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TDMS Study 88031-06 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                     DIPROPYLENE GLYCOL                                  DATE: 06/26/02       
EXPERIMENT: 88031 TEST: 06                                                                                     TIME: 14:00:57       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55388                              ROUTE: DOSED WATER                                             NTP C#: C88031       
PATHOLOGIST: RYAN, MICHAEL                                                                                     CAS: 25265-71-8      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                        FINAL#1, REVISION #3                                                        
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25022 Accidently Killed                                                                      
                                       25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25026 Other                                                                                  
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                     DIPROPYLENE GLYCOL                                  DATE: 06/26/02       
EXPERIMENT: 88031 TEST: 06                                                                                     TIME: 14:00:57       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55388                              ROUTE: DOSED WATER                                             NTP C#: C88031       
PATHOLOGIST: RYAN, MICHAEL                                                                                     CAS: 25265-71-8      
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 Medulla                                                                    
                                                 Bone Marrow                                                                        
                                                 Clitoral/Preputial Gland                                                           
                                                 Islets, Pancreatic                                                                 
                                                 Kidney                                                                             
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Nose                                                                               
                                                 Ovary                                                                              
                                                 Pituitary Gland                                                                    
                                                 Spleen                                                                             
                                                 Testes                                                                             
                                                 Thymus                                                                             
                                                 Thyroid Gland                                                                      
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                     DIPROPYLENE GLYCOL                                  DATE: 06/26/02       
EXPERIMENT: 88031 TEST: 06                                                                                     TIME: 14:00:57       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55388                              ROUTE: DOSED WATER                                             NTP C#: C88031       
PATHOLOGIST: RYAN, MICHAEL                                                                                     CAS: 25265-71-8      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                DIPROPYLENE GLYCOL                                                                                
===============================================================                                                                     
Male Mice                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Liver                                  Hepatocellular Adenoma                                                                       
Lung                                   Alveolar/Bronchiolar Adenoma                                                                 
                                       Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                               
All Organs                             Benign Tumors                                                                                
                                       Malignant Tumors                                                                             
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
                                       Hemangiosarcoma                                                                              
===============================================================                                                                     
                                                                                                                                   
       Date:  06/26/02                           EXPERIMENT: 88031 TEST: 06                                            Page 1       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)        -                 DIPROPYLENE GLYCOL             
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/49 (0%)    0/50 (0%)    0/49 (0%)   |0/50 (0%)    0/49 (0%)    2/49 (4%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/45.94      0/43.93      0/45.14      0/41.99     |0/45.83      0/45.33      2/44.15      1/40.93      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         4.5%         2.4%         | 
|TERMINAL (d)       |     0/40 (0%)    0/39 (0%)    0/35 (0%)    0/34 (0%)   |0/37 (0%)    0/37 (0%)    1/38 (3%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          693          395          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.220      (e)          P=0.237      P=0.496      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.203      (e)          P=0.229      P=0.477      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.216      (e)          P=0.231      P=0.485      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.192      (e)          P=0.228      P=0.471      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.337      (e)          P=0.230      P=0.652      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.247      (e)          P=0.242      P=0.500      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    3/50 (6%)    4/50 (8%)    1/49 (2%)   |1/50 (2%)    2/50 (4%)    2/50 (4%)    3/50 (6%)    | 
|POLY-3 RATE (b)    |     2/45.94      3/44.17      4/45.14      1/41.99     |1/45.83      2/46.65      2/44.12      3/40.09      | 
|POLY-3 PERCENT (g) |     4.4%         6.8%         8.9%         2.4%        |2.2%         4.3%         4.5%         7.5%         | 
|TERMINAL (d)       |     2/40 (5%)    2/39 (5%)    4/35 (11%)   1/34 (3%)   |1/37 (3%)    1/38 (3%)    2/38 (5%)    3/33 (9%)    | 
|FIRST INCIDENCE    |     729 (T)      710          729 (T)      729 (T)     |728 (T)      641          728 (T)      728 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.451N     P=0.489      P=0.277      P=0.557N    |P=0.186      P=0.509      P=0.509      P=0.265      | 
|POLY 3             |     P=0.416N     P=0.482      P=0.329      P=0.531N    |P=0.184      P=0.506      P=0.487      P=0.259      | 
