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TDMS Study 56111-04 Pathology Tables

                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                    TRANS-CINNAMALDEHYDE                                 DATE: 06/14/01       
EXPERIMENT: 56111 TEST: 04                                                                                     TIME: 09:37:06       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55384                              ROUTE: DOSED FEED                                              NTP C#: 56111B       
PATHOLOGIST: MARIT, GARY                                                                                       CAS: 14371-10-9      
Mice(B6C3F1)                                                                                                                        
-----------------------------                                                                                                       
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE                                                                   
BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES                                                                 
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Adrenal Cortex                                                                     
                                                 Adrenal Medulla                                                                    
                                                 Bone Marrow                                                                        
                                                 Clitoral/Preputial Gland                                                           
                                                 Epididymis                                                                         
                                                 Heart                                                                              
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Ovary                                                                              
                                                 Pancreas                                                                           
                                                 Pituitary Gland                                                                    
                                                 Spleen                                                                             
                                                 Testes                                                                             
                                                 Thyroid Gland                                                                      
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                    TRANS-CINNAMALDEHYDE                                 DATE: 06/14/01       
EXPERIMENT: 56111 TEST: 04                                                                                     TIME: 09:37:06       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55384                              ROUTE: DOSED FEED                                              NTP C#: 56111B       
PATHOLOGIST: MARIT, GARY                                                                                       CAS: 14371-10-9      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                  TRANS-CINNAMALDEHYDE                                                                            
===============================================================                                                                     
Male Mice                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
All Organs                             Benign Tumors                                                                                
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  06/14/01                           EXPERIMENT: 56111 TEST: 04                                            Page 1       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)        -                   TRANS-CINNAMALDEHYDE         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  4/50 (8%)                4/50 (8%)    |           1/50 (2%)                1/50 (2%)       | 
|POLY-3 RATE (b)    |                  4/46.45                  4/48.41      |           1/47.03                  1/46.06         | 
|POLY-3 PERCENT (g) |                  8.6%                     8.3%         |           2.1%                     2.2%            | 
|TERMINAL (d)       |                  4/44 (9%)                4/47 (9%)    |           1/43 (2%)                1/41 (2%)       | 
|FIRST INCIDENCE    |                  728 (T)                  728 (T)      |           733 (T)                  733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.607N     |                                    P=0.751         | 
|POLY 3             |                                           P=0.617N     |                                    P=0.758         | 
|POLY 1.5           |                                           P=0.627N     |                                    P=0.759         | 
|POLY 6             |                                           P=0.610N     |                                    P=0.758         | 
|LOGISTIC REGRESSION|                                           P=0.607N     |                                    P=0.751         | 
|COCH-ARM / FISHERS |                                           P=0.643N     |                                    P=0.753N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  4/50 (8%)                4/50 (8%)    |           2/50 (4%)                1/50 (2%)       | 
|POLY-3 RATE (b)    |                  4/46.45                  4/48.41      |           2/47.03                  1/46.06         | 
|POLY-3 PERCENT (g) |                  8.6%                     8.3%         |           4.3%                     2.2%            | 
|TERMINAL (d)       |                  4/44 (9%)                4/47 (9%)    |           2/43 (5%)                1/41 (2%)       | 
|FIRST INCIDENCE    |                  728 (T)                  728 (T)      |           733 (T)                  733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.607N     |                                    P=0.517N        | 
|POLY 3             |                                           P=0.617N     |                                    P=0.510N        | 
|POLY 1.5           |                                           P=0.627N     |                                    P=0.507N        | 
|POLY 6             |                                           P=0.610N     |                                    P=0.512N        | 
|LOGISTIC REGRESSION|                                           P=0.607N     |                                    P=0.517N        | 
|COCH-ARM / FISHERS |                                           P=0.643N     |                                    P=0.500N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/14/01                           EXPERIMENT: 56111 TEST: 04                                            Page 2       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                   TRANS-CINNAMALDEHYDE          
