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TDMS Study 05161-06 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Southern Research Inst                                   RIDDELLIINE                                      DATE: 12/12/00       
EXPERIMENT: 05161 TEST: 06                                                                                     TIME: 09:46:32       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 61358C       
PATHOLOGIST: FARNELL, D.                                                                                       CAS: 23246-96-0      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                        FEMALE MICE/FINAL#1                                                         
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 002    0       MG/KG/DY                                                              
                                       INCLUDE 007    3.0     MG/KG/DY                                                              
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Southern Research Inst                                   RIDDELLIINE                                      DATE: 12/12/00       
EXPERIMENT: 05161 TEST: 06                                                                                     TIME: 09:46:32       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 61358C       
PATHOLOGIST: FARNELL, D.                                                                                       CAS: 23246-96-0      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                   RIDDELLIINE                                                                                    
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Cortex                         Cytoplasmic Alteration Focal                                                                 
                                       Inflammation Chronic Focal                                                                   
Bone: Vertebra                         Hyperostosis Focal                                                                           
Brain                                  Hemorrhage Focal                                                                             
Intestine Large, Cecum                 Edema                                                                                        
                                       Hemorrhage Focal                                                                             
Intestine Large, Cecum: Artery         Inflammation Chronic Focal                                                                   
Intestine Large, Cecum: Epithelium     Erosion Focal                                                                                
Intestine Small, Duodenum: Artery      Inflammation Chronic                                                                         
Kidney                                 Metaplasia Focal Osseous                                                                     
                                       Nephropathy                                                                                  
Kidney: Artery                         Inflammation Chronic                                                                         
Kidney: Glomerulus                     Glomerulosclerosis                                                                           
Kidney: Renal Tubule                   Accumulation, Hyaline Droplet                                                                
                                       Pigmentation                                                                                 
Liver                                  Infiltration Cellular Mixed Cell                                                             
Liver: Bile Duct                       Hyperplasia                                                                                  
Liver: Hepatocyte                      Cytomegaly                                                                                   
                                       Karyomegaly                                                                                  
                                       Necrosis Focal                                                                               
                                       Vacuolization Cytoplasmic Diffuse                                                            
Liver: Hepatocyte, Midzonal            Vacuolization Cytoplasmic                                                                    
Lung                                   Hyperplasia                                                                                  
Lung: Alveolar Epithelium              Hyperplasia                                                                                  
Lymph Node, Mesenteric                 Hematopoietic Cell Proliferation                                                             
Mesentery: Artery                      Inflammation Chronic Focal                                                                   
Mesentery: Fat                         Necrosis                                                                                     
Ovary                                  Cyst                                                                                         
Ovary: Artery                          Inflammation Chronic                                                                         
Spleen                                 Hematopoietic Cell Proliferation                                                             
Spleen: Artery                         Inflammation Chronic Focal                                                                   
Thyroid Gland                          Degeneration Cystic Focal                                                                    
Uterus: Artery                         Inflammation Chronic Focal                                                                   
Uterus: Endometrium                    Hyperplasia Cystic                                                                           
===============================================================                                                                     
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 1       
                     Statistical Analysis of Non-neoplastic Lesions in        Mice(B6C3F1)  -                    RIDDELLIINE        
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Accessory Adrenal Cortical Nodule                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/42.06                                           2/41.80                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              4.8%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         1/17 (6%)                    | 
|FIRST INCIDENCE    |                              ---                                               637                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.171                                           P=0.171                      | 
|POLY 3             |                              P=0.236                                           P=0.236                      | 
|POLY 1.5           |                              P=0.238                                           P=0.238                      | 
|POLY 6             |                              P=0.231                                           P=0.231                      | 
|LOGISTIC REGRESSION|                              P=0.238                                           P=0.238                      | 
|COCH-ARM / FISHERS |                              P=0.238                                           P=0.247                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Cytoplasmic Alteration Focal                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/50 (2%)                                         25/50 (50%)                  | 
|POLY-3 RATE (b)    |                              1/42.06                                           25/43.78                     | 
|POLY-3 PERCENT (g) |                              2.4%                                              57.1%                        | 
|TERMINAL (d)       |                              1/34 (3%)                                         9/17 (53%)                   | 
|FIRST INCIDENCE    |                              729 (T)                                           587                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 2       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Inflammation Chronic Focal                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         6/50 (12%)                   | 
|POLY-3 RATE (b)    |                              0/42.06                                           6/41.99                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              14.3%                        | 
|TERMINAL (d)       |                              0/34 (0%)                                         1/17 (6%)                    | 
|FIRST INCIDENCE    |                              ---                                               675                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.006 **                                        P=0.006 **                   | 
|POLY 3             |                              P=0.015 *                                         P=0.015 *                    | 
|POLY 1.5           |                              P=0.016 *                                         P=0.016 *                    | 
|POLY 6             |                              P=0.013 *                                         P=0.013 *                    | 
|LOGISTIC REGRESSION|                              P=0.015 *                                         P=0.015 *                    | 
|COCH-ARM / FISHERS |                              P=0.018 *                                         P=0.013 *                    | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/50 (4%)                                         6/50 (12%)                   | 
|POLY-3 RATE (b)    |                              2/42.27                                           6/43.85                      | 
|POLY-3 PERCENT (g) |                              4.7%                                              13.7%                        | 
|TERMINAL (d)       |                              1/34 (3%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              675                                               489                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.112                                           P=0.112                      | 
|POLY 3             |                              P=0.142                                           P=0.142                      | 
|POLY 1.5           |                              P=0.143                                           P=0.143                      | 
|POLY 6             |                              P=0.135                                           P=0.135                      | 
|LOGISTIC REGRESSION|                              P=0.109                                           P=0.109                      | 
|COCH-ARM / FISHERS |                              P=0.134                                           P=0.134                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 3       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone: Vertebra                                                                                                                   | 
|     Hyperostosis Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              40/50 (80%)                                       33/50 (66%)                  | 
|POLY-3 RATE (b)    |                              40/44.60                                          33/44.35                     | 
|POLY-3 PERCENT (g) |                              89.7%                                             74.4%                        | 
|TERMINAL (d)       |                              34/34 (100%)                                      14/17 (82%)                  | 
|FIRST INCIDENCE    |                              545                                               587                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.025 *                                         P=0.025 *                    | 
|POLY 3             |                              P=0.034N*                                         P=0.034N*                    | 
|POLY 1.5           |                              P=0.040N*                                         P=0.040N*                    | 
|POLY 6             |                              P=0.037N*                                         P=0.037N*                    | 
|LOGISTIC REGRESSION|                              P=0.033N*                                         P=0.033N*                    | 
|COCH-ARM / FISHERS |                              P=0.088N                                          P=0.088N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain                                                                                                                            | 
|     Hemorrhage Focal                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              0/42.06                                           4/41.73                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              9.6%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         2/17 (12%)                   | 
|FIRST INCIDENCE    |                              ---                                               669                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.020 *                                         P=0.020 *                    | 
|POLY 3             |                              P=0.059                                           P=0.059                      | 
|POLY 1.5           |                              P=0.061                                           P=0.061                      | 
|POLY 6             |                              P=0.054                                           P=0.054                      | 
|LOGISTIC REGRESSION|                              P=0.052                                           P=0.052                      | 
|COCH-ARM / FISHERS |                              P=0.063                                           P=0.059                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 4       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/49 (0%)                                         2/49 (4%)                    | 
