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TDMS Study 05161-05 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                   RIDDELLIINE                                      DATE: 12/15/00       
EXPERIMENT: 05161 TEST: 05                                                                                     TIME: 12:17:58       
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_FEMALES                                                        
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 003    0       MG/KG/DY                                                              
                                       INCLUDE 004    0.01    MG/KG/DY                                                              
                                       INCLUDE 005    0.033   MG/KG/DY                                                              
                                       INCLUDE 006    0.1     MG/KG/DY                                                              
                                       INCLUDE 007    0.33    MG/KG/DY                                                              
                                       INCLUDE 008    1.0     MG/KG/DY                                                              
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                   RIDDELLIINE                                      DATE: 12/15/00       
EXPERIMENT: 05161 TEST: 05                                                                                     TIME: 12:17:58       
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      
Rats(FISCHER 344)                                                                                                                   
-----------------------------                                                                                                       
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE                                                                   
BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES                                                                 
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Adrenal Cortex                                                                     
                                                 Adrenal Medulla                                                                    
                                                 Brain                                                                              
                                                 Clitoral/Preputial Gland                                                           
                                                 Islets, Pancreatic                                                                 
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Ovary                                                                              
                                                 Pancreas                                                                           
                                                 Pituitary Gland                                                                    
                                                 Thymus                                                                             
                                                 Thyroid Gland                                                                      
                                                 Urinary Bladder                                                                    
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                   RIDDELLIINE                                      DATE: 12/15/00       
EXPERIMENT: 05161 TEST: 05                                                                                     TIME: 12:17:58       
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                                                                                    
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Medulla                        Pheochromocytoma Benign                                                                      
Clitoral/Preputial Gland               Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
Liver                                  Hemangiosarcoma                                                                              
                                       Hepatocellular Adenoma                                                                       
                                       Hepatocellular Carcinoma or Hepatocellular Adenoma                                           
                                       Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                          
Mammary Gland                          Fibroadenoma                                                                                 
                                       Fibroma, Fibroadenoma or Adenoma                                                             
                                       Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                 
Pituitary Gland: Pars Distalis or Unspecified Site                                                                                  
                                       Adenoma                                                                                      
Thyroid Gland: C-Cell                  Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
Uterus                                 Polyp Stromal                                                                                
                                       Sarcoma Stromal                                                                              
                                       Sarcoma Stromal or Polyp Stromal                                                             
All Organs                             Hemangiosarcoma                                                                              
                                       Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                           
                                       Benign Tumors                                                                                
                                       Malignant Tumors                                                                             
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 1       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)        -                    RIDDELLIINE            
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Benign                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        5/49 (10%)       2/50 (4%)        1/50 (2%)        3/50 (6%)        1/50 (2%)       | 
|POLY-3 RATE (b)    |        1/42.87          5/39.41          2/41.60          1/40.79          3/42.37          1/18.33         | 
|POLY-3 PERCENT (g) |        2.3%             12.7%            4.8%             2.5%             7.1%             5.5%            | 
|TERMINAL (d)       |        1/33 (3%)        4/22 (18%)       2/28 (7%)        1/22 (5%)        1/29 (3%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        729 (T)          715              729 (T)          729 (T)          671              472             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.166          P=0.038 *        P=0.442          P=0.669          P=0.266          P=0.429         | 
|POLY 3             |        P=0.538          P=0.082          P=0.490          P=0.750          P=0.301          P=0.552         | 
|POLY 1.5           |        P=0.475N         P=0.089          P=0.496          P=0.753          P=0.304          P=0.655         | 
|POLY 6             |        P=0.453          P=0.071          P=0.478          P=0.742          P=0.292          P=0.424         | 
|LOGISTIC REGRESSION|        P=0.459          P=0.046 *        P=0.442          P=0.669          P=0.295          P=0.840         | 
|COCH-ARM / FISHERS |        P=0.299N         P=0.098          P=0.500          P=0.753N         P=0.309          P=0.753N        | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        5/49 (10%)       3/50 (6%)        1/50 (2%)        3/50 (6%)        1/50 (2%)       | 
|POLY-3 RATE (b)    |        2/43.28          5/39.41          3/42.12          1/40.79          3/42.37          1/18.33         | 
