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https://ntp.niehs.nih.gov/go/41007

P10 - Statistical Analysis of Non-Neoplastic Lesions (Mice)

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     

LAB: Battelle Columbus                                         ESTRAGOLE                                       DATE: 10/08/03       

EXPERIMENT: 60946 TEST: 02                                                                                     TIME: 08:04:23       

TEST TYPE:  SUBCHRON 90-DAY                     CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        

CONT: NO1-ES-15460                              ROUTE: GAVAGE                                                  NTP C#: C60946       

PATHOLOGIST: MISSING                                                                                           CAS: 140-67-0        

------------------------------------------------------------------------------------------------------------------------------------

                                                                                                                                    

                                                             FINAL/MICE                                                             

                                                                                                                                    

                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

               REMOVAL DATE RANGE:     ALL                                                                                          

                                                                                                                                    

               TREATMENT GROUPS:       INCLUDE ALL                                                                                  

                                                                                                                                   

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     

LAB: Battelle Columbus                                         ESTRAGOLE                                       DATE: 10/08/03       

EXPERIMENT: 60946 TEST: 02                                                                                     TIME: 08:04:23       

TEST TYPE:  SUBCHRON 90-DAY                     CAGES FROM 0000 TO LAST CAGE                                                        

CONT: NO1-ES-15460                              ROUTE: GAVAGE                                                  NTP C#: C60946       

PATHOLOGIST: MISSING                                                                                           CAS: 140-67-0        

                                                                                                                                    

                                                                                                                                    

SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               

IN THE ANALYSIS OF                       ESTRAGOLE                                                                                  

===============================================================                                                                     

Male Mice                                                                                                                           

------------                                                                                                                        

Organ                                 Morphology                                                                                    

-----                                 ----------                                                                                    

Kidney: Renal Tubule                   Vacuolization Cytoplasmic                                                                    

Liver                                  Inflammation Chronic                                                                         

Liver: Hepatocyte                      Degeneration                                                                                 

                                       Hypertrophy                                                                                  

Liver: Oval Cell                       Hyperplasia                                                                                  

Nose: Olfactory Epithelium             Degeneration                                                                                 

Spleen                                 Hematopoietic Cell Proliferation                                                             

Stomach, Glandular                     Infiltration Cellular Polymorphonuclear                                                      

===============================================================                                                                     

Female Mice                                                                                                                         

------------                                                                                                                        

Organ                                  Morphology                                                                                   

-----                                  ----------                                                                                   

Adrenal Cortex: Subcapsular            Hyperplasia                                                                                  

Kidney                                 Nephropathy                                                                                  

Liver                                  Fatty Change Diffuse                                                                         

                                       Inflammation Chronic                                                                         

                                       Necrosis                                                                                     

Liver: Bile Duct                       Hyperplasia                                                                                  

Liver: Hepatocyte                      Degeneration                                                                                 

                                       Hypertrophy                                                                                  

Liver: Oval Cell                       Hyperplasia                                                                                  

Lymph Node, Mandibular                 Atrophy                                                                                      

Lymph Node, Mesenteric                 Atrophy                                                                                      

Nose: Olfactory Epithelium             Degeneration                                                                                 

Salivary Glands                        Cytoplasmic Alteration                                                                       

Spleen                                 Hematopoietic Cell Proliferation                                                             

Spleen: Lymphoid Follicle              Atrophy                                                                                      

Spleen: Red Pulp                       Depletion Cellular                                                                           

Stomach, Forestomach                   Hyperplasia                                                                                  

                                       Mineralization                                                                               

                                       Ulcer                                                                                        

Stomach, Glandular                     Mineralization                                                                               

Stomach, Glandular: Epithelium, Glands                                                                                              

                                       Degeneration                                                                                 

Thymus                                 Necrosis Lymphoid                                                                            

===============================================================                                                                     

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 1       

                     Statistical Analysis of Non-neoplastic Lesions in        Mice(B6C3F1)  -                        ESTRAGOLE      

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Adrenal Cortex: Subcapsular                                                                                                      | 

|     Hyperplasia                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        5/10 (50%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         6/10 (60%)      | 

|POLY-3 RATE (b)    |        5/10.00          0/0.00           0/0.00           0/0.00           0/0.00           6/9.28          | 

|POLY-3 PERCENT (g) |        50.0%            0.0%             0.0%             0.0%             0.0%             64.6%           | 

|TERMINAL (d)       |        5/10 (50%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         6/9 (67%)       | 

|FIRST INCIDENCE    |        93 (T)           ---              ---              ---              ---              93 (T)          | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P=0.313          P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.397         | 

|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.428         | 

|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.454         | 

|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.406         | 

|LOGISTIC REGRESSION|        P=0.313          (e)              (e)              (e)              (e)              P=0.397         | 

|COCH-ARM / FISHERS |        P=0.411          P=1.000          P=1.000          P=1.000          P=1.000          P=0.500         | 

|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Adrenal Cortex: Subcapsular                                                                                                      | 