|POLY 1.5           |     P=0.402N     P=0.486      P=0.334      P=0.522N    |P=0.199      P=0.505      P=0.492      P=0.274      | 
|POLY 6             |     P=0.432N     P=0.482      P=0.320      P=0.540N    |P=0.172      P=0.507      P=0.483      P=0.246      | 
|LOGISTIC REGRESSION|     P=0.437N     P=0.481      P=0.277      P=0.557N    |P=0.175      P=0.498      P=0.509      P=0.265      | 
|COCH-ARM / FISHERS |     P=0.380N     P=0.500      P=0.339      P=0.508N    |P=0.232      P=0.500      P=0.500      P=0.309      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/26/02                           EXPERIMENT: 88031 TEST: 06                                            Page 2       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                 DIPROPYLENE GLYCOL              
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    3/50 (6%)    4/50 (8%)    1/49 (2%)   |1/50 (2%)    3/50 (6%)    2/50 (4%)    3/50 (6%)    | 
|POLY-3 RATE (b)    |     3/45.94      3/44.17      4/45.14      1/41.99     |1/45.83      3/46.65      2/44.12      3/40.09      | 
|POLY-3 PERCENT (g) |     6.5%         6.8%         8.9%         2.4%        |2.2%         6.4%         4.5%         7.5%         | 
|TERMINAL (d)       |     3/40 (8%)    2/39 (5%)    4/35 (11%)   1/34 (3%)   |1/37 (3%)    2/38 (5%)    2/38 (5%)    3/33 (9%)    | 
|FIRST INCIDENCE    |     729 (T)      710          729 (T)      729 (T)     |728 (T)      641          728 (T)      728 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.320N     P=0.650      P=0.427      P=0.365N    |P=0.248      P=0.316      P=0.509      P=0.265      | 
|POLY 3             |     P=0.285N     P=0.644      P=0.490      P=0.338N    |P=0.242      P=0.312      P=0.487      P=0.259      | 
|POLY 1.5           |     P=0.273N     P=0.648      P=0.496      P=0.329N    |P=0.261      P=0.311      P=0.492      P=0.274      | 
|POLY 6             |     P=0.297N     P=0.644      P=0.480      P=0.347N    |P=0.226      P=0.312      P=0.483      P=0.246      | 
|LOGISTIC REGRESSION|     P=0.307N     P=0.645      P=0.427      P=0.365N    |P=0.231      P=0.307      P=0.509      P=0.265      | 
|COCH-ARM / FISHERS |     P=0.255N     P=0.661N     P=0.500      P=0.316N    |P=0.302      P=0.309      P=0.500      P=0.309      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small: Duodenum                                                                                                        | 
|     Polyp Adenomatous                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    0/50 (0%)    0/49 (0%)   |0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/45.94      2/44.10      0/45.14      0/41.99     |0/45.83      1/46.33      1/44.12      0/40.09      | 
|POLY-3 PERCENT (g) |     2.2%         4.5%         0.0%         0.0%        |0.0%         2.2%         2.3%         0.0%         | 
|TERMINAL (d)       |     1/40 (3%)    2/39 (5%)    0/35 (0%)    0/34 (0%)   |0/37 (0%)    1/38 (3%)    1/38 (3%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      ---          ---         |---          728 (T)      728 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.218N     P=0.491      P=0.527N     P=0.532N    |P=0.622N     P=0.505      P=0.505      (e)          | 
|POLY 3             |     P=0.200N     P=0.486      P=0.504N     P=0.518N    |P=0.629N     P=0.502      P=0.492      (e)          | 
|POLY 1.5           |     P=0.196N     P=0.489      P=0.502N     P=0.513N    |P=0.618N     P=0.502      P=0.496      (e)          | 
|POLY 6             |     P=0.203N     P=0.485      P=0.507N     P=0.523N    |P=0.639N     P=0.502      P=0.490      (e)          | 
|LOGISTIC REGRESSION|     P=0.218N     P=0.491      (e)          (e)         |(e)          P=0.505      P=0.505      (e)          | 
|COCH-ARM / FISHERS |     P=0.191N     P=0.500      P=0.500N     P=0.505N    |P=0.595N     P=0.500      P=0.500      (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/26/02                           EXPERIMENT: 88031 TEST: 06                                            Page 3       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                 DIPROPYLENE GLYCOL              
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small: Jejunum                                                                                                         | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    3/50 (6%)    0/49 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/45.94      2/44.10      3/45.14      0/41.99     |0/45.83      0/46.33      0/44.12      0/40.09      | 
|POLY-3 PERCENT (g) |     2.2%         4.5%         6.7%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/40 (3%)    2/39 (5%)    3/35 (9%)    0/34 (0%)   |0/37 (0%)    0/38 (0%)    0/38 (0%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.396N     P=0.491      P=0.258      P=0.532N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.375N     P=0.486      P=0.299      P=0.518N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.363N     P=0.489      P=0.303      P=0.513N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.387N     P=0.485      P=0.292      P=0.523N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.396N     P=0.491      P=0.258      (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.344N     P=0.500      P=0.309      P=0.505N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small: Site Unspecified                                                                                                | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    3/50 (6%)    0/49 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/45.94      2/44.10      3/45.14      0/41.99     |0/45.83      0/46.33      0/44.12      0/40.09      | 
|POLY-3 PERCENT (g) |     2.2%         4.5%         6.7%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/40 (3%)    2/39 (5%)    3/35 (9%)    0/34 (0%)   |0/37 (0%)    0/38 (0%)    0/38 (0%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.396N     P=0.491      P=0.258      P=0.532N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.375N     P=0.486      P=0.299      P=0.518N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.363N     P=0.489      P=0.303      P=0.513N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.387N     P=0.485      P=0.292      P=0.523N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.396N     P=0.491      P=0.258      (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.344N     P=0.500      P=0.309      P=0.505N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/26/02                           EXPERIMENT: 88031 TEST: 06                                            Page 4       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                 DIPROPYLENE GLYCOL              
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small: Site Unspecified                                                                                                | 
|     Polyp Adenomatous                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    3/50 (6%)    0/50 (0%)    0/49 (0%)   |0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/45.94      3/44.10      0/45.14      0/41.99     |0/45.83      1/46.33      1/44.12      0/40.09      | 
|POLY-3 PERCENT (g) |     4.4%         6.8%         0.0%         0.0%        |0.0%         2.2%         2.3%         0.0%         | 
|TERMINAL (d)       |     2/40 (5%)    3/39 (8%)    0/35 (0%)    0/34 (0%)   |0/37 (0%)    1/38 (3%)    1/38 (3%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      ---          ---         |---          728 (T)      728 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.093N     P=0.488      P=0.268N     P=0.275N    |P=0.622N     P=0.505      P=0.505      (e)          | 
