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TDMS Study 56111-03 Pathology Tables

                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                    TRANS-CINNAMALDEHYDE                                 DATE: 06/18/01       
EXPERIMENT: 56111 TEST: 03                                                                                     TIME: 13:34:00       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55384                              ROUTE: DOSED FEED                                              NTP C#: 56111B       
PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 14371-10-9      
Rats(FISCHER 344)                                                                                                                   
-----------------------------                                                                                                       
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE                                                                   
BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES                                                                 
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Adrenal Cortex                                                                     
                                                 Adrenal Medulla                                                                    
                                                 Brain                                                                              
                                                 Clitoral/Preputial Gland                                                           
                                                 Heart                                                                              
                                                 Islets, Pancreatic                                                                 
                                                 Kidney                                                                             
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Nose                                                                               
                                                 Ovary                                                                              
                                                 Pancreas                                                                           
                                                 Parathyroid Gland                                                                  
                                                 Pituitary Gland                                                                    
                                                 Prostate                                                                           
                                                 Salivary Glands                                                                    
                                                 Testes                                                                             
                                                 Thymus                                                                             
                                                 Thyroid Gland                                                                      
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                    TRANS-CINNAMALDEHYDE                                 DATE: 06/18/01       
EXPERIMENT: 56111 TEST: 03                                                                                     TIME: 13:34:00       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55384                              ROUTE: DOSED FEED                                              NTP C#: 56111B       
PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 14371-10-9      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                  TRANS-CINNAMALDEHYDE                                                                            
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Adrenal Medulla                        Pheochromocytoma Benign                                                                      
                                       Pheochromocytoma: Benign, Complex, Malignant, NOS                                            
Skin                                   Fibroma                                                                                      
===============================================================                                                                     
                                                                                                                                   
       Date:  06/18/01                           EXPERIMENT: 56111 TEST: 03                                            Page 1       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)        -                   TRANS-CINNAMALDEHYDE    
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Benign                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  5/50 (10%)               0/50 (0%)    |           0/50 (0%)                1/50 (2%)       | 
|POLY-3 RATE (b)    |                  5/44.44                  0/41.64      |           0/45.04                  1/45.91         | 
|POLY-3 PERCENT (g) |                  11.3%                    0.0%         |           0.0%                     2.2%            | 
|TERMINAL (d)       |                  5/29 (17%)               0/31 (0%)    |           0/34 (0%)                1/36 (3%)       | 
|FIRST INCIDENCE    |                  731 (T)                  ---          |           ---                      735 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.027N*    |                                    P=0.511         | 
|POLY 3             |                                           P=0.037N*    |                                    P=0.500         | 
|POLY 1.5           |                                           P=0.035N*    |                                    P=0.500         | 
|POLY 6             |                                           P=0.040N*    |                                    P=0.500         | 
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.511         | 
|COCH-ARM / FISHERS |                                           P=0.028N*    |                                    P=0.500         | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  5/50 (10%)               0/50 (0%)    |           1/50 (2%)                3/50 (6%)       | 
|POLY-3 RATE (b)    |                  5/44.44                  0/41.64      |           1/45.04                  3/46.09         | 
|POLY-3 PERCENT (g) |                  11.3%                    0.0%         |           2.2%                     6.5%            | 
|TERMINAL (d)       |                  5/29 (17%)               0/31 (0%)    |           1/34 (3%)                2/36 (6%)       | 
|FIRST INCIDENCE    |                  731 (T)                  ---          |           735 (T)                  690             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.027N*    |                                    P=0.324         | 
|POLY 3             |                                           P=0.037N*    |                                    P=0.311         | 
|POLY 1.5           |                                           P=0.035N*    |                                    P=0.310         | 
|POLY 6             |                                           P=0.040N*    |                                    P=0.313         | 
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.313         | 
|COCH-ARM / FISHERS |                                           P=0.028N*    |                                    P=0.309         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/01                           EXPERIMENT: 56111 TEST: 03                                            Page 2       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   TRANS-CINNAMALDEHYDE     