|POLY-3 PERCENT (g) |        4.6%             12.7%            7.1%             2.5%             7.1%             5.5%            | 
|TERMINAL (d)       |        1/33 (3%)        4/22 (18%)       2/28 (7%)        1/22 (5%)        1/29 (3%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        611              715              572              729 (T)          671              472             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.300          P=0.105          P=0.449          P=0.593N         P=0.450          P=0.483         | 
|POLY 3             |        P=0.469N         P=0.178          P=0.488          P=0.521N         P=0.490          P=0.666         | 
|POLY 1.5           |        P=0.356N         P=0.192          P=0.495          P=0.513N         P=0.497          P=0.645N        | 
|POLY 6             |        P=0.587          P=0.157          P=0.473          P=0.535N         P=0.476          P=0.502         | 
|LOGISTIC REGRESSION|        P=0.523N         P=0.162          P=0.502          P=0.509N         P=0.499          P=0.570N        | 
|COCH-ARM / FISHERS |        P=0.202N         P=0.210          P=0.500          P=0.500N         P=0.500          P=0.500N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 2       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/49 (14%)       7/49 (14%)       8/49 (16%)       10/48 (21%)      4/49 (8%)        2/50 (4%)       | 
|POLY-3 RATE (b)    |        7/41.95          7/39.59          8/42.00          10/40.42         4/41.62          2/18.54         | 
|POLY-3 PERCENT (g) |        16.7%            17.7%            19.1%            24.7%            9.6%             10.8%           | 
|TERMINAL (d)       |        7/33 (21%)       5/22 (23%)       5/28 (18%)       7/22 (32%)       3/29 (10%)       0/0 (0%)        | 
|FIRST INCIDENCE    |        729 (T)          719              532              651              686              503             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.272          P=0.300          P=0.381          P=0.080          P=0.337N         P=0.021 *       | 
|POLY 3             |        P=0.149N         P=0.569          P=0.501          P=0.263          P=0.263N         P=0.430N        | 
|POLY 1.5           |        P=0.074N         P=0.591          P=0.504          P=0.269          P=0.260N         P=0.222N        | 
|POLY 6             |        P=0.223N         P=0.528          P=0.489          P=0.247          P=0.276N         P=0.533         | 
|LOGISTIC REGRESSION|        P=0.612          P=0.363          P=0.465          P=0.176          P=0.320N         P=0.347         | 
|COCH-ARM / FISHERS |        P=0.015N*        P=0.613N         P=0.500          P=0.281          P=0.262N         P=0.075N        | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/49 (6%)        2/49 (4%)        4/49 (8%)        3/48 (6%)        2/49 (4%)        0/50 (0%)       | 
|POLY-3 RATE (b)    |        3/42.73          2/40.36          4/41.67          3/40.00          2/41.46          0/17.60         | 
|POLY-3 PERCENT (g) |        7.0%             5.0%             9.6%             7.5%             4.8%             0.0%            | 
|TERMINAL (d)       |        2/33 (6%)        1/22 (5%)        3/28 (11%)       2/22 (9%)        2/29 (7%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        437              407              562              715              729 (T)          ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.379N         P=0.610N         P=0.442          P=0.504          P=0.545N         P=0.536N        | 
|POLY 3             |        P=0.220N         P=0.526N         P=0.486          P=0.632          P=0.514N         P=0.341N        | 
|POLY 1.5           |        P=0.139N         P=0.513N         P=0.494          P=0.640          P=0.506N         P=0.219N        | 
|POLY 6             |        P=0.350N         P=0.550N         P=0.472          P=0.616          P=0.529N         P=0.515N        | 
|LOGISTIC REGRESSION|        P=0.074N         P=0.463N         P=0.500          P=0.654          P=0.502N         P=0.110N        | 
|COCH-ARM / FISHERS |        P=0.060N         P=0.500N         P=0.500          P=0.651          P=0.500N         P=0.117N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 3       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/49 (20%)      9/49 (18%)       12/49 (24%)      13/48 (27%)      6/49 (12%)       2/50 (4%)       | 
|POLY-3 RATE (b)    |        10/42.73         9/40.42          12/42.54         13/40.48         6/41.62          2/18.54         | 
|POLY-3 PERCENT (g) |        23.4%            22.3%            28.2%            32.1%            14.4%            10.8%           | 
|TERMINAL (d)       |        9/33 (27%)       6/22 (27%)       8/28 (29%)       9/22 (41%)       5/29 (17%)       0/0 (0%)        | 
|FIRST INCIDENCE    |        437              407              532              651              686              503             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.518          P=0.361          P=0.278          P=0.069          P=0.285N         P=0.197         | 
|POLY 3             |        P=0.072N         P=0.555N         P=0.397          P=0.258          P=0.218N         P=0.245N        | 
|POLY 1.5           |        P=0.022N*        P=0.528N         P=0.403          P=0.272          P=0.211N         P=0.078N        | 
|POLY 6             |        P=0.153N         P=0.604          P=0.383          P=0.234          P=0.235N         P=0.582N        | 
|LOGISTIC REGRESSION|        P=0.170N         P=0.546N         P=0.393          P=0.250          P=0.218N         P=0.525N        | 
|COCH-ARM / FISHERS |        P=0.002N**       P=0.500N         P=0.405          P=0.297          P=0.207N         P=0.013N*       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large: Colon/Rectum                                                                                                    | 
|     Lipoma                                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        2/50 (4%)        0/50 (0%)        0/50 (0%)        0/50 (0%)        0/50 (0%)       | 
|POLY-3 RATE (b)    |        0/42.87          2/39.94          0/41.60          0/40.79          0/41.99          0/17.60         | 
|POLY-3 PERCENT (g) |        0.0%             5.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/33 (0%)        2/22 (9%)        0/28 (0%)        0/22 (0%)        0/29 (0%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        ---              729 (T)          ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.817N         P=0.154          (e)              (e)              (e)              (e)             | 
|POLY 3             |        P=0.341N         P=0.221          (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.371N         P=0.229          (e)              (e)              (e)              (e)             | 
|POLY 6             |        P=0.383N         P=0.209          (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              P=0.154          (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.393N         P=0.247          (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 4       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        2/50 (4%)        4/50 (8%)        0/46 (0%)        1/50 (2%)        0/50 (0%)       | 
|POLY-3 RATE (b)    |        2/42.87          2/39.94          4/41.66          0/39.53          1/41.99          0/17.60         | 
|POLY-3 PERCENT (g) |        4.7%             5.0%             9.6%             0.0%             2.4%             0.0%            | 
|TERMINAL (d)       |        2/33 (6%)        2/22 (9%)        3/28 (11%)       0/22 (0%)        1/29 (3%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        729 (T)          729 (T)          715              ---              729 (T)          ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.450N         P=0.542          P=0.267          P=0.331N         P=0.545N         P=1.000N        | 
|POLY 3             |        P=0.168N         P=0.669          P=0.323          P=0.255N         P=0.507N         P=0.457N        | 
|POLY 1.5           |        P=0.139N         P=0.681          P=0.331          P=0.255N         P=0.502N         P=0.349N        | 
|POLY 6             |        P=0.210N         P=0.647          P=0.308          P=0.260N         P=0.519N         P=0.589N        | 
