Skip to Main Navigation
Skip to Page Content
Share This:
https://ntp.niehs.nih.gov/go/12919

TDMS Study 56348-03 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                           CITRAL                                        DATE: 07/05/01       
EXPERIMENT: 56348 TEST: 03                                                                                     TIME: 13:13:17       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55384                              ROUTE: DOSED FEED                                              NTP C#: C56348       
PATHOLOGIST: SINGER, ALLEN                                                                                     CAS: 5392-40-5       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    UNTREAT CONTROL                                                               
                                       INCLUDE 002    UNTREAT CONTROL                                                               
                                       INCLUDE 005    1000 PPM                                                                      
                                       INCLUDE 006    1000 PPM                                                                      
                                       INCLUDE 007    2000 PPM                                                                      
                                       INCLUDE 008    2000 PPM                                                                      
                                       INCLUDE 009    4000 PPM                                                                      
                                       INCLUDE 010    4000 PPM                                                                      
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                           CITRAL                                        DATE: 07/05/01       
EXPERIMENT: 56348 TEST: 03                                                                                     TIME: 13:13:17       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55384                              ROUTE: DOSED FEED                                              NTP C#: C56348       
PATHOLOGIST: SINGER, ALLEN                                                                                     CAS: 5392-40-5       
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                      CITRAL                                                                                      
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Adrenal Medulla                        Hyperplasia                                                                                  
Heart                                  Cardiomyopathy                                                                               
Intestine Large, Cecum                 Inflammation                                                                                 
Intestine Large, Colon                 Parasite Metazoan                                                                            
Kidney                                 Accumulation, Hyaline Droplet                                                                
                                       Mineralization                                                                               
                                       Pigmentation                                                                                 
Liver                                  Basophilic Focus                                                                             
Lung                                   Hemorrhage                                                                                   
                                       Inflammation                                                                                 
Pancreas                               Atrophy                                                                                      
Prostate                               Inflammation Chronic                                                                         
Stomach, Forestomach: Epithelium       Hyperplasia                                                                                  
Testes: Interstitial Cell              Hyperplasia                                                                                  
Thyroid Gland: C-Cell                  Hyperplasia                                                                                  
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Cortex                         Angiectasis                                                                                  
                                       Hypertrophy                                                                                  
Bone                                   Osteopetrosis                                                                                
Brain                                  Hemorrhage                                                                                   
Clitoral Gland                         Hyperplasia                                                                                  
                                       Inflammation                                                                                 
Intestine Large, Rectum                Parasite Metazoan                                                                            
Kidney                                 Necrosis                                                                                     
                                       Nephropathy                                                                                  
Liver                                  Fatty Change                                                                                 
Liver: Bile Duct                       Hyperplasia                                                                                  
Lymph Node, Mandibular                 Ectasia                                                                                      
                                       Hyperplasia                                                                                  
Mammary Gland                          Hyperplasia                                                                                  
Pancreas                               Atrophy                                                                                      
Stomach, Forestomach: Epithelium       Hyperplasia                                                                                  
Thyroid Gland: C-Cell                  Hyperplasia                                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 1       
                     Statistical Analysis of Non-neoplastic Lesions in        Rats(FISCHER 344)  -                       CITRAL     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    1/50 (2%)   |0/50 (0%)    1/50 (2%)    3/50 (6%)    10/50 (20%)  | 
|POLY-3 RATE (b)    |     0/43.44      1/45.85      0/47.40      1/45.40     |0/45.20      1/45.60      3/45.17      10/44.18     | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         0.0%         2.2%        |0.0%         2.2%         6.6%         22.6%        | 
|TERMINAL (d)       |     0/30 (0%)    1/32 (3%)    0/35 (0%)    1/34 (3%)   |0/35 (0%)    1/36 (3%)    3/36 (8%)    10/36 (28%)  | 
|FIRST INCIDENCE    |     ---          726 (T)      ---          726 (T)     |---          732 (T)      732 (T)      732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.430      P=0.513      (e)          P=0.525     |P<0.001 **   P=0.506      P=0.126      P<0.001 **   | 
|POLY 3             |     P=0.419      P=0.511      (e)          P=0.509     |P<0.001 **   P=0.502      P=0.118      P<0.001 **   | 
|POLY 1.5           |     P=0.413      P=0.506      (e)          P=0.505     |P<0.001 **   P=0.501      P=0.118      P<0.001 **   | 
|POLY 6             |     P=0.430      P=0.518      (e)          P=0.516     |P<0.001 **   P=0.503      P=0.120      P<0.001 **   | 
|LOGISTIC REGRESSION|     (e)          P=0.513      (e)          P=0.525     |(e)          P=0.506      P=0.126      P<0.001 **   | 
|COCH-ARM / FISHERS |     P=0.405      P=0.500      (e)          P=0.500     |P<0.001 **   P=0.500      P=0.121      P<0.001 **   | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     12/50 (24%)  20/50 (40%)  11/50 (22%)  14/50 (28%) |14/50 (28%)  13/50 (26%)  12/50 (24%)  8/50 (16%)   | 
|POLY-3 RATE (b)    |     12/44.54     20/46.64     11/47.82     14/45.81    |14/45.75     13/45.86     12/45.34     8/44.18      | 
|POLY-3 PERCENT (g) |     26.9%        42.9%        23.0%        30.6%       |30.6%        28.4%        26.5%        18.1%        | 
|TERMINAL (d)       |     8/30 (27%)   15/32 (47%)  8/35 (23%)   11/34 (32%) |12/35 (34%)  12/36 (33%)  11/36 (31%)  8/36 (22%)   | 
|FIRST INCIDENCE    |     600          639          639          636         |627          662          690          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.326N     P=0.124      P=0.333N     P=0.549     |P=0.070N     P=0.463N     P=0.374N     P=0.097N     | 
|POLY 3             |     P=0.430N     P=0.081      P=0.422N     P=0.441     |P=0.097N     P=0.497N     P=0.419N     P=0.127N     | 
|POLY 1.5           |     P=0.448N     P=0.073      P=0.455N     P=0.426     |P=0.094N     P=0.500N     P=0.419N     P=0.123N     | 
|POLY 6             |     P=0.403N     P=0.095      P=0.380N     P=0.467     |P=0.097N     P=0.492N     P=0.413N     P=0.127N     | 
|LOGISTIC REGRESSION|     P=0.398N     P=0.100      P=0.413N     P=0.484     |P=0.082N     P=0.474N     P=0.389N     P=0.113N     | 
|COCH-ARM / FISHERS |     P=0.468N     P=0.066      P=0.500N     P=0.410     |P=0.084N     P=0.500N     P=0.410N     P=0.114N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 2       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)   |10/50 (20%)  3/50 (6%)    3/50 (6%)    4/50 (8%)    | 
|POLY-3 RATE (b)    |     0/43.44      0/45.85      1/47.40      0/45.40     |10/45.57     3/45.92      3/45.17      4/44.35      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.1%         0.0%        |21.9%        6.5%         6.6%         9.0%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    1/35 (3%)    0/34 (0%)   |9/35 (26%)   2/36 (6%)    3/36 (8%)    3/36 (8%)    | 
|FIRST INCIDENCE    |     ---          ---          726 (T)      ---         |627          645          732 (T)      687          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.710      (e)          P=0.531      (e)         |P=0.071N     P=0.033N*    P=0.032N*    P=0.068N     | 
|POLY 3             |     P=0.702      (e)          P=0.517      (e)         |P=0.078N     P=0.033N*    P=0.035N*    P=0.079N     | 
|POLY 1.5           |     P=0.698      (e)          P=0.510      (e)         |P=0.077N     P=0.034N*    P=0.036N*    P=0.078N     | 
|POLY 6             |     P=0.711      (e)          P=0.528      (e)         |P=0.077N     P=0.031N*    P=0.034N*    P=0.077N     | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.531      (e)         |P=0.080N     P=0.035N*    P=0.034N*    P=0.078N     | 
|COCH-ARM / FISHERS |     P=0.694      (e)          P=0.500      (e)         |P=0.076N     P=0.036N*    P=0.036N*    P=0.074N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    1/50 (2%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     3/44.20      1/46.16      0/47.40      2/46.43     |0/45.20      0/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     6.8%         2.2%         0.0%         4.3%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/35 (0%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     549          639          ---          544         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.426N     P=0.273N     P=0.093N     P=0.472N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.441N     P=0.290N     P=0.107N     P=0.478N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.442N     P=0.297N     P=0.112N     P=0.488N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.441N     P=0.279N     P=0.100N     P=0.461N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.459N     P=0.351N     P=0.185N     P=0.531N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.444N     P=0.309N     P=0.121N     P=0.500N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 3       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    1/50 (2%)    2/50 (4%)    3/50 (6%)   |1/50 (2%)    6/50 (12%)   2/50 (4%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     4/44.01      1/45.91      2/47.63      3/45.47     |1/45.59      6/45.75      2/45.23      0/44.18      | 
|POLY-3 PERCENT (g) |     9.1%         2.2%         4.2%         6.6%        |2.2%         13.1%        4.4%         0.0%         | 
|TERMINAL (d)       |     1/30 (3%)    0/32 (0%)    0/35 (0%)    2/34 (6%)   |0/35 (0%)    5/36 (14%)   1/36 (3%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     660          709          674          709         |622          694          719          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.483N     P=0.144N     P=0.251N     P=0.426N    |P=0.138N     P=0.066      P=0.500      P=0.514N     | 
|POLY 3             |     P=0.539N     P=0.166N     P=0.302N     P=0.482N    |P=0.142N     P=0.056      P=0.497      P=0.506N     | 
|POLY 1.5           |     P=0.541N     P=0.172N     P=0.317N     P=0.491N    |P=0.140N     P=0.056      P=0.497      P=0.505N     | 
|POLY 6             |     P=0.536N     P=0.158N     P=0.282N     P=0.469N    |P=0.141N     P=0.057      P=0.499      P=0.506N     | 
|LOGISTIC REGRESSION|     P=0.541N     P=0.180N     P=0.366N     P=0.483N    |P=0.141N     P=0.059      P=0.504      P=0.440N     | 
|COCH-ARM / FISHERS |     P=0.544N     P=0.181N     P=0.339N     P=0.500N    |P=0.136N     P=0.056      P=0.500      P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     12/50 (24%)  23/50 (46%)  14/50 (28%)  15/50 (30%) |8/49 (16%)   4/50 (8%)    3/50 (6%)    3/50 (6%)    | 
|POLY-3 RATE (b)    |     12/43.97     23/47.17     14/47.58     15/46.31    |8/44.80      4/45.84      3/45.23      3/44.18      | 
|POLY-3 PERCENT (g) |     27.3%        48.8%        29.4%        32.4%       |17.9%        8.7%         6.6%         6.8%         | 
|TERMINAL (d)       |     9/30 (30%)   13/32 (41%)  12/35 (34%)  11/34 (32%) |5/34 (15%)   2/36 (6%)    2/36 (6%)    3/36 (8%)    | 
