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TDMS Study 96007-03 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 03                                                                                     TIME: 08:58:59       
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       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                   FINAL # 3 RATS CONTROL VS STOP                                                   
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 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: 09/30/03       
EXPERIMENT: 96007 TEST: 03                                                                                     TIME: 08:58:59       
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                                                                                  
Clitoral Gland                         Inflammation                                                                                 
Clitoral Gland: Duct                   Cyst                                                                                         
Eye: Retina                            Atrophy                                                                                      
Harderian Gland                        Inflammation                                                                                 
Heart                                  Cardiomyopathy                                                                               
Heart: Atrium                          Thrombosis                                                                                   
Intestine Large, Rectum                Parasite Metazoan                                                                            
Kidney                                 Accumulation, Hyaline Droplet                                                                
                                       Casts Protein                                                                                
                                       Cyst                                                                                         
                                       Inflammation Chronic                                                                         
                                       Mineralization                                                                               
                                       Nephropathy                                                                                  
Kidney: Pelvis                         Dilatation                                                                                   
                                       Inflammation                                                                                 
Kidney: Transitional Epithelium        Hyperplasia                                                                                  
Liver                                  Angiectasis                                                                                  
                                       Basophilic Focus                                                                             
                                       Clear Cell Focus                                                                             
                                       Congestion                                                                                   
                                       Eosinophilic Focus                                                                           
                                       Fatty Change Diffuse                                                                         
                                       Fatty Change Focal                                                                           
                                       Hematopoietic Cell Proliferation                                                             
                                       Inflammation                                                                                 
                                       Mixed Cell Focus                                                                             
                                       Necrosis                                                                                     
                                       Pigmentation                                                                                 
                                       Toxic Hepatopathy                                                                            
Liver: Bile Duct                       Cyst                                                                                         
                                       Fibrosis                                                                                     
                                       Hyperplasia                                                                                  
Liver: Centrilobular                   Degeneration                                                                                 
Liver: Hepatocyte                      Hypertrophy                                                                                  
                                       Multinucleated                                                                               
Lung                                   Infiltration Cellular Histiocyte                                                             
                                       Inflammation Granulomatous                                                                   
                                       Metaplasia                                                                                   
Lung: Alveolar Epithelium              Hyperplasia                                                                                  
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 03                                                                                     TIME: 08:58:59       
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       
                                       Metaplasia Bronchiolar                                                                       
Lymph Node, Mandibular                 Ectasia                                                                                      
                                       Hyperplasia                                                                                  
                                       Hyperplasia Lymphoid                                                                         
Lymph Node: Lumbar                     Ectasia                                                                                      
                                       Hyperplasia                                                                                  
Mammary Gland                          Cyst                                                                                         
                                       Hyperplasia                                                                                  
Nose                                   Inflammation                                                                                 
Nose: Nasolacrimal Duct                Inflammation                                                                                 
Oral Mucosa: Gingival                  Hyperplasia                                                                                  
Ovary                                  Atrophy                                                                                      
                                       Cyst                                                                                         
Pancreas                               Inflammation Chronic                                                                         
Pancreas: Acinus                       Atrophy                                                                                      
                                       Hyperplasia                                                                                  
Pancreas: Artery                       Inflammation Chronic                                                                         
Pituitary Gland                        Angiectasis                                                                                  
                                       Vacuolization Cytoplasmic                                                                    
Pituitary Gland: Pars Distalis         Hyperplasia                                                                                  
Pituitary Gland: Pars Intermedia       Hyperplasia                                                                                  
Salivary Glands                        Atrophy                                                                                      
Spleen                                 Hematopoietic Cell Proliferation                                                             
                                       Pigmentation                                                                                 
Spleen: Lymphoid Follicle              Atrophy                                                                                      
Stomach, Forestomach                   Hyperplasia                                                                                  
                                       Inflammation                                                                                 
                                       Ulcer                                                                                        
Stomach, Glandular                     Mineralization                                                                               
Thymus                                 Atrophy                                                                                      
Thyroid Gland: C-Cell                  Hyperplasia                                                                                  
Thyroid Gland: Follicular Cell         Hyperplasia                                                                                  
                                       Hypertrophy                                                                                  
Tooth: Peridontal Tissue               Inflammation                                                                                 
Urinary Bladder                        Inflammation                                                                                 
Uterus                                 Inflammation                                                                                 
                                       Metaplasia                                                                                   
Uterus: Endometrium                    Hyperplasia Cystic                                                                           
===============================================================                                                                     
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              11/53 (21%)                                       15/50 (30%)                  | 
|POLY-3 RATE (b)    |                              11/40.84                                          15/38.86                     | 
|POLY-3 PERCENT (g) |                              26.9%                                             38.6%                        | 
|TERMINAL (d)       |                              6/25 (24%)                                        10/21 (48%)                  | 
|FIRST INCIDENCE    |                              645                                               641                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.146                      | 
|POLY 3             |                                                                                P=0.188                      | 
|POLY 1.5           |                                                                                P=0.201                      | 
|POLY 6             |                                                                                P=0.164                      | 
|LOGISTIC REGRESSION|                                                                                P=0.192                      | 
|COCH-ARM / FISHERS |                                                                                P=0.197                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              2/39.86                                           4/38.66                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              10.4%                        | 
|TERMINAL (d)       |                              1/25 (4%)                                         3/21 (14%)                   | 
|FIRST INCIDENCE    |                              646                                               578                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.277                      | 
|POLY 3             |                                                                                P=0.324                      | 
|POLY 1.5           |                                                                                P=0.324                      | 
|POLY 6             |                                                                                P=0.320                      | 
|LOGISTIC REGRESSION|                                                                                P=0.318                      | 
|COCH-ARM / FISHERS |                                                                                P=0.312                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              11/53 (21%)                                       17/50 (34%)                  | 
|POLY-3 RATE (b)    |                              11/41.19                                          17/40.19                     | 
|POLY-3 PERCENT (g) |                              26.7%                                             42.3%                        | 
|TERMINAL (d)       |                              4/25 (16%)                                        10/21 (48%)                  | 
|FIRST INCIDENCE    |                              646                                               474                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.086                      | 
|POLY 3             |                                                                                P=0.101                      | 
