Skip to Main Navigation
Skip to Page Content
Share This:
https://ntp.niehs.nih.gov/go/1231

TDMS Study 05161-05 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Southern Research Inst                                   RIDDELLIINE                                      DATE: 12/15/00       
EXPERIMENT: 05161 TEST: 05                                                                                     TIME: 12:19:53       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 61358C       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 23246-96-0      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                         RATS/FINAL#1 MALES                                                         
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0       MG/KG/DY                                                              
                                       INCLUDE 002    1.0     MG/KG/DY                                                              
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Southern Research Inst                                   RIDDELLIINE                                      DATE: 12/15/00       
EXPERIMENT: 05161 TEST: 05                                                                                     TIME: 12:19:53       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 61358C       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 23246-96-0      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                   RIDDELLIINE                                                                                    
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Adrenal Cortex                         Accessory Adrenal Cortical Nodule                                                            
                                       Degeneration Fatty                                                                           
Bone Marrow                            Hyperplasia                                                                                  
Epididymis                             Atypia Cellular                                                                              
Heart                                  Cardiomyopathy                                                                               
Intestine Large, Cecum                 Edema                                                                                        
Kidney                                 Nephropathy                                                                                  
Kidney: Renal Tubule                   Hyaline Droplet                                                                              
                                       Necrosis                                                                                     
                                       Pigmentation                                                                                 
Liver                                  Basophilic Focus                                                                             
                                       Clear Cell Focus                                                                             
                                       Degeneration Cystic                                                                          
                                       Eosinophilic Focus                                                                           
                                       Hematopoietic Cell Proliferation                                                             
                                       Hemorrhage                                                                                   
                                       Infiltration Cellular Mixed Cell                                                             
                                       Mixed Cell Focus                                                                             
                                       Necrosis Focal                                                                               
Liver: Bile Duct                       Hyperplasia                                                                                  
Liver: Hepatocyte                      Cytomegaly                                                                                   
                                       Hyperplasia Regenerative                                                                     
                                       Vacuolization Cytoplasmic                                                                    
Lung                                   Edema                                                                                        
                                       Hemorrhage                                                                                   
                                       Infiltration Cellular Histiocyte                                                             
Lymph Node, Mediastinal                Congestion                                                                                   
                                       Hemorrhage                                                                                   
                                       Pigmentation                                                                                 
Lymph Node, Mesenteric                 Congestion                                                                                   
                                       Hemorrhage                                                                                   
Lymph Node: Renal                      Hemorrhage                                                                                   
                                       Pigmentation                                                                                 
Mesentery: Fat                         Necrosis                                                                                     
Nose                                   Foreign Body                                                                                 
                                       Inflammation Chronic                                                                         
Nose: Respiratory Epithelium           Hyperplasia                                                                                  
Pancreas                               Atrophy                                                                                      
Pituitary Gland: Pars Distalis         Hyperplasia Focal                                                                            
Preputial Gland                        Inflammation Chronic                                                                         
Prostate                               Inflammation Chronic                                                                         
Skeletal Muscle                        Hemorrhage                                                                                   
Spleen                                 Congestion                                                                                   
                                       Hematopoietic Cell Proliferation                                                             
Stomach, Forestomach                   Ulcer                                                                                        
Stomach, Glandular                     Erosion                                                                                      
                                       Ulcer                                                                                        
Testes                                 Atrophy                                                                                      
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Southern Research Inst                                   RIDDELLIINE                                      DATE: 12/15/00       
EXPERIMENT: 05161 TEST: 05                                                                                     TIME: 12:19:53       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 61358C       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 23246-96-0      
Testes: Interstitial Cell              Hyperplasia                                                                                  
Thymus                                 Hemorrhage                                                                                   
===============================================================                                                                     
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 1       
                     Statistical Analysis of Non-neoplastic Lesions in        Rats(FISCHER 344)  -                    RIDDELLIINE   
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Accessory Adrenal Cortical Nodule                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              8/49 (16%)                                        1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              8/48.84                                           1/28.57                      | 
|POLY-3 PERCENT (g) |                              16.4%                                             3.5%                         | 
|TERMINAL (d)       |                              8/48 (17%)                                        0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           327                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.707                                           P=0.707                      | 
|POLY 3             |                              P=0.133N                                          P=0.135N                     | 
|POLY 1.5           |                              P=0.053N                                          P=0.053N                     | 
|POLY 6             |                              P=0.393N                                          P=0.395N                     | 
|LOGISTIC REGRESSION|                              P=0.093N                                          P=0.093N                     | 
|COCH-ARM / FISHERS |                              P=0.017N*                                         P=0.014N*                    | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Degeneration Fatty                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/49 (10%)                                        4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              5/49.00                                           4/28.71                      | 
|POLY-3 PERCENT (g) |                              10.2%                                             13.9%                        | 
|TERMINAL (d)       |                              4/48 (8%)                                         1/3 (33%)                    | 
|FIRST INCIDENCE    |                              468                                               424                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.513                                           P=0.514                      | 
|POLY 1.5           |                              P=0.626                                           P=0.627                      | 
|POLY 6             |                              P=0.394                                           P=0.396                      | 
|LOGISTIC REGRESSION|                              P=0.187                                           P=0.187                      | 
|COCH-ARM / FISHERS |                              P=0.487N                                          P=0.487N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 2       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/49 (6%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              3/48.84                                           1/27.85                      | 
