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TDMS Study 05161-06 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                   RIDDELLIINE                                      DATE: 12/12/00       
EXPERIMENT: 05161 TEST: 06                                                                                     TIME: 09:44:23       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 61358C       
PATHOLOGIST: FARNELL, D.                                                                                       CAS: 23246-96-0      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                         MALE MICE/FINAL#1                                                          
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0       MG/KG/DY                                                              
                                       INCLUDE 003    0.1     MG/KG/DY                                                              
                                       INCLUDE 004    0.3     MG/KG/DY                                                              
                                       INCLUDE 005    1.0     MG/KG/DY                                                              
                                       INCLUDE 006    3.0     MG/KG/DY                                                              
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                   RIDDELLIINE                                      DATE: 12/12/00       
EXPERIMENT: 05161 TEST: 06                                                                                     TIME: 09:44:23       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 61358C       
PATHOLOGIST: FARNELL, D.                                                                                       CAS: 23246-96-0      
Mice(B6C3F1)                                                                                                                        
-----------------------------                                                                                                       
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE                                                                   
BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES                                                                 
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Adrenal Cortex                                                                     
                                                 Adrenal Medulla                                                                    
                                                 Bone Marrow                                                                        
                                                 Clitoral/Preputial Gland                                                           
                                                 Epididymis                                                                         
                                                 Islets, Pancreatic                                                                 
                                                 Kidney                                                                             
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Pancreas                                                                           
                                                 Pituitary Gland                                                                    
                                                 Spleen                                                                             
                                                 Testes                                                                             
                                                 Thyroid Gland                                                                      
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                   RIDDELLIINE                                      DATE: 12/12/00       
EXPERIMENT: 05161 TEST: 06                                                                                     TIME: 09:44:23       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 61358C       
PATHOLOGIST: FARNELL, D.                                                                                       CAS: 23246-96-0      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                   RIDDELLIINE                                                                                    
===============================================================                                                                     
Male Mice                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Liver                                  Hemangiosarcoma                                                                              
                                       Hepatocellular Adenoma                                                                       
                                       Hepatocellular Carcinoma                                                                     
                                       Hepatocellular Carcinoma or Hepatoblastoma                                                   
                                       Hepatocellular Carcinoma or Hepatocellular Adenoma                                           
                                       Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                          
Lung                                   Alveolar/Bronchiolar Adenoma                                                                 
                                       Alveolar/Bronchiolar Carcinoma                                                               
                                       Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                               
