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TDMS Study 56348-04 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                           CITRAL                                        DATE: 07/06/01       
EXPERIMENT: 56348 TEST: 04                                                                                     TIME: 08:03:53       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55384                              ROUTE: DOSED FEED                                              NTP C#: C56348       
PATHOLOGIST: DR. M. RYAN                                                                                           CAS: 5392-40-5       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    UNTREAT CONTROL                                                               
                                       INCLUDE 002    UNTREAT CONTROL                                                               
                                       INCLUDE 005    500 PPM                                                                       
                                       INCLUDE 006    500 PPM                                                                       
                                       INCLUDE 007    1000 PPM                                                                      
                                       INCLUDE 008    1000 PPM                                                                      
                                       INCLUDE 009    2000 PPM                                                                      
                                       INCLUDE 010    2000 PPM                                                                      
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                           CITRAL                                        DATE: 07/06/01       
EXPERIMENT: 56348 TEST: 04                                                                                     TIME: 08:03:53       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55384                              ROUTE: DOSED FEED                                              NTP C#: C56348       
PATHOLOGIST: DR. M. RYAN                                                                                           CAS: 5392-40-5       
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                                                                        
                                                 Brain                                                                              
                                                 Clitoral/Preputial Gland                                                           
                                                 Heart                                                                              
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Ovary                                                                              
                                                 Pancreas                                                                           
                                                 Pituitary Gland                                                                    
                                                 Spleen                                                                             
                                                 Testes                                                                             
                                                 Thymus                                                                             
                                                 Thyroid Gland                                                                      
                                                 Urinary Bladder                                                                    
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                           CITRAL                                        DATE: 07/06/01       
EXPERIMENT: 56348 TEST: 04                                                                                     TIME: 08:03:53       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55384                              ROUTE: DOSED FEED                                              NTP C#: C56348       
PATHOLOGIST: DR. M. RYAN                                                                                           CAS: 5392-40-5       
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                      CITRAL                                                                                      
===============================================================                                                                     
Male Mice                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Liver                                  Hepatocellular Carcinoma                                                                     
                                       Hepatocellular Carcinoma or Hepatocellular Adenoma                                           
                                       Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                          
All Organs                             Malignant and Benign Tumors                                                                  
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Lung                                   Alveolar/Bronchiolar Carcinoma                                                               