|POLY-3 PERCENT (g) |                              6.1%                                              3.6%                         | 
|TERMINAL (d)       |                              3/48 (6%)                                         1/3 (33%)                    | 
|FIRST INCIDENCE    |                              497 (T)                                           497 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.281                                           P=0.281                      | 
|POLY 3             |                              P=0.611N                                          P=0.613N                     | 
|POLY 1.5           |                              P=0.455N                                          P=0.456N                     | 
|POLY 6             |                              P=0.840N                                          P=0.841N                     | 
|LOGISTIC REGRESSION|                              P=0.281                                           P=0.281                      | 
|COCH-ARM / FISHERS |                              P=0.298N                                          P=0.301N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/50 (2%)                                         36/49 (73%)                  | 
|POLY-3 RATE (b)    |                              1/50.00                                           36/41.84                     | 
|POLY-3 PERCENT (g) |                              2.0%                                              86.1%                        | 
|TERMINAL (d)       |                              0/49 (0%)                                         2/3 (67%)                    | 
|FIRST INCIDENCE    |                              468                                               307                          | 
|-------------------|                                                                                                             | 
|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:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 3       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone: Femur                                                                                                                      | 
|     Osteopetrosis                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/49.84                                           2/29.03                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              6.9%                         | 
|TERMINAL (d)       |                              0/49 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               321                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.165                                           P=0.165                      | 
|POLY 3             |                              P=0.226                                           P=0.226                      | 
|POLY 1.5           |                              P=0.218                                           P=0.218                      | 
|POLY 6             |                              P=0.308                                           P=0.308                      | 
|LOGISTIC REGRESSION|                              P=0.670                                           P=0.670                      | 
|COCH-ARM / FISHERS |                              P=0.238                                           P=0.247                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain                                                                                                                            | 
|     Compression                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/50 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/49.84                                           0/27.85                      | 
|POLY-3 PERCENT (g) |                              4.0%                                              0.0%                         | 
|TERMINAL (d)       |                              2/49 (4%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.881N                                          P=0.881N                     | 
|POLY 3             |                              P=0.520N                                          P=0.520N                     | 
|POLY 1.5           |                              P=0.368N                                          P=0.368N                     | 
|POLY 6             |                              P=0.794N                                          P=0.794N                     | 
|LOGISTIC REGRESSION|                              P=0.881N                                          (e)                          | 
|COCH-ARM / FISHERS |                              P=0.238N                                          P=0.247N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 4       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Epididymis                                                                                                                       | 
|     Atypia Cellular                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              9/50 (18%)                                        9/50 (18%)                   | 
|POLY-3 RATE (b)    |                              9/49.84                                           9/31.19                      | 
|POLY-3 PERCENT (g) |                              18.1%                                             28.9%                        | 
|TERMINAL (d)       |                              9/49 (18%)                                        1/3 (33%)                    | 
|FIRST INCIDENCE    |                              497 (T)                                           373                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.232                                           P=0.232                      | 
|POLY 1.5           |                              P=0.379                                           P=0.379                      | 
|POLY 6             |                              P=0.104                                           P=0.104                      | 
|LOGISTIC REGRESSION|                              P=0.259                                           P=0.259                      | 
|COCH-ARM / FISHERS |                              P=0.603                                           P=0.602N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              32/50 (64%)                                       28/50 (56%)                  | 
|POLY-3 RATE (b)    |                              32/49.84                                          28/40.39                     | 
|POLY-3 PERCENT (g) |                              64.2%                                             69.3%                        | 
|TERMINAL (d)       |                              32/49 (65%)                                       3/3 (100%)                   | 
|FIRST INCIDENCE    |                              497 (T)                                           204                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.394                                           P=0.394                      | 
|POLY 1.5           |                              P=0.557N                                          P=0.557N                     | 
|POLY 6             |                              P=0.121                                           P=0.121                      | 
|LOGISTIC REGRESSION|                              P=0.297N                                          P=0.297N                     | 
|COCH-ARM / FISHERS |                              P=0.270N                                          P=0.270N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 5       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Cecum                                                                                                           | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/50 (2%)                                         3/49 (6%)                    | 
|POLY-3 RATE (b)    |                              1/50.00                                           3/28.02                      | 
|POLY-3 PERCENT (g) |                              2.0%                                              10.7%                        | 
|TERMINAL (d)       |                              0/49 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              468                                               412                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.018 *                                         P=0.018 *                    | 
|POLY 3             |                              P=0.210                                           P=0.208                      | 
|POLY 1.5           |                              P=0.236                                           P=0.235                      | 
|POLY 6             |                              P=0.223                                           P=0.220                      | 
|LOGISTIC REGRESSION|                              P=0.334                                           P=0.334                      | 
|COCH-ARM / FISHERS |                              P=0.298                                           P=0.301                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Hydronephrosis                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/49.84                                           2/29.09                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              6.9%                         | 
|TERMINAL (d)       |                              0/49 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               204                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.103                                           P=0.103                      | 
|POLY 3             |                              P=0.226                                           P=0.226                      | 
|POLY 1.5           |                              P=0.218                                           P=0.218                      | 
|POLY 6             |                              P=0.310                                           P=0.310                      | 
|LOGISTIC REGRESSION|                              P=0.890                                           P=0.890                      | 
|COCH-ARM / FISHERS |                              P=0.238                                           P=0.247                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 6       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              47/50 (94%)                                       38/50 (76%)                  | 
|POLY-3 RATE (b)    |                              47/49.84                                          38/43.64                     | 
|POLY-3 PERCENT (g) |                              94.3%                                             87.1%                        | 
|TERMINAL (d)       |                              47/49 (96%)                                       3/3 (100%)                   | 
|FIRST INCIDENCE    |                              497 (T)                                           266                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.169N                                          P=0.169N                     | 
|POLY 1.5           |                              P=0.056N                                          P=0.056N                     | 
|POLY 6             |                              P=0.475N                                          P=0.475N                     | 
|LOGISTIC REGRESSION|                              P=0.507N                                          P=0.507N                     | 