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                5/50 (10%)   |           4/49 (8%)                0/50 (0%)       | 
|POLY-3 RATE (b)    |                  2/44.58                  5/42.15      |           4/44.09                  0/45.91         | 
|POLY-3 PERCENT (g) |                  4.5%                     11.9%        |           9.1%                     0.0%            | 
|TERMINAL (d)       |                  1/29 (3%)                4/31 (13%)   |           3/33 (9%)                0/36 (0%)       | 
|FIRST INCIDENCE    |                  696                      577          |           723                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.226      |                                    P=0.056N        | 
|POLY 3             |                                           P=0.196      |                                    P=0.054N        | 
|POLY 1.5           |                                           P=0.204      |                                    P=0.055N        | 
|POLY 6             |                                           P=0.189      |                                    P=0.053N        | 
|LOGISTIC REGRESSION|                                           P=0.193      |                                    P=0.054N        | 
|COCH-ARM / FISHERS |                                           P=0.218      |                                    P=0.056N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  3/50 (6%)                1/50 (2%)    |           3/49 (6%)                6/50 (12%)      | 
|POLY-3 RATE (b)    |                  3/44.44                  1/41.64      |           3/44.55                  6/46.28         | 
|POLY-3 PERCENT (g) |                  6.8%                     2.4%         |           6.7%                     13.0%           | 
|TERMINAL (d)       |                  3/29 (10%)               1/31 (3%)    |           1/33 (3%)                4/36 (11%)      | 
|FIRST INCIDENCE    |                  731 (T)                  731 (T)      |           597                      683             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.280N     |                                    P=0.280         | 
|POLY 3             |                                           P=0.335N     |                                    P=0.259         | 
|POLY 1.5           |                                           P=0.323N     |                                    P=0.258         | 
|POLY 6             |                                           P=0.346N     |                                    P=0.261         | 
|LOGISTIC REGRESSION|                                           P=0.280N     |                                    P=0.253         | 
|COCH-ARM / FISHERS |                                           P=0.309N     |                                    P=0.254         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/01                           EXPERIMENT: 56111 TEST: 03                                            Page 3       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   TRANS-CINNAMALDEHYDE     
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  5/50 (10%)               6/50 (12%)   |           7/49 (14%)               6/50 (12%)      | 
|POLY-3 RATE (b)    |                  5/44.58                  6/42.15      |           7/44.60                  6/46.28         | 
|POLY-3 PERCENT (g) |                  11.2%                    14.2%        |           15.7%                    13.0%           | 
|TERMINAL (d)       |                  4/29 (14%)               5/31 (16%)   |           4/33 (12%)               4/36 (11%)      | 
|FIRST INCIDENCE    |                  696                      577          |           597                      683             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.525      |                                    P=0.452N        | 
|POLY 3             |                                           P=0.464      |                                    P=0.469N        | 
|POLY 1.5           |                                           P=0.478      |                                    P=0.471N        | 
|POLY 6             |                                           P=0.452      |                                    P=0.466N        | 
|LOGISTIC REGRESSION|                                           P=0.441      |                                    P=0.472N        | 
|COCH-ARM / FISHERS |                                           P=0.500      |                                    P=0.484N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Schwannoma Malignant                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  0/50 (0%)                2/50 (4%)    |           0/50 (0%)                0/50 (0%)       | 
|POLY-3 RATE (b)    |                  0/44.44                  2/41.64      |           0/45.04                  0/45.91         | 
|POLY-3 PERCENT (g) |                  0.0%                     4.8%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/29 (0%)                2/31 (7%)    |           0/34 (0%)                0/36 (0%)       | 
|FIRST INCIDENCE    |                  ---                      731 (T)      |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.253      |                                    (e)             | 
|POLY 3             |                                           P=0.230      |                                    (e)             | 
|POLY 1.5           |                                           P=0.233      |                                    (e)             | 
|POLY 6             |                                           P=0.228      |                                    (e)             | 
|LOGISTIC REGRESSION|                                           P=0.253      |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.247      |                                    (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/01                           EXPERIMENT: 56111 TEST: 03                                            Page 4       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   TRANS-CINNAMALDEHYDE     
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  0/50 (0%)                0/50 (0%)    |           2/50 (4%)                0/50 (0%)       | 
|POLY-3 RATE (b)    |                  0/44.44                  0/41.64      |           2/45.34                  0/45.91         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%         |           4.4%                     0.0%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/31 (0%)    |           1/34 (3%)                0/36 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---          |           652                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           (e)          |                                    P=0.231N        | 
|POLY 3             |                                           (e)          |                                    P=0.233N        | 
|POLY 1.5           |                                           (e)          |                                    P=0.233N        | 
|POLY 6             |                                           (e)          |                                    P=0.233N        | 
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.242N        | 
|COCH-ARM / FISHERS |                                           (e)          |                                    P=0.247N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  1/50 (2%)                1/50 (2%)    |           2/50 (4%)                0/50 (0%)       | 
|POLY-3 RATE (b)    |                  1/44.44                  1/41.67      |           2/45.34                  0/45.91         | 
|POLY-3 PERCENT (g) |                  2.3%                     2.4%         |           4.4%                     0.0%            | 
|TERMINAL (d)       |                  1/29 (3%)                0/31 (0%)    |           1/34 (3%)                0/36 (0%)       | 
