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TDMS Study 56348-04 Pathology Tables

                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                           CITRAL                                        DATE: 12/19/00       
EXPERIMENT: 56348 TEST: 04                                                                                     TIME: 14:40:03       
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                                                                                    
-----                                 ----------                                                                                    
Adrenal Cortex: Subcapsular            Hyperplasia                                                                                  
Bone Marrow                            Hyperplasia                                                                                  
Kidney                                 Infarct                                                                                      
Kidney: Renal Tubule                   Mineralization                                                                               
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Bone                                   Fibrosis                                                                                     
Bone Marrow                            Hyperplasia                                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 1       
                     Statistical Analysis of Non-neoplastic Lesions in        Mice(B6C3F1)  -                          CITRAL       
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  25/50 (50%)              25/50 (50%)  |           3/50 (6%)                3/49 (6%)       | 
|POLY-3 RATE (b)    |                  25/49.16                 25/47.12     |           3/43.96                  3/46.22         | 
|POLY-3 PERCENT (g) |                  50.9%                    53.1%        |           6.8%                     6.5%            | 
|TERMINAL (d)       |                  24/48 (50%)              23/43 (54%)  |           3/40 (8%)                3/41 (7%)       | 
|FIRST INCIDENCE    |                  626                      530          |           733 (T)                  733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.372      |                                    P=0.652N        | 
|POLY 3             |                                           P=0.497      |                                    P=0.635N        | 
|POLY 1.5           |                                           P=0.515      |                                    P=0.639N        | 
|POLY 6             |                                           P=0.477      |                                    P=0.636N        | 
|LOGISTIC REGRESSION|                                           P=0.496      |                                    P=0.652N        | 
|COCH-ARM / FISHERS |                                           P=0.579N     |                                    P=0.651         | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex: Subcapsular                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  36/50 (72%)              42/50 (84%)  |           47/50 (94%)              49/49 (100%)    | 
|POLY-3 RATE (b)    |                  36/48.80                 42/48.08     |           47/47.48                 49/49.00        | 
|POLY-3 PERCENT (g) |                  73.8%                    87.4%        |           99.0%                    100.0%          | 
|TERMINAL (d)       |                  36/48 (75%)              37/43 (86%)  |           40/40 (100%)             41/41 (100%)    | 
|FIRST INCIDENCE    |                  727 (T)                  530          |           242                      441             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.019 *    |                                    P=0.529         | 
|POLY 3             |                                           P=0.074      |                                    P=0.872         | 
|POLY 1.5           |                                           P=0.072      |                                    P=0.571         | 
|POLY 6             |                                           P=0.081      |                                    P=1.000         | 
|LOGISTIC REGRESSION|                                           P=0.047 *    |                                    P=0.566         | 
|COCH-ARM / FISHERS |                                           P=0.114      |                                    P=0.125         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 2       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone                                                                                                                             | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  0/50 (0%)                1/50 (2%)    |           19/50 (38%)              11/49 (22%)     | 
|POLY-3 RATE (b)    |                  0/48.80                  1/46.15      |           19/44.00                 11/46.39        | 
|POLY-3 PERCENT (g) |                  0.0%                     2.2%         |           43.2%                    23.7%           | 
|TERMINAL (d)       |                  0/48 (0%)                1/43 (2%)    |           18/40 (45%)              10/41 (24%)     | 
|FIRST INCIDENCE    |                  ---                      727 (T)      |           722                      688             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.478      |                                    P=0.052N        | 
|POLY 3             |                                           P=0.501      |                                    P=0.038N*       | 
|POLY 1.5           |                                           P=0.500      |                                    P=0.042N*       | 
|POLY 6             |                                           P=0.501      |                                    P=0.037N*       | 
|LOGISTIC REGRESSION|                                           P=0.478      |                                    P=0.043N*       | 
|COCH-ARM / FISHERS |                                           P=0.500      |                                    P=0.071N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  9/50 (18%)               19/50 (38%)  |           2/50 (4%)                11/49 (22%)     | 
|POLY-3 RATE (b)    |                  9/48.80                  19/48.29     |           2/44.05                  11/48.39        | 
|POLY-3 PERCENT (g) |                  18.4%                    39.3%        |           4.5%                     22.7%           | 
|TERMINAL (d)       |                  9/48 (19%)               16/43 (37%)  |           1/40 (3%)                6/41 (15%)      | 
|FIRST INCIDENCE    |                  727 (T)                  310          |           709                      441             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.012 *    |                                    P=0.014 *       | 
|POLY 3             |                                           P=0.018 *    |                                    P=0.011 *       | 
|POLY 1.5           |                                           P=0.019 *    |                                    P=0.010 *       | 
|POLY 6             |                                           P=0.018 *    |                                    P=0.012 *       | 
|LOGISTIC REGRESSION|                                           P=0.026 *    |                                    P=0.005 **      | 
|COCH-ARM / FISHERS |                                           P=0.022 *    |                                    P=0.007 **      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 3       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart: Myocardium                                                                                                                | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  1/50 (2%)                2/50 (4%)    |           3/50 (6%)                1/49 (2%)       | 
|POLY-3 RATE (b)    |                  1/48.80                  2/46.32      |           3/44.55                  1/47.00         | 
|POLY-3 PERCENT (g) |                  2.1%                     4.3%         |           6.7%                     2.1%            | 
|TERMINAL (d)       |                  1/48 (2%)                1/43 (2%)    |           2/40 (5%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  682          |           544                      441             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.467      |                                    P=0.296N        | 
|POLY 3             |                                           P=0.488      |                                    P=0.282N        | 
|POLY 1.5           |                                           P=0.491      |                                    P=0.285N        | 
|POLY 6             |                                           P=0.485      |                                    P=0.283N        | 
|LOGISTIC REGRESSION|                                           P=0.494      |                                    P=0.399N        | 