|COCH-ARM / FISHERS |                              P=0.013N*                                         P=0.011N*                    | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Hyaline Droplet                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/50 (2%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              1/50.00                                           3/29.20                      | 
|POLY-3 PERCENT (g) |                              2.0%                                              10.3%                        | 
|TERMINAL (d)       |                              0/49 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              468                                               373                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.045 *                                         P=0.045 *                    | 
|POLY 3             |                              P=0.212                                           P=0.212                      | 
|POLY 1.5           |                              P=0.241                                           P=0.241                      | 
|POLY 6             |                              P=0.217                                           P=0.217                      | 
|LOGISTIC REGRESSION|                              P=0.536                                           P=0.536                      | 
|COCH-ARM / FISHERS |                              P=0.305                                           P=0.309                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 7       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         6/50 (12%)                   | 
|POLY-3 RATE (b)    |                              0/49.84                                           6/30.56                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              19.6%                        | 
|TERMINAL (d)       |                              0/49 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               307                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.004 **                                        P=0.004 **                   | 
|POLY 1.5           |                              P=0.007 **                                        P=0.007 **                   | 
|POLY 6             |                              P=0.003 **                                        P=0.003 **                   | 
|LOGISTIC REGRESSION|                              P=0.064                                           P=0.064                      | 
|COCH-ARM / FISHERS |                              P=0.018 *                                         P=0.013 *                    | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/50 (2%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              1/50.00                                           4/29.26                      | 
|POLY-3 PERCENT (g) |                              2.0%                                              13.7%                        | 
|TERMINAL (d)       |                              0/49 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              468                                               388                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.004 **                                        P=0.004 **                   | 
|POLY 3             |                              P=0.097                                           P=0.097                      | 
|POLY 1.5           |                              P=0.122                                           P=0.122                      | 
|POLY 6             |                              P=0.090                                           P=0.090                      | 
|LOGISTIC REGRESSION|                              P=0.190                                           P=0.190                      | 
|COCH-ARM / FISHERS |                              P=0.179                                           P=0.181                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 8       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Transitional Epithelium                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/49.84                                           2/28.72                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              7.0%                         | 
|TERMINAL (d)       |                              0/49 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               408                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.092                                           P=0.092                      | 
|POLY 3             |                              P=0.227                                           P=0.227                      | 
|POLY 1.5           |                              P=0.218                                           P=0.218                      | 
|POLY 6             |                              P=0.313                                           P=0.313                      | 
|LOGISTIC REGRESSION|                              P=0.383                                           P=0.383                      | 
|COCH-ARM / FISHERS |                              P=0.238                                           P=0.247                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              32/50 (64%)                                       21/50 (42%)                  | 
|POLY-3 RATE (b)    |                              32/49.84                                          21/38.20                     | 
|POLY-3 PERCENT (g) |                              64.2%                                             55.0%                        | 
|TERMINAL (d)       |                              32/49 (65%)                                       1/3 (33%)                    | 
|FIRST INCIDENCE    |                              497 (T)                                           204                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.261N                                          P=0.261N                     | 
|POLY 1.5           |                              P=0.098N                                          P=0.098N                     | 
|POLY 6             |                              P=0.605                                           P=0.605                      | 
|LOGISTIC REGRESSION|                              P=0.013N*                                         P=0.013N*                    | 
|COCH-ARM / FISHERS |                              P=0.023N*                                         P=0.022N*                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 9       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Clear Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/50 (6%)                                         5/50 (10%)                   | 
|POLY-3 RATE (b)    |                              3/49.84                                           5/29.69                      | 
|POLY-3 PERCENT (g) |                              6.0%                                              16.8%                        | 
|TERMINAL (d)       |                              3/49 (6%)                                         1/3 (33%)                    | 
|FIRST INCIDENCE    |                              497 (T)                                           373                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.003 **                                        P=0.003 **                   | 
|POLY 3             |                              P=0.172                                           P=0.172                      | 
|POLY 1.5           |                              P=0.238                                           P=0.238                      | 
|POLY 6             |                              P=0.121                                           P=0.121                      | 
|LOGISTIC REGRESSION|                              P=0.256                                           P=0.256                      | 
|COCH-ARM / FISHERS |                              P=0.356                                           P=0.357                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/50 (2%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              1/49.84                                           3/29.01                      | 
|POLY-3 PERCENT (g) |                              2.0%                                              10.3%                        | 
|TERMINAL (d)       |                              1/49 (2%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           414                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.019 *                                         P=0.019 *                    | 
|POLY 3             |                              P=0.212                                           P=0.212                      | 
|POLY 1.5           |                              P=0.241                                           P=0.241                      | 
|POLY 6             |                              P=0.217                                           P=0.217                      | 
|LOGISTIC REGRESSION|                              P=0.311                                           P=0.311                      | 
|COCH-ARM / FISHERS |                              P=0.305                                           P=0.309                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 10      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/50 (6%)                                         15/50 (30%)                  | 
|POLY-3 RATE (b)    |                              3/49.84                                           15/33.98                     | 
|POLY-3 PERCENT (g) |                              6.0%                                              44.2%                        | 
|TERMINAL (d)       |                              3/49 (6%)                                         1/3 (33%)                    | 
|FIRST INCIDENCE    |                              497 (T)                                           318                          | 
|-------------------|                                                                                                             | 
|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=0.004 **                                        P=0.004 **                   | 
|COCH-ARM / FISHERS |                              P=0.002 **                                        P=0.002 **                   | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/49.84                                           2/28.47                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              7.0%                         | 
|TERMINAL (d)       |                              0/49 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               440                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.022 *                                         P=0.022 *                    | 
|POLY 3             |                              P=0.228                                           P=0.228                      | 
|POLY 1.5           |                              P=0.218                                           P=0.218                      | 
|POLY 6             |                              P=0.319                                           P=0.319                      | 
|LOGISTIC REGRESSION|                              P=0.194                                           P=0.194                      | 
|COCH-ARM / FISHERS |                              P=0.238                                           P=0.247                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 11      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              0/49.84                                           4/30.00                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              13.3%                        | 