|POLY 3             |     P=0.079N     P=0.481      P=0.241N     P=0.258N    |P=0.629N     P=0.502      P=0.492      (e)          | 
|POLY 1.5           |     P=0.077N     P=0.485      P=0.239N     P=0.252N    |P=0.618N     P=0.502      P=0.496      (e)          | 
|POLY 6             |     P=0.082N     P=0.481      P=0.245N     P=0.263N    |P=0.639N     P=0.502      P=0.490      (e)          | 
|LOGISTIC REGRESSION|     P=0.093N     P=0.488      (e)          (e)         |(e)          P=0.505      P=0.505      (e)          | 
|COCH-ARM / FISHERS |     P=0.075N     P=0.500      P=0.247N     P=0.253N    |P=0.595N     P=0.500      P=0.500      (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    1/50 (2%)    0/49 (0%)   |2/50 (4%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/45.94      0/44.10      1/45.45      0/41.99     |2/45.83      0/46.33      0/44.12      1/40.93      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.2%         0.0%        |4.4%         0.0%         0.0%         2.4%         | 
|TERMINAL (d)       |     0/40 (0%)    0/39 (0%)    0/35 (0%)    0/34 (0%)   |2/37 (5%)    0/38 (0%)    0/38 (0%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          645          ---         |728 (T)      ---          ---          395          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.688      (e)          P=0.505      (e)         |P=0.483N     P=0.232N     P=0.232N     P=0.529N     | 
|POLY 3             |     P=0.665      (e)          P=0.498      (e)         |P=0.461N     P=0.235N     P=0.246N     P=0.539N     | 
|POLY 1.5           |     P=0.676      (e)          P=0.499      (e)         |P=0.462N     P=0.235N     P=0.242N     P=0.527N     | 
|POLY 6             |     P=0.655      (e)          P=0.495      (e)         |P=0.459N     P=0.235N     P=0.248N     P=0.551N     | 
|LOGISTIC REGRESSION|     P=0.702      (e)          P=0.493      (e)         |P=0.375N     (e)          (e)          P=0.439N     | 
|COCH-ARM / FISHERS |     P=0.692      (e)          P=0.500      (e)         |P=0.461N     P=0.247N     P=0.247N     P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/26/02                           EXPERIMENT: 88031 TEST: 06                                            Page 5       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                 DIPROPYLENE GLYCOL              
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hemangioma                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    2/50 (4%)    0/49 (0%)   |1/50 (2%)    0/50 (0%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     1/45.94      1/44.10      2/45.14      0/41.99     |1/45.83      0/46.33      1/44.12      1/40.09      | 
|POLY-3 PERCENT (g) |     2.2%         2.3%         4.4%         0.0%        |2.2%         0.0%         2.3%         2.5%         | 
|TERMINAL (d)       |     1/40 (3%)    1/39 (3%)    2/35 (6%)    0/34 (0%)   |1/37 (3%)    0/38 (0%)    1/38 (3%)    1/33 (3%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      ---         |728 (T)      ---          728 (T)      728 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.415N     P=0.756      P=0.453      P=0.532N    |P=0.509      P=0.495N     P=0.756N     P=0.736      | 
|POLY 3             |     P=0.393N     P=0.751      P=0.494      P=0.518N    |P=0.495      P=0.498N     P=0.752      P=0.730      | 
|POLY 1.5           |     P=0.385N     P=0.753      P=0.497      P=0.513N    |P=0.508      P=0.498N     P=0.756      P=0.740      | 
|POLY 6             |     P=0.402N     P=0.751      P=0.487      P=0.523N    |P=0.483      P=0.498N     P=0.750      P=0.721      | 
|LOGISTIC REGRESSION|     P=0.415N     P=0.756      P=0.453      (e)         |P=0.509      (e)          P=0.756N     P=0.736      | 
|COCH-ARM / FISHERS |     P=0.372N     P=0.753N     P=0.500      P=0.505N    |P=0.539      P=0.500N     P=0.753N     P=0.753N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    3/50 (6%)    1/50 (2%)    2/49 (4%)   |2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/45.94      3/44.10      1/45.15      2/41.99     |2/45.83      0/46.33      0/44.12      0/40.09      | 
|POLY-3 PERCENT (g) |     0.0%         6.8%         2.2%         4.8%        |4.4%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/40 (0%)    3/39 (8%)    0/35 (0%)    2/34 (6%)   |2/37 (5%)    0/38 (0%)    0/38 (0%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     ---          729 (T)      727          729 (T)     |728 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.280      P=0.117      P=0.479      P=0.203     |P=0.122N     P=0.232N     P=0.232N     P=0.264N     | 
|POLY 3             |     P=0.299      P=0.111      P=0.497      P=0.218     |P=0.111N     P=0.235N     P=0.246N     P=0.268N     | 
|POLY 1.5           |     P=0.310      P=0.113      P=0.498      P=0.223     |P=0.112N     P=0.235N     P=0.242N     P=0.258N     | 
|POLY 6             |     P=0.289      P=0.111      P=0.493      P=0.212     |P=0.109N     P=0.235N     P=0.248N     P=0.278N     | 
|LOGISTIC REGRESSION|     P=0.278      P=0.117      P=0.482      P=0.203     |P=0.122N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.330      P=0.121      P=0.500      P=0.242     |P=0.115N     P=0.247N     P=0.247N     P=0.247N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/26/02                           EXPERIMENT: 88031 TEST: 06                                            Page 6       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                 DIPROPYLENE GLYCOL              
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatoblastoma                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    4/50 (8%)    1/49 (2%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/45.94      0/44.10      4/46.37      1/42.22     |0/45.83      0/46.33      1/44.26      0/40.09      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         8.6%         2.4%        |0.0%         0.0%         2.3%         0.0%         | 
|TERMINAL (d)       |     0/40 (0%)    0/39 (0%)    0/35 (0%)    0/34 (0%)   |0/37 (0%)    0/38 (0%)    0/38 (0%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          616          668         |---          ---          693          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.223      (e)          P=0.068      P=0.480     |P=0.671      (e)          P=0.490      (e)          | 
|POLY 3             |     P=0.207      (e)          P=0.061      P=0.483     |P=0.634      (e)          P=0.493      (e)          | 
|POLY 1.5           |     P=0.218      (e)          P=0.061      P=0.488     |P=0.654      (e)          P=0.496      (e)          | 
|POLY 6             |     P=0.197      (e)          P=0.061      P=0.479     |P=0.616      (e)          P=0.492      (e)          | 
|LOGISTIC REGRESSION|     P=0.261      (e)          P=0.056      P=0.514     |P=0.693      (e)          P=0.500      (e)          | 
|COCH-ARM / FISHERS |     P=0.239      (e)          P=0.059      P=0.495     |P=0.694      (e)          P=0.500      (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Adenoma                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     17/50 (34%)  17/50 (34%)  20/50 (40%)  6/49 (12%)  |11/50 (22%)  14/50 (28%)  12/50 (24%)  11/50 (22%)  | 
|POLY-3 RATE (b)    |     17/46.41     17/44.10     20/46.26     6/42.99     |11/46.08     14/46.65     12/44.12     11/40.68     | 
|POLY-3 PERCENT (g) |     36.6%        38.6%        43.2%        14.0%       |23.9%        30.0%        27.2%        27.0%        | 
|TERMINAL (d)       |     16/40 (40%)  17/39 (44%)  17/35 (49%)  4/34 (12%)  |9/37 (24%)   12/38 (32%)  12/38 (32%)  10/33 (30%)  | 
|FIRST INCIDENCE    |     592          729 (T)      542          464         |693          687          728 (T)      542          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.029N*    P=0.548      P=0.187      P=0.025N*   |P=0.485      P=0.347      P=0.522      P=0.466      | 