|COCH-ARM / FISHERS |                                           P=0.500      |                                    P=0.316N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart: Valve                                                                                                                     | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  0/50 (0%)                2/50 (4%)    |           2/50 (4%)                2/49 (4%)       | 
|POLY-3 RATE (b)    |                  0/48.80                  2/47.68      |           2/45.11                  2/47.05         | 
|POLY-3 PERCENT (g) |                  0.0%                     4.2%         |           4.4%                     4.3%            | 
|TERMINAL (d)       |                  0/48 (0%)                0/43 (0%)    |           0/40 (0%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  ---                      310          |           544                      470             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.235      |                                    P=0.678N        | 
|POLY 3             |                                           P=0.235      |                                    P=0.675N        | 
|POLY 1.5           |                                           P=0.235      |                                    P=0.676N        | 
|POLY 6             |                                           P=0.234      |                                    P=0.678N        | 
|LOGISTIC REGRESSION|                                           P=0.467      |                                    P=0.545         | 
|COCH-ARM / FISHERS |                                           P=0.247      |                                    P=0.684         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 4       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Duodenum: Epithelium                                                                                            | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                0/50 (0%)    |           0/50 (0%)                0/49 (0%)       | 
|POLY-3 RATE (b)    |                  2/48.80                  0/46.15      |           0/43.96                  0/46.22         | 
|POLY-3 PERCENT (g) |                  4.1%                     0.0%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/48 (4%)                0/43 (0%)    |           0/40 (0%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  ---          |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.263N     |                                    (e)             | 
|POLY 3             |                                           P=0.257N     |                                    (e)             | 
|POLY 1.5           |                                           P=0.252N     |                                    (e)             | 
|POLY 6             |                                           P=0.263N     |                                    (e)             | 
|LOGISTIC REGRESSION|                                           (e)          |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.247N     |                                    (e)             | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Jejunum: Peyer's Patch                                                                                          | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  0/50 (0%)                1/50 (2%)    |           2/50 (4%)                0/49 (0%)       | 
|POLY-3 RATE (b)    |                  0/48.80                  1/46.15      |           2/43.96                  0/46.22         | 
|POLY-3 PERCENT (g) |                  0.0%                     2.2%         |           4.6%                     0.0%            | 
|TERMINAL (d)       |                  0/48 (0%)                1/43 (2%)    |           2/40 (5%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  ---                      727 (T)      |           733 (T)                  ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.478      |                                    P=0.233N        | 
|POLY 3             |                                           P=0.501      |                                    P=0.221N        | 
|POLY 1.5           |                                           P=0.500      |                                    P=0.223N        | 
|POLY 6             |                                           P=0.501      |                                    P=0.222N        | 
|LOGISTIC REGRESSION|                                           P=0.478      |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.500      |                                    P=0.253N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 5       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Jejunum: Serosa                                                                                                 | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  1/50 (2%)                2/50 (4%)    |           0/50 (0%)                0/49 (0%)       | 
|POLY-3 RATE (b)    |                  1/48.80                  2/46.15      |           0/43.96                  0/46.22         | 
|POLY-3 PERCENT (g) |                  2.1%                     4.3%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  1/48 (2%)                2/43 (5%)    |           0/40 (0%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)      |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.462      |                                    (e)             | 
|POLY 3             |                                           P=0.487      |                                    (e)             | 
|POLY 1.5           |                                           P=0.491      |                                    (e)             | 
|POLY 6             |                                           P=0.484      |                                    (e)             | 
|LOGISTIC REGRESSION|                                           P=0.462      |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.500      |                                    (e)             | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  15/50 (30%)              18/50 (36%)  |           2/50 (4%)                0/49 (0%)       | 
|POLY-3 RATE (b)    |                  15/48.80                 18/47.12     |           2/43.96                  0/46.22         | 
|POLY-3 PERCENT (g) |                  30.7%                    38.2%        |           4.6%                     0.0%            | 
|TERMINAL (d)       |                  15/48 (31%)              16/43 (37%)  |           2/40 (5%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  530          |           733 (T)                  ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.215      |                                    P=0.233N        | 
|POLY 3             |                                           P=0.292      |                                    P=0.221N        | 
|POLY 1.5           |                                           P=0.299      |                                    P=0.223N        | 
|POLY 6             |                                           P=0.285      |                                    P=0.222N        | 
|LOGISTIC REGRESSION|                                           P=0.285      |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.335      |                                    P=0.253N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 6       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Infarct                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                8/50 (16%)   |           4/50 (8%)                1/49 (2%)       | 
|POLY-3 RATE (b)    |                  2/48.80                  8/46.76      |           4/45.11                  1/46.22         | 
|POLY-3 PERCENT (g) |                  4.1%                     17.1%        |           8.9%                     2.2%            | 
|TERMINAL (d)       |                  2/48 (4%)                7/43 (16%)   |           2/40 (5%)                1/41 (2%)       | 
|FIRST INCIDENCE    |                  727 (T)                  530          |           544                      733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.035 *    |                                    P=0.174N        | 
|POLY 3             |                                           P=0.039 *    |                                    P=0.170N        | 
|POLY 1.5           |                                           P=0.041 *    |                                    P=0.169N        | 
|POLY 6             |                                           P=0.038 *    |                                    P=0.175N        | 
|LOGISTIC REGRESSION|                                           P=0.046 *    |                                    P=0.210N        | 
|COCH-ARM / FISHERS |                                           P=0.046 *    |                                    P=0.187N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Metaplasia Osseous                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                3/50 (6%)    |           0/50 (0%)                0/49 (0%)       | 
