineralization                                                                               
                                       Nephropathy                                                                                  
Kidney: Pelvis                         Dilatation                                                                                   
                                       Inflammation                                                                                 
Kidney: Transitional Epithelium        Hyperplasia                                                                                  
Liver                                  Angiectasis                                                                                  
                                       Basophilic Focus                                                                             
                                       Cholangiofibrosis                                                                            
                                       Clear Cell Focus                                                                             
                                       Congestion                                                                                   
                                       Cytoplasmic Alteration                                                                       
                                       Degeneration Cystic                                                                          
                                       Eosinophilic Focus                                                                           
                                       Fatty Change Diffuse                                                                         
                                       Fatty Change Focal                                                                           
                                       Hematopoietic Cell Proliferation                                                             
                                       Inflammation                                                                                 
                                       Mixed Cell Focus                                                                             
                                       Necrosis                                                                                     
                                       Pigmentation                                                                                 
                                       Regeneration                                                                                 
                                       Toxic Hepatopathy                                                                            
Liver: Artery                          Inflammation Chronic                                                                         
Liver: Bile Duct                       Cyst                                                                                         
                                       Fibrosis                                                                                     
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD)                      DATE: 11/25/02       
EXPERIMENT: 96007 TEST: 03                                                                                     TIME: 12:43:22       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007G       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 1746-01-6       
                                       Hyperplasia                                                                                  
Liver: Centrilobular                   Degeneration                                                                                 
Liver: Hepatocyte                      Hypertrophy                                                                                  
                                       Multinucleated                                                                               
Liver: Oval Cell                       Hyperplasia                                                                                  
Liver: Portal                          Fibrosis                                                                                     
Lung                                   Hemorrhage                                                                                   
                                       Infiltration Cellular Histiocyte                                                             
                                       Inflammation Granulomatous                                                                   
                                       Metaplasia                                                                                   
Lung: Alveolar Epithelium              Hyperplasia                                                                                  
                                       Metaplasia Bronchiolar                                                                       
Lymph Node, Mandibular                 Ectasia                                                                                      
                                       Hyperplasia                                                                                  
                                       Hyperplasia Lymphoid                                                                         
Lymph Node, Mesenteric                 Hyperplasia                                                                                  
Lymph Node: Lumbar                     Ectasia                                                                                      
                                       Hyperplasia                                                                                  
Lymph Node: Mediastinal                Ectasia                                                                                      
                                       Hemorrhage                                                                                   
Mammary Gland                          Cyst                                                                                         
                                       Hyperplasia                                                                                  
Mesentery: Artery                      Inflammation Chronic                                                                         
Nose                                   Inflammation                                                                                 
Nose: Nasolacrimal Duct                Inflammation                                                                                 
Nose: Septum                           Inflammation                                                                                 
Nose: Turbinate, Septum                Inflammation                                                                                 
Oral Mucosa: Gingival                  Hyperplasia                                                                                  
Ovary                                  Atrophy                                                                                      
                                       Cyst                                                                                         
Pancreas                               Inflammation Chronic                                                                         
Pancreas: Acinus                       Atrophy                                                                                      
                                       Hyperplasia                                                                                  
                                       Vacuolization Cytoplasmic                                                                    
Pancreas: Artery                       Inflammation Chronic                                                                         
Pituitary Gland                        Angiectasis                                                                                  
                                       Vacuolization Cytoplasmic                                                                    
Pituitary Gland: Pars Distalis         Hyperplasia                                                                                  
Pituitary Gland: Pars Intermedia       Hyperplasia                                                                                  
Salivary Glands                        Atrophy                                                                                      
Skin                                   Cyst Epithelial Inclusion                                                                    
Spleen                                 Hematopoietic Cell Proliferation                                                             
                                       Hyperplasia Lymphoid                                                                         
                                       Pigmentation                                                                                 
Spleen: Lymphoid Follicle              Atrophy                                                                                      
Stomach, Forestomach                   Hyperkeratosis                                                                               
                                       Hyperplasia                                                                                  
                                       Inflammation                                                                                 
                                       Ulcer                                                                                        
Stomach, Glandular                     Mineralization                                                                               
                                       Ulcer                                                                                        
Thymus                                 Atrophy                                                                                      
Thyroid Gland: C-Cell                  Hyperplasia                                                                                  
Thyroid Gland: Follicular Cell         Hyperplasia                                                                                  
                                       Hypertrophy                                                                                  
Tooth: Peridontal Tissue               Inflammation                                                                                 
Urinary Bladder                        Inflammation                                                                                 
Urinary Bladder: Transitional Epithelium                                                                                            
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD)                      DATE: 11/25/02       
EXPERIMENT: 96007 TEST: 03                                                                                     TIME: 12:43:22       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007G       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 1746-01-6       
                                                                                                                                    
                                       Hyperplasia                                                                                  
Uterus                                 Inflammation                                                                                 
                                       Metaplasia                                                                                   
Uterus: Endometrium                    Hyperplasia Cystic                                                                           
===============================================================                                                                     
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              11/53 (21%)                                       26/103 (25%)                 | 
|POLY-3 RATE (b)    |                              11/40.84                                          26/83.93                     | 
|POLY-3 PERCENT (g) |                              26.9%                                             31.0%                        | 
|TERMINAL (d)       |                              6/25 (24%)                                        14/42 (33%)                  | 
|FIRST INCIDENCE    |                              645                                               396                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.252                                           P=0.252                      | 
|POLY 3             |                              P=0.397                                           P=0.372                      | 
|POLY 1.5           |                              P=0.393                                           P=0.368                      | 
|POLY 6             |                              P=0.372                                           P=0.345                      | 
|LOGISTIC REGRESSION|                              P=0.387                                           P=0.387                      | 
|COCH-ARM / FISHERS |                              P=0.335                                           P=0.339                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         31/103 (30%)                 | 
|POLY-3 RATE (b)    |                              2/39.86                                           31/85.18                     | 
|POLY-3 PERCENT (g) |                              5.0%                                              36.4%                        | 
|TERMINAL (d)       |                              1/25 (4%)                                         15/42 (36%)                  | 
|FIRST INCIDENCE    |                              646                                               396                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              11/53 (21%)                                       34/103 (33%)                 | 
|POLY-3 RATE (b)    |                              11/41.19                                          34/86.31                     | 
|POLY-3 PERCENT (g) |                              26.7%                                             39.4%                        | 
|TERMINAL (d)       |                              4/25 (16%)                                        16/42 (38%)                  | 
|FIRST INCIDENCE    |                              646                                               474                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.069                                           P=0.069                      | 
|POLY 3             |                              P=0.132                                           P=0.100                      | 
|POLY 1.5           |                              P=0.126                                           P=0.095                      | 
|POLY 6             |                              P=0.124                                           P=0.092                      | 
|LOGISTIC REGRESSION|                              P=0.100                                           P=0.100                      | 
|COCH-ARM / FISHERS |                              P=0.079                                           P=0.077                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              16/53 (30%)                                       50/103 (49%)                 | 
|POLY-3 RATE (b)    |                              16/41.46                                          50/88.21                     | 
|POLY-3 PERCENT (g) |                              38.6%                                             56.7%                        | 
|TERMINAL (d)       |                              10/25 (40%)                                       27/42 (64%)                  | 
|FIRST INCIDENCE    |                              487                                               396                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.015 *                                         P=0.015 *                    | 
|POLY 3             |                              P=0.052                                           P=0.032 *                    | 
|POLY 1.5           |                              P=0.047 *                                         P=0.029 *                    | 
|POLY 6             |                              P=0.049 *                                         P=0.029 *                    | 
|LOGISTIC REGRESSION|                              P=0.031 *                                         P=0.031 *                    | 
|COCH-ARM / FISHERS |                              P=0.021 *                                         P=0.021 *                    | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              41/53 (77%)                                       93/103 (90%)                 | 
|POLY-3 RATE (b)    |                              41/44.21                                          93/99.14                     | 
|POLY-3 PERCENT (g) |                              92.8%                                             93.8%                        | 
|TERMINAL (d)       |                              25/25 (100%)                                      41/42 (98%)                  | 
|FIRST INCIDENCE    |                              474                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.061                                           P=0.061                      | 
|POLY 3             |                              P=0.529                                           P=0.501                      | 
|POLY 1.5           |                              P=0.260                                           P=0.216                      | 
|POLY 6             |                              P=0.497N                                          P=0.455N                     | 
|LOGISTIC REGRESSION|                              P=0.091                                           P=0.091                      | 
|COCH-ARM / FISHERS |                              P=0.025 *                                         P=0.027 *                    | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         4/103 (4%)                   | 
|POLY-3 RATE (b)    |                              0/39.55                                           4/82.39                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              4.9%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/42 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               578                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.194                                           P=0.194                      | 
|POLY 3             |                              P=0.199                                           P=0.150                      | 
