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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: 12:19:29       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 61358C       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 23246-96-0      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                         RATS/FINAL#1 MALES                                                         
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0       MG/KG/DY                                                              
                                       INCLUDE 002    1.0     MG/KG/DY                                                              
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                   RIDDELLIINE                                      DATE: 12/15/00       
EXPERIMENT: 05161 TEST: 05                                                                                     TIME: 12:19:29       
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 Medulla                                                                    
                                                 Clitoral/Preputial Gland                                                           
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Pancreas                                                                           
                                                 Pituitary Gland                                                                    
                                                 Testes                                                                             
                                                 Thymus                                                                             
                                                 Thyroid Gland                                                                      
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                   RIDDELLIINE                                      DATE: 12/15/00       
EXPERIMENT: 05161 TEST: 05                                                                                     TIME: 12:19:29       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 61358C       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 23246-96-0      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                   RIDDELLIINE                                                                                    
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Liver                                  Hemangiosarcoma                                                                              
                                       Hepatocellular Adenoma                                                                       
Lung                                   Alveolar/Bronchiolar Adenoma                                                                 
                                       Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                               
Pituitary Gland: Pars Distalis or Unspecified Site                                                                                  
                                       Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
Testes                                 Adenoma                                                                                      
Thyroid Gland: C-Cell                  Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
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 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Benign                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/49 (4%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              2/48.84                                           2/28.50                      | 
|POLY-3 PERCENT (g) |                              4.1%                                              7.0%                         | 
|TERMINAL (d)       |                              2/48 (4%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           414                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.078                                           P=0.078                      | 
|POLY 3             |                              P=0.578                                           P=0.579                      | 
|POLY 1.5           |                              P=0.623                                           P=0.624                      | 
|POLY 6             |                              P=0.570                                           P=0.573                      | 
|LOGISTIC REGRESSION|                              P=0.526                                           P=0.526                      | 
|COCH-ARM / FISHERS |                              P=0.688N                                          P=0.684N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/50 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/49.84                                           0/27.85                      | 
|POLY-3 PERCENT (g) |                              4.0%                                              0.0%                         | 
|TERMINAL (d)       |                              2/49 (4%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.881N                                          P=0.881N                     | 
|POLY 3             |                              P=0.520N                                          P=0.520N                     | 
|POLY 1.5           |                              P=0.368N                                          P=0.368N                     | 
|POLY 6             |                              P=0.794N                                          P=0.794N                     | 
|LOGISTIC REGRESSION|                              P=0.881N                                          (e)                          | 
|COCH-ARM / FISHERS |                              P=0.238N                                          P=0.247N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 2       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/50 (4%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              2/49.84                                           1/28.34                      | 
|POLY-3 PERCENT (g) |                              4.0%                                              3.5%                         | 
|TERMINAL (d)       |                              2/49 (4%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           398                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.514                                           P=0.514                      | 
|POLY 3             |                              P=0.770N                                          P=0.770N                     | 
|POLY 1.5           |                              P=0.648N                                          P=0.648N                     | 
|POLY 6             |                              P=0.839                                           P=0.839                      | 
|LOGISTIC REGRESSION|                              P=0.714N                                          P=0.714N                     | 
|COCH-ARM / FISHERS |                              P=0.500N                                          P=0.500N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         43/50 (86%)                  | 
|POLY-3 RATE (b)    |                              0/49.84                                           43/46.51                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              92.5%                        | 
|TERMINAL (d)       |                              0/49 (0%)                                         1/3 (33%)                    | 
|FIRST INCIDENCE    |                              ---                                               307                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 3       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Adenoma                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              0/49.84                                           4/29.17                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              13.7%                        | 
|TERMINAL (d)       |                              0/49 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               398                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.033 *                                         P=0.033 *                    | 
|POLY 1.5           |                              P=0.040 *                                         P=0.040 *                    | 
|POLY 6             |                              P=0.037 *                                         P=0.037 *                    | 
|LOGISTIC REGRESSION|                              P=0.039 *                                         P=0.039 *                    | 
|COCH-ARM / FISHERS |                              P=0.063                                           P=0.059                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              0/49.84                                           3/28.63                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              10.5%                        | 