Testes                                 Adenoma                                                                                      
All Organs                             Hemangiosarcoma                                                                              
                                       Histiocytic Sarcoma                                                                          
                                       Benign Tumors                                                                                
                                       Malignant Tumors                                                                             
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 1       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)        -                    RIDDELLIINE                 
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/49 (6%)        7/49 (14%)       4/50 (8%)        3/50 (6%)        2/49 (4%)                        | 
|POLY-3 RATE (b)    |        3/44.94          7/45.16          4/47.70          3/45.55          2/39.41                          | 
|POLY-3 PERCENT (g) |        6.7%             15.5%            8.4%             6.6%             5.1%                             | 
|TERMINAL (d)       |        3/39 (8%)        7/40 (18%)       4/40 (10%)       2/38 (5%)        1/20 (5%)                        | 
|FIRST INCIDENCE    |        729 (T)          729 (T)          729 (T)          707              660                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.452N         P=0.167          P=0.514          P=0.650          P=0.604                          | 
|POLY 3             |        P=0.207N         P=0.159          P=0.532          P=0.656N         P=0.560N                         | 
|POLY 1.5           |        P=0.180N         P=0.161          P=0.528          P=0.651N         P=0.529N                         | 
|POLY 6             |        P=0.251N         P=0.155          P=0.535          P=0.661          P=0.607N                         | 
|LOGISTIC REGRESSION|        P=0.317N         P=0.167          P=0.514          P=0.655          P=0.633N                         | 
|COCH-ARM / FISHERS |        P=0.152N         P=0.159          P=0.511          P=0.651N         P=0.500N                         | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/50 (8%)        1/50 (2%)        6/50 (12%)       8/50 (16%)       2/50 (4%)                        | 
|POLY-3 RATE (b)    |        4/45.50          1/46.29          6/48.10          8/46.47          2/39.65                          | 
|POLY-3 PERCENT (g) |        8.8%             2.2%             12.5%            17.2%            5.0%                             | 
|TERMINAL (d)       |        4/39 (10%)       0/41 (0%)        5/40 (13%)       4/38 (11%)       2/20 (10%)                       | 
|FIRST INCIDENCE    |        729 (T)          696              614              554              729 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.421          P=0.170N         P=0.388          P=0.177          P=0.663N                         | 
|POLY 3             |        P=0.510N         P=0.173N         P=0.405          P=0.187          P=0.402N                         | 
|POLY 1.5           |        P=0.445N         P=0.174N         P=0.395          P=0.186          P=0.369N                         | 
|POLY 6             |        P=0.534          P=0.173N         P=0.414          P=0.187          P=0.459N                         | 
|LOGISTIC REGRESSION|        P=0.444N         P=0.175N         P=0.395          P=0.179          P=0.663N                         | 
|COCH-ARM / FISHERS |        P=0.373N         P=0.181N         P=0.370          P=0.178          P=0.339N                         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 2       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                    RIDDELLIINE                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        0/50 (0%)        1/50 (2%)        1/50 (2%)        1/50 (2%)                        | 
|POLY-3 RATE (b)    |        2/45.56          0/46.16          1/47.70          1/45.46          1/39.93                          | 
|POLY-3 PERCENT (g) |        4.4%             0.0%             2.1%             2.2%             2.5%                             | 
|TERMINAL (d)       |        1/39 (3%)        0/41 (0%)        1/40 (3%)        1/38 (3%)        0/20 (0%)                        | 
|FIRST INCIDENCE    |        713              ---              729 (T)          729 (T)          652                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.509          P=0.234N         P=0.486N         P=0.512N         P=0.673N                         | 
|POLY 3             |        P=0.618          P=0.234N         P=0.484N         P=0.501N         P=0.546N                         | 
|POLY 1.5           |        P=0.642          P=0.234N         P=0.488N         P=0.498N         P=0.522N                         | 
|POLY 6             |        P=0.581          P=0.235N         P=0.481N         P=0.506N         P=0.583N                         | 
|LOGISTIC REGRESSION|        P=0.638          P=0.235N         P=0.480N         P=0.507N         P=0.535N                         | 
|COCH-ARM / FISHERS |        P=0.642N         P=0.247N         P=0.500N         P=0.500N         P=0.500N                         | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/50 (12%)       1/50 (2%)        7/50 (14%)       8/50 (16%)       3/50 (6%)                        | 
|POLY-3 RATE (b)    |        6/45.56          1/46.29          7/48.10          8/46.47          3/39.93                          | 
|POLY-3 PERCENT (g) |        13.2%            2.2%             14.6%            17.2%            7.5%                             | 
|TERMINAL (d)       |        5/39 (13%)       0/41 (0%)        6/40 (15%)       4/38 (11%)       2/20 (10%)                       | 