|TERMINAL (d)       |                              0/49 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               307                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.024 *                                         P=0.024 *                    | 
|POLY 3             |                              P=0.033 *                                         P=0.033 *                    | 
|POLY 1.5           |                              P=0.041 *                                         P=0.041 *                    | 
|POLY 6             |                              P=0.035 *                                         P=0.035 *                    | 
|LOGISTIC REGRESSION|                              P=0.301                                           P=0.301                      | 
|COCH-ARM / FISHERS |                              P=0.063                                           P=0.059                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatodiaphragmatic Nodule                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/50 (8%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              4/49.84                                           4/30.12                      | 
|POLY-3 PERCENT (g) |                              8.0%                                              13.3%                        | 
|TERMINAL (d)       |                              4/49 (8%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           321                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.076                                           P=0.076                      | 
|POLY 3             |                              P=0.419                                           P=0.419                      | 
|POLY 1.5           |                              P=0.513                                           P=0.513                      | 
|POLY 6             |                              P=0.326                                           P=0.326                      | 
|LOGISTIC REGRESSION|                              P=0.457N                                          P=0.457N                     | 
|COCH-ARM / FISHERS |                              P=0.644                                           P=0.643N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 12      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Infiltration Cellular Mixed Cell                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              8/50 (16%)                                        0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              8/49.84                                           0/27.85                      | 
|POLY-3 PERCENT (g) |                              16.1%                                             0.0%                         | 
|TERMINAL (d)       |                              8/49 (16%)                                        0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.525N                                          P=0.525N                     | 
|POLY 3             |                              P=0.060N                                          P=0.060N                     | 
|POLY 1.5           |                              P=0.018N*                                         P=0.018N*                    | 
|POLY 6             |                              P=0.258N                                          P=0.258N                     | 
|LOGISTIC REGRESSION|                              P=0.525N                                          (e)                          | 
|COCH-ARM / FISHERS |                              P=0.005N**                                        P=0.003N**                   | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/50 (6%)                                         7/50 (14%)                   | 
|POLY-3 RATE (b)    |                              3/49.84                                           7/30.51                      | 
|POLY-3 PERCENT (g) |                              6.0%                                              22.9%                        | 
|TERMINAL (d)       |                              3/49 (6%)                                         1/3 (33%)                    | 
|FIRST INCIDENCE    |                              497 (T)                                           314                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.046 *                                         P=0.046 *                    | 
|POLY 1.5           |                              P=0.080                                           P=0.080                      | 
|POLY 6             |                              P=0.024 *                                         P=0.024 *                    | 
|LOGISTIC REGRESSION|                              P=0.143                                           P=0.143                      | 
|COCH-ARM / FISHERS |                              P=0.159                                           P=0.159                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 13      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         23/50 (46%)                  | 
|POLY-3 RATE (b)    |                              0/49.84                                           23/38.52                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              59.7%                        | 
|TERMINAL (d)       |                              0/49 (0%)                                         1/3 (33%)                    | 
|FIRST INCIDENCE    |                              ---                                               204                          | 
|-------------------|                                                                                                             | 
|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 **                   | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              48/50 (96%)                                       37/50 (74%)                  | 
|POLY-3 RATE (b)    |                              48/49.84                                          37/46.07                     | 
|POLY-3 PERCENT (g) |                              96.3%                                             80.3%                        | 
|TERMINAL (d)       |                              48/49 (98%)                                       2/3 (67%)                    | 
|FIRST INCIDENCE    |                              497 (T)                                           204                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.007N**                                        P=0.007N**                   | 
|POLY 1.5           |                              P=0.004N**                                        P=0.004N**                   | 
|POLY 6             |                              P=0.024N*                                         P=0.024N*                    | 
|LOGISTIC REGRESSION|                              P<0.001N**                                        P<0.001N**                   | 
|COCH-ARM / FISHERS |                              P=0.003N**                                        P=0.002N**                   | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 14      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Cytomegaly                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         32/50 (64%)                  | 
|POLY-3 RATE (b)    |                              0/49.84                                           32/42.85                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              74.7%                        | 
|TERMINAL (d)       |                              0/49 (0%)                                         1/3 (33%)                    | 
|FIRST INCIDENCE    |                              ---                                               266                          | 
|-------------------|                                                                                                             | 
|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 **                   | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Hyperplasia Regenerative                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         49/50 (98%)                  | 
|POLY-3 RATE (b)    |                              0/49.84                                           49/49.58                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              98.8%                        | 
|TERMINAL (d)       |                              0/49 (0%)                                         3/3 (100%)                   | 
|FIRST INCIDENCE    |                              ---                                               204                          | 
|-------------------|                                                                                                             | 
|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:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 15      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              30/50 (60%)                                       5/50 (10%)                   | 
|POLY-3 RATE (b)    |                              30/49.84                                          5/30.96                      | 
|POLY-3 PERCENT (g) |                              60.2%                                             16.2%                        | 
|TERMINAL (d)       |                              30/49 (61%)                                       0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           266                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.290                                           P=0.290                      | 
|POLY 3             |                              P<0.001N**                                        P<0.001N**                   | 
|POLY 1.5           |                              P<0.001N**                                        P<0.001N**                   | 
|POLY 6             |                              P=0.011N*                                         P=0.011N*                    | 
|LOGISTIC REGRESSION|                              P<0.001N**                                        P<0.001N**                   | 
|COCH-ARM / FISHERS |                              P<0.001N**                                        P<0.001N**                   | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         5/50 (10%)                   | 
|POLY-3 RATE (b)    |                              0/49.84                                           5/30.23                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              16.5%                        | 
|TERMINAL (d)       |                              0/49 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               364                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.004 **                                        P=0.004 **                   | 
|POLY 3             |                              P=0.012 *                                         P=0.012 *                    | 
|POLY 1.5           |                              P=0.017 *                                         P=0.017 *                    | 
|POLY 6             |                              P=0.011 *                                         P=0.011 *                    | 
|LOGISTIC REGRESSION|                              P=0.112                                           P=0.112                      | 
|COCH-ARM / FISHERS |                              P=0.033 *                                         P=0.028 *                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 16      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/50 (2%)                                         21/50 (42%)                  | 