|TERMINAL (d)       |                              0/49 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               415                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.088                                           P=0.088                      | 
|POLY 1.5           |                              P=0.093                                           P=0.093                      | 
|POLY 6             |                              P=0.114                                           P=0.114                      | 
|LOGISTIC REGRESSION|                              P=0.039 *                                         P=0.039 *                    | 
|COCH-ARM / FISHERS |                              P=0.121                                           P=0.121                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 4       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/50 (2%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              1/49.84                                           3/28.63                      | 
|POLY-3 PERCENT (g) |                              2.0%                                              10.5%                        | 
|TERMINAL (d)       |                              1/49 (2%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           415                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.003 **                                        P=0.003 **                   | 
|POLY 3             |                              P=0.211                                           P=0.211                      | 
|POLY 1.5           |                              P=0.240                                           P=0.240                      | 
|POLY 6             |                              P=0.220                                           P=0.220                      | 
|LOGISTIC REGRESSION|                              P=0.101                                           P=0.101                      | 
|COCH-ARM / FISHERS |                              P=0.305                                           P=0.309                      | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              11/50 (22%)                                       2/49 (4%)                    | 
|POLY-3 RATE (b)    |                              11/49.84                                          2/27.81                      | 
|POLY-3 PERCENT (g) |                              22.1%                                             7.2%                         | 
|TERMINAL (d)       |                              11/49 (22%)                                       0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           414                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.313                                           P=0.313                      | 
|POLY 3             |                              P=0.129N                                          P=0.128N                     | 
|POLY 1.5           |                              P=0.042N*                                         P=0.042N*                    | 
|POLY 6             |                              P=0.415N                                          P=0.413N                     | 
|LOGISTIC REGRESSION|                              P=0.519N                                          P=0.519N                     | 
|COCH-ARM / FISHERS |                              P=0.010N*                                         P=0.008N**                   | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 5       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              12/50 (24%)                                       2/49 (4%)                    | 
|POLY-3 RATE (b)    |                              12/49.84                                          2/27.81                      | 
|POLY-3 PERCENT (g) |                              24.1%                                             7.2%                         | 
|TERMINAL (d)       |                              12/49 (25%)                                       0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           414                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.339                                           P=0.339                      | 
|POLY 3             |                              P=0.095N                                          P=0.094N                     | 
|POLY 1.5           |                              P=0.027N*                                         P=0.027N*                    | 
|POLY 6             |                              P=0.360N                                          P=0.358N                     | 
|LOGISTIC REGRESSION|                              P=0.479N                                          P=0.479N                     | 
|COCH-ARM / FISHERS |                              P=0.005N**                                        P=0.004N**                   | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              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)        |                              3/50 (6%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              3/49.84                                           1/28.32                      | 
|POLY-3 PERCENT (g) |                              6.0%                                              3.5%                         | 
|TERMINAL (d)       |                              3/49 (6%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           402                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.535                                           P=0.535                      | 
|POLY 3             |                              P=0.613N                                          P=0.613N                     | 
|POLY 1.5           |                              P=0.462N                                          P=0.462N                     | 
|POLY 6             |                              P=0.832N                                          P=0.832N                     | 
|LOGISTIC REGRESSION|                              P=0.626N                                          P=0.626N                     | 
|COCH-ARM / FISHERS |                              P=0.305N                                          P=0.309N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 6       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/50 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/49.84                                           0/27.85                      | 
|POLY-3 PERCENT (g) |                              4.0%                                              0.0%                         | 
|TERMINAL (d)       |                              2/49 (4%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.881N                                          P=0.881N                     | 
|POLY 3             |                              P=0.520N                                          P=0.520N                     | 
|POLY 1.5           |                              P=0.368N                                          P=0.368N                     | 
|POLY 6             |                              P=0.794N                                          P=0.794N                     | 
|LOGISTIC REGRESSION|                              P=0.881N                                          (e)                          | 
|COCH-ARM / FISHERS |                              P=0.238N                                          P=0.247N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Keratoacanthoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/50 (4%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              2/49.84                                           1/28.32                      | 
|POLY-3 PERCENT (g) |                              4.0%                                              3.5%                         | 
|TERMINAL (d)       |                              2/49 (4%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           402                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.499                                           P=0.499                      | 
|POLY 3             |                              P=0.770N                                          P=0.770N                     | 
|POLY 1.5           |                              P=0.648N                                          P=0.648N                     | 
|POLY 6             |                              P=0.839                                           P=0.839                      | 
|LOGISTIC REGRESSION|                              P=0.733N                                          P=0.733N                     | 
|COCH-ARM / FISHERS |                              P=0.500N                                          P=0.500N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 7       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma, Papilloma, Squamous Cell                                                                           | 
