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TDMS Study 56348-04 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                           CITRAL                                        DATE: 07/06/01       
EXPERIMENT: 56348 TEST: 04                                                                                     TIME: 08:03:53       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55384                              ROUTE: DOSED FEED                                              NTP C#: C56348       
PATHOLOGIST: DR. M. RYAN                                                                                           CAS: 5392-40-5       
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    UNTREAT CONTROL                                                               
                                       INCLUDE 002    UNTREAT CONTROL                                                               
                                       INCLUDE 005    500 PPM                                                                       
                                       INCLUDE 006    500 PPM                                                                       
                                       INCLUDE 007    1000 PPM                                                                      
                                       INCLUDE 008    1000 PPM                                                                      
                                       INCLUDE 009    2000 PPM                                                                      
                                       INCLUDE 010    2000 PPM                                                                      
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                           CITRAL                                        DATE: 07/06/01       
EXPERIMENT: 56348 TEST: 04                                                                                     TIME: 08:03:53       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55384                              ROUTE: DOSED FEED                                              NTP C#: C56348       
PATHOLOGIST: DR. M. RYAN                                                                                           CAS: 5392-40-5       
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                      CITRAL                                                                                      
===============================================================                                                                     
Male Mice                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Adrenal Cortex: Subcapsular            Hyperplasia                                                                                  
Bone Marrow                            Hyperplasia                                                                                  
Islets, Pancreatic                     Hyperplasia                                                                                  
Kidney                                 Nephropathy                                                                                  
Kidney: Renal Tubule                   Mineralization                                                                               
Liver                                  Angiectasis                                                                                  
                                       Clear Cell Focus                                                                             
Lung                                   Hemorrhage                                                                                   
Oral Mucosa                            Inflammation Chronic                                                                         
                                       Ulcer                                                                                        
Parathyroid Gland                      Cyst                                                                                         
Pituitary Gland: Pars Distalis         Hyperplasia Focal                                                                            
Spleen                                 Hematopoietic Cell Proliferation                                                             
Stomach, Forestomach                   Inflammation                                                                                 
Thymus                                 Atrophy                                                                                      
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Bone Marrow                            Hyperplasia                                                                                  
Kidney: Renal Tubule                   Mineralization                                                                               
Liver                                  Infiltration Cellular Lymphocyte                                                             
                                       Inflammation Granulomatous                                                                   
Oral Mucosa                            Inflammation Chronic                                                                         
                                       Ulcer                                                                                        
Spleen: Lymphoid Follicle              Atrophy                                                                                      
Thymus                                 Atrophy                                                                                      
                                       Hyperplasia Lymphoid                                                                         
Uterus: Endometrium                    Hyperplasia Cystic                                                                           
===============================================================                                                                     
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    3/50 (6%)    1/50 (2%)    5/50 (10%)  |1/50 (2%)    0/50 (0%)    2/50 (4%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     1/48.80      3/45.50      1/47.99      5/45.81     |1/43.96      0/47.89      2/47.49      2/45.29      | 
|POLY-3 PERCENT (g) |     2.1%         6.6%         2.1%         10.9%       |2.3%         0.0%         4.2%         4.4%         | 
|TERMINAL (d)       |     1/48 (2%)    2/40 (5%)    1/42 (2%)    5/40 (13%)  |1/40 (3%)    0/45 (0%)    2/43 (5%)    2/40 (5%)    | 
|FIRST INCIDENCE    |     727 (T)      626          727 (T)      727 (T)     |733 (T)      ---          733 (T)      733 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.057      P=0.251      P=0.732      P=0.067     |P=0.233      P=0.477N     P=0.525      P=0.500      | 
|POLY 3             |     P=0.068      P=0.281      P=0.757      P=0.088     |P=0.241      P=0.483N     P=0.527      P=0.510      | 
|POLY 1.5           |     P=0.072      P=0.291      P=0.758      P=0.094     |P=0.246      P=0.486N     P=0.524      P=0.513      | 
|POLY 6             |     P=0.064      P=0.271      P=0.753      P=0.081     |P=0.235      P=0.482N     P=0.527      P=0.505      | 
|LOGISTIC REGRESSION|     P=0.070      P=0.311      P=0.732      P=0.067     |P=0.233      (e)          P=0.525      P=0.500      | 
|COCH-ARM / FISHERS |     P=0.077      P=0.309      P=0.753N     P=0.102     |P=0.246      P=0.500N     P=0.500      P=0.500      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     25/50 (50%)  17/50 (34%)  28/50 (56%)  22/50 (44%) |3/50 (6%)    2/50 (4%)    2/50 (4%)    3/50 (6%)    | 
|POLY-3 RATE (b)    |     25/49.16     17/45.14     28/49.18     22/47.26    |3/43.96      2/47.89      2/47.49      3/45.75      | 
|POLY-3 PERCENT (g) |     50.9%        37.7%        56.9%        46.6%       |6.8%         4.2%         4.2%         6.6%         | 
|TERMINAL (d)       |     24/48 (50%)  17/40 (43%)  26/42 (62%)  18/40 (45%) |3/40 (8%)    2/45 (4%)    2/43 (5%)    2/40 (5%)    | 
|FIRST INCIDENCE    |     626          727 (T)      427          456         |733 (T)      733 (T)      733 (T)      597          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.287      P=0.251N     P=0.145      P=0.498     |P=0.531      P=0.446N     P=0.467N     P=0.658N     | 
|POLY 3             |     P=0.523      P=0.139N     P=0.344      P=0.414N    |P=0.547      P=0.461N     P=0.465N     P=0.644N     | 
|POLY 1.5           |     P=0.535      P=0.110N     P=0.351      P=0.382N    |P=0.551      P=0.467N     P=0.469N     P=0.643N     | 
|POLY 6             |     P=0.499      P=0.181N     P=0.322      P=0.458N    |P=0.542      P=0.458N     P=0.465N     P=0.648N     | 
|LOGISTIC REGRESSION|     P=0.479      P=0.179N     P=0.341      P=0.399N    |P=0.550      P=0.446N     P=0.467N     P=0.651N     | 
|COCH-ARM / FISHERS |     P=0.538N     P=0.078N     P=0.344      P=0.344N    |P=0.544      P=0.500N     P=0.500N     P=0.661N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex: Subcapsular                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     36/50 (72%)  40/50 (80%)  47/50 (94%)  39/50 (78%) |47/50 (94%)  50/50 (100%) 49/50 (98%)  49/50 (98%)  | 
|POLY-3 RATE (b)    |     36/48.80     40/47.54     47/49.93     39/48.55    |47/47.48     50/50.00     49/49.68     49/50.00     | 
|POLY-3 PERCENT (g) |     73.8%        84.2%        94.1%        80.3%       |99.0%        100.0%       98.6%        98.0%        | 
|TERMINAL (d)       |     36/48 (75%)  35/40 (88%)  40/42 (95%)  32/40 (80%) |40/40 (100%) 45/45 (100%) 43/43 (100%) 39/40 (98%)  | 
|FIRST INCIDENCE    |     727 (T)      419          427          447         |242          413          469          264          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.035 *    P=0.013 *    P<0.001 **   P=0.037 *   |P=0.274      P=0.336N     P=0.450N     P=0.424      | 
|POLY 3             |     P=0.251      P=0.153      P=0.005 **   P=0.297     |P=0.388N     P=0.877      P=0.842N     P=0.680N     | 
|POLY 1.5           |     P=0.254      P=0.186      P=0.004 **   P=0.310     |P=0.514N     P=0.573      P=0.807      P=0.769N     | 
|POLY 6             |     P=0.240      P=0.121      P=0.005 **   P=0.277     |P=0.277N     P=1.000      P=0.929N     P=0.588N     | 
|LOGISTIC REGRESSION|     P=0.200      P=0.104      P=0.003 **   P=0.227     |P=0.590      P=0.581      P=0.703N     P=0.611      | 
|COCH-ARM / FISHERS |     P=0.252      P=0.241      P=0.003 **   P=0.322     |P=0.296      P=0.121      P=0.309      P=0.309      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/49 (0%)    0/50 (0%)    1/50 (2%)    1/50 (2%)   |1/50 (2%)    0/50 (0%)    2/50 (4%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/47.80      0/45.14      1/48.06      1/45.81     |1/43.96      0/47.89      2/47.49      2/45.29      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.1%         2.2%        |2.3%         0.0%         4.2%         4.4%         | 
|TERMINAL (d)       |     0/47 (0%)    0/40 (0%)    0/42 (0%)    1/40 (3%)   |1/40 (3%)    0/45 (0%)    2/43 (5%)    2/40 (5%)    | 
|FIRST INCIDENCE    |     ---          ---          710          727 (T)     |733 (T)      ---          733 (T)      733 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.215      (e)          P=0.483      P=0.468     |P=0.233      P=0.477N     P=0.525      P=0.500      | 
|POLY 3             |     P=0.228      (e)          P=0.501      P=0.492     |P=0.241      P=0.483N     P=0.527      P=0.510      | 
|POLY 1.5           |     P=0.233      (e)          P=0.503      P=0.497     |P=0.246      P=0.486N     P=0.524      P=0.513      | 
|POLY 6             |     P=0.221      (e)          P=0.498      P=0.484     |P=0.235      P=0.482N     P=0.527      P=0.505      | 
|LOGISTIC REGRESSION|     P=0.230      (e)          P=0.505      P=0.468     |P=0.233      (e)          P=0.525      P=0.500      | 
|COCH-ARM / FISHERS |     P=0.238      (e)          P=0.505      P=0.505     |P=0.246      P=0.500N     P=0.500      P=0.500      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone                                                                                                                             | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    3/50 (6%)    0/50 (0%)    1/50 (2%)   |19/50 (38%)  22/50 (44%)  21/50 (42%)  18/50 (36%)  | 
|POLY-3 RATE (b)    |     0/48.80      3/45.14      0/47.99      1/45.81     |19/44.00     22/47.89     21/47.87     18/45.39     | 