|POLY 3             |     P=0.011N*    P=0.511      P=0.330      P=0.012N*   |P=0.468      P=0.333      P=0.452      P=0.464      | 
|POLY 1.5           |     P=0.010N*    P=0.530      P=0.337      P=0.010N*   |P=0.520      P=0.334      P=0.472      P=0.507      | 
|POLY 6             |     P=0.013N*    P=0.501      P=0.314      P=0.013N*   |P=0.421      P=0.330      P=0.434      P=0.424      | 
|LOGISTIC REGRESSION|     P=0.015N*    P=0.528      P=0.305      P=0.014N*   |P=0.412      P=0.327      P=0.452      P=0.421      | 
|COCH-ARM / FISHERS |     P=0.010N*    P=0.583N     P=0.339      P=0.009N**  |P=0.455N     P=0.322      P=0.500      P=0.595N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/26/02                           EXPERIMENT: 88031 TEST: 06                                            Page 7       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                 DIPROPYLENE GLYCOL              
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     14/50 (28%)  10/50 (20%)  11/50 (22%)  16/49 (33%) |7/50 (14%)   2/50 (4%)    2/50 (4%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     14/49.44     10/46.13     11/46.50     16/45.31    |7/46.24      2/46.33      2/44.12      2/40.68      | 
|POLY-3 PERCENT (g) |     28.3%        21.7%        23.7%        35.3%       |15.1%        4.3%         4.5%         4.9%         | 
|TERMINAL (d)       |     5/40 (13%)   5/39 (13%)   6/35 (17%)   7/34 (21%)  |5/37 (14%)   2/38 (5%)    2/38 (5%)    1/33 (3%)    | 
|FIRST INCIDENCE    |     416          501          616          451         |621          728 (T)      728 (T)      542          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.175      P=0.299N     P=0.410N     P=0.286     |P=0.090N     P=0.079N     P=0.082N     P=0.121N     | 
|POLY 3             |     P=0.200      P=0.306N     P=0.388N     P=0.306     |P=0.081N     P=0.078N     P=0.090N     P=0.113N     | 
|POLY 1.5           |     P=0.217      P=0.287N     P=0.360N     P=0.334     |P=0.076N     P=0.077N     P=0.086N     P=0.101N     | 
|POLY 6             |     P=0.183      P=0.319N     P=0.425N     P=0.282     |P=0.085N     P=0.080N     P=0.094N     P=0.125N     | 
|LOGISTIC REGRESSION|     P=0.303      P=0.160N     P=0.288N     P=0.549     |P=0.081N     P=0.078N     P=0.090N     P=0.095N     | 
|COCH-ARM / FISHERS |     P=0.243      P=0.241N     P=0.322N     P=0.388     |P=0.066N     P=0.080N     P=0.080N     P=0.080N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     14/50 (28%)  10/50 (20%)  13/50 (26%)  16/49 (33%) |7/50 (14%)   2/50 (4%)    3/50 (6%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     14/49.44     10/46.13     13/47.02     16/45.31    |7/46.24      2/46.33      3/44.26      2/40.68      | 
|POLY-3 PERCENT (g) |     28.3%        21.7%        27.7%        35.3%       |15.1%        4.3%         6.8%         4.9%         | 
|TERMINAL (d)       |     5/40 (13%)   5/39 (13%)   6/35 (17%)   7/34 (21%)  |5/37 (14%)   2/38 (5%)    2/38 (5%)    1/33 (3%)    | 
|FIRST INCIDENCE    |     416          501          616          451         |621          728 (T)      693          542          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.165      P=0.299N     P=0.572N     P=0.286     |P=0.111N     P=0.079N     P=0.163N     P=0.121N     | 
|POLY 3             |     P=0.186      P=0.306N     P=0.561N     P=0.306     |P=0.101N     P=0.078N     P=0.175N     P=0.113N     | 
|POLY 1.5           |     P=0.202      P=0.287N     P=0.536N     P=0.334     |P=0.095N     P=0.077N     P=0.168N     P=0.101N     | 
|POLY 6             |     P=0.169      P=0.319N     P=0.588      P=0.282     |P=0.107N     P=0.080N     P=0.181N     P=0.125N     | 
|LOGISTIC REGRESSION|     P=0.289      P=0.160N     P=0.463N     P=0.549     |P=0.097N     P=0.078N     P=0.172N     P=0.095N     | 
|COCH-ARM / FISHERS |     P=0.228      P=0.241N     P=0.500N     P=0.388     |P=0.080N     P=0.080N     P=0.159N     P=0.080N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/26/02                           EXPERIMENT: 88031 TEST: 06                                            Page 8       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                 DIPROPYLENE GLYCOL              
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     29/50 (58%)  25/50 (50%)  28/50 (56%)  21/49 (43%) |17/50 (34%)  15/50 (30%)  13/50 (26%)  13/50 (26%)  | 
|POLY-3 RATE (b)    |     29/49.44     25/46.13     28/47.61     21/46.31    |17/46.49     15/46.65     13/44.12     13/41.27     | 
|POLY-3 PERCENT (g) |     58.7%        54.2%        58.8%        45.4%       |36.6%        32.2%        29.5%        31.5%        | 
|TERMINAL (d)       |     20/40 (50%)  20/39 (51%)  20/35 (57%)  10/34 (29%) |13/37 (35%)  13/38 (34%)  13/38 (34%)  11/33 (33%)  | 
|FIRST INCIDENCE    |     416          501          542          451         |621          687          728 (T)      542          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.316N     P=0.356N     P=0.443      P=0.286N    |P=0.355N     P=0.391N     P=0.241N     P=0.406N     | 
|POLY 3             |     P=0.126N     P=0.408N     P=0.576      P=0.135N    |P=0.345N     P=0.409N     P=0.310N     P=0.392N     | 
|POLY 1.5           |     P=0.116N     P=0.368N     P=0.552N     P=0.120N    |P=0.301N     P=0.404N     P=0.286N     P=0.346N     | 
|POLY 6             |     P=0.137N     P=0.437N     P=0.532      P=0.148N    |P=0.387N     P=0.419N     P=0.335N     P=0.438N     | 
|LOGISTIC REGRESSION|     P=0.102N     P=0.284N     P=0.489N     P=0.059N    |P=0.408N     P=0.402N     P=0.306N     P=0.410N     | 
|COCH-ARM / FISHERS |     P=0.104N     P=0.274N     P=0.500N     P=0.096N    |P=0.215N     P=0.415N     P=0.257N     P=0.257N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma, Hepatocellular Adenoma,                                                                           | 
|     or Hepatoblastoma                                                                                                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     29/50 (58%)  25/50 (50%)  28/50 (56%)  21/49 (43%) |17/50 (34%)  15/50 (30%)  14/50 (28%)  13/50 (26%)  | 
|POLY-3 RATE (b)    |     29/49.44     25/46.13     28/47.61     21/46.31    |17/46.49     15/46.65     14/44.26     13/41.27     | 
|POLY-3 PERCENT (g) |     58.7%        54.2%        58.8%        45.4%       |36.6%        32.2%        31.6%        31.5%        | 
|TERMINAL (d)       |     20/40 (50%)  20/39 (51%)  20/35 (57%)  10/34 (29%) |13/37 (35%)  13/38 (34%)  13/38 (34%)  11/33 (33%)  | 
|FIRST INCIDENCE    |     416          501          542          451         |621          687          693          542          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.316N     P=0.356N     P=0.443      P=0.286N    |P=0.371N     P=0.391N     P=0.319N     P=0.406N     | 
|POLY 3             |     P=0.126N     P=0.408N     P=0.576      P=0.135N    |P=0.360N     P=0.409N     P=0.392N     P=0.392N     | 
|POLY 1.5           |     P=0.116N     P=0.368N     P=0.552N     P=0.120N    |P=0.315N     P=0.404N     P=0.366N     P=0.346N     | 
|POLY 6             |     P=0.137N     P=0.437N     P=0.532      P=0.148N    |P=0.403N     P=0.419N     P=0.416N     P=0.438N     | 
|LOGISTIC REGRESSION|     P=0.102N     P=0.284N     P=0.489N     P=0.059N    |P=0.420N     P=0.402N     P=0.392N     P=0.410N     | 
|COCH-ARM / FISHERS |     P=0.104N     P=0.274N     P=0.500N     P=0.096N    |P=0.224N     P=0.415N     P=0.333N     P=0.257N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/26/02                           EXPERIMENT: 88031 TEST: 06                                            Page 9       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                 DIPROPYLENE GLYCOL              