                                       Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                               
All Organs                             Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type      
===============================================================                                                                     
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 1       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)        -                       CITRAL                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/50 (4%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/48.80      0/45.14      2/47.99      1/45.81     |0/43.96      0/47.89      0/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         4.2%         2.2%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    2/42 (5%)    1/40 (3%)   |0/40 (0%)    0/45 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          727 (T)      727 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.219      (e)          P=0.210      P=0.464     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.231      (e)          P=0.234      P=0.487     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.238      (e)          P=0.236      P=0.493     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.221      (e)          P=0.230      P=0.480     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.210      P=0.464     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.246      (e)          P=0.247      P=0.500     |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    2/50 (4%)    0/50 (0%)   |1/50 (2%)    1/50 (2%)    2/50 (4%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     2/48.80      1/45.14      2/47.99      0/45.81     |1/43.96      1/47.89      2/47.49      1/45.29      | 
|POLY-3 PERCENT (g) |     4.1%         2.2%         4.2%         0.0%        |2.3%         2.1%         4.2%         2.2%         | 
|TERMINAL (d)       |     2/48 (4%)    1/40 (3%)    2/42 (5%)    0/40 (0%)   |1/40 (3%)    1/45 (2%)    2/43 (5%)    1/40 (3%)    | 
|FIRST INCIDENCE    |     727 (T)      727 (T)      727 (T)      ---         |733 (T)      733 (T)      733 (T)      733 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.236N     P=0.564N     P=0.646      P=0.280N    |P=0.582      P=0.735N     P=0.525      P=0.762      | 
|POLY 3             |     P=0.209N     P=0.527N     P=0.687      P=0.252N    |P=0.592      P=0.741N     P=0.527      P=0.754N     | 
|POLY 1.5           |     P=0.205N     P=0.516N     P=0.690      P=0.246N    |P=0.597      P=0.744N     P=0.524      P=0.752N     | 
|POLY 6             |     P=0.215N     P=0.539N     P=0.682      P=0.260N    |P=0.584      P=0.740N     P=0.527      P=0.758N     | 
|LOGISTIC REGRESSION|     P=0.236N     P=0.564N     P=0.646      (e)         |P=0.582      P=0.735N     P=0.525      P=0.762      | 
|COCH-ARM / FISHERS |     P=0.200N     P=0.500N     P=0.691N     P=0.247N    |P=0.591      P=0.753N     P=0.500      P=0.753N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 2       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                       CITRAL                    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    3/50 (6%)    0/50 (0%)   |2/50 (4%)    1/50 (2%)    3/50 (6%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     2/48.80      1/45.14      3/47.99      0/45.81     |2/43.96      1/47.89      3/47.49      1/45.29      | 
|POLY-3 PERCENT (g) |     4.1%         2.2%         6.3%         0.0%        |4.6%         2.1%         6.3%         2.2%         | 
|TERMINAL (d)       |     2/48 (4%)    1/40 (3%)    3/42 (7%)    0/40 (0%)   |2/40 (5%)    1/45 (2%)    3/43 (7%)    1/40 (3%)    | 
|FIRST INCIDENCE    |     727 (T)      727 (T)      727 (T)      ---         |733 (T)      733 (T)      733 (T)      733 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.286N     P=0.564N     P=0.439      P=0.280N    |P=0.487N     P=0.459N     P=0.533      P=0.500N     | 
|POLY 3             |     P=0.255N     P=0.527N     P=0.492      P=0.252N    |P=0.477N     P=0.470N     P=0.535      P=0.490N     | 
|POLY 1.5           |     P=0.249N     P=0.516N     P=0.496      P=0.246N    |P=0.471N     P=0.475N     P=0.531      P=0.487N     | 
|POLY 6             |     P=0.264N     P=0.539N     P=0.486      P=0.260N    |P=0.485N     P=0.468N     P=0.535      P=0.495N     | 
|LOGISTIC REGRESSION|     P=0.286N     P=0.564N     P=0.439      (e)         |P=0.487N     P=0.459N     P=0.533      P=0.500N     | 
|COCH-ARM / FISHERS |     P=0.242N     P=0.500N     P=0.500      P=0.247N    |P=0.474N     P=0.500N     P=0.500      P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/48.80      0/45.14      0/47.99      0/45.81     |0/43.96      0/47.89      1/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     4.1%         0.0%         0.0%         0.0%        |0.0%         0.0%         2.1%         0.0%         | 
|TERMINAL (d)       |     2/48 (4%)    0/40 (0%)    0/42 (0%)    0/40 (0%)   |0/40 (0%)    0/45 (0%)    1/43 (2%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      ---          ---          ---         |---          ---          733 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.132N     P=0.280N     P=0.268N     P=0.280N    |P=0.694      (e)          P=0.514      (e)          | 
|POLY 3             |     P=0.107N     P=0.255N     P=0.241N     P=0.252N    |P=0.694      (e)          P=0.515      (e)          | 
|POLY 1.5           |     P=0.109N     P=0.248N     P=0.239N     P=0.246N    |P=0.699      (e)          P=0.514      (e)          | 