|FIRST INCIDENCE    |        713              696              614              554              652                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.377          P=0.056N         P=0.524          P=0.375          P=0.598N                         | 
|POLY 3             |        P=0.499N         P=0.053N         P=0.542          P=0.402          P=0.311N                         | 
|POLY 1.5           |        P=0.437N         P=0.054N         P=0.530          P=0.400          P=0.275N                         | 
|POLY 6             |        P=0.541          P=0.053N         P=0.552          P=0.402          P=0.374N                         | 
|LOGISTIC REGRESSION|        P=0.441N         P=0.056N         P=0.535          P=0.389          P=0.433N                         | 
|COCH-ARM / FISHERS |        P=0.367N         P=0.056N         P=0.500          P=0.387          P=0.243N                         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 3       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                    RIDDELLIINE                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small: Jejunum                                                                                                         | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        1/50 (2%)        2/50 (4%)        0/50 (0%)                        | 
|POLY-3 RATE (b)    |        0/45.50          0/46.16          1/47.70          2/45.46          0/39.65                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             2.1%             4.4%             0.0%                             | 
|TERMINAL (d)       |        0/39 (0%)        0/41 (0%)        1/40 (3%)        2/38 (5%)        0/20 (0%)                        | 
|FIRST INCIDENCE    |        ---              ---              729 (T)          729 (T)          ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.654          (e)              P=0.505          P=0.233          (e)                              | 
|POLY 3             |        P=0.689N         (e)              P=0.509          P=0.237          (e)                              | 
|POLY 1.5           |        P=0.663N         (e)              P=0.507          P=0.239          (e)                              | 
|POLY 6             |        P=0.628          (e)              P=0.511          P=0.234          (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              P=0.505          P=0.233          (e)                              | 
|COCH-ARM / FISHERS |        P=0.634N         (e)              P=0.500          P=0.247          (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small: Site Unspecified                                                                                                | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        1/50 (2%)        2/50 (4%)        0/50 (0%)                        | 
|POLY-3 RATE (b)    |        0/45.50          0/46.16          1/47.70          2/45.46          0/39.65                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             2.1%             4.4%             0.0%                             | 
|TERMINAL (d)       |        0/39 (0%)        0/41 (0%)        1/40 (3%)        2/38 (5%)        0/20 (0%)                        | 
|FIRST INCIDENCE    |        ---              ---              729 (T)          729 (T)          ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.654          (e)              P=0.505          P=0.233          (e)                              | 
|POLY 3             |        P=0.689N         (e)              P=0.509          P=0.237          (e)                              | 
|POLY 1.5           |        P=0.663N         (e)              P=0.507          P=0.239          (e)                              | 
|POLY 6             |        P=0.628          (e)              P=0.511          P=0.234          (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              P=0.505          P=0.233          (e)                              | 
|COCH-ARM / FISHERS |        P=0.634N         (e)              P=0.500          P=0.247          (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 4       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                    RIDDELLIINE                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/49 (6%)        0/50 (0%)        0/50 (0%)        0/50 (0%)        0/48 (0%)                        | 
|POLY-3 RATE (b)    |        3/45.55          0/46.16          0/47.70          0/45.46          0/38.29                          | 
|POLY-3 PERCENT (g) |        6.6%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        2/39 (5%)        0/41 (0%)        0/40 (0%)        0/38 (0%)        0/20 (0%)                        | 
|FIRST INCIDENCE    |        637              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.260N         P=0.119N         P=0.118N         P=0.126N         P=0.227N                         | 
|POLY 3             |        P=0.202N         P=0.116N         P=0.111N         P=0.119N         P=0.153N                         | 
|POLY 1.5           |        P=0.202N         P=0.115N         P=0.111N         P=0.116N         P=0.137N                         | 
|POLY 6             |        P=0.200N         P=0.118N         P=0.111N         P=0.123N         P=0.180N                         | 
|LOGISTIC REGRESSION|        P=0.195N         P=0.117N         P=0.120N         P=0.117N         P=0.131N                         | 
|COCH-ARM / FISHERS |        P=0.200N         P=0.117N         P=0.117N         P=0.117N         P=0.125N                         | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        1/50 (2%)        0/50 (0%)        2/50 (4%)        31/50 (62%)                      | 
|POLY-3 RATE (b)    |        2/45.50          1/46.16          0/47.70          2/45.46          31/46.49                         | 
|POLY-3 PERCENT (g) |        4.4%             2.2%             0.0%             4.4%             66.7%                            | 