|POLY-3 RATE (b)    |                              0/41.64                                           2/41.31                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              4.8%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               700                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.161                                           P=0.161                      | 
|POLY 3             |                              P=0.236                                           P=0.236                      | 
|POLY 1.5           |                              P=0.238                                           P=0.238                      | 
|POLY 6             |                              P=0.231                                           P=0.231                      | 
|LOGISTIC REGRESSION|                              P=0.223                                           P=0.223                      | 
|COCH-ARM / FISHERS |                              P=0.237                                           P=0.247                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Gallbladder                                                                                                                      | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/45 (2%)                                         2/45 (4%)                    | 
|POLY-3 RATE (b)    |                              1/39.48                                           2/37.52                      | 
|POLY-3 PERCENT (g) |                              2.5%                                              5.3%                         | 
|TERMINAL (d)       |                              1/33 (3%)                                         1/16 (6%)                    | 
|FIRST INCIDENCE    |                              729 (T)                                           709                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.297                                           P=0.297                      | 
|POLY 3             |                              P=0.488                                           P=0.488                      | 
|POLY 1.5           |                              P=0.497                                           P=0.497                      | 
|POLY 6             |                              P=0.474                                           P=0.474                      | 
|LOGISTIC REGRESSION|                              P=0.402                                           P=0.402                      | 
|COCH-ARM / FISHERS |                              P=0.500                                           P=0.500                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 5       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Infiltration Cellular Mixed Cell                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/50 (6%)                                         6/50 (12%)                   | 
|POLY-3 RATE (b)    |                              3/42.57                                           6/43.19                      | 
|POLY-3 PERCENT (g) |                              7.1%                                              13.9%                        | 
|TERMINAL (d)       |                              2/34 (6%)                                         2/17 (12%)                   | 
|FIRST INCIDENCE    |                              577                                               489                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.123                                           P=0.123                      | 
|POLY 3             |                              P=0.247                                           P=0.247                      | 
|POLY 1.5           |                              P=0.252                                           P=0.252                      | 
|POLY 6             |                              P=0.230                                           P=0.230                      | 
|LOGISTIC REGRESSION|                              P=0.226                                           P=0.226                      | 
|COCH-ARM / FISHERS |                              P=0.242                                           P=0.243                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Inflammation Chronic Focal                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/42.06                                           2/41.53                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              4.8%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         1/17 (6%)                    | 
|FIRST INCIDENCE    |                              ---                                               713                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.128                                           P=0.128                      | 
|POLY 3             |                              P=0.235                                           P=0.235                      | 
|POLY 1.5           |                              P=0.238                                           P=0.238                      | 
|POLY 6             |                              P=0.230                                           P=0.230                      | 
|LOGISTIC REGRESSION|                              P=0.190                                           P=0.190                      | 
|COCH-ARM / FISHERS |                              P=0.238                                           P=0.247                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 6       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Mineralization Focal                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              0/42.06                                           4/42.59                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              9.4%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               618                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.067                                           P=0.067                      | 
|POLY 3             |                              P=0.061                                           P=0.061                      | 
|POLY 1.5           |                              P=0.062                                           P=0.062                      | 
|POLY 6             |                              P=0.058                                           P=0.058                      | 
|LOGISTIC REGRESSION|                              P=0.058                                           P=0.058                      | 
|COCH-ARM / FISHERS |                              P=0.063                                           P=0.059                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Cecum                                                                                                           | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/48 (0%)                                         5/47 (11%)                   | 
|POLY-3 RATE (b)    |                              0/40.80                                           5/40.42                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              12.4%                        | 
|TERMINAL (d)       |                              0/34 (0%)                                         2/17 (12%)                   | 
|FIRST INCIDENCE    |                              ---                                               530                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.009 **                                        P=0.009 **                   | 
|POLY 3             |                              P=0.029 *                                         P=0.029 *                    | 
|POLY 1.5           |                              P=0.030 *                                         P=0.030 *                    | 
|POLY 6             |                              P=0.026 *                                         P=0.026 *                    | 
|LOGISTIC REGRESSION|                              P=0.032 *                                         P=0.032 *                    | 
|COCH-ARM / FISHERS |                              P=0.031 *                                         P=0.026 *                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 7       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Cecum                                                                                                           | 
|     Hemorrhage Focal                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/48 (0%)                                         6/47 (13%)                   | 
|POLY-3 RATE (b)    |                              0/40.80                                           6/40.55                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              14.8%                        | 
|TERMINAL (d)       |                              0/34 (0%)                                         2/17 (12%)                   | 
|FIRST INCIDENCE    |                              ---                                               530                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.005 **                                        P=0.005 **                   | 
|POLY 3             |                              P=0.014 *                                         P=0.014 *                    | 
|POLY 1.5           |                              P=0.015 *                                         P=0.015 *                    | 
|POLY 6             |                              P=0.013 *                                         P=0.013 *                    | 
|LOGISTIC REGRESSION|                              P=0.017 *                                         P=0.017 *                    | 
|COCH-ARM / FISHERS |                              P=0.016 *                                         P=0.012 *                    | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Cecum: Artery                                                                                                   | 
|     Inflammation Chronic Focal                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/48 (0%)                                         18/47 (38%)                  | 
|POLY-3 RATE (b)    |                              0/40.80                                           18/42.21                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              42.6%                        | 
|TERMINAL (d)       |                              0/34 (0%)                                         4/17 (24%)                   | 
|FIRST INCIDENCE    |                              ---                                               530                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 8       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Cecum: Epithelium                                                                                               | 
|     Erosion Focal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/48 (0%)                                         6/47 (13%)                   | 
|POLY-3 RATE (b)    |                              0/40.80                                           6/40.55                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              14.8%                        | 
|TERMINAL (d)       |                              0/34 (0%)                                         2/17 (12%)                   | 
|FIRST INCIDENCE    |                              ---                                               530                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.005 **                                        P=0.005 **                   | 
|POLY 3             |                              P=0.014 *                                         P=0.014 *                    | 
|POLY 1.5           |                              P=0.015 *                                         P=0.015 *                    | 
|POLY 6             |                              P=0.013 *                                         P=0.013 *                    | 
|LOGISTIC REGRESSION|                              P=0.017 *                                         P=0.017 *                    | 
|COCH-ARM / FISHERS |                              P=0.016 *                                         P=0.012 *                    | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Duodenum                                                                                                        | 
|     Hemorrhage Focal                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/47 (0%)                                         2/46 (4%)                    | 
|POLY-3 RATE (b)    |                              0/40.38                                           2/39.57                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.1%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               696                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.207                                           P=0.207                      | 
|POLY 3             |                              P=0.234                                           P=0.234                      | 
|POLY 1.5           |                              P=0.236                                           P=0.236                      | 
|POLY 6             |                              P=0.230                                           P=0.230                      | 
|LOGISTIC REGRESSION|                              P=0.233                                           P=0.233                      | 
|COCH-ARM / FISHERS |                              P=0.233                                           P=0.242                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 9       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Duodenum                                                                                                        | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/47 (0%)                                         2/46 (4%)                    | 
|POLY-3 RATE (b)    |                              0/40.38                                           2/39.57                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.1%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               696                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.207                                           P=0.207                      | 
|POLY 3             |                              P=0.234                                           P=0.234                      | 