|POLY 1.5           |                              P=0.195                                           P=0.148                      | 
|POLY 6             |                              P=0.198                                           P=0.149                      | 
|LOGISTIC REGRESSION|                              P=0.155                                           P=0.155                      | 
|COCH-ARM / FISHERS |                              P=0.179                                           P=0.186                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              11/53 (21%)                                       28/103 (27%)                 | 
|POLY-3 RATE (b)    |                              11/40.73                                          28/86.20                     | 
|POLY-3 PERCENT (g) |                              27.0%                                             32.5%                        | 
|TERMINAL (d)       |                              9/25 (36%)                                        12/42 (29%)                  | 
|FIRST INCIDENCE    |                              366                                               345                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.194                                           P=0.194                      | 
|POLY 3             |                              P=0.343                                           P=0.313                      | 
|POLY 1.5           |                              P=0.321                                           P=0.289                      | 
|POLY 6             |                              P=0.359                                           P=0.329                      | 
|LOGISTIC REGRESSION|                              P=0.285                                           P=0.285                      | 
|COCH-ARM / FISHERS |                              P=0.247                                           P=0.249                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              19/53 (36%)                                       24/103 (23%)                 | 
|POLY-3 RATE (b)    |                              19/41.29                                          24/84.44                     | 
|POLY-3 PERCENT (g) |                              46.0%                                             28.4%                        | 
|TERMINAL (d)       |                              11/25 (44%)                                       11/42 (26%)                  | 
|FIRST INCIDENCE    |                              487                                               578                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.137N                                          P=0.137N                     | 
|POLY 3             |                              P=0.051N                                          P=0.031N*                    | 
|POLY 1.5           |                              P=0.058N                                          P=0.037N*                    | 
|POLY 6             |                              P=0.050N                                          P=0.031N*                    | 
|LOGISTIC REGRESSION|                              P=0.044N*                                         P=0.044N*                    | 
|COCH-ARM / FISHERS |                              P=0.071N                                          P=0.072N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              36/53 (68%)                                       79/103 (77%)                 | 
|POLY-3 RATE (b)    |                              36/52.64                                          79/100.3                     | 
|POLY-3 PERCENT (g) |                              68.4%                                             78.8%                        | 
|TERMINAL (d)       |                              9/25 (36%)                                        26/42 (62%)                  | 
|FIRST INCIDENCE    |                              169                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.236                                           P=0.236                      | 
|POLY 3             |                              P=0.124                                           P=0.095                      | 
|POLY 1.5           |                              P=0.147                                           P=0.116                      | 
|POLY 6             |                              P=0.096                                           P=0.070                      | 
|LOGISTIC REGRESSION|                              P=0.123                                           P=0.123                      | 
|COCH-ARM / FISHERS |                              P=0.162                                           P=0.162                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain                                                                                                                            | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/103 (2%)                   | 
|POLY-3 RATE (b)    |                              0/39.55                                           2/80.75                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              2.5%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         2/42 (5%)                    | 
|FIRST INCIDENCE    |                              ---                                               731 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.358                                           P=0.358                      | 
|POLY 3             |                              P=0.373                                           P=0.314                      | 
|POLY 1.5           |                              P=0.372                                           P=0.313                      | 
|POLY 6             |                              P=0.369                                           P=0.310                      | 
|LOGISTIC REGRESSION|                              (e)                                               P=0.358                      | 
|COCH-ARM / FISHERS |                              P=0.394                                           P=0.434                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              41/50 (82%)                                       61/102 (60%)                 | 
|POLY-3 RATE (b)    |                              41/46.36                                          61/93.09                     | 
|POLY-3 PERCENT (g) |                              88.4%                                             65.5%                        | 
|TERMINAL (d)       |                              22/25 (88%)                                       27/42 (64%)                  | 
|FIRST INCIDENCE    |                              169                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.128N                                          P=0.128N                     | 
|POLY 3             |                              P=0.004N**                                        P<0.001N**                   | 
|POLY 1.5           |                              P=0.005N**                                        P=0.002N**                   | 
|POLY 6             |                              P=0.005N**                                        P=0.002N**                   | 
|LOGISTIC REGRESSION|                              P=0.005N**                                        P=0.005N**                   | 
|COCH-ARM / FISHERS |                              P=0.005N**                                        P=0.004N**                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland: Duct                                                                                                             | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              34/50 (68%)                                       83/102 (81%)                 | 
|POLY-3 RATE (b)    |                              34/44.15                                          83/97.26                     | 
|POLY-3 PERCENT (g) |                              77.0%                                             85.3%                        | 
|TERMINAL (d)       |                              19/25 (76%)                                       35/42 (83%)                  | 
|FIRST INCIDENCE    |                              169                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.047 *                                         P=0.047 *                    | 
|POLY 3             |                              P=0.175                                           P=0.133                      | 
|POLY 1.5           |                              P=0.141                                           P=0.103                      | 
|POLY 6             |                              P=0.195                                           P=0.152                      | 
|LOGISTIC REGRESSION|                              P=0.079                                           P=0.079                      | 
|COCH-ARM / FISHERS |                              P=0.051                                           P=0.053                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Retina                                                                                                                      | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         12/103 (12%)                 | 
|POLY-3 RATE (b)    |                              5/39.55                                           12/81.41                     | 
|POLY-3 PERCENT (g) |                              12.6%                                             14.7%                        | 
|TERMINAL (d)       |                              5/25 (20%)                                        8/42 (19%)                   | 
|FIRST INCIDENCE    |                              731 (T)                                           645                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.341                                           P=0.341                      | 
|POLY 3             |                              P=0.472                                           P=0.450                      | 
|POLY 1.5           |                              P=0.466                                           P=0.444                      | 
|POLY 6             |                              P=0.465                                           P=0.442                      | 
|LOGISTIC REGRESSION|                              P=0.431                                           P=0.431                      | 
|COCH-ARM / FISHERS |                              P=0.441                                           P=0.450                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              12/53 (23%)                                       15/103 (15%)                 | 
|POLY-3 RATE (b)    |                              12/42.07                                          15/83.10                     | 
|POLY-3 PERCENT (g) |                              28.5%                                             18.1%                        | 
|TERMINAL (d)       |                              6/25 (24%)                                        7/42 (17%)                   | 
|FIRST INCIDENCE    |                              366                                               546                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.214N                                          P=0.214N                     | 
|POLY 3             |                              P=0.147N                                          P=0.114N                     | 
|POLY 1.5           |                              P=0.147N                                          P=0.114N                     | 
|POLY 6             |                              P=0.158N                                          P=0.125N                     | 
|LOGISTIC REGRESSION|                              P=0.127N                                          P=0.127N                     | 
|COCH-ARM / FISHERS |                              P=0.149N                                          P=0.149N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              10/53 (19%)                                       58/102 (57%)                 | 
|POLY-3 RATE (b)    |                              10/41.81                                          58/89.75                     | 
|POLY-3 PERCENT (g) |                              23.9%                                             64.6%                        | 
|TERMINAL (d)       |                              6/25 (24%)                                        24/42 (57%)                  | 
|FIRST INCIDENCE    |                              169                                               396                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart: Atrium                                                                                                                    | 
|     Thrombosis                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/102 (2%)                   | 
|POLY-3 RATE (b)    |                              0/39.55                                           2/80.62                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              2.5%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/42 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               484                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.406                                           P=0.406                      | 
|POLY 3             |                              P=0.372                                           P=0.314                      | 
|POLY 1.5           |                              P=0.371                                           P=0.313                      | 
|POLY 6             |                              P=0.369                                           P=0.312                      | 
|LOGISTIC REGRESSION|                              P=0.354                                           P=0.354                      | 
|COCH-ARM / FISHERS |                              P=0.391                                           P=0.432                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Colon                                                                                                           | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/52 (2%)                                         3/100 (3%)                   | 
|POLY-3 RATE (b)    |                              1/39.56                                           3/79.41                      | 
|POLY-3 PERCENT (g) |                              2.5%                                              3.8%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/42 (2%)                    | 
|FIRST INCIDENCE    |                              701                                               614                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.550                                           P=0.550                      | 
|POLY 3             |                              P=0.533                                           P=0.503                      | 
|POLY 1.5           |                              P=0.532                                           P=0.502                      | 
|POLY 6             |                              P=0.529                                           P=0.499                      | 
|LOGISTIC REGRESSION|                              P=0.565                                           P=0.565                      | 
|COCH-ARM / FISHERS |                              P=0.556                                           P=0.577                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Rectum                                                                                                          | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              6/52 (12%)                                        6/103 (6%)                   | 
|POLY-3 RATE (b)    |                              6/39.78                                           6/81.39                      | 
|POLY-3 PERCENT (g) |                              15.1%                                             7.4%                         | 
|TERMINAL (d)       |                              2/25 (8%)                                         4/42 (10%)                   | 
|FIRST INCIDENCE    |                              645                                               641                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.235N                                          P=0.235N                     | 
|POLY 3             |                              P=0.171N                                          P=0.131N                     | 
|POLY 1.5           |                              P=0.171N                                          P=0.131N                     | 
|POLY 6             |                              P=0.182N                                          P=0.143N                     | 
|LOGISTIC REGRESSION|                              P=0.156N                                          P=0.156N                     | 
|COCH-ARM / FISHERS |                              P=0.174N                                          P=0.173N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Accumulation, Hyaline Droplet                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/103 (2%)                   | 
|POLY-3 RATE (b)    |                              0/39.55                                           2/81.60                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              2.5%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/42 (2%)                    | 
|FIRST INCIDENCE    |                              ---                                               394                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.386                                           P=0.386                      | 
|POLY 3             |                              P=0.375                                           P=0.316                      | 
|POLY 1.5           |                              P=0.374                                           P=0.314                      | 
|POLY 6             |                              P=0.372                                           P=0.313                      | 
|LOGISTIC REGRESSION|                              P=0.332                                           P=0.332                      | 
|COCH-ARM / FISHERS |                              P=0.394                                           P=0.434                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Casts Protein                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         2/103 (2%)                   | 
|POLY-3 RATE (b)    |                              3/40.58                                           2/81.71                      | 
|POLY-3 PERCENT (g) |                              7.4%                                              2.5%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/42 (0%)                    | 
|FIRST INCIDENCE    |                              512                                               578                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.206N                                          P=0.206N                     | 