|FIRST INCIDENCE    |     674          639          688          520         |627          694          719          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.337N     P=0.057      P=0.572N     P=0.479     |P=0.076N     P=0.169N     P=0.095N     P=0.094N     | 
|POLY 3             |     P=0.426N     P=0.026 *    P=0.502      P=0.382     |P=0.079N     P=0.165N     P=0.095N     P=0.102N     | 
|POLY 1.5           |     P=0.459N     P=0.021 *    P=0.463      P=0.356     |P=0.077N     P=0.167N     P=0.095N     P=0.100N     | 
|POLY 6             |     P=0.383N     P=0.038 *    P=0.555      P=0.423     |P=0.079N     P=0.162N     P=0.093N     P=0.102N     | 
|LOGISTIC REGRESSION|     P=0.421N     P=0.033 *    P=0.551N     P=0.401     |P=0.077N     P=0.164N     P=0.092N     P=0.098N     | 
|COCH-ARM / FISHERS |     P=0.500N     P=0.018 *    P=0.410      P=0.326     |P=0.074N     P=0.168N     P=0.094N     P=0.094N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 4       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Blood Vessel                                                                                                                     | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/43.44      0/45.85      2/47.40      0/45.40     |0/45.20      0/45.60      0/45.17      1/44.18      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         4.2%         0.0%        |0.0%         0.0%         0.0%         2.3%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    2/35 (6%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          726 (T)      ---         |---          ---          ---          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.620      (e)          P=0.273      (e)         |P=0.201      (e)          (e)          P=0.506      | 
|POLY 3             |     P=0.607      (e)          P=0.257      (e)         |P=0.195      (e)          (e)          P=0.495      | 
|POLY 1.5           |     P=0.601      (e)          P=0.249      (e)         |P=0.196      (e)          (e)          P=0.496      | 
|POLY 6             |     P=0.618      (e)          P=0.270      (e)         |P=0.196      (e)          (e)          P=0.497      | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.273      (e)         |(e)          (e)          (e)          P=0.506      | 
|COCH-ARM / FISHERS |     P=0.595      (e)          P=0.247      (e)         |P=0.198      (e)          (e)          P=0.500      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone                                                                                                                             | 
|     Osteopetrosis                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)   |3/50 (6%)    12/50 (24%)  5/50 (10%)   8/50 (16%)   | 
|POLY-3 RATE (b)    |     0/43.44      1/45.85      1/47.42      0/45.40     |3/45.20      12/45.70     5/45.32      8/44.91      | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         2.1%         0.0%        |6.6%         26.3%        11.0%        17.8%        | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/35 (0%)    0/34 (0%)   |3/35 (9%)    11/36 (31%)  4/36 (11%)   7/36 (19%)   | 
|FIRST INCIDENCE    |     ---          725          722          ---         |732 (T)      708          694          473          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.569N     P=0.519      P=0.542      (e)         |P=0.302      P=0.013 *    P=0.374      P=0.107      | 
|POLY 3             |     P=0.581N     P=0.511      P=0.517      (e)         |P=0.281      P=0.011 *    P=0.358      P=0.096      | 
|POLY 1.5           |     P=0.587N     P=0.506      P=0.510      (e)         |P=0.280      P=0.011 *    P=0.355      P=0.096      | 
|POLY 6             |     P=0.570N     P=0.518      P=0.528      (e)         |P=0.290      P=0.011 *    P=0.365      P=0.098      | 
|LOGISTIC REGRESSION|     P=0.569N     P=0.528      P=0.545      (e)         |P=0.272      P=0.012 *    P=0.367      P=0.095      | 
|COCH-ARM / FISHERS |     P=0.595N     P=0.500      P=0.500      (e)         |P=0.291      P=0.011 *    P=0.357      P=0.100      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 5       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    3/50 (6%)    1/50 (2%)    2/50 (4%)   |1/50 (2%)    0/50 (0%)    2/50 (4%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/43.44      3/45.89      1/47.40      2/45.41     |1/45.25      0/45.60      2/45.17      1/44.18      | 
|POLY-3 PERCENT (g) |     0.0%         6.5%         2.1%         4.4%        |2.2%         0.0%         4.4%         2.3%         | 
|TERMINAL (d)       |     0/30 (0%)    2/32 (6%)    1/35 (3%)    1/34 (3%)   |0/35 (0%)    0/36 (0%)    2/36 (6%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     ---          716          726 (T)      723         |719          ---          732 (T)      732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.383      P=0.140      P=0.531      P=0.271     |P=0.503      P=0.516N     P=0.504      P=0.758      | 
|POLY 3             |     P=0.360      P=0.129      P=0.517      P=0.247     |P=0.487      P=0.498N     P=0.499      P=0.755      | 
|POLY 1.5           |     P=0.350      P=0.124      P=0.510      P=0.242     |P=0.490      P=0.499N     P=0.499      P=0.756      | 
|POLY 6             |     P=0.378      P=0.136      P=0.528      P=0.255     |P=0.488      P=0.497N     P=0.503      P=0.757      | 
|LOGISTIC REGRESSION|     P=0.381      P=0.147      P=0.531      P=0.274     |P=0.498      P=0.497N     P=0.508      P=0.761      | 
|COCH-ARM / FISHERS |     P=0.337      P=0.121      P=0.500      P=0.247     |P=0.500      P=0.500N     P=0.500      P=0.753N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     14/50 (28%)  20/50 (40%)  14/50 (28%)  13/50 (26%) |11/50 (22%)  12/50 (24%)  10/50 (20%)  10/50 (20%)  | 
|POLY-3 RATE (b)    |     14/44.96     20/46.68     14/47.99     13/46.16    |11/46.72     12/45.87     10/47.84     10/46.03     | 
|POLY-3 PERCENT (g) |     31.1%        42.8%        29.2%        28.2%       |23.5%        26.2%        20.9%        21.7%        | 
|TERMINAL (d)       |     10/30 (33%)  16/32 (50%)  11/35 (31%)  11/34 (32%) |5/35 (14%)   10/36 (28%)  4/36 (11%)   5/36 (14%)   | 
|FIRST INCIDENCE    |     610          639          624          544         |588          687          445          491          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.165N     P=0.222      P=0.407N     P=0.371N    |P=0.404N     P=0.511      P=0.496N     P=0.507N     | 
|POLY 3             |     P=0.241N     P=0.170      P=0.508N     P=0.467N    |P=0.402N     P=0.480      P=0.476N     P=0.515N     | 
|POLY 1.5           |     P=0.256N     P=0.158      P=0.542N     P=0.483N    |P=0.405N     P=0.487      P=0.486N     P=0.514N     | 
|POLY 6             |     P=0.219N     P=0.192      P=0.462N     P=0.443N    |P=0.390N     P=0.471      P=0.464N     P=0.508N     | 
|LOGISTIC REGRESSION|     P=0.236N     P=0.191      P=0.528N     P=0.466N    |P=0.355N     P=0.503      P=0.466N     P=0.466N     | 
|COCH-ARM / FISHERS |     P=0.275N     P=0.146      P=0.588N     P=0.500N    |P=0.397N     P=0.500      P=0.500N     P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 6       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Myelofibrosis                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    1/50 (2%)    0/50 (0%)   |1/50 (2%)    1/50 (2%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     2/44.18      1/45.85      1/47.42      0/45.40     |1/45.54      1/45.60      0/45.17      1/44.35      | 
|POLY-3 PERCENT (g) |     4.5%         2.2%         2.1%         0.0%        |2.2%         2.2%         0.0%         2.3%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/35 (0%)    0/34 (0%)   |0/35 (0%)    1/36 (3%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     589          725          722          ---         |636          732 (T)      ---          687          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.140N     P=0.475N     P=0.455N     P=0.232N    |P=0.611N     P=0.750N     P=0.486N     P=0.752N     | 
|POLY 3             |     P=0.151N     P=0.487N     P=0.475N     P=0.231N    |P=0.618N     P=0.760N     P=0.502N     P=0.755      | 
|POLY 1.5           |     P=0.152N     P=0.493N     P=0.486N     P=0.234N    |P=0.617N     P=0.760      P=0.502N     P=0.756      | 
|POLY 6             |     P=0.149N     P=0.478N     P=0.461N     P=0.226N    |P=0.617N     P=0.760N     P=0.501N     P=0.756      | 
|LOGISTIC REGRESSION|     P=0.165N     P=0.541N     P=0.647N     P=0.243N    |P=0.605N     P=0.762N     P=0.467N     P=0.742N     | 
|COCH-ARM / FISHERS |     P=0.153N     P=0.500N     P=0.500N     P=0.247N    |P=0.616N     P=0.753N     P=0.500N     P=0.753N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain                                                                                                                            | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/50 (10%)   1/50 (2%)    2/50 (4%)    2/50 (4%)   |3/50 (6%)    4/50 (8%)    4/50 (8%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     5/44.17      1/46.06      2/47.94      2/46.08     |3/46.51      4/47.81      4/46.76      0/44.18      | 
|POLY-3 PERCENT (g) |     11.3%        2.2%         4.2%         4.3%        |6.5%         8.4%         8.6%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/35 (0%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     674          671          600          628         |508          400          504          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.191N     P=0.075N     P=0.144N     P=0.176N    |P=0.107N     P=0.513      P=0.507      P=0.129N     | 
|POLY 3             |     P=0.216N     P=0.092N     P=0.184N     P=0.199N    |P=0.110N     P=0.515      P=0.503      P=0.128N     | 
|POLY 1.5           |     P=0.218N     P=0.096N     P=0.198N     P=0.207N    |P=0.105N     P=0.509      P=0.500      P=0.125N     | 
|POLY 6             |     P=0.212N     P=0.086N     P=0.168N     P=0.187N    |P=0.114N     P=0.522      P=0.510      P=0.130N     | 
|LOGISTIC REGRESSION|     P=0.241N     P=0.109N     P=0.291N     P=0.231N    |P=0.017N*    P=0.473      P=0.627      P=0.047N*    | 
|COCH-ARM / FISHERS |     P=0.221N     P=0.102N     P=0.218N     P=0.218N    |P=0.095N     P=0.500      P=0.500      P=0.121N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 7       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain                                                                                                                            | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    1/50 (2%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    4/50 (8%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/43.44      0/45.85      1/47.42      1/45.43     |0/45.20      0/45.60      4/45.91      0/44.18      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.1%         2.2%        |0.0%         0.0%         8.7%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/35 (0%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          723          720         |---          ---          649          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.260      (e)          P=0.536      P=0.536     |P=0.503      (e)          P=0.075      (e)          | 
|POLY 3             |     P=0.243      (e)          P=0.517      P=0.509     |P=0.479      (e)          P=0.062      (e)          | 
|POLY 1.5           |     P=0.240      (e)          P=0.510      P=0.505     |P=0.484      (e)          P=0.061      (e)          | 
|POLY 6             |     P=0.249      (e)          P=0.528      P=0.516     |P=0.479      (e)          P=0.065      (e)          | 
|LOGISTIC REGRESSION|     P=0.250      (e)          P=0.547      P=0.526     |P=0.515      (e)          P=0.065      (e)          | 
|COCH-ARM / FISHERS |     P=0.235      (e)          P=0.500      P=0.500     |P=0.500      (e)          P=0.059      (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |7/49 (14%)   8/49 (16%)   15/50 (30%)  4/49 (8%)    | 
|POLY-3 RATE (b)    |                                                        |7/44.55      8/44.60      15/45.17     4/43.58      | 
|POLY-3 PERCENT (g) |                                                        |15.7%        17.9%        33.2%        9.2%         | 
|TERMINAL (d)       |                                                        |7/35 (20%)   8/35 (23%)   15/36 (42%)  3/35 (9%)    | 
|FIRST INCIDENCE    |                                                        |732 (T)      732 (T)      732 (T)      617          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.274N     P=0.500      P=0.044 *    P=0.262N     | 
|POLY 3             |                                                        |P=0.300N     P=0.501      P=0.044 *    P=0.273N     | 
|POLY 1.5           |                                                        |P=0.297N     P=0.499      P=0.045 *    P=0.271N     | 
|POLY 6             |                                                        |P=0.292N     P=0.504      P=0.044 *    P=0.268N     | 
|LOGISTIC REGRESSION|                                                        |P=0.295N     P=0.500      P=0.044 *    P=0.277N     | 
|COCH-ARM / FISHERS |                                                        |P=0.281N     P=0.500      P=0.050      P=0.262N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 8       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |13/49 (27%)  20/49 (41%)  19/50 (38%)  24/49 (49%)  | 
|POLY-3 RATE (b)    |                                                        |13/45.53     20/45.87     19/47.38     24/45.91     | 
|POLY-3 PERCENT (g) |                                                        |28.6%        43.6%        40.1%        52.3%        | 
|TERMINAL (d)       |                                                        |9/35 (26%)   16/35 (46%)  13/36 (36%)  16/35 (46%)  | 
|FIRST INCIDENCE    |                                                        |595          582          445          473          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.033 *    P=0.112      P=0.178      P=0.028 *    | 
|POLY 3             |                                                        |P=0.022 *    P=0.098      P=0.169      P=0.015 *    | 
|POLY 1.5           |                                                        |P=0.022 *    P=0.097      P=0.163      P=0.015 *    | 
|POLY 6             |                                                        |P=0.026 *    P=0.100      P=0.181      P=0.018 *    | 