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    9/50 (18%)   5/50 (10%)   4/49 (8%)   |2/50 (4%)    0/50 (0%)    4/49 (8%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     3/46.30      9/44.10      5/46.15      4/41.99     |2/45.83      0/46.33      4/44.07      1/40.09      | 
|POLY-3 PERCENT (g) |     6.5%         20.4%        10.8%        9.5%        |4.4%         0.0%         9.1%         2.5%         | 
|TERMINAL (d)       |     2/40 (5%)    9/39 (23%)   2/35 (6%)    4/34 (12%)  |2/37 (5%)    0/38 (0%)    3/38 (8%)    1/33 (3%)    | 
|FIRST INCIDENCE    |     629          729 (T)      542          729 (T)     |728 (T)      ---          576          728 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.557      P=0.056      P=0.322      P=0.417     |P=0.577      P=0.232N     P=0.345      P=0.540N     | 
|POLY 3             |     P=0.526N     P=0.048 *    P=0.355      P=0.447     |P=0.543      P=0.235N     P=0.319      P=0.546N     | 
|POLY 1.5           |     P=0.504N     P=0.051      P=0.357      P=0.463     |P=0.569      P=0.235N     P=0.323      P=0.531N     | 
|POLY 6             |     P=0.551N     P=0.047 *    P=0.348      P=0.431     |P=0.520      P=0.235N     P=0.319      P=0.560N     | 
|LOGISTIC REGRESSION|     P=0.503N     P=0.052      P=0.359      P=0.448     |P=0.588      (e)          P=0.322      P=0.540N     | 
|COCH-ARM / FISHERS |     P=0.468N     P=0.061      P=0.357      P=0.489     |P=0.578N     P=0.247N     P=0.329      P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    5/50 (10%)   8/50 (16%)   4/49 (8%)   |2/50 (4%)    2/50 (4%)    2/49 (4%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     3/45.94      5/44.35      8/46.56      4/41.99     |2/45.83      2/46.33      2/43.84      2/40.09      | 
|POLY-3 PERCENT (g) |     6.5%         11.3%        17.2%        9.5%        |4.4%         4.3%         4.6%         5.0%         | 
|TERMINAL (d)       |     3/40 (8%)    4/39 (10%)   5/35 (14%)   4/34 (12%)  |2/37 (5%)    2/38 (5%)    1/38 (3%)    2/33 (6%)    | 
|FIRST INCIDENCE    |     729 (T)      661          494          729 (T)     |728 (T)      728 (T)      654          728 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.332      P=0.344      P=0.076      P=0.411     |P=0.544      P=0.686N     P=0.688N     P=0.654      | 
|POLY 3             |     P=0.366      P=0.337      P=0.102      P=0.451     |P=0.529      P=0.690N     P=0.678      P=0.645      | 
|POLY 1.5           |     P=0.388      P=0.341      P=0.102      P=0.465     |P=0.550      P=0.689N     P=0.681      P=0.661      | 
|POLY 6             |     P=0.343      P=0.339      P=0.100      P=0.438     |P=0.512      P=0.691N     P=0.678      P=0.630      | 
|LOGISTIC REGRESSION|     P=0.404      P=0.333      P=0.102      P=0.411     |P=0.524      P=0.686N     P=0.681      P=0.654      | 
|COCH-ARM / FISHERS |     P=0.422      P=0.357      P=0.100      P=0.489     |P=0.595      P=0.691N     P=0.684      P=0.691N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/26/02                           EXPERIMENT: 88031 TEST: 06                                            Page 10      
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                 DIPROPYLENE GLYCOL              
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/50 (12%)   14/50 (28%)  13/50 (26%)  8/49 (16%)  |3/50 (6%)    2/50 (4%)    6/49 (12%)   3/50 (6%)    | 
|POLY-3 RATE (b)    |     6/46.30      14/44.35     13/47.56     8/41.99     |3/45.83      2/46.33      6/44.34      3/40.09      | 
|POLY-3 PERCENT (g) |     13.0%        31.6%        27.3%        19.1%       |6.6%         4.3%         13.5%        7.5%         | 
|TERMINAL (d)       |     5/40 (13%)   13/39 (33%)  7/35 (20%)   8/34 (24%)  |3/37 (8%)    2/38 (5%)    4/38 (11%)   3/33 (9%)    | 
|FIRST INCIDENCE    |     629          661          494          729 (T)     |728 (T)      728 (T)      576          728 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.370      P=0.035 *    P=0.048 *    P=0.270     |P=0.386      P=0.488N     P=0.252      P=0.610      | 
|POLY 3             |     P=0.422      P=0.028 *    P=0.068      P=0.312     |P=0.359      P=0.495N     P=0.226      P=0.599      | 
|POLY 1.5           |     P=0.458      P=0.030 *    P=0.066      P=0.334     |P=0.390      P=0.495N     P=0.228      P=0.620      | 
|POLY 6             |     P=0.384      P=0.027 *    P=0.068      P=0.291     |P=0.333      P=0.496N     P=0.228      P=0.580      | 
|LOGISTIC REGRESSION|     P=0.474      P=0.030 *    P=0.064      P=0.297     |P=0.381      P=0.488N     P=0.227      P=0.610      | 
|COCH-ARM / FISHERS |     P=0.514      P=0.039 *    P=0.062      P=0.371     |P=0.461      P=0.500N     P=0.233      P=0.661N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)   |2/50 (4%)    1/50 (2%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/45.94      0/44.10      0/45.14      0/41.99     |2/45.84      1/46.33      0/44.12      1/40.09      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |4.4%         2.2%         0.0%         2.5%         | 
|TERMINAL (d)       |     0/40 (0%)    0/39 (0%)    0/35 (0%)    0/34 (0%)   |1/37 (3%)    1/38 (3%)    0/38 (0%)    1/33 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |725          728 (T)      ---          728 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.400N     P=0.491N     P=0.237N     P=0.543N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.378N     P=0.496N     P=0.246N     P=0.546N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.375N     P=0.496N     P=0.242N     P=0.531N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.380N     P=0.497N     P=0.248N     P=0.560N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.413N     P=0.496N     P=0.244N     P=0.560N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.366N     P=0.500N     P=0.247N     P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/26/02                           EXPERIMENT: 88031 TEST: 06                                            Page 11      
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                 DIPROPYLENE GLYCOL              
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)   |2/50 (4%)    1/50 (2%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/45.94      0/44.10      0/45.14      0/41.99     |2/45.84      1/46.33      0/44.12      1/40.09      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |4.4%         2.2%         0.0%         2.5%         | 
|TERMINAL (d)       |     0/40 (0%)    0/39 (0%)    0/35 (0%)    0/34 (0%)   |1/37 (3%)    1/38 (3%)    0/38 (0%)    1/33 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |725          728 (T)      ---          728 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.400N     P=0.491N     P=0.237N     P=0.543N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.378N     P=0.496N     P=0.246N     P=0.546N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.375N     P=0.496N     P=0.242N     P=0.531N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.380N     P=0.497N     P=0.248N     P=0.560N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.413N     P=0.496N     P=0.244N     P=0.560N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.366N     P=0.500N     P=0.247N     P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery                                                                                                                        | 
|     Sarcoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)   |0/50 (0%)    2/50 (4%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/45.94      0/44.10      0/45.14      0/41.99     |0/45.83      2/46.78      1/44.56      0/40.09      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         4.3%         2.2%         0.0%         | 