|FIRST INCIDENCE    |                  731 (T)                  724          |           652                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.746N     |                                    P=0.231N        | 
|POLY 3             |                                           P=0.754      |                                    P=0.233N        | 
|POLY 1.5           |                                           P=0.756      |                                    P=0.233N        | 
|POLY 6             |                                           P=0.752      |                                    P=0.233N        | 
|LOGISTIC REGRESSION|                                           P=0.751      |                                    P=0.242N        | 
|COCH-ARM / FISHERS |                                           P=0.753N     |                                    P=0.247N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/01                           EXPERIMENT: 56111 TEST: 03                                            Page 5       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   TRANS-CINNAMALDEHYDE     
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                2/50 (4%)    |           2/50 (4%)                4/50 (8%)       | 
|POLY-3 RATE (b)    |                  2/44.65                  2/41.64      |           2/45.04                  4/45.91         | 
|POLY-3 PERCENT (g) |                  4.5%                     4.8%         |           4.4%                     8.7%            | 
|TERMINAL (d)       |                  1/29 (3%)                2/31 (7%)    |           2/34 (6%)                4/36 (11%)      | 
|FIRST INCIDENCE    |                  676                      731 (T)      |           735 (T)                  735 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.693N     |                                    P=0.363         | 
|POLY 3             |                                           P=0.676      |                                    P=0.345         | 
|POLY 1.5           |                                           P=0.683      |                                    P=0.343         | 
|POLY 6             |                                           P=0.669      |                                    P=0.346         | 
|LOGISTIC REGRESSION|                                           P=0.664      |                                    P=0.363         | 
|COCH-ARM / FISHERS |                                           P=0.691N     |                                    P=0.339         | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                3/50 (6%)    |           3/50 (6%)                4/50 (8%)       | 
|POLY-3 RATE (b)    |                  2/44.65                  3/41.92      |           3/45.04                  4/45.91         | 
|POLY-3 PERCENT (g) |                  4.5%                     7.2%         |           6.7%                     8.7%            | 
|TERMINAL (d)       |                  1/29 (3%)                2/31 (7%)    |           3/34 (9%)                4/36 (11%)      | 
|FIRST INCIDENCE    |                  676                      655          |           735 (T)                  735 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.482      |                                    P=0.532         | 
|POLY 3             |                                           P=0.477      |                                    P=0.509         | 
|POLY 1.5           |                                           P=0.486      |                                    P=0.507         | 
|POLY 6             |                                           P=0.470      |                                    P=0.511         | 
|LOGISTIC REGRESSION|                                           P=0.473      |                                    P=0.532         | 
|COCH-ARM / FISHERS |                                           P=0.500      |                                    P=0.500         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/01                           EXPERIMENT: 56111 TEST: 03                                            Page 6       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   TRANS-CINNAMALDEHYDE     
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroadenoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                1/50 (2%)    |           25/50 (50%)              30/50 (60%)     | 
|POLY-3 RATE (b)    |                  2/44.52                  1/42.07      |           25/46.40                 30/47.49        | 
|POLY-3 PERCENT (g) |                  4.5%                     2.4%         |           53.9%                    63.2%           | 
|TERMINAL (d)       |                  1/29 (3%)                0/31 (0%)    |           18/34 (53%)              22/36 (61%)     | 
|FIRST INCIDENCE    |                  710                      606          |           649                      632             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.507N     |                                    P=0.322         | 
|POLY 3             |                                           P=0.527N     |                                    P=0.237         | 
|POLY 1.5           |                                           P=0.517N     |                                    P=0.232         | 
|POLY 6             |                                           P=0.536N     |                                    P=0.244         | 
|LOGISTIC REGRESSION|                                           P=0.491N     |                                    P=0.235         | 
|COCH-ARM / FISHERS |                                           P=0.500N     |                                    P=0.211         | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma or Adenoma                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                1/50 (2%)    |           25/50 (50%)              30/50 (60%)     | 
|POLY-3 RATE (b)    |                  2/44.52                  1/42.07      |           25/46.40                 30/47.49        | 
|POLY-3 PERCENT (g) |                  4.5%                     2.4%         |           53.9%                    63.2%           | 
|TERMINAL (d)       |                  1/29 (3%)                0/31 (0%)    |           18/34 (53%)              22/36 (61%)     | 
|FIRST INCIDENCE    |                  710                      606          |           649                      632             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.507N     |                                    P=0.322         | 
|POLY 3             |                                           P=0.527N     |                                    P=0.237         | 
|POLY 1.5           |                                           P=0.517N     |                                    P=0.232         | 
|POLY 6             |                                           P=0.536N     |                                    P=0.244         | 
|LOGISTIC REGRESSION|                                           P=0.491N     |                                    P=0.235         | 
|COCH-ARM / FISHERS |                                           P=0.500N     |                                    P=0.211         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/01                           EXPERIMENT: 56111 TEST: 03                                            Page 7       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   TRANS-CINNAMALDEHYDE     
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                1/50 (2%)    |           26/50 (52%)              30/50 (60%)     | 
|POLY-3 RATE (b)    |                  2/44.52                  1/42.07      |           26/46.40                 30/47.49        | 
|POLY-3 PERCENT (g) |                  4.5%                     2.4%         |           56.0%                    63.2%           | 
|TERMINAL (d)       |                  1/29 (3%)                0/31 (0%)    |           19/34 (56%)              22/36 (61%)     | 