|POLY-3 PERCENT (g) |     0.0%         6.7%         0.0%         2.2%        |43.2%        45.9%        43.9%        39.7%        | 
|TERMINAL (d)       |     0/48 (0%)    3/40 (8%)    0/42 (0%)    1/40 (3%)   |18/40 (45%)  22/45 (49%)  20/43 (47%)  17/40 (43%)  | 
|FIRST INCIDENCE    |     ---          727 (T)      ---          727 (T)     |722          733 (T)      625          706          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.592      P=0.091      (e)          P=0.464     |P=0.436N     P=0.534      P=0.537      P=0.502N     | 
|POLY 3             |     P=0.604      P=0.106      (e)          P=0.487     |P=0.359N     P=0.478      P=0.557      P=0.451N     | 
|POLY 1.5           |     P=0.617      P=0.111      (e)          P=0.493     |P=0.345N     P=0.457      P=0.537      P=0.442N     | 
|POLY 6             |     P=0.587      P=0.100      (e)          P=0.480     |P=0.385N     P=0.487      P=0.564      P=0.473N     | 
|LOGISTIC REGRESSION|     (e)          P=0.091      (e)          P=0.464     |P=0.422N     P=0.500      P=0.542      P=0.513N     | 
|COCH-ARM / FISHERS |     P=0.634      P=0.121      (e)          P=0.500     |P=0.385N     P=0.342      P=0.419      P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     9/50 (18%)   18/50 (36%)  14/50 (28%)  14/50 (28%) |2/50 (4%)    6/50 (12%)   6/50 (12%)   13/50 (26%)  | 
|POLY-3 RATE (b)    |     9/48.80      18/47.35     14/48.08     14/47.41    |2/44.05      6/48.30      6/48.29      13/48.27     | 
|POLY-3 PERCENT (g) |     18.4%        38.0%        29.1%        29.5%       |4.5%         12.4%        12.4%        26.9%        | 
|TERMINAL (d)       |     9/48 (19%)   14/40 (35%)  12/42 (29%)  10/40 (25%) |1/40 (3%)    5/45 (11%)   4/43 (9%)    8/40 (20%)   | 
|FIRST INCIDENCE    |     727 (T)      419          710          447         |709          615          469          264          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.189      P=0.013 *    P=0.099      P=0.089     |P<0.001 **   P=0.177      P=0.165      P=0.004 **   | 
|POLY 3             |     P=0.272      P=0.026 *    P=0.160      P=0.150     |P=0.002 **   P=0.165      P=0.165      P=0.003 **   | 
|POLY 1.5           |     P=0.288      P=0.029 *    P=0.165      P=0.159     |P<0.001 **   P=0.160      P=0.160      P=0.003 **   | 
|POLY 6             |     P=0.251      P=0.023 *    P=0.151      P=0.138     |P=0.002 **   P=0.169      P=0.166      P=0.003 **   | 
|LOGISTIC REGRESSION|     P=0.316      P=0.043 *    P=0.127      P=0.184     |P<0.001 **   P=0.151      P=0.129      P<0.001 **   | 
|COCH-ARM / FISHERS |     P=0.306      P=0.035 *    P=0.171      P=0.171     |P<0.001 **   P=0.134      P=0.134      P=0.002 **   | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart: Artery                                                                                                                    | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    1/50 (2%)   |0/50 (0%)    2/50 (4%)    1/50 (2%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/48.80      1/45.14      0/47.99      1/45.81     |0/43.96      2/47.89      1/47.49      2/45.29      | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         0.0%         2.2%        |0.0%         4.2%         2.1%         4.4%         | 
|TERMINAL (d)       |     0/48 (0%)    1/40 (3%)    0/42 (0%)    1/40 (3%)   |0/40 (0%)    2/45 (4%)    1/43 (2%)    2/40 (5%)    | 
|FIRST INCIDENCE    |     ---          727 (T)      ---          727 (T)     |---          733 (T)      733 (T)      733 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.376      P=0.464      (e)          P=0.464     |P=0.233      P=0.265      P=0.514      P=0.238      | 
|POLY 3             |     P=0.388      P=0.484      (e)          P=0.487     |P=0.256      P=0.257      P=0.515      P=0.244      | 
|POLY 1.5           |     P=0.396      P=0.491      (e)          P=0.493     |P=0.259      P=0.254      P=0.514      P=0.245      | 
|POLY 6             |     P=0.378      P=0.477      (e)          P=0.480     |P=0.251      P=0.258      P=0.515      P=0.240      | 
|LOGISTIC REGRESSION|     (e)          P=0.464      (e)          P=0.464     |(e)          P=0.265      P=0.514      P=0.238      | 
|COCH-ARM / FISHERS |     P=0.405      P=0.500      (e)          P=0.500     |P=0.246      P=0.247      P=0.500      P=0.247      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart: Myocardium                                                                                                                | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    3/50 (6%)    1/50 (2%)   |3/50 (6%)    1/50 (2%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     1/48.80      0/45.14      3/47.99      1/45.81     |3/44.55      1/47.89      1/47.49      1/45.41      | 
|POLY-3 PERCENT (g) |     2.1%         0.0%         6.3%         2.2%        |6.7%         2.1%         2.1%         2.2%         | 
|TERMINAL (d)       |     1/48 (2%)    0/40 (0%)    3/42 (7%)    1/40 (3%)   |2/40 (5%)    1/45 (2%)    1/43 (2%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      ---          727 (T)      727 (T)     |544          733 (T)      733 (T)      700          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.422      P=0.536N     P=0.259      P=0.720     |P=0.247N     P=0.271N     P=0.282N     P=0.306N     | 
|POLY 3             |     P=0.451      P=0.516N     P=0.300      P=0.746     |P=0.247N     P=0.280N     P=0.283N     P=0.298N     | 
|POLY 1.5           |     P=0.460      P=0.509N     P=0.303      P=0.752     |P=0.245N     P=0.283N     P=0.284N     P=0.295N     | 
|POLY 6             |     P=0.438      P=0.523N     P=0.294      P=0.738     |P=0.250N     P=0.280N     P=0.285N     P=0.305N     | 
|LOGISTIC REGRESSION|     P=0.422      (e)          P=0.259      P=0.720     |P=0.246N     P=0.314N     P=0.313N     P=0.310N     | 
|COCH-ARM / FISHERS |     P=0.470      P=0.500N     P=0.309      P=0.753N    |P=0.242N     P=0.309N     P=0.309N     P=0.309N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart: Valve                                                                                                                     | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    1/50 (2%)    2/50 (4%)   |2/50 (4%)    4/50 (8%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/48.80      1/45.95      1/48.11      2/46.99     |2/45.11      4/48.63      0/47.49      1/46.24      | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         2.1%         4.3%        |4.4%         8.2%         0.0%         2.2%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    0/42 (0%)    0/40 (0%)   |0/40 (0%)    2/45 (4%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          419          697          447         |544          600          ---          264          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.151      P=0.500      P=0.487      P=0.237     |P=0.199N     P=0.389      P=0.221N     P=0.480N     | 
|POLY 3             |     P=0.148      P=0.488      P=0.497      P=0.229     |P=0.189N     P=0.373      P=0.226N     P=0.491N     | 
|POLY 1.5           |     P=0.151      P=0.493      P=0.499      P=0.233     |P=0.187N     P=0.368      P=0.226N     P=0.487N     | 
|POLY 6             |     P=0.143      P=0.482      P=0.495      P=0.223     |P=0.195N     P=0.375      P=0.229N     P=0.500N     | 
|LOGISTIC REGRESSION|     P=0.144      P=0.609      P=0.502      P=0.292     |P=0.307N     P=0.238      P=0.334N     P=0.712N     | 
|COCH-ARM / FISHERS |     P=0.153      P=0.500      P=0.500      P=0.247     |P=0.199N     P=0.339      P=0.247N     P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Duodenum: Epithelium                                                                                            | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/49 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)    | 
|POLY-3 RATE (b)    |     2/48.80      0/45.14      0/47.27      0/45.81     |0/43.96      0/47.89      0/47.49      0/44.29      | 
|POLY-3 PERCENT (g) |     4.1%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/48 (4%)    0/40 (0%)    0/42 (0%)    0/40 (0%)   |0/40 (0%)    0/45 (0%)    0/43 (0%)    0/39 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      ---          ---          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.132N     P=0.280N     P=0.268N     P=0.280N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.107N     P=0.255N     P=0.245N     P=0.252N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.110N     P=0.248N     P=0.243N     P=0.246N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.104N     P=0.264N     P=0.247N     P=0.260N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.132N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.116N     P=0.247N     P=0.253N     P=0.247N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Jejunum: Peyer's Patch                                                                                          | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)   |2/50 (4%)    0/50 (0%)    2/50 (4%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/48.80      0/45.14      1/47.99      0/45.81     |2/43.96      0/47.89      2/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.1%         0.0%        |4.6%         0.0%         4.2%         0.0%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    1/42 (2%)    0/40 (0%)   |2/40 (5%)    0/45 (0%)    2/43 (5%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          727 (T)      ---         |733 (T)      ---          733 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.675      (e)          P=0.473      (e)         |P=0.251N     P=0.213N     P=0.669N     P=0.238N     | 
|POLY 3             |     P=0.675      (e)          P=0.497      (e)         |P=0.255N     P=0.219N     P=0.666N     P=0.231N     | 
|POLY 1.5           |     P=0.684      (e)          P=0.498      (e)         |P=0.251N     P=0.222N     P=0.669N     P=0.229N     | 
|POLY 6             |     P=0.663      (e)          P=0.494      (e)         |P=0.260N     P=0.217N     P=0.666N     P=0.234N     | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.473      (e)         |P=0.251N     (e)          P=0.669N     (e)          | 
|COCH-ARM / FISHERS |     P=0.695      (e)          P=0.500      (e)         |P=0.247N     P=0.247N     P=0.691N     P=0.247N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     15/50 (30%)  28/50 (56%)  30/50 (60%)  9/50 (18%)  |2/50 (4%)    3/50 (6%)    1/50 (2%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     15/48.80     28/47.42     30/48.38     9/47.10     |2/43.96      3/48.03      1/47.49      2/45.29      | 
|POLY-3 PERCENT (g) |     30.7%        59.1%        62.0%        19.1%       |4.6%         6.3%         2.1%         4.4%         | 
|TERMINAL (d)       |     15/48 (31%)  23/40 (58%)  27/42 (64%)  6/40 (15%)  |2/40 (5%)    2/45 (4%)    1/43 (2%)    2/40 (5%)    | 
|FIRST INCIDENCE    |     727 (T)      419          682          456         |733 (T)      698          733 (T)      733 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.121N     P<0.001 **   P<0.001 **   P=0.246N    |P=0.514N     P=0.551      P=0.475N     P=0.695      | 
|POLY 3             |     P=0.039N*    P=0.004 **   P<0.001 **   P=0.140N    |P=0.491N     P=0.540      P=0.473N     P=0.683N     | 
|POLY 1.5           |     P=0.033N*    P=0.004 **   P<0.001 **   P=0.131N    |P=0.489N     P=0.534      P=0.476N     P=0.681N     | 
|POLY 6             |     P=0.051N     P=0.003 **   P<0.001 **   P=0.154N    |P=0.497N     P=0.544      P=0.473N     P=0.689N     | 
|LOGISTIC REGRESSION|     P=0.040N*    P=0.005 **   P<0.001 **   P=0.118N    |P=0.505N     P=0.539      P=0.475N     P=0.695      | 
|COCH-ARM / FISHERS |     P=0.036N*    P=0.007 **   P=0.002 **   P=0.121N    |P=0.500N     P=0.500      P=0.500N     P=0.691N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Infarct                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    5/50 (10%)   6/50 (12%)   3/50 (6%)   |4/50 (8%)    1/50 (2%)    5/50 (10%)   2/50 (4%)    | 
|POLY-3 RATE (b)    |     2/48.80      5/45.57      6/48.02      3/46.99     |4/45.11      1/47.89      5/47.55      2/46.61      | 
|POLY-3 PERCENT (g) |     4.1%         11.0%        12.5%        6.4%        |8.9%         2.1%         10.5%        4.3%         | 
|TERMINAL (d)       |     2/48 (4%)    4/40 (10%)   5/42 (12%)   1/40 (3%)   |2/40 (5%)    1/45 (2%)    4/43 (9%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      601          720          447         |544          733 (T)      717          264          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.430      P=0.157      P=0.099      P=0.449     |P=0.427N     P=0.154N     P=0.546      P=0.327N     | 