|     Hyperplasia                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        10/10 (100%)     0/0 (0%)         0/0 (0%)         0/0 (0%)         10/10 (100%)     6/10 (60%)      | 

|POLY-3 RATE (b)    |        10/10.00         0/0.00           0/0.00           0/0.00           10/10.00         6/6.00          | 

|POLY-3 PERCENT (g) |        100.0%           0.0%             0.0%             0.0%             100.0%           100.0%          | 

|TERMINAL (d)       |        10/10 (100%)     0/0 (0%)         0/0 (0%)         0/0 (0%)         10/10 (100%)     0/0 (0%)        | 

|FIRST INCIDENCE    |        93 (T)           ---              ---              ---              93 (T)           3               | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.003 **      | 

|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=1.000N        | 

|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=1.000N        | 

|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=1.000N        | 

|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P=0.011N*        (e)              (e)              (e)              (e)              P=0.043N*       | 

|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 2       

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Kidney                                                                                                                           | 

|     Nephropathy                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        3/10 (30%)       5/10 (50%)       2/10 (20%)       4/10 (40%)       4/10 (40%)       2/10 (20%)      | 

|POLY-3 RATE (b)    |        3/10.00          5/10.00          2/10.00          4/10.00          4/10.00          2/9.28          | 

|POLY-3 PERCENT (g) |        30.0%            50.0%            20.0%            40.0%            40.0%            21.6%           | 

|TERMINAL (d)       |        3/10 (30%)       5/10 (50%)       2/10 (20%)       4/10 (40%)       4/10 (40%)       2/9 (22%)       | 

|FIRST INCIDENCE    |        93 (T)           93 (T)           93 (T)           93 (T)           93 (T)           93 (T)          | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P=0.367N         P=0.328          P=0.500N         P=0.500          P=0.500          P=0.553N        | 

|POLY 3             |        P=0.356N         P=0.329          P=0.500N         P=0.500          P=0.500          P=0.537N        | 

|POLY 1.5           |        P=0.339N         P=0.329          P=0.500N         P=0.500          P=0.500          P=0.524N        | 

|POLY 6             |        P=0.371N         P=0.329          P=0.500N         P=0.500          P=0.500          P=0.548N        | 

|LOGISTIC REGRESSION|        P=0.367N         P=0.328          P=0.500N         P=0.500          P=0.500          P=0.553N        | 

|COCH-ARM / FISHERS |        P=0.303N         P=0.325          P=0.500N         P=0.500          P=0.500          P=0.500N        | 

|ORDER RESTRICTED   |        P=0.372N         (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Kidney                                                                                                                           | 

|     Nephropathy                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        5/10 (50%)       0/9 (0%)         0/9 (0%)         0/10 (0%)        1/10 (10%)       1/10 (10%)      | 

|POLY-3 RATE (b)    |        5/10.00          0/9.00           0/9.00           0/10.00          1/10.00          1/1.00          | 

|POLY-3 PERCENT (g) |        50.0%            0.0%             0.0%             0.0%             10.0%            99.9%           | 

|TERMINAL (d)       |        5/10 (50%)       0/9 (0%)         0/9 (0%)         0/10 (0%)        1/10 (10%)       0/0 (0%)        | 

|FIRST INCIDENCE    |        93 (T)           ---              ---              ---              93 (T)           4               | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P=0.653          P=0.029N*        P=0.029N*        P=0.022N*        P=0.077N         P=0.479         | 

|POLY 3             |        P=0.101N         P=0.013N*        P=0.013N*        P=0.008N**       P=0.061N         P=0.516         | 

|POLY 1.5           |        P=0.104N         P=0.013N*        P=0.013N*        P=0.008N**       P=0.061N         P=0.531         | 

|POLY 6             |        P=0.101N         P=0.013N*        P=0.013N*        P=0.008N**       P=0.061N         P=0.516         | 

|LOGISTIC REGRESSION|        P=0.166N         (e)              (e)              (e)              P=0.077N         (e)             | 

|COCH-ARM / FISHERS |        P=0.255N         P=0.022N*        P=0.022N*        P=0.016N*        P=0.070N         P=0.070N        | 

|ORDER RESTRICTED   |        P=0.283          (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 3       

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Kidney: Renal Tubule                                                                                                             | 

|     Vacuolization Cytoplasmic                                                                                                   | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        9/10 (90%)       9/10 (90%)       2/10 (20%)       1/10 (10%)       0/10 (0%)        0/10 (0%)       | 

|POLY-3 RATE (b)    |        9/10.00          9/10.00          2/10.00          1/10.00          0/10.00          0/9.28          | 

|POLY-3 PERCENT (g) |        90.0%            90.0%            20.0%            10.0%            0.0%             0.0%            | 

|TERMINAL (d)       |        9/10 (90%)       9/10 (90%)       2/10 (20%)       1/10 (10%)       0/10 (0%)        0/9 (0%)        | 

|FIRST INCIDENCE    |        93 (T)           93 (T)           93 (T)           93 (T)           ---              ---             | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001N**       P=0.766          P=0.004N**       P<0.001N**       P<0.001N**       P<0.001N**      | 