|POLY 1.5           |                              P=0.236                                           P=0.236                      | 
|POLY 6             |                              P=0.230                                           P=0.230                      | 
|LOGISTIC REGRESSION|                              P=0.233                                           P=0.233                      | 
|COCH-ARM / FISHERS |                              P=0.233                                           P=0.242                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Duodenum: Artery                                                                                                | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/47 (0%)                                         13/46 (28%)                  | 
|POLY-3 RATE (b)    |                              0/40.38                                           13/40.50                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              32.1%                        | 
|TERMINAL (d)       |                              0/34 (0%)                                         3/17 (18%)                   | 
|FIRST INCIDENCE    |                              ---                                               656                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 10      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/49 (6%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              3/41.79                                           2/42.07                      | 
|POLY-3 PERCENT (g) |                              7.2%                                              4.8%                         | 
|TERMINAL (d)       |                              3/34 (9%)                                         1/17 (6%)                    | 
|FIRST INCIDENCE    |                              729 (T)                                           532                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.627                                           P=0.627                      | 
|POLY 3             |                              P=0.496N                                          P=0.496N                     | 
|POLY 1.5           |                              P=0.485N                                          P=0.485N                     | 
|POLY 6             |                              P=0.523N                                          P=0.523N                     | 
|LOGISTIC REGRESSION|                              P=0.493N                                          P=0.493N                     | 
|COCH-ARM / FISHERS |                              P=0.491N                                          P=0.490N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Metaplasia Focal Osseous                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/49 (2%)                                         8/50 (16%)                   | 
|POLY-3 RATE (b)    |                              1/41.79                                           8/42.09                      | 
|POLY-3 PERCENT (g) |                              2.4%                                              19.0%                        | 
|TERMINAL (d)       |                              1/34 (3%)                                         3/17 (18%)                   | 
|FIRST INCIDENCE    |                              729 (T)                                           675                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.003 **                                        P=0.003 **                   | 
|POLY 3             |                              P=0.015 *                                         P=0.015 *                    | 
|POLY 1.5           |                              P=0.017 *                                         P=0.017 *                    | 
|POLY 6             |                              P=0.013 *                                         P=0.013 *                    | 
|LOGISTIC REGRESSION|                              P=0.013 *                                         P=0.013 *                    | 
|COCH-ARM / FISHERS |                              P=0.019 *                                         P=0.017 *                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 11      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              18/49 (37%)                                       47/50 (94%)                  | 
|POLY-3 RATE (b)    |                              18/45.32                                          47/47.93                     | 
|POLY-3 PERCENT (g) |                              39.7%                                             98.1%                        | 
|TERMINAL (d)       |                              11/34 (32%)                                       17/17 (100%)                 | 
|FIRST INCIDENCE    |                              27                                                489                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Artery                                                                                                                   | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/49 (2%)                                         16/50 (32%)                  | 
|POLY-3 RATE (b)    |                              1/41.79                                           16/42.44                     | 
|POLY-3 PERCENT (g) |                              2.4%                                              37.7%                        | 
|TERMINAL (d)       |                              1/34 (3%)                                         8/17 (47%)                   | 
|FIRST INCIDENCE    |                              729 (T)                                           637                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 12      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Glomerulus                                                                                                               | 
|     Glomerulosclerosis                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/49 (0%)                                         40/50 (80%)                  | 
|POLY-3 RATE (b)    |                              0/41.79                                           40/46.73                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              85.6%                        | 
|TERMINAL (d)       |                              0/34 (0%)                                         14/17 (82%)                  | 
|FIRST INCIDENCE    |                              ---                                               489                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Accumulation, Hyaline Droplet                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/49 (4%)                                         14/50 (28%)                  | 
|POLY-3 RATE (b)    |                              2/42.01                                           14/43.25                     | 
|POLY-3 PERCENT (g) |                              4.8%                                              32.4%                        | 
|TERMINAL (d)       |                              0/34 (0%)                                         5/17 (29%)                   | 
|FIRST INCIDENCE    |                              675                                               530                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P=0.002 **                                        P<0.001 **                   | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 13      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Casts Protein                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/49 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/42.05                                           0/41.46                      | 
|POLY-3 PERCENT (g) |                              4.8%                                              0.0%                         | 
|TERMINAL (d)       |                              1/34 (3%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              657                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.317N                                          P=0.317N                     | 
|POLY 3             |                              P=0.242N                                          P=0.242N                     | 
|POLY 1.5           |                              P=0.232N                                          P=0.232N                     | 
|POLY 6             |                              P=0.264N                                          P=0.264N                     | 
|LOGISTIC REGRESSION|                              P=0.235N                                          P=0.235N                     | 
|COCH-ARM / FISHERS |                              P=0.233N                                          P=0.242N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/49 (4%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              2/41.87                                           2/41.57                      | 
|POLY-3 PERCENT (g) |                              4.8%                                              4.8%                         | 
|TERMINAL (d)       |                              1/34 (3%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              709                                               709                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.517                                           P=0.517                      | 
|POLY 3             |                              P=0.692                                           P=0.693                      | 
|POLY 1.5           |                              P=0.686N                                          P=0.686N                     | 
|POLY 6             |                              P=0.678                                           P=0.678                      | 
|LOGISTIC REGRESSION|                              P=0.655                                           P=0.655                      | 
|COCH-ARM / FISHERS |                              P=0.688N                                          P=0.684N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 14      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/49 (4%)                                         27/50 (54%)                  | 
|POLY-3 RATE (b)    |                              2/42.01                                           27/43.55                     | 
|POLY-3 PERCENT (g) |                              4.8%                                              62.0%                        | 
|TERMINAL (d)       |                              0/34 (0%)                                         9/17 (53%)                   | 
|FIRST INCIDENCE    |                              675                                               656                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/49 (4%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              2/41.79                                           2/41.51                      | 
|POLY-3 PERCENT (g) |                              4.8%                                              4.8%                         | 
|TERMINAL (d)       |                              2/34 (6%)                                         1/17 (6%)                    | 
|FIRST INCIDENCE    |                              729 (T)                                           716                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.452                                           P=0.452                      | 
|POLY 3             |                              P=0.693                                           P=0.693                      | 
|POLY 1.5           |                              P=0.685N                                          P=0.685N                     | 
|POLY 6             |                              P=0.678                                           P=0.679                      | 
|LOGISTIC REGRESSION|                              P=0.564                                           P=0.564                      | 
|COCH-ARM / FISHERS |                              P=0.688N                                          P=0.684N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 15      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/49 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/41.79                                           0/41.46                      | 
|POLY-3 PERCENT (g) |                              4.8%                                              0.0%                         | 
|TERMINAL (d)       |                              2/34 (6%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              729 (T)                                           ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.400N                                          P=0.400N                     | 
|POLY 3             |                              P=0.239N                                          P=0.239N                     | 
|POLY 1.5           |                              P=0.231N                                          P=0.231N                     | 
|POLY 6             |                              P=0.259N                                          P=0.259N                     | 
|LOGISTIC REGRESSION|                              P=0.400N                                          (e)                          | 
|COCH-ARM / FISHERS |                              P=0.233N                                          P=0.242N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fibrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/49 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/41.79                                           2/41.80                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              4.8%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         1/17 (6%)                    | 
|FIRST INCIDENCE    |                              ---                                               637                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.171                                           P=0.171                      | 
|POLY 3             |                              P=0.237                                           P=0.237                      | 
|POLY 1.5           |                              P=0.240                                           P=0.240                      | 
|POLY 6             |                              P=0.231                                           P=0.231                      | 
|LOGISTIC REGRESSION|                              P=0.242                                           P=0.242                      | 