|POLY 3             |     P=0.477      P=0.190      P=0.128      P=0.483     |P=0.419N     P=0.161N     P=0.533      P=0.322N     | 
|POLY 1.5           |     P=0.489      P=0.200      P=0.131      P=0.491     |P=0.412N     P=0.162N     P=0.534      P=0.318N     | 
|POLY 6             |     P=0.458      P=0.179      P=0.124      P=0.471     |P=0.428N     P=0.163N     P=0.526      P=0.331N     | 
|LOGISTIC REGRESSION|     P=0.520      P=0.208      P=0.111      P=0.601     |P=0.484N     P=0.208N     P=0.488      P=0.446N     | 
|COCH-ARM / FISHERS |     P=0.501      P=0.218      P=0.134      P=0.500     |P=0.420N     P=0.181N     P=0.500      P=0.339N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Metaplasia Osseous                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    3/50 (6%)    0/50 (0%)    1/50 (2%)   |0/50 (0%)    3/50 (6%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/48.80      3/45.68      0/47.99      1/46.22     |0/43.96      3/47.89      1/47.55      0/45.29      | 
|POLY-3 PERCENT (g) |     4.1%         6.6%         0.0%         2.2%        |0.0%         6.3%         2.1%         0.0%         | 
|TERMINAL (d)       |     2/48 (4%)    1/40 (3%)    0/42 (0%)    0/40 (0%)   |0/40 (0%)    3/45 (7%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      626          ---          608         |---          733 (T)      717          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.273N     P=0.430      P=0.268N     P=0.547N    |P=0.375N     P=0.143      P=0.514      (e)          | 
|POLY 3             |     P=0.252N     P=0.470      P=0.241N     P=0.519N    |P=0.344N     P=0.135      P=0.516      (e)          | 
|POLY 1.5           |     P=0.248N     P=0.482      P=0.239N     P=0.511N    |P=0.343N     P=0.133      P=0.514      (e)          | 
|POLY 6             |     P=0.258N     P=0.458      P=0.245N     P=0.529N    |P=0.349N     P=0.136      P=0.516      (e)          | 
|LOGISTIC REGRESSION|     P=0.228N     P=0.522      (e)          P=0.468N    |P=0.368N     P=0.143      P=0.512      (e)          | 
|COCH-ARM / FISHERS |     P=0.242N     P=0.500      P=0.247N     P=0.500N    |P=0.366N     P=0.121      P=0.500      (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     45/50 (90%)  36/50 (72%)  46/50 (92%)  38/50 (76%) |13/50 (26%)  16/50 (32%)  15/50 (30%)  17/50 (34%)  | 
|POLY-3 RATE (b)    |     45/48.80     36/45.50     46/49.20     38/46.93    |13/45.61     16/48.59     15/48.27     17/45.75     | 
|POLY-3 PERCENT (g) |     92.2%        79.1%        93.5%        81.0%       |28.5%        32.9%        31.1%        37.2%        | 
|TERMINAL (d)       |     45/48 (94%)  35/40 (88%)  39/42 (93%)  34/40 (85%) |10/40 (25%)  14/45 (31%)  13/43 (30%)  16/40 (40%)  | 
|FIRST INCIDENCE    |     727 (T)      626          616          626         |243          615          618          597          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.352      P=0.408N     P=0.052      P=0.571     |P=0.229      P=0.468      P=0.503      P=0.264      | 
|POLY 3             |     P=0.158N     P=0.049N*    P=0.560      P=0.081N    |P=0.244      P=0.405      P=0.482      P=0.255      | 
|POLY 1.5           |     P=0.152N     P=0.030N*    P=0.535      P=0.064N    |P=0.262      P=0.394      P=0.475      P=0.270      | 
|POLY 6             |     P=0.174N     P=0.090N     P=0.592      P=0.111N    |P=0.220      P=0.414      P=0.483      P=0.234      | 
|LOGISTIC REGRESSION|     P=0.337N     P=0.198N     P=0.429      P=0.238N    |P=0.271      P=0.344      P=0.423      P=0.280      | 
|COCH-ARM / FISHERS |     P=0.165N     P=0.020N*    P=0.500      P=0.054N    |P=0.258      P=0.330      P=0.412      P=0.257      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/50 (16%)   6/50 (12%)   6/50 (12%)   4/50 (8%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     8/48.80      6/46.13      6/48.78      4/45.81     |1/43.96      0/47.89      0/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     16.4%        13.0%        12.3%        8.7%        |2.3%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     8/48 (17%)   4/40 (10%)   5/42 (12%)   4/40 (10%)  |1/40 (3%)    0/45 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      419          427          727 (T)     |733 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.220N     P=0.518N     P=0.484N     P=0.277N    |P=0.307N     P=0.477N     P=0.486N     P=0.500N     | 
|POLY 3             |     P=0.171N     P=0.431N     P=0.387N     P=0.210N    |P=0.314N     P=0.483N     P=0.485N     P=0.494N     | 
|POLY 1.5           |     P=0.163N     P=0.413N     P=0.385N     P=0.196N    |P=0.314N     P=0.486N     P=0.486N     P=0.493N     | 
|POLY 6             |     P=0.184N     P=0.453N     P=0.396N     P=0.229N    |P=0.313N     P=0.482N     P=0.485N     P=0.497N     | 
|LOGISTIC REGRESSION|     P=0.143N     P=0.364N     P=0.377N     P=0.277N    |P=0.307N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.152N     P=0.387N     P=0.387N     P=0.178N    |P=0.306N     P=0.500N     P=0.500N     P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    2/50 (4%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/48.80      1/45.14      2/47.99      2/45.98     |0/43.96      0/47.89      0/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     4.1%         2.2%         4.2%         4.4%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/48 (4%)    1/40 (3%)    2/42 (5%)    1/40 (3%)   |0/40 (0%)    0/45 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      727 (T)      727 (T)      682         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.471      P=0.564N     P=0.646      P=0.629     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.513      P=0.527N     P=0.687      P=0.672     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.519      P=0.516N     P=0.690      P=0.681     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.504      P=0.539N     P=0.682      P=0.660     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.504      P=0.564N     P=0.646      P=0.684     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.526      P=0.500N     P=0.691N     P=0.691N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     45/50 (90%)  43/50 (86%)  50/50 (100%) 33/50 (66%) |3/50 (6%)    14/50 (28%)  18/50 (36%)  6/50 (12%)   | 
|POLY-3 RATE (b)    |     45/49.64     43/47.76     50/50.00     33/47.01    |3/44.92      14/48.89     18/48.48     6/45.91      | 
|POLY-3 PERCENT (g) |     90.7%        90.0%        100.0%       70.2%       |6.7%         28.6%        37.1%        13.1%        | 
|TERMINAL (d)       |     44/48 (92%)  38/40 (95%)  42/42 (100%) 29/40 (73%) |2/40 (5%)    11/45 (24%)  15/43 (35%)  4/40 (10%)   | 
|FIRST INCIDENCE    |     397          419          427          608         |243          600          575          576          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.108N     P=0.088      P=0.003 **   P=0.158N    |P=0.417      P=0.010 *    P<0.001 **   P=0.254      | 
|POLY 3             |     P<0.001N**   P=0.599N     P=0.035 *    P=0.008N**  |P=0.456      P=0.005 **   P<0.001 **   P=0.253      | 
|POLY 1.5           |     P<0.001N**   P=0.510N     P=0.033 *    P=0.005N**  |P=0.469      P=0.005 **   P<0.001 **   P=0.255      | 
|POLY 6             |     P<0.001N**   P=0.601      P=0.040 *    P=0.012N*   |P=0.437      P=0.006 **   P<0.001 **   P=0.248      | 
|LOGISTIC REGRESSION|     P<0.001N**   P=0.557N     P=0.032 *    P=0.009N**  |P=0.441      P=0.003 **   P<0.001 **   P=0.213      | 
|COCH-ARM / FISHERS |     P<0.001N**   P=0.380N     P=0.028 *    P=0.004N**  |P=0.443      P=0.003 **   P<0.001 **   P=0.243      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/48.80      0/45.14      0/47.99      2/45.81     |0/43.96      0/47.89      0/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         4.4%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    0/42 (0%)    2/40 (5%)   |0/40 (0%)    0/45 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          727 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.040 *    (e)          (e)          P=0.199     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.044 *    (e)          (e)          P=0.224     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.045 *    (e)          (e)          P=0.229     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.044 *    (e)          (e)          P=0.216     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.199     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.046 *    (e)          (e)          P=0.247     |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Clear Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/50 (16%)   3/50 (6%)    7/50 (14%)   2/50 (4%)   |3/50 (6%)    2/50 (4%)    6/50 (12%)   0/50 (0%)    | 
|POLY-3 RATE (b)    |     8/48.80      3/45.14      7/47.99      2/45.81     |3/43.96      2/47.89      6/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     16.4%        6.7%         14.6%        4.4%        |6.8%         4.2%         12.6%        0.0%         | 
|TERMINAL (d)       |     8/48 (17%)   3/40 (8%)    7/42 (17%)   2/40 (5%)   |3/40 (8%)    2/45 (4%)    6/43 (14%)   0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      727 (T)      727 (T)      727 (T)     |733 (T)      733 (T)      733 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.118N     P=0.167N     P=0.611      P=0.085N    |P=0.192N     P=0.446N     P=0.278      P=0.121N     | 
|POLY 3             |     P=0.082N     P=0.126N     P=0.514N     P=0.057N    |P=0.184N     P=0.461N     P=0.282      P=0.113N     | 
|POLY 1.5           |     P=0.078N     P=0.115N     P=0.507N     P=0.052N    |P=0.178N     P=0.467N     P=0.278      P=0.112N     | 
|POLY 6             |     P=0.088N     P=0.139N     P=0.527N     P=0.064N    |P=0.192N     P=0.458N     P=0.281      P=0.116N     | 
|LOGISTIC REGRESSION|     P=0.118N     P=0.167N     P=0.611      P=0.085N    |P=0.192N     P=0.446N     P=0.278      (e)          | 
|COCH-ARM / FISHERS |     P=0.076N     P=0.100N     P=0.500N     P=0.046N*   |P=0.186N     P=0.500N     P=0.243      P=0.121N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    2/50 (4%)    5/50 (10%)   1/50 (2%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     3/48.80      2/45.14      5/47.99      1/45.81     |0/43.96      1/47.89      0/47.49      1/45.29      | 
|POLY-3 PERCENT (g) |     6.2%         4.4%         10.4%        2.2%        |0.0%         2.1%         0.0%         2.2%         | 
|TERMINAL (d)       |     3/48 (6%)    2/40 (5%)    5/42 (12%)   1/40 (3%)   |0/40 (0%)    1/45 (2%)    0/43 (0%)    1/40 (3%)    | 
|FIRST INCIDENCE    |     727 (T)      727 (T)      727 (T)      727 (T)     |---          733 (T)      ---          733 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.386N     P=0.583N     P=0.286      P=0.373N    |P=0.397      P=0.523      (e)          P=0.500      | 
|POLY 3             |     P=0.340N     P=0.535N     P=0.348      P=0.329N    |P=0.415      P=0.517      (e)          P=0.506      | 
|POLY 1.5           |     P=0.330N     P=0.521N     P=0.352      P=0.319N    |P=0.417      P=0.514      (e)          P=0.507      | 
|POLY 6             |     P=0.356N     P=0.551N     P=0.340      P=0.342N    |P=0.411      P=0.518      (e)          P=0.503      | 
|LOGISTIC REGRESSION|     P=0.386N     P=0.583N     P=0.286      P=0.373N    |(e)          P=0.523      (e)          P=0.500      | 
|COCH-ARM / FISHERS |     P=0.318N     P=0.500N     P=0.357      P=0.309N    |P=0.405      P=0.500      (e)          P=0.500      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    3/50 (6%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/48.80      2/45.50      0/47.99      0/45.81     |1/44.05      0/47.89      3/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     2.1%         4.4%         0.0%         0.0%        |2.3%         0.0%         6.3%         0.0%         | 
|TERMINAL (d)       |     1/48 (2%)    1/40 (3%)    0/42 (0%)    0/40 (0%)   |0/40 (0%)    0/45 (0%)    3/43 (7%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      626          ---          ---         |709          ---          733 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.209N     P=0.446      P=0.527N     P=0.536N    |P=0.512N     P=0.486N     P=0.333      P=0.510N     | 
|POLY 3             |     P=0.197N     P=0.476      P=0.503N     P=0.513N    |P=0.506N     P=0.483N     P=0.333      P=0.494N     | 
|POLY 1.5           |     P=0.193N     P=0.485      P=0.502N     P=0.507N    |P=0.500N     P=0.486N     P=0.330      P=0.493N     | 
|POLY 6             |     P=0.203N     P=0.465      P=0.506N     P=0.520N    |P=0.515N     P=0.482N     P=0.332      P=0.498N     | 