|FIRST INCIDENCE    |                  710                      606          |           649                      632             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.507N     |                                    P=0.389         | 
|POLY 3             |                                           P=0.527N     |                                    P=0.307         | 
|POLY 1.5           |                                           P=0.517N     |                                    P=0.301         | 
|POLY 6             |                                           P=0.536N     |                                    P=0.318         | 
|LOGISTIC REGRESSION|                                           P=0.491N     |                                    P=0.304         | 
|COCH-ARM / FISHERS |                                           P=0.500N     |                                    P=0.273         | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  13/50 (26%)              8/50 (16%)   |           19/50 (38%)              16/50 (32%)     | 
|POLY-3 RATE (b)    |                  13/45.01                 8/42.81      |           19/46.79                 16/46.45        | 
|POLY-3 PERCENT (g) |                  28.9%                    18.7%        |           40.6%                    34.5%           | 
|TERMINAL (d)       |                  10/29 (35%)              4/31 (13%)   |           14/34 (41%)              14/36 (39%)     | 
|FIRST INCIDENCE    |                  631                      606          |           557                      632             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.161N     |                                    P=0.281N        | 
|POLY 3             |                                           P=0.193N     |                                    P=0.344N        | 
|POLY 1.5           |                                           P=0.182N     |                                    P=0.335N        | 
|POLY 6             |                                           P=0.200N     |                                    P=0.358N        | 
|LOGISTIC REGRESSION|                                           P=0.207N     |                                    P=0.316N        | 
|COCH-ARM / FISHERS |                                           P=0.163N     |                                    P=0.338N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/01                           EXPERIMENT: 56111 TEST: 03                                            Page 8       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   TRANS-CINNAMALDEHYDE     
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Prostate                                                                                                                         | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  0/50 (0%)                4/50 (8%)    |                                                    | 
|POLY-3 RATE (b)    |                  0/44.44                  4/41.67      |                                                    | 
|POLY-3 PERCENT (g) |                  0.0%                     9.6%         |                                                    | 
|TERMINAL (d)       |                  0/29 (0%)                3/31 (10%)   |                                                    | 
|FIRST INCIDENCE    |                  ---                      724          |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.073      |                                                    | 
|POLY 3             |                                           P=0.054      |                                                    | 
|POLY 1.5           |                                           P=0.057      |                                                    | 
|POLY 6             |                                           P=0.052      |                                                    | 
|LOGISTIC REGRESSION|                                           P=0.057      |                                                    | 
|COCH-ARM / FISHERS |                                           P=0.059      |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Basal Cell Adenoma, Basosquamous Tumor Benign, or                                                                           | 
|     Trichoepithelioma                                                                                                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  0/50 (0%)                2/50 (4%)    |           0/50 (0%)                0/50 (0%)       | 
|POLY-3 RATE (b)    |                  0/44.44                  2/41.64      |           0/45.04                  0/45.91         | 
|POLY-3 PERCENT (g) |                  0.0%                     4.8%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/29 (0%)                2/31 (7%)    |           0/34 (0%)                0/36 (0%)       | 
|FIRST INCIDENCE    |                  ---                      731 (T)      |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.253      |                                    (e)             | 
|POLY 3             |                                           P=0.230      |                                    (e)             | 
|POLY 1.5           |                                           P=0.233      |                                    (e)             | 
|POLY 6             |                                           P=0.228      |                                    (e)             | 
|LOGISTIC REGRESSION|                                           P=0.253      |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.247      |                                    (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/01                           EXPERIMENT: 56111 TEST: 03                                            Page 9       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   TRANS-CINNAMALDEHYDE     
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous                                                                      | 
|     Tumor (benign, malignant or NOS), or Trichoepithelioma                                                                      | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  1/50 (2%)                2/50 (4%)    |           0/50 (0%)                0/50 (0%)       | 
|POLY-3 RATE (b)    |                  1/44.93                  2/41.64      |           0/45.04                  0/45.91         | 
|POLY-3 PERCENT (g) |                  2.2%                     4.8%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/29 (0%)                2/31 (7%)    |           0/34 (0%)                0/36 (0%)       | 
|FIRST INCIDENCE    |                  586                      731 (T)      |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.502      |                                    (e)             | 
|POLY 3             |                                           P=0.483      |                                    (e)             | 
|POLY 1.5           |                                           P=0.490      |                                    (e)             | 
|POLY 6             |                                           P=0.477      |                                    (e)             | 
|LOGISTIC REGRESSION|                                           P=0.509      |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.500      |                                    (e)             | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor                                                                       | 
|     (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  4/50 (8%)                4/50 (8%)    |           0/50 (0%)                0/50 (0%)       | 
|POLY-3 RATE (b)    |                  4/45.06                  4/42.10      |           0/45.04                  0/45.91         | 
|POLY-3 PERCENT (g) |                  8.9%                     9.5%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/29 (7%)                2/31 (7%)    |           0/34 (0%)                0/36 (0%)       | 