|POLY 3             |        P<0.001N**       P=0.760          P<0.001N**       P<0.001N**       P<0.001N**       P<0.001N**      | 

|POLY 1.5           |        P<0.001N**       P=0.760          P<0.001N**       P<0.001N**       P<0.001N**       P<0.001N**      | 

|POLY 6             |        P<0.001N**       P=0.760          P<0.001N**       P<0.001N**       P<0.001N**       P<0.001N**      | 

|LOGISTIC REGRESSION|        P<0.001N**       P=0.766          P=0.004N**       P<0.001N**       (e)              (e)             | 

|COCH-ARM / FISHERS |        P<0.001N**       P=0.763N         P=0.003N**       P<0.001N**       P<0.001N**       P<0.001N**      | 

|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Kidney: Renal Tubule                                                                                                             | 

|     Vacuolization Cytoplasmic                                                                                                   | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/9 (0%)         0/9 (0%)         0/10 (0%)        0/10 (0%)        0/10 (0%)       | 

|POLY-3 RATE (b)    |        0/10.00          0/9.00           0/9.00           0/10.00          0/10.00          0/0.00          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             0.0%            | 

|TERMINAL (d)       |        0/10 (0%)        0/9 (0%)         0/9 (0%)         0/10 (0%)        0/10 (0%)        0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              ---             | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 3             |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 6             |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 4       

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Liver                                                                                                                            | 

|     Fatty Change Diffuse                                                                                                        | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          0/9.28          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             0.0%            | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              ---             | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 3             |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 6             |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Liver                                                                                                                            | 

|     Fatty Change Diffuse                                                                                                        | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        5/10 (50%)      | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          5/5.00          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              3               | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.006 **      | 

|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.016 *       | 

|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 5       

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Liver                                                                                                                            | 

|     Inflammation Chronic                                                                                                        | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        2/10 (20%)       2/10 (20%)       4/10 (40%)       4/10 (40%)       7/10 (70%)       7/10 (70%)      | 

|POLY-3 RATE (b)    |        2/10.00          2/10.00          4/10.00          4/10.00          7/10.00          7/9.28          | 

|POLY-3 PERCENT (g) |        20.0%            20.0%            40.0%            40.0%            70.0%            75.4%           | 

|TERMINAL (d)       |        2/10 (20%)       2/10 (20%)       4/10 (40%)       4/10 (40%)       7/10 (70%)       7/9 (78%)       | 

|FIRST INCIDENCE    |        93 (T)           93 (T)           93 (T)           93 (T)           93 (T)           93 (T)          | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P=0.002 **       P=0.707          P=0.317          P=0.317          P=0.040 *        P=0.023 *       | 

|POLY 3             |        P<0.001 **       P=0.702          P=0.318          P=0.318          P=0.024 *        P=0.012 *       | 

|POLY 1.5           |        P=0.002 **       P=0.702          P=0.318          P=0.318          P=0.024 *        P=0.016 *       | 

|POLY 6             |        P<0.001 **       P=0.702          P=0.318          P=0.318          P=0.024 *        P=0.010 *       | 

|LOGISTIC REGRESSION|        P=0.002 **       P=0.707          P=0.317          P=0.317          P=0.040 *        P=0.023 *       | 

|COCH-ARM / FISHERS |        P=0.004 **       P=0.709N         P=0.314          P=0.314          P=0.035 *        P=0.035 *       | 

|ORDER RESTRICTED   |        P=0.008 **       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Liver                                                                                                                            | 

|     Inflammation Chronic                                                                                                        | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        10/10 (100%)     9/10 (90%)       10/10 (100%)     10/10 (100%)     10/10 (100%)     2/10 (20%)      | 

|POLY-3 RATE (b)    |        10/10.00         9/10.00          10/10.00         10/10.00         10/10.00         2/2.00          | 

|POLY-3 PERCENT (g) |        100.0%           90.0%            100.0%           100.0%           100.0%           100.0%          | 

|TERMINAL (d)       |        10/10 (100%)     9/10 (90%)       10/10 (100%)     10/10 (100%)     10/10 (100%)     0/0 (0%)        | 

|FIRST INCIDENCE    |        93 (T)           93 (T)           93 (T)           93 (T)           93 (T)           3               | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       P=0.500N         (e)              (e)              (e)              P=0.057         | 

|POLY 3             |        P=0.485          P=0.500N         (e)              (e)              (e)              P=1.000N        | 

|POLY 1.5           |        P=0.511          P=0.500N         (e)              (e)              (e)              P=1.000N        | 

|POLY 6             |        P=0.485          P=0.500N         (e)              (e)              (e)              P=1.000N        | 

|LOGISTIC REGRESSION|        P=0.763          P=0.500N         (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P<0.001N**       P=0.500N         (e)              (e)              (e)              P<0.001N**      | 

|ORDER RESTRICTED   |        P=0.710          (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 6       

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Liver                                                                                                                            | 

|     Necrosis                                                                                                                    | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          0/9.28          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             0.0%            | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              ---             | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 3             |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 6             |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Liver                                                                                                                            | 

|     Necrosis                                                                                                                    | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)    | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          10/10.00        | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              3               | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 7       