|POLY-3 RATE (b)    |                  2/48.80                  3/46.51      |           0/43.96                  0/46.22         | 
|POLY-3 PERCENT (g) |                  4.1%                     6.5%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/48 (4%)                2/43 (5%)    |           0/40 (0%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  626          |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.455      |                                    (e)             | 
|POLY 3             |                                           P=0.483      |                                    (e)             | 
|POLY 1.5           |                                           P=0.487      |                                    (e)             | 
|POLY 6             |                                           P=0.479      |                                    (e)             | 
|LOGISTIC REGRESSION|                                           P=0.500      |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.500      |                                    (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 7       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  45/50 (90%)              46/50 (92%)  |           13/50 (26%)              9/49 (18%)      | 
|POLY-3 RATE (b)    |                  45/48.80                 46/48.08     |           13/45.61                 9/46.58         | 
|POLY-3 PERCENT (g) |                  92.2%                    95.7%        |           28.5%                    19.3%           | 
|TERMINAL (d)       |                  45/48 (94%)              41/43 (95%)  |           10/40 (25%)              8/41 (20%)      | 
|FIRST INCIDENCE    |                  727 (T)                  530          |           243                      633             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.060      |                                    P=0.219N        | 
|POLY 3             |                                           P=0.385      |                                    P=0.215N        | 
|POLY 1.5           |                                           P=0.369      |                                    P=0.216N        | 
|POLY 6             |                                           P=0.429      |                                    P=0.218N        | 
|LOGISTIC REGRESSION|                                           P=0.218      |                                    P=0.245N        | 
|COCH-ARM / FISHERS |                                           P=0.500      |                                    P=0.251N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  8/50 (16%)               4/50 (8%)    |           1/50 (2%)                1/49 (2%)       | 
|POLY-3 RATE (b)    |                  8/48.80                  4/46.51      |           1/43.96                  1/46.22         | 
|POLY-3 PERCENT (g) |                  16.4%                    8.6%         |           2.3%                     2.2%            | 
|TERMINAL (d)       |                  8/48 (17%)               3/43 (7%)    |           1/40 (3%)                1/41 (2%)       | 
|FIRST INCIDENCE    |                  727 (T)                  626          |           733 (T)                  733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.235N     |                                    P=0.756N        | 
|POLY 3             |                                           P=0.204N     |                                    P=0.744N        | 
|POLY 1.5           |                                           P=0.198N     |                                    P=0.746N        | 
|POLY 6             |                                           P=0.210N     |                                    P=0.744N        | 
|LOGISTIC REGRESSION|                                           P=0.197N     |                                    P=0.756N        | 
|COCH-ARM / FISHERS |                                           P=0.178N     |                                    P=0.747         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 8       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                0/50 (0%)    |           0/50 (0%)                0/49 (0%)       | 
|POLY-3 RATE (b)    |                  2/48.80                  0/46.15      |           0/43.96                  0/46.22         | 
|POLY-3 PERCENT (g) |                  4.1%                     0.0%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/48 (4%)                0/43 (0%)    |           0/40 (0%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  ---          |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.263N     |                                    (e)             | 
|POLY 3             |                                           P=0.257N     |                                    (e)             | 
|POLY 1.5           |                                           P=0.252N     |                                    (e)             | 
|POLY 6             |                                           P=0.263N     |                                    (e)             | 
|LOGISTIC REGRESSION|                                           (e)          |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.247N     |                                    (e)             | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  45/50 (90%)              48/50 (96%)  |           3/50 (6%)                4/49 (8%)       | 
|POLY-3 RATE (b)    |                  45/49.64                 48/48.08     |           3/44.92                  4/46.58         | 
|POLY-3 PERCENT (g) |                  90.7%                    99.8%        |           6.7%                     8.6%            | 
|TERMINAL (d)       |                  44/48 (92%)              43/43 (100%) |           2/40 (5%)                3/41 (7%)       | 
|FIRST INCIDENCE    |                  397                      530          |           243                      633             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.014 *    |                                    P=0.518         | 
|POLY 3             |                                           P=0.043 *    |                                    P=0.517         | 
|POLY 1.5           |                                           P=0.054      |                                    P=0.514         | 
|POLY 6             |                                           P=0.046 *    |                                    P=0.518         | 
|LOGISTIC REGRESSION|                                           P=0.060      |                                    P=0.412         | 
|COCH-ARM / FISHERS |                                           P=0.218      |                                    P=0.489         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 9       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Clear Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  8/50 (16%)               9/50 (18%)   |           3/50 (6%)                0/49 (0%)       | 
|POLY-3 RATE (b)    |                  8/48.80                  9/46.15      |           3/43.96                  0/46.22         | 
|POLY-3 PERCENT (g) |                  16.4%                    19.5%        |           6.8%                     0.0%            | 
|TERMINAL (d)       |                  8/48 (17%)               9/43 (21%)   |           3/40 (8%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)      |           733 (T)                  ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.401      |                                    P=0.117N        | 
|POLY 3             |                                           P=0.453      |                                    P=0.107N        | 
|POLY 1.5           |                                           P=0.465      |                                    P=0.109N        | 
|POLY 6             |                                           P=0.440      |                                    P=0.108N        | 
|LOGISTIC REGRESSION|                                           P=0.401      |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.500      |                                    P=0.125N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  3/50 (6%)                4/50 (8%)    |           0/50 (0%)                0/49 (0%)       | 
|POLY-3 RATE (b)    |                  3/48.80                  4/46.15      |           0/43.96                  0/46.22         | 
|POLY-3 PERCENT (g) |                  6.2%                     8.7%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  3/48 (6%)                4/43 (9%)    |           0/40 (0%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)      |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.440      |                                    (e)             | 
|POLY 3             |                                           P=0.474      |                                    (e)             | 
|POLY 1.5           |                                           P=0.481      |                                    (e)             | 
|POLY 6             |                                           P=0.467      |                                    (e)             | 