|     Carcinoma or Keratoacanthoma                                                                                                | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/50 (6%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              3/49.84                                           1/28.32                      | 
|POLY-3 PERCENT (g) |                              6.0%                                              3.5%                         | 
|TERMINAL (d)       |                              3/49 (6%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           402                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.535                                           P=0.535                      | 
|POLY 3             |                              P=0.613N                                          P=0.613N                     | 
|POLY 1.5           |                              P=0.462N                                          P=0.462N                     | 
|POLY 6             |                              P=0.832N                                          P=0.832N                     | 
|LOGISTIC REGRESSION|                              P=0.626N                                          P=0.626N                     | 
|COCH-ARM / FISHERS |                              P=0.305N                                          P=0.309N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/50 (6%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              3/49.84                                           1/28.32                      | 
|POLY-3 PERCENT (g) |                              6.0%                                              3.5%                         | 
|TERMINAL (d)       |                              3/49 (6%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           402                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.535                                           P=0.535                      | 
|POLY 3             |                              P=0.613N                                          P=0.613N                     | 
|POLY 1.5           |                              P=0.462N                                          P=0.462N                     | 
|POLY 6             |                              P=0.832N                                          P=0.832N                     | 
|LOGISTIC REGRESSION|                              P=0.626N                                          P=0.626N                     | 
|COCH-ARM / FISHERS |                              P=0.305N                                          P=0.309N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 8       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              39/50 (78%)                                       7/50 (14%)                   | 
|POLY-3 RATE (b)    |                              39/50.00                                          7/29.67                      | 
|POLY-3 PERCENT (g) |                              78.0%                                             23.6%                        | 
|TERMINAL (d)       |                              38/49 (78%)                                       2/3 (67%)                    | 
|FIRST INCIDENCE    |                              468                                               342                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.010 *                                         P=0.010 *                    | 
|POLY 3             |                              P<0.001N**                                        P<0.001N**                   | 
|POLY 1.5           |                              P<0.001N**                                        P<0.001N**                   | 
|POLY 6             |                              P=0.002N**                                        P=0.002N**                   | 
|LOGISTIC REGRESSION|                              P=0.086N                                          P=0.086N                     | 
|COCH-ARM / FISHERS |                              P<0.001N**                                        P<0.001N**                   | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/50 (6%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              3/49.84                                           3/29.03                      | 
|POLY-3 PERCENT (g) |                              6.0%                                              10.3%                        | 
|TERMINAL (d)       |                              3/49 (6%)                                         1/3 (33%)                    | 
|FIRST INCIDENCE    |                              497 (T)                                           307                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.032 *                                         P=0.032 *                    | 
|POLY 3             |                              P=0.479                                           P=0.479                      | 
|POLY 1.5           |                              P=0.554                                           P=0.554                      | 
|POLY 6             |                              P=0.421                                           P=0.421                      | 
|LOGISTIC REGRESSION|                              P=0.692                                           P=0.692                      | 
|COCH-ARM / FISHERS |                              P=0.663                                           P=0.661N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 9       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/50 (8%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              4/49.84                                           3/29.03                      | 
|POLY-3 PERCENT (g) |                              8.0%                                              10.3%                        | 
|TERMINAL (d)       |                              4/49 (8%)                                         1/3 (33%)                    | 
|FIRST INCIDENCE    |                              497 (T)                                           307                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.043 *                                         P=0.043 *                    | 
|POLY 3             |                              P=0.592                                           P=0.592                      | 
|POLY 1.5           |                              P=0.676                                           P=0.676                      | 
|POLY 6             |                              P=0.508                                           P=0.508                      | 
|LOGISTIC REGRESSION|                              P=0.695N                                          P=0.695N                     | 
|COCH-ARM / FISHERS |                              P=0.500N                                          P=0.500N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         43/50 (86%)                  | 
|POLY-3 RATE (b)    |                              0/49.84                                           43/46.51                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              92.5%                        | 
|TERMINAL (d)       |                              0/49 (0%)                                         1/3 (33%)                    | 
|FIRST INCIDENCE    |                              ---                                               307                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 10      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or                                                                           | 
|     Undifferentiated                                                                                                            | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/50 (4%)                                         9/50 (18%)                   | 
|POLY-3 RATE (b)    |                              2/49.84                                           9/31.57                      | 
|POLY-3 PERCENT (g) |                              4.0%                                              28.5%                        | 
|TERMINAL (d)       |                              2/49 (4%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              497 (T)                                           204                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.004 **                                        P=0.004 **                   | 
|POLY 1.5           |                              P=0.009 **                                        P=0.009 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P=0.096                                           P=0.096                      | 
|COCH-ARM / FISHERS |                              P=0.028 *                                         P=0.026 *                    | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        | 