|TERMINAL (d)       |     0/40 (0%)    0/39 (0%)    0/35 (0%)    0/34 (0%)   |0/37 (0%)    0/38 (0%)    0/38 (0%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          643          599          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.515N     P=0.240      P=0.482      (e)          | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.505N     P=0.242      P=0.494      (e)          | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.490N     P=0.241      P=0.497      (e)          | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.517N     P=0.243      P=0.494      (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.408N     P=0.216      P=0.500      (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.461N     P=0.247      P=0.500      (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/26/02                           EXPERIMENT: 88031 TEST: 06                                            Page 12      
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                 DIPROPYLENE GLYCOL              
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cystadenoma                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |0/50 (0%)    2/50 (4%)    2/50 (4%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |                                                        |0/45.83      2/46.33      2/44.12      1/40.09      | 
|POLY-3 PERCENT (g) |                                                        |0.0%         4.3%         4.5%         2.5%         | 
|TERMINAL (d)       |                                                        |0/37 (0%)    2/38 (5%)    2/38 (5%)    1/33 (3%)    | 
|FIRST INCIDENCE    |                                                        |---          728 (T)      728 (T)      728 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.428      P=0.244      P=0.244      P=0.477      | 
|POLY 3             |                                                        |P=0.395      P=0.240      P=0.229      P=0.473      | 
|POLY 1.5           |                                                        |P=0.419      P=0.240      P=0.232      P=0.482      | 
|POLY 6             |                                                        |P=0.374      P=0.239      P=0.226      P=0.466      | 
|LOGISTIC REGRESSION|                                                        |(e)          P=0.244      P=0.244      P=0.477      | 
|COCH-ARM / FISHERS |                                                        |P=0.469      P=0.247      P=0.247      P=0.500      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/49 (0%)    0/48 (0%)    0/49 (0%)    0/49 (0%)   |1/49 (2%)    3/49 (6%)    3/49 (6%)    3/49 (6%)    | 
|POLY-3 RATE (b)    |     0/45.41      0/42.52      0/44.14      0/41.99     |1/45.81      3/45.47      3/43.56      3/39.37      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |2.2%         6.6%         6.9%         7.6%         | 
|TERMINAL (d)       |     0/40 (0%)    0/39 (0%)    0/34 (0%)    0/34 (0%)   |1/37 (3%)    3/38 (8%)    3/38 (8%)    2/32 (6%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |728 (T)      728 (T)      728 (T)      654          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.226      P=0.314      P=0.314      P=0.254      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.218      P=0.303      P=0.287      P=0.253      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.238      P=0.304      P=0.293      P=0.268      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.203      P=0.302      P=0.285      P=0.242      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.206      P=0.314      P=0.314      P=0.249      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.292      P=0.309      P=0.309      P=0.309      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/26/02                           EXPERIMENT: 88031 TEST: 06                                            Page 13      
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                 DIPROPYLENE GLYCOL              
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skeletal Muscle                                                                                                                  | 
|     Sarcoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    1/50 (2%)    0/49 (0%)   |2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/45.94      0/44.10      1/45.83      0/41.99     |2/46.15      0/46.33      0/44.12      0/40.09      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.2%         0.0%        |4.3%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/40 (0%)    0/39 (0%)    0/35 (0%)    0/34 (0%)   |1/37 (3%)    0/38 (0%)    0/38 (0%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          494          ---         |641          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.688      (e)          P=0.504      (e)         |P=0.127N     P=0.234N     P=0.244N     P=0.274N     | 
|POLY 3             |     P=0.665      (e)          P=0.500      (e)         |P=0.110N     P=0.236N     P=0.247N     P=0.270N     | 
|POLY 1.5           |     P=0.675      (e)          P=0.500      (e)         |P=0.112N     P=0.235N     P=0.243N     P=0.259N     | 
|POLY 6             |     P=0.654      (e)          P=0.497      (e)         |P=0.108N     P=0.238N     P=0.251N     P=0.281N     | 
|LOGISTIC REGRESSION|     P=0.706      (e)          P=0.358      (e)         |P=0.110N     P=0.244N     P=0.235N     P=0.241N     | 
|COCH-ARM / FISHERS |     P=0.692      (e)          P=0.500      (e)         |P=0.115N     P=0.247N     P=0.247N     P=0.247N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Sarcoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)   |3/50 (6%)    7/50 (14%)   2/50 (4%)    3/50 (6%)    | 
|POLY-3 RATE (b)    |     0/45.94      0/44.10      0/45.14      0/41.99     |3/46.67      7/47.51      2/44.90      3/40.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |6.4%         14.7%        4.5%         7.4%         | 
|TERMINAL (d)       |     0/40 (0%)    0/39 (0%)    0/35 (0%)    0/34 (0%)   |1/37 (3%)    2/38 (5%)    0/38 (0%)    2/33 (6%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |570          561          576          565          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.444N     P=0.177      P=0.516N     P=0.579      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.417N     P=0.165      P=0.518N     P=0.597      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.392N     P=0.164      P=0.510N     P=0.619      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.440N     P=0.166      P=0.522N     P=0.576      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.277N     P=0.129      P=0.484N     P=0.644N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.341N     P=0.159      P=0.500N     P=0.661N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/26/02                           EXPERIMENT: 88031 TEST: 06                                            Page 14      
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                 DIPROPYLENE GLYCOL              
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    0/50 (0%)    0/49 (0%)   |2/50 (4%)    1/50 (2%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     1/45.94      0/44.10      0/45.14      0/41.99     |2/45.83      1/46.40      0/44.12      1/40.09      | 
|POLY-3 PERCENT (g) |     2.2%         0.0%         0.0%         0.0%        |4.4%         2.2%         0.0%         2.5%         | 
|TERMINAL (d)       |     1/40 (3%)    0/39 (0%)    0/35 (0%)    0/34 (0%)   |2/37 (5%)    0/38 (0%)    0/38 (0%)    1/33 (3%)    | 