|POLY 1.5           |                                                                                P=0.105                      | 
|POLY 6             |                                                                                P=0.089                      | 
|LOGISTIC REGRESSION|                                                                                P=0.104                      | 
|COCH-ARM / FISHERS |                                                                                P=0.099                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              16/53 (30%)                                       20/50 (40%)                  | 
|POLY-3 RATE (b)    |                              16/41.46                                          20/40.70                     | 
|POLY-3 PERCENT (g) |                              38.6%                                             49.1%                        | 
|TERMINAL (d)       |                              10/25 (40%)                                       11/21 (52%)                  | 
|FIRST INCIDENCE    |                              487                                               578                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.155                      | 
|POLY 3             |                                                                                P=0.223                      | 
|POLY 1.5           |                                                                                P=0.222                      | 
|POLY 6             |                                                                                P=0.219                      | 
|LOGISTIC REGRESSION|                                                                                P=0.214                      | 
|COCH-ARM / FISHERS |                                                                                P=0.201                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              41/53 (77%)                                       46/50 (92%)                  | 
|POLY-3 RATE (b)    |                              41/44.21                                          46/48.07                     | 
|POLY-3 PERCENT (g) |                              92.8%                                             95.7%                        | 
|TERMINAL (d)       |                              25/25 (100%)                                      21/21 (100%)                 | 
|FIRST INCIDENCE    |                              474                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.076                      | 
|POLY 3             |                                                                                P=0.404                      | 
|POLY 1.5           |                                                                                P=0.181                      | 
|POLY 6             |                                                                                P=0.769                      | 
|LOGISTIC REGRESSION|                                                                                P=0.038 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.036 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              0/39.55                                           3/39.47                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              7.6%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/21 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               578                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.119                      | 
|POLY 3             |                                                                                P=0.117                      | 
|POLY 1.5           |                                                                                P=0.116                      | 
|POLY 6             |                                                                                P=0.119                      | 
|LOGISTIC REGRESSION|                                                                                P=0.103                      | 
|COCH-ARM / FISHERS |                                                                                P=0.111                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              11/53 (21%)                                       13/50 (26%)                  | 
|POLY-3 RATE (b)    |                              11/40.73                                          13/40.76                     | 
|POLY-3 PERCENT (g) |                              27.0%                                             31.9%                        | 
|TERMINAL (d)       |                              9/25 (36%)                                        6/21 (29%)                   | 
|FIRST INCIDENCE    |                              366                                               345                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.275                      | 
|POLY 3             |                                                                                P=0.404                      | 
|POLY 1.5           |                                                                                P=0.387                      | 
|POLY 6             |                                                                                P=0.424                      | 
|LOGISTIC REGRESSION|                                                                                P=0.364                      | 
|COCH-ARM / FISHERS |                                                                                P=0.346                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              19/53 (36%)                                       15/50 (30%)                  | 
|POLY-3 RATE (b)    |                              19/41.29                                          15/39.68                     | 
|POLY-3 PERCENT (g) |                              46.0%                                             37.8%                        | 
|TERMINAL (d)       |                              11/25 (44%)                                       9/21 (43%)                   | 
|FIRST INCIDENCE    |                              487                                               578                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.429N                     | 
|POLY 3             |                                                                                P=0.297N                     | 
|POLY 1.5           |                                                                                P=0.302N                     | 
|POLY 6             |                                                                                P=0.305N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.303N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.337N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              36/53 (68%)                                       36/50 (72%)                  | 
|POLY-3 RATE (b)    |                              36/52.64                                          36/49.61                     | 
|POLY-3 PERCENT (g) |                              68.4%                                             72.6%                        | 
|TERMINAL (d)       |                              9/25 (36%)                                        9/21 (43%)                   | 
|FIRST INCIDENCE    |                              169                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.411                      | 
|POLY 3             |                                                                                P=0.405                      | 
|POLY 1.5           |                                                                                P=0.408                      | 
|POLY 6             |                                                                                P=0.399                      | 
|LOGISTIC REGRESSION|                                                                                P=0.396                      | 
|COCH-ARM / FISHERS |                                                                                P=0.407                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              41/50 (82%)                                       35/49 (71%)                  | 
|POLY-3 RATE (b)    |                              41/46.36                                          35/46.06                     | 
|POLY-3 PERCENT (g) |                              88.4%                                             76.0%                        | 
|TERMINAL (d)       |                              22/25 (88%)                                       15/21 (71%)                  | 
|FIRST INCIDENCE    |                              169                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.445N                     | 
|POLY 3             |                                                                                P=0.080N                     | 
|POLY 1.5           |                                                                                P=0.094N                     | 
|POLY 6             |                                                                                P=0.091N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.150N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.157N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland: Duct                                                                                                             | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              34/50 (68%)                                       35/49 (71%)                  | 
|POLY-3 RATE (b)    |                              34/44.15                                          35/46.42                     | 
|POLY-3 PERCENT (g) |                              77.0%                                             75.4%                        | 
|TERMINAL (d)       |                              19/25 (76%)                                       14/21 (67%)                  | 
|FIRST INCIDENCE    |                              169                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.287                      | 
|POLY 3             |                                                                                P=0.525N                     | 
|POLY 1.5           |                                                                                P=0.575N                     | 
|POLY 6             |                                                                                P=0.502N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.467                      | 
|COCH-ARM / FISHERS |                                                                                P=0.440                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Retina                                                                                                                      | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         6/50 (12%)                   | 
|POLY-3 RATE (b)    |                              5/39.55                                           6/38.82                      | 
|POLY-3 PERCENT (g) |                              12.6%                                             15.5%                        | 
|TERMINAL (d)       |                              5/25 (20%)                                        2/21 (10%)                   | 
|FIRST INCIDENCE    |                              731 (T)                                           645                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.403                      | 
|POLY 3             |                                                                                P=0.488                      | 
|POLY 1.5           |                                                                                P=0.482                      | 
|POLY 6             |                                                                                P=0.492                      | 
|LOGISTIC REGRESSION|                                                                                P=0.463                      | 
|COCH-ARM / FISHERS |                                                                                P=0.459                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              12/53 (23%)                                       9/50 (18%)                   | 
|POLY-3 RATE (b)    |                              12/42.07                                          9/39.34                      | 
|POLY-3 PERCENT (g) |                              28.5%                                             22.9%                        | 
|TERMINAL (d)       |                              6/25 (24%)                                        5/21 (24%)                   | 
|FIRST INCIDENCE    |                              366                                               629                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.443N                     | 
|POLY 3             |                                                                                P=0.373N                     | 
|POLY 1.5           |                                                                                P=0.365N                     | 
|POLY 6             |                                                                                P=0.388N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.349N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.368N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              10/53 (19%)                                       22/50 (44%)                  | 
|POLY-3 RATE (b)    |                              10/41.81                                          22/41.80                     | 
|POLY-3 PERCENT (g) |                              23.9%                                             52.6%                        | 
|TERMINAL (d)       |                              6/25 (24%)                                        9/21 (43%)                   | 
|FIRST INCIDENCE    |                              169                                               520                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.007 **                   | 
|POLY 3             |                                                                                P=0.004 **                   | 
|POLY 1.5           |                                                                                P=0.004 **                   | 
|POLY 6             |                                                                                P=0.005 **                   | 