|FIRST INCIDENCE    |                  586                      606          |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.640N     |                                    (e)             | 
|POLY 3             |                                           P=0.611      |                                    (e)             | 
|POLY 1.5           |                                           P=0.623      |                                    (e)             | 
|POLY 6             |                                           P=0.599      |                                    (e)             | 
|LOGISTIC REGRESSION|                                           P=0.638      |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.643N     |                                    (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/01                           EXPERIMENT: 56111 TEST: 03                                            Page 10      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   TRANS-CINNAMALDEHYDE     
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  1/50 (2%)                6/50 (12%)   |           0/50 (0%)                1/50 (2%)       | 
|POLY-3 RATE (b)    |                  1/44.52                  6/42.61      |           0/45.04                  1/45.91         | 
|POLY-3 PERCENT (g) |                  2.3%                     14.1%        |           0.0%                     2.2%            | 
|TERMINAL (d)       |                  0/29 (0%)                3/31 (10%)   |           0/34 (0%)                1/36 (3%)       | 
|FIRST INCIDENCE    |                  711                      577          |           ---                      735 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.067      |                                    P=0.511         | 
|POLY 3             |                                           P=0.049 *    |                                    P=0.500         | 
|POLY 1.5           |                                           P=0.052      |                                    P=0.500         | 
|POLY 6             |                                           P=0.047 *    |                                    P=0.500         | 
|LOGISTIC REGRESSION|                                           P=0.058      |                                    P=0.511         | 
|COCH-ARM / FISHERS |                                           P=0.056      |                                    P=0.500         | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma or Fibrosarcoma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  5/50 (10%)               7/50 (14%)   |           0/50 (0%)                1/50 (2%)       | 
|POLY-3 RATE (b)    |                  5/45.39                  7/42.61      |           0/45.04                  1/45.91         | 
|POLY-3 PERCENT (g) |                  11.0%                    16.4%        |           0.0%                     2.2%            | 
|TERMINAL (d)       |                  1/29 (3%)                4/31 (13%)   |           0/34 (0%)                1/36 (3%)       | 
|FIRST INCIDENCE    |                  603                      577          |           ---                      735 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.371      |                                    P=0.511         | 
|POLY 3             |                                           P=0.338      |                                    P=0.500         | 
|POLY 1.5           |                                           P=0.355      |                                    P=0.500         | 
|POLY 6             |                                           P=0.322      |                                    P=0.500         | 
|LOGISTIC REGRESSION|                                           P=0.388      |                                    P=0.511         | 
|COCH-ARM / FISHERS |                                           P=0.380      |                                    P=0.500         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/01                           EXPERIMENT: 56111 TEST: 03                                            Page 11      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   TRANS-CINNAMALDEHYDE     
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        | 
|     or Fibrous Histiocytoma                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  5/50 (10%)               7/50 (14%)   |           0/50 (0%)                1/50 (2%)       | 
|POLY-3 RATE (b)    |                  5/45.39                  7/42.61      |           0/45.04                  1/45.91         | 
|POLY-3 PERCENT (g) |                  11.0%                    16.4%        |           0.0%                     2.2%            | 
|TERMINAL (d)       |                  1/29 (3%)                4/31 (13%)   |           0/34 (0%)                1/36 (3%)       | 
|FIRST INCIDENCE    |                  603                      577          |           ---                      735 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.371      |                                    P=0.511         | 
|POLY 3             |                                           P=0.338      |                                    P=0.500         | 
|POLY 1.5           |                                           P=0.355      |                                    P=0.500         | 
|POLY 6             |                                           P=0.322      |                                    P=0.500         | 
|LOGISTIC REGRESSION|                                           P=0.388      |                                    P=0.511         | 
|COCH-ARM / FISHERS |                                           P=0.380      |                                    P=0.500         | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibrosarcoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  4/50 (8%)                2/50 (4%)    |           0/50 (0%)                0/50 (0%)       | 
|POLY-3 RATE (b)    |                  4/45.31                  2/41.67      |           0/45.04                  0/45.91         | 
|POLY-3 PERCENT (g) |                  8.8%                     4.8%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  1/29 (3%)                1/31 (3%)    |           0/34 (0%)                0/36 (0%)       | 
|FIRST INCIDENCE    |                  603                      724          |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.364N     |                                    (e)             | 
|POLY 3             |                                           P=0.384N     |                                    (e)             | 
|POLY 1.5           |                                           P=0.364N     |                                    (e)             | 
|POLY 6             |                                           P=0.406N     |                                    (e)             | 
|LOGISTIC REGRESSION|                                           P=0.337N     |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.339N     |                                    (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/01                           EXPERIMENT: 56111 TEST: 03                                            Page 12      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   TRANS-CINNAMALDEHYDE     
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  4/50 (8%)                2/50 (4%)    |           0/50 (0%)                0/50 (0%)       | 
|POLY-3 RATE (b)    |                  4/45.31                  2/41.67      |           0/45.04                  0/45.91         | 
|POLY-3 PERCENT (g) |                  8.8%                     4.8%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  1/29 (3%)                1/31 (3%)    |           0/34 (0%)                0/36 (0%)       | 
|FIRST INCIDENCE    |                  603                      724          |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.364N     |                                    (e)             | 