|LOGISTIC REGRESSION|                                           P=0.440      |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.500      |                                    (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 10      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                1/50 (2%)    |           16/50 (32%)              18/49 (37%)     | 
|POLY-3 RATE (b)    |                  2/48.80                  1/46.15      |           16/43.96                 18/46.58        | 
|POLY-3 PERCENT (g) |                  4.1%                     2.2%         |           36.4%                    38.7%           | 
|TERMINAL (d)       |                  2/48 (4%)                1/43 (2%)    |           16/40 (40%)              17/41 (42%)     | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)      |           733 (T)                  633             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.538N     |                                    P=0.451         | 
|POLY 3             |                                           P=0.526N     |                                    P=0.496         | 
|POLY 1.5           |                                           P=0.519N     |                                    P=0.481         | 
|POLY 6             |                                           P=0.534N     |                                    P=0.502         | 
|LOGISTIC REGRESSION|                                           P=0.538N     |                                    P=0.482         | 
|COCH-ARM / FISHERS |                                           P=0.500N     |                                    P=0.388         | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  9/50 (18%)               7/50 (14%)   |           20/50 (40%)              14/49 (29%)     | 
|POLY-3 RATE (b)    |                  9/48.80                  7/46.15      |           20/45.02                 14/46.60        | 
|POLY-3 PERCENT (g) |                  18.4%                    15.2%        |           44.4%                    30.0%           | 
|TERMINAL (d)       |                  9/48 (19%)               7/43 (16%)   |           18/40 (45%)              13/41 (32%)     | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)      |           242                      625             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.487N     |                                    P=0.125N        | 
|POLY 3             |                                           P=0.443N     |                                    P=0.111N        | 
|POLY 1.5           |                                           P=0.430N     |                                    P=0.117N        | 
|POLY 6             |                                           P=0.458N     |                                    P=0.109N        | 
|LOGISTIC REGRESSION|                                           P=0.487N     |                                    P=0.118N        | 
|COCH-ARM / FISHERS |                                           P=0.393N     |                                    P=0.162N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 11      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  9/50 (18%)               10/50 (20%)  |           4/50 (8%)                5/49 (10%)      | 
|POLY-3 RATE (b)    |                  9/48.80                  10/46.76     |           4/43.96                  5/46.22         | 
|POLY-3 PERCENT (g) |                  18.4%                    21.4%        |           9.1%                     10.8%           | 
|TERMINAL (d)       |                  9/48 (19%)               9/43 (21%)   |           4/40 (10%)               5/41 (12%)      | 
|FIRST INCIDENCE    |                  727 (T)                  530          |           733 (T)                  733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.400      |                                    P=0.516         | 
|POLY 3             |                                           P=0.461      |                                    P=0.528         | 
|POLY 1.5           |                                           P=0.470      |                                    P=0.524         | 
|POLY 6             |                                           P=0.452      |                                    P=0.527         | 
|LOGISTIC REGRESSION|                                           P=0.467      |                                    P=0.516         | 
|COCH-ARM / FISHERS |                                           P=0.500      |                                    P=0.487         | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  3/50 (6%)                1/50 (2%)    |           2/50 (4%)                3/49 (6%)       | 
|POLY-3 RATE (b)    |                  3/48.80                  1/46.15      |           2/45.89                  3/47.13         | 
|POLY-3 PERCENT (g) |                  6.2%                     2.2%         |           4.4%                     6.4%            | 
|TERMINAL (d)       |                  3/48 (6%)                1/43 (2%)    |           0/40 (0%)                1/41 (2%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)      |           242                      470             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.346N     |                                    P=0.514         | 
|POLY 3             |                                           P=0.331N     |                                    P=0.510         | 
|POLY 1.5           |                                           P=0.325N     |                                    P=0.507         | 
|POLY 6             |                                           P=0.339N     |                                    P=0.511         | 
|LOGISTIC REGRESSION|                                           P=0.346N     |                                    P=0.158         | 
|COCH-ARM / FISHERS |                                           P=0.309N     |                                    P=0.490         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 12      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Vacuolization Cytoplasmic Focal                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  6/50 (12%)               11/50 (22%)  |           4/50 (8%)                3/49 (6%)       | 
|POLY-3 RATE (b)    |                  6/48.80                  11/46.50     |           4/44.92                  3/46.22         | 
|POLY-3 PERCENT (g) |                  12.3%                    23.7%        |           8.9%                     6.5%            | 
|TERMINAL (d)       |                  6/48 (13%)               9/43 (21%)   |           3/40 (8%)                3/41 (7%)       | 
|FIRST INCIDENCE    |                  727 (T)                  682          |           242                      733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.100      |                                    P=0.489N        | 
|POLY 3             |                                           P=0.120      |                                    P=0.482N        | 
|POLY 1.5           |                                           P=0.125      |                                    P=0.484N        | 
|POLY 6             |                                           P=0.116      |                                    P=0.484N        | 
|LOGISTIC REGRESSION|                                           P=0.116      |                                    P=0.564N        | 
|COCH-ARM / FISHERS |                                           P=0.143      |                                    P=0.511N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                1/50 (2%)    |           2/50 (4%)                0/49 (0%)       | 
|POLY-3 RATE (b)    |                  2/48.80                  1/46.15      |           2/43.96                  0/46.22         | 
|POLY-3 PERCENT (g) |                  4.1%                     2.2%         |           4.6%                     0.0%            | 
|TERMINAL (d)       |                  2/48 (4%)                1/43 (2%)    |           2/40 (5%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)      |           733 (T)                  ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.538N     |                                    P=0.233N        | 
|POLY 3             |                                           P=0.526N     |                                    P=0.221N        | 
|POLY 1.5           |                                           P=0.519N     |                                    P=0.223N        | 
|POLY 6             |                                           P=0.534N     |                                    P=0.222N        | 
|LOGISTIC REGRESSION|                                           P=0.538N     |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.500N     |                                    P=0.253N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 13      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Serosa                                                                                                                     | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                0/50 (0%)    |           0/50 (0%)                0/49 (0%)       | 