|LOGISTIC REGRESSION|                                                                                P=0.006 **                   | 
|COCH-ARM / FISHERS |                                                                                P=0.005 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart: Atrium                                                                                                                    | 
|     Thrombosis                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/39.55                                           2/38.98                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.1%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/21 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               484                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.241                      | 
|POLY 3             |                                                                                P=0.235                      | 
|POLY 1.5           |                                                                                P=0.234                      | 
|POLY 6             |                                                                                P=0.235                      | 
|LOGISTIC REGRESSION|                                                                                P=0.213                      | 
|COCH-ARM / FISHERS |                                                                                P=0.233                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Rectum                                                                                                          | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              6/52 (12%)                                        5/50 (10%)                   | 
|POLY-3 RATE (b)    |                              6/39.78                                           5/38.80                      | 
|POLY-3 PERCENT (g) |                              15.1%                                             12.9%                        | 
|TERMINAL (d)       |                              2/25 (8%)                                         3/21 (14%)                   | 
|FIRST INCIDENCE    |                              645                                               641                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.587N                     | 
|POLY 3             |                                                                                P=0.519N                     | 
|POLY 1.5           |                                                                                P=0.515N                     | 
|POLY 6             |                                                                                P=0.534N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.518N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.528N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Accumulation, Hyaline Droplet                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/39.55                                           2/39.00                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.1%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/21 (5%)                    | 
|FIRST INCIDENCE    |                              ---                                               394                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.221                      | 
|POLY 3             |                                                                                P=0.235                      | 
|POLY 1.5           |                                                                                P=0.234                      | 
|POLY 6             |                                                                                P=0.234                      | 
|LOGISTIC REGRESSION|                                                                                P=0.204                      | 
|COCH-ARM / FISHERS |                                                                                P=0.233                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Casts Protein                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              3/40.58                                           1/38.66                      | 
|POLY-3 PERCENT (g) |                              7.4%                                              2.6%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/21 (0%)                    | 
|FIRST INCIDENCE    |                              512                                               578                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.319N                     | 
|POLY 3             |                                                                                P=0.326N                     | 
|POLY 1.5           |                                                                                P=0.324N                     | 
|POLY 6             |                                                                                P=0.334N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.335N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.331N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/39.90                                           0/38.16                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              0.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/21 (0%)                    | 
|FIRST INCIDENCE    |                              631                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.271N                     | 
|POLY 3             |                                                                                P=0.252N                     | 
|POLY 1.5           |                                                                                P=0.250N                     | 
|POLY 6             |                                                                                P=0.257N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.246N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.262N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              5/40.43                                           0/38.16                      | 
|POLY-3 PERCENT (g) |                              12.4%                                             0.0%                         | 
|TERMINAL (d)       |                              4/25 (16%)                                        0/21 (0%)                    | 
|FIRST INCIDENCE    |                              361                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.047N*                    | 
|POLY 3             |                                                                                P=0.036N*                    | 
|POLY 1.5           |                                                                                P=0.035N*                    | 
|POLY 6             |                                                                                P=0.037N*                    | 
|LOGISTIC REGRESSION|                                                                                P=0.038N*                    | 
|COCH-ARM / FISHERS |                                                                                P=0.033N*                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              40/53 (75%)                                       42/50 (84%)                  | 
|POLY-3 RATE (b)    |                              40/47.18                                          42/46.21                     | 
|POLY-3 PERCENT (g) |                              84.8%                                             90.9%                        | 
|TERMINAL (d)       |                              22/25 (88%)                                       19/21 (91%)                  | 
|FIRST INCIDENCE    |                              169                                               394                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.202                      | 
|POLY 3             |                                                                                P=0.256                      | 
|POLY 1.5           |                                                                                P=0.207                      | 
|POLY 6             |                                                                                P=0.358                      | 
|LOGISTIC REGRESSION|                                                                                P=0.247                      | 
|COCH-ARM / FISHERS |                                                                                P=0.204                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              34/53 (64%)                                       41/50 (82%)                  | 
|POLY-3 RATE (b)    |                              34/45.60                                          41/45.19                     | 
|POLY-3 PERCENT (g) |                              74.6%                                             90.7%                        | 
|TERMINAL (d)       |                              21/25 (84%)                                       20/21 (95%)                  | 
|FIRST INCIDENCE    |                              169                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.047 *                    | 
|POLY 3             |                                                                                P=0.023 *                    | 
|POLY 1.5           |                                                                                P=0.024 *                    | 
|POLY 6             |                                                                                P=0.028 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.041 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.034 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              2/40.16                                           1/38.87                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              2.6%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/21 (0%)                    | 
|FIRST INCIDENCE    |                              533                                               484                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.520N                     | 
|POLY 3             |                                                                                P=0.515N                     | 
|POLY 1.5           |                                                                                P=0.515N                     | 
|POLY 6             |                                                                                P=0.520N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.542N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.522N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/39.55                                           0/38.16                      | 
|POLY-3 PERCENT (g) |                              5.1%                                              0.0%                         | 
|TERMINAL (d)       |                              2/25 (8%)                                         0/21 (0%)                    | 
|FIRST INCIDENCE    |                              731 (T)                                           ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.277N                     | 
|POLY 3             |                                                                                P=0.248N                     | 
|POLY 1.5           |                                                                                P=0.249N                     | 
|POLY 6             |                                                                                P=0.251N                     | 
|LOGISTIC REGRESSION|                                                                                (e)                          | 
|COCH-ARM / FISHERS |                                                                                P=0.262N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Transitional Epithelium                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         5/50 (10%)                   | 
|POLY-3 RATE (b)    |                              3/40.54                                           5/39.18                      | 
|POLY-3 PERCENT (g) |                              7.4%                                              12.8%                        | 
|TERMINAL (d)       |                              2/25 (8%)                                         1/21 (5%)                    | 
|FIRST INCIDENCE    |                              169                                               584                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.318                      | 
|POLY 3             |                                                                                P=0.338                      | 
|POLY 1.5           |                                                                                P=0.335                      | 
|POLY 6             |                                                                                P=0.341                      | 
|LOGISTIC REGRESSION|                                                                                P=0.316                      | 
|COCH-ARM / FISHERS |                                                                                P=0.325                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              2/39.55                                           4/38.16                      | 
|POLY-3 PERCENT (g) |                              5.1%                                              10.5%                        | 
|TERMINAL (d)       |                              2/25 (8%)                                         4/21 (19%)                   | 
|FIRST INCIDENCE    |                              731 (T)                                           731 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.254                      | 
|POLY 3             |                                                                                P=0.322                      | 
|POLY 1.5           |                                                                                P=0.323                      | 
|POLY 6             |                                                                                P=0.317                      | 
|LOGISTIC REGRESSION|                                                                                P=0.254                      | 
|COCH-ARM / FISHERS |                                                                                P=0.312                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              12/53 (23%)                                       16/50 (32%)                  | 