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Liver: Bile Duct                                                                                                                 | 

|     Hyperplasia                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          0/9.28          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             0.0%            | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              ---             | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 3             |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 6             |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Liver: Bile Duct                                                                                                                 | 

|     Hyperplasia                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/10 (10%)       2/10 (20%)       0/10 (0%)       | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          1/10.00          2/10.00          0/0.00          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             10.0%            20.0%            0.0%            | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/10 (10%)       2/10 (20%)       0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              93 (T)           93 (T)           ---             | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P=0.072          (e)              (e)              P=0.500          P=0.234          (e)             | 

|POLY 3             |        P=0.018 *        (e)              (e)              P=0.500          P=0.227          (e)             | 

|POLY 1.5           |        P=0.018 *        (e)              (e)              P=0.500          P=0.227          (e)             | 

|POLY 6             |        P=0.018 *        (e)              (e)              P=0.500          P=0.227          (e)             | 

|LOGISTIC REGRESSION|        P=0.070          (e)              (e)              P=0.500          P=0.234          (e)             | 

|COCH-ARM / FISHERS |        P=0.478          (e)              (e)              P=0.500          P=0.237          (e)             | 

|ORDER RESTRICTED   |        P=0.831          (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 8       

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Liver: Hepatocyte                                                                                                                | 

|     Degeneration                                                                                                                | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        5/10 (50%)       10/10 (100%)    | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          5/10.00          10/10.00        | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             50.0%            100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        5/10 (50%)       9/9 (100%)      | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              93 (T)           61              | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              P=0.022 *        P<0.001 **      | 

|POLY 3             |        P<0.001 **       (e)              (e)              (e)              P=0.008 **       P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P=0.008 **       P<0.001 **      | 

|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P=0.008 **       P<0.001 **      | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P=0.022 *        (e)             | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              P=0.016 *        P<0.001 **      | 

|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Liver: Hepatocyte                                                                                                                | 

|     Degeneration                                                                                                                | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        1/10 (10%)       3/10 (30%)       10/10 (100%)     10/10 (100%)     0/10 (0%)       | 

|POLY-3 RATE (b)    |        0/10.00          1/10.00          3/10.00          10/10.00         10/10.00         0/0.00          | 

|POLY-3 PERCENT (g) |        0.0%             10.0%            30.0%            100.0%           100.0%           0.0%            | 

|TERMINAL (d)       |        0/10 (0%)        1/10 (10%)       3/10 (30%)       10/10 (100%)     10/10 (100%)     0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              93 (T)           93 (T)           93 (T)           93 (T)           ---             | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       P=0.500          P=0.111          P<0.001 **       P<0.001 **       (e)             | 

|POLY 3             |        P<0.001 **       P=0.500          P=0.095          P<0.001 **       P<0.001 **       (e)             | 

|POLY 1.5           |        P<0.001 **       P=0.500          P=0.095          P<0.001 **       P<0.001 **       (e)             | 

|POLY 6             |        P<0.001 **       P=0.500          P=0.095          P<0.001 **       P<0.001 **       (e)             | 

|LOGISTIC REGRESSION|        (e)              P=0.500          P=0.111          P<0.001 **       P<0.001 **       (e)             | 

|COCH-ARM / FISHERS |        P=0.519          P=0.500          P=0.105          P<0.001 **       P<0.001 **       (e)             | 

|ORDER RESTRICTED   |        P=0.830          (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 9       

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Liver: Hepatocyte                                                                                                                | 

|     Hypertrophy                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        8/10 (80%)       10/10 (100%)    | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          8/10.00          10/10.00        | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             80.0%            100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        8/10 (80%)       9/9 (100%)      | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              93 (T)           61              | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 

|POLY 3             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001N**      | 

|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001N**      | 

|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001N**      | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P<0.001 **       (e)             | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 

|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Liver: Hepatocyte                                                                                                                | 

|     Hypertrophy                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        3/10 (30%)       10/10 (100%)     10/10 (100%)     0/10 (0%)       | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          3/10.00          10/10.00         10/10.00         0/0.00          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             30.0%            100.0%           100.0%           0.0%            | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        3/10 (30%)       10/10 (100%)     10/10 (100%)     0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              93 (T)           93 (T)           93 (T)           ---             | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       (e)              P=0.111          P<0.001 **       P<0.001 **       (e)             | 

|POLY 3             |        P<0.001 **       (e)              P=0.095          P<0.001 **       P<0.001 **       (e)             | 

|POLY 1.5           |        P<0.001 **       (e)              P=0.095          P<0.001 **       P<0.001 **       (e)             | 

|POLY 6             |        P<0.001 **       (e)              P=0.095          P<0.001 **       P<0.001 **       (e)             | 

|LOGISTIC REGRESSION|        P<0.001 **       (e)              P=0.111          P<0.001 **       P<0.001 **       (e)             | 

|COCH-ARM / FISHERS |        P=0.439          (e)              P=0.105          P<0.001 **       P<0.001 **       (e)             | 

|ORDER RESTRICTED   |        P=0.830          (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 10      