|LOGISTIC REGRESSION|                                                        |P=0.023 *    P=0.099      P=0.159      P=0.017 *    | 
|COCH-ARM / FISHERS |                                                        |P=0.024 *    P=0.100      P=0.157      P=0.018 *    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland: Duct                                                                                                             | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |5/49 (10%)   3/49 (6%)    6/50 (12%)   4/49 (8%)    | 
|POLY-3 RATE (b)    |                                                        |5/44.60      3/44.60      6/45.84      4/43.28      | 
|POLY-3 PERCENT (g) |                                                        |11.2%        6.7%         13.1%        9.2%         | 
|TERMINAL (d)       |                                                        |4/35 (11%)   3/35 (9%)    5/36 (14%)   3/35 (9%)    | 
|FIRST INCIDENCE    |                                                        |719          732 (T)      510          708          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.537N     P=0.362N     P=0.512      P=0.505N     | 
|POLY 3             |                                                        |P=0.552N     P=0.356N     P=0.519      P=0.519N     | 
|POLY 1.5           |                                                        |P=0.547N     P=0.357N     P=0.515      P=0.514N     | 
|POLY 6             |                                                        |P=0.551N     P=0.355N     P=0.527      P=0.518N     | 
|LOGISTIC REGRESSION|                                                        |P=0.553N     P=0.362N     P=0.511      P=0.516N     | 
|COCH-ARM / FISHERS |                                                        |P=0.532N     P=0.357N     P=0.514      P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 9       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Epididymis                                                                                                                       | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    3/50 (6%)    1/50 (2%)    2/50 (4%)   |                                                    | 
|POLY-3 RATE (b)    |     1/43.44      3/46.09      1/47.43      2/45.74     |                                                    | 
|POLY-3 PERCENT (g) |     2.3%         6.5%         2.1%         4.4%        |                                                    | 
|TERMINAL (d)       |     1/30 (3%)    2/32 (6%)    0/35 (0%)    0/34 (0%)   |                                                    | 
|FIRST INCIDENCE    |     726 (T)      660          720          655         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.572      P=0.337      P=0.714N     P=0.549     |                                                    | 
|POLY 3             |     P=0.551      P=0.327      P=0.741N     P=0.518     |                                                    | 
|POLY 1.5           |     P=0.539      P=0.317      P=0.749N     P=0.509     |                                                    | 
|POLY 6             |     P=0.569      P=0.342      P=0.728N     P=0.532     |                                                    | 
|LOGISTIC REGRESSION|     P=0.531      P=0.330      P=0.710N     P=0.504     |                                                    | 
|COCH-ARM / FISHERS |     P=0.526      P=0.309      P=0.753N     P=0.500     |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye                                                                                                                              | 
|     Cataract                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/1 (100%)   2/3 (67%)    1/2 (50%)    3/3 (100%)  |2/2 (100%)   1/1 (100%)   0/0 (0%)     1/2 (50%)    | 
|POLY-3 RATE (b)    |     1/1.00       2/3.00       1/1.98       3/3.00      |2/2.00       1/1.00       0/0.00       1/2.00       | 
|POLY-3 PERCENT (g) |     100.0%       66.7%        50.6%        100.0%      |100.0%       100.0%       0.0%         50.0%        | 
|TERMINAL (d)       |     0/0 (0%)     2/3 (67%)    1/1 (100%)   2/2 (100%)  |2/2 (100%)   0/0 (0%)     0/0 (0%)     1/2 (50%)    | 
|FIRST INCIDENCE    |     505          726 (T)      726 (T)      723         |732 (T)      582          ---          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.419      P=0.482N     P=0.454N     (e)         |P=0.240N     (e)          (e)          P=0.500N     | 
|POLY 3             |     P=0.458      P=0.691N     P=0.619N     (e)         |(e)          (e)          (e)          P=0.500N     | 
|POLY 1.5           |     P=0.458      P=0.691N     P=0.616N     (e)         |(e)          (e)          (e)          P=0.500N     | 
|POLY 6             |     P=0.458      P=0.691N     P=0.625N     (e)         |(e)          (e)          (e)          P=0.500N     | 
|LOGISTIC REGRESSION|     P=0.332      P=0.482N     P=0.454N     (e)         |P=0.240N     (e)          (e)          P=0.500N     | 
|COCH-ARM / FISHERS |     P=0.451      P=0.750N     P=0.667N     (e)         |P=0.232N     (e)          (e)          P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 10      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Retina                                                                                                                      | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/1 (100%)   2/3 (67%)    1/2 (50%)    3/3 (100%)  |2/2 (100%)   1/1 (100%)   0/0 (0%)     1/2 (50%)    | 
|POLY-3 RATE (b)    |     1/1.00       2/3.00       1/1.98       3/3.00      |2/2.00       1/1.00       0/0.00       1/2.00       | 
|POLY-3 PERCENT (g) |     100.0%       66.7%        50.6%        100.0%      |100.0%       100.0%       0.0%         50.0%        | 
|TERMINAL (d)       |     0/0 (0%)     2/3 (67%)    1/1 (100%)   2/2 (100%)  |2/2 (100%)   0/0 (0%)     0/0 (0%)     1/2 (50%)    | 
|FIRST INCIDENCE    |     505          726 (T)      726 (T)      723         |732 (T)      582          ---          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.419      P=0.482N     P=0.454N     (e)         |P=0.240N     (e)          (e)          P=0.500N     | 
|POLY 3             |     P=0.458      P=0.691N     P=0.619N     (e)         |(e)          (e)          (e)          P=0.500N     | 
|POLY 1.5           |     P=0.458      P=0.691N     P=0.616N     (e)         |(e)          (e)          (e)          P=0.500N     | 
|POLY 6             |     P=0.458      P=0.691N     P=0.625N     (e)         |(e)          (e)          (e)          P=0.500N     | 
|LOGISTIC REGRESSION|     P=0.332      P=0.482N     P=0.454N     (e)         |P=0.240N     (e)          (e)          P=0.500N     | 
|COCH-ARM / FISHERS |     P=0.451      P=0.750N     P=0.667N     (e)         |P=0.232N     (e)          (e)          P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     39/50 (78%)  45/50 (90%)  50/50 (100%) 47/50 (94%) |41/50 (82%)  40/50 (80%)  42/50 (84%)  39/50 (78%)  | 
|POLY-3 RATE (b)    |     39/48.10     45/48.27     50/50.00     47/49.24    |41/47.38     40/47.33     42/47.02     39/46.18     | 
|POLY-3 PERCENT (g) |     81.1%        93.2%        100.0%       95.5%       |86.5%        84.5%        89.3%        84.5%        | 
|TERMINAL (d)       |     26/30 (87%)  31/32 (97%)  35/35 (100%) 33/34 (97%) |32/35 (91%)  33/36 (92%)  35/36 (97%)  35/36 (97%)  | 
|FIRST INCIDENCE    |     450          478          573          397         |508          594          445          473          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.358      P=0.393      P=0.296      P=0.354     |P=0.329N     P=0.420N     P=0.582N     P=0.333N     | 
|POLY 3             |     P=0.005 **   P=0.054      P<0.001 **   P=0.019 *   |P=0.493N     P=0.506N     P=0.455      P=0.503N     | 
|POLY 1.5           |     P=0.005 **   P=0.064      P<0.001 **   P=0.019 *   |P=0.453N     P=0.513N     P=0.465      P=0.470N     | 
|POLY 6             |     P=0.006 **   P=0.051      P<0.001 **   P=0.022 *   |P=0.527N     P=0.478N     P=0.473      P=0.529N     | 
|LOGISTIC REGRESSION|     P=0.008 **   P=0.124      P<0.001 **   P=0.025 *   |P=0.551N     P=0.436N     P=0.457      P=0.540N     | 
|COCH-ARM / FISHERS |     P=0.006 **   P=0.086      P<0.001 **   P=0.020 *   |P=0.380N     P=0.500N     P=0.500      P=0.402N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 11      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Thrombosis                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    2/50 (4%)    2/50 (4%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/43.44      2/46.17      2/47.57      2/45.59     |0/45.20      1/46.07      0/45.17      1/44.35      | 
|POLY-3 PERCENT (g) |     0.0%         4.3%         4.2%         4.4%        |0.0%         2.2%         0.0%         2.3%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/35 (0%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     ---          674          688          684         |---          594          ---          687          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.279      P=0.279      P=0.292      P=0.278     |P=0.404      P=0.500      (e)          P=0.515      | 
|POLY 3             |     P=0.261      P=0.251      P=0.258      P=0.248     |P=0.401      P=0.504      (e)          P=0.496      | 
|POLY 1.5           |     P=0.252      P=0.245      P=0.249      P=0.243     |P=0.401      P=0.502      (e)          P=0.497      | 
|POLY 6             |     P=0.276      P=0.261      P=0.271      P=0.257     |P=0.404      P=0.507      (e)          P=0.498      | 
|LOGISTIC REGRESSION|     P=0.240      P=0.228      P=0.244      P=0.243     |P=0.452      P=0.552      (e)          P=0.505      | 
|COCH-ARM / FISHERS |     P=0.242      P=0.247      P=0.247      P=0.247     |P=0.405      P=0.500      (e)          P=0.500      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Cecum                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/49 (0%)    2/50 (4%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    0/49 (0%)    | 
|POLY-3 RATE (b)    |     0/43.44      0/45.85      0/46.40      2/45.98     |0/45.20      1/45.60      0/45.17      0/43.18      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         4.4%        |0.0%         2.2%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/34 (0%)    1/34 (3%)   |0/35 (0%)    1/36 (3%)    0/36 (0%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          544         |---          732 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.050      (e)          (e)          P=0.253     |P=0.568N     P=0.506      (e)          (e)          | 
|POLY 3             |     P=0.047 *    (e)          (e)          P=0.250     |P=0.570N     P=0.502      (e)          (e)          | 
|POLY 1.5           |     P=0.047 *    (e)          (e)          P=0.244     |P=0.571N     P=0.501      (e)          (e)          | 
|POLY 6             |     P=0.048 *    (e)          (e)          P=0.260     |P=0.568N     P=0.503      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.053      (e)          (e)          P=0.225     |(e)          P=0.506      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.047 *    (e)          (e)          P=0.247     |P=0.570N     P=0.500      (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 12      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Colon                                                                                                           | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    4/50 (8%)    2/50 (4%)    0/50 (0%)   |2/50 (4%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     4/43.69      4/46.07      2/47.40      0/45.40     |2/45.20      0/45.60      0/45.17      2/44.18      | 
|POLY-3 PERCENT (g) |     9.2%         8.7%         4.2%         0.0%        |4.4%         0.0%         0.0%         4.5%         | 
|TERMINAL (d)       |     3/30 (10%)   2/32 (6%)    2/35 (6%)    0/34 (0%)   |2/35 (6%)    0/36 (0%)    0/36 (0%)    2/36 (6%)    | 
|FIRST INCIDENCE    |     660          674          726 (T)      ---         |732 (T)      ---          ---          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.023N*    P=0.590N     P=0.269N     P=0.051N    |P=0.506      P=0.232N     P=0.232N     P=0.685N     | 
|POLY 3             |     P=0.028N*    P=0.614N     P=0.300N     P=0.055N    |P=0.495      P=0.235N     P=0.237N     P=0.686      | 
|POLY 1.5           |     P=0.029N*    P=0.627N     P=0.316N     P=0.058N    |P=0.496      P=0.236N     P=0.238N     P=0.687      | 
|POLY 6             |     P=0.026N*    P=0.594N     P=0.280N     P=0.051N    |P=0.494      P=0.233N     P=0.235N     P=0.688      | 
|LOGISTIC REGRESSION|     P=0.025N*    P=0.601N     P=0.269N     P=0.054N    |P=0.506      (e)          (e)          P=0.685N     | 
|COCH-ARM / FISHERS |     P=0.031N*    P=0.643N     P=0.339N     P=0.059N    |P=0.500      P=0.247N     P=0.247N     P=0.691N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Rectum                                                                                                          | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/50 (14%)   7/50 (14%)   8/50 (16%)   8/50 (16%)  |7/50 (14%)   1/50 (2%)    6/50 (12%)   3/50 (6%)    | 
|POLY-3 RATE (b)    |     7/43.69      7/45.97      8/47.43      8/46.60     |7/45.68      1/45.60      6/45.17      3/44.18      | 
|POLY-3 PERCENT (g) |     16.0%        15.2%        16.9%        17.2%       |15.3%        2.2%         13.3%        6.8%         | 
|TERMINAL (d)       |     6/30 (20%)   6/32 (19%)   7/35 (20%)   3/34 (9%)   |6/35 (17%)   1/36 (3%)    6/36 (17%)   3/36 (8%)    | 
|FIRST INCIDENCE    |     660          695          720          520         |588          732 (T)      732 (T)      732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.523      P=0.551N     P=0.588N     P=0.595     |P=0.250N     P=0.031N*    P=0.482N     P=0.151N     | 
|POLY 3             |     P=0.470      P=0.574N     P=0.569      P=0.554     |P=0.275N     P=0.030N*    P=0.509N     P=0.171N     | 
|POLY 1.5           |     P=0.448      P=0.592N     P=0.539      P=0.529     |P=0.271N     P=0.030N*    P=0.507N     P=0.168N     | 
|POLY 6             |     P=0.505      P=0.547N     P=0.608      P=0.593     |P=0.275N     P=0.029N*    P=0.505N     P=0.170N     | 
|LOGISTIC REGRESSION|     P=0.455      P=0.507N     P=0.546N     P=0.513     |P=0.268N     P=0.032N*    P=0.494N     P=0.166N     | 