|POLY-3 RATE (b)    |                              12/42.33                                          16/39.93                     | 
|POLY-3 PERCENT (g) |                              28.4%                                             40.1%                        | 
|TERMINAL (d)       |                              4/25 (16%)                                        7/21 (33%)                   | 
|FIRST INCIDENCE    |                              492                                               520                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.183                      | 
|POLY 3             |                                                                                P=0.184                      | 
|POLY 1.5           |                                                                                P=0.199                      | 
|POLY 6             |                                                                                P=0.162                      | 
|LOGISTIC REGRESSION|                                                                                P=0.213                      | 
|COCH-ARM / FISHERS |                                                                                P=0.199                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Clear Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         8/50 (16%)                   | 
|POLY-3 RATE (b)    |                              5/40.18                                           8/38.16                      | 
|POLY-3 PERCENT (g) |                              12.4%                                             21.0%                        | 
|TERMINAL (d)       |                              3/25 (12%)                                        8/21 (38%)                   | 
|FIRST INCIDENCE    |                              548                                               731 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.180                      | 
|POLY 3             |                                                                                P=0.240                      | 
|POLY 1.5           |                                                                                P=0.247                      | 
|POLY 6             |                                                                                P=0.225                      | 
|LOGISTIC REGRESSION|                                                                                P=0.236                      | 
|COCH-ARM / FISHERS |                                                                                P=0.240                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Congestion                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/39.85                                           0/38.16                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              0.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/21 (0%)                    | 
|FIRST INCIDENCE    |                              648                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.269N                     | 
|POLY 3             |                                                                                P=0.251N                     | 
|POLY 1.5           |                                                                                P=0.250N                     | 
|POLY 6             |                                                                                P=0.257N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.246N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.262N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              11/53 (21%)                                       27/50 (54%)                  | 
|POLY-3 RATE (b)    |                              11/40.67                                          27/43.77                     | 
|POLY-3 PERCENT (g) |                              27.1%                                             61.7%                        | 
|TERMINAL (d)       |                              6/25 (24%)                                        12/21 (57%)                  | 
|FIRST INCIDENCE    |                              645                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Diffuse                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         10/50 (20%)                  | 
|POLY-3 RATE (b)    |                              0/39.55                                           10/40.49                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              24.7%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         3/21 (14%)                   | 
|FIRST INCIDENCE    |                              ---                                               520                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         8/50 (16%)                   | 
|POLY-3 RATE (b)    |                              2/39.69                                           8/38.49                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              20.8%                        | 
|TERMINAL (d)       |                              1/25 (4%)                                         6/21 (29%)                   | 
|FIRST INCIDENCE    |                              694                                               645                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.028 *                    | 
|POLY 3             |                                                                                P=0.038 *                    | 
|POLY 1.5           |                                                                                P=0.039 *                    | 
|POLY 6             |                                                                                P=0.035 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.036 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.037 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              1/39.86                                           2/38.27                      | 
|POLY-3 PERCENT (g) |                              2.5%                                              5.2%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/21 (5%)                    | 
|FIRST INCIDENCE    |                              646                                               702                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.464                      | 
|POLY 3             |                                                                                P=0.490                      | 
|POLY 1.5           |                                                                                P=0.491                      | 
|POLY 6             |                                                                                P=0.487                      | 
|LOGISTIC REGRESSION|                                                                                P=0.486                      | 
|COCH-ARM / FISHERS |                                                                                P=0.478                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              33/53 (62%)                                       43/50 (86%)                  | 
|POLY-3 RATE (b)    |                              33/47.21                                          43/46.89                     | 
|POLY-3 PERCENT (g) |                              69.9%                                             91.7%                        | 
|TERMINAL (d)       |                              17/25 (68%)                                       20/21 (95%)                  | 
|FIRST INCIDENCE    |                              351                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.026 *                    | 
|POLY 3             |                                                                                P=0.004 **                   | 
|POLY 1.5           |                                                                                P=0.004 **                   | 
|POLY 6             |                                                                                P=0.004 **                   | 
|LOGISTIC REGRESSION|                                                                                P=0.007 **                   | 
|COCH-ARM / FISHERS |                                                                                P=0.005 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              30/53 (57%)                                       29/50 (58%)                  | 
|POLY-3 RATE (b)    |                              30/41.81                                          29/41.58                     | 
|POLY-3 PERCENT (g) |                              71.8%                                             69.8%                        | 
|TERMINAL (d)       |                              22/25 (88%)                                       19/21 (91%)                  | 
|FIRST INCIDENCE    |                              492                                               474                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.333                      | 
|POLY 3             |                                                                                P=0.518N                     | 
|POLY 1.5           |                                                                                P=0.555N                     | 
|POLY 6             |                                                                                P=0.479N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.590                      | 
|COCH-ARM / FISHERS |                                                                                P=0.522                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         8/50 (16%)                   | 
|POLY-3 RATE (b)    |                              1/39.67                                           8/40.81                      | 
|POLY-3 PERCENT (g) |                              2.5%                                              19.6%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/21 (5%)                    | 
|FIRST INCIDENCE    |                              701                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.019 *                    | 
|POLY 3             |                                                                                P=0.016 *                    | 
|POLY 1.5           |                                                                                P=0.016 *                    | 
|POLY 6             |                                                                                P=0.016 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.012 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.012 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/53 (8%)                                         45/50 (90%)                  | 
|POLY-3 RATE (b)    |                              4/40.41                                           45/47.82                     | 
|POLY-3 PERCENT (g) |                              9.9%                                              94.1%                        | 
|TERMINAL (d)       |                              1/25 (4%)                                         20/21 (95%)                  | 
|FIRST INCIDENCE    |                              533                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Toxic Hepatopathy                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         16/50 (32%)                  | 
|POLY-3 RATE (b)    |                              0/39.55                                           16/40.19                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              39.8%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         9/21 (43%)                   | 
|FIRST INCIDENCE    |                              ---                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         6/50 (12%)                   | 
|POLY-3 RATE (b)    |                              3/39.85                                           6/38.64                      | 
|POLY-3 PERCENT (g) |                              7.5%                                              15.5%                        | 
|TERMINAL (d)       |                              2/25 (8%)                                         3/21 (14%)                   | 
|FIRST INCIDENCE    |                              648                                               643                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.194                      | 
|POLY 3             |                                                                                P=0.225                      | 
|POLY 1.5           |                                                                                P=0.226                      | 
|POLY 6             |                                                                                P=0.221                      | 
|LOGISTIC REGRESSION|                                                                                P=0.218                      | 
|COCH-ARM / FISHERS |                                                                                P=0.216                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         5/50 (10%)                   | 
|POLY-3 RATE (b)    |                              0/39.55                                           5/38.27                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              13.1%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         4/21 (19%)                   | 
|FIRST INCIDENCE    |                              ---                                               702                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.023 *                    | 
|POLY 3             |                                                                                P=0.027 *                    | 
|POLY 1.5           |                                                                                P=0.028 *                    | 
|POLY 6             |                                                                                P=0.026 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.026 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.024 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         7/50 (14%)                   | 
|POLY-3 RATE (b)    |                              5/40.16                                           7/39.33                      | 
|POLY-3 PERCENT (g) |                              12.5%                                             17.8%                        | 