|COCH-ARM / FISHERS |                              P=0.242                                           P=0.253                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 16      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hemorrhage Focal                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/49 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/41.79                                           2/42.13                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              4.8%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         1/17 (6%)                    | 
|FIRST INCIDENCE    |                              ---                                               504                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.170                                           P=0.170                      | 
|POLY 3             |                              P=0.238                                           P=0.238                      | 
|POLY 1.5           |                              P=0.240                                           P=0.240                      | 
|POLY 6             |                              P=0.232                                           P=0.232                      | 
|LOGISTIC REGRESSION|                              P=0.215                                           P=0.215                      | 
|COCH-ARM / FISHERS |                              P=0.242                                           P=0.253                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hyperplasia Focal Lymphoid                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/49 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/41.79                                           0/41.46                      | 
|POLY-3 PERCENT (g) |                              4.8%                                              0.0%                         | 
|TERMINAL (d)       |                              2/34 (6%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              729 (T)                                           ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.400N                                          P=0.400N                     | 
|POLY 3             |                              P=0.239N                                          P=0.239N                     | 
|POLY 1.5           |                              P=0.231N                                          P=0.231N                     | 
|POLY 6             |                              P=0.259N                                          P=0.259N                     | 
|LOGISTIC REGRESSION|                              P=0.400N                                          (e)                          | 
|COCH-ARM / FISHERS |                              P=0.233N                                          P=0.242N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 17      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Infiltration Cellular Mixed Cell                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              29/49 (59%)                                       41/50 (82%)                  | 
|POLY-3 RATE (b)    |                              29/44.89                                          41/46.76                     | 
|POLY-3 PERCENT (g) |                              64.6%                                             87.7%                        | 
|TERMINAL (d)       |                              23/34 (68%)                                       16/17 (94%)                  | 
|FIRST INCIDENCE    |                              27                                                434                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.005 **                                        P=0.005 **                   | 
|POLY 1.5           |                              P=0.007 **                                        P=0.007 **                   | 
|POLY 6             |                              P=0.003 **                                        P=0.003 **                   | 
|LOGISTIC REGRESSION|                              P=0.012 *                                         P=0.012 *                    | 
|COCH-ARM / FISHERS |                              P=0.012 *                                         P=0.011 *                    | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/49 (0%)                                         28/50 (56%)                  | 
|POLY-3 RATE (b)    |                              0/41.79                                           28/44.58                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              62.8%                        | 
|TERMINAL (d)       |                              0/34 (0%)                                         12/17 (71%)                  | 
|FIRST INCIDENCE    |                              ---                                               596                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 18      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Cytomegaly                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/49 (0%)                                         49/50 (98%)                  | 
|POLY-3 RATE (b)    |                              0/41.79                                           49/50.00                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              98.0%                        | 
|TERMINAL (d)       |                              0/34 (0%)                                         16/17 (94%)                  | 
|FIRST INCIDENCE    |                              ---                                               434                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Karyomegaly                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/49 (0%)                                         49/50 (98%)                  | 
|POLY-3 RATE (b)    |                              0/41.79                                           49/50.00                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              98.0%                        | 
|TERMINAL (d)       |                              0/34 (0%)                                         16/17 (94%)                  | 
|FIRST INCIDENCE    |                              ---                                               434                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 19      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              12/49 (24%)                                       19/50 (38%)                  | 
|POLY-3 RATE (b)    |                              12/41.87                                          19/44.35                     | 
|POLY-3 PERCENT (g) |                              28.7%                                             42.8%                        | 
|TERMINAL (d)       |                              11/34 (32%)                                       7/17 (41%)                   | 
|FIRST INCIDENCE    |                              709                                               489                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.003 **                                        P=0.003 **                   | 
|POLY 3             |                              P=0.120                                           P=0.120                      | 
|POLY 1.5           |                              P=0.123                                           P=0.123                      | 
|POLY 6             |                              P=0.107                                           P=0.107                      | 
|LOGISTIC REGRESSION|                              P=0.092                                           P=0.092                      | 
|COCH-ARM / FISHERS |                              P=0.109                                           P=0.109                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Vacuolization Cytoplasmic Diffuse                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              8/49 (16%)                                        1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              8/44.40                                           1/41.69                      | 
|POLY-3 PERCENT (g) |                              18.0%                                             2.4%                         | 
|TERMINAL (d)       |                              2/34 (6%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              545                                               669                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.044N*                                         P=0.044N*                    | 
|POLY 3             |                              P=0.020N*                                         P=0.020N*                    | 
|POLY 1.5           |                              P=0.016N*                                         P=0.016N*                    | 
|POLY 6             |                              P=0.029N*                                         P=0.029N*                    | 
|LOGISTIC REGRESSION|                              P=0.019N*                                         P=0.019N*                    | 
|COCH-ARM / FISHERS |                              P=0.017N*                                         P=0.014N*                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 20      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Vacuolization Cytoplasmic Focal                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/49 (6%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              3/42.37                                           0/41.46                      | 
|POLY-3 PERCENT (g) |                              7.1%                                              0.0%                         | 
|TERMINAL (d)       |                              2/34 (6%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              545                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.210N                                          P=0.210N                     | 
|POLY 3             |                              P=0.123N                                          P=0.123N                     | 
|POLY 1.5           |                              P=0.116N                                          P=0.116N                     | 
|POLY 6             |                              P=0.140N                                          P=0.140N                     | 
|LOGISTIC REGRESSION|                              P=0.118N                                          P=0.118N                     | 
|COCH-ARM / FISHERS |                              P=0.117N                                          P=0.117N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte, Midzonal                                                                                                      | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/49 (2%)                                         6/50 (12%)                   | 
|POLY-3 RATE (b)    |                              1/42.29                                           6/42.50                      | 
|POLY-3 PERCENT (g) |                              2.4%                                              14.1%                        | 
|TERMINAL (d)       |                              0/34 (0%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              577                                               618                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.045 *                                         P=0.045 *                    | 
|POLY 3             |                              P=0.056                                           P=0.056                      | 
|POLY 1.5           |                              P=0.059                                           P=0.059                      | 
|POLY 6             |                              P=0.049 *                                         P=0.050                      | 
|LOGISTIC REGRESSION|                              P=0.060                                           P=0.060                      | 
|COCH-ARM / FISHERS |                              P=0.062                                           P=0.059                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 21      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Congestion                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/50 (6%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              3/42.06                                           2/41.94                      | 
|POLY-3 PERCENT (g) |                              7.1%                                              4.8%                         | 
|TERMINAL (d)       |                              3/34 (9%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              729 (T)                                           656                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.676                                           P=0.676                      | 
|POLY 3             |                              P=0.502N                                          P=0.502N                     | 
|POLY 1.5           |                              P=0.493N                                          P=0.493N                     | 
|POLY 6             |                              P=0.524N                                          P=0.524N                     | 
|LOGISTIC REGRESSION|                              P=0.513N                                          P=0.513N                     | 
|COCH-ARM / FISHERS |                              P=0.500N                                          P=0.500N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Foreign Body                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/50 (8%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              4/44.39                                           0/41.46                      | 
|POLY-3 PERCENT (g) |                              9.0%                                              0.0%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              545                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.064N                                          P=0.064N                     | 
|POLY 3             |                              P=0.072N                                          P=0.072N                     | 
|POLY 1.5           |                              P=0.064N                                          P=0.064N                     | 
|POLY 6             |                              P=0.088N                                          P=0.088N                     | 