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Liver: Oval Cell                                                                                                                 | 

|     Hyperplasia                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)     9/10 (90%)      | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          10/10.00         9/10.00         | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             100.0%           90.0%           | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)     8/9 (89%)       | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              93 (T)           61              | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 

|POLY 3             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 

|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P<0.001 **       (e)             | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 

|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Liver: Oval Cell                                                                                                                 | 

|     Hyperplasia                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        1/10 (10%)       10/10 (100%)     10/10 (100%)     10/10 (100%)     5/10 (50%)      | 

|POLY-3 RATE (b)    |        0/10.00          1/10.00          10/10.00         10/10.00         10/10.00         5/5.00          | 

|POLY-3 PERCENT (g) |        0.0%             10.0%            100.0%           100.0%           100.0%           100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        1/10 (10%)       10/10 (100%)     10/10 (100%)     10/10 (100%)     0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              93 (T)           93 (T)           93 (T)           93 (T)           3               | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       P=0.500          P<0.001 **       P<0.001 **       P<0.001 **       P=0.006 **      | 

|POLY 3             |        P<0.001 **       P=0.500          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       P=0.500          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

|POLY 6             |        P<0.001 **       P=0.500          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

|LOGISTIC REGRESSION|        P<0.001 **       P=0.500          P<0.001 **       P<0.001 **       P<0.001 **       (e)             | 

|COCH-ARM / FISHERS |        P=0.068          P=0.500          P<0.001 **       P<0.001 **       P<0.001 **       P=0.016 *       | 

|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 11      

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Lymph Node, Mandibular                                                                                                           | 

|     Atrophy                                                                                                                     | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/10 (10%)      | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          1/10.00         | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             10.0%           | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              61              | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P=0.107          (e)              (e)              (e)              (e)              P=0.500         | 

|POLY 3             |        P=0.107          (e)              (e)              (e)              (e)              P=0.500         | 

|POLY 1.5           |        P=0.107          (e)              (e)              (e)              (e)              P=0.500         | 

|POLY 6             |        P=0.107          (e)              (e)              (e)              (e)              P=0.500         | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P=0.105          (e)              (e)              (e)              (e)              P=0.500         | 

|ORDER RESTRICTED   |        P=0.064          (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Lymph Node, Mandibular                                                                                                           | 

|     Atrophy                                                                                                                     | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/9 (0%)         0/9 (0%)         0/10 (0%)        0/9 (0%)         7/8 (88%)       | 

|POLY-3 RATE (b)    |        0/10.00          0/9.00           0/9.00           0/10.00          0/9.00           7/7.00          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        0/9 (0%)         0/9 (0%)         0/10 (0%)        0/9 (0%)         0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              3               | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 12      

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Lymph Node, Mesenteric                                                                                                           | 

|     Atrophy                                                                                                                     | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/10 (10%)      | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          1/10.00         | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             10.0%           | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              61              | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P=0.107          (e)              (e)              (e)              (e)              P=0.500         | 

|POLY 3             |        P=0.107          (e)              (e)              (e)              (e)              P=0.500         | 

|POLY 1.5           |        P=0.107          (e)              (e)              (e)              (e)              P=0.500         | 

|POLY 6             |        P=0.107          (e)              (e)              (e)              (e)              P=0.500         | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P=0.105          (e)              (e)              (e)              (e)              P=0.500         | 

|ORDER RESTRICTED   |        P=0.064          (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Lymph Node, Mesenteric                                                                                                           | 

|     Atrophy                                                                                                                     | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        9/10 (90%)      | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          9/9.00          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              3               | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 13      

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Nose: Olfactory Epithelium                                                                                                       | 

|     Degeneration                                                                                                                | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        1/10 (10%)       2/10 (20%)       10/10 (100%)     10/10 (100%)    | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          1/10.00          2/10.00          10/10.00         10/10.00        | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             10.0%            20.0%            100.0%           100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        1/10 (10%)       2/10 (20%)       10/10 (100%)     9/9 (100%)      | 

|FIRST INCIDENCE    |        ---              ---              93 (T)           93 (T)           93 (T)           61              | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       (e)              P=0.500          P=0.234          P<0.001 **       P<0.001 **      | 

|POLY 3             |        P<0.001 **       (e)              P=0.500          P=0.227          P<0.001N**       P<0.001N**      | 

|POLY 1.5           |        P<0.001 **       (e)              P=0.500          P=0.227          P<0.001N**       P<0.001N**      | 

|POLY 6             |        P<0.001 **       (e)              P=0.500          P=0.227          P<0.001N**       P<0.001N**      | 

|LOGISTIC REGRESSION|        (e)              (e)              P=0.500          P=0.234          P<0.001 **       (e)             | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              P=0.500          P=0.237          P<0.001 **       P<0.001 **      | 

|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Nose: Olfactory Epithelium                                                                                                       | 