|TERMINAL (d)       |                              4/25 (16%)                                        2/21 (10%)                   | 
|FIRST INCIDENCE    |                              533                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.318                      | 
|POLY 3             |                                                                                P=0.363                      | 
|POLY 1.5           |                                                                                P=0.364                      | 
|POLY 6             |                                                                                P=0.356                      | 
|LOGISTIC REGRESSION|                                                                                P=0.349                      | 
|COCH-ARM / FISHERS |                                                                                P=0.339                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Centrilobular                                                                                                             | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/39.97                                           0/38.16                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              0.0%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/21 (0%)                    | 
|FIRST INCIDENCE    |                              648                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.250N                     | 
|POLY 3             |                                                                                P=0.252N                     | 
|POLY 1.5           |                                                                                P=0.251N                     | 
|POLY 6             |                                                                                P=0.259N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.247N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.262N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         22/50 (44%)                  | 
|POLY-3 RATE (b)    |                              0/39.55                                           22/43.28                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              50.8%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         9/21 (43%)                   | 
|FIRST INCIDENCE    |                              ---                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Multinucleated                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         32/50 (64%)                  | 
|POLY-3 RATE (b)    |                              0/39.55                                           32/43.19                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              74.1%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         16/21 (76%)                  | 
|FIRST INCIDENCE    |                              ---                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              41/53 (77%)                                       41/50 (82%)                  | 
|POLY-3 RATE (b)    |                              41/48.55                                          41/44.42                     | 
|POLY-3 PERCENT (g) |                              84.5%                                             92.3%                        | 
|TERMINAL (d)       |                              19/25 (76%)                                       19/21 (91%)                  | 
|FIRST INCIDENCE    |                              351                                               520                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.314                      | 
|POLY 3             |                                                                                P=0.185                      | 
|POLY 1.5           |                                                                                P=0.261                      | 
|POLY 6             |                                                                                P=0.141                      | 
|LOGISTIC REGRESSION|                                                                                P=0.463                      | 
|COCH-ARM / FISHERS |                                                                                P=0.368                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/39.90                                           0/38.16                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              0.0%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/21 (0%)                    | 
|FIRST INCIDENCE    |                              645                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.260N                     | 
|POLY 3             |                                                                                P=0.251N                     | 
|POLY 1.5           |                                                                                P=0.250N                     | 
|POLY 6             |                                                                                P=0.257N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.246N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.262N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              1/39.55                                           3/39.10                      | 
|POLY-3 PERCENT (g) |                              2.5%                                              7.7%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/21 (0%)                    | 
|FIRST INCIDENCE    |                              731 (T)                                           578                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.293                      | 
|POLY 3             |                                                                                P=0.301                      | 
|POLY 1.5           |                                                                                P=0.298                      | 
|POLY 6             |                                                                                P=0.303                      | 
|LOGISTIC REGRESSION|                                                                                P=0.289                      | 
|COCH-ARM / FISHERS |                                                                                P=0.287                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              12/53 (23%)                                       0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              12/40.71                                          0/38.16                      | 
|POLY-3 PERCENT (g) |                              29.5%                                             0.0%                         | 
|TERMINAL (d)       |                              6/25 (24%)                                        0/21 (0%)                    | 
|FIRST INCIDENCE    |                              645                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001N**                   | 
|POLY 3             |                                                                                P<0.001N**                   | 
|POLY 1.5           |                                                                                P<0.001N**                   | 
|POLY 6             |                                                                                P<0.001N**                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001N**                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001N**                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Metaplasia Bronchiolar                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         31/50 (62%)                  | 
|POLY-3 RATE (b)    |                              2/39.55                                           31/41.68                     | 
|POLY-3 PERCENT (g) |                              5.1%                                              74.4%                        | 
|TERMINAL (d)       |                              2/25 (8%)                                         16/21 (76%)                  | 
|FIRST INCIDENCE    |                              731 (T)                                           578                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/51 (0%)                                         2/49 (4%)                    | 
|POLY-3 RATE (b)    |                              0/38.56                                           2/37.52                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.3%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         2/21 (10%)                   | 
|FIRST INCIDENCE    |                              ---                                               731 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.200                      | 
|POLY 3             |                                                                                P=0.233                      | 
|POLY 1.5           |                                                                                P=0.234                      | 
|POLY 6             |                                                                                P=0.231                      | 
|LOGISTIC REGRESSION|                                                                                P=0.200                      | 
|COCH-ARM / FISHERS |                                                                                P=0.238                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              25/51 (49%)                                       30/49 (61%)                  | 
|POLY-3 RATE (b)    |                              25/42.13                                          30/42.19                     | 
|POLY-3 PERCENT (g) |                              59.3%                                             71.1%                        | 
|TERMINAL (d)       |                              16/25 (64%)                                       15/21 (71%)                  | 
|FIRST INCIDENCE    |                              366                                               410                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.105                      | 
|POLY 3             |                                                                                P=0.169                      | 
|POLY 1.5           |                                                                                P=0.170                      | 
|POLY 6             |                                                                                P=0.160                      | 
|LOGISTIC REGRESSION|                                                                                P=0.163                      | 
|COCH-ARM / FISHERS |                                                                                P=0.153                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/51 (0%)                                         2/49 (4%)                    | 
|POLY-3 RATE (b)    |                              0/38.56                                           2/37.52                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.3%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         2/21 (10%)                   | 
|FIRST INCIDENCE    |                              ---                                               731 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.200                      | 
|POLY 3             |                                                                                P=0.233                      | 
|POLY 1.5           |                                                                                P=0.234                      | 
|POLY 6             |                                                                                P=0.231                      | 
|LOGISTIC REGRESSION|                                                                                P=0.200                      | 
|COCH-ARM / FISHERS |                                                                                P=0.238                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/2 (50%)                                         2/5 (40%)                    | 
|POLY-3 RATE (b)    |                              1/2.00                                            2/3.67                       | 
|POLY-3 PERCENT (g) |                              50.0%                                             54.5%                        | 
|TERMINAL (d)       |                              0/1 (0%)                                          0/0 (0%)                     | 
|FIRST INCIDENCE    |                              717                                               578                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.484                      | 
|POLY 3             |                                                                                P=0.668                      | 
|POLY 1.5           |                                                                                P=0.666N                     | 
|POLY 6             |                                                                                P=0.625                      | 
|LOGISTIC REGRESSION|                                                                                P=0.842N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.714N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/2 (0%)                                          2/5 (40%)                    | 
|POLY-3 RATE (b)    |                              0/1.94                                            2/3.89                       | 
|POLY-3 PERCENT (g) |                              0.0%                                              51.4%                        | 
|TERMINAL (d)       |                              0/1 (0%)                                          0/0 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               474                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.256                      | 
|POLY 3             |                                                                                P=0.245                      | 
|POLY 1.5           |                                                                                P=0.276                      | 
|POLY 6             |                                                                                P=0.199                      | 
|LOGISTIC REGRESSION|                                                                                P=0.999                      | 