|LOGISTIC REGRESSION|     P=0.183N     P=0.524      (e)          (e)         |P=0.501N     P=0.493N     P=0.332      P=0.495N     | 
|COCH-ARM / FISHERS |     P=0.188N     P=0.500      P=0.500N     P=0.500N    |P=0.500N     P=0.500N     P=0.309      P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    4/50 (8%)    5/50 (10%)   4/50 (8%)   |16/50 (32%)  12/50 (24%)  27/50 (54%)  25/50 (50%)  | 
|POLY-3 RATE (b)    |     2/48.80      4/45.14      5/48.16      4/45.81     |16/43.96     12/47.89     27/47.58     25/45.29     | 
|POLY-3 PERCENT (g) |     4.1%         8.9%         10.4%        8.7%        |36.4%        25.1%        56.8%        55.2%        | 
|TERMINAL (d)       |     2/48 (4%)    4/40 (10%)   4/42 (10%)   4/40 (10%)  |16/40 (40%)  12/45 (27%)  26/43 (61%)  25/40 (63%)  | 
|FIRST INCIDENCE    |     727 (T)      727 (T)      682          727 (T)     |733 (T)      733 (T)      709          733 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.239      P=0.257      P=0.175      P=0.257     |P=0.003 **   P=0.143N     P=0.036 *    P=0.038 *    | 
|POLY 3             |     P=0.279      P=0.302      P=0.212      P=0.309     |P=0.005 **   P=0.170N     P=0.038 *    P=0.054      | 
|POLY 1.5           |     P=0.293      P=0.316      P=0.214      P=0.321     |P=0.006 **   P=0.183N     P=0.036 *    P=0.061      | 
|POLY 6             |     P=0.259      P=0.287      P=0.207      P=0.293     |P=0.003 **   P=0.164N     P=0.037 *    P=0.045 *    | 
|LOGISTIC REGRESSION|     P=0.263      P=0.257      P=0.212      P=0.257     |P=0.002 **   P=0.143N     P=0.033 *    P=0.038 *    | 
|COCH-ARM / FISHERS |     P=0.309      P=0.339      P=0.218      P=0.339     |P=0.007 **   P=0.252N     P=0.021 *    P=0.052      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     9/50 (18%)   12/50 (24%)  12/50 (24%)  7/50 (14%)  |20/50 (40%)  20/50 (40%)  16/50 (32%)  11/50 (22%)  | 
|POLY-3 RATE (b)    |     9/48.80      12/45.64     12/48.14     7/46.48     |20/45.02     20/48.30     16/47.87     11/45.80     | 
|POLY-3 PERCENT (g) |     18.4%        26.3%        24.9%        15.1%       |44.4%        41.4%        33.4%        24.0%        | 
|TERMINAL (d)       |     9/48 (19%)   11/40 (28%)  11/42 (26%)  6/40 (15%)  |18/40 (45%)  19/45 (42%)  15/43 (35%)  10/40 (25%)  | 
|FIRST INCIDENCE    |     727 (T)      576          689          500         |242          615          625          576          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.407N     P=0.172      P=0.206      P=0.541N    |P=0.024N*    P=0.397N     P=0.186N     P=0.042N*    | 
|POLY 3             |     P=0.309N     P=0.253      P=0.299      P=0.434N    |P=0.017N*    P=0.466N     P=0.190N     P=0.031N*    | 
|POLY 1.5           |     P=0.293N     P=0.275      P=0.306      P=0.416N    |P=0.016N*    P=0.486N     P=0.200N     P=0.030N*    | 
|POLY 6             |     P=0.336N     P=0.228      P=0.288      P=0.460N    |P=0.019N*    P=0.452N     P=0.188N     P=0.033N*    | 
|LOGISTIC REGRESSION|     P=0.304N     P=0.237      P=0.270      P=0.407N    |P=0.016N*    P=0.482N     P=0.198N     P=0.033N*    | 
|COCH-ARM / FISHERS |     P=0.275N     P=0.312      P=0.312      P=0.393N    |P=0.020N*    P=0.581N     P=0.266N     P=0.041N*    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     9/50 (18%)   8/50 (16%)   9/50 (18%)   7/50 (14%)  |4/50 (8%)    1/50 (2%)    4/50 (8%)    3/50 (6%)    | 
|POLY-3 RATE (b)    |     9/48.80      8/45.50      9/47.99      7/45.81     |4/43.96      1/47.89      4/47.49      3/45.75      | 
|POLY-3 PERCENT (g) |     18.4%        17.6%        18.8%        15.3%       |9.1%         2.1%         8.4%         6.6%         | 
|TERMINAL (d)       |     9/48 (19%)   7/40 (18%)   9/42 (21%)   7/40 (18%)  |4/40 (10%)   1/45 (2%)    4/43 (9%)    2/40 (5%)    | 
|FIRST INCIDENCE    |     727 (T)      626          727 (T)      727 (T)     |733 (T)      733 (T)      733 (T)      597          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.490N     P=0.552      P=0.479      P=0.550N    |P=0.566      P=0.146N     P=0.604N     P=0.496N     | 
|POLY 3             |     P=0.400N     P=0.563N     P=0.587      P=0.447N    |P=0.577      P=0.154N     P=0.600N     P=0.478N     | 
|POLY 1.5           |     P=0.382N     P=0.538N     P=0.595      P=0.423N    |P=0.578N     P=0.158N     P=0.605N     P=0.477N     | 
|POLY 6             |     P=0.426N     P=0.589N     P=0.573      P=0.478N    |P=0.570      P=0.152N     P=0.601N     P=0.483N     | 
|LOGISTIC REGRESSION|     P=0.438N     P=0.585N     P=0.479      P=0.550N    |P=0.576N     P=0.146N     P=0.604N     P=0.485N     | 
|COCH-ARM / FISHERS |     P=0.362N     P=0.500N     P=0.602N     P=0.393N    |P=0.580      P=0.181N     P=0.643N     P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    4/50 (8%)    5/50 (10%)   1/50 (2%)   |2/50 (4%)    2/50 (4%)    3/50 (6%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     3/48.80      4/45.97      5/48.34      1/45.81     |2/45.89      2/47.89      3/48.63      0/45.29      | 
|POLY-3 PERCENT (g) |     6.2%         8.7%         10.3%        2.2%        |4.4%         4.2%         6.2%         0.0%         | 
|TERMINAL (d)       |     3/48 (6%)    2/40 (5%)    3/42 (7%)    1/40 (3%)   |0/40 (0%)    2/45 (4%)    1/43 (2%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      511          650          727 (T)     |242          733 (T)      469          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.292N     P=0.417      P=0.301      P=0.373N    |P=0.198N     P=0.664N     P=0.531      P=0.231N     | 
|POLY 3             |     P=0.261N     P=0.468      P=0.352      P=0.329N    |P=0.207N     P=0.678N     P=0.526      P=0.240N     | 
|POLY 1.5           |     P=0.249N     P=0.480      P=0.355      P=0.319N    |P=0.202N     P=0.680N     P=0.522      P=0.237N     | 
|POLY 6             |     P=0.279N     P=0.453      P=0.347      P=0.342N    |P=0.214N     P=0.677N     P=0.529      P=0.244N     | 
|LOGISTIC REGRESSION|     P=0.225N     P=0.548      P=0.357      P=0.373N    |P=0.358N     P=0.405      P=0.117      P=0.573N     | 
|COCH-ARM / FISHERS |     P=0.233N     P=0.500      P=0.357      P=0.309N    |P=0.199N     P=0.691N     P=0.500      P=0.247N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Vacuolization Cytoplasmic Focal                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/50 (12%)   7/50 (14%)   4/50 (8%)    4/50 (8%)   |4/50 (8%)    5/50 (10%)   3/50 (6%)    5/50 (10%)   | 
|POLY-3 RATE (b)    |     6/48.80      7/45.14      4/48.16      4/45.81     |4/44.92      5/47.89      3/47.49      5/45.91      | 
|POLY-3 PERCENT (g) |     12.3%        15.5%        8.3%         8.7%        |8.9%         10.4%        6.3%         10.9%        | 
|TERMINAL (d)       |     6/48 (13%)   7/40 (18%)   3/42 (7%)    4/40 (10%)  |3/40 (8%)    5/45 (11%)   3/43 (7%)    3/40 (8%)    | 
|FIRST INCIDENCE    |     727 (T)      727 (T)      682          727 (T)     |242          733 (T)      733 (T)      576          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.315N     P=0.361      P=0.449N     P=0.488N    |P=0.466      P=0.566      P=0.465N     P=0.504      | 
|POLY 3             |     P=0.253N     P=0.440      P=0.378N     P=0.410N    |P=0.489      P=0.540      P=0.470N     P=0.514      | 
|POLY 1.5           |     P=0.243N     P=0.464      P=0.374N     P=0.393N    |P=0.493      P=0.534      P=0.472N     P=0.516      | 
|POLY 6             |     P=0.269N     P=0.413      P=0.386N     P=0.434N    |P=0.483      P=0.543      P=0.471N     P=0.508      | 
|LOGISTIC REGRESSION|     P=0.284N     P=0.361      P=0.381N     P=0.488N    |P=0.471      P=0.461      P=0.561N     P=0.466      | 
|COCH-ARM / FISHERS |     P=0.230N     P=0.500      P=0.370N     P=0.370N    |P=0.483      P=0.500      P=0.500N     P=0.500      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Centrilobular                                                                                                             | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    1/50 (2%)    1/50 (2%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     1/49.64      1/45.83      0/47.99      0/45.81     |1/43.96      1/48.03      1/47.81      2/46.12      | 
|POLY-3 PERCENT (g) |     2.0%         2.2%         0.0%         0.0%        |2.3%         2.1%         2.1%         4.3%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    0/42 (0%)    0/40 (0%)   |1/40 (3%)    0/45 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     397          491          ---          ---         |733 (T)      698          645          597          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.238N     P=0.758      P=0.500N     P=0.500N    |P=0.346      P=0.737N     P=0.745N     P=0.508      | 
|POLY 3             |     P=0.241N     P=0.742      P=0.507N     P=0.516N    |P=0.359      P=0.740N     P=0.742N     P=0.517      | 
|POLY 1.5           |     P=0.239N     P=0.749      P=0.504N     P=0.510N    |P=0.360      P=0.744N     P=0.744N     P=0.516      | 
|POLY 6             |     P=0.243N     P=0.735      P=0.510N     P=0.524N    |P=0.357      P=0.738N     P=0.741N     P=0.515      | 
|LOGISTIC REGRESSION|     P=0.243N     P=0.633N     (e)          (e)         |P=0.318      P=0.752N     P=0.762      P=0.477      | 
|COCH-ARM / FISHERS |     P=0.236N     P=0.753N     P=0.500N     P=0.500N    |P=0.351      P=0.753N     P=0.753N     P=0.500      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    6/50 (12%)   2/50 (4%)    0/50 (0%)   |1/50 (2%)    2/50 (4%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/48.80      6/45.57      2/47.99      0/45.81     |1/44.92      2/48.18      1/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     0.0%         13.2%        4.2%         0.0%        |2.2%         4.2%         2.1%         0.0%         | 
|TERMINAL (d)       |     0/48 (0%)    5/40 (13%)   2/42 (5%)    0/40 (0%)   |0/40 (0%)    1/45 (2%)    1/43 (2%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          601          727 (T)      ---         |243          653          733 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.277N     P=0.011 *    P=0.210      (e)         |P=0.249N     P=0.531      P=0.745N     P=0.488N     | 
|POLY 3             |     P=0.264N     P=0.012 *    P=0.234      (e)         |P=0.245N     P=0.524      P=0.748N     P=0.498N     | 
|POLY 1.5           |     P=0.248N     P=0.013 *    P=0.236      (e)         |P=0.243N     P=0.520      P=0.749N     P=0.496N     | 
|POLY 6             |     P=0.287N     P=0.011 *    P=0.230      (e)         |P=0.249N     P=0.528      P=0.749N     P=0.502N     | 
|LOGISTIC REGRESSION|     P=0.235N     P=0.016 *    P=0.210      (e)         |P=0.332N     P=0.304      P=0.608      P=0.811N     | 
|COCH-ARM / FISHERS |     P=0.232N     P=0.013 *    P=0.247      (e)         |P=0.247N     P=0.500      P=0.753N     P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    1/50 (2%)    1/50 (2%)   |1/50 (2%)    2/50 (4%)    3/50 (6%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/48.80      0/45.14      1/47.99      1/45.81     |1/43.96      2/47.89      3/47.49      2/45.29      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.1%         2.2%        |2.3%         4.2%         6.3%         4.4%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    1/42 (2%)    1/40 (3%)   |1/40 (3%)    2/45 (4%)    3/43 (7%)    2/40 (5%)    | 
|FIRST INCIDENCE    |     ---          ---          727 (T)      727 (T)     |733 (T)      733 (T)      733 (T)      733 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.214      (e)          P=0.473      P=0.464     |P=0.388      P=0.541      P=0.331      P=0.500      | 
|POLY 3             |     P=0.226      (e)          P=0.497      P=0.487     |P=0.410      P=0.530      P=0.334      P=0.510      | 
|POLY 1.5           |     P=0.231      (e)          P=0.498      P=0.493     |P=0.416      P=0.525      P=0.331      P=0.513      | 
|POLY 6             |     P=0.219      (e)          P=0.494      P=0.480     |P=0.400      P=0.532      P=0.333      P=0.505      | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.473      P=0.464     |P=0.388      P=0.541      P=0.331      P=0.500      | 
|COCH-ARM / FISHERS |     P=0.236      (e)          P=0.500      P=0.500     |P=0.404      P=0.500      P=0.309      P=0.500      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    4/50 (8%)    2/50 (4%)   |2/50 (4%)    3/50 (6%)    2/50 (4%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     2/48.80      1/45.14      4/48.38      2/45.81     |2/43.96      3/47.89      2/47.49      2/45.29      | 
|POLY-3 PERCENT (g) |     4.1%         2.2%         8.3%         4.4%        |4.6%         6.3%         4.2%         4.4%         | 