|LOGISTIC REGRESSION|        P=0.463N         P=0.542          P=0.271          (e)              P=0.545N         (e)             | 
|COCH-ARM / FISHERS |        P=0.091N         P=0.691N         P=0.339          P=0.269N         P=0.500N         P=0.247N        | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        2/50 (4%)        5/50 (10%)       0/46 (0%)        1/50 (2%)        0/50 (0%)       | 
|POLY-3 RATE (b)    |        2/42.87          2/39.94          5/41.66          0/39.53          1/41.99          0/17.60         | 
|POLY-3 PERCENT (g) |        4.7%             5.0%             12.0%            0.0%             2.4%             0.0%            | 
|TERMINAL (d)       |        2/33 (6%)        2/22 (9%)        4/28 (14%)       0/22 (0%)        1/29 (3%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        729 (T)          729 (T)          715              ---              729 (T)          ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.389N         P=0.542          P=0.157          P=0.331N         P=0.545N         P=1.000         | 
|POLY 3             |        P=0.140N         P=0.669          P=0.203          P=0.255N         P=0.507N         P=0.457N        | 
|POLY 1.5           |        P=0.114N         P=0.681          P=0.211          P=0.255N         P=0.502N         P=0.349N        | 
|POLY 6             |        P=0.174N         P=0.647          P=0.190          P=0.260N         P=0.519N         P=0.589N        | 
|LOGISTIC REGRESSION|        P=0.402N         P=0.542          P=0.158          (e)              P=0.545N         (e)             | 
|COCH-ARM / FISHERS |        P=0.072N         P=0.691N         P=0.218          P=0.269N         P=0.500N         P=0.247N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 5       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/50 (0%)        0/50 (0%)        3/50 (6%)        38/50 (76%)     | 
|POLY-3 RATE (b)    |        0/42.87          0/39.94          0/41.60          0/40.79          3/42.84          38/42.35        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             7.0%             89.7%           | 
|TERMINAL (d)       |        0/33 (0%)        0/22 (0%)        0/28 (0%)        0/22 (0%)        1/29 (3%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              524              350             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              P=0.114          P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              P=0.118          P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P=0.119          P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P=0.114          P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              (e)              P=0.114          P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              P=0.121          P<0.001 **      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Adenoma                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        0/50 (0%)        0/50 (0%)        1/50 (2%)        7/50 (14%)      | 
|POLY-3 RATE (b)    |        1/42.87          0/39.94          0/41.60          0/40.79          1/41.99          7/21.65         | 
|POLY-3 PERCENT (g) |        2.3%             0.0%             0.0%             0.0%             2.4%             32.3%           | 
|TERMINAL (d)       |        1/33 (3%)        0/22 (0%)        0/28 (0%)        0/22 (0%)        1/29 (3%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        729 (T)          ---              ---              ---              729 (T)          426             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.581N         P=0.533N         P=0.581N         P=0.733          P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.514N         P=0.506N         P=0.510N         P=0.756          P=0.002 **      | 
|POLY 1.5           |        P<0.001 **       P=0.507N         P=0.503N         P=0.507N         P=0.759          P=0.007 **      | 
|POLY 6             |        P<0.001 **       P=0.526N         P=0.513N         P=0.517N         P=0.749          P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              (e)              P=0.733          P=0.030 *       | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500N         P=0.500N         P=0.500N         P=0.753N         P=0.030 *       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 6       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        0/50 (0%)        0/50 (0%)        2/50 (4%)        8/50 (16%)      | 
|POLY-3 RATE (b)    |        1/42.87          0/39.94          0/41.60          0/40.79          2/41.99          8/22.17         | 
|POLY-3 PERCENT (g) |        2.3%             0.0%             0.0%             0.0%             4.8%             36.1%           | 
|TERMINAL (d)       |        1/33 (3%)        0/22 (0%)        0/28 (0%)        0/22 (0%)        2/29 (7%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        729 (T)          ---              ---              ---              729 (T)          426             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.581N         P=0.533N         P=0.581N         P=0.455          P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.514N         P=0.506N         P=0.510N         P=0.493          P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.507N         P=0.503N         P=0.507N         P=0.498          P=0.003 **      | 
|POLY 6             |        P<0.001 **       P=0.526N         P=0.513N         P=0.517N         P=0.481          P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              (e)              P=0.455          P=0.013 *       | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500N         P=0.500N         P=0.500N         P=0.500          P=0.015 *       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma, Hepatocellular Adenoma,                                                                           | 
|     or Hepatoblastoma                                                                                                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        0/50 (0%)        0/50 (0%)        2/50 (4%)        8/50 (16%)      | 
|POLY-3 RATE (b)    |        1/42.87          0/39.94          0/41.60          0/40.79          2/41.99          8/22.17         | 
|POLY-3 PERCENT (g) |        2.3%             0.0%             0.0%             0.0%             4.8%             36.1%           | 
|TERMINAL (d)       |        1/33 (3%)        0/22 (0%)        0/28 (0%)        0/22 (0%)        2/29 (7%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        729 (T)          ---              ---              ---              729 (T)          426             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.581N         P=0.533N         P=0.581N         P=0.455          P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.514N         P=0.506N         P=0.510N         P=0.493          P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.507N         P=0.503N         P=0.507N         P=0.498          P=0.003 **      | 
|POLY 6             |        P<0.001 **       P=0.526N         P=0.513N         P=0.517N         P=0.481          P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              (e)              P=0.455          P=0.013 *       | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500N         P=0.500N         P=0.500N         P=0.500          P=0.015 *       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 7       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        0/50 (0%)        0/50 (0%)        3/50 (6%)        2/50 (4%)        0/50 (0%)       | 
|POLY-3 RATE (b)    |        2/42.87          0/39.94          0/41.60          3/41.13          2/41.99          0/17.60         | 
|POLY-3 PERCENT (g) |        4.7%             0.0%             0.0%             7.3%             4.8%             0.0%            | 
|TERMINAL (d)       |        2/33 (6%)        0/22 (0%)        0/28 (0%)        1/22 (5%)        2/29 (7%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        729 (T)          ---              ---              658              729 (T)          ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.562          P=0.331N         P=0.275N         P=0.364          P=0.648          P=1.000N        | 