|COCH-ARM / FISHERS |                                                                                P=0.476                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/53 (8%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              4/41.40                                           4/38.27                      | 
|POLY-3 PERCENT (g) |                              9.7%                                              10.5%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         3/21 (14%)                   | 
|FIRST INCIDENCE    |                              366                                               702                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.577                      | 
|POLY 3             |                                                                                P=0.606                      | 
|POLY 1.5           |                                                                                P=0.614                      | 
|POLY 6             |                                                                                P=0.591                      | 
|LOGISTIC REGRESSION|                                                                                P=0.613                      | 
|COCH-ARM / FISHERS |                                                                                P=0.609                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              25/53 (47%)                                       19/50 (38%)                  | 
|POLY-3 RATE (b)    |                              25/44.58                                          19/40.90                     | 
|POLY-3 PERCENT (g) |                              56.1%                                             46.5%                        | 
|TERMINAL (d)       |                              13/25 (52%)                                       9/21 (43%)                   | 
|FIRST INCIDENCE    |                              487                                               410                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.340N                     | 
|POLY 3             |                                                                                P=0.247N                     | 
|POLY 1.5           |                                                                                P=0.223N                     | 
|POLY 6             |                                                                                P=0.297N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.198N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.229N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              2/40.42                                           1/38.16                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              2.6%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/21 (5%)                    | 
|FIRST INCIDENCE    |                              474                                               731 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.530N                     | 
|POLY 3             |                                                                                P=0.527N                     | 
|POLY 1.5           |                                                                                P=0.522N                     | 
|POLY 6             |                                                                                P=0.537N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.523N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.522N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Nasolacrimal Duct                                                                                                          | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              2/40.42                                           1/38.80                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              2.6%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/21 (0%)                    | 
|FIRST INCIDENCE    |                              366                                               520                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.520N                     | 
|POLY 3             |                                                                                P=0.519N                     | 
|POLY 1.5           |                                                                                P=0.519N                     | 
|POLY 6             |                                                                                P=0.522N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.562N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.522N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Mucosa: Gingival                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/2 (50%)                                         8/11 (73%)                   | 
|POLY-3 RATE (b)    |                              1/1.13                                            8/10.01                      | 
|POLY-3 PERCENT (g) |                              88.9%                                             80.0%                        | 
|TERMINAL (d)       |                              1/1 (100%)                                        2/2 (100%)                   | 
|FIRST INCIDENCE    |                              731 (T)                                           345                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.019 *                    | 
|POLY 3             |                                                                                P=0.551N                     | 
|POLY 1.5           |                                                                                P=0.586                      | 
|POLY 6             |                                                                                P=0.522N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.663                      | 
|COCH-ARM / FISHERS |                                                                                P=0.538                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              49/51 (96%)                                       45/49 (92%)                  | 
|POLY-3 RATE (b)    |                              49/50.31                                          45/46.77                     | 
|POLY-3 PERCENT (g) |                              97.4%                                             96.2%                        | 
|TERMINAL (d)       |                              24/25 (96%)                                       20/21 (95%)                  | 
|FIRST INCIDENCE    |                              169                                               345                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.497                      | 
|POLY 3             |                                                                                P=0.617N                     | 
|POLY 1.5           |                                                                                P=0.529N                     | 
|POLY 6             |                                                                                P=0.682N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.266N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.320N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              14/51 (27%)                                       16/49 (33%)                  | 
|POLY-3 RATE (b)    |                              14/40.42                                          16/40.78                     | 
|POLY-3 PERCENT (g) |                              34.6%                                             39.2%                        | 
|TERMINAL (d)       |                              10/25 (40%)                                       5/21 (24%)                   | 
|FIRST INCIDENCE    |                              533                                               578                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.298                      | 
|POLY 3             |                                                                                P=0.420                      | 
|POLY 1.5           |                                                                                P=0.401                      | 
|POLY 6             |                                                                                P=0.449                      | 
|LOGISTIC REGRESSION|                                                                                P=0.376                      | 
|COCH-ARM / FISHERS |                                                                                P=0.363                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oviduct                                                                                                                          | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/2 (100%)                                        2/2 (100%)                   | 
|POLY-3 RATE (b)    |                              2/2.00                                            2/2.00                       | 
|POLY-3 PERCENT (g) |                              100.0%                                            100.0%                       | 
|TERMINAL (d)       |                              1/1 (100%)                                        1/1 (100%)                   | 
|FIRST INCIDENCE    |                              717                                               643                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                (e)                          | 
|POLY 3             |                                                                                (e)                          | 
|POLY 1.5           |                                                                                (e)                          | 
|POLY 6             |                                                                                (e)                          | 
|LOGISTIC REGRESSION|                                                                                (e)                          | 
|COCH-ARM / FISHERS |                                                                                (e)                          | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/51 (0%)                                         4/49 (8%)                    | 
|POLY-3 RATE (b)    |                              0/38.86                                           4/37.98                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              10.5%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         3/21 (14%)                   | 
|FIRST INCIDENCE    |                              ---                                               673                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.046 *                    | 
|POLY 3             |                                                                                P=0.057                      | 
|POLY 1.5           |                                                                                P=0.057                      | 
|POLY 6             |                                                                                P=0.056                      | 
|LOGISTIC REGRESSION|                                                                                P=0.055                      | 
|COCH-ARM / FISHERS |                                                                                P=0.054                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/51 (2%)                                         4/49 (8%)                    | 
|POLY-3 RATE (b)    |                              1/38.86                                           4/37.98                      | 
|POLY-3 PERCENT (g) |                              2.6%                                              10.5%                        | 
|TERMINAL (d)       |                              1/25 (4%)                                         3/21 (14%)                   | 
|FIRST INCIDENCE    |                              731 (T)                                           673                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.136                      | 
|POLY 3             |                                                                                P=0.171                      | 
|POLY 1.5           |                                                                                P=0.172                      | 
|POLY 6             |                                                                                P=0.168                      | 
|LOGISTIC REGRESSION|                                                                                P=0.161                      | 
|COCH-ARM / FISHERS |                                                                                P=0.169                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/51 (4%)                                         0/49 (0%)                    | 
|POLY-3 RATE (b)    |                              2/39.17                                           0/37.76                      | 
|POLY-3 PERCENT (g) |                              5.1%                                              0.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/21 (0%)                    | 
|FIRST INCIDENCE    |                              646                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.279N                     | 
|POLY 3             |                                                                                P=0.249N                     | 
|POLY 1.5           |                                                                                P=0.247N                     | 
|POLY 6             |                                                                                P=0.255N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.244N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.258N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Artery                                                                                                                 | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/51 (0%)                                         2/49 (4%)                    | 
|POLY-3 RATE (b)    |                              0/38.86                                           2/38.73                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.2%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/21 (5%)                    | 
|FIRST INCIDENCE    |                              ---                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.219                      | 