|TERMINAL (d)       |     2/48 (4%)    1/40 (3%)    3/42 (7%)    2/40 (5%)   |2/40 (5%)    3/45 (7%)    2/43 (5%)    2/40 (5%)    | 
|FIRST INCIDENCE    |     727 (T)      727 (T)      616          727 (T)     |733 (T)      733 (T)      733 (T)      733 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.419      P=0.564N     P=0.289      P=0.627     |P=0.539N     P=0.554      P=0.669N     P=0.695      | 
|POLY 3             |     P=0.455      P=0.527N     P=0.334      P=0.671     |P=0.515N     P=0.539      P=0.666N     P=0.683N     | 
|POLY 1.5           |     P=0.466      P=0.516N     P=0.336      P=0.681     |P=0.511N     P=0.533      P=0.669N     P=0.681N     | 
|POLY 6             |     P=0.440      P=0.539N     P=0.329      P=0.657     |P=0.522N     P=0.542      P=0.666N     P=0.689N     | 
|LOGISTIC REGRESSION|     P=0.466      P=0.564N     P=0.341      P=0.627     |P=0.539N     P=0.554      P=0.669N     P=0.695      | 
|COCH-ARM / FISHERS |     P=0.477      P=0.500N     P=0.339      P=0.691N    |P=0.523N     P=0.500      P=0.691N     P=0.691N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Serosa                                                                                                                     | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/48.80      0/45.14      1/47.99      0/45.81     |0/43.96      0/47.89      0/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     4.1%         0.0%         2.1%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/48 (4%)    0/40 (0%)    1/42 (2%)    0/40 (0%)   |0/40 (0%)    0/45 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      ---          727 (T)      ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.215N     P=0.280N     P=0.547N     P=0.280N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.185N     P=0.255N     P=0.506N     P=0.252N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.186N     P=0.248N     P=0.503N     P=0.246N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.185N     P=0.264N     P=0.511N     P=0.260N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.215N     (e)          P=0.547N     (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.188N     P=0.247N     P=0.500N     P=0.247N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Infiltration Cellular Plasma Cell                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    0/49 (0%)    1/48 (2%)    0/50 (0%)   |3/49 (6%)    1/48 (2%)    2/50 (4%)    1/49 (2%)    | 
|POLY-3 RATE (b)    |     1/46.80      0/44.14      1/46.78      0/45.81     |3/43.55      1/46.48      2/47.49      1/44.57      | 
|POLY-3 PERCENT (g) |     2.1%         0.0%         2.1%         0.0%        |6.9%         2.2%         4.2%         2.2%         | 
|TERMINAL (d)       |     1/46 (2%)    0/39 (0%)    1/41 (2%)    0/40 (0%)   |3/40 (8%)    1/45 (2%)    2/43 (5%)    1/40 (3%)    | 
|FIRST INCIDENCE    |     727 (T)      ---          727 (T)      ---         |733 (T)      733 (T)      733 (T)      733 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.427N     P=0.533N     P=0.736      P=0.528N    |P=0.286N     P=0.264N     P=0.467N     P=0.305N     | 
|POLY 3             |     P=0.398N     P=0.512N     P=0.760      P=0.504N    |P=0.283N     P=0.283N     P=0.461N     P=0.297N     | 
|POLY 1.5           |     P=0.398N     P=0.505N     P=0.760N     P=0.499N    |P=0.279N     P=0.287N     P=0.462N     P=0.294N     | 
|POLY 6             |     P=0.399N     P=0.519N     P=0.758      P=0.511N    |P=0.290N     P=0.280N     P=0.463N     P=0.303N     | 
|LOGISTIC REGRESSION|     P=0.427N     (e)          P=0.736      (e)         |P=0.286N     P=0.264N     P=0.467N     P=0.305N     | 
|COCH-ARM / FISHERS |     P=0.399N     P=0.495N     P=0.753N     P=0.490N    |P=0.276N     P=0.316N     P=0.490N     P=0.309N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery                                                                                                                        | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/6 (50%)    1/2 (50%)    0/3 (0%)     1/3 (33%)   |1/5 (20%)    0/1 (0%)     1/6 (17%)    0/2 (0%)     | 
|POLY-3 RATE (b)    |     3/5.64       1/2.00       0/3.00       1/3.00      |1/4.07       0/1.00       1/6.00       0/1.54       | 
|POLY-3 PERCENT (g) |     53.2%        50.0%        0.0%         33.3%       |24.6%        0.0%         16.7%        0.0%         | 
|TERMINAL (d)       |     3/5 (60%)    1/2 (50%)    0/3 (0%)     1/3 (33%)   |1/2 (50%)    0/1 (0%)     1/6 (17%)    0/1 (0%)     | 
|FIRST INCIDENCE    |     727 (T)      727 (T)      ---          727 (T)     |733 (T)      ---          733 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.275N     P=0.712N     P=0.189N     P=0.500N    |P=0.393N     P=0.638N     P=0.500N     P=0.638N     | 
|POLY 3             |     P=0.331N     P=0.748N     P=0.195N     P=0.558N    |P=0.480N     P=0.780N     P=0.672N     P=0.688N     | 
|POLY 1.5           |     P=0.340N     P=0.754N     P=0.207N     P=0.570N    |P=0.490N     P=0.786N     P=0.694N     P=0.681N     | 
|POLY 6             |     P=0.319N     P=0.736N     P=0.177N     P=0.539N    |P=0.464N     P=0.767N     P=0.637N     P=0.697N     | 
|LOGISTIC REGRESSION|     P=0.275N     P=0.712N     (e)          P=0.500N    |P=0.393N     (e)          P=0.500N     (e)          | 
|COCH-ARM / FISHERS |     P=0.341N     P=0.786N     P=0.238N     P=0.595N    |P=0.500N     P=0.833N     P=0.727N     P=0.714N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Fat                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/6 (17%)    0/2 (0%)     2/3 (67%)    1/3 (33%)   |3/5 (60%)    1/1 (100%)   2/6 (33%)    1/2 (50%)    | 
|POLY-3 RATE (b)    |     1/5.64       0/2.00       2/3.00       1/3.00      |3/4.73       1/1.00       2/6.00       1/2.00       | 
|POLY-3 PERCENT (g) |     17.7%        0.0%         66.7%        33.3%       |63.4%        100.0%       33.3%        50.0%        | 
|TERMINAL (d)       |     1/5 (20%)    0/2 (0%)     2/3 (67%)    1/3 (33%)   |1/2 (50%)    1/1 (100%)   2/6 (33%)    0/1 (0%)     | 
|FIRST INCIDENCE    |     727 (T)      ---          727 (T)      727 (T)     |557          733 (T)      733 (T)      597          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.377      P=0.682N     P=0.298      P=0.653     |P=0.259N     P=0.399N     P=0.205N     P=0.368N     | 
|POLY 3             |     P=0.341      P=0.701N     P=0.240      P=0.618     |P=0.403N     P=0.668      P=0.364N     P=0.681N     | 
|POLY 1.5           |     P=0.330      P=0.704N     P=0.232      P=0.610     |P=0.415N     P=0.650      P=0.380N     P=0.689N     | 
|POLY 6             |     P=0.358      P=0.695N     P=0.254      P=0.629     |P=0.383N     P=0.698      P=0.339N     P=0.667N     | 
|LOGISTIC REGRESSION|     P=0.377      (e)          P=0.298      P=0.653     |P=0.447N     P=0.625      P=0.592N     P=0.709N     | 
|COCH-ARM / FISHERS |     P=0.312      P=0.750N     P=0.226      P=0.583     |P=0.422N     P=0.667      P=0.392N     P=0.714N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Mucosa                                                                                                                      | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/50 (12%)   16/50 (32%)  21/50 (42%)  21/50 (42%) |20/50 (40%)  32/50 (64%)  35/50 (70%)  32/50 (64%)  | 
|POLY-3 RATE (b)    |     6/48.80      16/46.21     21/49.00     21/46.34    |20/45.11     32/48.43     35/49.44     32/46.50     | 
|POLY-3 PERCENT (g) |     12.3%        34.6%        42.9%        45.3%       |44.3%        66.1%        70.8%        68.8%        | 
|TERMINAL (d)       |     6/48 (13%)   13/40 (33%)  18/42 (43%)  19/40 (48%) |18/40 (45%)  30/45 (67%)  31/43 (72%)  29/40 (73%)  | 
|FIRST INCIDENCE    |     727 (T)      511          427          652         |545          615          469          557          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.005 **   P<0.001 **   P<0.001 **  |P=0.014 *    P=0.055      P=0.010 *    P=0.014 *    | 
|POLY 3             |     P<0.001 **   P=0.008 **   P<0.001 **   P<0.001 **  |P=0.022 *    P=0.026 *    P=0.007 **   P=0.013 *    | 
|POLY 1.5           |     P<0.001 **   P=0.010 *    P<0.001 **   P<0.001 **  |P=0.026 *    P=0.024 *    P=0.006 **   P=0.015 *    | 
|POLY 6             |     P<0.001 **   P=0.007 **   P<0.001 **   P<0.001 **  |P=0.017 *    P=0.026 *    P=0.007 **   P=0.010 *    | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.011 *    P<0.001 **   P<0.001 **  |P=0.024 *    P=0.032 *    P=0.005 **   P=0.018 *    | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.014 *    P<0.001 **   P<0.001 **  |P=0.022 *    P=0.014 *    P=0.002 **   P=0.014 *    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Mucosa                                                                                                                      | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    8/50 (16%)   12/50 (24%)  10/50 (20%) |6/50 (12%)   15/50 (30%)  22/50 (44%)  15/50 (30%)  | 
|POLY-3 RATE (b)    |     4/48.80      8/45.86      12/49.00     10/46.06    |6/44.55      15/48.30     22/48.70     15/45.66     | 
|POLY-3 PERCENT (g) |     8.2%         17.5%        24.5%        21.7%       |13.5%        31.1%        45.2%        32.9%        | 
|TERMINAL (d)       |     4/48 (8%)    6/40 (15%)   9/42 (21%)   9/40 (23%)  |5/40 (13%)   14/45 (31%)  19/43 (44%)  14/40 (35%)  | 
|FIRST INCIDENCE    |     727 (T)      511          427          661         |545          615          575          628          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.041 *    P=0.112      P=0.018 *    P=0.037 *   |P=0.032 *    P=0.049 *    P<0.001 **   P=0.026 *    | 
|POLY 3             |     P=0.054      P=0.149      P=0.027 *    P=0.057     |P=0.039 *    P=0.036 *    P<0.001 **   P=0.025 *    | 
|POLY 1.5           |     P=0.061      P=0.160      P=0.027 *    P=0.064     |P=0.044 *    P=0.034 *    P<0.001 **   P=0.027 *    | 
|POLY 6             |     P=0.046 *    P=0.136      P=0.025 *    P=0.050     |P=0.033 *    P=0.037 *    P<0.001 **   P=0.022 *    | 
|LOGISTIC REGRESSION|     P=0.071      P=0.171      P=0.029 *    P=0.049 *   |P=0.043 *    P=0.035 *    P<0.001 **   P=0.028 *    | 
|COCH-ARM / FISHERS |     P=0.072      P=0.178      P=0.027 *    P=0.074     |P=0.041 *    P=0.024 *    P<0.001 **   P=0.024 *    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |0/50 (0%)    0/50 (0%)    2/49 (4%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |                                                        |0/43.96      0/47.89      2/46.49      0/45.29      | 
|POLY-3 PERCENT (g) |                                                        |0.0%         0.0%         4.3%         0.0%         | 
|TERMINAL (d)       |                                                        |0/40 (0%)    0/45 (0%)    2/42 (5%)    0/40 (0%)    | 
|FIRST INCIDENCE    |                                                        |---          ---          733 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.590      (e)          P=0.249      (e)          | 
|POLY 3             |                                                        |P=0.594      (e)          P=0.250      (e)          | 
|POLY 1.5           |                                                        |P=0.601      (e)          P=0.248      (e)          | 
|POLY 6             |                                                        |P=0.584      (e)          P=0.250      (e)          | 
|LOGISTIC REGRESSION|                                                        |(e)          (e)          P=0.249      (e)          | 
|COCH-ARM / FISHERS |                                                        |P=0.595      (e)          P=0.242      (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |19/50 (38%)  23/50 (46%)  16/49 (33%)  17/50 (34%)  | 
|POLY-3 RATE (b)    |                                                        |19/43.96     23/48.18     16/46.49     17/47.21     | 
|POLY-3 PERCENT (g) |                                                        |43.2%        47.7%        34.4%        36.0%        | 
|TERMINAL (d)       |                                                        |19/40 (48%)  22/45 (49%)  16/42 (38%)  13/40 (33%)  | 
|FIRST INCIDENCE    |                                                        |733 (T)      653          733 (T)      264          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.274N     P=0.454      P=0.263N     P=0.412N     | 
|POLY 3             |                                                        |P=0.173N     P=0.411      P=0.260N     P=0.312N     | 
|POLY 1.5           |                                                        |P=0.178N     P=0.385      P=0.272N     P=0.323N     | 