|POLY 3             |        P=0.538          P=0.253N         P=0.244N         P=0.481          P=0.687          P=0.457N        | 
|POLY 1.5           |        P=0.494N         P=0.245N         P=0.240N         P=0.487          P=0.692          P=0.349N        | 
|POLY 6             |        P=0.362          P=0.267N         P=0.251N         P=0.469          P=0.675          P=0.589N        | 
|LOGISTIC REGRESSION|        P=0.628          (e)              (e)              P=0.462          P=0.648          (e)             | 
|COCH-ARM / FISHERS |        P=0.324N         P=0.247N         P=0.247N         P=0.500          P=0.691N         P=0.247N        | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        0/50 (0%)        0/50 (0%)        3/50 (6%)        3/50 (6%)        0/50 (0%)       | 
|POLY-3 RATE (b)    |        2/42.87          0/39.94          0/41.60          3/41.13          3/41.99          0/17.60         | 
|POLY-3 PERCENT (g) |        4.7%             0.0%             0.0%             7.3%             7.2%             0.0%            | 
|TERMINAL (d)       |        2/33 (6%)        0/22 (0%)        0/28 (0%)        1/22 (5%)        3/29 (10%)       0/0 (0%)        | 
|FIRST INCIDENCE    |        729 (T)          ---              ---              658              729 (T)          ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.311          P=0.331N         P=0.275N         P=0.364          P=0.441          P=1.000N        | 
|POLY 3             |        P=0.383          P=0.253N         P=0.244N         P=0.481          P=0.490          P=0.457N        | 
|POLY 1.5           |        P=0.587N         P=0.245N         P=0.240N         P=0.487          P=0.497          P=0.349N        | 
|POLY 6             |        P=0.170          P=0.267N         P=0.251N         P=0.469          P=0.475          P=0.589N        | 
|LOGISTIC REGRESSION|        P=0.396          (e)              (e)              P=0.462          P=0.441          (e)             | 
|COCH-ARM / FISHERS |        P=0.366N         P=0.247N         P=0.247N         P=0.500          P=0.500          P=0.247N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 8       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        3/50 (6%)        2/50 (4%)        0/50 (0%)        4/50 (8%)        1/50 (2%)       | 
|POLY-3 RATE (b)    |        2/43.28          3/40.80          2/41.66          0/40.79          4/42.15          1/18.17         | 
|POLY-3 PERCENT (g) |        4.6%             7.4%             4.8%             0.0%             9.5%             5.5%            | 
|TERMINAL (d)       |        1/33 (3%)        1/22 (5%)        1/28 (4%)        0/22 (0%)        3/29 (10%)       0/0 (0%)        | 
|FIRST INCIDENCE    |        611              520              715              ---              686              552             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.078          P=0.406          P=0.645          P=0.284N         P=0.287          P=0.358         | 
|POLY 3             |        P=0.334          P=0.473          P=0.681          P=0.250N         P=0.324          P=0.664         | 
|POLY 1.5           |        P=0.524          P=0.486          P=0.688          P=0.246N         P=0.333          P=0.646N        | 
|POLY 6             |        P=0.210          P=0.449          P=0.667          P=0.260N         P=0.308          P=0.500         | 
|LOGISTIC REGRESSION|        P=0.564          P=0.519          P=0.689          P=0.235N         P=0.326          P=0.759N        | 
|COCH-ARM / FISHERS |        P=0.436N         P=0.500          P=0.691N         P=0.247N         P=0.339          P=0.500N        | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/50 (6%)        4/50 (8%)        2/50 (4%)        1/50 (2%)        4/50 (8%)        1/50 (2%)       | 
|POLY-3 RATE (b)    |        3/43.28          4/40.80          2/41.66          1/40.93          4/42.15          1/18.17         | 
|POLY-3 PERCENT (g) |        6.9%             9.8%             4.8%             2.4%             9.5%             5.5%            | 
|TERMINAL (d)       |        2/33 (6%)        2/22 (9%)        1/28 (4%)        0/22 (0%)        3/29 (10%)       0/0 (0%)        | 
|FIRST INCIDENCE    |        611              520              715              691              686              552             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.151          P=0.359          P=0.562N         P=0.401N         P=0.436          P=0.358         | 
|POLY 3             |        P=0.497          P=0.468          P=0.517N         P=0.325N         P=0.486          P=0.619N        | 
|POLY 1.5           |        P=0.475N         P=0.483          P=0.508N         P=0.318N         P=0.495          P=0.475N        | 
|POLY 6             |        P=0.368          P=0.439          P=0.535N         P=0.339N         P=0.466          P=0.557         | 
|LOGISTIC REGRESSION|        P=0.649N         P=0.500          P=0.515N         P=0.314N         P=0.482          P=0.728N        | 
|COCH-ARM / FISHERS |        P=0.270N         P=0.500          P=0.500N         P=0.309N         P=0.500          P=0.309N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 9       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroadenoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        28/50 (56%)      21/50 (42%)      26/50 (52%)      24/50 (48%)      23/50 (46%)      3/50 (6%)       | 
|POLY-3 RATE (b)    |        28/43.61         21/42.70         26/44.59         24/43.11         23/44.66         3/19.53         | 
|POLY-3 PERCENT (g) |        64.2%            49.2%            58.3%            55.7%            51.5%            15.4%           | 
|TERMINAL (d)       |        24/33 (73%)      12/22 (55%)      18/28 (64%)      12/22 (55%)      15/29 (52%)      0/0 (0%)        | 
|FIRST INCIDENCE    |        611              513              562              638              570              461             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.239          P=0.472          P=0.432          P=0.260          P=0.415N         P=0.045 *       | 
|POLY 3             |        P=0.006N**       P=0.105N         P=0.358N         P=0.269N         P=0.151N         P<0.001N**      | 
|POLY 1.5           |        P<0.001N**       P=0.106N         P=0.379N         P=0.283N         P=0.170N         P<0.001N**      | 
|POLY 6             |        P=0.112N         P=0.117N         P=0.346N         P=0.254N         P=0.140N         P=0.080N        | 
|LOGISTIC REGRESSION|        P=0.033N*        P=0.219N         P=0.510N         P=0.392N         P=0.250N         P=0.428N        | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.115N         P=0.421N         P=0.274N         P=0.212N         P<0.001N**      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma or Adenoma                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        28/50 (56%)      21/50 (42%)      26/50 (52%)      24/50 (48%)      24/50 (48%)      3/50 (6%)       | 
|POLY-3 RATE (b)    |        28/43.61         21/42.70         26/44.59         24/43.11         24/44.66         3/19.53         | 
|POLY-3 PERCENT (g) |        64.2%            49.2%            58.3%            55.7%            53.7%            15.4%           | 
|TERMINAL (d)       |        24/33 (73%)      12/22 (55%)      18/28 (64%)      12/22 (55%)      16/29 (55%)      0/0 (0%)        | 
|FIRST INCIDENCE    |        611              513              562              638              570              461             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.189          P=0.472          P=0.432          P=0.260          P=0.497N         P=0.045 *       | 
|POLY 3             |        P=0.009N**       P=0.105N         P=0.358N         P=0.269N         P=0.208N         P<0.001N**      | 
|POLY 1.5           |        P<0.001N**       P=0.106N         P=0.379N         P=0.283N         P=0.229N         P<0.001N**      | 
|POLY 6             |        P=0.162N         P=0.117N         P=0.346N         P=0.254N         P=0.196N         P=0.080N        | 
|LOGISTIC REGRESSION|        P=0.045N*        P=0.219N         P=0.510N         P=0.392N         P=0.326N         P=0.428N        | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.115N         P=0.421N         P=0.274N         P=0.274N         P<0.001N**      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 10      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        30/50 (60%)      23/50 (46%)      27/50 (54%)      24/50 (48%)      25/50 (50%)      4/50 (8%)       | 