|TERMINAL (d)       |        2/39 (5%)        1/41 (2%)        0/40 (0%)        2/38 (5%)        8/20 (40%)                       | 
|FIRST INCIDENCE    |        729 (T)          729 (T)          ---              729 (T)          550                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.483N         P=0.233N         P=0.686          P<0.001 **                       | 
|POLY 3             |        P<0.001 **       P=0.495N         P=0.227N         P=0.694          P<0.001 **                       | 
|POLY 1.5           |        P<0.001 **       P=0.495N         P=0.230N         P=0.691N         P<0.001 **                       | 
|POLY 6             |        P<0.001 **       P=0.496N         P=0.225N         P=0.689          P<0.001 **                       | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.483N         (e)              P=0.686          P<0.001 **                       | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500N         P=0.247N         P=0.691N         P<0.001 **                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 5       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                    RIDDELLIINE                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatoblastoma                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/50 (6%)        2/50 (4%)        0/50 (0%)        1/50 (2%)        0/50 (0%)                        | 
|POLY-3 RATE (b)    |        3/45.59          2/46.16          0/47.70          1/46.02          0/39.65                          | 
|POLY-3 PERCENT (g) |        6.6%             4.3%             0.0%             2.2%             0.0%                             | 
|TERMINAL (d)       |        2/39 (5%)        2/41 (5%)        0/40 (0%)        0/38 (0%)        0/20 (0%)                        | 
|FIRST INCIDENCE    |        706              729 (T)          ---              552              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.206N         P=0.484N         P=0.117N         P=0.315N         P=0.258N                         | 
|POLY 3             |        P=0.151N         P=0.494N         P=0.111N         P=0.302N         P=0.146N                         | 
|POLY 1.5           |        P=0.140N         P=0.494N         P=0.113N         P=0.301N         P=0.131N                         | 
|POLY 6             |        P=0.165N         P=0.496N         P=0.110N         P=0.305N         P=0.172N                         | 
|LOGISTIC REGRESSION|        P=0.121N         P=0.495N         P=0.111N         P=0.314N         P=0.192N                         | 
|COCH-ARM / FISHERS |        P=0.127N         P=0.500N         P=0.121N         P=0.309N         P=0.121N                         | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Adenoma                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        16/50 (32%)      18/50 (36%)      14/50 (28%)      5/50 (10%)       0/50 (0%)                        | 
|POLY-3 RATE (b)    |        16/46.83         18/46.34         14/48.23         5/45.99          0/39.65                          | 
|POLY-3 PERCENT (g) |        34.2%            38.8%            29.0%            10.9%            0.0%                             | 
|TERMINAL (d)       |        13/39 (33%)      17/41 (42%)      13/40 (33%)      4/38 (11%)       0/20 (0%)                        | 
|FIRST INCIDENCE    |        475              681              567              566              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001N**       P=0.481          P=0.378N         P=0.010N*        P<0.001N**                       | 
|POLY 3             |        P<0.001N**       P=0.400          P=0.375N         P=0.006N**       P<0.001N**                       | 
|POLY 1.5           |        P<0.001N**       P=0.414          P=0.383N         P=0.006N**       P<0.001N**                       | 
|POLY 6             |        P<0.001N**       P=0.383          P=0.372N         P=0.007N**       P<0.001N**                       | 
|LOGISTIC REGRESSION|        P<0.001N**       P=0.435          P=0.399N         P=0.007N**       P<0.001N**                       | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.417          P=0.414N         P=0.006N**       P<0.001N**                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 6       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                    RIDDELLIINE                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        23/50 (46%)      21/50 (42%)      19/50 (38%)      20/50 (40%)      3/50 (6%)                        | 
|POLY-3 RATE (b)    |        23/48.23         21/48.57         19/49.44         20/46.73         3/40.12                          | 
|POLY-3 PERCENT (g) |        47.7%            43.2%            38.4%            42.8%            7.5%                             | 
|TERMINAL (d)       |        15/39 (39%)      15/41 (37%)      11/40 (28%)      16/38 (42%)      2/20 (10%)                       | 
|FIRST INCIDENCE    |        486              542              592              566              590                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.004N**       P=0.378N         P=0.257N         P=0.393N         P=0.003N**                       | 
|POLY 3             |        P<0.001N**       P=0.407N         P=0.237N         P=0.393N         P<0.001N**                       | 
|POLY 1.5           |        P<0.001N**       P=0.403N         P=0.242N         P=0.361N         P<0.001N**                       | 
|POLY 6             |        P<0.001N**       P=0.417N         P=0.236N         P=0.439N         P<0.001N**                       | 
|LOGISTIC REGRESSION|        P<0.001N**       P=0.436N         P=0.316N         P=0.340N         P<0.001N**                       | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.420N         P=0.272N         P=0.343N         P<0.001N**                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        24/50 (48%)      22/50 (44%)      19/50 (38%)      21/50 (42%)      3/50 (6%)                        | 