|     Degeneration                                                                                                                | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        2/10 (20%)       10/10 (100%)     10/10 (100%)    | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          2/10.00          10/10.00         10/10.00        | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             20.0%            100.0%           100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        2/10 (20%)       10/10 (100%)     0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              93 (T)           93 (T)           3               | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.234          P<0.001 **       P<0.001 **      | 

|POLY 3             |        P<0.001 **       (e)              (e)              P=0.227          P<0.001 **       P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       (e)              (e)              P=0.227          P<0.001 **       P<0.001 **      | 

|POLY 6             |        P<0.001 **       (e)              (e)              P=0.227          P<0.001 **       P<0.001 **      | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              P=0.234          P<0.001 **       (e)             | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P=0.237          P<0.001 **       P<0.001 **      | 

|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 14      

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Salivary Glands                                                                                                                  | 

|     Cytoplasmic Alteration                                                                                                      | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)        1/10 (10%)      | 

|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/0.00           0/0.00           0/10.00          1/10.00         | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             10.0%           | 

|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)        0/9 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              61              | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P=0.107          (e)              (e)              (e)              (e)              P=0.500         | 

|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.500         | 

|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.500         | 

|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.500         | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P=0.267          (e)              (e)              (e)              (e)              P=0.500         | 

|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Salivary Glands                                                                                                                  | 

|     Cytoplasmic Alteration                                                                                                      | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)        10/10 (100%)    | 

|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/0.00           0/0.00           0/10.00          10/10.00        | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)        0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              3               | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 15      

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Spleen                                                                                                                           | 

|     Hematopoietic Cell Proliferation                                                                                            | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     8/10 (80%)      | 

|POLY-3 RATE (b)    |        10/10.00         10/10.00         10/10.00         10/10.00         10/10.00         8/9.28          | 

|POLY-3 PERCENT (g) |        100.0%           100.0%           100.0%           100.0%           100.0%           86.2%           | 

|TERMINAL (d)       |        10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     8/9 (89%)       | 

|FIRST INCIDENCE    |        93 (T)           93 (T)           93 (T)           93 (T)           93 (T)           93 (T)          | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P=0.095N         (e)              (e)              (e)              (e)              P=0.479N        | 

|POLY 3             |        P=0.035N*        (e)              (e)              (e)              (e)              P=0.373N        | 

|POLY 1.5           |        P=0.016N*        (e)              (e)              (e)              (e)              P=0.302N        | 

|POLY 6             |        P=0.073N         (e)              (e)              (e)              (e)              P=0.447N        | 

|LOGISTIC REGRESSION|        P=0.095N         (e)              (e)              (e)              (e)              P=0.479N        | 

|COCH-ARM / FISHERS |        P=0.010N*        (e)              (e)              (e)              (e)              P=0.237N        | 

|ORDER RESTRICTED   |        P=0.014N*        (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Spleen                                                                                                                           | 

|     Hematopoietic Cell Proliferation                                                                                            | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     2/10 (20%)      | 

|POLY-3 RATE (b)    |        10/10.00         10/10.00         10/10.00         10/10.00         10/10.00         2/2.00          | 

|POLY-3 PERCENT (g) |        100.0%           100.0%           100.0%           100.0%           100.0%           100.0%          | 

|TERMINAL (d)       |        10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     0/0 (0%)        | 

|FIRST INCIDENCE    |        93 (T)           93 (T)           93 (T)           93 (T)           93 (T)           4               | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P=0.008 **       (e)              (e)              (e)              (e)              P=0.210         | 

|POLY 3             |        P=1.000N         (e)              (e)              (e)              (e)              P=1.000N        | 

|POLY 1.5           |        P=1.000N         (e)              (e)              (e)              (e)              P=1.000N        | 

|POLY 6             |        P=1.000N         (e)              (e)              (e)              (e)              P=1.000N        | 

|LOGISTIC REGRESSION|        P=0.008 **       (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P<0.001N**       (e)              (e)              (e)              (e)              P<0.001N**      | 

|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 16      

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Spleen: Lymphoid Follicle                                                                                                        | 

|     Atrophy                                                                                                                     | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/10 (10%)      | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          1/10.00         | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             10.0%           | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              61              | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P=0.107          (e)              (e)              (e)              (e)              P=0.500         | 

|POLY 3             |        P=0.107          (e)              (e)              (e)              (e)              P=0.500         | 

|POLY 1.5           |        P=0.107          (e)              (e)              (e)              (e)              P=0.500         | 

|POLY 6             |        P=0.107          (e)              (e)              (e)              (e)              P=0.500         | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P=0.105          (e)              (e)              (e)              (e)              P=0.500         | 

|ORDER RESTRICTED   |        P=0.064          (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Spleen: Lymphoid Follicle                                                                                                        | 

|     Atrophy                                                                                                                     | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)    | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          10/10.00        | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              3               | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 17      

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Spleen: Red Pulp                                                                                                                 | 

|     Depletion Cellular                                                                                                          | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          0/9.28          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             0.0%            | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              ---             | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 3             |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 6             |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Spleen: Red Pulp                                                                                                                 | 

|     Depletion Cellular                                                                                                          | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        9/10 (90%)      | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          9/9.00          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              4               | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 18      