|POLY 6             |     P=0.104N     P=0.264N     P=0.245N     P=0.260N    |P=0.686      (e)          P=0.515      (e)          | 
|LOGISTIC REGRESSION|     P=0.132N     (e)          (e)          (e)         |(e)          (e)          P=0.514      (e)          | 
|COCH-ARM / FISHERS |     P=0.115N     P=0.247N     P=0.247N     P=0.247N    |P=0.695      (e)          P=0.500      (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 3       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                       CITRAL                    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Adenoma                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     10/50 (20%)  11/50 (22%)  11/50 (22%)  13/50 (26%) |5/50 (10%)   2/50 (4%)    8/50 (16%)   8/50 (16%)   | 
|POLY-3 RATE (b)    |     10/48.80     11/46.67     11/48.78     13/46.16    |5/43.96      2/47.89      8/47.49      8/45.57      | 
|POLY-3 PERCENT (g) |     20.5%        23.6%        22.6%        28.2%       |11.4%        4.2%         16.9%        17.6%        | 
|TERMINAL (d)       |     10/48 (21%)  8/40 (20%)   10/42 (24%)  11/40 (28%) |5/40 (13%)   2/45 (4%)    8/43 (19%)   7/40 (18%)   | 
|FIRST INCIDENCE    |     727 (T)      419          427          681         |733 (T)      733 (T)      733 (T)      656          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.170      P=0.338      P=0.373      P=0.170     |P=0.080      P=0.172N     P=0.323      P=0.276      | 
|POLY 3             |     P=0.235      P=0.454      P=0.500      P=0.264     |P=0.092      P=0.183N     P=0.328      P=0.299      | 
|POLY 1.5           |     P=0.252      P=0.474      P=0.503      P=0.286     |P=0.096      P=0.188N     P=0.322      P=0.302      | 
|POLY 6             |     P=0.214      P=0.429      P=0.488      P=0.238     |P=0.087      P=0.181N     P=0.327      P=0.291      | 
|LOGISTIC REGRESSION|     P=0.275      P=0.530      P=0.506      P=0.222     |P=0.085      P=0.172N     P=0.323      P=0.284      | 
|COCH-ARM / FISHERS |     P=0.274      P=0.500      P=0.500      P=0.318     |P=0.095      P=0.218N     P=0.277      P=0.277      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    13/50 (26%)  5/50 (10%)   9/50 (18%)  |1/50 (2%)    1/50 (2%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     4/48.80      13/47.34     5/48.20      9/47.04     |1/43.96      1/47.89      1/47.89      1/45.29      | 
|POLY-3 PERCENT (g) |     8.2%         27.5%        10.4%        19.1%       |2.3%         2.1%         2.1%         2.2%         | 
|TERMINAL (d)       |     4/48 (8%)    7/40 (18%)   3/42 (7%)    5/40 (13%)  |1/40 (3%)    1/45 (2%)    0/43 (0%)    1/40 (3%)    | 
|FIRST INCIDENCE    |     727 (T)      418          689          626         |733 (T)      733 (T)      618          733 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.238      P=0.009 **   P=0.428      P=0.076     |P=0.629      P=0.735N     P=0.740N     P=0.762      | 
|POLY 3             |     P=0.278      P=0.012 *    P=0.492      P=0.102     |P=0.630N     P=0.741N     P=0.741N     P=0.754N     | 
|POLY 1.5           |     P=0.290      P=0.013 *    P=0.496      P=0.108     |P=0.628N     P=0.744N     P=0.744N     P=0.752N     | 
|POLY 6             |     P=0.264      P=0.011 *    P=0.486      P=0.096     |P=0.629      P=0.740N     P=0.740N     P=0.758N     | 
|LOGISTIC REGRESSION|     P=0.338      P=0.025 *    P=0.493      P=0.130     |P=0.634N     P=0.735N     P=0.754      P=0.762      | 
|COCH-ARM / FISHERS |     P=0.310      P=0.016 *    P=0.500      P=0.117     |P=0.634      P=0.753N     P=0.753N     P=0.753N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 4       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                       CITRAL                    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     13/50 (26%)  22/50 (44%)  15/50 (30%)  21/50 (42%) |6/50 (12%)   3/50 (6%)    9/50 (18%)   9/50 (18%)   | 
|POLY-3 RATE (b)    |     13/48.80     22/48.81     15/49.00     21/47.39    |6/43.96      3/47.89      9/47.89      9/45.57      | 
|POLY-3 PERCENT (g) |     26.6%        45.1%        30.6%        44.3%       |13.7%        6.3%         18.8%        19.8%        | 
|TERMINAL (d)       |     13/48 (27%)  14/40 (35%)  12/42 (29%)  15/40 (38%) |6/40 (15%)   3/45 (7%)    8/43 (19%)   8/40 (20%)   | 
|FIRST INCIDENCE    |     727 (T)      418          427          626         |733 (T)      733 (T)      618          656          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.077      P=0.019 *    P=0.277      P=0.025 *   |P=0.095      P=0.187N     P=0.344      P=0.287      | 
|POLY 3             |     P=0.114      P=0.044 *    P=0.417      P=0.053     |P=0.108      P=0.202N     P=0.352      P=0.313      | 
|POLY 1.5           |     P=0.123      P=0.045 *    P=0.419      P=0.058     |P=0.113      P=0.208N     P=0.342      P=0.316      | 
|POLY 6             |     P=0.105      P=0.043 *    P=0.408      P=0.049 *   |P=0.102      P=0.199N     P=0.355      P=0.304      | 
|LOGISTIC REGRESSION|     P=0.161      P=0.076      P=0.416      P=0.055     |P=0.106      P=0.187N     P=0.342      P=0.294      | 
|COCH-ARM / FISHERS |     P=0.141      P=0.046 *    P=0.412      P=0.069     |P=0.111      P=0.243N     P=0.288      P=0.288      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma, Hepatocellular Adenoma,                                                                           | 