|POLY-3 RATE (b)    |        24/48.23         22/48.57         19/49.44         21/47.29         3/40.12                          | 
|POLY-3 PERCENT (g) |        49.8%            45.3%            38.4%            44.4%            7.5%                             | 
|TERMINAL (d)       |        16/39 (41%)      16/41 (39%)      11/40 (28%)      16/38 (42%)      2/20 (10%)                       | 
|FIRST INCIDENCE    |        486              542              592              552              590                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.003N**       P=0.375N         P=0.205N         P=0.396N         P=0.002N**                       | 
|POLY 3             |        P<0.001N**       P=0.407N         P=0.178N         P=0.375N         P<0.001N**                       | 
|POLY 1.5           |        P<0.001N**       P=0.402N         P=0.183N         P=0.351N         P<0.001N**                       | 
|POLY 6             |        P<0.001N**       P=0.417N         P=0.177N         P=0.412N         P<0.001N**                       | 
|LOGISTIC REGRESSION|        P<0.001N**       P=0.434N         P=0.245N         P=0.344N         P<0.001N**                       | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.421N         P=0.210N         P=0.344N         P<0.001N**                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 7       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                    RIDDELLIINE                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        36/50 (72%)      39/50 (78%)      33/50 (66%)      23/50 (46%)      3/50 (6%)                        | 
|POLY-3 RATE (b)    |        36/49.02         39/48.76         33/49.97         23/46.73         3/40.12                          | 
|POLY-3 PERCENT (g) |        73.4%            80.0%            66.0%            49.2%            7.5%                             | 
|TERMINAL (d)       |        26/39 (67%)      32/41 (78%)      24/40 (60%)      19/38 (50%)      2/20 (10%)                       | 
|FIRST INCIDENCE    |        475              542              567              566              590                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001N**       P=0.465          P=0.302N         P=0.024N*        P<0.001N**                       | 
|POLY 3             |        P<0.001N**       P=0.299          P=0.281N         P=0.011N*        P<0.001N**                       | 
|POLY 1.5           |        P<0.001N**       P=0.322          P=0.287N         P=0.007N**       P<0.001N**                       | 
|POLY 6             |        P<0.001N**       P=0.273          P=0.282N         P=0.018N*        P<0.001N**                       | 
|LOGISTIC REGRESSION|        P<0.001N**       P=0.338          P=0.356N         P=0.007N**       P<0.001N**                       | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.322          P=0.333N         P=0.007N**       P<0.001N**                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma, Hepatocellular Adenoma,                                                                           | 
|     or Hepatoblastoma                                                                                                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        36/50 (72%)      40/50 (80%)      33/50 (66%)      24/50 (48%)      3/50 (6%)                        | 
|POLY-3 RATE (b)    |        36/49.02         40/48.76         33/49.97         24/47.29         3/40.12                          | 
|POLY-3 PERCENT (g) |        73.4%            82.0%            66.0%            50.8%            7.5%                             | 
|TERMINAL (d)       |        26/39 (67%)      33/41 (81%)      24/40 (60%)      19/38 (50%)      2/20 (10%)                       | 
|FIRST INCIDENCE    |        475              542              567              552              590                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001N**       P=0.398          P=0.302N         P=0.038N*        P<0.001N**                       | 
|POLY 3             |        P<0.001N**       P=0.218          P=0.281N         P=0.016N*        P<0.001N**                       | 
|POLY 1.5           |        P<0.001N**       P=0.238          P=0.287N         P=0.012N*        P<0.001N**                       | 
|POLY 6             |        P<0.001N**       P=0.195          P=0.282N         P=0.024N*        P<0.001N**                       | 
|LOGISTIC REGRESSION|        P<0.001N**       P=0.257          P=0.356N         P=0.012N*        P<0.001N**                       | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.241          P=0.333N         P=0.012N*        P<0.001N**                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 8       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                    RIDDELLIINE                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        12/50 (24%)      10/50 (20%)      11/50 (22%)      8/50 (16%)       12/50 (24%)                      | 
|POLY-3 RATE (b)    |        12/45.59         10/46.16         11/47.70         8/45.70          12/42.14                         | 
|POLY-3 PERCENT (g) |        26.3%            21.7%            23.1%            17.5%            28.5%                            | 
|TERMINAL (d)       |        11/39 (28%)      10/41 (24%)      11/40 (28%)      6/38 (16%)       5/20 (25%)                       | 
|FIRST INCIDENCE    |        706              729 (T)          729 (T)          689              559                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.024 *        P=0.355N         P=0.471N         P=0.250N         P=0.114                          | 
|POLY 3             |        P=0.356          P=0.391N         P=0.450N         P=0.222N         P=0.505                          | 