|POLY 3             |                              P=0.212N                                          P=0.166N                     | 
|POLY 1.5           |                              P=0.212N                                          P=0.166N                     | 
|POLY 6             |                              P=0.218N                                          P=0.173N                     | 
|LOGISTIC REGRESSION|                              P=0.252N                                          P=0.252N                     | 
|COCH-ARM / FISHERS |                              P=0.221N                                          P=0.216N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         1/103 (1%)                   | 
|POLY-3 RATE (b)    |                              2/39.90                                           1/81.20                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              1.2%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/42 (0%)                    | 
|FIRST INCIDENCE    |                              631                                               598                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.283N                                          P=0.283N                     | 
|POLY 3             |                              P=0.255N                                          P=0.202N                     | 
|POLY 1.5           |                              P=0.256N                                          P=0.203N                     | 
|POLY 6             |                              P=0.259N                                          P=0.207N                     | 
|LOGISTIC REGRESSION|                              P=0.276N                                          P=0.276N                     | 
|COCH-ARM / FISHERS |                              P=0.277N                                          P=0.266N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/103 (2%)                   | 
|POLY-3 RATE (b)    |                              0/39.55                                           2/81.41                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              2.5%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/42 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               604                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.401                                           P=0.401                      | 
|POLY 3             |                              P=0.375                                           P=0.315                      | 
|POLY 1.5           |                              P=0.373                                           P=0.314                      | 
|POLY 6             |                              P=0.372                                           P=0.313                      | 
|LOGISTIC REGRESSION|                              P=0.386                                           P=0.386                      | 
|COCH-ARM / FISHERS |                              P=0.394                                           P=0.434                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         0/103 (0%)                   | 
|POLY-3 RATE (b)    |                              5/40.43                                           0/80.75                      | 
|POLY-3 PERCENT (g) |                              12.4%                                             0.0%                         | 
|TERMINAL (d)       |                              4/25 (16%)                                        0/42 (0%)                    | 
|FIRST INCIDENCE    |                              361                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.006N**                                        P=0.006N**                   | 
|POLY 3             |                              P=0.004N**                                        P<0.001N**                   | 
|POLY 1.5           |                              P=0.004N**                                        P<0.001N**                   | 
|POLY 6             |                              P=0.004N**                                        P=0.002N**                   | 
|LOGISTIC REGRESSION|                              P=0.003N**                                        P=0.003N**                   | 
|COCH-ARM / FISHERS |                              P=0.004N**                                        P=0.004N**                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              40/53 (75%)                                       84/103 (82%)                 | 
|POLY-3 RATE (b)    |                              40/47.18                                          84/97.90                     | 
|POLY-3 PERCENT (g) |                              84.8%                                             85.8%                        | 
|TERMINAL (d)       |                              22/25 (88%)                                       34/42 (81%)                  | 
|FIRST INCIDENCE    |                              169                                               394                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.215                                           P=0.215                      | 
|POLY 3             |                              P=0.518                                           P=0.502                      | 
|POLY 1.5           |                              P=0.395                                           P=0.368                      | 
|POLY 6             |                              P=0.510N                                          P=0.491N                     | 
|LOGISTIC REGRESSION|                              P=0.343                                           P=0.343                      | 
|COCH-ARM / FISHERS |                              P=0.248                                           P=0.246                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 13      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              34/53 (64%)                                       93/103 (90%)                 | 
|POLY-3 RATE (b)    |                              34/45.60                                          93/97.74                     | 
|POLY-3 PERCENT (g) |                              74.6%                                             95.2%                        | 
|TERMINAL (d)       |                              21/25 (84%)                                       41/42 (98%)                  | 
|FIRST INCIDENCE    |                              169                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.004 **                                        P=0.004 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         1/103 (1%)                   | 
|POLY-3 RATE (b)    |                              2/40.16                                           1/81.46                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              1.2%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/42 (0%)                    | 
|FIRST INCIDENCE    |                              533                                               484                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.272N                                          P=0.272N                     | 
|POLY 3             |                              P=0.256N                                          P=0.203N                     | 
|POLY 1.5           |                              P=0.257N                                          P=0.203N                     | 
|POLY 6             |                              P=0.260N                                          P=0.208N                     | 
|LOGISTIC REGRESSION|                              P=0.327N                                          P=0.327N                     | 
|COCH-ARM / FISHERS |                              P=0.277N                                          P=0.266N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 14      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         2/103 (2%)                   | 
|POLY-3 RATE (b)    |                              2/39.55                                           2/80.87                      | 
|POLY-3 PERCENT (g) |                              5.1%                                              2.5%                         | 
|TERMINAL (d)       |                              2/25 (8%)                                         1/42 (2%)                    | 
|FIRST INCIDENCE    |                              731 (T)                                           701                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.482N                                          P=0.482N                     | 
|POLY 3             |                              P=0.398N                                          P=0.353N                     | 
|POLY 1.5           |                              P=0.400N                                          P=0.355N                     | 
|POLY 6             |                              P=0.403N                                          P=0.359N                     | 
|LOGISTIC REGRESSION|                              P=0.448N                                          P=0.448N                     | 
|COCH-ARM / FISHERS |                              P=0.440N                                          P=0.419N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Transitional Epithelium                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         16/103 (16%)                 | 
|POLY-3 RATE (b)    |                              3/40.54                                           16/83.25                     | 
|POLY-3 PERCENT (g) |                              7.4%                                              19.2%                        | 
|TERMINAL (d)       |                              2/25 (8%)                                         7/42 (17%)                   | 
|FIRST INCIDENCE    |                              169                                               584                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.057                                           P=0.057                      | 
|POLY 3             |                              P=0.090                                           P=0.062                      | 
|POLY 1.5           |                              P=0.087                                           P=0.060                      | 
|POLY 6             |                              P=0.089                                           P=0.061                      | 
|LOGISTIC REGRESSION|                              P=0.067                                           P=0.067                      | 
|COCH-ARM / FISHERS |                              P=0.063                                           P=0.058                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 15      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         9/103 (9%)                   | 
|POLY-3 RATE (b)    |                              2/39.55                                           9/81.34                      | 
|POLY-3 PERCENT (g) |                              5.1%                                              11.1%                        | 
|TERMINAL (d)       |                              2/25 (8%)                                         7/42 (17%)                   | 
|FIRST INCIDENCE    |                              731 (T)                                           561                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.159                                           P=0.159                      | 
|POLY 3             |                              P=0.239                                           P=0.198                      | 
|POLY 1.5           |                              P=0.237                                           P=0.197                      | 
|POLY 6             |                              P=0.232                                           P=0.191                      | 
|LOGISTIC REGRESSION|                              P=0.207                                           P=0.207                      | 
|COCH-ARM / FISHERS |                              P=0.207                                           P=0.211                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              12/53 (23%)                                       24/103 (23%)                 | 
|POLY-3 RATE (b)    |                              12/42.33                                          24/83.76                     | 
|POLY-3 PERCENT (g) |                              28.4%                                             28.7%                        | 
|TERMINAL (d)       |                              4/25 (16%)                                        10/42 (24%)                  | 
|FIRST INCIDENCE    |                              492                                               520                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.462                                           P=0.462                      | 
|POLY 3             |                              P=0.550                                           P=0.542                      | 
|POLY 1.5           |                              P=0.560                                           P=0.554                      | 
|POLY 6             |                              P=0.510                                           P=0.497                      | 
|LOGISTIC REGRESSION|                              P=0.564N                                          P=0.564N                     | 
|COCH-ARM / FISHERS |                              P=0.543                                           P=0.548                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 16      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Cholangiofibrosis                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         32/103 (31%)                 | 
|POLY-3 RATE (b)    |                              1/39.86                                           32/85.28                     | 
|POLY-3 PERCENT (g) |                              2.5%                                              37.5%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         14/42 (33%)                  | 
|FIRST INCIDENCE    |                              645                                               581                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Clear Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         10/103 (10%)                 | 
|POLY-3 RATE (b)    |                              5/40.18                                           10/80.75                     | 
|POLY-3 PERCENT (g) |                              12.4%                                             12.4%                        | 
|TERMINAL (d)       |                              3/25 (12%)                                        10/42 (24%)                  | 
|FIRST INCIDENCE    |                              548                                               731 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.499                                           P=0.499                      | 
|POLY 3             |                              P=0.583N                                          P=0.574N                     | 
|POLY 1.5           |                              P=0.580N                                          P=0.571N                     | 
|POLY 6             |                              P=0.572                                           P=0.562                      | 
|LOGISTIC REGRESSION|                              P=0.594                                           P=0.594                      | 
|COCH-ARM / FISHERS |                              P=0.592                                           P=0.624N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 17      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Congestion                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         2/103 (2%)                   | 
|POLY-3 RATE (b)    |                              2/39.85                                           2/82.01                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              2.4%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/42 (0%)                    | 
|FIRST INCIDENCE    |                              648                                               396                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.443N                                          P=0.443N                     | 
|POLY 3             |                              P=0.396N                                          P=0.351N                     | 
|POLY 1.5           |                              P=0.398N                                          P=0.354N                     | 
|POLY 6             |                              P=0.401N                                          P=0.357N                     | 
|LOGISTIC REGRESSION|                              P=0.492N                                          P=0.492N                     | 
|COCH-ARM / FISHERS |                              P=0.440N                                          P=0.419N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         3/103 (3%)                   | 
|POLY-3 RATE (b)    |                              0/39.55                                           3/80.75                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              3.7%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         3/42 (7%)                    | 
|FIRST INCIDENCE    |                              ---                                               731 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.226                                           P=0.226                      | 
|POLY 3             |                              P=0.264                                           P=0.211                      | 
|POLY 1.5           |                              P=0.264                                           P=0.210                      | 
|POLY 6             |                              P=0.259                                           P=0.207                      | 
|LOGISTIC REGRESSION|                              (e)                                               P=0.226                      | 
|COCH-ARM / FISHERS |                              P=0.261                                           P=0.285                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 18      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         4/103 (4%)                   | 
|POLY-3 RATE (b)    |                              0/39.55                                           4/81.49                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              4.9%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         2/42 (5%)                    | 
|FIRST INCIDENCE    |                              ---                                               610                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.166                                           P=0.166                      | 
|POLY 3             |                              P=0.196                                           P=0.148                      | 
|POLY 1.5           |                              P=0.194                                           P=0.146                      | 