|POLY-3 RATE (b)    |                              1/49.84                                           21/36.82                     | 
|POLY-3 PERCENT (g) |                              2.0%                                              57.0%                        | 
|TERMINAL (d)       |                              1/49 (2%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           266                          | 
|-------------------|                                                                                                             | 
|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 **                   | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              41/50 (82%)                                       32/50 (64%)                  | 
|POLY-3 RATE (b)    |                              41/50.00                                          32/40.80                     | 
|POLY-3 PERCENT (g) |                              82.0%                                             78.4%                        | 
|TERMINAL (d)       |                              40/49 (82%)                                       2/3 (67%)                    | 
|FIRST INCIDENCE    |                              468                                               321                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.446N                                          P=0.446N                     | 
|POLY 1.5           |                              P=0.192N                                          P=0.192N                     | 
|POLY 6             |                              P=0.472                                           P=0.472                      | 
|LOGISTIC REGRESSION|                              P=0.548                                           P=0.548                      | 
|COCH-ARM / FISHERS |                              P=0.036N*                                         P=0.035N*                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 17      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Metaplasia Osseous                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/50 (4%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              2/50.00                                           1/28.08                      | 
|POLY-3 PERCENT (g) |                              4.0%                                              3.6%                         | 
|TERMINAL (d)       |                              1/49 (2%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              468                                               457                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.337                                           P=0.337                      | 
|POLY 3             |                              P=0.775N                                          P=0.775N                     | 
|POLY 1.5           |                              P=0.651N                                          P=0.651N                     | 
|POLY 6             |                              P=0.842                                           P=0.842                      | 
|LOGISTIC REGRESSION|                              P=0.820                                           P=0.820                      | 
|COCH-ARM / FISHERS |                              P=0.500N                                          P=0.500N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/50 (6%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              3/49.84                                           1/28.30                      | 
|POLY-3 PERCENT (g) |                              6.0%                                              3.5%                         | 
|TERMINAL (d)       |                              3/49 (6%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           407                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.521                                           P=0.521                      | 
|POLY 3             |                              P=0.614N                                          P=0.614N                     | 
|POLY 1.5           |                              P=0.462N                                          P=0.462N                     | 
|POLY 6             |                              P=0.832N                                          P=0.832N                     | 
|LOGISTIC REGRESSION|                              P=0.654N                                          P=0.654N                     | 
|COCH-ARM / FISHERS |                              P=0.305N                                          P=0.309N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 18      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/50 (4%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              2/49.84                                           1/28.32                      | 
|POLY-3 PERCENT (g) |                              4.0%                                              3.5%                         | 
|TERMINAL (d)       |                              2/49 (4%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           402                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.499                                           P=0.499                      | 
|POLY 3             |                              P=0.770N                                          P=0.770N                     | 
|POLY 1.5           |                              P=0.648N                                          P=0.648N                     | 
|POLY 6             |                              P=0.839                                           P=0.839                      | 
|LOGISTIC REGRESSION|                              P=0.733N                                          P=0.733N                     | 
|COCH-ARM / FISHERS |                              P=0.500N                                          P=0.500N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mediastinal                                                                                                          | 
|     Congestion                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/50 (6%)                                         11/50 (22%)                  | 
|POLY-3 RATE (b)    |                              3/49.84                                           11/31.82                     | 
|POLY-3 PERCENT (g) |                              6.0%                                              34.6%                        | 
|TERMINAL (d)       |                              3/49 (6%)                                         1/3 (33%)                    | 
|FIRST INCIDENCE    |                              497 (T)                                           373                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.002 **                                        P=0.002 **                   | 
|POLY 1.5           |                              P=0.005 **                                        P=0.005 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P=0.006 **                                        P=0.006 **                   | 
|COCH-ARM / FISHERS |                              P=0.022 *                                         P=0.020 *                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 19      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mediastinal                                                                                                          | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/50 (6%)                                         20/50 (40%)                  | 
|POLY-3 RATE (b)    |                              3/49.84                                           20/36.43                     | 
|POLY-3 PERCENT (g) |                              6.0%                                              54.9%                        | 
|TERMINAL (d)       |                              3/49 (6%)                                         1/3 (33%)                    | 
|FIRST INCIDENCE    |                              497 (T)                                           307                          | 
|-------------------|                                                                                                             | 
|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 **                   | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mediastinal                                                                                                          | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              10/50 (20%)                                       20/50 (40%)                  | 
|POLY-3 RATE (b)    |                              10/49.84                                          20/35.37                     | 
|POLY-3 PERCENT (g) |                              20.1%                                             56.6%                        | 
|TERMINAL (d)       |                              10/49 (20%)                                       2/3 (67%)                    | 
|FIRST INCIDENCE    |                              497 (T)                                           314                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P=0.003 **                                        P=0.003 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P=0.003 **                                        P=0.003 **                   | 
|COCH-ARM / FISHERS |                              P=0.025 *                                         P=0.024 *                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 20      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Congestion                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              0/49.84                                           4/29.37                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              13.6%                        | 
|TERMINAL (d)       |                              0/49 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               407                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.004 **                                        P=0.004 **                   | 
|POLY 3             |                              P=0.033 *                                         P=0.033 *                    | 
|POLY 1.5           |                              P=0.040 *                                         P=0.040 *                    | 
|POLY 6             |                              P=0.036 *                                         P=0.036 *                    | 
|LOGISTIC REGRESSION|                              P=0.070                                           P=0.070                      | 
|COCH-ARM / FISHERS |                              P=0.063                                           P=0.059                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/50 (2%)                                         8/50 (16%)                   | 
|POLY-3 RATE (b)    |                              1/49.84                                           8/31.08                      | 
|POLY-3 PERCENT (g) |                              2.0%                                              25.7%                        | 
|TERMINAL (d)       |                              1/49 (2%)                                         1/3 (33%)                    | 
|FIRST INCIDENCE    |                              497 (T)                                           327                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.003 **                                        P=0.003 **                   | 
|POLY 1.5           |                              P=0.006 **                                        P=0.006 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P=0.034 *                                         P=0.034 *                    | 