|COCH-ARM / FISHERS |     P=0.420      P=0.613N     P=0.500      P=0.500     |P=0.260N     P=0.030N*    P=0.500N     P=0.159N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 13      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Ileum                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/49 (2%)    1/50 (2%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/43.44      1/44.85      1/47.40      2/45.40     |0/45.20      0/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         2.1%         4.4%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    1/31 (3%)    1/35 (3%)    2/34 (6%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     ---          726 (T)      726 (T)      726 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.177      P=0.507      P=0.531      P=0.266     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.164      P=0.506      P=0.517      P=0.247     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.160      P=0.502      P=0.510      P=0.242     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.172      P=0.514      P=0.528      P=0.255     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          P=0.507      P=0.531      P=0.266     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.154      P=0.495      P=0.500      P=0.247     |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Jejunum                                                                                                         | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    1/50 (2%)    1/50 (2%)   |0/50 (0%)    1/50 (2%)    0/49 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/43.44      2/45.85      1/47.40      1/45.72     |0/45.20      1/45.60      0/44.17      0/44.18      | 
|POLY-3 PERCENT (g) |     2.3%         4.4%         2.1%         2.2%        |0.0%         2.2%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/30 (3%)    2/32 (6%)    1/35 (3%)    0/34 (0%)   |0/35 (0%)    1/36 (3%)    0/35 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     726 (T)      726 (T)      726 (T)      639         |---          732 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.496N     P=0.523      P=0.727N     P=0.741N    |P=0.564N     P=0.506      (e)          (e)          | 
|POLY 3             |     P=0.513N     P=0.519      P=0.741N     P=0.749N    |P=0.567N     P=0.502      (e)          (e)          | 
|POLY 1.5           |     P=0.521N     P=0.510      P=0.749N     P=0.755N    |P=0.568N     P=0.501      (e)          (e)          | 
|POLY 6             |     P=0.501N     P=0.532      P=0.729N     P=0.740N    |P=0.565N     P=0.503      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.520N     P=0.523      P=0.727N     P=0.758     |(e)          P=0.506      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.530N     P=0.500      P=0.753N     P=0.753N    |P=0.567N     P=0.500      (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 14      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Accumulation, Hyaline Droplet                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/50 (4%)    3/50 (6%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/43.44      0/45.85      2/47.67      3/45.63     |0/45.20      0/45.60      1/45.23      0/44.18      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         4.2%         6.6%        |0.0%         0.0%         2.2%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/35 (0%)    1/34 (3%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          674          684         |---          ---          719          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.035 *    (e)          P=0.296      P=0.155     |P=0.690      (e)          P=0.495      (e)          | 
|POLY 3             |     P=0.029 *    (e)          P=0.259      P=0.128     |P=0.683      (e)          P=0.500      (e)          | 
|POLY 1.5           |     P=0.028 *    (e)          P=0.249      P=0.123     |P=0.686      (e)          P=0.499      (e)          | 
|POLY 6             |     P=0.031 *    (e)          P=0.272      P=0.135     |P=0.684      (e)          P=0.502      (e)          | 
|LOGISTIC REGRESSION|     P=0.028 *    (e)          P=0.213      P=0.128     |P=0.692      (e)          P=0.501      (e)          | 
|COCH-ARM / FISHERS |     P=0.028 *    (e)          P=0.247      P=0.121     |P=0.694      (e)          P=0.500      (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    4/50 (8%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/43.44      0/45.85      4/47.45      0/45.40     |0/45.20      0/45.60      0/45.17      1/44.18      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         8.4%         0.0%        |0.0%         0.0%         0.0%         2.3%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    2/35 (6%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          720          ---         |---          ---          ---          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.541      (e)          P=0.094      (e)         |P=0.201      (e)          (e)          P=0.506      | 
|POLY 3             |     P=0.516      (e)          P=0.072      (e)         |P=0.195      (e)          (e)          P=0.495      | 
|POLY 1.5           |     P=0.507      (e)          P=0.067      (e)         |P=0.196      (e)          (e)          P=0.496      | 
|POLY 6             |     P=0.531      (e)          P=0.080      (e)         |P=0.196      (e)          (e)          P=0.497      | 
|LOGISTIC REGRESSION|     P=0.540      (e)          P=0.095      (e)         |(e)          (e)          (e)          P=0.506      | 
|COCH-ARM / FISHERS |     P=0.500      (e)          P=0.059      (e)         |P=0.198      (e)          (e)          P=0.500      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 15      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Hydronephrosis                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    2/50 (4%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/43.44      0/45.85      0/47.40      0/45.40     |0/45.20      0/45.60      2/45.56      1/44.83      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         4.4%         2.2%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/35 (0%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          638          519          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.240      (e)          P=0.247      P=0.487      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.241      (e)          P=0.239      P=0.498      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.241      (e)          P=0.237      P=0.498      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.244      (e)          P=0.243      P=0.501      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.308      (e)          P=0.244      P=0.718      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.246      (e)          P=0.247      P=0.500      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     45/50 (90%)  45/50 (90%)  48/50 (96%)  50/50 (100%)|41/50 (82%)  43/50 (86%)  38/50 (76%)  41/50 (82%)  | 
|POLY-3 RATE (b)    |     45/48.64     45/49.73     48/50.00     50/50.00    |41/48.52     43/49.34     38/48.59     41/49.16     | 
|POLY-3 PERCENT (g) |     92.5%        90.5%        96.0%        100.0%      |84.5%        87.2%        78.2%        83.4%        | 
|TERMINAL (d)       |     29/30 (97%)  29/32 (91%)  33/35 (94%)  34/34 (100%)|29/35 (83%)  32/36 (89%)  29/36 (81%)  31/36 (86%)  | 
|FIRST INCIDENCE    |     450          478          573          397         |519          400          445          386          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.510      P=0.314N     P=0.273N     P=0.539N    |P=0.424N     P=0.499      P=0.299N     P=0.533N     | 
|POLY 3             |     P=0.026 *    P=0.500N     P=0.371      P=0.051     |P=0.398N     P=0.465      P=0.292N     P=0.553N     | 
|POLY 1.5           |     P=0.018 *    P=0.561N     P=0.292      P=0.038 *   |P=0.412N     P=0.436      P=0.299N     P=0.570N     | 
|POLY 6             |     P=0.044 *    P=0.412N     P=0.510      P=0.089     |P=0.394N     P=0.490      P=0.287N     P=0.546N     | 
|LOGISTIC REGRESSION|     P=0.015 *    P=0.598N     P=0.323      P=0.036 *   |P=0.448N     P=0.393      P=0.321N     P=0.595      | 
|COCH-ARM / FISHERS |     P=0.013 *    P=0.630N     P=0.218      P=0.028 *   |P=0.439N     P=0.393      P=0.312N     P=0.602N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 16      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/43.44      0/45.85      0/47.40      0/45.40     |0/45.20      0/45.60      0/45.17      2/45.21      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         4.4%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/35 (0%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          ---          386          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.048 *    (e)          (e)          P=0.248      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.045 *    (e)          (e)          P=0.237      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.045 *    (e)          (e)          P=0.236      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.045 *    (e)          (e)          P=0.240      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.091      (e)          (e)          P=0.413      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.046 *    (e)          (e)          P=0.247      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     49/50 (98%)  50/50 (100%) 49/50 (98%)  50/50 (100%)|41/50 (82%)  45/50 (90%)  48/50 (96%)  44/50 (88%)  | 
|POLY-3 RATE (b)    |     49/49.43     50/50.00     49/49.56     50/50.00    |41/46.97     45/49.41     48/49.24     44/47.83     | 
|POLY-3 PERCENT (g) |     99.1%        100.0%       98.9%        100.0%      |87.3%        91.1%        97.5%        92.0%        | 
|TERMINAL (d)       |     30/30 (100%) 32/32 (100%) 35/35 (100%) 34/34 (100%)|34/35 (97%)  33/36 (92%)  35/36 (97%)  33/36 (92%)  | 
|FIRST INCIDENCE    |     450          478          573          397         |588          400          445          386          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.213N     P=0.355N     P=0.113N     P=0.270N    |P=0.376      P=0.344      P=0.147      P=0.397      | 
|POLY 3             |     P=0.643      P=0.903      P=0.887N     P=0.903     |P=0.225      P=0.385      P=0.041 *    P=0.323      | 
|POLY 1.5           |     P=0.510      P=0.697      P=0.817N     P=0.697     |P=0.211      P=0.286      P=0.028 *    P=0.286      | 
|POLY 6             |     P=0.915      P=1.000      P=0.990N     P=1.000     |P=0.311      P=0.554      P=0.094      P=0.448      | 
|LOGISTIC REGRESSION|     P=0.385      P=0.557      P=0.479N     P=0.479     |P=0.124      P=0.183      P=0.009 **   P=0.134      | 
|COCH-ARM / FISHERS |     P=0.405      P=0.500      P=0.753N     P=0.500     |P=0.246      P=0.194      P=0.026 *    P=0.288      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 17      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    0/50 (0%)    2/50 (4%)    6/50 (12%)  |2/50 (4%)    4/50 (8%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     3/44.58      0/45.85      2/47.72      6/45.51     |2/45.55      4/45.85      0/45.17      1/44.28      | 
|POLY-3 PERCENT (g) |     6.7%         0.0%         4.2%         13.2%       |4.4%         8.7%         0.0%         2.3%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/35 (0%)    3/34 (9%)   |0/35 (0%)    2/36 (6%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     450          ---          660          709         |650          687          ---          708          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.071      P=0.105N     P=0.417N     P=0.317     |P=0.202N     P=0.346      P=0.237N     P=0.506N     | 
|POLY 3             |     P=0.051      P=0.114N     P=0.469N     P=0.252     |P=0.203N     P=0.340      P=0.239N     P=0.510N     | 
|POLY 1.5           |     P=0.050      P=0.116N     P=0.483N     P=0.246     |P=0.202N     P=0.338      P=0.239N     P=0.508N     | 
|POLY 6             |     P=0.051      P=0.109N     P=0.449N     P=0.263     |P=0.202N     P=0.343      P=0.238N     P=0.509N     | 
|LOGISTIC REGRESSION|     P=0.049 *    P=0.148N     P=0.627      P=0.230     |P=0.201N     P=0.337      P=0.232N     P=0.495N     | 
|COCH-ARM / FISHERS |     P=0.052      P=0.121N     P=0.500N     P=0.243     |P=0.199N     P=0.339      P=0.247N     P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    1/50 (2%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/43.44      2/46.16      1/47.47      2/45.40     |0/45.20      0/45.60      0/45.17      1/44.18      | 
|POLY-3 PERCENT (g) |     0.0%         4.3%         2.1%         4.4%        |0.0%         0.0%         0.0%         2.3%         | 
|TERMINAL (d)       |     0/30 (0%)    1/32 (3%)    0/35 (0%)    2/34 (6%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     ---          639          709          726 (T)     |---          ---          ---          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.275      P=0.259      P=0.561      P=0.266     |P=0.201      (e)          (e)          P=0.506      | 
|POLY 3             |     P=0.262      P=0.251      P=0.518      P=0.247     |P=0.195      (e)          (e)          P=0.495      | 
|POLY 1.5           |     P=0.255      P=0.245      P=0.510      P=0.242     |P=0.196      (e)          (e)          P=0.496      | 
|POLY 6             |     P=0.274      P=0.261      P=0.528      P=0.255     |P=0.196      (e)          (e)          P=0.497      | 
|LOGISTIC REGRESSION|     P=0.249      P=0.227      P=0.518      P=0.266     |(e)          (e)          (e)          P=0.506      | 
|COCH-ARM / FISHERS |     P=0.246      P=0.247      P=0.500      P=0.247     |P=0.198      (e)          (e)          P=0.500      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 18      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    4/50 (8%)    1/50 (2%)   |0/50 (0%)    1/50 (2%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/43.44      1/45.85      4/47.40      1/45.40     |0/45.20      1/45.92      1/45.84      1/44.18      | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         8.4%         2.2%        |0.0%         2.2%         2.2%         2.3%         | 
|TERMINAL (d)       |     0/30 (0%)    1/32 (3%)    4/35 (11%)   1/34 (3%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     ---          726 (T)      726 (T)      726 (T)     |---          645          510          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.378      P=0.513      P=0.083      P=0.525     |P=0.380      P=0.519      P=0.492      P=0.506      | 