|POLY 6             |                              P=0.193                                           P=0.145                      | 
|LOGISTIC REGRESSION|                              P=0.187                                           P=0.187                      | 
|COCH-ARM / FISHERS |                              P=0.179                                           P=0.186                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              11/53 (21%)                                       71/103 (69%)                 | 
|POLY-3 RATE (b)    |                              11/40.67                                          71/95.23                     | 
|POLY-3 PERCENT (g) |                              27.1%                                             74.6%                        | 
|TERMINAL (d)       |                              6/25 (24%)                                        30/42 (71%)                  | 
|FIRST INCIDENCE    |                              645                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 19      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Diffuse                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         58/103 (56%)                 | 
|POLY-3 RATE (b)    |                              0/39.55                                           58/92.31                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              62.8%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         22/42 (52%)                  | 
|FIRST INCIDENCE    |                              ---                                               396                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         10/103 (10%)                 | 
|POLY-3 RATE (b)    |                              2/39.69                                           10/81.52                     | 
|POLY-3 PERCENT (g) |                              5.0%                                              12.3%                        | 
|TERMINAL (d)       |                              1/25 (4%)                                         7/42 (17%)                   | 
|FIRST INCIDENCE    |                              694                                               604                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.122                                           P=0.122                      | 
|POLY 3             |                              P=0.191                                           P=0.152                      | 
|POLY 1.5           |                              P=0.190                                           P=0.151                      | 
|POLY 6             |                              P=0.183                                           P=0.144                      | 
|LOGISTIC REGRESSION|                              P=0.164                                           P=0.164                      | 
|COCH-ARM / FISHERS |                              P=0.159                                           P=0.159                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 20      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         4/103 (4%)                   | 
|POLY-3 RATE (b)    |                              1/39.86                                           4/81.74                      | 
|POLY-3 PERCENT (g) |                              2.5%                                              4.9%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/42 (2%)                    | 
|FIRST INCIDENCE    |                              646                                               599                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.421                                           P=0.421                      | 
|POLY 3             |                              P=0.424                                           P=0.385                      | 
|POLY 1.5           |                              P=0.422                                           P=0.383                      | 
|POLY 6             |                              P=0.418                                           P=0.379                      | 
|LOGISTIC REGRESSION|                              P=0.427                                           P=0.427                      | 
|COCH-ARM / FISHERS |                              P=0.424                                           P=0.446                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              33/53 (62%)                                       92/103 (89%)                 | 
|POLY-3 RATE (b)    |                              33/47.21                                          92/99.30                     | 
|POLY-3 PERCENT (g) |                              69.9%                                             92.6%                        | 
|TERMINAL (d)       |                              17/25 (68%)                                       38/42 (91%)                  | 
|FIRST INCIDENCE    |                              351                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.006 **                                        P=0.006 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 21      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              30/53 (57%)                                       50/103 (49%)                 | 
|POLY-3 RATE (b)    |                              30/41.81                                          50/86.61                     | 
|POLY-3 PERCENT (g) |                              71.8%                                             57.7%                        | 
|TERMINAL (d)       |                              22/25 (88%)                                       33/42 (79%)                  | 
|FIRST INCIDENCE    |                              492                                               396                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.429N                                          P=0.429N                     | 
|POLY 3             |                              P=0.094N                                          P=0.066N                     | 
|POLY 1.5           |                              P=0.125N                                          P=0.094N                     | 
|POLY 6             |                              P=0.078N                                          P=0.053N                     | 
|LOGISTIC REGRESSION|                              P=0.106N                                          P=0.106N                     | 
|COCH-ARM / FISHERS |                              P=0.216N                                          P=0.216N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         25/103 (24%)                 | 
|POLY-3 RATE (b)    |                              1/39.67                                           25/87.58                     | 
|POLY-3 PERCENT (g) |                              2.5%                                              28.6%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         3/42 (7%)                    | 
|FIRST INCIDENCE    |                              701                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.002 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P=0.002 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 22      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/53 (8%)                                         98/103 (95%)                 | 
|POLY-3 RATE (b)    |                              4/40.41                                           98/100.8                     | 
|POLY-3 PERCENT (g) |                              9.9%                                              97.2%                        | 
|TERMINAL (d)       |                              1/25 (4%)                                         41/42 (98%)                  | 
|FIRST INCIDENCE    |                              533                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Regeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         36/103 (35%)                 | 
|POLY-3 RATE (b)    |                              0/39.55                                           36/87.12                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              41.3%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         14/42 (33%)                  | 
|FIRST INCIDENCE    |                              ---                                               396                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 23      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Toxic Hepatopathy                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         69/103 (67%)                 | 
|POLY-3 RATE (b)    |                              0/39.55                                           69/93.19                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              74.0%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         30/42 (71%)                  | 
|FIRST INCIDENCE    |                              ---                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Artery                                                                                                                    | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/103 (2%)                   | 
|POLY-3 RATE (b)    |                              0/39.55                                           2/81.47                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              2.5%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/42 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               581                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.407                                           P=0.407                      | 
|POLY 3             |                              P=0.375                                           P=0.315                      | 
|POLY 1.5           |                              P=0.373                                           P=0.314                      | 
|POLY 6             |                              P=0.372                                           P=0.313                      | 
|LOGISTIC REGRESSION|                              P=0.379                                           P=0.379                      | 
|COCH-ARM / FISHERS |                              P=0.394                                           P=0.434                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 24      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         27/103 (26%)                 | 
|POLY-3 RATE (b)    |                              3/39.85                                           27/83.11                     | 
|POLY-3 PERCENT (g) |                              7.5%                                              32.5%                        | 
|TERMINAL (d)       |                              2/25 (8%)                                         17/42 (41%)                  | 
|FIRST INCIDENCE    |                              648                                               612                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.004 **                                        P=0.002 **                   | 
|POLY 1.5           |                              P=0.004 **                                        P=0.002 **                   | 
|POLY 6             |                              P=0.004 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P=0.002 **                                        P=0.002 **                   | 
|COCH-ARM / FISHERS |                              P=0.002 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         9/103 (9%)                   | 
|POLY-3 RATE (b)    |                              0/39.55                                           9/81.65                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              11.0%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         6/42 (14%)                   | 
|FIRST INCIDENCE    |                              ---                                               598                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.026 *                                         P=0.026 *                    | 
|POLY 3             |                              P=0.047 *                                         P=0.027 *                    | 
|POLY 1.5           |                              P=0.046 *                                         P=0.027 *                    | 
|POLY 6             |                              P=0.045 *                                         P=0.025 *                    | 
|LOGISTIC REGRESSION|                              P=0.034 *                                         P=0.034 *                    | 
|COCH-ARM / FISHERS |                              P=0.032 *                                         P=0.021 *                    | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 25      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         60/103 (58%)                 | 
|POLY-3 RATE (b)    |                              5/40.16                                           60/92.33                     | 
|POLY-3 PERCENT (g) |                              12.5%                                             65.0%                        | 
|TERMINAL (d)       |                              4/25 (16%)                                        23/42 (55%)                  | 
|FIRST INCIDENCE    |                              533                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Centrilobular                                                                                                             | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         5/103 (5%)                   | 
|POLY-3 RATE (b)    |                              2/39.97                                           5/82.04                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              6.1%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/42 (2%)                    | 
|FIRST INCIDENCE    |                              648                                               610                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.531                                           P=0.531                      | 
|POLY 3             |                              P=0.536                                           P=0.513                      | 
|POLY 1.5           |                              P=0.533                                           P=0.510                      | 
|POLY 6             |                              P=0.530                                           P=0.507                      | 
|LOGISTIC REGRESSION|                              P=0.549                                           P=0.549                      | 
|COCH-ARM / FISHERS |                              P=0.540                                           P=0.556                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 26      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         74/103 (72%)                 | 
|POLY-3 RATE (b)    |                              0/39.55                                           74/95.87                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              77.2%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         30/42 (71%)                  | 
|FIRST INCIDENCE    |                              ---                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Multinucleated                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         83/103 (81%)                 | 
|POLY-3 RATE (b)    |                              0/39.55                                           83/95.86                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              86.6%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         36/42 (86%)                  | 
|FIRST INCIDENCE    |                              ---                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 27      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Oval Cell                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         54/103 (52%)                 | 
|POLY-3 RATE (b)    |                              0/39.55                                           54/91.16                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              59.2%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         22/42 (52%)                  | 
|FIRST INCIDENCE    |                              ---                                               396                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Portal                                                                                                                    | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         28/103 (27%)                 | 
|POLY-3 RATE (b)    |                              0/39.55                                           28/85.88                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              32.6%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         11/42 (26%)                  | 
|FIRST INCIDENCE    |                              ---                                               474                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 28      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/102 (2%)                   | 
|POLY-3 RATE (b)    |                              0/39.55                                           2/80.64                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              2.5%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/42 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               474                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.404                                           P=0.404                      | 
|POLY 3             |                              P=0.373                                           P=0.314                      | 
|POLY 1.5           |                              P=0.371                                           P=0.313                      | 
|POLY 6             |                              P=0.369                                           P=0.312                      | 
|LOGISTIC REGRESSION|                              P=0.350                                           P=0.350                      | 
|COCH-ARM / FISHERS |                              P=0.391                                           P=0.432                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              41/53 (77%)                                       91/102 (89%)                 | 
|POLY-3 RATE (b)    |                              41/48.55                                          91/95.84                     | 
|POLY-3 PERCENT (g) |                              84.5%                                             95.0%                        | 
|TERMINAL (d)       |                              19/25 (76%)                                       39/42 (93%)                  | 
|FIRST INCIDENCE    |                              351                                               396                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.120                                           P=0.120                      | 
|POLY 3             |                              P=0.033 *                                         P=0.018 *                    | 