|POLY-3 RATE (b)    |                  2/48.80                  0/46.15      |           0/43.96                  0/46.22         | 
|POLY-3 PERCENT (g) |                  4.1%                     0.0%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/48 (4%)                0/43 (0%)    |           0/40 (0%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  ---          |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.263N     |                                    (e)             | 
|POLY 3             |                                           P=0.257N     |                                    (e)             | 
|POLY 1.5           |                                           P=0.252N     |                                    (e)             | 
|POLY 6             |                                           P=0.263N     |                                    (e)             | 
|LOGISTIC REGRESSION|                                           (e)          |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.247N     |                                    (e)             | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Infiltration Cellular Plasma Cell                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  1/48 (2%)                0/47 (0%)    |           3/49 (6%)                2/47 (4%)       | 
|POLY-3 RATE (b)    |                  1/46.80                  0/44.76      |           3/43.55                  2/44.59         | 
|POLY-3 PERCENT (g) |                  2.1%                     0.0%         |           6.9%                     4.5%            | 
|TERMINAL (d)       |                  1/46 (2%)                0/42 (0%)    |           3/40 (8%)                2/41 (5%)       | 
|FIRST INCIDENCE    |                  727 (T)                  ---          |           733 (T)                  733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.518N     |                                    P=0.489N        | 
|POLY 3             |                                           P=0.518N     |                                    P=0.487N        | 
|POLY 1.5           |                                           P=0.515N     |                                    P=0.490N        | 
|POLY 6             |                                           P=0.523N     |                                    P=0.488N        | 
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.489N        | 
|COCH-ARM / FISHERS |                                           P=0.505N     |                                    P=0.520N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 14      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery                                                                                                                        | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  3/6 (50%)                1/3 (33%)    |           1/5 (20%)                0/3 (0%)        | 
|POLY-3 RATE (b)    |                  3/5.64                   1/3.00       |           1/4.07                   0/2.22          | 
|POLY-3 PERCENT (g) |                  53.2%                    33.3%        |           24.6%                    0.0%            | 
|TERMINAL (d)       |                  3/5 (60%)                1/3 (33%)    |           1/2 (50%)                0/2 (0%)        | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)      |           733 (T)                  ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.500N     |                                    P=0.500N        | 
|POLY 3             |                                           P=0.629N     |                                    P=0.740N        | 
|POLY 1.5           |                                           P=0.646N     |                                    P=0.732N        | 
|POLY 6             |                                           P=0.604N     |                                    P=0.717N        | 
|LOGISTIC REGRESSION|                                           P=0.500N     |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.595N     |                                    P=0.625N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Fat                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  1/6 (17%)                1/3 (33%)    |           3/5 (60%)                2/3 (67%)       | 
|POLY-3 RATE (b)    |                  1/5.64                   1/3.00       |           3/4.73                   2/2.22          | 
|POLY-3 PERCENT (g) |                  17.7%                    33.3%        |           63.4%                    90.2%           | 
|TERMINAL (d)       |                  1/5 (20%)                1/3 (33%)    |           1/2 (50%)                2/2 (100%)      | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)      |           557                      733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.653      |                                    P=0.497N        | 
|POLY 3             |                                           P=0.697      |                                    P=0.716         | 
|POLY 1.5           |                                           P=0.696      |                                    P=0.722         | 
|POLY 6             |                                           P=0.699      |                                    P=0.724         | 
|LOGISTIC REGRESSION|                                           P=0.653      |                                    P=0.649         | 
|COCH-ARM / FISHERS |                                           P=0.583      |                                    P=0.714         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 15      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Mucosa                                                                                                                      | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  6/50 (12%)               12/50 (24%)  |           20/50 (40%)              14/49 (29%)     | 
|POLY-3 RATE (b)    |                  6/48.80                  12/46.15     |           20/45.11                 14/46.73        | 
|POLY-3 PERCENT (g) |                  12.3%                    26.0%        |           44.3%                    30.0%           | 
|TERMINAL (d)       |                  6/48 (13%)               12/43 (28%)  |           18/40 (45%)              11/41 (27%)     | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)      |           545                      633             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.058      |                                    P=0.131N        | 
|POLY 3             |                                           P=0.075      |                                    P=0.111N        | 
|POLY 1.5           |                                           P=0.080      |                                    P=0.114N        | 
|POLY 6             |                                           P=0.069      |                                    P=0.113N        | 
|LOGISTIC REGRESSION|                                           P=0.058      |                                    P=0.113N        | 
|COCH-ARM / FISHERS |                                           P=0.096      |                                    P=0.162N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Mucosa                                                                                                                      | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  4/50 (8%)                9/50 (18%)   |           6/50 (12%)               6/49 (12%)      | 
|POLY-3 RATE (b)    |                  4/48.80                  9/46.15      |           6/44.55                  6/46.58         | 
|POLY-3 PERCENT (g) |                  8.2%                     19.5%        |           13.5%                    12.9%           | 
|TERMINAL (d)       |                  4/48 (8%)                9/43 (21%)   |           5/40 (13%)               5/41 (12%)      | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)      |           545                      633             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.080      |                                    P=0.598N        | 
|POLY 3             |                                           P=0.097      |                                    P=0.587N        | 
|POLY 1.5           |                                           P=0.102      |                                    P=0.590N        | 
|POLY 6             |                                           P=0.092      |                                    P=0.588N        | 
|LOGISTIC REGRESSION|                                           P=0.080      |                                    P=0.610N        | 
|COCH-ARM / FISHERS |                                           P=0.117      |                                    P=0.606         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 16      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |           19/50 (38%)              20/49 (41%)     | 
|POLY-3 RATE (b)    |                                                        |           19/43.96                 20/46.60        | 
|POLY-3 PERCENT (g) |                                                        |           43.2%                    42.9%           | 