|     or Hepatoblastoma                                                                                                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     13/50 (26%)  22/50 (44%)  15/50 (30%)  21/50 (42%) |6/50 (12%)   3/50 (6%)    9/50 (18%)   9/50 (18%)   | 
|POLY-3 RATE (b)    |     13/48.80     22/48.81     15/49.00     21/47.39    |6/43.96      3/47.89      9/47.89      9/45.57      | 
|POLY-3 PERCENT (g) |     26.6%        45.1%        30.6%        44.3%       |13.7%        6.3%         18.8%        19.8%        | 
|TERMINAL (d)       |     13/48 (27%)  14/40 (35%)  12/42 (29%)  15/40 (38%) |6/40 (15%)   3/45 (7%)    8/43 (19%)   8/40 (20%)   | 
|FIRST INCIDENCE    |     727 (T)      418          427          626         |733 (T)      733 (T)      618          656          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.077      P=0.019 *    P=0.277      P=0.025 *   |P=0.095      P=0.187N     P=0.344      P=0.287      | 
|POLY 3             |     P=0.114      P=0.044 *    P=0.417      P=0.053     |P=0.108      P=0.202N     P=0.352      P=0.313      | 
|POLY 1.5           |     P=0.123      P=0.045 *    P=0.419      P=0.058     |P=0.113      P=0.208N     P=0.342      P=0.316      | 
|POLY 6             |     P=0.105      P=0.043 *    P=0.408      P=0.049 *   |P=0.102      P=0.199N     P=0.355      P=0.304      | 
|LOGISTIC REGRESSION|     P=0.161      P=0.076      P=0.416      P=0.055     |P=0.106      P=0.187N     P=0.342      P=0.294      | 
|COCH-ARM / FISHERS |     P=0.141      P=0.046 *    P=0.412      P=0.069     |P=0.111      P=0.243N     P=0.288      P=0.288      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 5       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                       CITRAL                    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    5/50 (10%)   6/50 (12%)   2/50 (4%)   |3/50 (6%)    7/50 (14%)   3/50 (6%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     4/48.80      5/45.14      6/48.16      2/45.81     |3/43.96      7/47.89      3/47.49      1/45.57      | 
|POLY-3 PERCENT (g) |     8.2%         11.1%        12.5%        4.4%        |6.8%         14.6%        6.3%         2.2%         | 
|TERMINAL (d)       |     4/48 (8%)    5/40 (13%)   5/42 (12%)   2/40 (5%)   |3/40 (8%)    7/45 (16%)   3/43 (7%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      727 (T)      682          727 (T)     |733 (T)      733 (T)      733 (T)      656          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.339N     P=0.387      P=0.297      P=0.424N    |P=0.116N     P=0.209      P=0.629N     P=0.307N     | 
|POLY 3             |     P=0.290N     P=0.451      P=0.362      P=0.367N    |P=0.098N     P=0.195      P=0.626N     P=0.292N     | 
|POLY 1.5           |     P=0.276N     P=0.471      P=0.366      P=0.354N    |P=0.097N     P=0.189      P=0.630N     P=0.291N     | 
|POLY 6             |     P=0.309N     P=0.429      P=0.354      P=0.384N    |P=0.101N     P=0.198      P=0.626N     P=0.296N     | 
|LOGISTIC REGRESSION|     P=0.308N     P=0.387      P=0.357      P=0.424N    |P=0.109N     P=0.209      P=0.629N     P=0.295N     | 
|COCH-ARM / FISHERS |     P=0.260N     P=0.500      P=0.370      P=0.339N    |P=0.112N     P=0.159      P=0.661N     P=0.309N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    4/50 (8%)    1/50 (2%)    3/50 (6%)   |3/50 (6%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     4/48.80      4/45.14      1/47.99      3/45.81     |3/43.96      1/47.89      0/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     8.2%         8.9%         2.1%         6.6%        |6.8%         2.1%         0.0%         0.0%         | 
|TERMINAL (d)       |     4/48 (8%)    4/40 (10%)   1/42 (2%)    3/40 (8%)   |3/40 (8%)    1/45 (2%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      727 (T)      727 (T)      727 (T)     |733 (T)      733 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.417N     P=0.540      P=0.222N     P=0.599N    |P=0.043N*    P=0.264N     P=0.109N     P=0.121N     | 
|POLY 3             |     P=0.358N     P=0.599      P=0.184N     P=0.534N    |P=0.044N*    P=0.276N     P=0.106N     P=0.113N     | 
|POLY 1.5           |     P=0.352N     P=0.617      P=0.182N     P=0.520N    |P=0.044N*    P=0.280N     P=0.107N     P=0.112N     | 
|POLY 6             |     P=0.368N     P=0.579      P=0.189N     P=0.554N    |P=0.045N*    P=0.273N     P=0.106N     P=0.116N     | 
|LOGISTIC REGRESSION|     P=0.417N     P=0.540      P=0.222N     P=0.599N    |P=0.043N*    P=0.264N     (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.344N     P=0.643N     P=0.181N     P=0.500N    |P=0.044N*    P=0.309N     P=0.121N     P=0.121N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 6       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                       CITRAL                    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/50 (16%)   9/50 (18%)   7/50 (14%)   4/50 (8%)   |6/50 (12%)   8/50 (16%)   3/50 (6%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     8/48.80      9/45.14      7/48.16      4/45.81     |6/43.96      8/47.89      3/47.49      1/45.57      | 
|POLY-3 PERCENT (g) |     16.4%        19.9%        14.5%        8.7%        |13.7%        16.7%        6.3%         2.2%         | 
|TERMINAL (d)       |     8/48 (17%)   9/40 (23%)   6/42 (14%)   4/40 (10%)  |6/40 (15%)   8/45 (18%)   3/43 (7%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      727 (T)      682          727 (T)     |733 (T)      733 (T)      733 (T)      656          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.174N     P=0.338      P=0.604N     P=0.277N    |P=0.019N*    P=0.480      P=0.207N     P=0.060N     | 