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Adenoma                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  5/50 (10%)               9/50 (18%)   |           4/50 (8%)                3/49 (6%)       | 
|POLY-3 RATE (b)    |                  5/47.13                  9/48.41      |           4/47.03                  3/45.21         | 
|POLY-3 PERCENT (g) |                  10.6%                    18.6%        |           8.5%                     6.6%            | 
|TERMINAL (d)       |                  4/44 (9%)                9/47 (19%)   |           4/43 (9%)                3/41 (7%)       | 
|FIRST INCIDENCE    |                  498                      728 (T)      |           733 (T)                  733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.232      |                                    P=0.526N        | 
|POLY 3             |                                           P=0.208      |                                    P=0.525N        | 
|POLY 1.5           |                                           P=0.203      |                                    P=0.521N        | 
|POLY 6             |                                           P=0.211      |                                    P=0.525N        | 
|LOGISTIC REGRESSION|                                           P=0.198      |                                    P=0.526N        | 
|COCH-ARM / FISHERS |                                           P=0.194      |                                    P=0.511N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  6/50 (12%)               7/50 (14%)   |           1/50 (2%)                2/49 (4%)       | 
|POLY-3 RATE (b)    |                  6/47.28                  7/48.49      |           1/47.03                  2/45.21         | 
|POLY-3 PERCENT (g) |                  12.7%                    14.4%        |           2.1%                     4.4%            | 
|TERMINAL (d)       |                  4/44 (9%)                6/47 (13%)   |           1/43 (2%)                2/41 (5%)       | 
|FIRST INCIDENCE    |                  538                      708          |           733 (T)                  733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.548      |                                    P=0.483         | 
|POLY 3             |                                           P=0.518      |                                    P=0.491         | 
|POLY 1.5           |                                           P=0.512      |                                    P=0.492         | 
|POLY 6             |                                           P=0.521      |                                    P=0.491         | 
|LOGISTIC REGRESSION|                                           P=0.502      |                                    P=0.483         | 
|COCH-ARM / FISHERS |                                           P=0.500      |                                    P=0.492         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/14/01                           EXPERIMENT: 56111 TEST: 04                                            Page 3       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                   TRANS-CINNAMALDEHYDE          
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  10/50 (20%)              16/50 (32%)  |           4/50 (8%)                5/49 (10%)      | 
|POLY-3 RATE (b)    |                  10/47.96                 16/48.49     |           4/47.03                  5/45.21         | 
|POLY-3 PERCENT (g) |                  20.9%                    33.0%        |           8.5%                     11.1%           | 
|TERMINAL (d)       |                  7/44 (16%)               15/47 (32%)  |           4/43 (9%)                5/41 (12%)      | 
|FIRST INCIDENCE    |                  498                      708          |           733 (T)                  733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.180      |                                    P=0.470         | 
|POLY 3             |                                           P=0.132      |                                    P=0.478         | 
|POLY 1.5           |                                           P=0.131      |                                    P=0.481         | 
|POLY 6             |                                           P=0.132      |                                    P=0.477         | 
|LOGISTIC REGRESSION|                                           P=0.130      |                                    P=0.470         | 
|COCH-ARM / FISHERS |                                           P=0.127      |                                    P=0.487         | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma, Hepatocellular Adenoma,                                                                           | 
|     or Hepatoblastoma                                                                                                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  10/50 (20%)              16/50 (32%)  |           4/50 (8%)                5/49 (10%)      | 
|POLY-3 RATE (b)    |                  10/47.96                 16/48.49     |           4/47.03                  5/45.21         | 
|POLY-3 PERCENT (g) |                  20.9%                    33.0%        |           8.5%                     11.1%           | 
|TERMINAL (d)       |                  7/44 (16%)               15/47 (32%)  |           4/43 (9%)                5/41 (12%)      | 
|FIRST INCIDENCE    |                  498                      708          |           733 (T)                  733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.180      |                                    P=0.470         | 
|POLY 3             |                                           P=0.132      |                                    P=0.478         | 
|POLY 1.5           |                                           P=0.131      |                                    P=0.481         | 
|POLY 6             |                                           P=0.132      |                                    P=0.477         | 
|LOGISTIC REGRESSION|                                           P=0.130      |                                    P=0.470         | 
|COCH-ARM / FISHERS |                                           P=0.127      |                                    P=0.487         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/14/01                           EXPERIMENT: 56111 TEST: 04                                            Page 4       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                   TRANS-CINNAMALDEHYDE          
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  3/50 (6%)                6/50 (12%)   |           1/50 (2%)                2/50 (4%)       | 
|POLY-3 RATE (b)    |                  3/46.45                  6/48.92      |           1/47.03                  2/46.06         | 
|POLY-3 PERCENT (g) |                  6.5%                     12.3%        |           2.1%                     4.3%            | 
|TERMINAL (d)       |                  3/44 (7%)                5/47 (11%)   |           1/43 (2%)                2/41 (5%)       | 