|TERMINAL (d)       |                                                        |           19/40 (48%)              19/41 (46%)     | 
|FIRST INCIDENCE    |                                                        |           733 (T)                  625             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |                                    P=0.544         | 
|POLY 3             |                                                        |                                    P=0.570N        | 
|POLY 1.5           |                                                        |                                    P=0.575         | 
|POLY 6             |                                                        |                                    P=0.564N        | 
|LOGISTIC REGRESSION|                                                        |                                    P=0.578         | 
|COCH-ARM / FISHERS |                                                        |                                    P=0.468         | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Duct                                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  0/50 (0%)                0/50 (0%)    |           2/50 (4%)                1/49 (2%)       | 
|POLY-3 RATE (b)    |                  0/48.80                  0/46.15      |           2/44.05                  1/46.22         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%         |           4.5%                     2.2%            | 
|TERMINAL (d)       |                  0/48 (0%)                0/43 (0%)    |           1/40 (3%)                1/41 (2%)       | 
|FIRST INCIDENCE    |                  ---                      ---          |           709                      733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           (e)          |                                    P=0.492N        | 
|POLY 3             |                                           (e)          |                                    P=0.478N        | 
|POLY 1.5           |                                           (e)          |                                    P=0.481N        | 
|POLY 6             |                                           (e)          |                                    P=0.480N        | 
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.483N        | 
|COCH-ARM / FISHERS |                                           (e)          |                                    P=0.508N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 17      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  0/50 (0%)                0/48 (0%)    |           7/49 (14%)               7/48 (15%)      | 
|POLY-3 RATE (b)    |                  0/48.80                  0/44.15      |           7/43.05                  7/45.22         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%         |           16.3%                    15.5%           | 
|TERMINAL (d)       |                  0/48 (0%)                0/41 (0%)    |           6/39 (15%)               7/40 (18%)      | 
|FIRST INCIDENCE    |                  ---                      ---          |           709                      733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           (e)          |                                    P=0.594N        | 
|POLY 3             |                                           (e)          |                                    P=0.573N        | 
|POLY 1.5           |                                           (e)          |                                    P=0.578N        | 
|POLY 6             |                                           (e)          |                                    P=0.576N        | 
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.583N        | 
|COCH-ARM / FISHERS |                                           (e)          |                                    P=0.597         | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  17/50 (34%)              14/50 (28%)  |                                                    | 
|POLY-3 RATE (b)    |                  17/49.16                 14/46.15     |                                                    | 
|POLY-3 PERCENT (g) |                  34.6%                    30.3%        |                                                    | 
|TERMINAL (d)       |                  16/48 (33%)              14/43 (33%)  |                                                    | 
|FIRST INCIDENCE    |                  626                      727 (T)      |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.472N     |                                                    | 
|POLY 3             |                                           P=0.415N     |                                                    | 
|POLY 1.5           |                                           P=0.391N     |                                                    | 
|POLY 6             |                                           P=0.443N     |                                                    | 
|LOGISTIC REGRESSION|                                           P=0.414N     |                                                    | 
|COCH-ARM / FISHERS |                                           P=0.333N     |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 18      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                3/50 (6%)    |                                                    | 
|POLY-3 RATE (b)    |                  2/48.80                  3/46.51      |                                                    | 
|POLY-3 PERCENT (g) |                  4.1%                     6.5%         |                                                    | 
|TERMINAL (d)       |                  2/48 (4%)                2/43 (5%)    |                                                    | 
|FIRST INCIDENCE    |                  727 (T)                  626          |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.455      |                                                    | 
|POLY 3             |                                           P=0.483      |                                                    | 
|POLY 1.5           |                                           P=0.487      |                                                    | 
|POLY 6             |                                           P=0.479      |                                                    | 
|LOGISTIC REGRESSION|                                           P=0.500      |                                                    | 
|COCH-ARM / FISHERS |                                           P=0.500      |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  0/50 (0%)                3/50 (6%)    |                                                    | 
|POLY-3 RATE (b)    |                  0/48.80                  3/46.15      |                                                    | 
|POLY-3 PERCENT (g) |                  0.0%                     6.5%         |                                                    | 
|TERMINAL (d)       |                  0/48 (0%)                3/43 (7%)    |                                                    | 
|FIRST INCIDENCE    |                  ---                      727 (T)      |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.103      |                                                    | 
|POLY 3             |                                           P=0.113      |                                                    | 
|POLY 1.5           |                                           P=0.114      |                                                    | 
|POLY 6             |                                           P=0.111      |                                                    | 
|LOGISTIC REGRESSION|                                           P=0.103      |                                                    | 
|COCH-ARM / FISHERS |                                           P=0.121      |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 19      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Epidermis                                                                                                                  | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                0/50 (0%)    |           0/50 (0%)                0/49 (0%)       | 
|POLY-3 RATE (b)    |                  2/48.80                  0/46.15      |           0/43.96                  0/46.22         | 
|POLY-3 PERCENT (g) |                  4.1%                     0.0%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/48 (4%)                0/43 (0%)    |           0/40 (0%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  ---          |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.263N     |                                    (e)             | 
|POLY 3             |                                           P=0.257N     |                                    (e)             | 
|POLY 1.5           |                                           P=0.252N     |                                    (e)             | 