|POLY 3             |     P=0.355      P=0.511      P=0.072      P=0.509     |P=0.375      P=0.503      P=0.503      P=0.495      | 
|POLY 1.5           |     P=0.345      P=0.506      P=0.067      P=0.505     |P=0.377      P=0.501      P=0.501      P=0.496      | 
|POLY 6             |     P=0.371      P=0.518      P=0.080      P=0.516     |P=0.377      P=0.506      P=0.506      P=0.497      | 
|LOGISTIC REGRESSION|     (e)          P=0.513      P=0.083      P=0.525     |P=0.454      P=0.516      P=0.722      P=0.506      | 
|COCH-ARM / FISHERS |     P=0.337      P=0.500      P=0.059      P=0.500     |P=0.384      P=0.500      P=0.500      P=0.500      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     33/50 (66%)  33/50 (66%)  33/50 (66%)  29/50 (58%) |42/50 (84%)  44/50 (88%)  45/50 (90%)  42/50 (84%)  | 
|POLY-3 RATE (b)    |     33/45.74     33/46.87     33/48.06     29/45.90    |42/46.87     44/47.31     45/48.59     42/46.90     | 
|POLY-3 PERCENT (g) |     72.2%        70.4%        68.7%        63.2%       |89.6%        93.0%        92.6%        89.6%        | 
|TERMINAL (d)       |     27/30 (90%)  28/32 (88%)  29/35 (83%)  26/34 (77%) |34/35 (97%)  36/36 (100%) 36/36 (100%) 36/36 (100%) | 
|FIRST INCIDENCE    |     505          505          624          674         |588          594          445          491          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.031N*    P=0.370N     P=0.168N     P=0.058N    |P=0.456N     P=0.497      P=0.405      P=0.530N     | 
|POLY 3             |     P=0.185N     P=0.518N     P=0.441N     P=0.233N    |P=0.506N     P=0.398      P=0.430      P=0.645N     | 
|POLY 1.5           |     P=0.202N     P=0.549N     P=0.504N     P=0.253N    |P=0.534N     P=0.379      P=0.349      P=0.611      | 
|POLY 6             |     P=0.153N     P=0.467N     P=0.347N     P=0.194N    |P=0.415N     P=0.464      P=0.577      P=0.593N     | 
|LOGISTIC REGRESSION|     P=0.086N     P=0.361N     P=0.236N     P=0.109N    |P=0.359      P=0.512      P=0.190      P=0.426      | 
|COCH-ARM / FISHERS |     P=0.213N     P=0.583N     P=0.583N     P=0.268N    |P=0.514N     P=0.387      P=0.277      P=0.607N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 19      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Clear Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     14/50 (28%)  11/50 (22%)  16/50 (32%)  9/50 (18%)  |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     14/43.44     11/45.87     16/47.43     9/45.40     |0/45.20      0/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     32.2%        24.0%        33.7%        19.8%       |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     14/30 (47%)  10/32 (31%)  15/35 (43%)  9/34 (27%)  |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     726 (T)      720          720          726 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.097N     P=0.239N     P=0.561N     P=0.080N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.171N     P=0.262N     P=0.528      P=0.135N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.186N     P=0.290N     P=0.478      P=0.152N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.148N     P=0.223N     P=0.581N     P=0.110N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.083N     P=0.187N     P=0.482N     P=0.080N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.204N     P=0.322N     P=0.414      P=0.171N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    1/50 (2%)    1/50 (2%)    5/50 (10%)  |1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     3/43.76      1/46.06      1/47.40      5/45.47     |1/45.20      0/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     6.9%         2.2%         2.1%         11.0%       |2.2%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/30 (7%)    0/32 (0%)    1/35 (3%)    4/34 (12%)  |1/35 (3%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     639          671          726 (T)      709         |732 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.197      P=0.272N     P=0.257N     P=0.427     |P=0.303N     P=0.494N     P=0.494N     P=0.494N     | 
|POLY 3             |     P=0.164      P=0.287N     P=0.277N     P=0.377     |P=0.305N     P=0.498N     P=0.500N     P=0.505N     | 
|POLY 1.5           |     P=0.163      P=0.295N     P=0.289N     P=0.367     |P=0.305N     P=0.499N     P=0.501N     P=0.504N     | 
|POLY 6             |     P=0.166      P=0.275N     P=0.261N     P=0.394     |P=0.305N     P=0.497N     P=0.498N     P=0.503N     | 
|LOGISTIC REGRESSION|     P=0.170      P=0.309N     P=0.285N     P=0.401     |P=0.303N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.162      P=0.309N     P=0.309N     P=0.357     |P=0.306N     P=0.500N     P=0.500N     P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 20      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/50 (12%)   5/50 (10%)   3/50 (6%)    6/50 (12%)  |8/50 (16%)   7/50 (14%)   3/50 (6%)    9/50 (18%)   | 
|POLY-3 RATE (b)    |     6/43.44      5/45.99      3/47.40      6/45.54     |8/45.25      7/45.60      3/45.17      9/44.18      | 
|POLY-3 PERCENT (g) |     13.8%        10.9%        6.3%         13.2%       |17.7%        15.4%        6.6%         20.4%        | 
|TERMINAL (d)       |     6/30 (20%)   4/32 (13%)   3/35 (9%)    4/34 (12%)  |7/35 (20%)   7/36 (19%)   3/36 (8%)    9/36 (25%)   | 
|FIRST INCIDENCE    |     726 (T)      688          726 (T)      695         |719          732 (T)      732 (T)      732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.478N     P=0.445N     P=0.168N     P=0.525N    |P=0.474      P=0.482N     P=0.093N     P=0.522      | 
|POLY 3             |     P=0.543N     P=0.460N     P=0.201N     P=0.588N    |P=0.440      P=0.494N     P=0.098N     P=0.478      | 
|POLY 1.5           |     P=0.552N     P=0.478N     P=0.218N     P=0.604N    |P=0.444      P=0.498N     P=0.100N     P=0.482      | 
|POLY 6             |     P=0.529N     P=0.432N     P=0.177N     P=0.560N    |P=0.442      P=0.487N     P=0.094N     P=0.482      | 
|LOGISTIC REGRESSION|     P=0.479N     P=0.394N     P=0.168N     P=0.509N    |P=0.458      P=0.496N     P=0.091N     P=0.498      | 
|COCH-ARM / FISHERS |     P=0.563      P=0.500N     P=0.243N     P=0.620N    |P=0.458      P=0.500N     P=0.100N     P=0.500      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    4/50 (8%)    | 
|POLY-3 RATE (b)    |     2/44.38      0/45.85      1/47.91      0/45.40     |0/45.20      0/45.60      1/45.22      4/45.37      | 
|POLY-3 PERCENT (g) |     4.5%         0.0%         2.1%         0.0%        |0.0%         0.0%         2.2%         8.8%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/35 (0%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     505          ---          573          ---         |---          ---          721          432          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.185N     P=0.227N     P=0.474N     P=0.232N    |P=0.006 **   (e)          P=0.505      P=0.069      | 
|POLY 3             |     P=0.188N     P=0.230N     P=0.473N     P=0.232N    |P=0.005 **   (e)          P=0.500      P=0.061      | 
|POLY 1.5           |     P=0.188N     P=0.233N     P=0.485N     P=0.235N    |P=0.005 **   (e)          P=0.499      P=0.060      | 
|POLY 6             |     P=0.189N     P=0.224N     P=0.457N     P=0.227N    |P=0.005 **   (e)          P=0.502      P=0.063      | 
|LOGISTIC REGRESSION|     P=0.180N     P=0.281N     P=0.639      P=0.225N    |P=0.008 **   (e)          P=0.502      P=0.085      | 
|COCH-ARM / FISHERS |     P=0.188N     P=0.247N     P=0.500N     P=0.247N    |P=0.006 **   (e)          P=0.500      P=0.059      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 21      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatodiaphragmatic Nodule                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/50 (12%)   7/50 (14%)   4/50 (8%)    7/50 (14%)  |10/50 (20%)  8/50 (16%)   4/50 (8%)    5/50 (10%)   | 
|POLY-3 RATE (b)    |     6/43.64      7/46.32      4/47.92      7/45.71     |10/46.04     8/45.97      4/45.48      5/44.18      | 
|POLY-3 PERCENT (g) |     13.8%        15.1%        8.4%         15.3%       |21.7%        17.4%        8.8%         11.3%        | 
|TERMINAL (d)       |     5/30 (17%)   3/32 (9%)    2/35 (6%)    4/34 (12%)  |8/35 (23%)   6/36 (17%)   3/36 (8%)    5/36 (14%)   | 
|FIRST INCIDENCE    |     674          671          624          655         |508          659          649          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.523N     P=0.579      P=0.274N     P=0.597     |P=0.072N     P=0.373N     P=0.071N     P=0.122N     | 
|POLY 3             |     P=0.529      P=0.546      P=0.312N     P=0.536     |P=0.084N     P=0.398N     P=0.075N     P=0.147N     | 
|POLY 1.5           |     P=0.516      P=0.525      P=0.337N     P=0.518     |P=0.082N     P=0.400N     P=0.075N     P=0.143N     | 
|POLY 6             |     P=0.550      P=0.579      P=0.279N     P=0.564     |P=0.084N     P=0.392N     P=0.072N     P=0.148N     | 
|LOGISTIC REGRESSION|     P=0.528      P=0.571      P=0.325N     P=0.577     |P=0.081N     P=0.393N     P=0.075N     P=0.139N     | 
|COCH-ARM / FISHERS |     P=0.500      P=0.500      P=0.370N     P=0.500     |P=0.076N     P=0.398N     P=0.074N     P=0.131N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     21/50 (42%)  28/50 (56%)  27/50 (54%)  28/50 (56%) |40/50 (80%)  44/50 (88%)  41/50 (82%)  43/50 (86%)  | 
|POLY-3 RATE (b)    |     21/44.90     28/46.34     27/48.01     28/48.03    |40/46.48     44/47.28     41/48.05     43/47.13     | 
|POLY-3 PERCENT (g) |     46.8%        60.4%        56.2%        58.3%       |86.1%        93.1%        85.3%        91.2%        | 
|TERMINAL (d)       |     18/30 (60%)  23/32 (72%)  24/35 (69%)  23/34 (68%) |33/35 (94%)  35/36 (97%)  34/36 (94%)  36/36 (100%) | 
|FIRST INCIDENCE    |     505          688          573          397         |588          612          445          491          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.326      P=0.189      P=0.383      P=0.245     |P=0.425      P=0.324      P=0.592      P=0.380      | 
|POLY 3             |     P=0.238      P=0.129      P=0.236      P=0.178     |P=0.373      P=0.184      P=0.583N     P=0.300      | 
|POLY 1.5           |     P=0.195      P=0.120      P=0.200      P=0.147     |P=0.338      P=0.182      P=0.590      P=0.274      | 
|POLY 6             |     P=0.304      P=0.152      P=0.297      P=0.229     |P=0.478      P=0.228      P=0.495N     P=0.403      | 
|LOGISTIC REGRESSION|     P=0.190      P=0.226      P=0.337      P=0.130     |P=0.157      P=0.245      P=0.458      P=0.130      | 
|COCH-ARM / FISHERS |     P=0.146      P=0.115      P=0.158      P=0.115     |P=0.348      P=0.207      P=0.500      P=0.298      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 22      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/50 (10%)   8/50 (16%)   5/50 (10%)   7/50 (14%)  |16/50 (32%)  11/50 (22%)  16/50 (32%)  15/50 (30%)  | 
|POLY-3 RATE (b)    |     5/43.44      8/45.85      5/47.43      7/45.40     |16/45.25     11/45.60     16/45.32     15/44.18     | 
|POLY-3 PERCENT (g) |     11.5%        17.5%        10.5%        15.4%       |35.4%        24.1%        35.3%        34.0%        | 
|TERMINAL (d)       |     5/30 (17%)   8/32 (25%)   4/35 (11%)   7/34 (21%)  |15/35 (43%)  11/36 (31%)  15/36 (42%)  15/36 (42%)  | 
|FIRST INCIDENCE    |     726 (T)      726 (T)      720          726 (T)     |719          732 (T)      694          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.527      P=0.312      P=0.524N     P=0.468     |P=0.507      P=0.152N     P=0.551N     P=0.463N     | 
|POLY 3             |     P=0.462      P=0.311      P=0.574N     P=0.410     |P=0.440      P=0.171N     P=0.585N     P=0.533N     | 
|POLY 1.5           |     P=0.446      P=0.295      P=0.598N     P=0.395     |P=0.450      P=0.178N     P=0.583      P=0.526N     | 
|POLY 6             |     P=0.486      P=0.335      P=0.540N     P=0.435     |P=0.444      P=0.162N     P=0.569N     P=0.527N     | 
|LOGISTIC REGRESSION|     P=0.542      P=0.312      P=0.475N     P=0.468     |P=0.472      P=0.167N     P=0.560N     P=0.501N     | 
|COCH-ARM / FISHERS |     P=0.428      P=0.277      P=0.630N     P=0.380     |P=0.479      P=0.184N     P=0.585N     P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    0/50 (0%)    1/50 (2%)   |0/50 (0%)    2/50 (4%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     1/44.01      0/45.85      0/47.40      1/45.40     |0/45.20      2/46.07      0/45.17      1/44.88      | 
|POLY-3 PERCENT (g) |     2.3%         0.0%         0.0%         2.2%        |0.0%         4.3%         0.0%         2.2%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/35 (0%)    1/34 (3%)   |0/35 (0%)    1/36 (3%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     549          ---          ---          726 (T)     |---          594          ---          491          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.606      P=0.504N     P=0.492N     P=0.749N    |P=0.530      P=0.243      (e)          P=0.488      | 
|POLY 3             |     P=0.595      P=0.492N     P=0.485N     P=0.754N    |P=0.538      P=0.241      (e)          P=0.499      | 
|POLY 1.5           |     P=0.594      P=0.496N     P=0.492N     P=0.757N    |P=0.537      P=0.239      (e)          P=0.498      | 
|POLY 6             |     P=0.595      P=0.486N     P=0.476N     P=0.748N    |P=0.543      P=0.245      (e)          P=0.501      | 
|LOGISTIC REGRESSION|     P=0.587      P=0.557N     P=0.833N     P=0.754     |P=0.643      P=0.243      (e)          P=0.783      | 
|COCH-ARM / FISHERS |     P=0.595      P=0.500N     P=0.500N     P=0.753N    |P=0.539      P=0.247      (e)          P=0.500      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 23      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/50 (14%)   7/50 (14%)   8/50 (16%)   3/50 (6%)   |5/50 (10%)   7/50 (14%)   4/50 (8%)    6/50 (12%)   | 
|POLY-3 RATE (b)    |     7/43.44      7/45.98      8/47.50      3/45.53     |5/45.63      7/46.01      4/45.40      6/44.18      | 
|POLY-3 PERCENT (g) |     16.1%        15.2%        16.8%        6.6%        |11.0%        15.2%        8.8%         13.6%        | 
|TERMINAL (d)       |     7/30 (23%)   5/32 (16%)   6/35 (17%)   2/34 (6%)   |3/35 (9%)    5/36 (14%)   3/36 (8%)    6/36 (17%)   | 
|FIRST INCIDENCE    |     726 (T)      692          709          695         |622          645          673          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.084N     P=0.553N     P=0.581N     P=0.109N    |P=0.541      P=0.402      P=0.484N     P=0.512      | 