|COCH-ARM / FISHERS |                              P=0.018 *                                         P=0.015 *                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 21      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Pancreatic                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/13 (0%)                                         2/39 (5%)                    | 
|POLY-3 RATE (b)    |                              0/13.00                                           2/22.87                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              8.8%                         | 
|TERMINAL (d)       |                              0/13 (0%)                                         0/2 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               373                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.069                                           P=0.069                      | 
|POLY 3             |                              P=0.337                                           P=0.252                      | 
|POLY 1.5           |                              P=0.395                                           P=0.287                      | 
|POLY 6             |                              P=0.253                                           P=0.224                      | 
|LOGISTIC REGRESSION|                              P=0.606                                           P=0.606                      | 
|COCH-ARM / FISHERS |                              P=0.500                                           P=0.559                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Pancreatic                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/13 (0%)                                         2/39 (5%)                    | 
|POLY-3 RATE (b)    |                              0/13.00                                           2/22.87                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              8.8%                         | 
|TERMINAL (d)       |                              0/13 (0%)                                         0/2 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               373                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.069                                           P=0.069                      | 
|POLY 3             |                              P=0.337                                           P=0.252                      | 
|POLY 1.5           |                              P=0.395                                           P=0.287                      | 
|POLY 6             |                              P=0.253                                           P=0.224                      | 
|LOGISTIC REGRESSION|                              P=0.606                                           P=0.606                      | 
|COCH-ARM / FISHERS |                              P=0.500                                           P=0.559                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 22      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Renal                                                                                                                | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/13 (0%)                                         3/39 (8%)                    | 
|POLY-3 RATE (b)    |                              0/13.00                                           3/23.51                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              12.8%                        | 
|TERMINAL (d)       |                              0/13 (0%)                                         0/2 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               321                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.030 *                                         P=0.030 *                    | 
|POLY 3             |                              P=0.226                                           P=0.149                      | 
|POLY 1.5           |                              P=0.290                                           P=0.189                      | 
|POLY 6             |                              P=0.136                                           P=0.110                      | 
|LOGISTIC REGRESSION|                              P=0.591                                           P=0.591                      | 
|COCH-ARM / FISHERS |                              P=0.366                                           P=0.414                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Renal                                                                                                                | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/13 (0%)                                         3/39 (8%)                    | 
|POLY-3 RATE (b)    |                              0/13.00                                           3/23.51                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              12.8%                        | 
|TERMINAL (d)       |                              0/13 (0%)                                         0/2 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               321                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.030 *                                         P=0.030 *                    | 
|POLY 3             |                              P=0.226                                           P=0.149                      | 
|POLY 1.5           |                              P=0.290                                           P=0.189                      | 
|POLY 6             |                              P=0.136                                           P=0.110                      | 
|LOGISTIC REGRESSION|                              P=0.591                                           P=0.591                      | 
|COCH-ARM / FISHERS |                              P=0.366                                           P=0.414                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 23      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/42 (12%)                                        2/38 (5%)                    | 
|POLY-3 RATE (b)    |                              5/41.84                                           2/22.02                      | 
|POLY-3 PERCENT (g) |                              12.0%                                             9.1%                         | 
|TERMINAL (d)       |                              5/41 (12%)                                        0/2 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           321                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.307                                           P=0.307                      | 
|POLY 3             |                              P=0.614N                                          P=0.609N                     | 
|POLY 1.5           |                              P=0.447N                                          P=0.443N                     | 
|POLY 6             |                              P=0.767                                           P=0.761                      | 
|LOGISTIC REGRESSION|                              P=0.287N                                          P=0.287N                     | 
|COCH-ARM / FISHERS |                              P=0.257N                                          P=0.259N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Fat                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              7/8 (88%)                                         3/9 (33%)                    | 
|POLY-3 RATE (b)    |                              7/8.00                                            3/6.53                       | 
|POLY-3 PERCENT (g) |                              87.5%                                             46.0%                        | 
|TERMINAL (d)       |                              6/7 (86%)                                         0/0 (0%)                     | 
|FIRST INCIDENCE    |                              468                                               397                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.068                                           P=0.068                      | 
|POLY 3             |                              P=0.110N                                          P=0.113N                     | 
|POLY 1.5           |                              P=0.051N                                          P=0.052N                     | 
|POLY 6             |                              P=0.309N                                          P=0.318N                     | 
|LOGISTIC REGRESSION|                              P=0.201N                                          P=0.201N                     | 
|COCH-ARM / FISHERS |                              P=0.038N*                                         P=0.036N*                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 24      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Foreign Body                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/50 (10%)                                        5/50 (10%)                   | 
|POLY-3 RATE (b)    |                              5/49.84                                           5/30.11                      | 
|POLY-3 PERCENT (g) |                              10.0%                                             16.6%                        | 
|TERMINAL (d)       |                              5/49 (10%)                                        0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           364                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.014 *                                         P=0.014 *                    | 
|POLY 3             |                              P=0.364                                           P=0.364                      | 
|POLY 1.5           |                              P=0.474                                           P=0.474                      | 
|POLY 6             |                              P=0.254                                           P=0.254                      | 
|LOGISTIC REGRESSION|                              P=0.638                                           P=0.638                      | 
|COCH-ARM / FISHERS |                              P=0.631                                           P=0.630N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/50 (2%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              1/49.84                                           2/28.84                      | 
|POLY-3 PERCENT (g) |                              2.0%                                              6.9%                         | 
|TERMINAL (d)       |                              1/49 (2%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           364                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.136                                           P=0.136                      | 
|POLY 3             |                              P=0.424                                           P=0.424                      | 
|POLY 1.5           |                              P=0.444                                           P=0.444                      | 
|POLY 6             |                              P=0.461                                           P=0.461                      | 
|LOGISTIC REGRESSION|                              P=0.714                                           P=0.714                      | 
|COCH-ARM / FISHERS |                              P=0.500                                           P=0.500                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 25      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              7/50 (14%)                                        5/50 (10%)                   | 