|POLY 3             |                                           P=0.384N     |                                    (e)             | 
|POLY 1.5           |                                           P=0.364N     |                                    (e)             | 
|POLY 6             |                                           P=0.406N     |                                    (e)             | 
|LOGISTIC REGRESSION|                                           P=0.337N     |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.339N     |                                    (e)             | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Keratoacanthoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  3/50 (6%)                2/50 (4%)    |           0/50 (0%)                0/50 (0%)       | 
|POLY-3 RATE (b)    |                  3/44.58                  2/42.10      |           0/45.04                  0/45.91         | 
|POLY-3 PERCENT (g) |                  6.7%                     4.8%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/29 (7%)                0/31 (0%)    |           0/34 (0%)                0/36 (0%)       | 
|FIRST INCIDENCE    |                  696                      606          |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.501N     |                                    (e)             | 
|POLY 3             |                                           P=0.532N     |                                    (e)             | 
|POLY 1.5           |                                           P=0.520N     |                                    (e)             | 
|POLY 6             |                                           P=0.542N     |                                    (e)             | 
|LOGISTIC REGRESSION|                                           P=0.516N     |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.500N     |                                    (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/01                           EXPERIMENT: 56111 TEST: 03                                            Page 13      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   TRANS-CINNAMALDEHYDE     
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma, Papilloma, Squamous Cell                                                                           | 
|     Carcinoma or Keratoacanthoma                                                                                                | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  3/50 (6%)                2/50 (4%)    |           0/50 (0%)                0/50 (0%)       | 
|POLY-3 RATE (b)    |                  3/44.58                  2/42.10      |           0/45.04                  0/45.91         | 
|POLY-3 PERCENT (g) |                  6.7%                     4.8%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/29 (7%)                0/31 (0%)    |           0/34 (0%)                0/36 (0%)       | 
|FIRST INCIDENCE    |                  696                      606          |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.501N     |                                    (e)             | 
|POLY 3             |                                           P=0.532N     |                                    (e)             | 
|POLY 1.5           |                                           P=0.520N     |                                    (e)             | 
|POLY 6             |                                           P=0.542N     |                                    (e)             | 
|LOGISTIC REGRESSION|                                           P=0.516N     |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.500N     |                                    (e)             | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  45/50 (90%)              46/50 (92%)  |                                                    | 
|POLY-3 RATE (b)    |                  45/49.43                 46/48.92     |                                                    | 
|POLY-3 PERCENT (g) |                  91.0%                    94.0%        |                                                    | 
|TERMINAL (d)       |                  27/29 (93%)              31/31 (100%) |                                                    | 
|FIRST INCIDENCE    |                  508                      429          |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.526      |                                                    | 
|POLY 3             |                                           P=0.424      |                                                    | 
|POLY 1.5           |                                           P=0.460      |                                                    | 
|POLY 6             |                                           P=0.368      |                                                    | 
|LOGISTIC REGRESSION|                                           P=0.477      |                                                    | 
|COCH-ARM / FISHERS |                                           P=0.500      |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/01                           EXPERIMENT: 56111 TEST: 03                                            Page 14      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   TRANS-CINNAMALDEHYDE     
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  4/50 (8%)                8/50 (16%)   |           5/50 (10%)               6/50 (12%)      | 
|POLY-3 RATE (b)    |                  4/44.44                  8/41.64      |           5/45.15                  6/46.16         | 
|POLY-3 PERCENT (g) |                  9.0%                     19.2%        |           11.1%                    13.0%           | 
|TERMINAL (d)       |                  4/29 (14%)               8/31 (26%)   |           4/34 (12%)               5/36 (14%)      | 
|FIRST INCIDENCE    |                  731 (T)                  731 (T)      |           708                      670             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.203      |                                    P=0.537         | 
|POLY 3             |                                           P=0.147      |                                    P=0.514         | 
|POLY 1.5           |                                           P=0.159      |                                    P=0.511         | 
|POLY 6             |                                           P=0.136      |                                    P=0.518         | 
|LOGISTIC REGRESSION|                                           P=0.203      |                                    P=0.519         | 
|COCH-ARM / FISHERS |                                           P=0.178      |                                    P=0.500         | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  1/50 (2%)                2/50 (4%)    |           3/50 (6%)                0/50 (0%)       | 
|POLY-3 RATE (b)    |                  1/44.53                  2/42.07      |           3/45.09                  0/45.91         | 
|POLY-3 PERCENT (g) |                  2.3%                     4.8%         |           6.7%                     0.0%            | 
|TERMINAL (d)       |                  0/29 (0%)                1/31 (3%)    |           2/34 (6%)                0/36 (0%)       | 
|FIRST INCIDENCE    |                  709                      606          |           723                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.486      |                                    P=0.115N        | 
|POLY 3             |                                           P=0.487      |                                    P=0.114N        | 
|POLY 1.5           |                                           P=0.492      |                                    P=0.115N        | 
|POLY 6             |                                           P=0.483      |                                    P=0.113N        | 