|POLY 6             |                                           P=0.263N     |                                    (e)             | 
|LOGISTIC REGRESSION|                                           (e)          |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.247N     |                                    (e)             | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  17/50 (34%)              13/50 (26%)  |           17/50 (34%)              14/49 (29%)     | 
|POLY-3 RATE (b)    |                  17/49.64                 13/48.29     |           17/45.93                 14/47.60        | 
|POLY-3 PERCENT (g) |                  34.3%                    26.9%        |           37.0%                    29.4%           | 
|TERMINAL (d)       |                  16/48 (33%)              10/43 (23%)  |           12/40 (30%)              10/41 (24%)     | 
|FIRST INCIDENCE    |                  397                      310          |           9                        470             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.375N     |                                    P=0.314N        | 
|POLY 3             |                                           P=0.287N     |                                    P=0.287N        | 
|POLY 1.5           |                                           P=0.282N     |                                    P=0.298N        | 
|POLY 6             |                                           P=0.294N     |                                    P=0.286N        | 
|LOGISTIC REGRESSION|                                           P=0.195N     |                                    P=0.386N        | 
|COCH-ARM / FISHERS |                                           P=0.257N     |                                    P=0.358N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 20      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  3/50 (6%)                4/50 (8%)    |           8/50 (16%)               4/49 (8%)       | 
|POLY-3 RATE (b)    |                  3/49.64                  4/47.93      |           8/47.58                  4/47.34         | 
|POLY-3 PERCENT (g) |                  6.0%                     8.4%         |           16.8%                    8.5%            | 
|TERMINAL (d)       |                  2/48 (4%)                1/43 (2%)    |           2/40 (5%)                2/41 (5%)       | 
|FIRST INCIDENCE    |                  397                      121          |           242                      470             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.466      |                                    P=0.178N        | 
|POLY 3             |                                           P=0.484      |                                    P=0.180N        | 
|POLY 1.5           |                                           P=0.489      |                                    P=0.179N        | 
|POLY 6             |                                           P=0.479      |                                    P=0.182N        | 
|LOGISTIC REGRESSION|                                           P=0.584N     |                                    P=0.430N        | 
|COCH-ARM / FISHERS |                                           P=0.500      |                                    P=0.188N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  6/50 (12%)               8/50 (16%)   |           8/50 (16%)               14/49 (29%)     | 
|POLY-3 RATE (b)    |                  6/48.80                  8/46.51      |           8/43.96                  14/46.39        | 
|POLY-3 PERCENT (g) |                  12.3%                    17.2%        |           18.2%                    30.2%           | 
|TERMINAL (d)       |                  6/48 (13%)               7/43 (16%)   |           8/40 (20%)               13/41 (32%)     | 
|FIRST INCIDENCE    |                  727 (T)                  626          |           733 (T)                  688             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.309      |                                    P=0.125         | 
|POLY 3             |                                           P=0.353      |                                    P=0.138         | 
|POLY 1.5           |                                           P=0.361      |                                    P=0.134         | 
|POLY 6             |                                           P=0.346      |                                    P=0.138         | 
|LOGISTIC REGRESSION|                                           P=0.350      |                                    P=0.132         | 
|COCH-ARM / FISHERS |                                           P=0.387      |                                    P=0.103         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 21      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  0/50 (0%)                2/50 (4%)    |           0/50 (0%)                0/49 (0%)       | 
|POLY-3 RATE (b)    |                  0/48.80                  2/46.32      |           0/43.96                  0/46.22         | 
|POLY-3 PERCENT (g) |                  0.0%                     4.3%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/48 (0%)                1/43 (2%)    |           0/40 (0%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  ---                      682          |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.221      |                                    (e)             | 
|POLY 3             |                                           P=0.232      |                                    (e)             | 
|POLY 1.5           |                                           P=0.233      |                                    (e)             | 
|POLY 6             |                                           P=0.231      |                                    (e)             | 
|LOGISTIC REGRESSION|                                           P=0.237      |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.247      |                                    (e)             | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  0/50 (0%)                2/50 (4%)    |           0/50 (0%)                0/49 (0%)       | 
|POLY-3 RATE (b)    |                  0/48.80                  2/46.15      |           0/43.96                  0/46.22         | 
|POLY-3 PERCENT (g) |                  0.0%                     4.3%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/48 (0%)                2/43 (5%)    |           0/40 (0%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  ---                      727 (T)      |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.215      |                                    (e)             | 
|POLY 3             |                                           P=0.231      |                                    (e)             | 
|POLY 1.5           |                                           P=0.233      |                                    (e)             | 
|POLY 6             |                                           P=0.230      |                                    (e)             | 
|LOGISTIC REGRESSION|                                           P=0.215      |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.247      |                                    (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 22      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  1/50 (2%)                5/50 (10%)   |           3/50 (6%)                2/49 (4%)       | 
|POLY-3 RATE (b)    |                  1/48.80                  5/46.50      |           3/44.00                  2/46.22         | 
|POLY-3 PERCENT (g) |                  2.1%                     10.8%        |           6.8%                     4.3%            | 
|TERMINAL (d)       |                  1/48 (2%)                3/43 (7%)    |           2/40 (5%)                2/41 (5%)       | 
|FIRST INCIDENCE    |                  727 (T)                  682          |           722                      733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.087      |                                    P=0.491N        | 
|POLY 3             |                                           P=0.093      |                                    P=0.473N        | 
|POLY 1.5           |                                           P=0.095      |                                    P=0.477N        | 
|POLY 6             |                                           P=0.091      |                                    P=0.475N        | 
|LOGISTIC REGRESSION|                                           P=0.098      |                                    P=0.481N        | 
|COCH-ARM / FISHERS |                                           P=0.102      |                                    P=0.510N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular: Epithelium                                                                                                   | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  2/50 (4%)                0/50 (0%)    |           0/50 (0%)                0/49 (0%)       | 
|POLY-3 RATE (b)    |                  2/48.80                  0/46.15      |           0/43.96                  0/46.22         | 