|POLY 1.5           |        P=0.405          P=0.391N         P=0.463N         P=0.219N         P=0.553                          | 
|POLY 6             |        P=0.288          P=0.395N         P=0.442N         P=0.228N         P=0.426                          | 
|LOGISTIC REGRESSION|        P=0.244          P=0.386N         P=0.428N         P=0.240N         P=0.489                          | 
|COCH-ARM / FISHERS |        P=0.464          P=0.405N         P=0.500N         P=0.227N         P=0.592N                         | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/50 (14%)       8/50 (16%)       6/50 (12%)       1/50 (2%)        5/50 (10%)                       | 
|POLY-3 RATE (b)    |        7/46.01          8/46.16          6/48.26          1/45.46          5/40.38                          | 
|POLY-3 PERCENT (g) |        15.2%            17.3%            12.4%            2.2%             12.4%                            | 
|TERMINAL (d)       |        5/39 (13%)       8/41 (20%)       4/40 (10%)       1/38 (3%)        3/20 (15%)                       | 
|FIRST INCIDENCE    |        599              729 (T)          567              729 (T)          587                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.538          P=0.535          P=0.471N         P=0.039N*        P=0.483                          | 
|POLY 3             |        P=0.289N         P=0.503          P=0.463N         P=0.031N*        P=0.473N                         | 
|POLY 1.5           |        P=0.258N         P=0.507          P=0.473N         P=0.030N*        P=0.425N                         | 
|POLY 6             |        P=0.335N         P=0.495          P=0.457N         P=0.033N*        P=0.552N                         | 
|LOGISTIC REGRESSION|        P=0.296N         P=0.511          P=0.504N         P=0.032N*        P=0.454N                         | 
|COCH-ARM / FISHERS |        P=0.224N         P=0.500          P=0.500N         P=0.030N*        P=0.380N                         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 9       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                    RIDDELLIINE                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        18/50 (36%)      16/50 (32%)      15/50 (30%)      9/50 (18%)       17/50 (34%)                      | 
|POLY-3 RATE (b)    |        18/46.10         16/46.16         15/48.26         9/45.70          17/42.87                         | 
|POLY-3 PERCENT (g) |        39.1%            34.7%            31.1%            19.7%            39.7%                            | 
|TERMINAL (d)       |        15/39 (39%)      16/41 (39%)      13/40 (33%)      7/38 (18%)       8/20 (40%)                       | 
|FIRST INCIDENCE    |        599              729 (T)          567              689              559                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.016 *        P=0.355N         P=0.301N         P=0.048N*        P=0.079                          | 
|POLY 3             |        P=0.424          P=0.413N         P=0.276N         P=0.033N*        P=0.564                          | 
|POLY 1.5           |        P=0.480          P=0.405N         P=0.291N         P=0.031N*        P=0.550N                         | 
|POLY 6             |        P=0.345          P=0.429N         P=0.267N         P=0.036N*        P=0.468                          | 
|LOGISTIC REGRESSION|        P=0.319          P=0.399N         P=0.277N         P=0.036N*        P=0.543                          | 
|COCH-ARM / FISHERS |        P=0.544          P=0.417N         P=0.335N         P=0.035N*        P=0.500N                         | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/49 (2%)        0/49 (0%)        3/50 (6%)        1/50 (2%)        2/49 (4%)                        | 
|POLY-3 RATE (b)    |        1/45.22          0/45.69          3/48.20          1/45.55          2/39.34                          | 
|POLY-3 PERCENT (g) |        2.2%             0.0%             6.2%             2.2%             5.1%                             | 
|TERMINAL (d)       |        1/39 (3%)        0/41 (0%)        1/40 (3%)        0/38 (0%)        1/20 (5%)                        | 
|FIRST INCIDENCE    |        729 (T)          ---              592              707              681                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.201          P=0.490N         P=0.327          P=0.755          P=0.301                          | 
|POLY 3             |        P=0.339          P=0.498N         P=0.329          P=0.759N         P=0.452                          | 
|POLY 1.5           |        P=0.366          P=0.498N         P=0.324          P=0.756N         P=0.476                          | 
|POLY 6             |        P=0.299          P=0.498N         P=0.333          P=0.759          P=0.415                          | 
|LOGISTIC REGRESSION|        P=0.398          (e)              P=0.289          P=0.763          P=0.407                          | 
|COCH-ARM / FISHERS |        P=0.398          P=0.500N         P=0.316          P=0.747N         P=0.500                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 10      
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                    RIDDELLIINE                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/50 (0%)        0/50 (0%)        2/50 (4%)                        | 
|POLY-3 RATE (b)    |        0/45.50          0/46.16          0/47.70          0/45.46          2/39.85                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             5.0%                             | 
|TERMINAL (d)       |        0/39 (0%)        0/41 (0%)        0/40 (0%)        0/38 (0%)        1/20 (5%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              675                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.003 **       (e)              (e)              (e)              P=0.130                          | 
|POLY 3             |        P=0.016 *        (e)              (e)              (e)              P=0.209                          | 