|POLY 1.5           |                              P=0.043 *                                         P=0.026 *                    | 
|POLY 6             |                              P=0.028 *                                         P=0.015 *                    | 
|LOGISTIC REGRESSION|                              P=0.118                                           P=0.118                      | 
|COCH-ARM / FISHERS |                              P=0.042 *                                         P=0.044 *                    | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 29      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/102 (0%)                   | 
|POLY-3 RATE (b)    |                              2/39.90                                           0/79.79                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              0.0%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/42 (0%)                    | 
|FIRST INCIDENCE    |                              645                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.120N                                          P=0.120N                     | 
|POLY 3             |                              P=0.105N                                          P=0.066N                     | 
|POLY 1.5           |                              P=0.106N                                          P=0.066N                     | 
|POLY 6             |                              P=0.108N                                          P=0.068N                     | 
|LOGISTIC REGRESSION|                              P=0.104N                                          P=0.104N                     | 
|COCH-ARM / FISHERS |                              P=0.110N                                          P=0.115N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         9/102 (9%)                   | 
|POLY-3 RATE (b)    |                              1/39.55                                           9/82.29                      | 
|POLY-3 PERCENT (g) |                              2.5%                                              10.9%                        | 
|TERMINAL (d)       |                              1/25 (4%)                                         2/42 (5%)                    | 
|FIRST INCIDENCE    |                              731 (T)                                           561                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.100                                           P=0.100                      | 
|POLY 3             |                              P=0.126                                           P=0.090                      | 
|POLY 1.5           |                              P=0.121                                           P=0.087                      | 
|POLY 6             |                              P=0.126                                           P=0.090                      | 
|LOGISTIC REGRESSION|                              P=0.094                                           P=0.094                      | 
|COCH-ARM / FISHERS |                              P=0.093                                           P=0.087                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 30      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              12/53 (23%)                                       0/102 (0%)                   | 
|POLY-3 RATE (b)    |                              12/40.71                                          0/79.79                      | 
|POLY-3 PERCENT (g) |                              29.5%                                             0.0%                         | 
|TERMINAL (d)       |                              6/25 (24%)                                        0/42 (0%)                    | 
|FIRST INCIDENCE    |                              645                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001N**                                        P<0.001N**                   | 
|POLY 3             |                              P<0.001N**                                        P<0.001N**                   | 
|POLY 1.5           |                              P<0.001N**                                        P<0.001N**                   | 
|POLY 6             |                              P<0.001N**                                        P<0.001N**                   | 
|LOGISTIC REGRESSION|                              P<0.001N**                                        P<0.001N**                   | 
|COCH-ARM / FISHERS |                              P<0.001N**                                        P<0.001N**                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Metaplasia Bronchiolar                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         77/102 (75%)                 | 
|POLY-3 RATE (b)    |                              2/39.55                                           77/91.73                     | 
|POLY-3 PERCENT (g) |                              5.1%                                              83.9%                        | 
|TERMINAL (d)       |                              2/25 (8%)                                         35/42 (83%)                  | 
|FIRST INCIDENCE    |                              731 (T)                                           396                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 31      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/51 (0%)                                         8/101 (8%)                   | 
|POLY-3 RATE (b)    |                              0/38.56                                           8/79.18                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              10.1%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         8/42 (19%)                   | 
|FIRST INCIDENCE    |                              ---                                               731 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.027 *                                         P=0.027 *                    | 
|POLY 3             |                              P=0.061                                           P=0.036 *                    | 
|POLY 1.5           |                              P=0.062                                           P=0.037 *                    | 
|POLY 6             |                              P=0.055                                           P=0.033 *                    | 
|LOGISTIC REGRESSION|                              (e)                                               P=0.027 *                    | 
|COCH-ARM / FISHERS |                              P=0.046 *                                         P=0.034 *                    | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              25/51 (49%)                                       46/101 (46%)                 | 
|POLY-3 RATE (b)    |                              25/42.13                                          46/86.58                     | 
|POLY-3 PERCENT (g) |                              59.3%                                             53.1%                        | 
|TERMINAL (d)       |                              16/25 (64%)                                       25/42 (60%)                  | 
|FIRST INCIDENCE    |                              366                                               396                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.507                                           P=0.507                      | 
|POLY 3             |                              P=0.320N                                          P=0.288N                     | 
|POLY 1.5           |                              P=0.326N                                          P=0.295N                     | 
|POLY 6             |                              P=0.355N                                          P=0.326N                     | 
|LOGISTIC REGRESSION|                              P=0.330N                                          P=0.330N                     | 
|COCH-ARM / FISHERS |                              P=0.408N                                          P=0.407N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 32      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/51 (0%)                                         4/101 (4%)                   | 
|POLY-3 RATE (b)    |                              0/38.56                                           4/80.08                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.0%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         2/42 (5%)                    | 
|FIRST INCIDENCE    |                              ---                                               581                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.175                                           P=0.175                      | 
|POLY 3             |                              P=0.198                                           P=0.148                      | 
|POLY 1.5           |                              P=0.197                                           P=0.148                      | 
|POLY 6             |                              P=0.192                                           P=0.144                      | 
|LOGISTIC REGRESSION|                              P=0.186                                           P=0.186                      | 
|COCH-ARM / FISHERS |                              P=0.183                                           P=0.191                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/52 (2%)                                         3/100 (3%)                   | 
|POLY-3 RATE (b)    |                              1/40.17                                           3/79.68                      | 
|POLY-3 PERCENT (g) |                              2.5%                                              3.8%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/42 (0%)                    | 
|FIRST INCIDENCE    |                              469                                               598                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.570                                           P=0.570                      | 
|POLY 3             |                              P=0.529                                           P=0.499                      | 
|POLY 1.5           |                              P=0.529                                           P=0.499                      | 
|POLY 6             |                              P=0.525                                           P=0.495                      | 
|LOGISTIC REGRESSION|                              P=0.509                                           P=0.509                      | 
|COCH-ARM / FISHERS |                              P=0.556                                           P=0.577                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 33      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/2 (50%)                                         2/14 (14%)                   | 
|POLY-3 RATE (b)    |                              1/2.00                                            2/10.23                      | 
|POLY-3 PERCENT (g) |                              50.0%                                             19.5%                        | 
|TERMINAL (d)       |                              0/1 (0%)                                          0/3 (0%)                     | 
|FIRST INCIDENCE    |                              717                                               578                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.716                                           P=0.716                      | 
|POLY 3             |                              P=0.474N                                          P=0.228N                     | 
|POLY 1.5           |                              P=0.459N                                          P=0.198N                     | 
|POLY 6             |                              P=0.500N                                          P=0.282N                     | 
|LOGISTIC REGRESSION|                              P=0.376N                                          P=0.376N                     | 
|COCH-ARM / FISHERS |                              P=0.404N                                          P=0.350N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/2 (0%)                                          2/14 (14%)                   | 
|POLY-3 RATE (b)    |                              0/1.94                                            2/10.46                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              19.1%                        | 
|TERMINAL (d)       |                              0/1 (0%)                                          0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               474                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.417                                           P=0.417                      | 
|POLY 3             |                              P=0.546                                           P=0.341                      | 
|POLY 1.5           |                              P=0.557                                           P=0.365                      | 
|POLY 6             |                              P=0.528                                           P=0.306                      | 
|LOGISTIC REGRESSION|                              P=0.996                                           P=0.996                      | 
|COCH-ARM / FISHERS |                              P=0.716                                           P=0.758                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 34      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/2 (0%)                                          3/14 (21%)                   | 
|POLY-3 RATE (b)    |                              0/1.94                                            3/10.33                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              29.1%                        | 
|TERMINAL (d)       |                              0/1 (0%)                                          0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               546                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.280                                           P=0.280                      | 
|POLY 3             |                              P=0.487                                           P=0.249                      | 
|POLY 1.5           |                              P=0.503                                           P=0.281                      | 
|POLY 6             |                              P=0.461                                           P=0.207                      | 
|LOGISTIC REGRESSION|                              P=0.639                                           P=0.639                      | 
|COCH-ARM / FISHERS |                              P=0.596                                           P=0.650                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/2 (0%)                                          6/14 (43%)                   | 
|POLY-3 RATE (b)    |                              0/1.94                                            6/11.11                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              54.0%                        | 
|TERMINAL (d)       |                              0/1 (0%)                                          1/3 (33%)                    | 
|FIRST INCIDENCE    |                              ---                                               474                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.109                                           P=0.109                      | 
|POLY 3             |                              P=0.360                                           P=0.086                      | 
|POLY 1.5           |                              P=0.390                                           P=0.120                      | 
|POLY 6             |                              P=0.314                                           P=0.052                      | 
|LOGISTIC REGRESSION|                              P=0.341                                           P=0.341                      | 
|COCH-ARM / FISHERS |                              P=0.348                                           P=0.375                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 35      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/53 (8%)                                         5/103 (5%)                   | 
|POLY-3 RATE (b)    |                              4/41.40                                           5/81.19                      | 
|POLY-3 PERCENT (g) |                              9.7%                                              6.2%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         3/42 (7%)                    | 
|FIRST INCIDENCE    |                              366                                               641                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.405N                                          P=0.405N                     | 
|POLY 3             |                              P=0.361N                                          P=0.325N                     | 
|POLY 1.5           |                              P=0.355N                                          P=0.319N                     | 
|POLY 6             |                              P=0.379N                                          P=0.346N                     | 
|LOGISTIC REGRESSION|                              P=0.380N                                          P=0.380N                     | 
|COCH-ARM / FISHERS |                              P=0.374N                                          P=0.363N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              25/53 (47%)                                       35/103 (34%)                 | 
|POLY-3 RATE (b)    |                              25/44.58                                          35/84.93                     | 
|POLY-3 PERCENT (g) |                              56.1%                                             41.2%                        | 
|TERMINAL (d)       |                              13/25 (52%)                                       19/42 (45%)                  | 
|FIRST INCIDENCE    |                              487                                               410                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.170N                                          P=0.170N                     | 
|POLY 3             |                              P=0.085N                                          P=0.061N                     | 
|POLY 1.5           |                              P=0.076N                                          P=0.053N                     | 
|POLY 6             |                              P=0.117N                                          P=0.091N                     | 
|LOGISTIC REGRESSION|                              P=0.045N*                                         P=0.045N*                    | 
|COCH-ARM / FISHERS |                              P=0.076N                                          P=0.077N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 36      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Artery                                                                                                                | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/2 (0%)                                          8/9 (89%)                    | 