|POLY 3             |     P=0.127N     P=0.430      P=0.511N     P=0.210N    |P=0.015N*    P=0.454      P=0.206N     P=0.050N     | 
|POLY 1.5           |     P=0.118N     P=0.458      P=0.505N     P=0.196N    |P=0.015N*    P=0.444      P=0.210N     P=0.050N     | 
|POLY 6             |     P=0.140N     P=0.398      P=0.521N     P=0.229N    |P=0.016N*    P=0.459      P=0.205N     P=0.051N     | 
|LOGISTIC REGRESSION|     P=0.152N     P=0.338      P=0.524N     P=0.277N    |P=0.017N*    P=0.480      P=0.207N     P=0.054N     | 
|COCH-ARM / FISHERS |     P=0.107N     P=0.500      P=0.500N     P=0.178N    |P=0.018N*    P=0.387      P=0.243N     P=0.056N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/49 (0%)    0/47 (0%)    0/50 (0%)   |4/49 (8%)    5/50 (10%)   2/49 (4%)    3/49 (6%)    | 
|POLY-3 RATE (b)    |     0/48.80      0/44.95      0/45.31      0/45.81     |4/42.96      5/47.89      2/46.49      3/44.92      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |9.3%         10.4%        4.3%         6.7%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    0/41 (0%)    0/40 (0%)   |4/39 (10%)   5/45 (11%)   2/42 (5%)    3/40 (8%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |733 (T)      733 (T)      733 (T)      733 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.325N     P=0.589      P=0.303N     P=0.486N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.309N     P=0.567      P=0.302N     P=0.476N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.308N     P=0.559      P=0.306N     P=0.475N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.314N     P=0.572      P=0.302N     P=0.481N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.325N     P=0.589      P=0.303N     P=0.486N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.323N     P=0.513      P=0.339N     P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 7       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                       CITRAL                    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        | 
|     or Fibrous Histiocytoma                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    2/50 (4%)    2/50 (4%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/48.80      1/45.83      1/47.99      0/45.81     |0/43.96      2/47.89      2/47.49      2/45.95      | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         2.1%         0.0%        |0.0%         4.2%         4.2%         4.4%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    1/42 (2%)    0/40 (0%)   |0/40 (0%)    2/45 (4%)    2/43 (5%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          491          727 (T)      ---         |---          733 (T)      733 (T)      557          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.610N     P=0.496      P=0.473      (e)         |P=0.234      P=0.265      P=0.254      P=0.244      | 
|POLY 3             |     P=0.612N     P=0.487      P=0.497      (e)         |P=0.258      P=0.257      P=0.255      P=0.247      | 
|POLY 1.5           |     P=0.604N     P=0.493      P=0.498      (e)         |P=0.259      P=0.254      P=0.253      P=0.247      | 
|POLY 6             |     P=0.621N     P=0.481      P=0.494      (e)         |P=0.254      P=0.258      P=0.255      P=0.245      | 
|LOGISTIC REGRESSION|     P=0.581N     P=0.631      P=0.473      (e)         |P=0.240      P=0.265      P=0.254      P=0.207      | 
|COCH-ARM / FISHERS |     P=0.595N     P=0.500      P=0.500      (e)         |P=0.242      P=0.247      P=0.247      P=0.247      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    2/50 (4%)    2/50 (4%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/48.80      1/45.83      1/47.99      0/45.81     |0/43.96      2/47.89      2/47.49      2/45.95      | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         2.1%         0.0%        |0.0%         4.2%         4.2%         4.4%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    1/42 (2%)    0/40 (0%)   |0/40 (0%)    2/45 (4%)    2/43 (5%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          491          727 (T)      ---         |---          733 (T)      733 (T)      557          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.610N     P=0.496      P=0.473      (e)         |P=0.234      P=0.265      P=0.254      P=0.244      | 
|POLY 3             |     P=0.612N     P=0.487      P=0.497      (e)         |P=0.258      P=0.257      P=0.255      P=0.247      | 
|POLY 1.5           |     P=0.604N     P=0.493      P=0.498      (e)         |P=0.259      P=0.254      P=0.253      P=0.247      | 
|POLY 6             |     P=0.621N     P=0.481      P=0.494      (e)         |P=0.254      P=0.258      P=0.255      P=0.245      | 
|LOGISTIC REGRESSION|     P=0.581N     P=0.631      P=0.473      (e)         |P=0.240      P=0.265      P=0.254      P=0.207      | 
|COCH-ARM / FISHERS |     P=0.595N     P=0.500      P=0.500      (e)         |P=0.242      P=0.247      P=0.247      P=0.247      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 8       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                       CITRAL                    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Sarcoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    2/50 (4%)    1/50 (2%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/48.80      1/45.83      0/47.99      0/45.81     |0/43.96      2/47.89      1/47.49      2/45.95      | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         0.0%         0.0%        |0.0%         4.2%         2.1%         4.4%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    0/42 (0%)    0/40 (0%)   |0/40 (0%)    2/45 (4%)    1/43 (2%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          491          ---          ---         |---          733 (T)      733 (T)      557          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.570N     P=0.496      (e)          (e)         |P=0.238      P=0.265      P=0.514      P=0.244      | 