|POLY 1.5           |        P=0.017 *        (e)              (e)              (e)              P=0.223                          | 
|POLY 6             |        P=0.014 *        (e)              (e)              (e)              P=0.188                          | 
|LOGISTIC REGRESSION|        P=0.015 *        (e)              (e)              (e)              P=0.200                          | 
|COCH-ARM / FISHERS |        P=0.020 *        (e)              (e)              (e)              P=0.247                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/49 (0%)        2/50 (4%)        2/49 (4%)        1/50 (2%)        0/50 (0%)                        | 
|POLY-3 RATE (b)    |        0/44.83          2/46.16          2/46.70          1/46.12          0/39.65                          | 
|POLY-3 PERCENT (g) |        0.0%             4.3%             4.3%             2.2%             0.0%                             | 
|TERMINAL (d)       |        0/39 (0%)        2/41 (5%)        2/39 (5%)        0/38 (0%)        0/20 (0%)                        | 
|FIRST INCIDENCE    |        ---              729 (T)          729 (T)          507              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.379N         P=0.249          P=0.238          P=0.512          (e)                              | 
|POLY 3             |        P=0.293N         P=0.244          P=0.246          P=0.506          (e)                              | 
|POLY 1.5           |        P=0.274N         P=0.244          P=0.244          P=0.507          (e)                              | 
|POLY 6             |        P=0.323N         P=0.242          P=0.247          P=0.503          (e)                              | 
|LOGISTIC REGRESSION|        P=0.235N         P=0.249          P=0.238          P=0.366          (e)                              | 
|COCH-ARM / FISHERS |        P=0.255N         P=0.253          P=0.247          P=0.505          (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 11      
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                    RIDDELLIINE                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/50 (6%)        2/50 (4%)        4/50 (8%)        3/50 (6%)        33/50 (66%)                      | 
|POLY-3 RATE (b)    |        3/45.50          2/46.16          4/48.20          3/45.55          33/46.49                         | 
|POLY-3 PERCENT (g) |        6.6%             4.3%             8.3%             6.6%             71.0%                            | 
|TERMINAL (d)       |        3/39 (8%)        2/41 (5%)        2/40 (5%)        2/38 (5%)        10/20 (50%)                      | 
|FIRST INCIDENCE    |        729 (T)          729 (T)          592              707              550                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.477N         P=0.522          P=0.650          P<0.001 **                       | 
|POLY 3             |        P<0.001 **       P=0.493N         P=0.531          P=0.662N         P<0.001 **                       | 
|POLY 1.5           |        P<0.001 **       P=0.494N         P=0.522          P=0.659N         P<0.001 **                       | 
|POLY 6             |        P<0.001 **       P=0.495N         P=0.540          P=0.658          P<0.001 **                       | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.477N         P=0.504          P=0.653          P<0.001 **                       | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500N         P=0.500          P=0.661N         P<0.001 **                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Histiocytic Sarcoma                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        3/50 (6%)        3/50 (6%)        4/50 (8%)        0/50 (0%)                        | 
|POLY-3 RATE (b)    |        0/45.50          3/46.80          3/48.03          4/46.87          0/39.65                          | 
|POLY-3 PERCENT (g) |        0.0%             6.4%             6.3%             8.5%             0.0%                             | 
|TERMINAL (d)       |        0/39 (0%)        1/41 (2%)        1/40 (3%)        1/38 (3%)        0/20 (0%)                        | 
|FIRST INCIDENCE    |        ---              596              657              507              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.360N         P=0.128          P=0.134          P=0.067          (e)                              | 
|POLY 3             |        P=0.302N         P=0.124          P=0.129          P=0.064          (e)                              | 
|POLY 1.5           |        P=0.263N         P=0.123          P=0.126          P=0.064          (e)                              | 
|POLY 6             |        P=0.368N         P=0.125          P=0.132          P=0.064          (e)                              | 
|LOGISTIC REGRESSION|        P=0.174N         P=0.106          P=0.113          P=0.036 *        (e)                              | 
|COCH-ARM / FISHERS |        P=0.226N         P=0.121          P=0.121          P=0.059          (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 12      
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                    RIDDELLIINE                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        | 
|     NOS, or Undifferentiated Cell Type                                                                                          | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/50 (6%)        2/50 (4%)        1/50 (2%)        3/50 (6%)        2/50 (4%)                        | 
|POLY-3 RATE (b)    |        3/46.22          2/46.50          1/47.70          3/45.49          2/39.99                          | 
|POLY-3 PERCENT (g) |        6.5%             4.3%             2.1%             6.6%             5.0%                             | 
|TERMINAL (d)       |        2/39 (5%)        1/41 (2%)        1/40 (3%)        2/38 (5%)        1/20 (5%)                        | 