|POLY-3 RATE (b)    |                              0/0.71                                            8/8.72                       | 
|POLY-3 PERCENT (g) |                              0.0%                                              91.8%                        | 
|TERMINAL (d)       |                              0/0 (0%)                                          3/3 (100%)                   | 
|FIRST INCIDENCE    |                              ---                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.133                                           P=0.133                      | 
|POLY 3             |                              P=0.421                                           P=0.121                      | 
|POLY 1.5           |                              P=0.330                                           P=0.069                      | 
|POLY 6             |                              P=0.533                                           P=0.178                      | 
|LOGISTIC REGRESSION|                              P=0.082                                           P=0.082                      | 
|COCH-ARM / FISHERS |                              P=0.047 *                                         P=0.055                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         5/103 (5%)                   | 
|POLY-3 RATE (b)    |                              2/40.42                                           5/81.09                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              6.2%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         4/42 (10%)                   | 
|FIRST INCIDENCE    |                              474                                               638                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.499                                           P=0.499                      | 
|POLY 3             |                              P=0.526                                           P=0.503                      | 
|POLY 1.5           |                              P=0.527                                           P=0.504                      | 
|POLY 6             |                              P=0.515                                           P=0.490                      | 
|LOGISTIC REGRESSION|                              P=0.557                                           P=0.557                      | 
|COCH-ARM / FISHERS |                              P=0.540                                           P=0.556                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 37      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Nasolacrimal Duct                                                                                                          | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         1/103 (1%)                   | 
|POLY-3 RATE (b)    |                              2/40.42                                           1/81.39                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              1.2%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/42 (0%)                    | 
|FIRST INCIDENCE    |                              366                                               520                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.275N                                          P=0.275N                     | 
|POLY 3             |                              P=0.258N                                          P=0.205N                     | 
|POLY 1.5           |                              P=0.258N                                          P=0.205N                     | 
|POLY 6             |                              P=0.261N                                          P=0.209N                     | 
|LOGISTIC REGRESSION|                              P=0.367N                                          P=0.367N                     | 
|COCH-ARM / FISHERS |                              P=0.277N                                          P=0.266N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Septum                                                                                                                     | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/103 (2%)                   | 
|POLY-3 RATE (b)    |                              0/39.55                                           2/81.09                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              2.5%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/42 (2%)                    | 
|FIRST INCIDENCE    |                              ---                                               638                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.380                                           P=0.380                      | 
|POLY 3             |                              P=0.374                                           P=0.315                      | 
|POLY 1.5           |                              P=0.372                                           P=0.314                      | 
|POLY 6             |                              P=0.371                                           P=0.312                      | 
|LOGISTIC REGRESSION|                              P=0.403                                           P=0.403                      | 
|COCH-ARM / FISHERS |                              P=0.394                                           P=0.434                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 38      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Turbinate, Septum                                                                                                          | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/103 (2%)                   | 
|POLY-3 RATE (b)    |                              0/39.55                                           2/81.64                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              2.5%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/42 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               561                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.418                                           P=0.418                      | 
|POLY 3             |                              P=0.375                                           P=0.316                      | 
|POLY 1.5           |                              P=0.373                                           P=0.314                      | 
|POLY 6             |                              P=0.373                                           P=0.314                      | 
|LOGISTIC REGRESSION|                              P=0.360                                           P=0.360                      | 
|COCH-ARM / FISHERS |                              P=0.394                                           P=0.434                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Mucosa: Gingival                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/2 (50%)                                         24/40 (60%)                  | 
|POLY-3 RATE (b)    |                              1/1.13                                            24/34.97                     | 
|POLY-3 PERCENT (g) |                              88.9%                                             68.6%                        | 
|TERMINAL (d)       |                              1/1 (100%)                                        8/11 (73%)                   | 
|FIRST INCIDENCE    |                              731 (T)                                           345                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.009 **                                        P=0.009 **                   | 
|POLY 3             |                              P=0.543N                                          P=0.377N                     | 
|POLY 1.5           |                              P=0.554N                                          P=0.453N                     | 
|POLY 6             |                              P=0.546N                                          P=0.346N                     | 
|LOGISTIC REGRESSION|                              P=0.780N                                          P=0.780N                     | 
|COCH-ARM / FISHERS |                              P=0.676                                           P=0.652                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 39      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              49/51 (96%)                                       76/102 (75%)                 | 
|POLY-3 RATE (b)    |                              49/50.31                                          76/95.94                     | 
|POLY-3 PERCENT (g) |                              97.4%                                             79.2%                        | 
|TERMINAL (d)       |                              24/25 (96%)                                       31/42 (74%)                  | 
|FIRST INCIDENCE    |                              169                                               345                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.142N                                          P=0.142N                     | 
|POLY 3             |                              P=0.003N**                                        P<0.001N**                   | 
|POLY 1.5           |                              P=0.003N**                                        P<0.001N**                   | 
|POLY 6             |                              P=0.005N**                                        P=0.002N**                   | 
|LOGISTIC REGRESSION|                              P<0.001N**                                        P<0.001N**                   | 
|COCH-ARM / FISHERS |                              P<0.001N**                                        P<0.001N**                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              14/51 (27%)                                       29/102 (28%)                 | 
|POLY-3 RATE (b)    |                              14/40.42                                          29/86.11                     | 
|POLY-3 PERCENT (g) |                              34.6%                                             33.7%                        | 
|TERMINAL (d)       |                              10/25 (40%)                                       12/42 (29%)                  | 
|FIRST INCIDENCE    |                              533                                               474                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.404                                           P=0.404                      | 
|POLY 3             |                              P=0.522N                                          P=0.510N                     | 
|POLY 1.5           |                              P=0.538N                                          P=0.530N                     | 
|POLY 6             |                              P=0.519N                                          P=0.507N                     | 
|LOGISTIC REGRESSION|                              P=0.567                                           P=0.567                      | 
|COCH-ARM / FISHERS |                              P=0.525                                           P=0.529                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 40      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oviduct                                                                                                                          | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/2 (100%)                                        3/3 (100%)                   | 
|POLY-3 RATE (b)    |                              2/2.00                                            3/3.00                       | 
|POLY-3 PERCENT (g) |                              100.0%                                            100.0%                       | 
|TERMINAL (d)       |                              1/1 (100%)                                        2/2 (100%)                   | 
|FIRST INCIDENCE    |                              717                                               643                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              (e)                                               (e)                          | 
|POLY 3             |                              (e)                                               (e)                          | 
|POLY 1.5           |                              (e)                                               (e)                          | 
|POLY 6             |                              (e)                                               (e)                          | 
|LOGISTIC REGRESSION|                              (e)                                               (e)                          | 
|COCH-ARM / FISHERS |                              (e)                                               (e)                          | 
|ORDER RESTRICTED   |                              (e)                                               (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/51 (0%)                                         10/100 (10%)                 | 
|POLY-3 RATE (b)    |                              0/38.86                                           10/80.56                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              12.4%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         5/42 (12%)                   | 
|FIRST INCIDENCE    |                              ---                                               581                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.021 *                                         P=0.021 *                    | 
|POLY 3             |                              P=0.036 *                                         P=0.019 *                    | 
|POLY 1.5           |                              P=0.035 *                                         P=0.019 *                    | 
|POLY 6             |                              P=0.034 *                                         P=0.018 *                    | 
|LOGISTIC REGRESSION|                              P=0.025 *                                         P=0.025 *                    | 
|COCH-ARM / FISHERS |                              P=0.023 *                                         P=0.014 *                    | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 41      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/51 (2%)                                         13/100 (13%)                 | 
|POLY-3 RATE (b)    |                              1/38.86                                           13/81.31                     | 
|POLY-3 PERCENT (g) |                              2.6%                                              16.0%                        | 
|TERMINAL (d)       |                              1/25 (4%)                                         6/42 (14%)                   | 
|FIRST INCIDENCE    |                              731 (T)                                           581                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.025 *                                         P=0.025 *                    | 
|POLY 3             |                              P=0.045 *                                         P=0.026 *                    | 
|POLY 1.5           |                              P=0.043 *                                         P=0.025 *                    | 
|POLY 6             |                              P=0.044 *                                         P=0.025 *                    | 
|LOGISTIC REGRESSION|                              P=0.030 *                                         P=0.030 *                    | 
|COCH-ARM / FISHERS |                              P=0.028 *                                         P=0.021 *                    | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/51 (4%)                                         0/100 (0%)                   | 
|POLY-3 RATE (b)    |                              2/39.17                                           0/78.62                      | 
|POLY-3 PERCENT (g) |                              5.1%                                              0.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/42 (0%)                    | 
|FIRST INCIDENCE    |                              646                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.129N                                          P=0.129N                     | 
|POLY 3             |                              P=0.105N                                          P=0.064N                     | 
|POLY 1.5           |                              P=0.105N                                          P=0.064N                     | 
|POLY 6             |                              P=0.107N                                          P=0.067N                     | 
|LOGISTIC REGRESSION|                              P=0.103N                                          P=0.103N                     | 
|COCH-ARM / FISHERS |                              P=0.107N                                          P=0.113N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 42      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/51 (2%)                                         42/100 (42%)                 | 
|POLY-3 RATE (b)    |                              1/39.16                                           42/84.91                     | 
|POLY-3 PERCENT (g) |                              2.6%                                              49.5%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         21/42 (50%)                  | 
|FIRST INCIDENCE    |                              648                                               546                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Artery                                                                                                                 | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/51 (0%)                                         9/100 (9%)                   | 
|POLY-3 RATE (b)    |                              0/38.86                                           9/80.84                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              11.1%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         5/42 (12%)                   | 
|FIRST INCIDENCE    |                              ---                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.029 *                                         P=0.029 *                    | 
|POLY 3             |                              P=0.048 *                                         P=0.027 *                    | 
|POLY 1.5           |                              P=0.048 *                                         P=0.027 *                    | 
|POLY 6             |                              P=0.046 *                                         P=0.026 *                    | 
|LOGISTIC REGRESSION|                              P=0.028 *                                         P=0.028 *                    | 