|LOGISTIC REGRESSION|                              P=0.089N                                          P=0.089N                     | 
|COCH-ARM / FISHERS |                              P=0.063N                                          P=0.059N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 22      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/50 (2%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              1/42.69                                           4/41.85                      | 
|POLY-3 PERCENT (g) |                              2.3%                                              9.6%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         2/17 (12%)                   | 
|FIRST INCIDENCE    |                              524                                               637                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.093                                           P=0.093                      | 
|POLY 3             |                              P=0.173                                           P=0.173                      | 
|POLY 1.5           |                              P=0.179                                           P=0.179                      | 
|POLY 6             |                              P=0.161                                           P=0.161                      | 
|LOGISTIC REGRESSION|                              P=0.177                                           P=0.177                      | 
|COCH-ARM / FISHERS |                              P=0.179                                           P=0.181                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/50 (4%)                                         9/50 (18%)                   | 
|POLY-3 RATE (b)    |                              2/42.87                                           9/42.99                      | 
|POLY-3 PERCENT (g) |                              4.7%                                              20.9%                        | 
|TERMINAL (d)       |                              1/34 (3%)                                         3/17 (18%)                   | 
|FIRST INCIDENCE    |                              419                                               530                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.007 **                                        P=0.007 **                   | 
|POLY 3             |                              P=0.024 *                                         P=0.024 *                    | 
|POLY 1.5           |                              P=0.026 *                                         P=0.026 *                    | 
|POLY 6             |                              P=0.021 *                                         P=0.021 *                    | 
|LOGISTIC REGRESSION|                              P=0.025 *                                         P=0.025 *                    | 
|COCH-ARM / FISHERS |                              P=0.028 *                                         P=0.026 *                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 23      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/50 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/42.06                                           0/41.46                      | 
|POLY-3 PERCENT (g) |                              4.8%                                              0.0%                         | 
|TERMINAL (d)       |                              2/34 (6%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              729 (T)                                           ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.400N                                          P=0.400N                     | 
|POLY 3             |                              P=0.242N                                          P=0.242N                     | 
|POLY 1.5           |                              P=0.235N                                          P=0.235N                     | 
|POLY 6             |                              P=0.260N                                          P=0.260N                     | 
|LOGISTIC REGRESSION|                              P=0.400N                                          (e)                          | 
|COCH-ARM / FISHERS |                              P=0.238N                                          P=0.247N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Mixed Cell                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              0/42.06                                           3/42.78                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              7.0%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         1/17 (6%)                    | 
|FIRST INCIDENCE    |                              ---                                               489                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.090                                           P=0.090                      | 
|POLY 3             |                              P=0.120                                           P=0.120                      | 
|POLY 1.5           |                              P=0.122                                           P=0.122                      | 
|POLY 6             |                              P=0.115                                           P=0.115                      | 
|LOGISTIC REGRESSION|                              P=0.080                                           P=0.080                      | 
|COCH-ARM / FISHERS |                              P=0.121                                           P=0.121                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 24      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/50 (2%)                                         6/50 (12%)                   | 
|POLY-3 RATE (b)    |                              1/42.69                                           6/42.60                      | 
|POLY-3 PERCENT (g) |                              2.3%                                              14.1%                        | 
|TERMINAL (d)       |                              0/34 (0%)                                         2/17 (12%)                   | 
|FIRST INCIDENCE    |                              524                                               434                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.027 *                                         P=0.027 *                    | 
|POLY 3             |                              P=0.055                                           P=0.055                      | 
|POLY 1.5           |                              P=0.058                                           P=0.058                      | 
|POLY 6             |                              P=0.048 *                                         P=0.048 *                    | 
|LOGISTIC REGRESSION|                              P=0.050                                           P=0.050                      | 
|COCH-ARM / FISHERS |                              P=0.058                                           P=0.056                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Artery, Mediastinum                                                                                                        | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/42.06                                           2/41.63                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              4.8%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               696                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.171                                           P=0.171                      | 
|POLY 3             |                              P=0.236                                           P=0.236                      | 
|POLY 1.5           |                              P=0.238                                           P=0.238                      | 
|POLY 6             |                              P=0.230                                           P=0.230                      | 
|LOGISTIC REGRESSION|                              P=0.225                                           P=0.225                      | 
|COCH-ARM / FISHERS |                              P=0.238                                           P=0.247                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 25      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/48 (4%)                                         1/47 (2%)                    | 
|POLY-3 RATE (b)    |                              2/41.77                                           1/40.16                      | 
|POLY-3 PERCENT (g) |                              4.8%                                              2.5%                         | 
|TERMINAL (d)       |                              1/33 (3%)                                         1/17 (6%)                    | 
|FIRST INCIDENCE    |                              27                                                729 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.650N                                          P=0.650N                     | 
|POLY 3             |                              P=0.518N                                          P=0.518N                     | 
|POLY 1.5           |                              P=0.512N                                          P=0.512N                     | 
|POLY 6             |                              P=0.539N                                          P=0.539N                     | 
|LOGISTIC REGRESSION|                              P=0.697N                                          P=0.697N                     | 
|COCH-ARM / FISHERS |                              P=0.507N                                          P=0.508N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mediastinal                                                                                                          | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/42.06                                           2/42.83                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              4.7%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               489                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.251                                           P=0.251                      | 
|POLY 3             |                              P=0.239                                           P=0.239                      | 
|POLY 1.5           |                              P=0.240                                           P=0.240                      | 
|POLY 6             |                              P=0.234                                           P=0.234                      | 
|LOGISTIC REGRESSION|                              P=0.124                                           P=0.124                      | 
|COCH-ARM / FISHERS |                              P=0.238                                           P=0.247                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 26      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/48 (0%)                                         4/49 (8%)                    | 
|POLY-3 RATE (b)    |                              0/41.37                                           4/40.74                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              9.8%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         1/17 (6%)                    | 
|FIRST INCIDENCE    |                              ---                                               696                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.026 *                                         P=0.026 *                    | 
|POLY 3             |                              P=0.058                                           P=0.058                      | 
|POLY 1.5           |                              P=0.061                                           P=0.061                      | 
|POLY 6             |                              P=0.052                                           P=0.053                      | 
|LOGISTIC REGRESSION|                              P=0.047 *                                         P=0.047 *                    | 
|COCH-ARM / FISHERS |                              P=0.065                                           P=0.061                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/48 (0%)                                         4/49 (8%)                    | 
|POLY-3 RATE (b)    |                              0/41.37                                           4/41.23                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              9.7%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               656                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.053                                           P=0.053                      | 
|POLY 3             |                              P=0.059                                           P=0.059                      | 
|POLY 1.5           |                              P=0.062                                           P=0.062                      | 
|POLY 6             |                              P=0.054                                           P=0.055                      | 
|LOGISTIC REGRESSION|                              P=0.065                                           P=0.065                      | 
|COCH-ARM / FISHERS |                              P=0.065                                           P=0.061                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 27      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/48 (6%)                                         3/49 (6%)                    | 
|POLY-3 RATE (b)    |                              3/41.95                                           3/41.77                      | 
|POLY-3 PERCENT (g) |                              7.2%                                              7.2%                         | 
|TERMINAL (d)       |                              2/34 (6%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              545                                               489                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.559                                           P=0.559                      | 
|POLY 3             |                              P=0.661                                           P=0.661                      | 
|POLY 1.5           |                              P=0.651N                                          P=0.651N                     | 