|POLY 6             |                                                        |P=0.176N     P=0.429      P=0.260N     P=0.311N     | 
|LOGISTIC REGRESSION|                                                        |P=0.221N     P=0.413      P=0.263N     P=0.374N     | 
|COCH-ARM / FISHERS |                                                        |P=0.240N     P=0.272      P=0.365N     P=0.418N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Thrombosis                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |0/50 (0%)    2/50 (4%)    0/49 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |                                                        |0/43.96      2/48.03      0/46.49      0/45.29      | 
|POLY-3 PERCENT (g) |                                                        |0.0%         4.2%         0.0%         0.0%         | 
|TERMINAL (d)       |                                                        |0/40 (0%)    1/45 (2%)    0/42 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |                                                        |---          698          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.410N     P=0.263      (e)          (e)          | 
|POLY 3             |                                                        |P=0.384N     P=0.258      (e)          (e)          | 
|POLY 1.5           |                                                        |P=0.385N     P=0.254      (e)          (e)          | 
|POLY 6             |                                                        |P=0.385N     P=0.260      (e)          (e)          | 
|LOGISTIC REGRESSION|                                                        |P=0.403N     P=0.248      (e)          (e)          | 
|COCH-ARM / FISHERS |                                                        |P=0.406N     P=0.247      (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/48.80      0/45.14      0/47.99      0/45.81     |1/44.05      0/47.89      0/47.49      2/45.85      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |2.3%         0.0%         0.0%         4.4%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    0/42 (0%)    0/40 (0%)   |0/40 (0%)    0/45 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |709          ---          ---          597          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.236      P=0.486N     P=0.486N     P=0.497      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.242      P=0.483N     P=0.485N     P=0.514      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.243      P=0.486N     P=0.487N     P=0.515      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.240      P=0.482N     P=0.486N     P=0.511      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.230      P=0.493N     P=0.493N     P=0.489      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.245      P=0.500N     P=0.500N     P=0.500      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Hypertrophy Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    2/50 (4%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/48.80      0/45.14      0/47.99      0/45.81     |1/43.96      0/47.89      2/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |2.3%         0.0%         4.2%         0.0%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    0/42 (0%)    0/40 (0%)   |1/40 (3%)    0/45 (0%)    2/43 (5%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |733 (T)      ---          733 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.468N     P=0.477N     P=0.525      P=0.500N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.467N     P=0.483N     P=0.527      P=0.494N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.462N     P=0.486N     P=0.524      P=0.493N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.473N     P=0.482N     P=0.527      P=0.497N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.468N     (e)          P=0.525      (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.461N     P=0.500N     P=0.500      P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Duct                                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |2/50 (4%)    1/50 (2%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/48.80      0/45.14      0/47.99      0/45.81     |2/44.05      1/48.03      0/47.49      1/45.75      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |4.5%         2.1%         0.0%         2.2%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    0/42 (0%)    0/40 (0%)   |1/40 (3%)    0/45 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |709          698          ---          597          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.373N     P=0.468N     P=0.224N     P=0.500N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.369N     P=0.470N     P=0.221N     P=0.487N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.368N     P=0.475N     P=0.223N     P=0.486N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.370N     P=0.468N     P=0.221N     P=0.491N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.379N     P=0.483N     P=0.222N     P=0.505N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.367N     P=0.500N     P=0.247N     P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Parathyroid Gland                                                                                                                | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/43 (0%)    0/39 (0%)    0/44 (0%)    2/37 (5%)   |0/43 (0%)    0/35 (0%)    0/40 (0%)    0/43 (0%)    | 
|POLY-3 RATE (b)    |     0/42.64      0/34.20      0/42.27      2/34.24     |0/38.11      0/34.14      0/38.00      0/38.92      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         5.8%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/42 (0%)    0/30 (0%)    0/37 (0%)    2/30 (7%)   |0/35 (0%)    0/33 (0%)    0/34 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          727 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.033 *    (e)          (e)          P=0.168     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.036 *    (e)          (e)          P=0.190     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.036 *    (e)          (e)          P=0.195     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.036 *    (e)          (e)          P=0.184     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.168     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.038 *    (e)          (e)          P=0.211     |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Peripheral Nerve: Axon                                                                                                           | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/0 (0%)     0/0 (0%)     1/1 (100%)   0/0 (0%)    |0/0 (0%)     0/0 (0%)     0/0 (0%)     2/2 (100%)   | 
|POLY-3 RATE (b)    |     0/0.00       0/0.00       1/1.00       0/0.00      |0/0.00       0/0.00       0/0.00       2/2.00       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         100.0%       0.0%        |0.0%         0.0%         0.0%         100.0%       | 
|TERMINAL (d)       |     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)    |0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     | 
|FIRST INCIDENCE    |     ---          ---          616          ---         |---          ---          ---          576          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 3             |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 6             |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/49 (2%)    0/47 (0%)    3/50 (6%)   |7/49 (14%)   7/50 (14%)   10/49 (20%)  9/49 (18%)   | 
|POLY-3 RATE (b)    |     0/48.80      1/44.95      0/45.31      3/45.81     |7/43.05      7/47.89      10/47.40     9/44.92      | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         0.0%         6.6%        |16.3%        14.6%        21.1%        20.0%        | 
|TERMINAL (d)       |     0/48 (0%)    1/40 (3%)    0/41 (0%)    3/40 (8%)   |6/39 (15%)   7/45 (16%)   8/42 (19%)   9/40 (23%)   | 
|FIRST INCIDENCE    |     ---          727 (T)      ---          727 (T)     |709          733 (T)      575          733 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.035 *    P=0.464      (e)          P=0.091     |P=0.277      P=0.504N     P=0.365      P=0.410      | 
|POLY 3             |     P=0.041 *    P=0.484      (e)          P=0.108     |P=0.301      P=0.529N     P=0.376      P=0.428      | 
|POLY 1.5           |     P=0.043 *    P=0.489      (e)          P=0.113     |P=0.307      P=0.539N     P=0.362      P=0.430      | 
|POLY 6             |     P=0.040 *    P=0.477      (e)          P=0.102     |P=0.289      P=0.525N     P=0.383      P=0.417      | 
|LOGISTIC REGRESSION|     (e)          P=0.464      (e)          P=0.091     |P=0.300      P=0.520N     P=0.342      P=0.407      | 
|COCH-ARM / FISHERS |     P=0.045 *    P=0.495      (e)          P=0.121     |P=0.286      P=0.597N     P=0.297      P=0.393      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     17/50 (34%)  19/50 (38%)  18/50 (36%)  12/50 (24%) |                                                    | 
|POLY-3 RATE (b)    |     17/49.16     19/46.80     18/48.35     12/45.99    |                                                    | 
|POLY-3 PERCENT (g) |     34.6%        40.6%        37.2%        26.1%       |                                                    | 
|TERMINAL (d)       |     16/48 (33%)  15/40 (38%)  15/42 (36%)  11/40 (28%) |                                                    | 
|FIRST INCIDENCE    |     626          491          682          681         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.258N     P=0.210      P=0.331      P=0.375N    |                                                    | 
|POLY 3             |     P=0.168N     P=0.346      P=0.476      P=0.250N    |                                                    | 
|POLY 1.5           |     P=0.145N     P=0.374      P=0.488      P=0.223N    |                                                    | 
|POLY 6             |     P=0.202N     P=0.318      P=0.456      P=0.290N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.142N     P=0.387      P=0.482      P=0.268N    |                                                    | 
|COCH-ARM / FISHERS |     P=0.121N     P=0.418      P=0.500      P=0.189N    |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    2/50 (4%)    1/50 (2%)    4/50 (8%)   |                                                    | 
|POLY-3 RATE (b)    |     2/48.80      2/45.49      1/47.99      4/45.99     |                                                    | 
|POLY-3 PERCENT (g) |     4.1%         4.4%         2.1%         8.7%        |                                                    | 
|TERMINAL (d)       |     2/48 (4%)    1/40 (3%)    1/42 (2%)    3/40 (8%)   |                                                    | 
|FIRST INCIDENCE    |     727 (T)      629          727 (T)      681         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.188      P=0.633      P=0.547N     P=0.262     |                                                    | 
|POLY 3             |     P=0.217      P=0.668      P=0.506N     P=0.311     |                                                    | 
|POLY 1.5           |     P=0.222      P=0.678      P=0.503N     P=0.322     |                                                    | 
|POLY 6             |     P=0.210      P=0.657      P=0.511N     P=0.296     |                                                    | 
|LOGISTIC REGRESSION|     P=0.222      P=0.690N     P=0.547N     P=0.305     |                                                    | 
|COCH-ARM / FISHERS |     P=0.227      P=0.691N     P=0.500N     P=0.339     |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           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      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    2/50 (4%)    1/50 (2%)   |                                                    | 
|POLY-3 RATE (b)    |     0/48.80      1/45.14      2/47.99      1/45.81     |                                                    | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         4.2%         2.2%        |                                                    | 
|TERMINAL (d)       |     0/48 (0%)    1/40 (3%)    2/42 (5%)    1/40 (3%)   |                                                    | 
|FIRST INCIDENCE    |     ---          727 (T)      727 (T)      727 (T)     |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.328      P=0.464      P=0.210      P=0.464     |                                                    | 