|POLY-3 RATE (b)    |        30/44.02         23/43.56         27/44.65         24/43.11         25/44.66         4/20.10         | 
|POLY-3 PERCENT (g) |        68.2%            52.8%            60.5%            55.7%            56.0%            19.9%           | 
|TERMINAL (d)       |        25/33 (76%)      12/22 (55%)      18/28 (64%)      12/22 (55%)      17/29 (59%)      0/0 (0%)        | 
|FIRST INCIDENCE    |        611              513              562              638              570              461             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.108          P=0.449          P=0.497          P=0.382          P=0.433N         P=0.015 *       | 
|POLY 3             |        P=0.008N**       P=0.094N         P=0.289N         P=0.153N         P=0.157N         P<0.001N**      | 
|POLY 1.5           |        P<0.001N**       P=0.099N         P=0.305N         P=0.162N         P=0.172N         P<0.001N**      | 
|POLY 6             |        P=0.151N         P=0.101N         P=0.286N         P=0.146N         P=0.154N         P=0.080N        | 
|LOGISTIC REGRESSION|        P=0.035N*        P=0.190N         P=0.416N         P=0.223N         P=0.244N         P=0.335N        | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.115N         P=0.343N         P=0.158N         P=0.211N         P<0.001N**      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       | 
|     Papilloma Squamous or Papilloma                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        2/50 (4%)        1/50 (2%)        0/50 (0%)        0/50 (0%)       | 
|POLY-3 RATE (b)    |        0/42.87          0/39.94          2/41.66          1/40.79          0/41.99          0/17.60         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             4.8%             2.5%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/33 (0%)        0/22 (0%)        1/28 (4%)        1/22 (5%)        0/29 (0%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        ---              ---              715              729 (T)          ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.839N         (e)              P=0.209          P=0.419          (e)              (e)             | 
|POLY 3             |        P=0.381N         (e)              P=0.230          P=0.490          (e)              (e)             | 
|POLY 1.5           |        P=0.372N         (e)              P=0.234          P=0.493          (e)              (e)             | 
|POLY 6             |        P=0.459N         (e)              P=0.223          P=0.483          (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.822N         (e)              P=0.213          P=0.419          (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.350N         (e)              P=0.247          P=0.500          (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 11      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       | 
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        2/50 (4%)        2/50 (4%)        0/50 (0%)        0/50 (0%)       | 
|POLY-3 RATE (b)    |        0/42.87          0/39.94          2/41.66          2/40.79          0/41.99          0/17.60         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             4.8%             4.9%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/33 (0%)        0/22 (0%)        1/28 (4%)        2/22 (9%)        0/29 (0%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        ---              ---              715              729 (T)          ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.809N         (e)              P=0.209          P=0.154          (e)              (e)             | 
|POLY 3             |        P=0.369N         (e)              P=0.230          P=0.226          (e)              (e)             | 
|POLY 1.5           |        P=0.340N         (e)              P=0.234          P=0.230          (e)              (e)             | 
|POLY 6             |        P=0.462N         (e)              P=0.223          P=0.218          (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.802N         (e)              P=0.213          P=0.154          (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.295N         (e)              P=0.247          P=0.247          (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        27/50 (54%)      22/48 (46%)      21/50 (42%)      17/49 (35%)      24/50 (48%)      7/49 (14%)      | 
|POLY-3 RATE (b)    |        27/45.27         22/40.38         21/44.38         17/42.07         24/44.89         7/20.92         | 
|POLY-3 PERCENT (g) |        59.7%            54.5%            47.3%            40.4%            53.5%            33.5%           | 
|TERMINAL (d)       |        18/33 (55%)      16/21 (76%)      13/28 (46%)      9/22 (41%)       16/29 (55%)      0/0 (0%)        | 
|FIRST INCIDENCE    |        545              520              518              561              524              434             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.304          P=0.375N         P=0.327N         P=0.553N         P<0.001 **      | 
|POLY 3             |        P=0.150N         P=0.393N         P=0.163N         P=0.051N         P=0.349N         P=0.049N*       | 
|POLY 1.5           |        P=0.016N*        P=0.329N         P=0.153N         P=0.047N*        P=0.335N         P=0.002N**      | 
|POLY 6             |        P=0.509N         P=0.519N         P=0.196N         P=0.064N         P=0.399N         P=0.498N        | 
|LOGISTIC REGRESSION|        P=0.299N         P=0.402N         P=0.174N         P=0.051N         P=0.361N         P=0.428N        | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.272N         P=0.158N         P=0.041N*        P=0.345N         P<0.001N**      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 12      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous                                                                      | 
|     Tumor (benign, malignant or NOS), or Trichoepithelioma                                                                      | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        1/50 (2%)        2/50 (4%)        0/50 (0%)        0/50 (0%)        0/50 (0%)       | 
|POLY-3 RATE (b)    |        1/42.87          1/40.08          2/41.60          0/40.79          0/41.99          0/17.60         | 
|POLY-3 PERCENT (g) |        2.3%             2.5%             4.8%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        1/33 (3%)        0/22 (0%)        2/28 (7%)        0/22 (0%)        0/29 (0%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        729 (T)          693              729 (T)          ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.548N         P=0.686          P=0.442          P=0.581N         P=0.526N         P=1.000         | 
|POLY 3             |        P=0.202N         P=0.746          P=0.490          P=0.510N         P=0.504N         P=0.650N        | 
|POLY 1.5           |        P=0.216N         P=0.753          P=0.496          P=0.507N         P=0.501N         P=0.586N        | 
|POLY 6             |        P=0.208N         P=0.733          P=0.478          P=0.517N         P=0.511N         P=0.716N        | 
|LOGISTIC REGRESSION|        P=0.503N         P=0.735          P=0.442          (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.209N         P=0.753N         P=0.500          P=0.500N         P=0.500N         P=0.500N        | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor                                                                       | 
|     (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        3/50 (6%)        3/50 (6%)        0/50 (0%)        0/50 (0%)        0/50 (0%)       | 
|POLY-3 RATE (b)    |        1/42.87          3/40.38          3/41.60          0/40.79          0/41.99          0/17.60         | 
|POLY-3 PERCENT (g) |        2.3%             7.4%             7.2%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        1/33 (3%)        1/22 (5%)        3/28 (11%)       0/22 (0%)        0/29 (0%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        729 (T)          647              729 (T)          ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.264N         P=0.207          P=0.247          P=0.581N         P=0.526N         P=1.000         | 