|POLY 3             |     P=0.113N     P=0.569N     P=0.575      P=0.138N    |P=0.505      P=0.385      P=0.503N     P=0.477      | 
|POLY 1.5           |     P=0.122N     P=0.589N     P=0.542      P=0.148N    |P=0.512      P=0.382      P=0.504N     P=0.483      | 
|POLY 6             |     P=0.100N     P=0.537N     P=0.603N     P=0.123N    |P=0.504      P=0.391      P=0.498N     P=0.477      | 
|LOGISTIC REGRESSION|     P=0.079N     P=0.494N     P=0.518N     P=0.100N    |P=0.514      P=0.383      P=0.501N     P=0.488      | 
|COCH-ARM / FISHERS |     P=0.131N     P=0.613N     P=0.500      P=0.159N    |P=0.531      P=0.380      P=0.500N     P=0.500      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     48/50 (96%)  50/50 (100%) 45/50 (90%)  47/50 (94%) |25/50 (50%)  17/50 (34%)  13/50 (26%)  13/50 (26%)  | 
|POLY-3 RATE (b)    |     48/50.00     50/50.00     45/49.31     47/48.85    |25/48.04     17/47.83     13/46.23     13/44.80     | 
|POLY-3 PERCENT (g) |     96.0%        100.0%       91.3%        96.2%       |52.0%        35.5%        28.1%        29.0%        | 
|TERMINAL (d)       |     28/30 (93%)  32/32 (100%) 33/35 (94%)  33/34 (97%) |15/35 (43%)  10/36 (28%)  9/36 (25%)   9/36 (25%)   | 
|FIRST INCIDENCE    |     450          478          573          520         |519          515          595          687          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.107N     P=0.426N     P=0.057N     P=0.187N    |P=0.017N*    P=0.100N     P=0.019N*    P=0.020N*    | 
|POLY 3             |     P=0.411N     P=0.237      P=0.283N     P=0.684     |P=0.016N*    P=0.075N     P=0.013N*    P=0.018N*    | 
|POLY 1.5           |     P=0.333N     P=0.237      P=0.250N     P=0.648N    |P=0.013N*    P=0.076N     P=0.012N*    P=0.015N*    | 
|POLY 6             |     P=0.500N     P=0.237      P=0.342N     P=0.620     |P=0.018N*    P=0.075N     P=0.014N*    P=0.022N*    | 
|LOGISTIC REGRESSION|     P=0.207N     (e)          P=0.206N     P=0.473N    |P=0.011N*    P=0.079N     P=0.012N*    P=0.013N*    | 
|COCH-ARM / FISHERS |     P=0.221N     P=0.247      P=0.218N     P=0.500N    |P=0.010N*    P=0.078N     P=0.011N*    P=0.011N*    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 24      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Centrilobular                                                                                                             | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     22/50 (44%)  14/50 (28%)  15/50 (30%)  16/50 (32%) |5/50 (10%)   9/50 (18%)   7/50 (14%)   7/50 (14%)   | 
|POLY-3 RATE (b)    |     22/48.34     14/49.00     15/48.94     16/47.84    |5/46.85      9/48.21      7/47.00      7/45.53      | 
|POLY-3 PERCENT (g) |     45.5%        28.6%        30.7%        33.4%       |10.7%        18.7%        14.9%        15.4%        | 
|TERMINAL (d)       |     6/30 (20%)   1/32 (3%)    5/35 (14%)   6/34 (18%)  |0/35 (0%)    3/36 (8%)    2/36 (6%)    2/36 (6%)    | 
|FIRST INCIDENCE    |     450          478          624          544         |595          400          504          386          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.160N     P=0.065N     P=0.061N     P=0.124N    |P=0.445      P=0.229      P=0.407      P=0.391      | 
|POLY 3             |     P=0.214N     P=0.062N     P=0.095N     P=0.157N    |P=0.413      P=0.209      P=0.381      P=0.359      | 
|POLY 1.5           |     P=0.210N     P=0.066N     P=0.100N     P=0.156N    |P=0.424      P=0.204      P=0.379      P=0.366      | 
|POLY 6             |     P=0.216N     P=0.058N     P=0.091N     P=0.157N    |P=0.407      P=0.214      P=0.387      P=0.355      | 
|LOGISTIC REGRESSION|     P=0.291N     P=0.178N     P=0.322N     P=0.211N    |P=0.530N     P=0.145      P=0.433      P=0.468      | 
|COCH-ARM / FISHERS |     P=0.202N     P=0.072N     P=0.107N     P=0.151N    |P=0.445      P=0.194      P=0.380      P=0.380      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/50 (12%)   1/50 (2%)    0/50 (0%)    2/50 (4%)   |2/50 (4%)    1/50 (2%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     6/43.89      1/46.51      0/47.40      2/45.63     |2/46.33      1/46.25      1/45.17      1/44.18      | 
|POLY-3 PERCENT (g) |     13.7%        2.2%         0.0%         4.4%        |4.3%         2.2%         2.2%         2.3%         | 
|TERMINAL (d)       |     4/30 (13%)   0/32 (0%)    0/35 (0%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    1/36 (3%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     660          505          ---          674         |508          515          732 (T)      732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.077N     P=0.050N     P=0.011N*    P=0.104N    |P=0.421N     P=0.505N     P=0.506N     P=0.514N     | 
|POLY 3             |     P=0.090N     P=0.047N*    P=0.012N*    P=0.120N    |P=0.421N     P=0.501N     P=0.509N     P=0.517N     | 
|POLY 1.5           |     P=0.090N     P=0.051N     P=0.013N*    P=0.127N    |P=0.418N     P=0.501N     P=0.506N     P=0.512N     | 
|POLY 6             |     P=0.091N     P=0.042N*    P=0.010N*    P=0.110N    |P=0.423N     P=0.500N     P=0.509N     P=0.519N     | 
|LOGISTIC REGRESSION|     P=0.101N     P=0.066N     P=0.013N*    P=0.121N    |P=0.299N     P=0.382N     P=0.411N     P=0.379N     | 
|COCH-ARM / FISHERS |     P=0.093N     P=0.056N     P=0.013N*    P=0.134N    |P=0.409N     P=0.500N     P=0.500N     P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 25      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     12/50 (24%)  6/50 (12%)   8/50 (16%)   5/50 (10%)  |9/50 (18%)   17/50 (34%)  9/50 (18%)   9/50 (18%)   | 
|POLY-3 RATE (b)    |     12/44.55     6/47.24      8/48.06      5/45.40     |9/45.29      17/45.79     9/46.03      9/44.88      | 
|POLY-3 PERCENT (g) |     26.9%        12.7%        16.6%        11.0%       |19.9%        37.1%        19.6%        20.1%        | 
|TERMINAL (d)       |     8/30 (27%)   2/32 (6%)    4/35 (11%)   5/34 (15%)  |7/35 (20%)   15/36 (42%)  6/36 (17%)   8/36 (22%)   | 
|FIRST INCIDENCE    |     617          505          639          726 (T)     |719          708          510          491          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.048N*    P=0.076N     P=0.135N     P=0.033N*   |P=0.272N     P=0.064      P=0.581N     P=0.586N     | 
|POLY 3             |     P=0.066N     P=0.071N     P=0.170N     P=0.046N*   |P=0.285N     P=0.053      P=0.589N     P=0.595      | 
|POLY 1.5           |     P=0.067N     P=0.081N     P=0.193N     P=0.049N*   |P=0.288N     P=0.052      P=0.597N     P=0.594      | 
|POLY 6             |     P=0.065N     P=0.059N     P=0.143N     P=0.041N*   |P=0.273N     P=0.054      P=0.572N     P=0.604N     | 
|LOGISTIC REGRESSION|     P=0.071N     P=0.107N     P=0.203N     P=0.040N*   |P=0.302N     P=0.054      P=0.603N     P=0.585      | 
|COCH-ARM / FISHERS |     P=0.069N     P=0.096N     P=0.227N     P=0.054N    |P=0.282N     P=0.055      P=0.602N     P=0.602N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/50 (14%)   10/50 (20%)  10/50 (20%)  11/50 (22%) |9/50 (18%)   9/50 (18%)   10/50 (20%)  11/50 (22%)  | 
|POLY-3 RATE (b)    |     7/43.64      10/46.43     10/47.40     11/45.72    |9/45.24      9/46.67      10/45.17     11/44.45     | 
|POLY-3 PERCENT (g) |     16.0%        21.5%        21.1%        24.1%       |19.9%        19.3%        22.1%        24.8%        | 
|TERMINAL (d)       |     6/30 (20%)   6/32 (19%)   10/35 (29%)  10/34 (29%) |8/35 (23%)   7/36 (19%)   10/36 (28%)  9/36 (25%)   | 
|FIRST INCIDENCE    |     674          674          726 (T)      639         |722          515          732 (T)      687          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.310      P=0.381      P=0.427      P=0.305     |P=0.341      P=0.580N     P=0.526      P=0.427      | 
|POLY 3             |     P=0.242      P=0.346      P=0.364      P=0.247     |P=0.296      P=0.575N     P=0.499      P=0.383      | 
|POLY 1.5           |     P=0.229      P=0.323      P=0.335      P=0.233     |P=0.303      P=0.588N     P=0.496      P=0.385      | 
|POLY 6             |     P=0.263      P=0.383      P=0.405      P=0.273     |P=0.299      P=0.557N     P=0.508      P=0.393      | 
|LOGISTIC REGRESSION|     P=0.277      P=0.378      P=0.498      P=0.301     |P=0.302      P=0.598N     P=0.515      P=0.396      | 
|COCH-ARM / FISHERS |     P=0.214      P=0.298      P=0.298      P=0.218     |P=0.325      P=0.602N     P=0.500      P=0.402      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 26      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    2/50 (4%)    9/50 (18%)   1/50 (2%)   |0/50 (0%)    3/50 (6%)    5/50 (10%)   7/50 (14%)   | 
|POLY-3 RATE (b)    |     4/43.76      2/45.85      9/47.40      1/45.40     |0/45.20      3/45.60      5/45.17      7/44.33      | 
|POLY-3 PERCENT (g) |     9.1%         4.4%         19.0%        2.2%        |0.0%         6.6%         11.1%        15.8%        | 
|TERMINAL (d)       |     3/30 (10%)   2/32 (6%)    9/35 (26%)   1/34 (3%)   |0/35 (0%)    3/36 (8%)    5/36 (14%)   6/36 (17%)   | 
|FIRST INCIDENCE    |     639          726 (T)      726 (T)      726 (T)     |---          732 (T)      732 (T)      694          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.236N     P=0.304N     P=0.180      P=0.150N    |P=0.006 **   P=0.126      P=0.035 *    P=0.011 *    | 
|POLY 3             |     P=0.280N     P=0.316N     P=0.148      P=0.167N    |P=0.005 **   P=0.120      P=0.030 *    P=0.007 **   | 
|POLY 1.5           |     P=0.288N     P=0.326N     P=0.134      P=0.173N    |P=0.005 **   P=0.119      P=0.030 *    P=0.007 **   | 
|POLY 6             |     P=0.267N     P=0.301N     P=0.169      P=0.158N    |P=0.005 **   P=0.121      P=0.031 *    P=0.007 **   | 
|LOGISTIC REGRESSION|     P=0.240N     P=0.298N     P=0.201      P=0.161N    |P=0.006 **   P=0.126      P=0.035 *    P=0.009 **   | 
|COCH-ARM / FISHERS |     P=0.299N     P=0.339N     P=0.117      P=0.181N    |P=0.006 **   P=0.121      P=0.028 *    P=0.006 **   | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     17/50 (34%)  13/50 (26%)  18/50 (36%)  20/50 (40%) |6/50 (12%)   17/50 (34%)  7/50 (14%)   17/50 (34%)  | 
|POLY-3 RATE (b)    |     17/45.76     13/47.19     18/48.57     20/46.43    |6/45.55      17/46.09     7/46.07      17/44.77     | 
|POLY-3 PERCENT (g) |     37.2%        27.6%        37.1%        43.1%       |13.2%        36.9%        15.2%        38.0%        | 
|TERMINAL (d)       |     10/30 (33%)  9/32 (28%)   13/35 (37%)  14/34 (41%) |5/35 (14%)   15/36 (42%)  4/36 (11%)   13/36 (36%)  | 
|FIRST INCIDENCE    |     505          505          573          639         |635          645          445          687          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.316      P=0.195N     P=0.444N     P=0.513     |P=0.045 *    P=0.011 *    P=0.516      P=0.012 *    | 
|POLY 3             |     P=0.184      P=0.220N     P=0.581N     P=0.356     |P=0.028 *    P=0.007 **   P=0.509      P=0.005 **   | 
|POLY 1.5           |     P=0.181      P=0.236N     P=0.550      P=0.345     |P=0.029 *    P=0.007 **   P=0.504      P=0.006 **   | 
|POLY 6             |     P=0.196      P=0.198N     P=0.532N     P=0.382     |P=0.030 *    P=0.007 **   P=0.519      P=0.006 **   | 
|LOGISTIC REGRESSION|     P=0.186      P=0.274N     P=0.465      P=0.369     |P=0.031 *    P=0.009 **   P=0.501      P=0.007 **   | 
|COCH-ARM / FISHERS |     P=0.182      P=0.257N     P=0.500      P=0.339     |P=0.038 *    P=0.008 **   P=0.500      P=0.008 **   | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 27      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    0/50 (0%)    5/50 (10%)   1/50 (2%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     3/43.44      0/45.85      5/47.44      1/45.40     |0/45.20      1/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     6.9%         0.0%         10.5%        2.2%        |0.0%         2.2%         0.0%         0.0%         | 
|TERMINAL (d)       |     3/30 (10%)   0/32 (0%)    3/35 (9%)    1/34 (3%)   |0/35 (0%)    1/36 (3%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     726 (T)      ---          720          726 (T)     |---          732 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.375N     P=0.109N     P=0.454      P=0.261N    |P=0.564N     P=0.506      (e)          (e)          | 
|POLY 3             |     P=0.423N     P=0.109N     P=0.406      P=0.289N    |P=0.567N     P=0.502      (e)          (e)          | 
|POLY 1.5           |     P=0.427N     P=0.114N     P=0.385      P=0.297N    |P=0.567N     P=0.501      (e)          (e)          | 
|POLY 6             |     P=0.416N     P=0.103N     P=0.436      P=0.277N    |P=0.565N     P=0.503      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.365N     (e)          P=0.496      P=0.261N    |(e)          P=0.506      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.432N     P=0.121N     P=0.357      P=0.309N    |P=0.567N     P=0.500      (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Galactocele                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/49 (0%)    0/50 (0%)   |3/50 (6%)    2/50 (4%)    3/50 (6%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/43.44      0/45.85      0/46.40      0/45.40     |3/45.87      2/45.60      3/45.40      0/44.18      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |6.5%         4.4%         6.6%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/34 (0%)    0/34 (0%)   |1/35 (3%)    2/36 (6%)    2/36 (6%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |627          732 (T)      673          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.110N     P=0.484N     P=0.642N     P=0.124N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.120N     P=0.503N     P=0.658      P=0.125N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.117N     P=0.502N     P=0.658      P=0.124N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.120N     P=0.504N     P=0.660      P=0.126N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.111N     P=0.500N     P=0.658N     P=0.103N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.111N     P=0.500N     P=0.661N     P=0.121N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 28      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    5/50 (10%)   9/49 (18%)   6/50 (12%)  |0/50 (0%)    5/50 (10%)   0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     3/43.64      5/46.19      9/47.14      6/45.54     |0/45.20      5/45.79      0/45.17      1/44.18      | 