|FIRST INCIDENCE    |                  728 (T)                  572          |           733 (T)                  733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.278      |                                    P=0.483         | 
|POLY 3             |                                           P=0.266      |                                    P=0.495         | 
|POLY 1.5           |                                           P=0.257      |                                    P=0.497         | 
|POLY 6             |                                           P=0.274      |                                    P=0.494         | 
|LOGISTIC REGRESSION|                                           P=0.246      |                                    P=0.483         | 
|COCH-ARM / FISHERS |                                           P=0.243      |                                    P=0.500         | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                5/50 (10%)   |           2/50 (4%)                0/50 (0%)       | 
|POLY-3 RATE (b)    |                  2/46.45                  5/48.49      |           2/47.03                  0/46.06         | 
|POLY-3 PERCENT (g) |                  4.3%                     10.3%        |           4.3%                     0.0%            | 
|TERMINAL (d)       |                  2/44 (5%)                4/47 (9%)    |           2/43 (5%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  728 (T)                  708          |           733 (T)                  ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.248      |                                    P=0.249N        | 
|POLY 3             |                                           P=0.232      |                                    P=0.244N        | 
|POLY 1.5           |                                           P=0.226      |                                    P=0.242N        | 
|POLY 6             |                                           P=0.237      |                                    P=0.246N        | 
|LOGISTIC REGRESSION|                                           P=0.236      |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.218      |                                    P=0.247N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/14/01                           EXPERIMENT: 56111 TEST: 04                                            Page 5       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                   TRANS-CINNAMALDEHYDE          
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  4/50 (8%)                10/50 (20%)  |           3/50 (6%)                2/50 (4%)       | 
|POLY-3 RATE (b)    |                  4/46.45                  10/49.00     |           3/47.03                  2/46.06         | 
|POLY-3 PERCENT (g) |                  8.6%                     20.4%        |           6.4%                     4.3%            | 
|TERMINAL (d)       |                  4/44 (9%)                8/47 (17%)   |           3/43 (7%)                2/41 (5%)       | 
|FIRST INCIDENCE    |                  728 (T)                  572          |           733 (T)                  733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.100      |                                    P=0.522N        | 
|POLY 3             |                                           P=0.088      |                                    P=0.511N        | 
|POLY 1.5           |                                           P=0.082      |                                    P=0.508N        | 
|POLY 6             |                                           P=0.094      |                                    P=0.514N        | 
|LOGISTIC REGRESSION|                                           P=0.079      |                                    P=0.522N        | 
|COCH-ARM / FISHERS |                                           P=0.074      |                                    P=0.500N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cystadenoma                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |           2/50 (4%)                0/50 (0%)       | 
|POLY-3 RATE (b)    |                                                        |           2/47.25                  0/46.06         | 
|POLY-3 PERCENT (g) |                                                        |           4.2%                     0.0%            | 
|TERMINAL (d)       |                                                        |           1/43 (2%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                                                        |           675                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |                                    P=0.245N        | 
|POLY 3             |                                                        |                                    P=0.246N        | 
|POLY 1.5           |                                                        |                                    P=0.243N        | 
|POLY 6             |                                                        |                                    P=0.249N        | 
|LOGISTIC REGRESSION|                                                        |                                    P=0.234N        | 
|COCH-ARM / FISHERS |                                                        |                                    P=0.247N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/14/01                           EXPERIMENT: 56111 TEST: 04                                            Page 6       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                   TRANS-CINNAMALDEHYDE          
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  0/48 (0%)                0/50 (0%)    |           5/48 (10%)               6/49 (12%)      | 
|POLY-3 RATE (b)    |                  0/45.05                  0/48.41      |           5/45.70                  6/45.22         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%         |           10.9%                    13.3%           | 
|TERMINAL (d)       |                  0/43 (0%)                0/47 (0%)    |           4/42 (10%)               5/41 (12%)      | 
|FIRST INCIDENCE    |                  ---                      ---          |           652                      698             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           (e)          |                                    P=0.482         | 
|POLY 3             |                                           (e)          |                                    P=0.493         | 
|POLY 1.5           |                                           (e)          |                                    P=0.501         | 
|POLY 6             |                                           (e)          |                                    P=0.487         | 
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.497         | 
|COCH-ARM / FISHERS |                                           (e)          |                                    P=0.515         | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibrosarcoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  0/50 (0%)                0/50 (0%)    |           2/50 (4%)                2/50 (4%)       | 