|POLY 3             |        P=0.099N         P=0.284          P=0.294          P=0.510N         P=0.504N         P=0.650N        | 
|POLY 1.5           |        P=0.103N         P=0.294          P=0.301          P=0.507N         P=0.501N         P=0.586N        | 
|POLY 6             |        P=0.093N         P=0.267          P=0.282          P=0.517N         P=0.511N         P=0.716N        | 
|LOGISTIC REGRESSION|        P=0.216N         P=0.277          P=0.247          (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.089N         P=0.309          P=0.309          P=0.500N         P=0.500N         P=0.500N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 13      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        5/50 (10%)       3/50 (6%)        0/50 (0%)        1/50 (2%)       | 
|POLY-3 RATE (b)    |        1/43.58          0/39.94          5/42.18          3/41.17          0/41.99          1/18.37         | 
|POLY-3 PERCENT (g) |        2.3%             0.0%             11.9%            7.3%             0.0%             5.4%            | 
|TERMINAL (d)       |        0/33 (0%)        0/22 (0%)        3/28 (11%)       1/22 (5%)        0/29 (0%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        483              ---              647              638              ---              447             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.558          P=0.496N         P=0.088          P=0.252          P=0.496N         P=0.686         | 
|POLY 3             |        P=0.369N         P=0.517N         P=0.093          P=0.285          P=0.507N         P=0.549         | 
|POLY 1.5           |        P=0.351N         P=0.509N         P=0.097          P=0.292          P=0.503N         P=0.652         | 
|POLY 6             |        P=0.356N         P=0.530N         P=0.087          P=0.273          P=0.515N         P=0.422         | 
|LOGISTIC REGRESSION|        P=0.259N         P=0.441N         P=0.105          P=0.325          P=0.639N         P=0.391N        | 
|COCH-ARM / FISHERS |        P=0.277N         P=0.500N         P=0.102          P=0.309          P=0.500N         P=0.753N        | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        | 
|     or Fibrous Histiocytoma                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/50 (6%)        0/50 (0%)        5/50 (10%)       3/50 (6%)        0/50 (0%)        1/50 (2%)       | 
|POLY-3 RATE (b)    |        3/44.26          0/39.94          5/42.18          3/41.17          0/41.99          1/18.37         | 
|POLY-3 PERCENT (g) |        6.8%             0.0%             11.9%            7.3%             0.0%             5.4%            | 
|TERMINAL (d)       |        1/33 (3%)        0/22 (0%)        3/28 (11%)       1/22 (5%)        0/29 (0%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        483              ---              647              638              ---              447             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.670N         P=0.143N         P=0.316          P=0.577          P=0.128N         P=0.636N        | 
|POLY 3             |        P=0.239N         P=0.138N         P=0.330          P=0.629          P=0.128N         P=0.622N        | 
|POLY 1.5           |        P=0.229N         P=0.129N         P=0.343          P=0.640          P=0.123N         P=0.478N        | 
|POLY 6             |        P=0.210N         P=0.153N         P=0.311          P=0.611          P=0.137N         P=0.555         | 
|LOGISTIC REGRESSION|        P=0.119N         P=0.091N         P=0.359          P=0.628N         P=0.143N         P=0.054N        | 
|COCH-ARM / FISHERS |        P=0.171N         P=0.121N         P=0.357          P=0.661N         P=0.121N         P=0.309N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 14      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        0/50 (0%)        0/50 (0%)        0/50 (0%)        0/50 (0%)        0/50 (0%)       | 
|POLY-3 RATE (b)    |        2/43.55          0/39.94          0/41.60          0/40.79          0/41.99          0/17.60         | 
|POLY-3 PERCENT (g) |        4.6%             0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        1/33 (3%)        0/22 (0%)        0/28 (0%)        0/22 (0%)        0/29 (0%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        498              ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.562N         P=0.279N         P=0.253N         P=0.284N         P=0.249N         P=0.606N        | 
|POLY 3             |        P=0.289N         P=0.257N         P=0.247N         P=0.252N         P=0.245N         P=0.460N        | 
|POLY 1.5           |        P=0.336N         P=0.248N         P=0.242N         P=0.247N         P=0.241N         P=0.351N        | 
|POLY 6             |        P=0.290N         P=0.272N         P=0.256N         P=0.261N         P=0.254N         P=0.592N        | 
|LOGISTIC REGRESSION|        P=0.287N         P=0.215N         P=0.241N         P=0.206N         P=0.252N         P=0.201N        | 
|COCH-ARM / FISHERS |        P=0.378N         P=0.247N         P=0.247N         P=0.247N         P=0.247N         P=0.247N        | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma, Papilloma, Squamous Cell                                                                           | 
|     Carcinoma or Keratoacanthoma                                                                                                | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        2/50 (4%)        1/50 (2%)        0/50 (0%)        0/50 (0%)        0/50 (0%)       | 
|POLY-3 RATE (b)    |        0/42.87          2/40.24          1/41.60          0/40.79          0/41.99          0/17.60         | 
|POLY-3 PERCENT (g) |        0.0%             5.0%             2.4%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/33 (0%)        1/22 (5%)        1/28 (4%)        0/22 (0%)        0/29 (0%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        ---              647              729 (T)          ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.646N         P=0.179          P=0.467          (e)              (e)              (e)             | 
|POLY 3             |        P=0.266N         P=0.223          P=0.494          (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.284N         P=0.230          P=0.497          (e)              (e)              (e)             | 
|POLY 6             |        P=0.292N         P=0.212          P=0.487          (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.478N         P=0.228          P=0.467          (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.285N         P=0.247          P=0.500          (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 15      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        2/50 (4%)        1/50 (2%)        0/50 (0%)        0/50 (0%)        0/50 (0%)       | 
|POLY-3 RATE (b)    |        0/42.87          2/40.24          1/41.60          0/40.79          0/41.99          0/17.60         | 
|POLY-3 PERCENT (g) |        0.0%             5.0%             2.4%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/33 (0%)        1/22 (5%)        1/28 (4%)        0/22 (0%)        0/29 (0%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        ---              647              729 (T)          ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.646N         P=0.179          P=0.467          (e)              (e)              (e)             | 
|POLY 3             |        P=0.266N         P=0.223          P=0.494          (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.284N         P=0.230          P=0.497          (e)              (e)              (e)             | 
|POLY 6             |        P=0.292N         P=0.212          P=0.487          (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.478N         P=0.228          P=0.467          (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.285N         P=0.247          P=0.500          (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/49 (4%)        4/50 (8%)        4/49 (8%)        6/49 (12%)       11/50 (22%)      0/50 (0%)       | 
