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

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     

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

EXPERIMENT: 60946 TEST: 01                                                                                     TIME: 09:15:40       

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/RATS                                                             

                                                                                                                                    

                                                                                                                                    

               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: 01                                                                                     TIME: 09:15:40       

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 Rats                                                                                                                           

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

Organ                                 Morphology                                                                                    

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

Bone Marrow                            Hyperplasia                                                                                  

Epididymis                             Hypospermia                                                                                  

Epididymis: Bilateral                  Hypospermia                                                                                  

Kidney                                 Infiltration Cellular Lymphocyte                                                             

Kidney: Cortex, Renal Tubule           Pigmentation                                                                                 

Kidney: Papilla, Renal Tubule          Mineralization                                                                               

Liver                                  Basophilic Focus                                                                             

                                       Cholangiofibrosis                                                                            

                                       Eosinophilic Focus                                                                           

                                       Mixed Cell Focus                                                                             

Liver: Bile Duct                       Hyperplasia                                                                                  

Liver: Hepatocyte                      Hypertrophy                                                                                  

Liver: Oval Cell                       Hyperplasia                                                                                  

Liver: Periportal                      Infiltration Cellular Histiocyte                                                             

                                       Inflammation Chronic                                                                         

Lung                                   Inflammation Granulomatous                                                                   

Lymph Node, Mesenteric                 Hyperplasia Lymphoid                                                                         

Nose: Olfactory Epithelium             Degeneration                                                                                 

Pituitary Gland: Pars Distalis, Chromophobe Cell                                                                                    

                                       Hypertrophy                                                                                  

Salivary Glands: Submandibular Gland   Cytoplasmic Alteration                                                                       

Stomach, Glandular: Epithelium, Glands                                                                                              

                                       Atrophy                                                                                      

Testes: Bilateral, Germinal Epithelium                                                                                              

                                       Degeneration                                                                                 

Testes: Germinal Epithelium            Degeneration                                                                                 

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

Female Rats                                                                                                                         

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

Organ                                  Morphology                                                                                   

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

Kidney                                 Infiltration Cellular Lymphocyte                                                             

Kidney: Papilla, Renal Tubule          Mineralization                                                                               

Kidney: Renal Tubule                   Regeneration                                                                                 

Liver                                  Basophilic Focus                                                                             

                                       Eosinophilic Focus                                                                           

                                       Inflammation Chronic                                                                         

                                       Mixed Cell Focus                                                                             

Liver: Bile Duct                       Hyperplasia                                                                                  

Liver: Hepatocyte                      Hypertrophy                                                                                  

Liver: Oval Cell                       Hyperplasia                                                                                  

Liver: Periportal                      Infiltration Cellular Histiocyte                                                             

                                       Inflammation Chronic                                                                         

Lung                                   Inflammation Chronic                                                                         

Lymph Node, Mesenteric                 Hyperplasia Lymphoid                                                                         

                                                                                                                                   

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     

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

EXPERIMENT: 60946 TEST: 01                                                                                     TIME: 09:15:40       

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        

Nose: Olfactory Epithelium             Degeneration                                                                                 

Salivary Glands: Submandibular Gland   Cytoplasmic Alteration                                                                       

Stomach, Glandular: Epithelium, Glands                                                                                              

                                       Atrophy                                                                                      

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 1       

                     Statistical Analysis of Non-neoplastic Lesions in        Rats(FISCHER 344)  -                        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           | 

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

|                                                                                                                                 | 

|Bone Marrow                                                                                                                      | 

|     Hyperplasia                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        4/10 (40%)       3/10 (30%)       10/10 (100%)     10/10 (100%)    | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          4/10.00          3/10.00          10/10.00         10/10.00        | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             40.0%            30.0%            100.0%           100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        4/10 (40%)       3/10 (30%)       10/10 (100%)     10/10 (100%)    | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P<0.001 **       (e)              P=0.051          P=0.111          P<0.001 **       P<0.001 **      | 

|POLY 3             |        P<0.001 **       (e)              P=0.033 *        P=0.095          P<0.001 **       P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       (e)              P=0.033 *        P=0.095          P<0.001 **       P<0.001 **      | 

|POLY 6             |        P<0.001 **       (e)              P=0.033 *        P=0.095          P<0.001 **       P<0.001 **      | 

|LOGISTIC REGRESSION|        (e)              (e)              P=0.051          P=0.111          P<0.001 **       P<0.001 **      | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              P=0.043 *        P=0.105          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           | 

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

|                                                                                                                                 | 

|Bone Marrow                                                                                                                      | 

|     Hyperplasia                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.309N         P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.500N        | 

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

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

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

|LOGISTIC REGRESSION|        P=0.309N         (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P=0.304N         P=1.000          P=1.000          P=1.000          P=1.000          P=0.500N        | 

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

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 2       

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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           | 

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

|                                                                                                                                 | 

|Epididymis                                                                                                                       | 

|     Hypospermia                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

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

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

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

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

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

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

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

|                                                                                                                                 | 

|Epididymis                                                                                                                       | 

|     Hypospermia                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |                                                                                                             | 

|POLY-3 RATE (b)    |                                                                                                             | 

|POLY-3 PERCENT (g) |                                                                                                             | 

|TERMINAL (d)       |                                                                                                             | 

|FIRST INCIDENCE    |                                                                                                             | 

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |                                                                                                             | 

|POLY 3             |                                                                                                             | 

|POLY 1.5           |                                                                                                             | 

|POLY 6             |                                                                                                             | 

|LOGISTIC REGRESSION|                                                                                                             | 

|COCH-ARM / FISHERS |                                                                                                             | 

|ORDER RESTRICTED   |                                                                                                             | 

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 3       

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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           | 