|POLY 6             |                              P=0.642                                           P=0.642                      | 
|LOGISTIC REGRESSION|                              P=0.651                                           P=0.651                      | 
|COCH-ARM / FISHERS |                              P=0.654N                                          P=0.651N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/48 (4%)                                         2/49 (4%)                    | 
|POLY-3 RATE (b)    |                              2/41.37                                           2/40.49                      | 
|POLY-3 PERCENT (g) |                              4.8%                                              4.9%                         | 
|TERMINAL (d)       |                              2/34 (6%)                                         2/17 (12%)                   | 
|FIRST INCIDENCE    |                              729 (T)                                           729 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.428                                           P=0.428                      | 
|POLY 3             |                              P=0.689                                           P=0.689                      | 
|POLY 1.5           |                              P=0.689N                                          P=0.689N                     | 
|POLY 6             |                              P=0.672                                           P=0.672                      | 
|LOGISTIC REGRESSION|                              P=0.428                                           P=0.428                      | 
|COCH-ARM / FISHERS |                              P=0.688N                                          P=0.684N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 28      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Renal                                                                                                                | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/7 (0%)                                          2/15 (13%)                   | 
|POLY-3 RATE (b)    |                              0/4.74                                            2/11.32                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              17.7%                        | 
|TERMINAL (d)       |                              0/2 (0%)                                          0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               596                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.248                                           P=0.248                      | 
|POLY 3             |                              P=0.406                                           P=0.326                      | 
|POLY 1.5           |                              P=0.411                                           P=0.332                      | 
|POLY 6             |                              P=0.399                                           P=0.319                      | 
|LOGISTIC REGRESSION|                              P=0.418                                           P=0.418                      | 
|COCH-ARM / FISHERS |                              P=0.414                                           P=0.455                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/49 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/41.79                                           2/41.46                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              4.8%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         2/17 (12%)                   | 
|FIRST INCIDENCE    |                              ---                                               729 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.103                                           P=0.103                      | 
|POLY 3             |                              P=0.236                                           P=0.236                      | 
|POLY 1.5           |                              P=0.239                                           P=0.239                      | 
|POLY 6             |                              P=0.230                                           P=0.230                      | 
|LOGISTIC REGRESSION|                              (e)                                               P=0.103                      | 
|COCH-ARM / FISHERS |                              P=0.242                                           P=0.253                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 29      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery                                                                                                                        | 
|     Fibrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/23 (0%)                                         2/29 (7%)                    | 
|POLY-3 RATE (b)    |                              0/19.50                                           2/23.39                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              8.6%                         | 
|TERMINAL (d)       |                              0/15 (0%)                                         1/5 (20%)                    | 
|FIRST INCIDENCE    |                              ---                                               637                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.130                                           P=0.130                      | 
|POLY 3             |                              P=0.260                                           P=0.253                      | 
|POLY 1.5           |                              P=0.265                                           P=0.257                      | 
|POLY 6             |                              P=0.247                                           P=0.243                      | 
|LOGISTIC REGRESSION|                              P=0.282                                           P=0.282                      | 
|COCH-ARM / FISHERS |                              P=0.288                                           P=0.306                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery                                                                                                                        | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/23 (0%)                                         2/29 (7%)                    | 
|POLY-3 RATE (b)    |                              0/19.50                                           2/23.80                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              8.4%                         | 
|TERMINAL (d)       |                              0/15 (0%)                                         0/5 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               587                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.256                                           P=0.256                      | 
|POLY 3             |                              P=0.263                                           P=0.255                      | 
|POLY 1.5           |                              P=0.267                                           P=0.259                      | 
|POLY 6             |                              P=0.252                                           P=0.247                      | 
|LOGISTIC REGRESSION|                              P=0.287                                           P=0.287                      | 
|COCH-ARM / FISHERS |                              P=0.288                                           P=0.306                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 30      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Artery                                                                                                                | 
|     Inflammation Chronic Focal                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/23 (4%)                                         19/29 (66%)                  | 
|POLY-3 RATE (b)    |                              1/19.50                                           19/26.08                     | 
|POLY-3 PERCENT (g) |                              5.1%                                              72.9%                        | 
|TERMINAL (d)       |                              1/15 (7%)                                         2/5 (40%)                    | 
|FIRST INCIDENCE    |                              729 (T)                                           434                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Fat                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              19/23 (83%)                                       2/29 (7%)                    | 
|POLY-3 RATE (b)    |                              19/22.27                                          2/23.31                      | 
|POLY-3 PERCENT (g) |                              85.3%                                             8.6%                         | 
|TERMINAL (d)       |                              14/15 (93%)                                       0/5 (0%)                     | 
|FIRST INCIDENCE    |                              419                                               669                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.004N**                                        P=0.004N**                   | 
|POLY 3             |                              P<0.001N**                                        P<0.001N**                   | 
|POLY 1.5           |                              P<0.001N**                                        P<0.001N**                   | 
|POLY 6             |                              P<0.001N**                                        P<0.001N**                   | 
|LOGISTIC REGRESSION|                              P<0.001N**                                        P<0.001N**                   | 
|COCH-ARM / FISHERS |                              P<0.001N**                                        P<0.001N**                   | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 31      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Nasolacrimal Duct                                                                                                          | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/50 (4%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              2/42.64                                           1/41.80                      | 
|POLY-3 PERCENT (g) |                              4.7%                                              2.4%                         | 
|TERMINAL (d)       |                              1/34 (3%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              545                                               637                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.572N                                          P=0.572N                     | 
|POLY 3             |                              P=0.509N                                          P=0.509N                     | 
|POLY 1.5           |                              P=0.499N                                          P=0.499N                     | 
|POLY 6             |                              P=0.534N                                          P=0.534N                     | 
|LOGISTIC REGRESSION|                              P=0.521N                                          P=0.521N                     | 
|COCH-ARM / FISHERS |                              P=0.500N                                          P=0.500N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/49 (6%)                                         1/48 (2%)                    | 
|POLY-3 RATE (b)    |                              3/41.80                                           1/40.23                      | 
|POLY-3 PERCENT (g) |                              7.2%                                              2.5%                         | 
|TERMINAL (d)       |                              2/34 (6%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              725                                               720                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.555N                                          P=0.555N                     | 
|POLY 3             |                              P=0.322N                                          P=0.322N                     | 
|POLY 1.5           |                              P=0.312N                                          P=0.312N                     | 
|POLY 6             |                              P=0.347N                                          P=0.347N                     | 
|LOGISTIC REGRESSION|                              P=0.442N                                          P=0.442N                     | 
|COCH-ARM / FISHERS |                              P=0.312N                                          P=0.316N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 32      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              16/49 (33%)                                       19/48 (40%)                  | 
|POLY-3 RATE (b)    |                              16/43.56                                          19/42.56                     | 
|POLY-3 PERCENT (g) |                              36.7%                                             44.6%                        | 
|TERMINAL (d)       |                              12/34 (35%)                                       11/17 (65%)                  | 
|FIRST INCIDENCE    |                              545                                               434                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.016 *                                         P=0.016 *                    | 
|POLY 3             |                              P=0.297                                           P=0.297                      | 
|POLY 1.5           |                              P=0.322                                           P=0.322                      | 
|POLY 6             |                              P=0.243                                           P=0.243                      | 
|LOGISTIC REGRESSION|                              P=0.311                                           P=0.311                      | 
|COCH-ARM / FISHERS |                              P=0.309                                           P=0.309                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary: Artery                                                                                                                    | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/49 (0%)                                         26/48 (54%)                  | 