|FIRST INCIDENCE    |        475              634              729 (T)          720              633                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.388          P=0.487N         P=0.298N         P=0.654          P=0.667                          | 
|POLY 3             |        P=0.540          P=0.497N         P=0.294N         P=0.655          P=0.565N                         | 
|POLY 1.5           |        P=0.580          P=0.496N         P=0.297N         P=0.661          P=0.533N                         | 
|POLY 6             |        P=0.481          P=0.498N         P=0.293N         P=0.647          P=0.615N                         | 
|LOGISTIC REGRESSION|        P=0.558N         P=0.541N         P=0.359N         P=0.656          P=0.474N                         | 
|COCH-ARM / FISHERS |        P=0.590N         P=0.500N         P=0.309N         P=0.661N         P=0.500N                         | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        32/50 (64%)      27/50 (54%)      28/50 (56%)      23/50 (46%)      17/50 (34%)                      | 
|POLY-3 RATE (b)    |        32/47.25         27/46.47         28/48.63         23/47.75         17/42.90                         | 
|POLY-3 PERCENT (g) |        67.7%            58.1%            57.6%            48.2%            39.6%                            | 
|TERMINAL (d)       |        27/39 (69%)      25/41 (61%)      26/40 (65%)      16/38 (42%)      8/20 (40%)                       | 
|FIRST INCIDENCE    |        475              681              567              507              559                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.537          P=0.147N         P=0.218N         P=0.093N         P=0.414N                         | 
|POLY 3             |        P=0.006N**       P=0.222N         P=0.205N         P=0.039N*        P=0.004N**                       | 
|POLY 1.5           |        P=0.003N**       P=0.205N         P=0.218N         P=0.040N*        P=0.003N**                       | 
|POLY 6             |        P=0.014N*        P=0.248N         P=0.199N         P=0.039N*        P=0.011N*                        | 
|LOGISTIC REGRESSION|        P=0.009N**       P=0.175N         P=0.200N         P=0.050N         P=0.006N**                       | 
|COCH-ARM / FISHERS |        P=0.002N**       P=0.208N         P=0.270N         P=0.054N         P=0.002N**                       | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/12/00                           EXPERIMENT: 05161 TEST: 06                                            Page 13      
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                    RIDDELLIINE                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        29/50 (58%)      31/50 (62%)      31/50 (62%)      33/50 (66%)      41/50 (82%)                      | 
|POLY-3 RATE (b)    |        29/49.02         31/49.21         31/50.00         33/48.83         41/48.95                         | 
|POLY-3 PERCENT (g) |        59.2%            63.0%            62.0%            67.6%            83.8%                            | 
|TERMINAL (d)       |        19/39 (49%)      23/41 (56%)      21/40 (53%)      23/38 (61%)      13/20 (65%)                      | 
|FIRST INCIDENCE    |        475              542              567              507              356                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.507          P=0.505          P=0.281          P<0.001 **                       | 
|POLY 3             |        P=0.003 **       P=0.428          P=0.467          P=0.257          P=0.005 **                       | 
|POLY 1.5           |        P=0.003 **       P=0.435          P=0.462          P=0.273          P=0.006 **                       | 
|POLY 6             |        P=0.002 **       P=0.421          P=0.468          P=0.236          P=0.004 **                       | 
|LOGISTIC REGRESSION|        P=0.014 *        P=0.404          P=0.363          P=0.263          P=0.016 *                        | 
|COCH-ARM / FISHERS |        P=0.004 **       P=0.419          P=0.419          P=0.268          P=0.008 **                       | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                0.1              0.3              1.0              3.0                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        44/50 (88%)      45/50 (90%)      47/50 (94%)      42/50 (84%)      47/50 (94%)                      | 
|POLY-3 RATE (b)    |        44/49.02         45/49.21         47/50.00         42/49.39         47/50.00                         | 
|POLY-3 PERCENT (g) |        89.8%            91.4%            94.0%            85.0%            94.0%                            | 
|TERMINAL (d)       |        34/39 (87%)      37/41 (90%)      37/40 (93%)      31/38 (82%)      17/20 (85%)                      | 
|FIRST INCIDENCE    |        475              542              567              507              356                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.514N         P=0.460          P=0.496N         P<0.001 **                       | 
|POLY 3             |        P=0.396          P=0.524          P=0.344          P=0.344N         P=0.344                          | 
|POLY 1.5           |        P=0.379          P=0.540          P=0.330          P=0.333N         P=0.330                          | 
|POLY 6             |        P=0.404          P=0.506          P=0.346          P=0.365N         P=0.346                          | 
|LOGISTIC REGRESSION|        P=0.267          P=0.565          P=0.314          P=0.362N         P=0.221                          | 
|COCH-ARM / FISHERS |        P=0.312          P=0.500          P=0.243          P=0.387N         P=0.243                          | 
|=================================================================================================================================| 
(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).