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

|                                                                                                                                 | 

|Epididymis: Bilateral                                                                                                            | 

|     Hypospermia                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|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 **       P<0.001 **      | 

|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           | 

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

|                                                                                                                                 | 

|Epididymis: Bilateral                                                                                                            | 

|     Hypospermia                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |                                                                                                             | 

|POLY-3 RATE (b)    |                                                                                                             | 

|POLY-3 PERCENT (g) |                                                                                                             | 

|TERMINAL (d)       |                                                                                                             | 

|FIRST INCIDENCE    |                                                                                                             | 

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |                                                                                                             | 

|POLY 3             |                                                                                                             | 

|POLY 1.5           |                                                                                                             | 

|POLY 6             |                                                                                                             | 

|LOGISTIC REGRESSION|                                                                                                             | 

|COCH-ARM / FISHERS |                                                                                                             | 

|ORDER RESTRICTED   |                                                                                                             | 

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 4       

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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           | 

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

|                                                                                                                                 | 

|Heart                                                                                                                            | 

|     Infiltration Cellular Mononuclear Cell                                                                                      | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        2/10 (20%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         3/10 (30%)      | 

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

|POLY-3 PERCENT (g) |        20.0%            0.0%             0.0%             0.0%             0.0%             30.0%           | 

|TERMINAL (d)       |        2/10 (20%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         3/10 (30%)      | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.401          P=1.000N         P=1.000N         P=1.000N         P=1.000N         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|        P=0.401          (e)              (e)              (e)              (e)              P=0.500         | 

|COCH-ARM / FISHERS |        P=0.398          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           | 

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

|                                                                                                                                 | 

|Heart                                                                                                                            | 

|     Infiltration Cellular Mononuclear Cell                                                                                      | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.309          (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)              P=0.500         | 

|COCH-ARM / FISHERS |        P=0.304          (e)              (e)              (e)              (e)              P=0.500         | 

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

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 5       

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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           | 

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

|                                                                                                                                 | 

|Heart: Myocardium                                                                                                                | 

|     Infiltration Cellular Mononuclear Cell                                                                                      | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        6/10 (60%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         3/10 (30%)      | 

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

|POLY-3 PERCENT (g) |        60.0%            0.0%             0.0%             0.0%             0.0%             30.0%           | 

|TERMINAL (d)       |        6/10 (60%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         3/10 (30%)      | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.137N         P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.190N        | 

|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.186N        | 

|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.186N        | 

|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.186N        | 

|LOGISTIC REGRESSION|        P=0.137N         (e)              (e)              (e)              (e)              P=0.190N        | 

|COCH-ARM / FISHERS |        P=0.131N         P=1.000          P=1.000          P=1.000          P=1.000          P=0.185N        | 

|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           | 

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

|                                                                                                                                 | 

|Heart: Myocardium                                                                                                                | 

|     Infiltration Cellular Mononuclear Cell                                                                                      | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.607          P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.707         | 

|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.702         | 

|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.702         | 

|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.702         | 

|LOGISTIC REGRESSION|        P=0.607          (e)              (e)              (e)              (e)              P=0.707         | 

|COCH-ARM / FISHERS |        P=0.610          P=1.000          P=1.000          P=1.000          P=1.000          P=0.709N        | 

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

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 6       

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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                                                                                                                           | 

|     Infiltration Cellular Lymphocyte                                                                                            | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        1/10 (10%)       0/10 (0%)        1/10 (10%)       2/10 (20%)       7/10 (70%)       0/10 (0%)       | 

|POLY-3 RATE (b)    |        1/10.00          0/10.00          1/10.00          2/10.00          7/10.00          0/10.00         | 

|POLY-3 PERCENT (g) |        10.0%            0.0%             10.0%            20.0%            70.0%            0.0%            | 

|TERMINAL (d)       |        1/10 (10%)       0/10 (0%)        1/10 (10%)       2/10 (20%)       7/10 (70%)       0/10 (0%)       | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.378          P=0.500N         P=0.766          P=0.500          P=0.013 *        P=0.500N        | 

|POLY 3             |        P=0.352          P=0.500N         P=0.760          P=0.500          P=0.003 **       P=0.500N        | 

|POLY 1.5           |        P=0.352          P=0.500N         P=0.760          P=0.500          P=0.003 **       P=0.500N        | 

|POLY 6             |        P=0.352          P=0.500N         P=0.760          P=0.500          P=0.003 **       P=0.500N        | 

|LOGISTIC REGRESSION|        P=0.378          (e)              P=0.766          P=0.500          P=0.013 *        (e)             | 

|COCH-ARM / FISHERS |        P=0.377          P=0.500N         P=0.763N         P=0.500          P=0.010 *        P=0.500N        | 

|ORDER RESTRICTED   |        P=0.024 *        (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                                                                                                                           | 

|     Infiltration Cellular Lymphocyte                                                                                            | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.002 **       (e)              (e)              (e)              P=0.500          P=0.111         | 

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

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

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

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P=0.500          P=0.111         | 

|COCH-ARM / FISHERS |        P=0.002 **       (e)              (e)              (e)              P=0.500          P=0.105         | 

|ORDER RESTRICTED   |        P=0.003 **       (e)              (e)              (e)              (e)              (e)             | 

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 7       

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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: Cortex, Renal Tubule                                                                                                     | 

|     Mineralization                                                                                                              | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|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          0/10.00         | 

|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%)        0/10 (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           | 