|POLY 3             |                                                                                P=0.236                      | 
|POLY 1.5           |                                                                                P=0.236                      | 
|POLY 6             |                                                                                P=0.235                      | 
|LOGISTIC REGRESSION|                                                                                P=0.180                      | 
|COCH-ARM / FISHERS |                                                                                P=0.238                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              25/53 (47%)                                       15/50 (30%)                  | 
|POLY-3 RATE (b)    |                              25/42.71                                          15/39.36                     | 
|POLY-3 PERCENT (g) |                              58.5%                                             38.1%                        | 
|TERMINAL (d)       |                              14/25 (56%)                                       8/21 (38%)                   | 
|FIRST INCIDENCE    |                              474                                               614                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.115N                     | 
|POLY 3             |                                                                                P=0.044N*                    | 
|POLY 1.5           |                                                                                P=0.043N*                    | 
|POLY 6             |                                                                                P=0.055N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.037N*                    | 
|COCH-ARM / FISHERS |                                                                                P=0.056N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              0/39.55                                           3/38.38                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              7.8%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         2/21 (10%)                   | 
|FIRST INCIDENCE    |                              ---                                               673                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.099                      | 
|POLY 3             |                                                                                P=0.114                      | 
|POLY 1.5           |                                                                                P=0.114                      | 
|POLY 6             |                                                                                P=0.113                      | 
|LOGISTIC REGRESSION|                                                                                P=0.111                      | 
|COCH-ARM / FISHERS |                                                                                P=0.111                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              19/53 (36%)                                       18/50 (36%)                  | 
|POLY-3 RATE (b)    |                              19/43.37                                          18/40.67                     | 
|POLY-3 PERCENT (g) |                              43.8%                                             44.3%                        | 
|TERMINAL (d)       |                              11/25 (44%)                                       9/21 (43%)                   | 
|FIRST INCIDENCE    |                              487                                               578                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.497                      | 
|POLY 3             |                                                                                P=0.575                      | 
|POLY 1.5           |                                                                                P=0.587                      | 
|POLY 6             |                                                                                P=0.558                      | 
|LOGISTIC REGRESSION|                                                                                P=0.559N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.575                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Intermedia                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/40.18                                           0/38.16                      | 
|POLY-3 PERCENT (g) |                              5.0%                                              0.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/21 (0%)                    | 
|FIRST INCIDENCE    |                              526                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.259N                     | 
|POLY 3             |                                                                                P=0.254N                     | 
|POLY 1.5           |                                                                                P=0.252N                     | 
|POLY 6             |                                                                                P=0.260N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.253N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.262N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/51 (0%)                                         2/49 (4%)                    | 
|POLY-3 RATE (b)    |                              0/38.56                                           2/37.63                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.3%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         1/21 (5%)                    | 
|FIRST INCIDENCE    |                              ---                                               702                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.224                      | 
|POLY 3             |                                                                                P=0.234                      | 
|POLY 1.5           |                                                                                P=0.234                      | 
|POLY 6             |                                                                                P=0.232                      | 
|LOGISTIC REGRESSION|                                                                                P=0.225                      | 
|COCH-ARM / FISHERS |                                                                                P=0.238                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              46/51 (90%)                                       42/49 (86%)                  | 
|POLY-3 RATE (b)    |                              46/47.32                                          42/45.72                     | 
|POLY-3 PERCENT (g) |                              97.2%                                             91.9%                        | 
|TERMINAL (d)       |                              25/25 (100%)                                      21/21 (100%)                 | 
|FIRST INCIDENCE    |                              185                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.491                      | 
|POLY 3             |                                                                                P=0.198N                     | 
|POLY 1.5           |                                                                                P=0.225N                     | 
|POLY 6             |                                                                                P=0.213N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.273N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.352N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              45/51 (88%)                                       42/49 (86%)                  | 
|POLY-3 RATE (b)    |                              45/49.73                                          42/45.30                     | 
|POLY-3 PERCENT (g) |                              90.5%                                             92.7%                        | 
|TERMINAL (d)       |                              23/25 (92%)                                       20/21 (95%)                  | 
|FIRST INCIDENCE    |                              169                                               215                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.447                      | 
|POLY 3             |                                                                                P=0.499                      | 
|POLY 1.5           |                                                                                P=0.592                      | 
|POLY 6             |                                                                                P=0.447                      | 
|LOGISTIC REGRESSION|                                                                                P=0.446N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.469N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/51 (8%)                                         1/49 (2%)                    | 
|POLY-3 RATE (b)    |                              4/42.10                                           1/38.40                      | 
|POLY-3 PERCENT (g) |                              9.5%                                              2.6%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/21 (0%)                    | 
|FIRST INCIDENCE    |                              169                                               520                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.198N                     | 
|POLY 3             |                                                                                P=0.213N                     | 
|POLY 1.5           |                                                                                P=0.205N                     | 
|POLY 6             |                                                                                P=0.223N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.238N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.194N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         5/50 (10%)                   | 
|POLY-3 RATE (b)    |                              3/39.67                                           5/40.27                      | 
|POLY-3 PERCENT (g) |                              7.6%                                              12.4%                        | 
|TERMINAL (d)       |                              2/25 (8%)                                         1/21 (5%)                    | 
|FIRST INCIDENCE    |                              701                                               474                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.314                      | 
|POLY 3             |                                                                                P=0.362                      | 
|POLY 1.5           |                                                                                P=0.352                      | 
|POLY 6             |                                                                                P=0.371                      | 
|LOGISTIC REGRESSION|                                                                                P=0.324                      | 
|COCH-ARM / FISHERS |                                                                                P=0.325                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              1/40.42                                           4/40.11                      | 
|POLY-3 PERCENT (g) |                              2.5%                                              10.0%                        | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/21 (0%)                    | 
|FIRST INCIDENCE    |                              366                                               474                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.170                      | 
|POLY 3             |                                                                                P=0.175                      | 
|POLY 1.5           |                                                                                P=0.172                      | 
|POLY 6             |                                                                                P=0.178                      | 
|LOGISTIC REGRESSION|                                                                                P=0.123                      | 
|COCH-ARM / FISHERS |                                                                                P=0.164                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              2/40.54                                           4/40.51                      | 
|POLY-3 PERCENT (g) |                              4.9%                                              9.9%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/21 (0%)                    | 
|FIRST INCIDENCE    |                              366                                               474                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.331                      | 
|POLY 3             |                                                                                P=0.336                      | 
|POLY 1.5           |                                                                                P=0.330                      | 
|POLY 6             |                                                                                P=0.340                      | 
|LOGISTIC REGRESSION|                                                                                P=0.252                      | 
|COCH-ARM / FISHERS |                                                                                P=0.312                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              3/41.09                                           0/38.16                      | 
|POLY-3 PERCENT (g) |                              7.3%                                              0.0%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/21 (0%)                    | 
|FIRST INCIDENCE    |                              169                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.144N                     | 
|POLY 3             |                                                                                P=0.136N                     | 
|POLY 1.5           |                                                                                P=0.134N                     | 