|COCH-ARM / FISHERS |                              P=0.032 *                                         P=0.022 *                    | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 43      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              25/53 (47%)                                       24/102 (24%)                 | 
|POLY-3 RATE (b)    |                              25/42.71                                          24/82.68                     | 
|POLY-3 PERCENT (g) |                              58.5%                                             29.0%                        | 
|TERMINAL (d)       |                              14/25 (56%)                                       12/42 (29%)                  | 
|FIRST INCIDENCE    |                              474                                               614                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.011N*                                         P=0.011N*                    | 
|POLY 3             |                              P=0.002N**                                        P<0.001N**                   | 
|POLY 1.5           |                              P=0.002N**                                        P<0.001N**                   | 
|POLY 6             |                              P=0.002N**                                        P<0.001N**                   | 
|LOGISTIC REGRESSION|                              P<0.001N**                                        P<0.001N**                   | 
|COCH-ARM / FISHERS |                              P=0.002N**                                        P=0.003N**                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         3/102 (3%)                   | 
|POLY-3 RATE (b)    |                              0/39.55                                           3/80.81                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              3.7%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         2/42 (5%)                    | 
|FIRST INCIDENCE    |                              ---                                               673                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.238                                           P=0.238                      | 
|POLY 3             |                              P=0.265                                           P=0.212                      | 
|POLY 1.5           |                              P=0.263                                           P=0.210                      | 
|POLY 6             |                              P=0.261                                           P=0.208                      | 
|LOGISTIC REGRESSION|                              P=0.265                                           P=0.265                      | 
|COCH-ARM / FISHERS |                              P=0.259                                           P=0.282                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 44      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              19/53 (36%)                                       37/102 (36%)                 | 
|POLY-3 RATE (b)    |                              19/43.37                                          37/87.40                     | 
|POLY-3 PERCENT (g) |                              43.8%                                             42.3%                        | 
|TERMINAL (d)       |                              11/25 (44%)                                       17/42 (41%)                  | 
|FIRST INCIDENCE    |                              487                                               578                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.472                                           P=0.472                      | 
|POLY 3             |                              P=0.498N                                          P=0.486N                     | 
|POLY 1.5           |                              P=0.507N                                          P=0.496N                     | 
|POLY 6             |                              P=0.507N                                          P=0.495N                     | 
|LOGISTIC REGRESSION|                              P=0.526N                                          P=0.526N                     | 
|COCH-ARM / FISHERS |                              P=0.549                                           P=0.551                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Intermedia                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         1/102 (1%)                   | 
|POLY-3 RATE (b)    |                              2/40.18                                           1/80.59                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              1.2%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         1/42 (2%)                    | 
|FIRST INCIDENCE    |                              526                                               731 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.296N                                          P=0.296N                     | 
|POLY 3             |                              P=0.258N                                          P=0.206N                     | 
|POLY 1.5           |                              P=0.259N                                          P=0.207N                     | 
|POLY 6             |                              P=0.263N                                          P=0.213N                     | 
|LOGISTIC REGRESSION|                              P=0.274N                                          P=0.274N                     | 
|COCH-ARM / FISHERS |                              P=0.280N                                          P=0.269N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 45      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/51 (0%)                                         2/101 (2%)                   | 
|POLY-3 RATE (b)    |                              0/38.56                                           2/79.29                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              2.5%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/42 (2%)                    | 
|FIRST INCIDENCE    |                              ---                                               702                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.378                                           P=0.378                      | 
|POLY 3             |                              P=0.374                                           P=0.313                      | 
|POLY 1.5           |                              P=0.375                                           P=0.314                      | 
|POLY 6             |                              P=0.369                                           P=0.309                      | 
|LOGISTIC REGRESSION|                              P=0.393                                           P=0.393                      | 
|COCH-ARM / FISHERS |                              P=0.398                                           P=0.440                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Cyst Epithelial Inclusion                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         2/103 (2%)                   | 
|POLY-3 RATE (b)    |                              1/39.55                                           2/80.99                      | 
|POLY-3 PERCENT (g) |                              2.5%                                              2.5%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         1/42 (2%)                    | 
|FIRST INCIDENCE    |                              731 (T)                                           668                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.688                                           P=0.688                      | 
|POLY 3             |                              P=0.670N                                          P=0.652N                     | 
|POLY 1.5           |                              P=0.671N                                          P=0.654N                     | 
|POLY 6             |                              P=0.674N                                          P=0.657N                     | 
|LOGISTIC REGRESSION|                              P=0.731                                           P=0.731                      | 
|COCH-ARM / FISHERS |                              P=0.723                                           P=0.715N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 46      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              46/51 (90%)                                       85/101 (84%)                 | 
|POLY-3 RATE (b)    |                              46/47.32                                          85/95.74                     | 
|POLY-3 PERCENT (g) |                              97.2%                                             88.8%                        | 
|TERMINAL (d)       |                              25/25 (100%)                                      41/42 (98%)                  | 
|FIRST INCIDENCE    |                              185                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.502                                           P=0.502                      | 
|POLY 3             |                              P=0.069N                                          P=0.043N*                    | 
|POLY 1.5           |                              P=0.099N                                          P=0.068N                     | 
|POLY 6             |                              P=0.058N                                          P=0.034N*                    | 
|LOGISTIC REGRESSION|                              P=0.123N                                          P=0.123N                     | 
|COCH-ARM / FISHERS |                              P=0.221N                                          P=0.224N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/51 (2%)                                         5/101 (5%)                   | 
|POLY-3 RATE (b)    |                              1/39.45                                           5/80.33                      | 
|POLY-3 PERCENT (g) |                              2.5%                                              6.2%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         2/42 (5%)                    | 
|FIRST INCIDENCE    |                              645                                               641                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.295                                           P=0.295                      | 
|POLY 3             |                              P=0.329                                           P=0.284                      | 
|POLY 1.5           |                              P=0.331                                           P=0.286                      | 
|POLY 6             |                              P=0.321                                           P=0.276                      | 
|LOGISTIC REGRESSION|                              P=0.332                                           P=0.332                      | 
|COCH-ARM / FISHERS |                              P=0.325                                           P=0.342                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 47      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              45/51 (88%)                                       89/101 (88%)                 | 
|POLY-3 RATE (b)    |                              45/49.73                                          89/95.56                     | 
|POLY-3 PERCENT (g) |                              90.5%                                             93.1%                        | 
|TERMINAL (d)       |                              23/25 (92%)                                       41/42 (98%)                  | 
|FIRST INCIDENCE    |                              169                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.319                                           P=0.319                      | 
|POLY 3             |                              P=0.381                                           P=0.347                      | 
|POLY 1.5           |                              P=0.461                                           P=0.436                      | 
|POLY 6             |                              P=0.299                                           P=0.256                      | 
|LOGISTIC REGRESSION|                              P=0.524N                                          P=0.524N                     | 
|COCH-ARM / FISHERS |                              P=0.597N                                          P=0.604                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/51 (8%)                                         2/101 (2%)                   | 
|POLY-3 RATE (b)    |                              4/42.10                                           2/80.28                      | 
|POLY-3 PERCENT (g) |                              9.5%                                              2.5%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/42 (0%)                    | 
|FIRST INCIDENCE    |                              169                                               520                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.095N                                          P=0.095N                     | 
|POLY 3             |                              P=0.111N                                          P=0.077N                     | 
|POLY 1.5           |                              P=0.108N                                          P=0.074N                     | 
|POLY 6             |                              P=0.118N                                          P=0.084N                     | 
|LOGISTIC REGRESSION|                              P=0.204N                                          P=0.204N                     | 
|COCH-ARM / FISHERS |                              P=0.095N                                          P=0.098N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 48      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Hyperkeratosis                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         4/103 (4%)                   | 
|POLY-3 RATE (b)    |                              1/40.16                                           4/82.30                      | 
|POLY-3 PERCENT (g) |                              2.5%                                              4.9%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/42 (2%)                    | 
|FIRST INCIDENCE    |                              533                                               520                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.447                                           P=0.447                      | 
|POLY 3             |                              P=0.424                                           P=0.384                      | 
|POLY 1.5           |                              P=0.422                                           P=0.382                      | 
|POLY 6             |                              P=0.418                                           P=0.379                      | 
|LOGISTIC REGRESSION|                              P=0.365                                           P=0.365                      | 
|COCH-ARM / FISHERS |                              P=0.424                                           P=0.446                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         16/103 (16%)                 | 
|POLY-3 RATE (b)    |                              3/39.67                                           16/85.58                     | 
|POLY-3 PERCENT (g) |                              7.6%                                              18.7%                        | 
|TERMINAL (d)       |                              2/25 (8%)                                         4/42 (10%)                   | 
|FIRST INCIDENCE    |                              701                                               474                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.068                                           P=0.068                      | 
|POLY 3             |                              P=0.109                                           P=0.077                      | 
|POLY 1.5           |                              P=0.100                                           P=0.070                      | 
|POLY 6             |                              P=0.115                                           P=0.081                      | 
|LOGISTIC REGRESSION|                              P=0.062                                           P=0.062                      | 
|COCH-ARM / FISHERS |                              P=0.063                                           P=0.058                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 49      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         9/103 (9%)                   | 
|POLY-3 RATE (b)    |                              1/40.42                                           9/84.35                      | 
|POLY-3 PERCENT (g) |                              2.5%                                              10.7%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/42 (2%)                    | 
|FIRST INCIDENCE    |                              366                                               474                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.112                                           P=0.112                      | 
|POLY 3             |                              P=0.127                                           P=0.091                      | 
|POLY 1.5           |                              P=0.123                                           P=0.088                      | 
|POLY 6             |                              P=0.127                                           P=0.091                      | 
|LOGISTIC REGRESSION|                              P=0.054                                           P=0.054                      | 
|COCH-ARM / FISHERS |                              P=0.095                                           P=0.089                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         8/103 (8%)                   | 
|POLY-3 RATE (b)    |                              2/40.54                                           8/84.00                      | 
|POLY-3 PERCENT (g) |                              4.9%                                              9.5%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/42 (2%)                    | 
|FIRST INCIDENCE    |                              366                                               474                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.285                                           P=0.285                      | 
|POLY 3             |                              P=0.301                                           P=0.260                      | 
|POLY 1.5           |                              P=0.295                                           P=0.255                      | 
|POLY 6             |                              P=0.299                                           P=0.258                      | 
|LOGISTIC REGRESSION|                              P=0.190                                           P=0.190                      | 