|POLY-3 RATE (b)    |                              0/41.79                                           26/43.35                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              60.0%                        | 
|TERMINAL (d)       |                              0/34 (0%)                                         8/17 (47%)                   | 
|FIRST INCIDENCE    |                              ---                                               434                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 33      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Artery                                                                                                                 | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/49 (0%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              0/41.79                                           3/41.83                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              7.2%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         1/17 (6%)                    | 
|FIRST INCIDENCE    |                              ---                                               637                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.064                                           P=0.064                      | 
|POLY 3             |                              P=0.118                                           P=0.118                      | 
|POLY 1.5           |                              P=0.121                                           P=0.121                      | 
|POLY 6             |                              P=0.112                                           P=0.112                      | 
|LOGISTIC REGRESSION|                              P=0.121                                           P=0.121                      | 
|COCH-ARM / FISHERS |                              P=0.124                                           P=0.125                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/48 (8%)                                         1/49 (2%)                    | 
|POLY-3 RATE (b)    |                              4/40.61                                           1/40.54                      | 
|POLY-3 PERCENT (g) |                              9.9%                                              2.5%                         | 
|TERMINAL (d)       |                              3/33 (9%)                                         1/17 (6%)                    | 
|FIRST INCIDENCE    |                              725                                               729 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.428N                                          P=0.428N                     | 
|POLY 3             |                              P=0.178N                                          P=0.178N                     | 
|POLY 1.5           |                              P=0.170N                                          P=0.170N                     | 
|POLY 6             |                              P=0.199N                                          P=0.199N                     | 
|LOGISTIC REGRESSION|                              P=0.364N                                          P=0.364N                     | 
|COCH-ARM / FISHERS |                              P=0.173N                                          P=0.175N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 34      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Cytoplasmic Alteration Focal                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/48 (6%)                                         3/49 (6%)                    | 
|POLY-3 RATE (b)    |                              3/40.59                                           3/40.62                      | 
|POLY-3 PERCENT (g) |                              7.4%                                              7.4%                         | 
|TERMINAL (d)       |                              3/33 (9%)                                         2/17 (12%)                   | 
|FIRST INCIDENCE    |                              729 (T)                                           709                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.368                                           P=0.368                      | 
|POLY 3             |                              P=0.663N                                          P=0.663N                     | 
|POLY 1.5           |                              P=0.649N                                          P=0.649N                     | 
|POLY 6             |                              P=0.643                                           P=0.643                      | 
|LOGISTIC REGRESSION|                              P=0.501                                           P=0.501                      | 
|COCH-ARM / FISHERS |                              P=0.654N                                          P=0.651N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands: Artery                                                                                                          | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/50 (2%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              1/42.06                                           2/41.75                      | 
|POLY-3 PERCENT (g) |                              2.4%                                              4.8%                         | 
|TERMINAL (d)       |                              1/34 (3%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              729 (T)                                           675                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.383                                           P=0.383                      | 
|POLY 3             |                              P=0.498                                           P=0.498                      | 
|POLY 1.5           |                              P=0.502                                           P=0.502                      | 
|POLY 6             |                              P=0.488                                           P=0.488                      | 
|LOGISTIC REGRESSION|                              P=0.489                                           P=0.489                      | 
|COCH-ARM / FISHERS |                              P=0.500                                           P=0.500                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 35      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              32/49 (65%)                                       43/50 (86%)                  | 
|POLY-3 RATE (b)    |                              32/45.69                                          43/48.52                     | 
|POLY-3 PERCENT (g) |                              70.0%                                             88.6%                        | 
|TERMINAL (d)       |                              22/34 (65%)                                       14/17 (82%)                  | 
|FIRST INCIDENCE    |                              27                                                434                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.018 *                                         P=0.018 *                    | 
|POLY 1.5           |                              P=0.016 *                                         P=0.016 *                    | 
|POLY 6             |                              P=0.018 *                                         P=0.018 *                    | 
|LOGISTIC REGRESSION|                              P=0.016 *                                         P=0.016 *                    | 
|COCH-ARM / FISHERS |                              P=0.015 *                                         P=0.015 *                    | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              9/49 (18%)                                        4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              9/41.79                                           4/41.46                      | 
|POLY-3 PERCENT (g) |                              21.5%                                             9.7%                         | 
|TERMINAL (d)       |                              9/34 (27%)                                        4/17 (24%)                   | 
|FIRST INCIDENCE    |                              729 (T)                                           729 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.545N                                          P=0.545N                     | 
|POLY 3             |                              P=0.115N                                          P=0.115N                     | 
|POLY 1.5           |                              P=0.106N                                          P=0.106N                     | 
|POLY 6             |                              P=0.138N                                          P=0.138N                     | 
|LOGISTIC REGRESSION|                              P=0.545N                                          P=0.545N                     | 
|COCH-ARM / FISHERS |                              P=0.109N                                          P=0.109N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 36      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Artery                                                                                                                   | 
|     Inflammation Chronic Focal                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/49 (0%)                                         6/50 (12%)                   | 
|POLY-3 RATE (b)    |                              0/41.79                                           6/42.17                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              14.2%                        | 
|TERMINAL (d)       |                              0/34 (0%)                                         2/17 (12%)                   | 
|FIRST INCIDENCE    |                              ---                                               637                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.006 **                                        P=0.006 **                   | 
|POLY 3             |                              P=0.015 *                                         P=0.015 *                    | 
|POLY 1.5           |                              P=0.016 *                                         P=0.016 *                    | 
|POLY 6             |                              P=0.013 *                                         P=0.013 *                    | 
|LOGISTIC REGRESSION|                              P=0.017 *                                         P=0.017 *                    | 
|COCH-ARM / FISHERS |                              P=0.019 *                                         P=0.014 *                    | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Inflammation Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/49 (4%)                                         0/49 (0%)                    | 
|POLY-3 RATE (b)    |                              2/42.41                                           0/40.53                      | 
|POLY-3 PERCENT (g) |                              4.7%                                              0.0%                         | 
|TERMINAL (d)       |                              1/34 (3%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              524                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.311N                                          P=0.311N                     | 
|POLY 3             |                              P=0.253N                                          P=0.253N                     | 
|POLY 1.5           |                              P=0.241N                                          P=0.241N                     | 
|POLY 6             |                              P=0.277N                                          P=0.277N                     | 
|LOGISTIC REGRESSION|                              P=0.250N                                          P=0.250N                     | 
|COCH-ARM / FISHERS |                              P=0.237N                                          P=0.247N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 37      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/49 (0%)                                         2/48 (4%)                    | 
|POLY-3 RATE (b)    |                              0/41.79                                           2/40.33                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.0%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         1/17 (6%)                    | 
|FIRST INCIDENCE    |                              ---                                               637                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.171                                           P=0.171                      | 
|POLY 3             |                              P=0.233                                           P=0.233                      | 
|POLY 1.5           |                              P=0.235                                           P=0.235                      | 
|POLY 6             |                              P=0.228                                           P=0.228                      | 
|LOGISTIC REGRESSION|                              P=0.233                                           P=0.233                      | 
|COCH-ARM / FISHERS |                              P=0.233                                           P=0.242                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/49 (0%)                                         2/39 (5%)                    | 
|POLY-3 RATE (b)    |                              0/41.77                                           2/32.86                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              6.1%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         0/14 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               696                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.182                                           P=0.182                      | 
|POLY 3             |                              P=0.219                                           P=0.209                      | 
|POLY 1.5           |                              P=0.220                                           P=0.211                      | 
|POLY 6             |                              P=0.217                                           P=0.206                      | 