|POLY-3 PERCENT (g) |     6.9%         10.8%        19.1%        13.2%       |0.0%         10.9%        0.0%         2.3%         | 
|TERMINAL (d)       |     2/30 (7%)    3/32 (9%)    3/34 (9%)    4/34 (12%)  |0/35 (0%)    3/36 (8%)    0/36 (0%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     674          671          573          695         |---          708          ---          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.270      P=0.418      P=0.123      P=0.317     |P=0.443N     P=0.038 *    (e)          P=0.506      | 
|POLY 3             |     P=0.213      P=0.388      P=0.078      P=0.263     |P=0.448N     P=0.032 *    (e)          P=0.495      | 
|POLY 1.5           |     P=0.203      P=0.374      P=0.068      P=0.253     |P=0.448N     P=0.031 *    (e)          P=0.496      | 
|POLY 6             |     P=0.230      P=0.410      P=0.095      P=0.280     |P=0.443N     P=0.032 *    (e)          P=0.497      | 
|LOGISTIC REGRESSION|     P=0.210      P=0.392      P=0.063      P=0.293     |P=0.450N     P=0.034 *    (e)          P=0.506      | 
|COCH-ARM / FISHERS |     P=0.194      P=0.357      P=0.056      P=0.243     |P=0.444N     P=0.028 *    (e)          P=0.500      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/49 (0%)    0/50 (0%)   |4/50 (8%)    10/50 (20%)  6/50 (12%)   3/50 (6%)    | 
|POLY-3 RATE (b)    |     0/43.44      0/45.85      0/46.40      0/45.40     |4/45.25      10/45.83     6/45.40      3/44.28      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |8.8%         21.8%        13.2%        6.8%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/34 (0%)    0/34 (0%)   |3/35 (9%)    8/36 (22%)   5/36 (14%)   2/36 (6%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |719          694          673          708          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.210N     P=0.083      P=0.388      P=0.495N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.227N     P=0.075      P=0.371      P=0.512N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.226N     P=0.074      P=0.369      P=0.510N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.222N     P=0.077      P=0.380      P=0.508N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.220N     P=0.078      P=0.379      P=0.503N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.215N     P=0.074      P=0.370      P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 29      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Fat                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/8 (88%)    7/11 (64%)   9/11 (82%)   3/5 (60%)   |8/10 (80%)   1/1 (100%)   4/5 (80%)    5/7 (71%)    | 
|POLY-3 RATE (b)    |     7/7.94       7/10.14      9/10.88      3/4.84      |8/9.27       1/1.00       4/4.84       5/6.15       | 
|POLY-3 PERCENT (g) |     88.1%        69.0%        82.8%        62.0%       |86.3%        100.0%       82.7%        81.3%        | 
|TERMINAL (d)       |     4/4 (100%)   4/5 (80%)    5/5 (100%)   2/3 (67%)   |8/8 (100%)   1/1 (100%)   2/2 (100%)   4/4 (100%)   | 
|FIRST INCIDENCE    |     610          505          624          695         |732 (T)      732 (T)      694          617          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.137N     P=0.463N     P=0.609      P=0.137N    |P=0.239      P=1.000N     P=0.244      P=0.491      | 
|POLY 3             |     P=0.316N     P=0.342N     P=0.627N     P=0.347N    |P=0.510N     P=0.916      P=0.743N     P=0.684N     | 
|POLY 1.5           |     P=0.324N     P=0.306N     P=0.620N     P=0.336N    |P=0.498N     P=0.854      P=0.739N     P=0.648N     | 
|POLY 6             |     P=0.314N     P=0.392N     P=0.642N     P=0.367N    |P=0.477N     P=0.989      P=0.764N     P=0.687N     | 
|LOGISTIC REGRESSION|     P=0.303N     P=0.283N     P=0.644N     P=0.336N    |P=0.613      P=1.000N     (e)          P=0.738      | 
|COCH-ARM / FISHERS |     P=0.336N     P=0.267N     P=0.624N     P=0.315N    |P=0.438N     P=0.818      P=0.736N     P=0.559N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Foreign Body                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/50 (14%)   6/50 (12%)   9/50 (18%)   7/50 (14%)  |3/50 (6%)    4/50 (8%)    1/50 (2%)    3/50 (6%)    | 
|POLY-3 RATE (b)    |     7/44.87      6/46.14      9/47.73      7/47.17     |3/45.20      4/45.60      1/45.17      3/44.91      | 
|POLY-3 PERCENT (g) |     15.6%        13.0%        18.9%        14.8%       |6.6%         8.8%         2.2%         6.7%         | 
|TERMINAL (d)       |     3/30 (10%)   3/32 (9%)    6/35 (17%)   4/34 (12%)  |3/35 (9%)    4/36 (11%)   1/36 (3%)    2/36 (6%)    | 
|FIRST INCIDENCE    |     505          660          674          397         |732 (T)      732 (T)      732 (T)      473          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.534N     P=0.433N     P=0.534      P=0.543N    |P=0.470N     P=0.516      P=0.295N     P=0.654N     | 
|POLY 3             |     P=0.530      P=0.478N     P=0.445      P=0.574N    |P=0.482N     P=0.505      P=0.305N     P=0.659      | 
|POLY 1.5           |     P=0.512      P=0.489N     P=0.423      P=0.591N    |P=0.483N     P=0.502      P=0.307N     P=0.658      | 
|POLY 6             |     P=0.552      P=0.462N     P=0.477      P=0.552N    |P=0.478N     P=0.510      P=0.301N     P=0.660N     | 
|LOGISTIC REGRESSION|     P=0.458      P=0.521N     P=0.348      P=0.556     |P=0.487N     P=0.516      P=0.295N     P=0.654N     | 
|COCH-ARM / FISHERS |     P=0.486      P=0.500N     P=0.393      P=0.613N    |P=0.479N     P=0.500      P=0.309N     P=0.661N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 30      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     13/50 (26%)  9/50 (18%)   14/50 (28%)  8/50 (16%)  |4/50 (8%)    5/50 (10%)   2/50 (4%)    3/50 (6%)    | 
|POLY-3 RATE (b)    |     13/46.24     9/46.46      14/47.74     8/47.29     |4/45.25      5/46.72      2/45.23      3/44.18      | 
|POLY-3 PERCENT (g) |     28.1%        19.4%        29.3%        16.9%       |8.8%         10.7%        4.4%         6.8%         | 
|TERMINAL (d)       |     5/30 (17%)   5/32 (16%)   10/35 (29%)  4/34 (12%)  |3/35 (9%)    3/36 (8%)    1/36 (3%)    3/36 (8%)    | 
|FIRST INCIDENCE    |     505          639          674          397         |719          515          719          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.153N     P=0.191N     P=0.487N     P=0.132N    |P=0.321N     P=0.506      P=0.334N     P=0.491N     | 
|POLY 3             |     P=0.187N     P=0.228N     P=0.539      P=0.146N    |P=0.334N     P=0.520      P=0.337N     P=0.513N     | 
|POLY 1.5           |     P=0.196N     P=0.232N     P=0.523      P=0.153N    |P=0.331N     P=0.511      P=0.339N     P=0.511N     | 
|POLY 6             |     P=0.177N     P=0.221N     P=0.560      P=0.137N    |P=0.333N     P=0.532      P=0.332N     P=0.510N     | 
|LOGISTIC REGRESSION|     P=0.235N     P=0.273N     P=0.419      P=0.209N    |P=0.324N     P=0.500      P=0.326N     P=0.500N     | 
|COCH-ARM / FISHERS |     P=0.210N     P=0.235N     P=0.500      P=0.163N    |P=0.320N     P=0.500      P=0.339N     P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |0/50 (0%)    2/50 (4%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |                                                        |0/45.20      2/45.87      1/45.25      0/44.18      | 
|POLY-3 PERCENT (g) |                                                        |0.0%         4.4%         2.2%         0.0%         | 
|TERMINAL (d)       |                                                        |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |                                                        |---          687          714          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.461N     P=0.251      P=0.500      (e)          | 
|POLY 3             |                                                        |P=0.467N     P=0.240      P=0.500      (e)          | 
|POLY 1.5           |                                                        |P=0.466N     P=0.239      P=0.499      (e)          | 
|POLY 6             |                                                        |P=0.464N     P=0.243      P=0.503      (e)          | 
|LOGISTIC REGRESSION|                                                        |P=0.462N     P=0.237      P=0.500      (e)          | 
|COCH-ARM / FISHERS |                                                        |P=0.461N     P=0.247      P=0.500      (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 31      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |3/50 (6%)    6/50 (12%)   4/50 (8%)    5/50 (10%)   | 
|POLY-3 RATE (b)    |                                                        |3/45.58      6/45.60      4/45.64      5/44.35      | 
|POLY-3 PERCENT (g) |                                                        |6.6%         13.2%        8.8%         11.3%        | 
|TERMINAL (d)       |                                                        |1/35 (3%)    6/36 (17%)   3/36 (8%)    4/36 (11%)   | 
|FIRST INCIDENCE    |                                                        |636          732 (T)      595          687          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.412      P=0.260      P=0.512      P=0.374      | 
|POLY 3             |                                                        |P=0.382      P=0.242      P=0.501      P=0.341      | 
|POLY 1.5           |                                                        |P=0.386      P=0.242      P=0.499      P=0.345      | 
|POLY 6             |                                                        |P=0.384      P=0.242      P=0.506      P=0.343      | 
|LOGISTIC REGRESSION|                                                        |P=0.386      P=0.249      P=0.502      P=0.345      | 
|COCH-ARM / FISHERS |                                                        |P=0.401      P=0.243      P=0.500      P=0.357      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |0/50 (0%)    0/50 (0%)    1/50 (2%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |                                                        |0/45.20      0/45.60      1/45.17      2/44.18      | 
|POLY-3 PERCENT (g) |                                                        |0.0%         0.0%         2.2%         4.5%         | 
|TERMINAL (d)       |                                                        |0/35 (0%)    0/36 (0%)    1/36 (3%)    2/36 (6%)    | 
|FIRST INCIDENCE    |                                                        |---          ---          732 (T)      732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.072      (e)          P=0.506      P=0.244      | 
|POLY 3             |                                                        |P=0.067      (e)          P=0.500      P=0.232      | 
|POLY 1.5           |                                                        |P=0.068      (e)          P=0.499      P=0.233      | 
|POLY 6             |                                                        |P=0.067      (e)          P=0.502      P=0.233      | 
|LOGISTIC REGRESSION|                                                        |(e)          (e)          P=0.506      P=0.244      | 
|COCH-ARM / FISHERS |                                                        |P=0.070      (e)          P=0.500      P=0.247      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 32      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     22/50 (44%)  17/50 (34%)  14/50 (28%)  16/50 (32%) |8/50 (16%)   20/50 (40%)  8/50 (16%)   10/50 (20%)  | 
|POLY-3 RATE (b)    |     22/45.67     17/46.85     14/47.75     16/45.51    |8/45.57      20/47.27     8/45.22      10/44.81     | 
|POLY-3 PERCENT (g) |     48.2%        36.3%        29.3%        35.2%       |17.6%        42.3%        17.7%        22.3%        | 
|TERMINAL (d)       |     15/30 (50%)  13/32 (41%)  12/35 (34%)  13/34 (38%) |7/35 (20%)   14/36 (39%)  7/36 (19%)   7/36 (19%)   | 
|FIRST INCIDENCE    |     450          639          674          709         |627          515          721          617          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.069N     P=0.141N     P=0.024N*    P=0.075N    |P=0.334N     P=0.012 *    P=0.584N     P=0.417      | 
|POLY 3             |     P=0.137N     P=0.168N     P=0.045N*    P=0.143N    |P=0.364N     P=0.007 **   P=0.601      P=0.381      | 
|POLY 1.5           |     P=0.140N     P=0.187N     P=0.056N     P=0.149N    |P=0.362N     P=0.006 **   P=0.601      P=0.383      | 
|POLY 6             |     P=0.132N     P=0.140N     P=0.033N*    P=0.131N    |P=0.353N     P=0.009 **   P=0.607      P=0.390      | 
|LOGISTIC REGRESSION|     P=0.106N     P=0.172N     P=0.048N*    P=0.106N    |P=0.369N     P=0.007 **   P=0.595N     P=0.378      | 
|COCH-ARM / FISHERS |     P=0.140N     P=0.206N     P=0.072N     P=0.151N    |P=0.345N     P=0.007 **   P=0.607N     P=0.398      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    3/50 (6%)    2/50 (4%)    1/50 (2%)   |2/50 (4%)    1/50 (2%)    0/50 (0%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     1/43.44      3/45.87      2/47.40      1/45.40     |2/45.25      1/45.68      0/45.17      2/44.18      | 
|POLY-3 PERCENT (g) |     2.3%         6.5%         4.2%         2.2%        |4.4%         2.2%         0.0%         4.5%         | 
|TERMINAL (d)       |     1/30 (3%)    2/32 (6%)    2/35 (6%)    1/34 (3%)   |1/35 (3%)    0/36 (0%)    0/36 (0%)    2/36 (6%)    | 
|FIRST INCIDENCE    |     726 (T)      720          726 (T)      726 (T)     |719          712          ---          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.423N     P=0.335      P=0.554      P=0.734N    |P=0.590      P=0.512N     P=0.239N     P=0.691N     | 
|POLY 3             |     P=0.452N     P=0.325      P=0.530      P=0.751N    |P=0.584      P=0.497N     P=0.237N     P=0.685      | 
|POLY 1.5           |     P=0.463N     P=0.316      P=0.517      P=0.756N    |P=0.586      P=0.499N     P=0.238N     P=0.687      | 
|POLY 6             |     P=0.437N     P=0.339      P=0.548      P=0.743N    |P=0.585      P=0.494N     P=0.235N     P=0.687      | 
|LOGISTIC REGRESSION|     P=0.415N     P=0.356      P=0.554      P=0.734N    |P=0.587      P=0.494N     P=0.233N     P=0.695      | 
|COCH-ARM / FISHERS |     P=0.474N     P=0.309      P=0.500      P=0.753N    |P=0.591      P=0.500N     P=0.247N     P=0.691N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 33      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    7/50 (14%)   0/50 (0%)    2/50 (4%)   |1/50 (2%)    2/50 (4%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     3/43.44      7/45.97      0/47.40      2/45.43     |1/45.20      2/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     6.9%         15.2%        0.0%         4.4%        |2.2%         4.4%         0.0%         0.0%         | 