|POLY-3 RATE (b)    |        2/41.87          4/40.51          4/41.89          6/40.90          11/43.81         0/17.60         | 
|POLY-3 PERCENT (g) |        4.8%             9.9%             9.6%             14.7%            25.1%            0.0%            | 
|TERMINAL (d)       |        2/32 (6%)        1/22 (5%)        2/28 (7%)        5/22 (23%)       6/29 (21%)       0/0 (0%)        | 
|FIRST INCIDENCE    |        729 (T)          613              647              682              570              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.029 *        P=0.216          P=0.291          P=0.048 *        P=0.008 **       P=1.000N        | 
|POLY 3             |        P=0.169          P=0.321          P=0.337          P=0.123          P=0.008 **       P=0.452N        | 
|POLY 1.5           |        P=0.543N         P=0.333          P=0.339          P=0.127          P=0.008 **       P=0.343N        | 
|POLY 6             |        P=0.009 **       P=0.300          P=0.328          P=0.114          P=0.008 **       P=0.586N        | 
|LOGISTIC REGRESSION|        P=0.447          P=0.305          P=0.326          P=0.080          P=0.009 **       (e)             | 
|COCH-ARM / FISHERS |        P=0.135N         P=0.349          P=0.339          P=0.134          P=0.008 **       P=0.242N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 16      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/49 (6%)        4/50 (8%)        4/49 (8%)        6/49 (12%)       11/50 (22%)      0/50 (0%)       | 
|POLY-3 RATE (b)    |        3/41.87          4/40.51          4/41.89          6/40.90          11/43.81         0/17.60         | 
|POLY-3 PERCENT (g) |        7.2%             9.9%             9.6%             14.7%            25.1%            0.0%            | 
|TERMINAL (d)       |        3/32 (9%)        1/22 (5%)        2/28 (7%)        5/22 (23%)       6/29 (21%)       0/0 (0%)        | 
|FIRST INCIDENCE    |        729 (T)          613              647              682              570              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.041 *        P=0.339          P=0.440          P=0.099          P=0.018 *        P=1.000N        | 
|POLY 3             |        P=0.212          P=0.482          P=0.500          P=0.228          P=0.023 *        P=0.336N        | 
|POLY 1.5           |        P=0.489N         P=0.496          P=0.503          P=0.234          P=0.023 *        P=0.215N        | 
|POLY 6             |        P=0.016 *        P=0.457          P=0.491          P=0.214          P=0.022 *        P=0.510N        | 
|LOGISTIC REGRESSION|        P=0.478          P=0.454          P=0.484          P=0.153          P=0.023 *        (e)             | 
|COCH-ARM / FISHERS |        P=0.111N         P=0.511          P=0.500          P=0.243          P=0.022 *        P=0.117N        | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tongue                                                                                                                           | 
|     Squamous Cell Papilloma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        2/50 (4%)        0/50 (0%)        0/50 (0%)        0/50 (0%)       | 
|POLY-3 RATE (b)    |        0/42.87          0/39.94          2/41.66          0/40.79          0/41.99          0/17.60         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             4.8%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/33 (0%)        0/22 (0%)        1/28 (4%)        0/22 (0%)        0/29 (0%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        ---              ---              715              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.884N         (e)              P=0.209          (e)              (e)              (e)             | 
|POLY 3             |        P=0.393N         (e)              P=0.230          (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.412N         (e)              P=0.234          (e)              (e)              (e)             | 
|POLY 6             |        P=0.454N         (e)              P=0.223          (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.849N         (e)              P=0.213          (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.429N         (e)              P=0.247          (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 17      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Polyp Stromal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        11/50 (22%)      14/50 (28%)      15/50 (30%)      12/50 (24%)      9/50 (18%)       5/50 (10%)      | 
|POLY-3 RATE (b)    |        11/44.24         14/43.17         15/43.65         12/42.10         9/43.22          5/20.54         | 
|POLY-3 PERCENT (g) |        24.9%            32.4%            34.4%            28.5%            20.8%            24.4%           | 
|TERMINAL (d)       |        7/33 (21%)       6/22 (27%)       10/28 (36%)      8/22 (36%)       6/29 (21%)       0/0 (0%)        | 
|FIRST INCIDENCE    |        498              328              518              561              524              447             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.062          P=0.126          P=0.161          P=0.227          P=0.499N         P=0.011 *       | 
|POLY 3             |        P=0.207N         P=0.291          P=0.227          P=0.445          P=0.423N         P=0.593N        | 
|POLY 1.5           |        P=0.081N         P=0.310          P=0.239          P=0.463          P=0.408N         P=0.309N        | 
|POLY 6             |        P=0.361N         P=0.254          P=0.205          P=0.412          P=0.456N         P=0.278         | 
|LOGISTIC REGRESSION|        P=0.057N         P=0.333          P=0.238          P=0.463          P=0.405N         P=0.501N        | 
|COCH-ARM / FISHERS |        P=0.009N**       P=0.322          P=0.247          P=0.500          P=0.402N         P=0.086N        | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Sarcoma Stromal                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        2/50 (4%)        4/50 (8%)        2/50 (4%)        0/50 (0%)       | 
|POLY-3 RATE (b)    |        0/42.87          0/39.94          2/42.39          4/41.36          2/42.73          0/17.60         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             4.7%             9.7%             4.7%             0.0%            | 
|TERMINAL (d)       |        0/33 (0%)        0/22 (0%)        1/28 (4%)        1/22 (5%)        1/29 (3%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        ---              ---              437              646              463              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.657          (e)              P=0.224          P=0.044 *        P=0.228          (e)             | 
|POLY 3             |        P=0.504          (e)              P=0.234          P=0.055          P=0.236          (e)             | 
|POLY 1.5           |        P=0.496N         (e)              P=0.237          P=0.057          P=0.238          (e)             | 
|POLY 6             |        P=0.303          (e)              P=0.228          P=0.052          P=0.230          (e)             | 
|LOGISTIC REGRESSION|        P=0.243N         (e)              P=0.217          P=0.059          P=0.205          (e)             | 
|COCH-ARM / FISHERS |        P=0.306N         (e)              P=0.247          P=0.059          P=0.247          (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 18      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Sarcoma Stromal or Polyp Stromal                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        11/50 (22%)      14/50 (28%)      17/50 (34%)      14/50 (28%)      11/50 (22%)      5/50 (10%)      | 
|POLY-3 RATE (b)    |        11/44.24         14/43.17         17/44.44         14/42.19         11/43.96         5/20.54         | 
|POLY-3 PERCENT (g) |        24.9%            32.4%            38.3%            33.2%            25.0%            24.4%           | 
|TERMINAL (d)       |        7/33 (21%)       6/22 (27%)       11/28 (39%)      9/22 (41%)       7/29 (24%)       0/0 (0%)        | 
|FIRST INCIDENCE    |        498              328              437              561              463              447             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.065          P=0.126          P=0.082          P=0.108          P=0.496          P=0.011 *       | 