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

|                                                                                                                                 | 

|Kidney: Cortex, Renal Tubule                                                                                                     | 

|     Mineralization                                                                                                              | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        2/10 (20%)       1/10 (10%)       4/10 (40%)       4/10 (40%)       1/10 (10%)       1/10 (10%)      | 

|POLY-3 RATE (b)    |        2/10.00          1/10.00          4/10.00          4/10.00          1/10.00          1/10.00         | 

|POLY-3 PERCENT (g) |        20.0%            10.0%            40.0%            40.0%            10.0%            10.0%           | 

|TERMINAL (d)       |        2/10 (20%)       1/10 (10%)       4/10 (40%)       4/10 (40%)       1/10 (10%)       1/10 (10%)      | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.211N         P=0.500N         P=0.317          P=0.317          P=0.500N         P=0.500N        | 

|POLY 3             |        P=0.209N         P=0.500N         P=0.318          P=0.318          P=0.500N         P=0.500N        | 

|POLY 1.5           |        P=0.209N         P=0.500N         P=0.318          P=0.318          P=0.500N         P=0.500N        | 

|POLY 6             |        P=0.209N         P=0.500N         P=0.318          P=0.318          P=0.500N         P=0.500N        | 

|LOGISTIC REGRESSION|        P=0.211N         P=0.500N         P=0.317          P=0.317          P=0.500N         P=0.500N        | 

|COCH-ARM / FISHERS |        P=0.209N         P=0.500N         P=0.314          P=0.314          P=0.500N         P=0.500N        | 

|ORDER RESTRICTED   |        P=0.304N         (e)              (e)              (e)              (e)              (e)             | 

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 8       

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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: Cortex, Renal Tubule                                                                                                     | 

|     Pigmentation                                                                                                                | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

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

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

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

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

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

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

|ORDER RESTRICTED   |        P=0.831          (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: Cortex, Renal Tubule                                                                                                     | 

|     Pigmentation                                                                                                                | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|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          0/10.00         | 

|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%)        0/10 (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: 01                                            Page 9       

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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: Papilla, Renal Tubule                                                                                                    | 

|     Mineralization                                                                                                              | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        4/10 (40%)       2/10 (20%)       2/10 (20%)       8/10 (80%)       10/10 (100%)     10/10 (100%)    | 

|POLY-3 RATE (b)    |        4/10.00          2/10.00          2/10.00          8/10.00          10/10.00         10/10.00        | 

|POLY-3 PERCENT (g) |        40.0%            20.0%            20.0%            80.0%            100.0%           100.0%          | 

|TERMINAL (d)       |        4/10 (40%)       2/10 (20%)       2/10 (20%)       8/10 (80%)       10/10 (100%)     10/10 (100%)    | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P<0.001 **       P=0.317N         P=0.317N         P=0.091          P=0.009 **       P=0.009 **      | 

|POLY 3             |        P<0.001 **       P=0.318N         P=0.318N         P=0.077          P<0.001 **       P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       P=0.318N         P=0.318N         P=0.077          P<0.001 **       P<0.001 **      | 

|POLY 6             |        P<0.001 **       P=0.318N         P=0.318N         P=0.077          P<0.001 **       P<0.001 **      | 

|LOGISTIC REGRESSION|        P<0.001 **       P=0.317N         P=0.317N         P=0.091          P=0.009 **       P=0.009 **      | 

|COCH-ARM / FISHERS |        P<0.001 **       P=0.314N         P=0.314N         P=0.085          P=0.005 **       P=0.005 **      | 

|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           | 

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

|                                                                                                                                 | 

|Kidney: Papilla, Renal Tubule                                                                                                    | 

|     Mineralization                                                                                                              | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        3/10 (30%)       4/10 (40%)       6/10 (60%)       7/10 (70%)       9/10 (90%)       7/10 (70%)      | 

|POLY-3 RATE (b)    |        3/10.00          4/10.00          6/10.00          7/10.00          9/10.00          7/10.00         | 

|POLY-3 PERCENT (g) |        30.0%            40.0%            60.0%            70.0%            90.0%            70.0%           | 

|TERMINAL (d)       |        3/10 (30%)       4/10 (40%)       6/10 (60%)       7/10 (70%)       9/10 (90%)       7/10 (70%)      | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.035 *        P=0.500          P=0.190          P=0.095          P=0.013 *        P=0.095         | 

|POLY 3             |        P=0.029 *        P=0.500          P=0.186          P=0.082          P=0.003 **       P=0.082         | 

|POLY 1.5           |        P=0.029 *        P=0.500          P=0.186          P=0.082          P=0.003 **       P=0.082         | 

|POLY 6             |        P=0.029 *        P=0.500          P=0.186          P=0.082          P=0.003 **       P=0.082         | 

|LOGISTIC REGRESSION|        P=0.035 *        P=0.500          P=0.190          P=0.095          P=0.013 *        P=0.095         | 

|COCH-ARM / FISHERS |        P=0.034 *        P=0.500          P=0.185          P=0.089          P=0.010 *        P=0.089         | 

|ORDER RESTRICTED   |        P=0.011 *        (e)              (e)              (e)              (e)              (e)             | 

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 10      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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                                                                                                             | 

|     Regeneration                                                                                                                | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        7/10 (70%)       7/10 (70%)       10/10 (100%)     10/10 (100%)     10/10 (100%)     8/10 (80%)      | 

|POLY-3 RATE (b)    |        7/10.00          7/10.00          10/10.00         10/10.00         10/10.00         8/10.00         | 

|POLY-3 PERCENT (g) |        70.0%            70.0%            100.0%           100.0%           100.0%           80.0%           | 

|TERMINAL (d)       |        7/10 (70%)       7/10 (70%)       10/10 (100%)     10/10 (100%)     10/10 (100%)     8/10 (80%)      | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.436          P=0.683          P=0.111          P=0.111          P=0.111          P=0.500         | 

|POLY 3             |        P=0.434          P=0.678          P=0.095          P=0.095          P=0.095          P=0.500         | 

|POLY 1.5           |        P=0.434          P=0.678          P=0.095          P=0.095          P=0.095          P=0.500         | 

|POLY 6             |        P=0.434          P=0.678          P=0.095          P=0.095          P=0.095          P=0.500         | 

|LOGISTIC REGRESSION|        P=0.436          P=0.683          P=0.111          P=0.111          P=0.111          P=0.500         | 