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Stomach, Forestomach                                                                                                             | 

|     Hyperplasia                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/10 (10%)      | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          1/9.28          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             10.8%           | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/9 (11%)       | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              93 (T)          | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P=0.095          (e)              (e)              (e)              (e)              P=0.479         | 

|POLY 3             |        P=0.100          (e)              (e)              (e)              (e)              P=0.485         | 

|POLY 1.5           |        P=0.102          (e)              (e)              (e)              (e)              P=0.490         | 

|POLY 6             |        P=0.098          (e)              (e)              (e)              (e)              P=0.481         | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P=0.479         | 

|COCH-ARM / FISHERS |        P=0.105          (e)              (e)              (e)              (e)              P=0.500         | 

|ORDER RESTRICTED   |        P=0.054          (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Stomach, Forestomach                                                                                                             | 

|     Hyperplasia                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)         0/10 (0%)        6/10 (60%)      | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/9.00           0/10.00          6/6.00          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)         0/10 (0%)        0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              4               | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.002 **      | 

|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.005 **      | 

|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 19      

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Stomach, Forestomach                                                                                                             | 

|     Mineralization                                                                                                              | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        1/10 (10%)       0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 

|POLY-3 RATE (b)    |        1/10.00          0/10.00          0/10.00          0/10.00          0/10.00          0/9.28          | 

|POLY-3 PERCENT (g) |        10.0%            0.0%             0.0%             0.0%             0.0%             0.0%            | 

|TERMINAL (d)       |        1/10 (10%)       0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)        | 

|FIRST INCIDENCE    |        93 (T)           ---              ---              ---              ---              ---             | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P=0.427N         P=0.500N         P=0.500N         P=0.500N         P=0.500N         P=0.521N        | 

|POLY 3             |        P=0.401N         P=0.500N         P=0.500N         P=0.500N         P=0.500N         P=0.515N        | 

|POLY 1.5           |        P=0.407N         P=0.500N         P=0.500N         P=0.500N         P=0.500N         P=0.510N        | 

|POLY 6             |        P=0.396N         P=0.500N         P=0.500N         P=0.500N         P=0.500N         P=0.519N        | 

|LOGISTIC REGRESSION|        P=0.427N         (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P=0.415N         P=0.500N         P=0.500N         P=0.500N         P=0.500N         P=0.500N        | 

|ORDER RESTRICTED   |        P=0.075N         (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Stomach, Forestomach                                                                                                             | 

|     Mineralization                                                                                                              | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)         0/10 (0%)        6/10 (60%)      | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/9.00           0/10.00          6/6.00          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)         0/10 (0%)        0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              3               | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.003 **      | 

|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.005 **      | 

|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 20      

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Stomach, Forestomach                                                                                                             | 

|     Ulcer                                                                                                                       | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          0/9.28          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             0.0%            | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              ---             | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 3             |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 6             |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Stomach, Forestomach                                                                                                             | 

|     Ulcer                                                                                                                       | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)         0/10 (0%)        6/10 (60%)      | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/9.00           0/10.00          6/6.00          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)         0/10 (0%)        0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              4               | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.002 **      | 

|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.005 **      | 

|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 21      

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Stomach, Glandular                                                                                                               | 

|     Infiltration Cellular Polymorphonuclear                                                                                     | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        3/10 (30%)       0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 

|POLY-3 RATE (b)    |        3/10.00          0/10.00          0/10.00          0/10.00          0/10.00          0/9.28          | 

|POLY-3 PERCENT (g) |        30.0%            0.0%             0.0%             0.0%             0.0%             0.0%            | 

|TERMINAL (d)       |        3/10 (30%)       0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)        | 

|FIRST INCIDENCE    |        93 (T)           ---              ---              ---              ---              ---             | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P=0.115N         P=0.111N         P=0.111N         P=0.111N         P=0.111N         P=0.129N        | 

|POLY 3             |        P=0.082N         P=0.095N         P=0.095N         P=0.095N         P=0.095N         P=0.109N        | 

|POLY 1.5           |        P=0.083N         P=0.095N         P=0.095N         P=0.095N         P=0.095N         P=0.104N        | 

|POLY 6             |        P=0.081N         P=0.095N         P=0.095N         P=0.095N         P=0.095N         P=0.114N        | 

|LOGISTIC REGRESSION|        P=0.115N         (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P=0.107N         P=0.105N         P=0.105N         P=0.105N         P=0.105N         P=0.105N        | 

|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Stomach, Glandular                                                                                                               | 

|     Infiltration Cellular Polymorphonuclear                                                                                     | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/10 (10%)       0/10 (0%)       | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          1/10.00          0/0.00          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             10.0%            0.0%            | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/10 (10%)       0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              93 (T)           ---             | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P=0.362          (e)              (e)              (e)              P=0.500          (e)             | 

|POLY 3             |        P=0.123          (e)              (e)              (e)              P=0.500          (e)             | 

|POLY 1.5           |        P=0.123          (e)              (e)              (e)              P=0.500          (e)             | 

|POLY 6             |        P=0.123          (e)              (e)              (e)              P=0.500          (e)             | 

|LOGISTIC REGRESSION|        P=0.360          (e)              (e)              (e)              P=0.500          (e)             | 

|COCH-ARM / FISHERS |        P=0.585          (e)              (e)              (e)              P=0.500          (e)             | 

|ORDER RESTRICTED   |        P=0.831          (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 22      