|POLY-3 RATE (b)    |                              7/50.00                                           5/29.81                      | 
|POLY-3 PERCENT (g) |                              14.0%                                             16.8%                        | 
|TERMINAL (d)       |                              6/49 (12%)                                        0/3 (0%)                     | 
|FIRST INCIDENCE    |                              468                                               400                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.011 *                                         P=0.011 *                    | 
|POLY 3             |                              P=0.547                                           P=0.547                      | 
|POLY 1.5           |                              P=0.607N                                          P=0.607N                     | 
|POLY 6             |                              P=0.390                                           P=0.390                      | 
|LOGISTIC REGRESSION|                              P=0.655                                           P=0.655                      | 
|COCH-ARM / FISHERS |                              P=0.379N                                          P=0.380N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Respiratory Epithelium                                                                                                     | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              7/50 (14%)                                        6/50 (12%)                   | 
|POLY-3 RATE (b)    |                              7/49.84                                           6/30.62                      | 
|POLY-3 PERCENT (g) |                              14.1%                                             19.6%                        | 
|TERMINAL (d)       |                              7/49 (14%)                                        0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           364                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.010 *                                         P=0.010 *                    | 
|POLY 3             |                              P=0.416                                           P=0.416                      | 
|POLY 1.5           |                              P=0.551                                           P=0.551                      | 
|POLY 6             |                              P=0.267                                           P=0.267                      | 
|LOGISTIC REGRESSION|                              P=0.643N                                          P=0.643N                     | 
|COCH-ARM / FISHERS |                              P=0.500N                                          P=0.500N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 26      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              7/50 (14%)                                        7/50 (14%)                   | 
|POLY-3 RATE (b)    |                              7/49.84                                           7/30.71                      | 
|POLY-3 PERCENT (g) |                              14.1%                                             22.8%                        | 
|TERMINAL (d)       |                              7/49 (14%)                                        1/3 (33%)                    | 
|FIRST INCIDENCE    |                              497 (T)                                           266                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.288                                           P=0.288                      | 
|POLY 1.5           |                              P=0.423                                           P=0.423                      | 
|POLY 6             |                              P=0.158                                           P=0.158                      | 
|LOGISTIC REGRESSION|                              P=0.569                                           P=0.569                      | 
|COCH-ARM / FISHERS |                              P=0.613                                           P=0.613N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/50 (8%)                                         2/49 (4%)                    | 
|POLY-3 RATE (b)    |                              4/49.84                                           2/28.19                      | 
|POLY-3 PERCENT (g) |                              8.0%                                              7.1%                         | 
|TERMINAL (d)       |                              4/49 (8%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           373                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.253                                           P=0.253                      | 
|POLY 3             |                              P=0.681N                                          P=0.680N                     | 
|POLY 1.5           |                              P=0.527N                                          P=0.527N                     | 
|POLY 6             |                              P=0.718                                           P=0.716                      | 
|LOGISTIC REGRESSION|                              P=0.535N                                          P=0.535N                     | 
|COCH-ARM / FISHERS |                              P=0.346N                                          P=0.349N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 27      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/50 (10%)                                        4/49 (8%)                    | 
|POLY-3 RATE (b)    |                              5/49.84                                           4/28.94                      | 
|POLY-3 PERCENT (g) |                              10.0%                                             13.8%                        | 
|TERMINAL (d)       |                              5/49 (10%)                                        0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           375                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.033 *                                         P=0.033 *                    | 
|POLY 3             |                              P=0.509                                           P=0.509                      | 
|POLY 1.5           |                              P=0.614                                           P=0.614                      | 
|POLY 6             |                              P=0.399                                           P=0.397                      | 
|LOGISTIC REGRESSION|                              P=0.686                                           P=0.686                      | 
|COCH-ARM / FISHERS |                              P=0.513N                                          P=0.513N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              24/50 (48%)                                       16/50 (32%)                  | 
|POLY-3 RATE (b)    |                              24/50.00                                          16/34.36                     | 
|POLY-3 PERCENT (g) |                              48.0%                                             46.6%                        | 
|TERMINAL (d)       |                              23/49 (47%)                                       0/3 (0%)                     | 
|FIRST INCIDENCE    |                              468                                               297                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.560N                                          P=0.560N                     | 
|POLY 1.5           |                              P=0.290N                                          P=0.290N                     | 
|POLY 6             |                              P=0.332                                           P=0.332                      | 
|LOGISTIC REGRESSION|                              P=0.532N                                          P=0.532N                     | 
|COCH-ARM / FISHERS |                              P=0.077N                                          P=0.076N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 28      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Prostate                                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              18/50 (36%)                                       15/50 (30%)                  | 
|POLY-3 RATE (b)    |                              18/49.84                                          15/34.35                     | 
|POLY-3 PERCENT (g) |                              36.1%                                             43.7%                        | 
|TERMINAL (d)       |                              18/49 (37%)                                       1/3 (33%)                    | 
|FIRST INCIDENCE    |                              497 (T)                                           307                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.343                                           P=0.343                      | 
|POLY 1.5           |                              P=0.557                                           P=0.557                      | 
|POLY 6             |                              P=0.127                                           P=0.127                      | 
|LOGISTIC REGRESSION|                              P=0.601N                                          P=0.601N                     | 
|COCH-ARM / FISHERS |                              P=0.335N                                          P=0.335N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/49.84                                           2/29.13                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              6.9%                         | 
|TERMINAL (d)       |                              0/49 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               297                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.194                                           P=0.194                      | 
|POLY 3             |                              P=0.226                                           P=0.226                      | 
|POLY 1.5           |                              P=0.218                                           P=0.218                      | 
|POLY 6             |                              P=0.307                                           P=0.307                      | 
|LOGISTIC REGRESSION|                              P=0.762                                           P=0.762                      | 
|COCH-ARM / FISHERS |                              P=0.238                                           P=0.247                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 29      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skeletal Muscle                                                                                                                  | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/1 (0%)                                          3/5 (60%)                    | 
|POLY-3 RATE (b)    |                              0/0.84                                            3/3.91                       | 
|POLY-3 PERCENT (g) |                              0.0%                                              76.8%                        | 
|TERMINAL (d)       |                              0/0 (0%)                                          0/0 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               388                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.017 *                                         P=0.017 *                    | 
|POLY 3             |                              P=1.000                                           P=0.146                      | 
|POLY 1.5           |                              P=1.000                                           P=0.188                      | 