|POLY 3             |     P=0.577N     P=0.487      (e)          (e)         |P=0.261      P=0.257      P=0.515      P=0.247      | 
|POLY 1.5           |     P=0.573N     P=0.493      (e)          (e)         |P=0.262      P=0.254      P=0.514      P=0.247      | 
|POLY 6             |     P=0.582N     P=0.481      (e)          (e)         |P=0.258      P=0.258      P=0.515      P=0.245      | 
|LOGISTIC REGRESSION|     P=0.591N     P=0.631      (e)          (e)         |P=0.240      P=0.265      P=0.514      P=0.207      | 
|COCH-ARM / FISHERS |     P=0.568N     P=0.500      (e)          (e)         |P=0.246      P=0.247      P=0.500      P=0.247      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/49 (0%)    3/50 (6%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/49 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/48.80      0/44.79      3/47.99      2/45.81     |0/43.96      0/47.89      0/46.81      0/45.29      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         6.3%         4.4%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    3/42 (7%)    2/40 (5%)   |0/40 (0%)    0/45 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          727 (T)      727 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.078      (e)          P=0.099      P=0.199     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.087      (e)          P=0.116      P=0.224     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.092      (e)          P=0.118      P=0.229     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.081      (e)          P=0.113      P=0.216     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.099      P=0.199     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.098      (e)          P=0.121      P=0.247     |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 9       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                       CITRAL                    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    1/50 (2%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/48.80      0/45.14      1/47.99      0/45.81     |1/43.96      0/47.89      1/47.55      2/45.29      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.1%         0.0%        |2.3%         0.0%         2.1%         4.4%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    1/42 (2%)    0/40 (0%)   |1/40 (3%)    0/45 (0%)    0/43 (0%)    2/40 (5%)    | 
|FIRST INCIDENCE    |     ---          ---          727 (T)      ---         |733 (T)      ---          717          733 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.675      (e)          P=0.473      (e)         |P=0.235      P=0.477N     P=0.744N     P=0.500      | 
|POLY 3             |     P=0.675      (e)          P=0.497      (e)         |P=0.243      P=0.483N     P=0.743N     P=0.510      | 
|POLY 1.5           |     P=0.684      (e)          P=0.498      (e)         |P=0.247      P=0.486N     P=0.745N     P=0.513      | 
|POLY 6             |     P=0.663      (e)          P=0.494      (e)         |P=0.239      P=0.482N     P=0.743N     P=0.505      | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.473      (e)         |P=0.240      (e)          P=0.746N     P=0.500      | 
|COCH-ARM / FISHERS |     P=0.695      (e)          P=0.500      (e)         |P=0.247      P=0.500N     P=0.753N     P=0.500      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Squamous Cell Papilloma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/48.80      0/45.14      1/47.99      0/45.81     |1/43.96      0/47.89      0/47.49      2/45.29      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.1%         0.0%        |2.3%         0.0%         0.0%         4.4%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    1/42 (2%)    0/40 (0%)   |1/40 (3%)    0/45 (0%)    0/43 (0%)    2/40 (5%)    | 
|FIRST INCIDENCE    |     ---          ---          727 (T)      ---         |733 (T)      ---          ---          733 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.675      (e)          P=0.473      (e)         |P=0.235      P=0.477N     P=0.486N     P=0.500      | 
|POLY 3             |     P=0.675      (e)          P=0.497      (e)         |P=0.240      P=0.483N     P=0.485N     P=0.510      | 
|POLY 1.5           |     P=0.684      (e)          P=0.498      (e)         |P=0.242      P=0.486N     P=0.486N     P=0.513      | 
|POLY 6             |     P=0.663      (e)          P=0.494      (e)         |P=0.238      P=0.482N     P=0.485N     P=0.505      | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.473      (e)         |P=0.235      (e)          (e)          P=0.500      | 
|COCH-ARM / FISHERS |     P=0.695      (e)          P=0.500      (e)         |P=0.245      P=0.500N     P=0.500N     P=0.500      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 10      