|LOGISTIC REGRESSION|                                           P=0.510      |                                    P=0.113N        | 
|COCH-ARM / FISHERS |                                           P=0.500      |                                    P=0.121N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/01                           EXPERIMENT: 56111 TEST: 03                                            Page 15      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   TRANS-CINNAMALDEHYDE     
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  5/50 (10%)               10/50 (20%)  |           8/50 (16%)               6/50 (12%)      | 
|POLY-3 RATE (b)    |                  5/44.53                  10/42.07     |           8/45.20                  6/46.16         | 
|POLY-3 PERCENT (g) |                  11.2%                    23.8%        |           17.7%                    13.0%           | 
|TERMINAL (d)       |                  4/29 (14%)               9/31 (29%)   |           6/34 (18%)               5/36 (14%)      | 
|FIRST INCIDENCE    |                  709                      606          |           708                      670             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.149      |                                    P=0.349N        | 
|POLY 3             |                                           P=0.104      |                                    P=0.369N        | 
|POLY 1.5           |                                           P=0.114      |                                    P=0.373N        | 
|POLY 6             |                                           P=0.095      |                                    P=0.364N        | 
|LOGISTIC REGRESSION|                                           P=0.089      |                                    P=0.363N        | 
|COCH-ARM / FISHERS |                                           P=0.131      |                                    P=0.387N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  1/50 (2%)                2/50 (4%)    |           0/50 (0%)                0/50 (0%)       | 
|POLY-3 RATE (b)    |                  1/44.53                  2/41.73      |           0/45.04                  0/45.91         | 
|POLY-3 PERCENT (g) |                  2.3%                     4.8%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/29 (0%)                1/31 (3%)    |           0/34 (0%)                0/36 (0%)       | 
|FIRST INCIDENCE    |                  709                      707          |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.484      |                                    (e)             | 
|POLY 3             |                                           P=0.485      |                                    (e)             | 
|POLY 1.5           |                                           P=0.491      |                                    (e)             | 
|POLY 6             |                                           P=0.480      |                                    (e)             | 
|LOGISTIC REGRESSION|                                           P=0.470      |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.500      |                                    (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/01                           EXPERIMENT: 56111 TEST: 03                                            Page 16      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   TRANS-CINNAMALDEHYDE     
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                2/50 (4%)    |           0/50 (0%)                1/50 (2%)       | 
|POLY-3 RATE (b)    |                  2/44.89                  2/41.73      |           0/45.04                  1/46.09         | 
|POLY-3 PERCENT (g) |                  4.5%                     4.8%         |           0.0%                     2.2%            | 
|TERMINAL (d)       |                  0/29 (0%)                1/31 (3%)    |           0/34 (0%)                0/36 (0%)       | 
|FIRST INCIDENCE    |                  631                      707          |           ---                      690             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.666      |                                    P=0.505         | 
|POLY 3             |                                           P=0.675      |                                    P=0.500         | 
|POLY 1.5           |                                           P=0.682      |                                    P=0.500         | 
|POLY 6             |                                           P=0.668      |                                    P=0.500         | 
|LOGISTIC REGRESSION|                                           P=0.688      |                                    P=0.492         | 
|COCH-ARM / FISHERS |                                           P=0.691N     |                                    P=0.500         | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Polyp Stromal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |           7/50 (14%)               7/50 (14%)      | 
|POLY-3 RATE (b)    |                                                        |           7/45.35                  7/46.79         | 
|POLY-3 PERCENT (g) |                                                        |           15.4%                    15.0%           | 
|TERMINAL (d)       |                                                        |           6/34 (18%)               3/36 (8%)       | 
|FIRST INCIDENCE    |                                                        |           649                      632             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |                                    P=0.575N        | 
|POLY 3             |                                                        |                                    P=0.587N        | 
|POLY 1.5           |                                                        |                                    P=0.595N        | 
|POLY 6             |                                                        |                                    P=0.576N        | 
|LOGISTIC REGRESSION|                                                        |                                    P=0.606N        | 
|COCH-ARM / FISHERS |                                                        |                                    P=0.613N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/01                           EXPERIMENT: 56111 TEST: 03                                            Page 17      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   TRANS-CINNAMALDEHYDE     
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or                                                                           | 
|     Undifferentiated                                                                                                            | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  22/50 (44%)              18/50 (36%)  |           9/50 (18%)               12/50 (24%)     | 
|POLY-3 RATE (b)    |                  22/47.65                 18/46.02     |           9/47.27                  12/48.23        | 
|POLY-3 PERCENT (g) |                  46.2%                    39.1%        |           19.0%                    24.9%           | 
|TERMINAL (d)       |                  10/29 (35%)              9/31 (29%)   |           2/34 (6%)                6/36 (17%)      | 
|FIRST INCIDENCE    |                  524                      429          |           203                      523             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.322N     |                                    P=0.358         | 
|POLY 3             |                                           P=0.315N     |                                    P=0.329         | 
|POLY 1.5           |                                           P=0.296N     |                                    P=0.322         | 
|POLY 6             |                                           P=0.339N     |                                    P=0.337         | 