|POLY 3             |     P=0.342      P=0.484      P=0.234      P=0.487     |                                                    | 
|POLY 1.5           |     P=0.353      P=0.491      P=0.236      P=0.493     |                                                    | 
|POLY 6             |     P=0.327      P=0.477      P=0.230      P=0.480     |                                                    | 
|LOGISTIC REGRESSION|     (e)          P=0.464      P=0.210      P=0.464     |                                                    | 
|COCH-ARM / FISHERS |     P=0.367      P=0.500      P=0.247      P=0.500     |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Seminal Vesicle                                                                                                                  | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    3/50 (6%)    0/50 (0%)   |                                                    | 
|POLY-3 RATE (b)    |     0/48.80      1/45.14      3/48.14      0/45.81     |                                                    | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         6.2%         0.0%        |                                                    | 
|TERMINAL (d)       |     0/48 (0%)    1/40 (3%)    2/42 (5%)    0/40 (0%)   |                                                    | 
|FIRST INCIDENCE    |     ---          727 (T)      689          ---         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.593      P=0.464      P=0.106      (e)         |                                                    | 
|POLY 3             |     P=0.602      P=0.484      P=0.117      (e)         |                                                    | 
|POLY 1.5           |     P=0.617      P=0.491      P=0.118      (e)         |                                                    | 
|POLY 6             |     P=0.581      P=0.477      P=0.114      (e)         |                                                    | 
|LOGISTIC REGRESSION|     P=0.624      P=0.464      P=0.121      (e)         |                                                    | 
|COCH-ARM / FISHERS |     P=0.633N     P=0.500      P=0.121      (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 26      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                       CITRAL           
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Epidermis                                                                                                                  | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/48.80      1/45.14      0/47.99      0/45.81     |0/43.96      0/47.89      0/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     4.1%         2.2%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/48 (4%)    1/40 (3%)    0/42 (0%)    0/40 (0%)   |0/40 (0%)    0/45 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      727 (T)      ---          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.119N     P=0.564N     P=0.268N     P=0.280N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.100N     P=0.527N     P=0.241N     P=0.252N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.100N     P=0.516N     P=0.239N     P=0.246N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.100N     P=0.539N     P=0.245N     P=0.260N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.119N     P=0.564N     (e)          (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.101N     P=0.500N     P=0.247N     P=0.247N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     17/50 (34%)  18/49 (37%)  13/50 (26%)  11/50 (22%) |17/50 (34%)  19/50 (38%)  10/49 (20%)  19/50 (38%)  | 
|POLY-3 RATE (b)    |     17/49.64     18/47.53     13/48.32     11/48.20    |17/45.93     19/49.18     10/47.37     19/48.11     | 
|POLY-3 PERCENT (g) |     34.3%        37.9%        26.9%        22.8%       |37.0%        38.6%        21.1%        39.5%        | 
|TERMINAL (d)       |     16/48 (33%)  13/40 (33%)  10/42 (24%)  6/40 (15%)  |12/40 (30%)  15/45 (33%)  7/43 (16%)   13/40 (33%)  | 
|FIRST INCIDENCE    |     397          418          689          447         |9            600          618          264          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.156N     P=0.292      P=0.403N     P=0.273N    |P=0.454      P=0.573      P=0.073N     P=0.432      | 
|POLY 3             |     P=0.076N     P=0.437      P=0.286N     P=0.152N    |P=0.527      P=0.519      P=0.070N     P=0.486      | 
|POLY 1.5           |     P=0.071N     P=0.451      P=0.275N     P=0.144N    |P=0.527      P=0.497      P=0.074N     P=0.480      | 
|POLY 6             |     P=0.081N     P=0.416      P=0.298N     P=0.163N    |P=0.513      P=0.534      P=0.070N     P=0.476      | 
|LOGISTIC REGRESSION|     P=0.040N*    P=0.555N     P=0.250N     P=0.061N    |P=0.460      P=0.403      P=0.106N     P=0.388      | 
|COCH-ARM / FISHERS |     P=0.065N     P=0.470      P=0.257N     P=0.133N    |P=0.486      P=0.418      P=0.098N     P=0.418      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 27      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                       CITRAL           
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    5/49 (10%)   3/50 (6%)    6/50 (12%)  |8/50 (16%)   7/50 (14%)   2/49 (4%)    4/50 (8%)    | 
|POLY-3 RATE (b)    |     3/49.64      5/46.71      3/48.69      6/47.38     |8/47.58      7/49.55      2/46.87      4/47.42      | 
|POLY-3 PERCENT (g) |     6.0%         10.7%        6.2%         12.7%       |16.8%        14.1%        4.3%         8.4%         | 
|TERMINAL (d)       |     2/48 (4%)    1/40 (3%)    0/42 (0%)    2/40 (5%)   |2/40 (5%)    3/45 (7%)    1/43 (2%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     397          419          616          456         |242          413          717          264          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.208      P=0.307      P=0.630      P=0.199     |P=0.097N     P=0.432N     P=0.046N*    P=0.184N     | 
|POLY 3             |     P=0.219      P=0.324      P=0.653      P=0.220     |P=0.090N     P=0.466N     P=0.048N*    P=0.179N     | 
|POLY 1.5           |     P=0.226      P=0.333      P=0.656      P=0.229     |P=0.087N     P=0.473N     P=0.047N*    P=0.174N     | 
|POLY 6             |     P=0.210      P=0.315      P=0.649      P=0.211     |P=0.094N     P=0.458N     P=0.049N*    P=0.185N     | 
|LOGISTIC REGRESSION|     P=0.320      P=0.618      P=0.662N     P=0.399     |P=0.159N     P=0.405      P=0.157N     P=0.342N     | 
|COCH-ARM / FISHERS |     P=0.237      P=0.346      P=0.661N     P=0.243     |P=0.088N     P=0.500N     P=0.049N*    P=0.178N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/50 (12%)   3/49 (6%)    3/50 (6%)    5/50 (10%)  |8/50 (16%)   7/50 (14%)   12/49 (24%)  13/50 (26%)  | 
|POLY-3 RATE (b)    |     6/48.80      3/44.79      3/48.06      5/45.81     |8/43.96      7/47.89      12/47.19     13/45.29     | 
|POLY-3 PERCENT (g) |     12.3%        6.7%         6.2%         10.9%       |18.2%        14.6%        25.4%        28.7%        | 
|TERMINAL (d)       |     6/48 (13%)   3/40 (8%)    2/42 (5%)    5/40 (13%)  |8/40 (20%)   7/45 (16%)   11/43 (26%)  13/40 (33%)  | 
|FIRST INCIDENCE    |     727 (T)      727 (T)      710          727 (T)     |733 (T)      733 (T)      625          733 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.527      P=0.339N     P=0.311N     P=0.626     |P=0.058      P=0.401N     P=0.284      P=0.156      | 
|POLY 3             |     P=0.527N     P=0.287N     P=0.250N     P=0.544N    |P=0.074      P=0.429N     P=0.282      P=0.178      | 
|POLY 1.5           |     P=0.520N     P=0.273N     P=0.247N     P=0.525N    |P=0.079      P=0.440N     P=0.270      P=0.184      | 
|POLY 6             |     P=0.538N     P=0.303N     P=0.257N     P=0.569N    |P=0.067      P=0.423N     P=0.289      P=0.166      | 
|LOGISTIC REGRESSION|     P=0.543      P=0.339N     P=0.263N     P=0.626     |P=0.063      P=0.401N     P=0.276      P=0.156      | 
|COCH-ARM / FISHERS |     P=0.513N     P=0.254N     P=0.243N     P=0.500N    |P=0.075      P=0.500N     P=0.212      P=0.163      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 28      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                       CITRAL           
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/49 (0%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/48.80      0/44.79      0/47.99      2/45.98     |0/43.96      0/47.89      0/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         4.4%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    0/42 (0%)    1/40 (3%)   |0/40 (0%)    0/45 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          682         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.040 *    (e)          (e)          P=0.203     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.045 *    (e)          (e)          P=0.224     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.045 *    (e)          (e)          P=0.230     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.044 *    (e)          (e)          P=0.217     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.047 *    (e)          (e)          P=0.240     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.047 *    (e)          (e)          P=0.247     |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/49 (0%)    2/50 (4%)    0/50 (0%)   |1/50 (2%)    1/50 (2%)    0/50 (0%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     1/49.64      0/44.79      2/48.66      0/45.81     |1/43.96      1/47.89      0/47.49      2/46.38      | 
|POLY-3 PERCENT (g) |     2.0%         0.0%         4.1%         0.0%        |2.3%         2.1%         0.0%         4.3%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    0/42 (0%)    0/40 (0%)   |1/40 (3%)    1/45 (2%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     397          ---          616          ---         |733 (T)      733 (T)      ---          523          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.467N     P=0.500N     P=0.500      P=0.500N    |P=0.363      P=0.735N     P=0.486N     P=0.510      | 
|POLY 3             |     P=0.472N     P=0.520N     P=0.493      P=0.516N    |P=0.374      P=0.741N     P=0.485N     P=0.519      | 
|POLY 1.5           |     P=0.466N     P=0.514N     P=0.496      P=0.510N    |P=0.374      P=0.744N     P=0.486N     P=0.518      | 
|POLY 6             |     P=0.480N     P=0.527N     P=0.490      P=0.524N    |P=0.372      P=0.740N     P=0.485N     P=0.517      | 
|LOGISTIC REGRESSION|     P=0.431N     (e)          P=0.500      (e)         |P=0.325      P=0.735N     (e)          P=0.449      | 
|COCH-ARM / FISHERS |     P=0.459N     P=0.505N     P=0.500      P=0.500N    |P=0.366      P=0.753N     P=0.500N     P=0.500      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 29      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                       CITRAL           
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Hyperkeratosis Diffuse                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/49 (0%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/48.80      0/44.79      0/47.99      2/47.25     |0/43.96      0/47.89      0/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     2.1%         0.0%         0.0%         4.2%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/48 (2%)    0/40 (0%)    0/42 (0%)    0/40 (0%)   |0/40 (0%)    0/45 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      ---          ---          447         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.240      P=0.536N     P=0.527N     P=0.479     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.250      P=0.517N     P=0.503N     P=0.489     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.250      P=0.512N     P=0.502N     P=0.494     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.250      P=0.523N     P=0.506N     P=0.480     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.257      (e)          (e)          P=0.658     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.247      P=0.505N     P=0.500N     P=0.500     |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Hyperplasia Diffuse                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/49 (0%)    2/50 (4%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/48.80      0/44.79      2/48.27      0/45.81     |0/43.96      0/47.89      0/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     2.1%         0.0%         4.1%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/48 (2%)    0/40 (0%)    1/42 (2%)    0/40 (0%)   |0/40 (0%)    0/45 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      ---          650          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.489N     P=0.536N     P=0.469      P=0.536N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.469N     P=0.517N     P=0.496      P=0.513N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.464N     P=0.512N     P=0.498      P=0.507N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.476N     P=0.523N     P=0.493      P=0.520N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.454N     (e)          P=0.504      (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.459N     P=0.505N     P=0.500      P=0.500N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 30      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                       CITRAL           