|COCH-ARM / FISHERS |        P=0.436          P=0.686N         P=0.105          P=0.105          P=0.105          P=0.500         | 

|ORDER RESTRICTED   |        P=0.068          (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                                                                                                             | 

|     Regeneration                                                                                                                | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        1/10 (10%)       2/10 (20%)       1/10 (10%)       1/10 (10%)       3/10 (30%)       6/10 (60%)      | 

|POLY-3 RATE (b)    |        1/10.00          2/10.00          1/10.00          1/10.00          3/10.00          6/10.00         | 

|POLY-3 PERCENT (g) |        10.0%            20.0%            10.0%            10.0%            30.0%            60.0%           | 

|TERMINAL (d)       |        1/10 (10%)       2/10 (20%)       1/10 (10%)       1/10 (10%)       3/10 (30%)       6/10 (60%)      | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.002 **       P=0.500          P=0.766          P=0.766          P=0.293          P=0.034 *       | 

|POLY 3             |        P<0.001 **       P=0.500          P=0.760          P=0.760          P=0.292          P=0.018 *       | 

|POLY 1.5           |        P<0.001 **       P=0.500          P=0.760          P=0.760          P=0.292          P=0.018 *       | 

|POLY 6             |        P<0.001 **       P=0.500          P=0.760          P=0.760          P=0.292          P=0.018 *       | 

|LOGISTIC REGRESSION|        P=0.002 **       P=0.500          P=0.766          P=0.766          P=0.293          P=0.034 *       | 

|COCH-ARM / FISHERS |        P=0.002 **       P=0.500          P=0.763N         P=0.763N         P=0.291          P=0.029 *       | 

|ORDER RESTRICTED   |        P=0.004 **       (e)              (e)              (e)              (e)              (e)             | 

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 11      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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                                                                                                                            | 

|     Angiectasis Focal                                                                                                           | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.414          (e)              (e)              (e)              P=0.234          (e)             | 

|POLY 3             |        P=0.410          (e)              (e)              (e)              P=0.227          (e)             | 

|POLY 1.5           |        P=0.410          (e)              (e)              (e)              P=0.227          (e)             | 

|POLY 6             |        P=0.410          (e)              (e)              (e)              P=0.227          (e)             | 

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

|COCH-ARM / FISHERS |        P=0.414          (e)              (e)              (e)              P=0.237          (e)             | 

|ORDER RESTRICTED   |        P=0.165          (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                                                                                                                            | 

|     Angiectasis Focal                                                                                                           | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|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          0/10.00         | 

|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%)        0/10 (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: 01                                            Page 12      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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                                                                                                                            | 

|     Basophilic Focus                                                                                                            | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        6/10 (60%)       9/10 (90%)       6/10 (60%)      | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          6/10.00          9/10.00          6/10.00         | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             60.0%            90.0%            60.0%           | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        6/10 (60%)       9/10 (90%)       6/10 (60%)      | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.009 **       P<0.001 **       P=0.009 **      | 

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

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

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

|LOGISTIC REGRESSION|        (e)              (e)              (e)              P=0.009 **       P<0.001 **       P=0.009 **      | 

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

|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                                                                                                                            | 

|     Basophilic Focus                                                                                                            | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        3/10 (30%)       6/10 (60%)       10/10 (100%)     10/10 (100%)    | 

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

|POLY-3 PERCENT (g) |        0.0%             0.0%             30.0%            60.0%            100.0%           100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        3/10 (30%)       6/10 (60%)       10/10 (100%)     10/10 (100%)    | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P<0.001 **       (e)              P=0.111          P=0.009 **       P<0.001 **       P<0.001 **      | 

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

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

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

|LOGISTIC REGRESSION|        (e)              (e)              P=0.111          P=0.009 **       P<0.001 **       P<0.001 **      | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              P=0.105          P=0.005 **       P<0.001 **       P<0.001 **      | 

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

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 13      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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                                                                                                                            | 

|     Cholangiofibrosis                                                                                                           | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|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%)        10/10 (100%)    | 

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

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

|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)              P<0.001 **      | 

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

|     Cholangiofibrosis                                                                                                           | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|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%)        1/10 (10%)      | 

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

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

|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)              P=0.500         | 

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

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

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 14      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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                                                                                                                            | 

|     Clear Cell Focus                                                                                                            | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.301          (e)              (e)              P=0.111          P=0.500          P=0.500         | 

|POLY 3             |        P=0.295          (e)              (e)              P=0.095          P=0.500          P=0.500         | 

|POLY 1.5           |        P=0.295          (e)              (e)              P=0.095          P=0.500          P=0.500         | 

|POLY 6             |        P=0.295          (e)              (e)              P=0.095          P=0.500          P=0.500         | 

|LOGISTIC REGRESSION|        (e)              (e)              (e)              P=0.111          P=0.500          P=0.500         | 

|COCH-ARM / FISHERS |        P=0.300          (e)              (e)              P=0.105          P=0.500          P=0.500         | 

|ORDER RESTRICTED   |        P=0.138          (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                                                                                                                            | 

|     Clear Cell Focus                                                                                                            | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|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%)        1/10 (10%)      | 

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

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

|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)              P=0.500         | 

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

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

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 15      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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                                                                                                                            | 

|     Eosinophilic Focus                                                                                                          | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

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

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

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

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

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

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

|     Eosinophilic Focus                                                                                                          | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|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%)        10/10 (100%)    | 