|POLY 6             |                              P=1.000                                           P=0.102                      | 
|LOGISTIC REGRESSION|                              P=0.488                                           P=0.488                      | 
|COCH-ARM / FISHERS |                              P=0.500                                           P=0.500                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Congestion                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         24/49 (49%)                  | 
|POLY-3 RATE (b)    |                              0/49.84                                           24/38.55                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              62.3%                        | 
|TERMINAL (d)       |                              0/49 (0%)                                         1/3 (33%)                    | 
|FIRST INCIDENCE    |                              ---                                               266                          | 
|-------------------|                                                                                                             | 
|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:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 30      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/50 (2%)                                         23/49 (47%)                  | 
|POLY-3 RATE (b)    |                              1/49.84                                           23/36.96                     | 
|POLY-3 PERCENT (g) |                              2.0%                                              62.2%                        | 
|TERMINAL (d)       |                              1/49 (2%)                                         1/3 (33%)                    | 
|FIRST INCIDENCE    |                              497 (T)                                           307                          | 
|-------------------|                                                                                                             | 
|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 **                   | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/49.84                                           2/28.93                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              6.9%                         | 
|TERMINAL (d)       |                              0/49 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               318                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.106                                           P=0.106                      | 
|POLY 3             |                              P=0.227                                           P=0.227                      | 
|POLY 1.5           |                              P=0.218                                           P=0.218                      | 
|POLY 6             |                              P=0.310                                           P=0.310                      | 
|LOGISTIC REGRESSION|                              P=0.604                                           P=0.604                      | 
|COCH-ARM / FISHERS |                              P=0.238                                           P=0.247                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 31      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              0/49.84                                           3/28.97                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              10.4%                        | 
|TERMINAL (d)       |                              0/49 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               373                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.009 **                                        P=0.009 **                   | 
|POLY 3             |                              P=0.088                                           P=0.088                      | 
|POLY 1.5           |                              P=0.093                                           P=0.093                      | 
|POLY 6             |                              P=0.111                                           P=0.111                      | 
|LOGISTIC REGRESSION|                              P=0.147                                           P=0.147                      | 
|COCH-ARM / FISHERS |                              P=0.121                                           P=0.121                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Erosion                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         10/50 (20%)                  | 
|POLY-3 RATE (b)    |                              0/49.84                                           10/32.85                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              30.4%                        | 
|TERMINAL (d)       |                              0/49 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               297                          | 
|-------------------|                                                                                                             | 
|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=0.034 *                                         P=0.034 *                    | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 32      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         6/50 (12%)                   | 
|POLY-3 RATE (b)    |                              0/49.84                                           6/30.82                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              19.5%                        | 
|TERMINAL (d)       |                              0/49 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               297                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.002 **                                        P=0.002 **                   | 
|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=0.110                                           P=0.110                      | 
|COCH-ARM / FISHERS |                              P=0.018 *                                         P=0.013 *                    | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/50 (6%)                                         6/50 (12%)                   | 
|POLY-3 RATE (b)    |                              3/49.84                                           6/30.05                      | 
|POLY-3 PERCENT (g) |                              6.0%                                              20.0%                        | 
|TERMINAL (d)       |                              3/49 (6%)                                         1/3 (33%)                    | 
|FIRST INCIDENCE    |                              497 (T)                                           398                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.092                                           P=0.092                      | 
|POLY 1.5           |                              P=0.141                                           P=0.141                      | 
|POLY 6             |                              P=0.056                                           P=0.056                      | 
|LOGISTIC REGRESSION|                              P=0.150                                           P=0.150                      | 
|COCH-ARM / FISHERS |                              P=0.242                                           P=0.243                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 33      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Interstitial Cell                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              22/50 (44%)                                       12/50 (24%)                  | 
|POLY-3 RATE (b)    |                              22/50.00                                          12/30.56                     | 
|POLY-3 PERCENT (g) |                              44.0%                                             39.3%                        | 
|TERMINAL (d)       |                              21/49 (43%)                                       2/3 (67%)                    | 
|FIRST INCIDENCE    |                              468                                               411                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.464N                                          P=0.464N                     | 
|POLY 1.5           |                              P=0.176N                                          P=0.176N                     | 
|POLY 6             |                              P=0.395                                           P=0.395                      | 
|LOGISTIC REGRESSION|                              P=0.023 *                                         P=0.023 *                    | 
|COCH-ARM / FISHERS |                              P=0.029N*                                         P=0.028N*                    | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/49 (0%)                                         4/49 (8%)                    | 
|POLY-3 RATE (b)    |                              0/48.84                                           4/29.62                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              13.5%                        | 
|TERMINAL (d)       |                              0/48 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               266                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.021 *                                         P=0.021 *                    | 
|POLY 3             |                              P=0.033 *                                         P=0.033 *                    | 
|POLY 1.5           |                              P=0.041 *                                         P=0.041 *                    | 
|POLY 6             |                              P=0.035 *                                         P=0.035 *                    | 
|LOGISTIC REGRESSION|                              P=0.417                                           P=0.417                      | 
|COCH-ARM / FISHERS |                              P=0.063                                           P=0.059                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 34      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    RIDDELLIINE    
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/50 (8%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              4/49.84                                           1/28.43                      | 
|POLY-3 PERCENT (g) |                              8.0%                                              3.5%                         | 
|TERMINAL (d)       |                              4/49 (8%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           373                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.603                                           P=0.603                      | 
|POLY 3             |                              P=0.473N                                          P=0.473N                     | 
|POLY 1.5           |                              P=0.317N                                          P=0.317N                     | 
|POLY 6             |                              P=0.736N                                          P=0.736N                     | 
|LOGISTIC REGRESSION|                              P=0.390N                                          P=0.390N                     | 
|COCH-ARM / FISHERS |                              P=0.179N                                          P=0.181N                     | 
|=================================================================================================================================| 
(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).