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/49 (0%)    2/50 (4%)    2/50 (4%)   |3/50 (6%)    3/50 (6%)    1/50 (2%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     1/48.80      0/44.79      2/48.38      2/45.98     |3/44.00      3/47.89      1/47.49      2/46.38      | 
|POLY-3 PERCENT (g) |     2.1%         0.0%         4.1%         4.4%        |6.8%         6.3%         2.1%         4.3%         | 
|TERMINAL (d)       |     1/48 (2%)    0/40 (0%)    1/42 (2%)    1/40 (3%)   |2/40 (5%)    3/45 (7%)    1/43 (2%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      ---          616          682         |722          733 (T)      733 (T)      523          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.218      P=0.536N     P=0.469      P=0.440     |P=0.353N     P=0.608N     P=0.284N     P=0.494N     | 
|POLY 3             |     P=0.239      P=0.517N     P=0.497      P=0.479     |P=0.333N     P=0.622N     P=0.279N     P=0.476N     | 
|POLY 1.5           |     P=0.243      P=0.512N     P=0.499      P=0.488     |P=0.333N     P=0.628N     P=0.282N     P=0.477N     | 
|POLY 6             |     P=0.232      P=0.523N     P=0.494      P=0.468     |P=0.335N     P=0.620N     P=0.279N     P=0.478N     | 
|LOGISTIC REGRESSION|     P=0.257      (e)          P=0.504      P=0.495     |P=0.352N     P=0.619N     P=0.279N     P=0.522N     | 
|COCH-ARM / FISHERS |     P=0.248      P=0.505N     P=0.500      P=0.500     |P=0.344N     P=0.661N     P=0.309N     P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/48.80      0/45.14      2/48.50      0/45.81     |1/44.92      0/47.89      0/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         4.1%         0.0%        |2.2%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    0/42 (0%)    0/40 (0%)   |0/40 (0%)    0/45 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          616          ---         |243          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.578      (e)          P=0.233      (e)         |P=0.300N     P=0.488N     P=0.488N     P=0.488N     | 
|POLY 3             |     P=0.570      (e)          P=0.236      (e)         |P=0.311N     P=0.487N     P=0.489N     P=0.498N     | 
|POLY 1.5           |     P=0.582      (e)          P=0.237      (e)         |P=0.311N     P=0.489N     P=0.490N     P=0.496N     | 
|POLY 6             |     P=0.554      (e)          P=0.234      (e)         |P=0.309N     P=0.486N     P=0.489N     P=0.502N     | 
|LOGISTIC REGRESSION|     P=0.610      (e)          P=0.233      (e)         |P=0.594N     P=0.915N     P=0.924N     P=0.811N     | 
|COCH-ARM / FISHERS |     P=0.596      (e)          P=0.247      (e)         |P=0.306N     P=0.500N     P=0.500N     P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 31      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                       CITRAL           
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular: Epithelium                                                                                                   | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/50 (0%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/48.80      0/45.14      0/47.99      1/45.81     |0/43.96      0/47.89      0/47.49      0/45.29      | 
|POLY-3 PERCENT (g) |     4.1%         0.0%         0.0%         2.2%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/48 (4%)    0/40 (0%)    0/42 (0%)    1/40 (3%)   |0/40 (0%)    0/45 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      ---          ---          727 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.499N     P=0.280N     P=0.268N     P=0.564N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.448N     P=0.255N     P=0.241N     P=0.522N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.453N     P=0.248N     P=0.239N     P=0.513N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.443N     P=0.264N     P=0.245N     P=0.535N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.499N     (e)          (e)          P=0.564N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.462N     P=0.247N     P=0.247N     P=0.500N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Germinal Epithelium                                                                                                      | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    0/50 (0%)    4/50 (8%)    4/50 (8%)   |                                                    | 
|POLY-3 RATE (b)    |     4/48.80      0/45.14      4/48.53      4/46.06     |                                                    | 
|POLY-3 PERCENT (g) |     8.2%         0.0%         8.2%         8.7%        |                                                    | 
|TERMINAL (d)       |     4/48 (8%)    0/40 (0%)    2/42 (5%)    3/40 (8%)   |                                                    | 
|FIRST INCIDENCE    |     727 (T)      ---          616          661         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.286      P=0.089N     P=0.583      P=0.545     |                                                    | 
|POLY 3             |     P=0.338      P=0.071N     P=0.640      P=0.611     |                                                    | 
|POLY 1.5           |     P=0.341      P=0.067N     P=0.641      P=0.624     |                                                    | 
|POLY 6             |     P=0.332      P=0.077N     P=0.636      P=0.593     |                                                    | 
|LOGISTIC REGRESSION|     P=0.340      (e)          P=0.639N     P=0.612     |                                                    | 
|COCH-ARM / FISHERS |     P=0.344      P=0.059N     P=0.643N     P=0.643N    |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 32      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                       CITRAL           
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     41/50 (82%)  39/48 (81%)  32/48 (67%)  41/46 (89%) |26/47 (55%)  33/49 (67%)  24/48 (50%)  19/50 (38%)  | 
|POLY-3 RATE (b)    |     41/49.16     39/48.00     32/48.00     41/44.38    |26/46.00     33/49.00     24/45.96     19/49.72     | 
|POLY-3 PERCENT (g) |     83.4%        81.3%        66.7%        92.4%       |56.5%        67.4%        52.2%        38.2%        | 
|TERMINAL (d)       |     40/48 (83%)  30/39 (77%)  24/40 (60%)  36/37 (97%) |19/39 (49%)  29/45 (64%)  21/41 (51%)  10/40 (25%)  | 
|FIRST INCIDENCE    |     626          418          427          447         |242          413          645          264          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.078      P=0.172      P=0.347N     P=0.008 **  |P=0.046N*    P=0.353      P=0.336N     P=0.130N     | 
|POLY 3             |     P=0.209      P=0.496N     P=0.045N*    P=0.149     |P=0.009N**   P=0.192      P=0.419N     P=0.055N     | 
|POLY 1.5           |     P=0.243      P=0.516N     P=0.050N     P=0.192     |P=0.008N**   P=0.192      P=0.385N     P=0.054N     | 
|POLY 6             |     P=0.162      P=0.484N     P=0.043N*    P=0.094     |P=0.010N*    P=0.192      P=0.460N     P=0.057N     | 
|LOGISTIC REGRESSION|     P=0.282      P=0.559N     P=0.067N     P=0.122     |P=0.012N*    P=0.127      P=0.385N     P=0.073N     | 
|COCH-ARM / FISHERS |     P=0.286      P=0.565N     P=0.065N     P=0.243     |P=0.012N*    P=0.159      P=0.377N     P=0.066N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/48 (2%)    0/48 (0%)    0/46 (0%)   |11/47 (23%)  5/49 (10%)   16/48 (33%)  14/50 (28%)  | 
|POLY-3 RATE (b)    |     0/48.80      1/43.50      0/45.99      0/42.56     |11/42.19     5/47.03      16/46.27     14/45.29     | 
|POLY-3 PERCENT (g) |     0.0%         2.3%         0.0%         0.0%        |26.1%        10.6%        34.6%        30.9%        | 
|TERMINAL (d)       |     0/48 (0%)    1/39 (3%)    0/40 (0%)    0/37 (0%)   |11/39 (28%)  5/45 (11%)   14/41 (34%)  14/40 (35%)  | 
|FIRST INCIDENCE    |     ---          727 (T)      ---          ---         |733 (T)      733 (T)      618          733 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.600N     P=0.459      (e)          (e)         |P=0.081      P=0.044N*    P=0.228      P=0.343      | 
|POLY 3             |     P=0.589N     P=0.477      (e)          (e)         |P=0.104      P=0.051N     P=0.263      P=0.396      | 
|POLY 1.5           |     P=0.585N     P=0.483      (e)          (e)         |P=0.115      P=0.054N     P=0.254      P=0.410      | 
|POLY 6             |     P=0.594N     P=0.471      (e)          (e)         |P=0.091      P=0.050N     P=0.267      P=0.373      | 
|LOGISTIC REGRESSION|     (e)          P=0.459      (e)          (e)         |P=0.101      P=0.044N*    P=0.244      P=0.343      | 
|COCH-ARM / FISHERS |     P=0.579N     P=0.490      (e)          (e)         |P=0.123      P=0.071N     P=0.199      P=0.388      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/06/01                           EXPERIMENT: 56348 TEST: 04                                            Page 33      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                       CITRAL           
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland                                                                                                                    | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |2/48 (4%)    0/50 (0%)    0/50 (0%)    0/49 (0%)    | 
|POLY-3 RATE (b)    |     0/48.80      0/45.14      0/47.99      0/45.81     |2/43.11      0/47.89      0/47.49      0/44.92      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |4.6%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/48 (0%)    0/40 (0%)    0/42 (0%)    0/40 (0%)   |2/40 (5%)    0/45 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |733 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.114N     P=0.213N     P=0.223N     P=0.238N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.116N     P=0.214N     P=0.216N     P=0.228N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.116N     P=0.215N     P=0.216N     P=0.226N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.115N     P=0.215N     P=0.219N     P=0.233N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.114N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.113N     P=0.237N     P=0.237N     P=0.242N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      500 PPM      1000 PPM     2000 PPM    |UNTREAT      500 PPM      1000 PPM     2000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |43/50 (86%)  43/50 (86%)  44/50 (88%)  35/50 (70%)  | 
|POLY-3 RATE (b)    |                                                        |43/45.55     43/49.14     44/48.43     35/46.26     | 
|POLY-3 PERCENT (g) |                                                        |94.4%        87.5%        90.9%        75.7%        | 
|TERMINAL (d)       |                                                        |38/40 (95%)  40/45 (89%)  40/43 (93%)  33/40 (83%)  | 
|FIRST INCIDENCE    |                                                        |544          413          618          576          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.038N*    P=0.152N     P=0.379N     P=0.035N*    | 
|POLY 3             |                                                        |P=0.005N**   P=0.200N     P=0.390N     P=0.008N**   | 
|POLY 1.5           |                                                        |P=0.004N**   P=0.246N     P=0.414N     P=0.008N**   | 
|POLY 6             |                                                        |P=0.009N**   P=0.202N     P=0.429N     P=0.013N*    | 
|LOGISTIC REGRESSION|                                                        |P=0.005N**   P=0.209N     P=0.266N     P=0.008N**   | 
|COCH-ARM / FISHERS |                                                        |P=0.017N*    P=0.613N     P=0.500      P=0.045N*    | 
|=================================================================================================================================| 
(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).                                                    

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