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

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

|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)              P<0.001 **      | 

|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: 01                                            Page 16      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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                                                                                                                            | 

|     Hepatodiaphragmatic Nodule                                                                                                  | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.332N         P=0.293          P=0.500N         P=0.766          P=0.293          P=0.500N        | 

|POLY 3             |        P=0.328N         P=0.292          P=0.500N         P=0.760          P=0.292          P=0.500N        | 

|POLY 1.5           |        P=0.328N         P=0.292          P=0.500N         P=0.760          P=0.292          P=0.500N        | 

|POLY 6             |        P=0.328N         P=0.292          P=0.500N         P=0.760          P=0.292          P=0.500N        | 

|LOGISTIC REGRESSION|        P=0.332N         P=0.293          (e)              P=0.766          P=0.293          (e)             | 

|COCH-ARM / FISHERS |        P=0.331N         P=0.291          P=0.500N         P=0.763N         P=0.291          P=0.500N        | 

|ORDER RESTRICTED   |        P=0.151N         (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                                                                                                                            | 

|     Hepatodiaphragmatic Nodule                                                                                                  | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.141N         P=0.707          P=0.707          P=0.500N         P=0.707          P=0.234N        | 

|POLY 3             |        P=0.146N         P=0.702          P=0.702          P=0.500N         P=0.702          P=0.227N        | 

|POLY 1.5           |        P=0.146N         P=0.702          P=0.702          P=0.500N         P=0.702          P=0.227N        | 

|POLY 6             |        P=0.146N         P=0.702          P=0.702          P=0.500N         P=0.702          P=0.227N        | 

|LOGISTIC REGRESSION|        P=0.141N         P=0.707          P=0.707          P=0.500N         P=0.707          (e)             | 

|COCH-ARM / FISHERS |        P=0.139N         P=0.709N         P=0.709N         P=0.500N         P=0.709N         P=0.237N        | 

|ORDER RESTRICTED   |        P=0.193N         (e)              (e)              (e)              (e)              (e)             | 

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 17      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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)        |        1/10 (10%)       2/10 (20%)       1/10 (10%)       1/10 (10%)       3/10 (30%)       0/10 (0%)       | 

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

|POLY-3 PERCENT (g) |        10.0%            20.0%            10.0%            10.0%            30.0%            0.0%            | 

|TERMINAL (d)       |        1/10 (10%)       2/10 (20%)       1/10 (10%)       1/10 (10%)       3/10 (30%)       0/10 (0%)       | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.357N         P=0.500          P=0.766          P=0.766          P=0.293          P=0.500N        | 

|POLY 3             |        P=0.358N         P=0.500          P=0.760          P=0.760          P=0.292          P=0.500N        | 

|POLY 1.5           |        P=0.358N         P=0.500          P=0.760          P=0.760          P=0.292          P=0.500N        | 

|POLY 6             |        P=0.358N         P=0.500          P=0.760          P=0.760          P=0.292          P=0.500N        | 

|LOGISTIC REGRESSION|        P=0.357N         P=0.500          P=0.766          P=0.766          P=0.293          (e)             | 

|COCH-ARM / FISHERS |        P=0.356N         P=0.500          P=0.763N         P=0.763N         P=0.291          P=0.500N        | 

|ORDER RESTRICTED   |        P=0.265N         (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)        |        4/10 (40%)       4/10 (40%)       5/10 (50%)       6/10 (60%)       3/10 (30%)       0/10 (0%)       | 

|POLY-3 RATE (b)    |        4/10.00          4/10.00          5/10.00          6/10.00          3/10.00          0/10.00         | 

|POLY-3 PERCENT (g) |        40.0%            40.0%            50.0%            60.0%            30.0%            0.0%            | 

|TERMINAL (d)       |        4/10 (40%)       4/10 (40%)       5/10 (50%)       6/10 (60%)       3/10 (30%)       0/10 (0%)       | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.011N*        P=0.672          P=0.500          P=0.331          P=0.500N         P=0.051N        | 

|POLY 3             |        P=0.008N**       P=0.667          P=0.500          P=0.333          P=0.500N         P=0.033N*       | 

|POLY 1.5           |        P=0.008N**       P=0.667          P=0.500          P=0.333          P=0.500N         P=0.033N*       | 

|POLY 6             |        P=0.008N**       P=0.667          P=0.500          P=0.333          P=0.500N         P=0.033N*       | 

|LOGISTIC REGRESSION|        P=0.011N*        P=0.672          P=0.500          P=0.331          P=0.500N         (e)             | 

|COCH-ARM / FISHERS |        P=0.010N*        P=0.675N         P=0.500          P=0.328          P=0.500N         P=0.043N*       | 

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

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 18      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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                                                                                                                            | 

|     Mixed Cell Focus                                                                                                            | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        1/10 (10%)       9/10 (90%)       10/10 (100%)     8/10 (80%)      | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          1/10.00          9/10.00          10/10.00         8/10.00         | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             10.0%            90.0%            100.0%           80.0%           | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        1/10 (10%)       9/10 (90%)       10/10 (100%)     8/10 (80%)      | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

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

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

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

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

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

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

|     Mixed Cell Focus                                                                                                            | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        1/10 (10%)       6/10 (60%)       10/10 (100%)     10/10 (100%)    | 

|POLY-3 RATE (b)    |        0/10.00          0/10.00          1/10.00          6/10.00          10/10.00         10/10.00        | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             10.0%            60.0%            100.0%           100.0%          | 

|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        1/10 (10%)       6/10 (60%)       10/10 (100%)     10/10 (100%)    | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P<0.001 **       (e)              P=0.500          P=0.009 **       P<0.001 **       P<0.001 **      | 

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

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

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

|LOGISTIC REGRESSION|        (e)              (e)              P=0.500          P=0.009 **       P<0.001 **       P<0.001 **      | 

|COCH-ARM / FISHERS |        P<0.001 **       (e)              P=0.500          P=0.005 **       P<0.001 **       P<0.001 **      | 

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

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 19      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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%)        10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)    | 