|LOGISTIC REGRESSION|                              P=0.183                                           P=0.183                      | 
|COCH-ARM / FISHERS |                              P=0.188                                           P=0.194                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 38      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/49 (6%)                                         0/39 (0%)                    | 
|POLY-3 RATE (b)    |                              3/41.77                                           0/32.65                      | 
|POLY-3 PERCENT (g) |                              7.2%                                              0.0%                         | 
|TERMINAL (d)       |                              3/34 (9%)                                         0/14 (0%)                    | 
|FIRST INCIDENCE    |                              729 (T)                                           ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.313N                                          P=0.313N                     | 
|POLY 3             |                              P=0.193N                                          P=0.185N                     | 
|POLY 1.5           |                              P=0.185N                                          P=0.178N                     | 
|POLY 6             |                              P=0.213N                                          P=0.202N                     | 
|LOGISTIC REGRESSION|                              P=0.313N                                          (e)                          | 
|COCH-ARM / FISHERS |                              P=0.163N                                          P=0.168N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland                                                                                                                    | 
|     Degeneration Cystic Focal                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              13/49 (27%)                                       21/50 (42%)                  | 
|POLY-3 RATE (b)    |                              13/42.56                                          21/44.09                     | 
|POLY-3 PERCENT (g) |                              30.5%                                             47.6%                        | 
|TERMINAL (d)       |                              10/34 (29%)                                       9/17 (53%)                   | 
|FIRST INCIDENCE    |                              577                                               434                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.002 **                                        P=0.002 **                   | 
|POLY 3             |                              P=0.074                                           P=0.074                      | 
|POLY 1.5           |                              P=0.083                                           P=0.083                      | 
|POLY 6             |                              P=0.056                                           P=0.056                      | 
|LOGISTIC REGRESSION|                              P=0.068                                           P=0.068                      | 
|COCH-ARM / FISHERS |                              P=0.079                                           P=0.079                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 39      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland                                                                                                                    | 
|     Inflammation Chronic Focal                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/49 (2%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              1/41.77                                           2/41.50                      | 
|POLY-3 PERCENT (g) |                              2.4%                                              4.8%                         | 
|TERMINAL (d)       |                              1/34 (3%)                                         1/17 (6%)                    | 
|FIRST INCIDENCE    |                              729 (T)                                           720                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.288                                           P=0.288                      | 
|POLY 3             |                              P=0.498                                           P=0.498                      | 
|POLY 1.5           |                              P=0.505                                           P=0.504                      | 
|POLY 6             |                              P=0.486                                           P=0.486                      | 
|LOGISTIC REGRESSION|                              P=0.365                                           P=0.365                      | 
|COCH-ARM / FISHERS |                              P=0.507                                           P=0.508                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth: Peridontal Tissue                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              6/7 (86%)                                         0/0 (0%)                     | 
|POLY-3 RATE (b)    |                              6/6.98                                            0/0.00                       | 
|POLY-3 PERCENT (g) |                              85.9%                                             0.0%                         | 
|TERMINAL (d)       |                              4/4 (100%)                                        0/0 (0%)                     | 
|FIRST INCIDENCE    |                              475                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.342N                                          P=0.342N                     | 
|POLY 3             |                              P=1.000N                                          (e)                          | 
|POLY 1.5           |                              P=1.000N                                          (e)                          | 
|POLY 6             |                              P=1.000N                                          (e)                          | 
|LOGISTIC REGRESSION|                              (e)                                               (e)                          | 
|COCH-ARM / FISHERS |                              P=1.000N                                          P=1.000                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 40      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/49 (2%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              1/41.79                                           2/42.16                      | 
|POLY-3 PERCENT (g) |                              2.4%                                              4.7%                         | 
|TERMINAL (d)       |                              1/34 (3%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              729 (T)                                           530                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.394                                           P=0.394                      | 
|POLY 3             |                              P=0.502                                           P=0.502                      | 
|POLY 1.5           |                              P=0.507                                           P=0.506                      | 
|POLY 6             |                              P=0.491                                           P=0.492                      | 
|LOGISTIC REGRESSION|                              P=0.500                                           P=0.500                      | 
|COCH-ARM / FISHERS |                              P=0.507                                           P=0.508                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Hydrometra                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              27/49 (55%)                                       19/50 (38%)                  | 
|POLY-3 RATE (b)    |                              27/45.17                                          19/43.46                     | 
|POLY-3 PERCENT (g) |                              59.8%                                             43.7%                        | 
|TERMINAL (d)       |                              20/34 (59%)                                       10/17 (59%)                  | 
|FIRST INCIDENCE    |                              482                                               530                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.379                                           P=0.379                      | 
|POLY 3             |                              P=0.091N                                          P=0.091N                     | 
|POLY 1.5           |                              P=0.069N                                          P=0.069N                     | 
|POLY 6             |                              P=0.143N                                          P=0.143N                     | 
|LOGISTIC REGRESSION|                              P=0.065N                                          P=0.065N                     | 
|COCH-ARM / FISHERS |                              P=0.066N                                          P=0.066N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 41      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/49 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/42.05                                           0/41.46                      | 
|POLY-3 PERCENT (g) |                              4.8%                                              0.0%                         | 
|TERMINAL (d)       |                              1/34 (3%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              657                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.317N                                          P=0.317N                     | 
|POLY 3             |                              P=0.242N                                          P=0.242N                     | 
|POLY 1.5           |                              P=0.232N                                          P=0.232N                     | 
|POLY 6             |                              P=0.264N                                          P=0.264N                     | 
|LOGISTIC REGRESSION|                              P=0.235N                                          P=0.235N                     | 
|COCH-ARM / FISHERS |                              P=0.233N                                          P=0.242N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Artery                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/49 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/41.79                                           2/41.75                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              4.8%                         | 
|TERMINAL (d)       |                              0/34 (0%)                                         0/17 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               675                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.203                                           P=0.203                      | 
|POLY 3             |                              P=0.237                                           P=0.237                      | 
|POLY 1.5           |                              P=0.240                                           P=0.240                      | 
|POLY 6             |                              P=0.231                                           P=0.231                      | 
|LOGISTIC REGRESSION|                              P=0.240                                           P=0.240                      | 
|COCH-ARM / FISHERS |                              P=0.242                                           P=0.253                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 42      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    RIDDELLIINE         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Artery                                                                                                                   | 
|     Inflammation Chronic Focal                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/49 (0%)                                         21/50 (42%)                  | 
|POLY-3 RATE (b)    |                              0/41.79                                           21/44.32                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              47.4%                        | 
|TERMINAL (d)       |                              0/34 (0%)                                         5/17 (29%)                   | 
|FIRST INCIDENCE    |                              ---                                               434                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0                                                 3.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              43/49 (88%)                                       41/50 (82%)                  | 
|POLY-3 RATE (b)    |                              43/45.35                                          41/47.58                     | 
|POLY-3 PERCENT (g) |                              94.8%                                             86.2%                        | 
|TERMINAL (d)       |                              33/34 (97%)                                       14/17 (82%)                  | 
|FIRST INCIDENCE    |                              545                                               434                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.007 **                                        P=0.007 **                   | 
|POLY 3             |                              P=0.115N                                          P=0.115N                     | 
|POLY 1.5           |                              P=0.144N                                          P=0.144N                     | 
|POLY 6             |                              P=0.109N                                          P=0.109N                     | 
|LOGISTIC REGRESSION|                              P=0.219N                                          P=0.219N                     | 
|COCH-ARM / FISHERS |                              P=0.302N                                          P=0.303N                     | 
|=================================================================================================================================| 
(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).