|LOGISTIC REGRESSION|                                           P=0.181N     |                                    P=0.244         | 
|COCH-ARM / FISHERS |                                           P=0.270N     |                                    P=0.312         | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Mesothelioma: Benign, Malignant, NOS                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  3/50 (6%)                2/50 (4%)    |           0/50 (0%)                0/50 (0%)       | 
|POLY-3 RATE (b)    |                  3/44.60                  2/41.64      |           0/45.04                  0/45.91         | 
|POLY-3 PERCENT (g) |                  6.7%                     4.8%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/29 (7%)                2/31 (7%)    |           0/34 (0%)                0/36 (0%)       | 
|FIRST INCIDENCE    |                  690                      731 (T)      |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.491N     |                                    (e)             | 
|POLY 3             |                                           P=0.538N     |                                    (e)             | 
|POLY 1.5           |                                           P=0.523N     |                                    (e)             | 
|POLY 6             |                                           P=0.553N     |                                    (e)             | 
|LOGISTIC REGRESSION|                                           P=0.541N     |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.500N     |                                    (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/01                           EXPERIMENT: 56111 TEST: 03                                            Page 18      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   TRANS-CINNAMALDEHYDE     
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Mesothelioma: Malignant                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  3/50 (6%)                2/50 (4%)    |           0/50 (0%)                0/50 (0%)       | 
|POLY-3 RATE (b)    |                  3/44.60                  2/41.64      |           0/45.04                  0/45.91         | 
|POLY-3 PERCENT (g) |                  6.7%                     4.8%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/29 (7%)                2/31 (7%)    |           0/34 (0%)                0/36 (0%)       | 
|FIRST INCIDENCE    |                  690                      731 (T)      |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.491N     |                                    (e)             | 
|POLY 3             |                                           P=0.538N     |                                    (e)             | 
|POLY 1.5           |                                           P=0.523N     |                                    (e)             | 
|POLY 6             |                                           P=0.553N     |                                    (e)             | 
|LOGISTIC REGRESSION|                                           P=0.541N     |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.500N     |                                    (e)             | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  50/50 (100%)             49/50 (98%)  |           39/50 (78%)              39/50 (78%)     | 
|POLY-3 RATE (b)    |                  50/50.00                 49/49.71     |           39/47.85                 39/47.49        | 
|POLY-3 PERCENT (g) |                  100.0%                   98.6%        |           81.5%                    82.1%           | 
|TERMINAL (d)       |                  29/29 (100%)             31/31 (100%) |           28/34 (82%)              31/36 (86%)     | 
|FIRST INCIDENCE    |                  508                      429          |           557                      632             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.484N     |                                    P=0.430N        | 
|POLY 3             |                                           P=0.656N     |                                    P=0.578         | 
|POLY 1.5           |                                           P=0.573N     |                                    P=0.601N        | 
|POLY 6             |                                           P=0.833N     |                                    P=0.535         | 
|LOGISTIC REGRESSION|                                           P=0.534N     |                                    P=0.538N        | 
|COCH-ARM / FISHERS |                                           P=0.500N     |                                    P=0.595N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/01                           EXPERIMENT: 56111 TEST: 03                                            Page 19      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   TRANS-CINNAMALDEHYDE     
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  30/50 (60%)              27/50 (54%)  |           21/50 (42%)              18/50 (36%)     | 
|POLY-3 RATE (b)    |                  30/48.60                 27/46.76     |           21/48.39                 18/48.80        | 
|POLY-3 PERCENT (g) |                  61.7%                    57.8%        |           43.4%                    36.9%           | 
|TERMINAL (d)       |                  14/29 (48%)              15/31 (48%)  |           10/34 (29%)              10/36 (28%)     | 
|FIRST INCIDENCE    |                  524                      429          |           203                      523             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.403N     |                                    P=0.315N        | 
|POLY 3             |                                           P=0.427N     |                                    P=0.327N        | 
|POLY 1.5           |                                           P=0.390N     |                                    P=0.332N        | 
|POLY 6             |                                           P=0.475N     |                                    P=0.324N        | 
|LOGISTIC REGRESSION|                                           P=0.282N     |                                    P=0.381N        | 
|COCH-ARM / FISHERS |                                           P=0.343N     |                                    P=0.341N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  50/50 (100%)             50/50 (100%) |           45/50 (90%)              47/50 (94%)     | 
|POLY-3 RATE (b)    |                  50/50.00                 50/50.00     |           45/50.00                 47/50.00        | 
|POLY-3 PERCENT (g) |                  100.0%                   100.0%       |           90.0%                    94.0%           | 
|TERMINAL (d)       |                  29/29 (100%)             31/31 (100%) |           29/34 (85%)              33/36 (92%)     | 
|FIRST INCIDENCE    |                  508                      429          |           203                      523             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           (e)          |                                    P=0.557N        | 
|POLY 3             |                                           (e)          |                                    P=0.357         | 
|POLY 1.5           |                                           (e)          |                                    P=0.357         | 
|POLY 6             |                                           (e)          |                                    P=0.357         | 
|LOGISTIC REGRESSION|                                           (e)          |                                    (e)             | 
|COCH-ARM / FISHERS |                                           (e)          |                                    P=0.357         | 
|=================================================================================================================================| 
(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).