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

|POLY 3             |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

|POLY 6             |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

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

|COCH-ARM / FISHERS |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       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: Bile Duct                                                                                                                 | 

|     Hyperplasia                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

|POLY 3             |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

|POLY 6             |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

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

|COCH-ARM / FISHERS |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

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

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 20      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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%)        10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)    | 

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

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

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

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

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

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

|COCH-ARM / FISHERS |        P<0.001 **       (e)              P<0.001 **       P<0.001 **       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%)        0/10 (0%)        10/10 (100%)     10/10 (100%)     10/10 (100%)    | 

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

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

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

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

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

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

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

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

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 21      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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%)        10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)    | 

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

|POLY 3             |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

|POLY 6             |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

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

|COCH-ARM / FISHERS |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       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%)        10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)    | 

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

|POLY 3             |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

|POLY 1.5           |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

|POLY 6             |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

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

|COCH-ARM / FISHERS |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

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

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 22      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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: Periportal                                                                                                                | 

|     Infiltration Cellular Histiocyte                                                                                            | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

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

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

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

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

|COCH-ARM / FISHERS |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       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: Periportal                                                                                                                | 

|     Infiltration Cellular Histiocyte                                                                                            | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

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

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

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

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

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

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

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

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 23      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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: Periportal                                                                                                                | 

|     Inflammation Chronic                                                                                                        | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

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

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

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

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

|COCH-ARM / FISHERS |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       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: Periportal                                                                                                                | 

|     Inflammation Chronic                                                                                                        | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P<0.001 **       P=0.022 *        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

|POLY 3             |        P<0.001 **       P=0.008 **       P<0.001 **       P<0.001 **       P<0.001N**       P<0.001N**      | 

|POLY 1.5           |        P<0.001 **       P=0.008 **       P<0.001 **       P<0.001 **       P<0.001N**       P<0.001N**      | 

|POLY 6             |        P<0.001 **       P=0.008 **       P<0.001 **       P<0.001 **       P<0.001N**       P<0.001N**      | 

|LOGISTIC REGRESSION|        (e)              P=0.022 *        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 

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

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

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 24      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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           | 

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

|                                                                                                                                 | 

|Lung                                                                                                                             | 

|     Inflammation Chronic                                                                                                        | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        5/10 (50%)       3/10 (30%)       6/10 (60%)       7/10 (70%)       6/10 (60%)       8/10 (80%)      | 

|POLY-3 RATE (b)    |        5/10.00          3/10.00          6/10.00          7/10.00          6/10.00          8/10.00         | 

|POLY-3 PERCENT (g) |        50.0%            30.0%            60.0%            70.0%            60.0%            80.0%           | 

|TERMINAL (d)       |        5/10 (50%)       3/10 (30%)       6/10 (60%)       7/10 (70%)       6/10 (60%)       8/10 (80%)      | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.053          P=0.328N         P=0.500          P=0.328          P=0.500          P=0.180         | 

|POLY 3             |        P=0.051          P=0.329N         P=0.500          P=0.329          P=0.500          P=0.174         | 

|POLY 1.5           |        P=0.051          P=0.329N         P=0.500          P=0.329          P=0.500          P=0.174         | 

|POLY 6             |        P=0.051          P=0.329N         P=0.500          P=0.329          P=0.500          P=0.174         | 

|LOGISTIC REGRESSION|        P=0.053          P=0.328N         P=0.500          P=0.328          P=0.500          P=0.180         | 

|COCH-ARM / FISHERS |        P=0.052          P=0.325N         P=0.500          P=0.325          P=0.500          P=0.175         | 

|ORDER RESTRICTED   |        P=0.051          (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           | 

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

|                                                                                                                                 | 

|Lung                                                                                                                             | 

|     Inflammation Chronic                                                                                                        | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        5/10 (50%)       6/10 (60%)       3/10 (30%)       4/10 (40%)       8/10 (80%)       10/10 (100%)    | 

|POLY-3 RATE (b)    |        5/10.00          6/10.00          3/10.00          4/10.00          8/10.00          10/10.00        | 

|POLY-3 PERCENT (g) |        50.0%            60.0%            30.0%            40.0%            80.0%            100.0%          | 

|TERMINAL (d)       |        5/10 (50%)       6/10 (60%)       3/10 (30%)       4/10 (40%)       8/10 (80%)       10/10 (100%)    | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.002 **       P=0.500          P=0.328N         P=0.500N         P=0.180          P=0.022 *       | 

|POLY 3             |        P<0.001 **       P=0.500          P=0.329N         P=0.500N         P=0.174          P=0.008 **      | 

|POLY 1.5           |        P<0.001 **       P=0.500          P=0.329N         P=0.500N         P=0.174          P=0.008 **      | 

|POLY 6             |        P<0.001 **       P=0.500          P=0.329N         P=0.500N         P=0.174          P=0.008 **      | 

|LOGISTIC REGRESSION|        P=0.002 **       P=0.500          P=0.328N         P=0.500N         P=0.180          P=0.022 *       | 

|COCH-ARM / FISHERS |        P<0.001 **       P=0.500          P=0.325N         P=0.500N         P=0.175          P=0.016 *       | 

|ORDER RESTRICTED   |        P=0.005 **       (e)              (e)              (e)              (e)              (e)             | 

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 25      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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           | 