|POLY-3 RATE (b)    |                  0/46.45                  0/48.41      |           2/47.03                  2/46.06         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%         |           4.3%                     4.3%            | 
|TERMINAL (d)       |                  0/44 (0%)                0/47 (0%)    |           2/43 (5%)                2/41 (5%)       | 
|FIRST INCIDENCE    |                  ---                      ---          |           733 (T)                  733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           (e)          |                                    P=0.678         | 
|POLY 3             |                                           (e)          |                                    P=0.688         | 
|POLY 1.5           |                                           (e)          |                                    P=0.690         | 
|POLY 6             |                                           (e)          |                                    P=0.687         | 
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.678         | 
|COCH-ARM / FISHERS |                                           (e)          |                                    P=0.691N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/14/01                           EXPERIMENT: 56111 TEST: 04                                            Page 7       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                   TRANS-CINNAMALDEHYDE          
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Hemangioma                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                0/50 (0%)    |           0/50 (0%)                1/50 (2%)       | 
|POLY-3 RATE (b)    |                  2/46.45                  0/48.41      |           0/47.03                  1/46.06         | 
|POLY-3 PERCENT (g) |                  4.3%                     0.0%         |           0.0%                     2.2%            | 
|TERMINAL (d)       |                  2/44 (5%)                0/47 (0%)    |           0/43 (0%)                1/41 (2%)       | 
|FIRST INCIDENCE    |                  728 (T)                  ---          |           ---                      733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.224N     |                                    P=0.490         | 
|POLY 3             |                                           P=0.224N     |                                    P=0.500         | 
|POLY 1.5           |                                           P=0.229N     |                                    P=0.500         | 
|POLY 6             |                                           P=0.220N     |                                    P=0.500         | 
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.490         | 
|COCH-ARM / FISHERS |                                           P=0.247N     |                                    P=0.500         | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Hemangioma                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                1/50 (2%)    |           2/50 (4%)                2/50 (4%)       | 
|POLY-3 RATE (b)    |                  2/46.45                  1/48.41      |           2/47.03                  2/46.06         | 
|POLY-3 PERCENT (g) |                  4.3%                     2.1%         |           4.3%                     4.3%            | 
|TERMINAL (d)       |                  2/44 (5%)                1/47 (2%)    |           2/43 (5%)                2/41 (5%)       | 
|FIRST INCIDENCE    |                  728 (T)                  728 (T)      |           733 (T)                  733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.477N     |                                    P=0.678         | 
|POLY 3             |                                           P=0.481N     |                                    P=0.688         | 
|POLY 1.5           |                                           P=0.488N     |                                    P=0.690         | 
|POLY 6             |                                           P=0.475N     |                                    P=0.687         | 
|LOGISTIC REGRESSION|                                           P=0.477N     |                                    P=0.678         | 
|COCH-ARM / FISHERS |                                           P=0.500N     |                                    P=0.691N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/14/01                           EXPERIMENT: 56111 TEST: 04                                            Page 8       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                   TRANS-CINNAMALDEHYDE          
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Hemangiosarcoma or Hemangioma                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  3/50 (6%)                2/50 (4%)    |           2/50 (4%)                3/50 (6%)       | 
|POLY-3 RATE (b)    |                  3/46.45                  2/48.92      |           2/47.03                  3/46.19         | 
|POLY-3 PERCENT (g) |                  6.5%                     4.1%         |           4.3%                     6.5%            | 
|TERMINAL (d)       |                  3/44 (7%)                1/47 (2%)    |           2/43 (5%)                2/41 (5%)       | 
|FIRST INCIDENCE    |                  728 (T)                  572          |           733 (T)                  698             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.470N     |                                    P=0.483         | 
|POLY 3             |                                           P=0.472N     |                                    P=0.493         | 
|POLY 1.5           |                                           P=0.482N     |                                    P=0.495         | 
|POLY 6             |                                           P=0.463N     |                                    P=0.493         | 
|LOGISTIC REGRESSION|                                           P=0.505N     |                                    P=0.490         | 
|COCH-ARM / FISHERS |                                           P=0.500N     |                                    P=0.500         | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Histiocytic Sarcoma                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  0/50 (0%)                0/50 (0%)    |           0/50 (0%)                2/50 (4%)       | 
|POLY-3 RATE (b)    |                  0/46.45                  0/48.41      |           0/47.03                  2/46.82         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%         |           0.0%                     4.3%            | 
|TERMINAL (d)       |                  0/44 (0%)                0/47 (0%)    |           0/43 (0%)                1/41 (2%)       | 
|FIRST INCIDENCE    |                  ---                      ---          |           ---                      456             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           (e)          |                                    P=0.237         | 
|POLY 3             |                                           (e)          |                                    P=0.237         | 
|POLY 1.5           |                                           (e)          |                                    P=0.237         | 