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                       CITRAL                    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Hemangioma                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    1/50 (2%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/48.80      0/45.14      1/47.99      0/45.81     |1/43.96      0/47.89      0/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     4.1%         0.0%         2.1%         0.0%        |2.3%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/48 (4%)    0/40 (0%)    1/42 (2%)    0/40 (0%)   |1/40 (3%)    0/45 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      ---          727 (T)      ---         |733 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.215N     P=0.280N     P=0.547N     P=0.280N    |P=0.307N     P=0.477N     P=0.486N     P=0.500N     | 
|POLY 3             |     P=0.185N     P=0.255N     P=0.506N     P=0.252N    |P=0.314N     P=0.483N     P=0.485N     P=0.494N     | 
|POLY 1.5           |     P=0.186N     P=0.248N     P=0.503N     P=0.246N    |P=0.314N     P=0.486N     P=0.486N     P=0.493N     | 
|POLY 6             |     P=0.185N     P=0.264N     P=0.511N     P=0.260N    |P=0.313N     P=0.482N     P=0.485N     P=0.497N     | 
|LOGISTIC REGRESSION|     P=0.215N     (e)          P=0.547N     (e)         |P=0.307N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.188N     P=0.247N     P=0.500N     P=0.247N    |P=0.306N     P=0.500N     P=0.500N     P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    3/50 (6%)    3/50 (6%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/48.80      0/45.14      3/47.99      3/45.81     |0/43.96      0/47.89      1/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     4.1%         0.0%         6.3%         6.6%        |0.0%         0.0%         2.1%         0.0%         | 
|TERMINAL (d)       |     2/48 (4%)    0/40 (0%)    3/42 (7%)    3/40 (8%)   |0/40 (0%)    0/45 (0%)    1/43 (2%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      ---          727 (T)      727 (T)     |---          ---          733 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.188      P=0.280N     P=0.439      P=0.417     |P=0.694      (e)          P=0.514      (e)          | 
|POLY 3             |     P=0.224      P=0.255N     P=0.492      P=0.471     |P=0.694      (e)          P=0.515      (e)          | 
|POLY 1.5           |     P=0.228      P=0.248N     P=0.496      P=0.484     |P=0.699      (e)          P=0.514      (e)          | 
|POLY 6             |     P=0.216      P=0.264N     P=0.486      P=0.455     |P=0.686      (e)          P=0.515      (e)          | 
|LOGISTIC REGRESSION|     P=0.188      (e)          P=0.439      P=0.417     |(e)          (e)          P=0.514      (e)          | 
|COCH-ARM / FISHERS |     P=0.232      P=0.247N     P=0.500      P=0.500     |P=0.695      (e)          P=0.500      (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 11      
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                       CITRAL                    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Hemangiosarcoma or Hemangioma                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    0/50 (0%)    4/50 (8%)    3/50 (6%)   |1/50 (2%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     4/48.80      0/45.14      4/47.99      3/45.81     |1/43.96      0/47.89      1/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     8.2%         0.0%         8.3%         6.6%        |2.3%         0.0%         2.1%         0.0%         | 
|TERMINAL (d)       |     4/48 (8%)    0/40 (0%)    4/42 (10%)   3/40 (8%)   |1/40 (3%)    0/45 (0%)    1/43 (2%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      ---          727 (T)      727 (T)     |733 (T)      ---          733 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.448      P=0.089N     P=0.568      P=0.599N    |P=0.410N     P=0.477N     P=0.746N     P=0.500N     | 
|POLY 3             |     P=0.511      P=0.071N     P=0.633      P=0.534N    |P=0.412N     P=0.483N     P=0.743N     P=0.494N     | 
|POLY 1.5           |     P=0.517      P=0.067N     P=0.638      P=0.520N    |P=0.410N     P=0.486N     P=0.745N     P=0.493N     | 
|POLY 6             |     P=0.501      P=0.077N     P=0.625      P=0.554N    |P=0.416N     P=0.482N     P=0.743N     P=0.497N     | 
|LOGISTIC REGRESSION|     P=0.448      (e)          P=0.568      P=0.599N    |P=0.410N     (e)          P=0.746N     (e)          | 
|COCH-ARM / FISHERS |     P=0.521      P=0.059N     P=0.643N     P=0.500N    |P=0.405N     P=0.500N     P=0.753N     P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        | 
|     NOS, or Undifferentiated Cell Type                                                                                          | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    2/50 (4%)    3/50 (6%)    1/50 (2%)   |4/50 (8%)    5/50 (10%)   9/50 (18%)   12/50 (24%)  | 
|POLY-3 RATE (b)    |     4/50.00      2/45.64      3/48.02      1/46.48     |4/43.96      5/47.89      9/48.32      12/46.62     | 
|POLY-3 PERCENT (g) |     8.0%         4.4%         6.3%         2.2%        |9.1%         10.4%        18.6%        25.7%        | 
|TERMINAL (d)       |     2/48 (4%)    1/40 (3%)    2/42 (5%)    0/40 (0%)   |4/40 (10%)   5/45 (11%)   7/43 (16%)   10/40 (25%)  | 
|FIRST INCIDENCE    |     397          576          720          500         |733 (T)      733 (T)      469          491          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.196N     P=0.396N     P=0.550N     P=0.213N    |P=0.008 **   P=0.574      P=0.151      P=0.030 *    | 
|POLY 3             |     P=0.174N     P=0.381N     P=0.522N     P=0.202N    |P=0.011 *    P=0.553      P=0.156      P=0.034 *    | 