|FIRST INCIDENCE    |     729 (T)      ---          ---          ---         |728 (T)      711          ---          728 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.327N     P=0.505N     P=0.527N     P=0.532N    |P=0.402N     P=0.491N     P=0.232N     P=0.540N     | 
|POLY 3             |     P=0.298N     P=0.508N     P=0.504N     P=0.518N    |P=0.378N     P=0.496N     P=0.246N     P=0.546N     | 
|POLY 1.5           |     P=0.301N     P=0.506N     P=0.502N     P=0.513N    |P=0.375N     P=0.496N     P=0.242N     P=0.531N     | 
|POLY 6             |     P=0.296N     P=0.508N     P=0.507N     P=0.523N    |P=0.380N     P=0.496N     P=0.248N     P=0.560N     | 
|LOGISTIC REGRESSION|     P=0.327N     (e)          (e)          (e)         |P=0.418N     P=0.497N     (e)          P=0.540N     | 
|COCH-ARM / FISHERS |     P=0.308N     P=0.500N     P=0.500N     P=0.505N    |P=0.366N     P=0.500N     P=0.247N     P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Squamous Cell Papilloma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)   |2/50 (4%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/45.94      0/44.10      0/45.14      0/41.99     |2/45.83      0/46.33      0/44.12      1/40.09      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |4.4%         0.0%         0.0%         2.5%         | 
|TERMINAL (d)       |     0/40 (0%)    0/39 (0%)    0/35 (0%)    0/34 (0%)   |2/37 (5%)    0/38 (0%)    0/38 (0%)    1/33 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |728 (T)      ---          ---          728 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.491N     P=0.232N     P=0.232N     P=0.540N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.460N     P=0.235N     P=0.246N     P=0.546N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.461N     P=0.235N     P=0.242N     P=0.531N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.457N     P=0.235N     P=0.248N     P=0.560N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.491N     (e)          (e)          P=0.540N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.461N     P=0.247N     P=0.247N     P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/26/02                           EXPERIMENT: 88031 TEST: 06                                            Page 15      
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                 DIPROPYLENE GLYCOL              
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    0/50 (0%)    0/50 (0%)    1/49 (2%)   |                                                    | 
|POLY-3 RATE (b)    |     3/46.03      0/44.10      0/45.14      1/41.99     |                                                    | 
|POLY-3 PERCENT (g) |     6.5%         0.0%         0.0%         2.4%        |                                                    | 
|TERMINAL (d)       |     2/40 (5%)    0/39 (0%)    0/35 (0%)    1/34 (3%)   |                                                    | 
|FIRST INCIDENCE    |     708          ---          ---          729 (T)     |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.288N     P=0.129N     P=0.147N     P=0.365N    |                                                    | 
|POLY 3             |     P=0.243N     P=0.127N     P=0.122N     P=0.339N    |                                                    | 
|POLY 1.5           |     P=0.245N     P=0.125N     P=0.120N     P=0.329N    |                                                    | 
|POLY 6             |     P=0.244N     P=0.127N     P=0.126N     P=0.348N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.274N     P=0.127N     P=0.128N     P=0.350N    |                                                    | 
|COCH-ARM / FISHERS |     P=0.251N     P=0.121N     P=0.121N     P=0.316N    |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Hemangioma                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    2/50 (4%)    0/49 (0%)   |2/50 (4%)    0/50 (0%)    2/50 (4%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     2/45.94      1/44.10      2/45.14      0/41.99     |2/45.83      0/46.33      2/44.12      2/40.76      | 
|POLY-3 PERCENT (g) |     4.4%         2.3%         4.4%         0.0%        |4.4%         0.0%         4.5%         4.9%         | 
|TERMINAL (d)       |     2/40 (5%)    1/39 (3%)    2/35 (6%)    0/34 (0%)   |2/37 (5%)    0/38 (0%)    2/38 (5%)    1/33 (3%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      ---         |728 (T)      ---          728 (T)      504          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.240N     P=0.509N     P=0.646      P=0.275N    |P=0.401      P=0.232N     P=0.686N     P=0.654      | 
|POLY 3             |     P=0.218N     P=0.514N     P=0.688      P=0.258N    |P=0.396      P=0.235N     P=0.680      P=0.651      | 
|POLY 1.5           |     P=0.212N     P=0.511N     P=0.691      P=0.252N    |P=0.410      P=0.235N     P=0.686      P=0.665      | 
|POLY 6             |     P=0.225N     P=0.515N     P=0.681      P=0.263N    |P=0.385      P=0.235N     P=0.677      P=0.639      | 
|LOGISTIC REGRESSION|     P=0.240N     P=0.509N     P=0.646      (e)         |P=0.434      (e)          P=0.686N     P=0.695N     | 
|COCH-ARM / FISHERS |     P=0.204N     P=0.500N     P=0.691N     P=0.253N    |P=0.444      P=0.247N     P=0.691N     P=0.691N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/26/02                           EXPERIMENT: 88031 TEST: 06                                            Page 16      
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                 DIPROPYLENE GLYCOL              
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    4/50 (8%)    2/50 (4%)    3/49 (6%)   |3/50 (6%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/45.94      4/44.10      2/45.15      3/42.41     |3/46.21      1/46.33      0/44.12      0/40.09      | 
|POLY-3 PERCENT (g) |     0.0%         9.1%         4.4%         7.1%        |6.5%         2.2%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/40 (0%)    4/39 (10%)   1/35 (3%)    2/34 (6%)   |2/37 (5%)    1/38 (3%)    0/38 (0%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     ---          729 (T)      727          610         |621          728 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.175      P=0.060      P=0.214      P=0.101     |P=0.051N     P=0.300N     P=0.125N     P=0.151N     | 
|POLY 3             |     P=0.193      P=0.055      P=0.233      P=0.105     |P=0.046N*    P=0.304N     P=0.127N     P=0.146N     | 
|POLY 1.5           |     P=0.202      P=0.056      P=0.236      P=0.108     |P=0.045N*    P=0.303N     P=0.124N     P=0.137N     | 
|POLY 6             |     P=0.185      P=0.055      P=0.229      P=0.102     |P=0.046N*    P=0.307N     P=0.130N     P=0.156N     | 
|LOGISTIC REGRESSION|     P=0.195      P=0.060      P=0.214      P=0.116     |P=0.046N*    P=0.305N     P=0.120N     P=0.128N     | 
|COCH-ARM / FISHERS |     P=0.219      P=0.059      P=0.247      P=0.117     |P=0.044N*    P=0.309N     P=0.121N     P=0.121N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Hemangiosarcoma or Hemangioma                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    5/50 (10%)   4/50 (8%)    3/49 (6%)   |5/50 (10%)   1/50 (2%)    2/50 (4%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     2/45.94      5/44.10      4/45.15      3/42.41     |5/46.21      1/46.33      2/44.12      2/40.76      | 
|POLY-3 PERCENT (g) |     4.4%         11.3%        8.9%         7.1%        |10.8%        2.2%         4.5%         4.9%         | 
|TERMINAL (d)       |     2/40 (5%)    5/39 (13%)   3/35 (9%)    2/34 (6%)   |4/37 (11%)   1/38 (3%)    2/38 (5%)    1/33 (3%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      727          610         |621          728 (T)      728 (T)      504          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.443      P=0.206      P=0.281      P=0.435     |P=0.266N     P=0.100N     P=0.214N     P=0.273N     | 