|POLY 6             |                                           (e)          |                                    P=0.237         | 
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.282         | 
|COCH-ARM / FISHERS |                                           (e)          |                                    P=0.247         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/14/01                           EXPERIMENT: 56111 TEST: 04                                            Page 9       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                   TRANS-CINNAMALDEHYDE          
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        | 
|     NOS, or Undifferentiated Cell Type                                                                                          | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  4/50 (8%)                4/50 (8%)    |           13/50 (26%)              10/50 (20%)     | 
|POLY-3 RATE (b)    |                  4/47.05                  4/48.41      |           13/47.03                 10/46.51        | 
|POLY-3 PERCENT (g) |                  8.5%                     8.3%         |           27.6%                    21.5%           | 
|TERMINAL (d)       |                  3/44 (7%)                4/47 (9%)    |           13/43 (30%)              8/41 (20%)      | 
|FIRST INCIDENCE    |                  538                      728 (T)      |           733 (T)                  609             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.607N     |                                    P=0.365N        | 
|POLY 3             |                                           P=0.625N     |                                    P=0.327N        | 
|POLY 1.5           |                                           P=0.631N     |                                    P=0.326N        | 
|POLY 6             |                                           P=0.621N     |                                    P=0.324N        | 
|LOGISTIC REGRESSION|                                           P=0.643      |                                    P=0.339N        | 
|COCH-ARM / FISHERS |                                           P=0.643N     |                                    P=0.318N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  14/50 (28%)              23/50 (46%)  |           17/50 (34%)              15/50 (30%)     | 
|POLY-3 RATE (b)    |                  14/47.13                 23/48.92     |           17/47.55                 15/46.61        | 
|POLY-3 PERCENT (g) |                  29.7%                    47.0%        |           35.8%                    32.2%           | 
|TERMINAL (d)       |                  13/44 (30%)              22/47 (47%)  |           15/43 (35%)              13/41 (32%)     | 
|FIRST INCIDENCE    |                  498                      572          |           652                      614             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.081      |                                    P=0.477N        | 
|POLY 3             |                                           P=0.061      |                                    P=0.442N        | 
|POLY 1.5           |                                           P=0.055      |                                    P=0.433N        | 
|POLY 6             |                                           P=0.067      |                                    P=0.447N        | 
|LOGISTIC REGRESSION|                                           P=0.056      |                                    P=0.444N        | 
|COCH-ARM / FISHERS |                                           P=0.048 *    |                                    P=0.415N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/14/01                           EXPERIMENT: 56111 TEST: 04                                            Page 10      
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                   TRANS-CINNAMALDEHYDE          
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  12/50 (24%)              16/50 (32%)  |           24/50 (48%)              22/50 (44%)     | 
|POLY-3 RATE (b)    |                  12/47.28                 16/49.00     |           24/48.84                 22/48.50        | 
|POLY-3 PERCENT (g) |                  25.4%                    32.7%        |           49.1%                    45.4%           | 
|TERMINAL (d)       |                  10/44 (23%)              14/47 (30%)  |           20/43 (47%)              15/41 (37%)     | 
|FIRST INCIDENCE    |                  538                      572          |           429                      456             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.327      |                                    P=0.499N        | 
|POLY 3             |                                           P=0.287      |                                    P=0.433N        | 
|POLY 1.5           |                                           P=0.275      |                                    P=0.432N        | 
|POLY 6             |                                           P=0.297      |                                    P=0.424N        | 
|LOGISTIC REGRESSION|                                           P=0.263      |                                    P=0.397N        | 
|COCH-ARM / FISHERS |                                           P=0.252      |                                    P=0.421N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREATD                 VEHICLE      |           UNTREATD                 VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #            |           #                        #               | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  23/50 (46%)              34/50 (68%)  |           33/50 (66%)              29/50 (58%)     | 
|POLY-3 RATE (b)    |                  23/47.96                 34/49.00     |           33/49.36                 29/48.50        | 
|POLY-3 PERCENT (g) |                  48.0%                    69.4%        |           66.9%                    59.8%           | 
|TERMINAL (d)       |                  20/44 (46%)              32/47 (68%)  |           27/43 (63%)              22/41 (54%)     | 
|FIRST INCIDENCE    |                  498                      572          |           429                      456             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.060      |                                    P=0.387N        | 
|POLY 3             |                                           P=0.024 *    |                                    P=0.304N        | 
|POLY 1.5           |                                           P=0.022 *    |                                    P=0.293N        | 
|POLY 6             |                                           P=0.026 *    |                                    P=0.311N        | 
|LOGISTIC REGRESSION|                                           P=0.026 *    |                                    P=0.262N        | 
|COCH-ARM / FISHERS |                                           P=0.021 *    |                                    P=0.268N        | 
|=================================================================================================================================| 
(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).