|POLY 1.5           |     P=0.169N     P=0.364N     P=0.513N     P=0.193N    |P=0.011 *    P=0.545      P=0.149      P=0.034 *    | 
|POLY 6             |     P=0.182N     P=0.398N     P=0.534N     P=0.215N    |P=0.010 *    P=0.557      P=0.158      P=0.033 *    | 
|LOGISTIC REGRESSION|     P=0.130N     P=0.181N     P=0.486N     P=0.056N    |P=0.010 *    P=0.574      P=0.132      P=0.031 *    | 
|COCH-ARM / FISHERS |     P=0.162N     P=0.339N     P=0.500N     P=0.181N    |P=0.010 *    P=0.500      P=0.117      P=0.027 *    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 12      
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                       CITRAL                    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     20/50 (40%)  18/50 (36%)  21/50 (42%)  14/50 (28%) |16/50 (32%)  19/50 (38%)  13/50 (26%)  14/50 (28%)  | 
|POLY-3 RATE (b)    |     20/48.80     18/46.67     21/48.96     14/46.16    |16/43.96     19/47.89     13/47.49     14/45.57     | 
|POLY-3 PERCENT (g) |     41.0%        38.6%        42.9%        30.3%       |36.4%        39.7%        27.4%        30.7%        | 
|TERMINAL (d)       |     20/48 (42%)  15/40 (38%)  19/42 (45%)  12/40 (30%) |16/40 (40%)  19/45 (42%)  13/43 (30%)  13/40 (33%)  | 
|FIRST INCIDENCE    |     727 (T)      419          427          681         |733 (T)      733 (T)      733 (T)      656          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.303N     P=0.477      P=0.299      P=0.341N    |P=0.278N     P=0.505      P=0.243N     P=0.411N     | 
|POLY 3             |     P=0.181N     P=0.488N     P=0.505      P=0.192N    |P=0.225N     P=0.457      P=0.242N     P=0.365N     | 
|POLY 1.5           |     P=0.164N     P=0.458N     P=0.508      P=0.171N    |P=0.220N     P=0.438      P=0.252N     P=0.362N     | 
|POLY 6             |     P=0.207N     P=0.526N     P=0.492      P=0.222N    |P=0.237N     P=0.467      P=0.241N     P=0.378N     | 
|LOGISTIC REGRESSION|     P=0.160N     P=0.472N     P=0.493      P=0.257N    |P=0.276N     P=0.505      P=0.243N     P=0.408N     | 
|COCH-ARM / FISHERS |     P=0.143N     P=0.418N     P=0.500      P=0.146N    |P=0.251N     P=0.338      P=0.330N     P=0.414N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     14/50 (28%)  20/50 (40%)  17/50 (34%)  18/50 (36%) |12/50 (24%)  13/50 (26%)  13/50 (26%)  18/50 (36%)  | 
|POLY-3 RATE (b)    |     14/50.00     20/48.54     17/48.52     18/47.89    |12/44.55     13/48.30     13/48.78     18/47.42     | 
|POLY-3 PERCENT (g) |     28.0%        41.2%        35.0%        37.6%       |26.9%        26.9%        26.7%        38.0%        | 
|TERMINAL (d)       |     12/48 (25%)  12/40 (30%)  13/42 (31%)  12/40 (30%) |11/40 (28%)  12/45 (27%)  9/43 (21%)   13/40 (33%)  | 
|FIRST INCIDENCE    |     397          418          650          500         |545          615          469          491          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.213      P=0.074      P=0.220      P=0.140     |P=0.092      P=0.550N     P=0.582      P=0.153      | 
|POLY 3             |     P=0.278      P=0.122      P=0.297      P=0.214     |P=0.125      P=0.591N     P=0.579N     P=0.183      | 
|POLY 1.5           |     P=0.299      P=0.129      P=0.311      P=0.231     |P=0.123      P=0.579      P=0.588      P=0.178      | 
|POLY 6             |     P=0.257      P=0.116      P=0.282      P=0.198     |P=0.123      P=0.585N     P=0.573N     P=0.182      | 
|LOGISTIC REGRESSION|     P=0.384      P=0.280      P=0.347      P=0.350     |P=0.104      P=0.582      P=0.542      P=0.153      | 
|COCH-ARM / FISHERS |     P=0.335      P=0.146      P=0.333      P=0.260     |P=0.101      P=0.500      P=0.500      P=0.138      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 13      
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                       CITRAL                    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     27/50 (54%)  35/50 (70%)  33/50 (66%)  26/50 (52%) |23/50 (46%)  27/50 (54%)  23/50 (46%)  30/50 (60%)  | 
|POLY-3 RATE (b)    |     27/50.00     35/50.00     33/49.49     26/48.06    |23/44.55     27/48.30     23/48.78     30/47.70     | 
|POLY-3 PERCENT (g) |     54.0%        70.0%        66.7%        54.1%       |51.6%        55.9%        47.2%        62.9%        | 
|TERMINAL (d)       |     25/48 (52%)  25/40 (63%)  27/42 (64%)  19/40 (48%) |22/40 (55%)  26/45 (58%)  19/43 (44%)  24/40 (60%)  | 
|FIRST INCIDENCE    |     397          418          427          500         |545          615          469          491          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.481      P=0.020 *    P=0.059      P=0.337     |P=0.105      P=0.493      P=0.446N     P=0.127      | 
|POLY 3             |     P=0.390N     P=0.074      P=0.138      P=0.576     |P=0.189      P=0.419      P=0.411N     P=0.187      | 
|POLY 1.5           |     P=0.351N     P=0.074      P=0.145      P=0.554N    |P=0.182      P=0.397      P=0.437N     P=0.176      | 
|POLY 6             |     P=0.427N     P=0.074      P=0.128      P=0.550     |P=0.191      P=0.430      P=0.399N     P=0.191      | 
|LOGISTIC REGRESSION|     P=0.239N     (e)          P=0.173      P=0.466N    |P=0.146      P=0.434      P=0.455N     P=0.146      | 
|COCH-ARM / FISHERS |     P=0.286N     P=0.074      P=0.154      P=0.500N    |P=0.130      P=0.274      P=0.579N     P=0.115      | 
|=================================================================================================================================| 
(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).