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

|                                                                                                                                 | 

|Lung                                                                                                                             | 

|     Inflammation Granulomatous                                                                                                  | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        0/10 (0%)        1/10 (10%)       0/10 (0%)        0/10 (0%)        4/10 (40%)       0/10 (0%)       | 

|POLY-3 RATE (b)    |        0/10.00          1/10.00          0/10.00          0/10.00          4/10.00          0/10.00         | 

|POLY-3 PERCENT (g) |        0.0%             10.0%            0.0%             0.0%             40.0%            0.0%            | 

|TERMINAL (d)       |        0/10 (0%)        1/10 (10%)       0/10 (0%)        0/10 (0%)        4/10 (40%)       0/10 (0%)       | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.395          P=0.500          (e)              (e)              P=0.051          (e)             | 

|POLY 3             |        P=0.382          P=0.500          (e)              (e)              P=0.033 *        (e)             | 

|POLY 1.5           |        P=0.382          P=0.500          (e)              (e)              P=0.033 *        (e)             | 

|POLY 6             |        P=0.382          P=0.500          (e)              (e)              P=0.033 *        (e)             | 

|LOGISTIC REGRESSION|        (e)              P=0.500          (e)              (e)              P=0.051          (e)             | 

|COCH-ARM / FISHERS |        P=0.394          P=0.500          (e)              (e)              P=0.043 *        (e)             | 

|ORDER RESTRICTED   |        P=0.052          (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           | 

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

|                                                                                                                                 | 

|Lung                                                                                                                             | 

|     Inflammation Granulomatous                                                                                                  | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|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          0/10.00         | 

|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%)        0/10 (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: 01                                            Page 26      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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                                                                                                           | 

|     Hyperplasia Lymphoid                                                                                                        | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        0/10 (0%)        1/10 (10%)       0/10 (0%)        0/10 (0%)        2/7 (29%)        2/10 (20%)      | 

|POLY-3 RATE (b)    |        0/10.00          1/10.00          0/10.00          0/10.00          2/7.00           2/10.00         | 

|POLY-3 PERCENT (g) |        0.0%             10.0%            0.0%             0.0%             28.6%            20.0%           | 

|TERMINAL (d)       |        0/10 (0%)        1/10 (10%)       0/10 (0%)        0/10 (0%)        2/7 (29%)        2/10 (20%)      | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.049 *        P=0.500          (e)              (e)              P=0.158          P=0.234         | 

|POLY 3             |        P=0.045 *        P=0.500          (e)              (e)              P=0.140          P=0.227         | 

|POLY 1.5           |        P=0.045 *        P=0.500          (e)              (e)              P=0.140          P=0.227         | 

|POLY 6             |        P=0.045 *        P=0.500          (e)              (e)              P=0.140          P=0.227         | 

|LOGISTIC REGRESSION|        (e)              P=0.500          (e)              (e)              P=0.158          P=0.234         | 

|COCH-ARM / FISHERS |        P=0.048 *        P=0.500          (e)              (e)              P=0.154          P=0.237         | 

|ORDER RESTRICTED   |        P=0.039 *        (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                                                                                                           | 

|     Hyperplasia Lymphoid                                                                                                        | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

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

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

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

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

|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P=0.111         | 

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

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

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 27      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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: Pancreatic                                                                                                           | 

|     Hyperplasia Lymphoid                                                                                                        | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         2/3 (67%)        3/3 (100%)      | 

|POLY-3 RATE (b)    |        0/0.00           0/0.00           0/0.00           0/0.00           2/3.00           3/3.00          | 

|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             66.7%            100.0%          | 

|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         2/3 (67%)        3/3 (100%)      | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.500          (e)              (e)              (e)              P=1.000N         (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)              P=1.000N         (e)             | 

|COCH-ARM / FISHERS |        P=0.500          (e)              (e)              (e)              P=1.000          (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           | 

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

|                                                                                                                                 | 

|Lymph Node: Pancreatic                                                                                                           | 

|     Hyperplasia Lymphoid                                                                                                        | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         4/4 (100%)      | 

|POLY-3 RATE (b)    |        0/0.00           0/0.00           0/0.00           0/0.00           0/0.00           4/4.00          | 

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

|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         4/4 (100%)      | 

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

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

|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: 01                                            Page 28      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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: Pancreatic                                                                                                           | 

|     Infiltration Cellular Histiocyte                                                                                            | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

|POLY-3 RATE (b)    |        0/0.00           0/0.00           0/0.00           0/0.00           3/3.00           3/3.00          | 

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

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

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

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

|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           | 

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

|                                                                                                                                 | 

|Lymph Node: Pancreatic                                                                                                           | 

|     Infiltration Cellular Histiocyte                                                                                            | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         4/4 (100%)      | 

|POLY-3 RATE (b)    |        0/0.00           0/0.00           0/0.00           0/0.00           0/0.00           4/4.00          | 

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

|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         4/4 (100%)      | 

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

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

|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: 01                                            Page 29      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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                                                                                                                             | 

|     Inflammation Chronic                                                                                                        | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.586N         (e)              (e)              P=0.234          (e)              (e)             | 

|POLY 3             |        P=0.590N         (e)              (e)              P=0.227          (e)              (e)             | 

|POLY 1.5           |        P=0.590N         (e)              (e)              P=0.227          (e)              (e)             | 

|POLY 6             |        P=0.590N         (e)              (e)              P=0.227          (e)              (e)             | 

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

|COCH-ARM / FISHERS |        P=0.586N         (e)              (e)              P=0.237          (e)              (e)             | 

|ORDER RESTRICTED   |        P=0.348          (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                                                                                                                             | 

|     Inflammation Chronic                                                                                                        | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|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          0/10.00         | 

|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%)        0/10 (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: 01                                            Page 30      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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%)        0/10 (0%)        0/10 (0%)        9/10 (90%)       10/10 (100%)    | 

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

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

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

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

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

|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 **       P<0.001 **      | 

|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           | 

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

|                                                                                                                                 | 

|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%)     10/10 (100%)    | 

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

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

|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<0.001 **       P<0.001 **      | 

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

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

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

|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)             | 

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 31      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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           | 

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

|                                                                                                                                 | 

|Pituitary Gland: Pars Distalis, Chromophobe Cell                                                                                 | 

|     Hypertrophy                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|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 **       P<0.001 **      | 

|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           | 

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

|                                                                                                                                 | 

|Pituitary Gland: Pars Distalis, Chromophobe Cell                                                                                 | 

|     Hypertrophy                                                                                                                 | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|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           0/10.00         | 

|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%)         0/10 (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: 01                                            Page 32      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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: Submandibular Gland                                                                                             | 

|     Cytoplasmic Alteration                                                                                                      | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