|     NOS, or Undifferentiated Cell Type                                                                                          | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/50 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/49.84                                           2/28.95                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              6.9%                         | 
|TERMINAL (d)       |                              0/49 (0%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              ---                                               297                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.100                                           P=0.100                      | 
|POLY 3             |                              P=0.227                                           P=0.227                      | 
|POLY 1.5           |                              P=0.218                                           P=0.218                      | 
|POLY 6             |                              P=0.311                                           P=0.311                      | 
|LOGISTIC REGRESSION|                              P=0.645                                           P=0.645                      | 
|COCH-ARM / FISHERS |                              P=0.238                                           P=0.247                      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 11      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Mesothelioma: Benign, Malignant, NOS                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/50 (8%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              4/50.00                                           3/29.24                      | 
|POLY-3 PERCENT (g) |                              8.0%                                              10.3%                        | 
|TERMINAL (d)       |                              3/49 (6%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              468                                               327                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.081                                           P=0.081                      | 
|POLY 3             |                              P=0.593                                           P=0.593                      | 
|POLY 1.5           |                              P=0.676                                           P=0.676                      | 
|POLY 6             |                              P=0.509                                           P=0.509                      | 
|LOGISTIC REGRESSION|                              P=0.524N                                          P=0.524N                     | 
|COCH-ARM / FISHERS |                              P=0.500N                                          P=0.500N                     | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Mesothelioma: Malignant                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/50 (8%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              4/50.00                                           3/29.24                      | 
|POLY-3 PERCENT (g) |                              8.0%                                              10.3%                        | 
|TERMINAL (d)       |                              3/49 (6%)                                         0/3 (0%)                     | 
|FIRST INCIDENCE    |                              468                                               327                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P=0.081                                           P=0.081                      | 
|POLY 3             |                              P=0.593                                           P=0.593                      | 
|POLY 1.5           |                              P=0.676                                           P=0.676                      | 
|POLY 6             |                              P=0.509                                           P=0.509                      | 
|LOGISTIC REGRESSION|                              P=0.524N                                          P=0.524N                     | 
|COCH-ARM / FISHERS |                              P=0.500N                                          P=0.500N                     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 12      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              47/50 (94%)                                       15/50 (30%)                  | 
|POLY-3 RATE (b)    |                              47/50.00                                          15/32.70                     | 
|POLY-3 PERCENT (g) |                              94.0%                                             45.9%                        | 
|TERMINAL (d)       |                              46/49 (94%)                                       2/3 (67%)                    | 
|FIRST INCIDENCE    |                              468                                               307                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001N**                                        P<0.001N**                   | 
|POLY 1.5           |                              P<0.001N**                                        P<0.001N**                   | 
|POLY 6             |                              P<0.001N**                                        P<0.001N**                   | 
|LOGISTIC REGRESSION|                              P=0.016N*                                         P=0.016N*                    | 
|COCH-ARM / FISHERS |                              P<0.001N**                                        P<0.001N**                   | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              9/50 (18%)                                        47/50 (94%)                  | 
|POLY-3 RATE (b)    |                              9/50.00                                           47/49.15                     | 
|POLY-3 PERCENT (g) |                              18.0%                                             95.6%                        | 
|TERMINAL (d)       |                              8/49 (16%)                                        1/3 (33%)                    | 
|FIRST INCIDENCE    |                              468                                               204                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 1.5           |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 6             |                              P<0.001 **                                        P<0.001 **                   | 
|LOGISTIC REGRESSION|                              P<0.001 **                                        P<0.001 **                   | 
|COCH-ARM / FISHERS |                              P<0.001 **                                        P<0.001 **                   | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/00                           EXPERIMENT: 05161 TEST: 05                                            Page 13      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    RIDDELLIINE             
                                         Terminal Sacrifice at 71 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |                              0                                                 1.0                          | 
|                   |                              MG/KG/DY                                          MG/KG/DY                     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              47/50 (94%)                                       49/50 (98%)                  | 
|POLY-3 RATE (b)    |                              47/50.00                                          49/49.15                     | 
|POLY-3 PERCENT (g) |                              94.0%                                             99.7%                        | 
|TERMINAL (d)       |                              46/49 (94%)                                       3/3 (100%)                   | 
|FIRST INCIDENCE    |                              468                                               204                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                              P<0.001 **                                        P<0.001 **                   | 
|POLY 3             |                              P=0.144                                           P=0.144                      | 
|POLY 1.5           |                              P=0.182                                           P=0.182                      | 
|POLY 6             |                              P=0.127                                           P=0.127                      | 
|LOGISTIC REGRESSION|                              P=0.138                                           P=0.138                      | 
|COCH-ARM / FISHERS |                              P=0.305                                           P=0.309                      | 
|=================================================================================================================================| 
(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).