|POLY 3             |     P=0.486      P=0.200      P=0.329      P=0.464     |P=0.253N     P=0.101N     P=0.235N     P=0.270N     | 
|POLY 1.5           |     P=0.500      P=0.203      P=0.334      P=0.473     |P=0.243N     P=0.100N     P=0.227N     P=0.252N     | 
|POLY 6             |     P=0.472      P=0.199      P=0.320      P=0.456     |P=0.260N     P=0.102N     P=0.242N     P=0.287N     | 
|LOGISTIC REGRESSION|     P=0.476      P=0.206      P=0.282      P=0.471     |P=0.233N     P=0.101N     P=0.230N     P=0.220N     | 
|COCH-ARM / FISHERS |     P=0.526      P=0.218      P=0.339      P=0.490     |P=0.221N     P=0.102N     P=0.218N     P=0.218N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/26/02                           EXPERIMENT: 88031 TEST: 06                                            Page 17      
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                 DIPROPYLENE GLYCOL              
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        | 
|     NOS, or Undifferentiated Cell Type                                                                                          | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    0/50 (0%)    0/49 (0%)   |5/50 (10%)   2/50 (4%)    2/50 (4%)    4/50 (8%)    | 
|POLY-3 RATE (b)    |     1/45.94      0/44.10      0/45.14      0/41.99     |5/46.82      2/46.55      2/44.20      4/40.21      | 
|POLY-3 PERCENT (g) |     2.2%         0.0%         0.0%         0.0%        |10.7%        4.3%         4.5%         10.0%        | 
|TERMINAL (d)       |     1/40 (3%)    0/39 (0%)    0/35 (0%)    0/34 (0%)   |3/37 (8%)    1/38 (3%)    1/38 (3%)    3/33 (9%)    | 
|FIRST INCIDENCE    |     729 (T)      ---          ---          ---         |193          671          708          698          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.327N     P=0.505N     P=0.527N     P=0.532N    |P=0.564      P=0.213N     P=0.216N     P=0.570N     | 
|POLY 3             |     P=0.298N     P=0.508N     P=0.504N     P=0.518N    |P=0.568      P=0.219N     P=0.240N     P=0.594N     | 
|POLY 1.5           |     P=0.301N     P=0.506N     P=0.502N     P=0.513N    |P=0.558N     P=0.218N     P=0.233N     P=0.566N     | 
|POLY 6             |     P=0.296N     P=0.508N     P=0.507N     P=0.523N    |P=0.553      P=0.218N     P=0.244N     P=0.617N     | 
|LOGISTIC REGRESSION|     P=0.327N     (e)          (e)          (e)         |P=0.497N     P=0.267N     P=0.200N     P=0.479N     | 
|COCH-ARM / FISHERS |     P=0.308N     P=0.500N     P=0.500N     P=0.505N    |P=0.519N     P=0.218N     P=0.218N     P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     27/50 (54%)  23/50 (46%)  26/50 (52%)  11/49 (22%) |22/50 (44%)  24/50 (48%)  22/50 (44%)  21/50 (42%)  | 
|POLY-3 RATE (b)    |     27/46.85     23/44.17     26/46.67     11/42.99    |22/46.09     24/46.96     22/44.76     21/43.05     | 
|POLY-3 PERCENT (g) |     57.6%        52.1%        55.7%        25.6%       |47.7%        51.1%        49.2%        48.8%        | 
|TERMINAL (d)       |     24/40 (60%)  22/39 (56%)  21/35 (60%)  9/34 (27%)  |19/37 (51%)  21/38 (55%)  20/38 (53%)  16/33 (49%)  | 
|FIRST INCIDENCE    |     592          710          542          464         |693          641          576          395          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.008N**   P=0.316N     P=0.415      P=0.006N**  |P=0.446      P=0.464      P=0.547N     P=0.458      | 
|POLY 3             |     P<0.001N**   P=0.372N     P=0.509N     P<0.001N**  |P=0.534      P=0.453      P=0.530      P=0.545      | 
|POLY 1.5           |     P<0.001N**   P=0.342N     P=0.501N     P<0.001N**  |P=0.504N     P=0.448      P=0.551      P=0.576      | 
|POLY 6             |     P=0.002N**   P=0.396N     P=0.531N     P=0.002N**  |P=0.504      P=0.458      P=0.518      P=0.522      | 
|LOGISTIC REGRESSION|     P=0.002N**   P=0.337N     P=0.541N     P=0.002N**  |P=0.410      P=0.431      P=0.488      P=0.484      | 
|COCH-ARM / FISHERS |     P<0.001N**   P=0.274N     P=0.500N     P<0.001N**  |P=0.396N     P=0.421      P=0.580N     P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/26/02                           EXPERIMENT: 88031 TEST: 06                                            Page 18      
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                 DIPROPYLENE GLYCOL              
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     19/50 (38%)  19/50 (38%)  26/50 (52%)  25/49 (51%) |18/50 (36%)  18/50 (36%)  14/50 (28%)  14/50 (28%)  | 
|POLY-3 RATE (b)    |     19/49.44     19/46.96     26/48.45     25/46.47    |18/48.75     18/48.25     14/46.34     14/42.33     | 
|POLY-3 PERCENT (g) |     38.4%        40.5%        53.7%        53.8%       |36.9%        37.3%        30.2%        33.1%        | 
|TERMINAL (d)       |     10/40 (25%)  13/39 (33%)  15/35 (43%)  14/34 (41%) |11/37 (30%)  9/38 (24%)   7/38 (18%)   9/33 (27%)   | 
|FIRST INCIDENCE    |     416          405          494          451         |193          561          576          395          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.043 *    P=0.525      P=0.095      P=0.091     |P=0.359N     P=0.546N     P=0.287N     P=0.426N     | 
|POLY 3             |     P=0.050      P=0.502      P=0.094      P=0.095     |P=0.331N     P=0.567      P=0.318N     P=0.435N     | 
|POLY 1.5           |     P=0.056      P=0.523      P=0.102      P=0.107     |P=0.282N     P=0.571      P=0.302N     P=0.380N     | 
|POLY 6             |     P=0.044 *    P=0.486      P=0.083      P=0.086     |P=0.375N     P=0.574      P=0.319N     P=0.485N     | 
|LOGISTIC REGRESSION|     P=0.092      P=0.513N     P=0.128      P=0.210     |P=0.147N     P=0.554      P=0.224N     P=0.234N     | 
|COCH-ARM / FISHERS |     P=0.070      P=0.582N     P=0.114      P=0.135     |P=0.178N     P=0.582N     P=0.260N     P=0.260N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         1.0%         2.0%         4.0%        |0.0%         1.0%         2.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     39/50 (78%)  37/50 (74%)  39/50 (78%)  33/49 (67%) |32/50 (64%)  35/50 (70%)  30/50 (60%)  29/50 (58%)  | 
|POLY-3 RATE (b)    |     39/49.44     37/47.03     39/49.03     33/46.72    |32/49.00     35/48.25     30/46.34     29/44.45     | 
|POLY-3 PERCENT (g) |     78.9%        78.7%        79.5%        70.6%       |65.3%        72.5%        64.7%        65.2%        | 
|TERMINAL (d)       |     30/40 (75%)  30/39 (77%)  27/35 (77%)  21/34 (62%) |23/37 (62%)  26/38 (68%)  23/38 (61%)  20/33 (61%)  | 
|FIRST INCIDENCE    |     416          405          494          451         |193          561          576          395          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.521      P=0.509N     P=0.300      P=0.517N    |P=0.527N     P=0.414      P=0.413N     P=0.513      | 
|POLY 3             |     P=0.187N     P=0.589N     P=0.567      P=0.242N    |P=0.435N     P=0.289      P=0.563N     P=0.584N     | 
|POLY 1.5           |     P=0.173N     P=0.540N     P=0.581      P=0.216N    |P=0.368N     P=0.304      P=0.520N     P=0.521N     | 
|POLY 6             |     P=0.197N     P=0.578      P=0.539      P=0.258N    |P=0.485N     P=0.284      P=0.579N     P=0.546      | 
|LOGISTIC REGRESSION|     P=0.174N     P=0.471N     P=0.587N     P=0.168N    |P=0.333N     P=0.335      P=0.435N     P=0.416N     | 
|COCH-ARM / FISHERS |     P=0.152N     P=0.408N     P=0.595N     P=0.168N    |P=0.200N     P=0.335      P=0.418N     P=0.341N     | 
|=================================================================================================================================| 
(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).