|POLY 6             |                                                                                P=0.143N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.158N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.132N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              36/51 (71%)                                       45/49 (92%)                  | 
|POLY-3 RATE (b)    |                              36/45.37                                          45/46.27                     | 
|POLY-3 PERCENT (g) |                              79.3%                                             97.3%                        | 
|TERMINAL (d)       |                              20/25 (80%)                                       21/21 (100%)                 | 
|FIRST INCIDENCE    |                              169                                               410                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.031 *                    | 
|POLY 3             |                                                                                P=0.004 **                   | 
|POLY 1.5           |                                                                                P=0.003 **                   | 
|POLY 6             |                                                                                P=0.009 **                   | 
|LOGISTIC REGRESSION|                                                                                P=0.008 **                   | 
|COCH-ARM / FISHERS |                                                                                P=0.006 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              19/52 (37%)                                       15/49 (31%)                  | 
|POLY-3 RATE (b)    |                              19/40.39                                          15/42.18                     | 
|POLY-3 PERCENT (g) |                              47.0%                                             35.6%                        | 
|TERMINAL (d)       |                              12/25 (48%)                                       4/21 (19%)                   | 
|FIRST INCIDENCE    |                              646                                               410                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.417N                     | 
|POLY 3             |                                                                                P=0.196N                     | 
|POLY 1.5           |                                                                                P=0.239N                     | 
|POLY 6             |                                                                                P=0.164N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.310N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.338N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/52 (4%)                                         0/49 (0%)                    | 
|POLY-3 RATE (b)    |                              2/38.90                                           0/37.52                      | 
|POLY-3 PERCENT (g) |                              5.1%                                              0.0%                         | 
|TERMINAL (d)       |                              2/25 (8%)                                         0/21 (0%)                    | 
|FIRST INCIDENCE    |                              731 (T)                                           ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.277N                     | 
|POLY 3             |                                                                                P=0.249N                     | 
|POLY 1.5           |                                                                                P=0.249N                     | 
|POLY 6             |                                                                                P=0.251N                     | 
|LOGISTIC REGRESSION|                                                                                (e)                          | 
|COCH-ARM / FISHERS |                                                                                P=0.263N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/52 (6%)                                         6/49 (12%)                   | 
|POLY-3 RATE (b)    |                              3/39.78                                           6/38.56                      | 
|POLY-3 PERCENT (g) |                              7.5%                                              15.6%                        | 
|TERMINAL (d)       |                              2/25 (8%)                                         3/21 (14%)                   | 
|FIRST INCIDENCE    |                              361                                               474                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.196                      | 
|POLY 3             |                                                                                P=0.225                      | 
|POLY 1.5           |                                                                                P=0.225                      | 
|POLY 6             |                                                                                P=0.223                      | 
|LOGISTIC REGRESSION|                                                                                P=0.217                      | 
|COCH-ARM / FISHERS |                                                                                P=0.215                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth: Peridontal Tissue                                                                                                         | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              15/16 (94%)                                       12/12 (100%)                 | 
|POLY-3 RATE (b)    |                              15/15.64                                          12/12.00                     | 
|POLY-3 PERCENT (g) |                              95.9%                                             100.0%                       | 
|TERMINAL (d)       |                              9/9 (100%)                                        5/5 (100%)                   | 
|FIRST INCIDENCE    |                              185                                               345                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.461                      | 
|POLY 3             |                                                                                P=0.810                      | 
|POLY 1.5           |                                                                                P=0.709                      | 
|POLY 6             |                                                                                P=0.964                      | 
|LOGISTIC REGRESSION|                                                                                P=0.550                      | 
|COCH-ARM / FISHERS |                                                                                P=0.571                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              6/52 (12%)                                        2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              6/39.16                                           2/38.52                      | 
|POLY-3 PERCENT (g) |                              15.3%                                             5.2%                         | 
|TERMINAL (d)       |                              4/25 (16%)                                        0/21 (0%)                    | 
|FIRST INCIDENCE    |                              697                                               645                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.179N                     | 
|POLY 3             |                                                                                P=0.136N                     | 
|POLY 1.5           |                                                                                P=0.137N                     | 
|POLY 6             |                                                                                P=0.138N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.144N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.148N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              7/52 (13%)                                        9/50 (18%)                   | 
|POLY-3 RATE (b)    |                              7/40.38                                           9/40.44                      | 
|POLY-3 PERCENT (g) |                              17.3%                                             22.3%                        | 
|TERMINAL (d)       |                              4/25 (16%)                                        4/21 (19%)                   | 
|FIRST INCIDENCE    |                              185                                               484                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.307                      | 
|POLY 3             |                                                                                P=0.391                      | 
|POLY 1.5           |                                                                                P=0.381                      | 
|POLY 6             |                                                                                P=0.399                      | 
|LOGISTIC REGRESSION|                                                                                P=0.362                      | 
|COCH-ARM / FISHERS |                                                                                P=0.360                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           100 NG/                      | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              29/52 (56%)                                       33/50 (66%)                  | 
|POLY-3 RATE (b)    |                              29/45.30                                          33/45.46                     | 
|POLY-3 PERCENT (g) |                              64.0%                                             72.6%                        | 
|TERMINAL (d)       |                              15/25 (60%)                                       16/21 (76%)                  | 
|FIRST INCIDENCE    |                              351                                               394                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.161                      | 
|POLY 3             |                                                                                P=0.248                      | 
|POLY 1.5           |                                                                                P=0.230                      | 
|POLY 6             |                                                                                P=0.275                      | 
|LOGISTIC REGRESSION|                                                                                P=0.212                      | 
|COCH-ARM / FISHERS |                                                                                P=0.196                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           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/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              30/52 (58%)                                       32/50 (64%)                  | 
|POLY-3 RATE (b)    |                              30/44.70                                          32/42.21                     | 
|POLY-3 PERCENT (g) |                              67.1%                                             75.8%                        | 
|TERMINAL (d)       |                              15/25 (60%)                                       18/21 (86%)                  | 
|FIRST INCIDENCE    |                              361                                               474                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.226                      | 
|POLY 3             |                                                                                P=0.244                      | 
|POLY 1.5           |                                                                                P=0.294                      | 
|POLY 6             |                                                                                P=0.180                      | 
|LOGISTIC REGRESSION|                                                                                P=0.372                      | 
|COCH-ARM / FISHERS |                                                                                P=0.327                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
(d)  Observed incidence at terminal kill.                                                                                           
(f)  Beneath the control incidence are the P-values associated with the trend                                                       
test.  Beneath the dosed group incidence are the P-values corresponding to                                                          
pairwise comparisons between the controls and that dosed group.  The life                                                           
table analysis regards tumors in animals dying prior to  terminal kill as                                                           
 being (directly or indirectly) the cause of death.                                                                                 
Logistic regression is an alternative                                                                                               
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage                                                       
and Fishers exact tests compare directly the overall incidence rates                                                                
For all tests a negative trend is indicated by N                                                                                    
(e)  Value of Statistic cannot be computed.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(I)  Interim sacrifice                                                                                                              
(T)  Terminal sacrifice                                                                                                             
#   Tumor rates based on number of animals necropsied.                                                                              
*   To the right of any statistical result, indicates significance at (P<=0.05).                                                    
**  To the right of any statistical result, indicates significance at (P<=0.01).