|POLY-3 PERCENT (g) |                  4.1%                     0.0%         |           0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/48 (4%)                0/43 (0%)    |           0/40 (0%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  ---          |           ---                      ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.263N     |                                    (e)             | 
|POLY 3             |                                           P=0.257N     |                                    (e)             | 
|POLY 1.5           |                                           P=0.252N     |                                    (e)             | 
|POLY 6             |                                           P=0.263N     |                                    (e)             | 
|LOGISTIC REGRESSION|                                           (e)          |                                    (e)             | 
|COCH-ARM / FISHERS |                                           P=0.247N     |                                    (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 23      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Germinal Epithelium                                                                                                      | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  4/50 (8%)                2/50 (4%)    |                                                    | 
|POLY-3 RATE (b)    |                  4/48.80                  2/46.32      |                                                    | 
|POLY-3 PERCENT (g) |                  8.2%                     4.3%         |                                                    | 
|TERMINAL (d)       |                  4/48 (8%)                1/43 (2%)    |                                                    | 
|FIRST INCIDENCE    |                  727 (T)                  682          |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.386N     |                                                    | 
|POLY 3             |                                           P=0.366N     |                                                    | 
|POLY 1.5           |                                           P=0.359N     |                                                    | 
|POLY 6             |                                           P=0.373N     |                                                    | 
|LOGISTIC REGRESSION|                                           P=0.357N     |                                                    | 
|COCH-ARM / FISHERS |                                           P=0.339N     |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  41/50 (82%)              43/49 (88%)  |           26/47 (55%)              31/48 (65%)     | 
|POLY-3 RATE (b)    |                  41/49.16                 43/49.00     |           26/46.00                 31/47.21        | 
|POLY-3 PERCENT (g) |                  83.4%                    87.8%        |           56.5%                    65.7%           | 
|TERMINAL (d)       |                  40/48 (83%)              36/42 (86%)  |           19/39 (49%)              25/40 (63%)     | 
|FIRST INCIDENCE    |                  626                      121          |           242                      441             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           P=0.081      |                                    P=0.291         | 
|POLY 3             |                                           P=0.372      |                                    P=0.244         | 
|POLY 1.5           |                                           P=0.351      |                                    P=0.256         | 
|POLY 6             |                                           P=0.385      |                                    P=0.234         | 
|LOGISTIC REGRESSION|                                           P=0.297      |                                    P=0.216         | 
|COCH-ARM / FISHERS |                                           P=0.303      |                                    P=0.238         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 24      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  0/50 (0%)                0/49 (0%)    |           11/47 (23%)              7/48 (15%)      | 
|POLY-3 RATE (b)    |                  0/48.80                  0/45.15      |           11/42.19                 7/45.22         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%         |           26.1%                    15.5%           | 
|TERMINAL (d)       |                  0/48 (0%)                0/42 (0%)    |           11/39 (28%)              7/40 (18%)      | 
|FIRST INCIDENCE    |                  ---                      ---          |           733 (T)                  733 (T)         | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           (e)          |                                    P=0.195N        | 
|POLY 3             |                                           (e)          |                                    P=0.167N        | 
|POLY 1.5           |                                           (e)          |                                    P=0.168N        | 
|POLY 6             |                                           (e)          |                                    P=0.170N        | 
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.195N        | 
|COCH-ARM / FISHERS |                                           (e)          |                                    P=0.202N        | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland                                                                                                                    | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                  0/50 (0%)                0/50 (0%)    |           2/48 (4%)                0/49 (0%)       | 
|POLY-3 RATE (b)    |                  0/48.80                  0/46.15      |           2/43.11                  0/46.22         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%         |           4.6%                     0.0%            | 
|TERMINAL (d)       |                  0/48 (0%)                0/43 (0%)    |           2/40 (5%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---          |           733 (T)                  ---             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                           (e)          |                                    P=0.233N        | 
|POLY 3             |                                           (e)          |                                    P=0.215N        | 
|POLY 1.5           |                                           (e)          |                                    P=0.214N        | 
|POLY 6             |                                           (e)          |                                    P=0.219N        | 
|LOGISTIC REGRESSION|                                           (e)          |                                    (e)             | 
|COCH-ARM / FISHERS |                                           (e)          |                                    P=0.242N        | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/19/00                           EXPERIMENT: 56348 TEST: 04                                            Page 25      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                          CITRAL        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |                  UNTREAT                  VEHICLE      |           UNTREAT                  VEHICLE         | 
|                   |                  CONTROL                  CONTROL      |           CONTROL                  CONTROL         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |           43/50 (86%)              45/49 (92%)     | 
|POLY-3 RATE (b)    |                                                        |           43/45.55                 45/47.68        | 
|POLY-3 PERCENT (g) |                                                        |           94.4%                    94.4%           | 
|TERMINAL (d)       |                                                        |           38/40 (95%)              40/41 (98%)     | 
|FIRST INCIDENCE    |                                                        |           544                      441             | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |                                    P=0.516         | 
|POLY 3             |                                                        |                                    P=0.681N        | 
|POLY 1.5           |                                                        |                                    P=0.640         | 
|POLY 6             |                                                        |                                    P=0.662         | 
|LOGISTIC REGRESSION|                                                        |                                    P=0.625N        | 
|COCH-ARM / FISHERS |                                                        |                                    P=0.274         | 
|=================================================================================================================================| 
(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).