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

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

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

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

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

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

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

|                                                                                                                                 | 

|Salivary Glands: Submandibular Gland                                                                                             | 

|     Cytoplasmic Alteration                                                                                                      | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

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

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

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

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

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

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

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

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 33      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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%)        1/10 (10%)       0/10 (0%)        0/10 (0%)       | 

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.697N         (e)              (e)              P=0.500          (e)              (e)             | 

|POLY 3             |        P=0.697N         (e)              (e)              P=0.500          (e)              (e)             | 

|POLY 1.5           |        P=0.697N         (e)              (e)              P=0.500          (e)              (e)             | 

|POLY 6             |        P=0.697N         (e)              (e)              P=0.500          (e)              (e)             | 

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

|COCH-ARM / FISHERS |        P=0.699N         (e)              (e)              P=0.500          (e)              (e)             | 

|ORDER RESTRICTED   |        P=0.513          (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          0/10.00         | 

|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%)       0/10 (0%)       | 

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.479          (e)              (e)              P=0.500          P=0.234          (e)             | 

|POLY 3             |        P=0.478          (e)              (e)              P=0.500          P=0.227          (e)             | 

|POLY 1.5           |        P=0.478          (e)              (e)              P=0.500          P=0.227          (e)             | 

|POLY 6             |        P=0.478          (e)              (e)              P=0.500          P=0.227          (e)             | 

|LOGISTIC REGRESSION|        (e)              (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=0.265          (e)              (e)              (e)              (e)              (e)             | 

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 34      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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                                                                                           | 

|     Atrophy                                                                                                                     | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

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

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

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

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

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

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

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

|                                                                                                                                 | 

|Stomach, Glandular: Epithelium, Glands                                                                                           | 

|     Atrophy                                                                                                                     | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

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

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

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

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

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

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

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

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 35      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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           | 

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

|                                                                                                                                 | 

|Testes: Bilateral, Germinal Epithelium                                                                                           | 

|     Degeneration                                                                                                                | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|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 **       P<0.001 **      | 

|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           | 

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

|                                                                                                                                 | 

|Testes: Bilateral, Germinal Epithelium                                                                                           | 

|     Degeneration                                                                                                                | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |                                                                                                             | 

|POLY-3 RATE (b)    |                                                                                                             | 

|POLY-3 PERCENT (g) |                                                                                                             | 

|TERMINAL (d)       |                                                                                                             | 

|FIRST INCIDENCE    |                                                                                                             | 

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |                                                                                                             | 

|POLY 3             |                                                                                                             | 

|POLY 1.5           |                                                                                                             | 

|POLY 6             |                                                                                                             | 

|LOGISTIC REGRESSION|                                                                                                             | 

|COCH-ARM / FISHERS |                                                                                                             | 

|ORDER RESTRICTED   |                                                                                                             | 

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 36      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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           | 

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

|                                                                                                                                 | 

|Testes: Germinal Epithelium                                                                                                      | 

|     Degeneration                                                                                                                | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

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

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

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

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

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

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

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

|                                                                                                                                 | 

|Testes: Germinal Epithelium                                                                                                      | 

|     Degeneration                                                                                                                | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |                                                                                                             | 

|POLY-3 RATE (b)    |                                                                                                             | 

|POLY-3 PERCENT (g) |                                                                                                             | 

|TERMINAL (d)       |                                                                                                             | 

|FIRST INCIDENCE    |                                                                                                             | 

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |                                                                                                             | 

|POLY 3             |                                                                                                             | 

|POLY 1.5           |                                                                                                             | 

|POLY 6             |                                                                                                             | 

|LOGISTIC REGRESSION|                                                                                                             | 

|COCH-ARM / FISHERS |                                                                                                             | 

|ORDER RESTRICTED   |                                                                                                             | 

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

                                                                                                                                   

       Date:  10/08/03                           EXPERIMENT: 60946 TEST: 01                                            Page 37      

                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                        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           | 

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

|                                                                                                                                 | 

|Uterus: Endometrium                                                                                                              | 

|     Hyperplasia Cystic                                                                                                          | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

|OVERALL (a)        |                                                                                                             | 

|POLY-3 RATE (b)    |                                                                                                             | 

|POLY-3 PERCENT (g) |                                                                                                             | 

|TERMINAL (d)       |                                                                                                             | 

|FIRST INCIDENCE    |                                                                                                             | 

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |                                                                                                             | 

|POLY 3             |                                                                                                             | 

|POLY 1.5           |                                                                                                             | 

|POLY 6             |                                                                                                             | 

|LOGISTIC REGRESSION|                                                                                                             | 

|COCH-ARM / FISHERS |                                                                                                             | 

|ORDER RESTRICTED   |                                                                                                             | 

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

|                   |                                                                                                             | 

|                   |                                                      Females                                                | 

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

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

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

|                                                                                                                                 | 

|Uterus: Endometrium                                                                                                              | 

|     Hyperplasia Cystic                                                                                                          | 

|                                                                                                                                 | 

|                                                                                                                                 | 

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

|LESION RATES       |                                                                                                             | 

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

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

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

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

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

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

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

|STATISTICAL TESTS  |                                                                                                             | 

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

|LIFE TABLE         |        P=0.064N         P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.111N        | 

|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.095N        | 

|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.095N        | 

|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.095N        | 

|LOGISTIC REGRESSION|        P=0.064N         (e)              (e)              (e)              (e)              (e)             | 

|COCH-ARM / FISHERS |        P=0.059N         P=1.000          P=1.000          P=1.000          P=1.000          P=0.105N        | 

|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).