|COCH-ARM / FISHERS |                              P=0.268                                           P=0.276                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 50      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         0/103 (0%)                   | 
|POLY-3 RATE (b)    |                              3/41.09                                           0/80.75                      | 
|POLY-3 PERCENT (g) |                              7.3%                                              0.0%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/42 (0%)                    | 
|FIRST INCIDENCE    |                              169                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.039N*                                         P=0.039N*                    | 
|POLY 3             |                              P=0.038N*                                         P=0.019N*                    | 
|POLY 1.5           |                              P=0.038N*                                         P=0.019N*                    | 
|POLY 6             |                              P=0.039N*                                         P=0.021N*                    | 
|LOGISTIC REGRESSION|                              P=0.069N                                          P=0.069N                     | 
|COCH-ARM / FISHERS |                              P=0.034N*                                         P=0.038N*                    | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/103 (2%)                   | 
|POLY-3 RATE (b)    |                              0/39.55                                           2/81.34                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              2.5%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/42 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               604                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.399                                           P=0.399                      | 
|POLY 3             |                              P=0.375                                           P=0.315                      | 
|POLY 1.5           |                              P=0.373                                           P=0.314                      | 
|POLY 6             |                              P=0.372                                           P=0.313                      | 
|LOGISTIC REGRESSION|                              P=0.391                                           P=0.391                      | 
|COCH-ARM / FISHERS |                              P=0.394                                           P=0.434                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 51      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              36/51 (71%)                                       87/91 (96%)                  | 
|POLY-3 RATE (b)    |                              36/45.37                                          87/88.27                     | 
|POLY-3 PERCENT (g) |                              79.3%                                             98.6%                        | 
|TERMINAL (d)       |                              20/25 (80%)                                       39/39 (100%)                 | 
|FIRST INCIDENCE    |                              169                                               396                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.020 *                                         P=0.020 *                    | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              19/52 (37%)                                       38/101 (38%)                 | 
|POLY-3 RATE (b)    |                              19/40.39                                          38/87.81                     | 
|POLY-3 PERCENT (g) |                              47.0%                                             43.3%                        | 
|TERMINAL (d)       |                              12/25 (48%)                                       15/42 (36%)                  | 
|FIRST INCIDENCE    |                              646                                               396                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.420                                           P=0.420                      | 
|POLY 3             |                              P=0.416N                                          P=0.392N                     | 
|POLY 1.5           |                              P=0.466N                                          P=0.449N                     | 
|POLY 6             |                              P=0.392N                                          P=0.366N                     | 
|LOGISTIC REGRESSION|                              P=0.558N                                          P=0.558N                     | 
|COCH-ARM / FISHERS |                              P=0.518                                           P=0.520                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 52      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/52 (4%)                                         0/101 (0%)                   | 
|POLY-3 RATE (b)    |                              2/38.90                                           0/79.18                      | 
|POLY-3 PERCENT (g) |                              5.1%                                              0.0%                         | 
|TERMINAL (d)       |                              2/25 (8%)                                         0/42 (0%)                    | 
|FIRST INCIDENCE    |                              731 (T)                                           ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.133N                                          P=0.133N                     | 
|POLY 3             |                              P=0.104N                                          P=0.063N                     | 
|POLY 1.5           |                              P=0.104N                                          P=0.064N                     | 
|POLY 6             |                              P=0.105N                                          P=0.065N                     | 
|LOGISTIC REGRESSION|                              P=0.133N                                          (e)                          | 
|COCH-ARM / FISHERS |                              P=0.109N                                          P=0.114N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/52 (6%)                                         23/101 (23%)                 | 
|POLY-3 RATE (b)    |                              3/39.78                                           23/83.83                     | 
|POLY-3 PERCENT (g) |                              7.5%                                              27.4%                        | 
|TERMINAL (d)       |                              2/25 (8%)                                         12/42 (29%)                  | 
|FIRST INCIDENCE    |                              361                                               396                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.007 **                                        P=0.007 **                   | 
|POLY 3             |                              P=0.017 *                                         P=0.008 **                   | 
|POLY 1.5           |                              P=0.016 *                                         P=0.007 **                   | 
|POLY 6             |                              P=0.016 *                                         P=0.008 **                   | 
|LOGISTIC REGRESSION|                              P=0.008 **                                        P=0.008 **                   | 
|COCH-ARM / FISHERS |                              P=0.008 **                                        P=0.005 **                   | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 53      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth: Peridontal Tissue                                                                                                         | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              15/16 (94%)                                       30/30 (100%)                 | 
|POLY-3 RATE (b)    |                              15/15.64                                          30/30.00                     | 
|POLY-3 PERCENT (g) |                              95.9%                                             100.0%                       | 
|TERMINAL (d)       |                              9/9 (100%)                                        13/13 (100%)                 | 
|FIRST INCIDENCE    |                              185                                               345                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.292                                           P=0.292                      | 
|POLY 3             |                              P=0.494                                           P=0.400                      | 
|POLY 1.5           |                              P=0.399                                           P=0.319                      | 
|POLY 6             |                              P=0.745                                           P=0.639                      | 
|LOGISTIC REGRESSION|                              P=0.374                                           P=0.374                      | 
|COCH-ARM / FISHERS |                              P=0.373                                           P=0.348                      | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              6/52 (12%)                                        5/103 (5%)                   | 
|POLY-3 RATE (b)    |                              6/39.16                                           5/81.24                      | 
|POLY-3 PERCENT (g) |                              15.3%                                             6.2%                         | 
|TERMINAL (d)       |                              4/25 (16%)                                        2/42 (5%)                    | 
|FIRST INCIDENCE    |                              697                                               645                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.162N                                          P=0.162N                     | 
|POLY 3             |                              P=0.114N                                          P=0.079N                     | 
|POLY 1.5           |                              P=0.116N                                          P=0.081N                     | 
|POLY 6             |                              P=0.117N                                          P=0.083N                     | 
|LOGISTIC REGRESSION|                              P=0.112N                                          P=0.112N                     | 
|COCH-ARM / FISHERS |                              P=0.115N                                          P=0.117N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 54      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder: Transitional Epithelium                                                                                         | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/52 (2%)                                         2/103 (2%)                   | 
|POLY-3 RATE (b)    |                              1/38.97                                           2/80.87                      | 
|POLY-3 PERCENT (g) |                              2.6%                                              2.5%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         1/42 (2%)                    | 
|FIRST INCIDENCE    |                              731 (T)                                           701                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.693                                           P=0.693                      | 
|POLY 3             |                              P=0.666N                                          P=0.647N                     | 
|POLY 1.5           |                              P=0.666N                                          P=0.648N                     | 
|POLY 6             |                              P=0.672N                                          P=0.654N                     | 
|LOGISTIC REGRESSION|                              P=0.722                                           P=0.722                      | 
|COCH-ARM / FISHERS |                              P=0.729                                           P=0.709N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              7/52 (13%)                                        14/103 (14%)                 | 
|POLY-3 RATE (b)    |                              7/40.38                                           14/84.16                     | 
|POLY-3 PERCENT (g) |                              17.3%                                             16.6%                        | 
|TERMINAL (d)       |                              4/25 (16%)                                        5/42 (12%)                   | 
|FIRST INCIDENCE    |                              185                                               484                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.521                                           P=0.521                      | 
|POLY 3             |                              P=0.540N                                          P=0.528N                     | 
|POLY 1.5           |                              P=0.549N                                          P=0.538N                     | 
|POLY 6             |                              P=0.545N                                          P=0.533N                     | 
|LOGISTIC REGRESSION|                              P=0.586                                           P=0.586                      | 
|COCH-ARM / FISHERS |                              P=0.589                                           P=0.599N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 55      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              29/52 (56%)                                       50/103 (49%)                 | 
|POLY-3 RATE (b)    |                              29/45.30                                          50/91.58                     | 
|POLY-3 PERCENT (g) |                              64.0%                                             54.6%                        | 
|TERMINAL (d)       |                              15/25 (60%)                                       23/42 (55%)                  | 
|FIRST INCIDENCE    |                              351                                               394                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.424N                                          P=0.424N                     | 
|POLY 3             |                              P=0.204N                                          P=0.169N                     | 
|POLY 1.5           |                              P=0.211N                                          P=0.176N                     | 
|POLY 6             |                              P=0.211N                                          P=0.176N                     | 
|LOGISTIC REGRESSION|                              P=0.223N                                          P=0.223N                     | 
|COCH-ARM / FISHERS |                              P=0.248N                                          P=0.249N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100                          | 
|                   |                                                                                NG/KG                        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              30/52 (58%)                                       51/103 (50%)                 | 
|POLY-3 RATE (b)    |                              30/44.70                                          51/87.17                     | 
|POLY-3 PERCENT (g) |                              67.1%                                             58.5%                        | 
|TERMINAL (d)       |                              15/25 (60%)                                       28/42 (67%)                  | 
|FIRST INCIDENCE    |                              361                                               474                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.432N                                          P=0.432N                     | 
|POLY 3             |                              P=0.223N                                          P=0.189N                     | 
|POLY 1.5           |                              P=0.198N                                          P=0.164N                     | 
|POLY 6             |                              P=0.306N                                          P=0.276N                     | 
|LOGISTIC REGRESSION|                              P=0.128N                                          P=0.128N                     | 
|COCH-ARM / FISHERS |                              P=0.214N                                          P=0.214N                     | 
|ORDER RESTRICTED   |                              P<0.001 **                                        (e)                          | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
                                                                                                                                   
(d)  Observed incidence at terminal kill.                                                                                           
(f)  Beneath the control incidence are the P-values associated with the trend                                                       
test.  Beneath the dosed group incidence are the P-values corresponding to                                                          
pairwise comparisons between the controls and that dosed group.  The life                                                           
table analysis regards tumors in animals dying prior to  terminal kill as                                                           
 being (directly or indirectly) the cause of death.                                                                                 
Logistic regression is an alternative                                                                                               
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage                                                       
and Fishers exact tests compare directly the overall incidence rates                                                                
For all tests a negative trend is indicated by N                                                                                    
(e)  Value of Statistic cannot be computed.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(I)  Interim sacrifice                                                                                                              
(T)  Terminal sacrifice                                                                                                             
#   Tumor rates based on number of animals necropsied.                                                                              
*   To the right of any statistical result, indicates significance at (P<=0.05).                                                    
**  To the right of any statistical result, indicates significance at (P<=0.01).                                                    
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.