|POLY 3             |        P=0.234N         P=0.291          P=0.126          P=0.268          P=0.591          P=0.593N        | 
|POLY 1.5           |        P=0.079N         P=0.310          P=0.132          P=0.285          P=0.593N         P=0.309N        | 
|POLY 6             |        P=0.449N         P=0.254          P=0.112          P=0.238          P=0.563          P=0.278         | 
|LOGISTIC REGRESSION|        P=0.031N*        P=0.333          P=0.132          P=0.283          P=0.595N         P=0.501N        | 
|COCH-ARM / FISHERS |        P=0.006N**       P=0.322          P=0.133          P=0.322          P=0.595N         P=0.086N        | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/50 (0%)        0/50 (0%)        3/50 (6%)        39/50 (78%)     | 
|POLY-3 RATE (b)    |        0/42.87          0/39.94          0/41.60          0/40.79          3/42.84          39/42.92        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             7.0%             90.9%           | 
|TERMINAL (d)       |        0/33 (0%)        0/22 (0%)        0/28 (0%)        0/22 (0%)        1/29 (3%)        0/0 (0%)        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              524              350             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              P=0.114          P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              P=0.118          P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P=0.119          P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P=0.114          P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              (e)              P=0.114          P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              P=0.121          P<0.001 **      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 19      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or                                                                           | 
|     Undifferentiated                                                                                                            | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        12/50 (24%)      8/50 (16%)       13/50 (26%)      18/50 (36%)      18/50 (36%)      14/50 (28%)     | 
|POLY-3 RATE (b)    |        12/44.48         8/42.25          13/43.54         18/44.72         18/46.12         14/27.13        | 
|POLY-3 PERCENT (g) |        27.0%            18.9%            29.9%            40.3%            39.0%            51.6%           | 
|TERMINAL (d)       |        8/33 (24%)       1/22 (5%)        7/28 (25%)       6/22 (27%)       6/29 (21%)       0/0 (0%)        | 
|FIRST INCIDENCE    |        393              513              532              451              463              352             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.454N         P=0.370          P=0.054          P=0.109          P<0.001 **      | 
|POLY 3             |        P=0.009 **       P=0.262N         P=0.475          P=0.132          P=0.158          P=0.033 *       | 
|POLY 1.5           |        P=0.051          P=0.246N         P=0.488          P=0.128          P=0.150          P=0.134         | 
|POLY 6             |        P<0.001 **       P=0.291N         P=0.451          P=0.138          P=0.166          P=0.003 **      | 
|LOGISTIC REGRESSION|        P=0.460          P=0.215N         P=0.496          P=0.139          P=0.138          P=0.544N        | 
|COCH-ARM / FISHERS |        P=0.288          P=0.227N         P=0.500          P=0.138          P=0.138          P=0.410         | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        45/50 (90%)      42/50 (84%)      45/50 (90%)      41/50 (82%)      45/50 (90%)      22/50 (44%)     | 
|POLY-3 RATE (b)    |        45/47.27         42/46.97         45/48.13         41/44.94         45/47.27         22/30.57        | 
|POLY-3 PERCENT (g) |        95.2%            89.4%            93.5%            91.2%            95.2%            72.0%           | 
|TERMINAL (d)       |        32/33 (97%)      21/22 (96%)      27/28 (96%)      22/22 (100%)     29/29 (100%)     0/0 (0%)        | 
|FIRST INCIDENCE    |        483              328              444              561              524              426             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.067          P=0.208          P=0.096          P=0.249          P<0.001 **      | 
|POLY 3             |        P<0.001N**       P=0.218N         P=0.538N         P=0.342N         P=0.727N         P<0.001N**      | 
|POLY 1.5           |        P<0.001N**       P=0.223N         P=0.564N         P=0.286N         P=0.661N         P<0.001N**      | 
|POLY 6             |        P=0.259N         P=0.279N         P=0.565N         P=0.426N         P=0.699          P=0.086N        | 
|LOGISTIC REGRESSION|        P=0.225N         P=0.341N         P=0.617N         P=0.179N         P=0.523N         P=0.252N        | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.277N         P=0.630N         P=0.194N         P=0.630N         P<0.001N**      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 20      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        20/50 (40%)      17/50 (34%)      21/50 (42%)      28/50 (56%)      28/50 (56%)      47/50 (94%)     | 
|POLY-3 RATE (b)    |        20/46.36         17/44.57         21/45.31         28/47.23         28/47.51         47/48.05        | 
|POLY-3 PERCENT (g) |        43.1%            38.2%            46.4%            59.3%            58.9%            97.8%           | 
|TERMINAL (d)       |        13/33 (39%)      5/22 (23%)       12/28 (43%)      10/22 (46%)      14/29 (48%)      0/0 (0%)        | 
|FIRST INCIDENCE    |        393              407              437              252              451              350             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.462          P=0.335          P=0.022 *        P=0.064          P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.392N         P=0.460          P=0.083          P=0.088          P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.370N         P=0.480          P=0.080          P=0.085          P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.428N         P=0.428          P=0.088          P=0.090          P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.290N         P=0.510          P=0.098          P=0.082          P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.339N         P=0.500          P=0.080          P=0.080          P<0.001 **      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                0.01             0.033            0.1              0.33             1.0             | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        47/50 (94%)      47/50 (94%)      48/50 (96%)      47/50 (94%)      50/50 (100%)     50/50 (100%)    | 
|POLY-3 RATE (b)    |        47/48.90         47/48.95         48/49.60         47/48.49         50/50.00         50/50.00        | 
|POLY-3 PERCENT (g) |        96.1%            96.0%            96.8%            96.9%            100.0%           100.0%          | 
|TERMINAL (d)       |        32/33 (97%)      21/22 (96%)      27/28 (96%)      22/22 (100%)     29/29 (100%)     0/0 (0%)        | 
|FIRST INCIDENCE    |        393              328              437              252              451              350             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.030 *        P=0.177          P=0.035 *        P=0.136          P<0.001 **      | 
|POLY 3             |        P=0.080          P=0.710N         P=0.658          P=0.645          P=0.222          P=0.222         | 
|POLY 1.5           |        P=0.058          P=0.686N         P=0.595          P=0.632          P=0.165          P=0.165         | 
|POLY 6             |        P=0.127          P=0.743N         P=0.717          P=0.685          P=0.323          P=0.323         | 
|LOGISTIC REGRESSION|        P=0.007 **       P=0.622          P=0.501          P=0.559          P=0.131          P=0.058         | 
|COCH-ARM / FISHERS |        P=0.044 *        P=0.661N         P=0.500          P=0.661N         P=0.121          P=0.121         | 
|=================================================================================================================================| 
(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).