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Stomach, Glandular                                                                                                               | 

|     Mineralization                                                                                                              | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/10 (10%)       0/10 (0%)       | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          1/10.00          0/9.28          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             10.0%            0.0%            | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/10 (10%)       0/9 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              93 (T)           ---             | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P=0.573          (e)              (e)              (e)              P=0.500          (e)             | 

|POLY 3             |        P=0.539          (e)              (e)              (e)              P=0.500          (e)             | 

|POLY 1.5           |        P=0.555          (e)              (e)              (e)              P=0.500          (e)             | 

|POLY 6             |        P=0.525          (e)              (e)              (e)              P=0.500          (e)             | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P=0.500          (e)             | 

|COCH-ARM / FISHERS |        P=0.585          (e)              (e)              (e)              P=0.500          (e)             | 

|ORDER RESTRICTED   |        P=0.349          (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Stomach, Glandular                                                                                                               | 

|     Mineralization                                                                                                              | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/10 (10%)       2/10 (20%)       0/10 (0%)       | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          1/10.00          2/10.00          0/0.00          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             10.0%            20.0%            0.0%            | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/10 (10%)       2/10 (20%)       0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              93 (T)           93 (T)           ---             | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P=0.072          (e)              (e)              P=0.500          P=0.234          (e)             | 

|POLY 3             |        P=0.018 *        (e)              (e)              P=0.500          P=0.227          (e)             | 

|POLY 1.5           |        P=0.018 *        (e)              (e)              P=0.500          P=0.227          (e)             | 

|POLY 6             |        P=0.018 *        (e)              (e)              P=0.500          P=0.227          (e)             | 

|LOGISTIC REGRESSION|        P=0.070          (e)              (e)              P=0.500          P=0.234          (e)             | 

|COCH-ARM / FISHERS |        P=0.478          (e)              (e)              P=0.500          P=0.237          (e)             | 

|ORDER RESTRICTED   |        P=0.831          (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 23      

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Stomach, Glandular: Epithelium, Glands                                                                                           | 

|     Degeneration                                                                                                                | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/10 (10%)      | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          1/10.00         | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             10.0%           | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              61              | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P=0.107          (e)              (e)              (e)              (e)              P=0.500         | 

|POLY 3             |        P=0.107          (e)              (e)              (e)              (e)              P=0.500         | 

|POLY 1.5           |        P=0.107          (e)              (e)              (e)              (e)              P=0.500         | 

|POLY 6             |        P=0.107          (e)              (e)              (e)              (e)              P=0.500         | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P=0.105          (e)              (e)              (e)              (e)              P=0.500         | 

|ORDER RESTRICTED   |        P=0.064          (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Stomach, Glandular: Epithelium, Glands                                                                                           | 

|     Degeneration                                                                                                                | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/10 (10%)       5/10 (50%)      | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          1/10.00          5/5.00          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             10.0%            100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/10 (10%)       0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              93 (T)           3               | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              P=0.500          P=0.006 **      | 

|POLY 3             |        P<0.001 **       (e)              (e)              (e)              P=0.500          P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P=0.500          P<0.001 **      | 

|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P=0.500          P<0.001 **      | 

|LOGISTIC REGRESSION|        P=0.360          (e)              (e)              (e)              P=0.500          (e)             | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              P=0.500          P=0.016 *       | 

|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 02                                            Page 24      

                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                        ESTRAGOLE       

                                         Terminal Sacrifice at 14 weeks                                                             

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Males                                                  | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Thymus                                                                                                                           | 

|     Necrosis Lymphoid                                                                                                           | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)       | 

|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/0.00           0/0.00           0/0.00           0/9.28          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             0.0%            | 

|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/9 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              ---             | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 3             |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|POLY 6             |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

|Dose               |        0 MG/KG          37.5             75               150              300              600             | 

|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 

|=================================================================================================================================| 

|                                                                                                                                 | 

|Thymus                                                                                                                           | 

|     Necrosis Lymphoid                                                                                                           | 

|                                                                                                                                 | 

|                                                                                                                                 | 

|---------------------------------------------------------------------------------------------------------------------------------| 

|LESION RATES       |                                                                                                             | 

|-----------        |                                                                                                             | 

|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)        10/10 (100%)    | 

|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/0.00           0/0.00           0/10.00          10/10.00        | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)        0/0 (0%)        | 

|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              3               | 

|-------------------|                                                                                                             | 

|STATISTICAL TESTS  |                                                                                                             | 

|-------------------|                                                                                                             | 

|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 

|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 

|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 

|=================================================================================================================================| 

(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).