|TERMINAL (d)       |     3/30 (10%)   6/32 (19%)   0/35 (0%)    1/34 (3%)   |1/35 (3%)    2/36 (6%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     726 (T)      695          ---          720         |732 (T)      732 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.118N     P=0.189      P=0.095N     P=0.438N    |P=0.184N     P=0.510      P=0.494N     P=0.494N     | 
|POLY 3             |     P=0.135N     P=0.181      P=0.104N     P=0.480N    |P=0.190N     P=0.503      P=0.500N     P=0.505N     | 
|POLY 1.5           |     P=0.143N     P=0.170      P=0.110N     P=0.490N    |P=0.190N     P=0.501      P=0.501N     P=0.504N     | 
|POLY 6             |     P=0.123N     P=0.198      P=0.096N     P=0.463N    |P=0.188N     P=0.506      P=0.498N     P=0.503N     | 
|LOGISTIC REGRESSION|     P=0.114N     P=0.222      (e)          P=0.424N    |P=0.184N     P=0.510      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.157N     P=0.159      P=0.121N     P=0.500N    |P=0.188N     P=0.500      P=0.500N     P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/43.44      0/45.85      0/47.40      0/45.40     |1/45.20      1/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     4.6%         0.0%         0.0%         0.0%        |2.2%         2.2%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/30 (7%)    0/32 (0%)    0/35 (0%)    0/34 (0%)   |1/35 (3%)    1/36 (3%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     726 (T)      ---          ---          ---         |732 (T)      732 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.102N     P=0.224N     P=0.205N     P=0.211N    |P=0.232N     P=0.756N     P=0.494N     P=0.494N     | 
|POLY 3             |     P=0.117N     P=0.225N     P=0.218N     P=0.227N    |P=0.237N     P=0.759N     P=0.500N     P=0.505N     | 
|POLY 1.5           |     P=0.115N     P=0.231N     P=0.226N     P=0.232N    |P=0.237N     P=0.760N     P=0.501N     P=0.504N     | 
|POLY 6             |     P=0.120N     P=0.217N     P=0.207N     P=0.220N    |P=0.237N     P=0.757N     P=0.498N     P=0.503N     | 
|LOGISTIC REGRESSION|     P=0.102N     (e)          (e)          (e)         |P=0.232N     P=0.756N     (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.115N     P=0.247N     P=0.247N     P=0.247N    |P=0.235N     P=0.753N     P=0.500N     P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 34      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Metaplasia Hepatocyte                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/43.44      0/45.85      2/47.70      0/45.40     |0/45.20      0/45.60      0/45.17      1/44.35      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         4.2%         0.0%        |0.0%         0.0%         0.0%         2.3%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/35 (0%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          674          ---         |---          ---          ---          687          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.624      (e)          P=0.299      (e)         |P=0.204      (e)          (e)          P=0.515      | 
|POLY 3             |     P=0.606      (e)          P=0.259      (e)         |P=0.196      (e)          (e)          P=0.496      | 
|POLY 1.5           |     P=0.600      (e)          P=0.249      (e)         |P=0.196      (e)          (e)          P=0.497      | 
|POLY 6             |     P=0.618      (e)          P=0.273      (e)         |P=0.197      (e)          (e)          P=0.498      | 
|LOGISTIC REGRESSION|     P=0.589      (e)          P=0.205      (e)         |P=0.202      (e)          (e)          P=0.505      | 
|COCH-ARM / FISHERS |     P=0.595      (e)          P=0.247      (e)         |P=0.198      (e)          (e)          P=0.500      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Artery                                                                                                                 | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    3/50 (6%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/43.44      3/45.91      0/47.40      2/45.40     |0/45.20      0/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     0.0%         6.5%         0.0%         4.4%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    2/32 (6%)    0/35 (0%)    2/34 (6%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     ---          709          ---          726 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.393      P=0.141      (e)          P=0.266     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.373      P=0.129      (e)          P=0.247     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.363      P=0.124      (e)          P=0.242     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.390      P=0.136      (e)          P=0.255     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.388      P=0.145      (e)          P=0.266     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.351      P=0.121      (e)          P=0.247     |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 35      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Parathyroid Gland                                                                                                                | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    2/47 (4%)    1/45 (2%)    0/45 (0%)   |1/43 (2%)    0/40 (0%)    0/43 (0%)    0/47 (0%)    | 
|POLY-3 RATE (b)    |     1/42.13      2/43.06      1/42.40      0/41.20     |1/38.24      0/35.97      0/39.01      0/41.18      | 
|POLY-3 PERCENT (g) |     2.4%         4.6%         2.4%         0.0%        |2.6%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/29 (0%)    2/31 (7%)    1/30 (3%)    0/31 (0%)   |1/29 (3%)    0/28 (0%)    0/31 (0%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     695          726 (T)      726 (T)      ---         |732 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.229N     P=0.538      P=0.724N     P=0.461N    |P=0.289N     P=0.507N     P=0.487N     P=0.474N     | 
|POLY 3             |     P=0.251N     P=0.508      P=0.759N     P=0.504N    |P=0.293N     P=0.512N     P=0.496N     P=0.485N     | 
|POLY 1.5           |     P=0.257N     P=0.501      P=0.755      P=0.509N    |P=0.293N     P=0.514N     P=0.498N     P=0.485N     | 
|POLY 6             |     P=0.242N     P=0.519      P=0.750N     P=0.498N    |P=0.295N     P=0.510N     P=0.492N     P=0.483N     | 
|LOGISTIC REGRESSION|     P=0.238N     P=0.528      P=0.760N     P=0.513N    |P=0.289N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.263N     P=0.492      P=0.736      P=0.516N    |P=0.294N     P=0.518N     P=0.500N     P=0.478N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/50 (10%)   5/50 (10%)   4/50 (8%)    2/49 (4%)   |1/50 (2%)    2/50 (4%)    3/50 (6%)    3/49 (6%)    | 
|POLY-3 RATE (b)    |     5/43.89      5/46.54      4/47.68      2/45.04     |1/45.20      2/45.60      3/45.17      3/43.97      | 
|POLY-3 PERCENT (g) |     11.4%        10.7%        8.4%         4.4%        |2.2%         4.4%         6.6%         6.8%         | 
|TERMINAL (d)       |     3/30 (10%)   2/32 (6%)    2/35 (6%)    2/34 (6%)   |1/35 (3%)    2/36 (6%)    3/36 (8%)    1/35 (3%)    | 
|FIRST INCIDENCE    |     660          639          660          726 (T)     |732 (T)      732 (T)      732 (T)      519          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.114N     P=0.560N     P=0.395N     P=0.175N    |P=0.222      P=0.510      P=0.315      P=0.302      | 
|POLY 3             |     P=0.138N     P=0.593N     P=0.448N     P=0.205N    |P=0.216      P=0.503      P=0.305      P=0.295      | 
|POLY 1.5           |     P=0.145N     P=0.610N     P=0.470N     P=0.214N    |P=0.215      P=0.501      P=0.304      P=0.295      | 
|POLY 6             |     P=0.131N     P=0.567N     P=0.419N     P=0.193N    |P=0.221      P=0.506      P=0.309      P=0.300      | 
|LOGISTIC REGRESSION|     P=0.147N     P=0.628N     P=0.469N     P=0.194N    |P=0.216      P=0.510      P=0.315      P=0.325      | 
|COCH-ARM / FISHERS |     P=0.152N     P=0.630N     P=0.500N     P=0.226N    |P=0.219      P=0.500      P=0.309      P=0.301      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 36      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     15/50 (30%)  24/50 (48%)  19/50 (38%)  18/49 (37%) |27/50 (54%)  31/50 (62%)  23/50 (46%)  27/49 (55%)  | 
|POLY-3 RATE (b)    |     15/44.63     24/48.22     19/48.17     18/45.38    |27/47.57     31/47.82     23/46.17     27/45.35     | 
|POLY-3 PERCENT (g) |     33.6%        49.8%        39.5%        39.7%       |56.8%        64.8%        49.8%        59.5%        | 
|TERMINAL (d)       |     11/30 (37%)  15/32 (47%)  16/35 (46%)  16/34 (47%) |20/35 (57%)  24/36 (67%)  18/36 (50%)  19/35 (54%)  | 
|FIRST INCIDENCE    |     589          505          624          680         |588          400          510          519          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.399N     P=0.112      P=0.469      P=0.501     |P=0.422N     P=0.338      P=0.256N     P=0.558      | 
|POLY 3             |     P=0.512      P=0.082      P=0.356      P=0.352     |P=0.506N     P=0.272      P=0.319N     P=0.475      | 
|POLY 1.5           |     P=0.491      P=0.066      P=0.315      P=0.332     |P=0.486N     P=0.274      P=0.302N     P=0.490      | 
|POLY 6             |     P=0.540N     P=0.111      P=0.416      P=0.385     |P=0.505N     P=0.263      P=0.338N     P=0.479      | 
|LOGISTIC REGRESSION|     P=0.528      P=0.058      P=0.388      P=0.436     |P=0.482N     P=0.274      P=0.278N     P=0.495      | 
|COCH-ARM / FISHERS |     P=0.466      P=0.050      P=0.263      P=0.310     |P=0.432N     P=0.272      P=0.274N     P=0.537      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/49 (0%)    1/50 (2%)    2/50 (4%)   |                                                    | 
|POLY-3 RATE (b)    |     2/43.56      0/44.97      1/47.40      2/45.40     |                                                    | 
|POLY-3 PERCENT (g) |     4.6%         0.0%         2.1%         4.4%        |                                                    | 
|TERMINAL (d)       |     1/30 (3%)    0/32 (0%)    1/35 (3%)    2/34 (6%)   |                                                    | 
|FIRST INCIDENCE    |     695          ---          726 (T)      726 (T)     |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.513      P=0.211N     P=0.430N     P=0.641N    |                                                    | 
|POLY 3             |     P=0.474      P=0.230N     P=0.471N     P=0.679N    |                                                    | 
|POLY 1.5           |     P=0.473      P=0.235N     P=0.483N     P=0.686N    |                                                    | 
|POLY 6             |     P=0.476      P=0.222N     P=0.453N     P=0.668N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.504      P=0.223N     P=0.445N     P=0.654N    |                                                    | 
|COCH-ARM / FISHERS |     P=0.472      P=0.253N     P=0.500N     P=0.691N    |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 37      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     47/50 (94%)  47/49 (96%)  49/50 (98%)  47/50 (94%) |                                                    | 
|POLY-3 RATE (b)    |     47/49.61     47/48.21     49/49.80     47/49.93    |                                                    | 
|POLY-3 PERCENT (g) |     94.7%        97.5%        98.4%        94.1%       |                                                    | 
|TERMINAL (d)       |     28/30 (93%)  32/32 (100%) 35/35 (100%) 32/34 (94%) |                                                    | 
|FIRST INCIDENCE    |     450          478          573          397         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.204N     P=0.313N     P=0.216N     P=0.246N    |                                                    | 
|POLY 3             |     P=0.474N     P=0.423      P=0.317      P=0.622N    |                                                    | 
|POLY 1.5           |     P=0.517N     P=0.457      P=0.312      P=0.640N    |                                                    | 
|POLY 6             |     P=0.420N     P=0.394      P=0.319      P=0.597N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.554N     P=0.565      P=0.343      P=0.645     |                                                    | 
|COCH-ARM / FISHERS |     P=0.572N     P=0.510      P=0.309      P=0.661N    |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland: Duct                                                                                                            | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    2/49 (4%)    0/50 (0%)    1/50 (2%)   |                                                    | 
|POLY-3 RATE (b)    |     1/43.56      2/45.22      0/47.40      1/45.40     |                                                    | 
|POLY-3 PERCENT (g) |     2.3%         4.4%         0.0%         2.2%        |                                                    | 
|TERMINAL (d)       |     0/30 (0%)    1/32 (3%)    0/35 (0%)    1/34 (3%)   |                                                    | 
|FIRST INCIDENCE    |     695          660          ---          726 (T)     |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.466N     P=0.547      P=0.441N     P=0.724N    |                                                    | 
|POLY 3             |     P=0.485N     P=0.513      P=0.483N     P=0.751N    |                                                    | 
|POLY 1.5           |     P=0.491N     P=0.504      P=0.490N     P=0.756N    |                                                    | 
|POLY 6             |     P=0.477N     P=0.527      P=0.473N     P=0.744N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.496N     P=0.492      P=0.508N     P=0.749N    |                                                    | 
|COCH-ARM / FISHERS |     P=0.498N     P=0.492      P=0.500N     P=0.753N    |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 38      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Prostate                                                                                                                         | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    8/50 (16%)   1/50 (2%)    2/50 (4%)   |                                                    | 
|POLY-3 RATE (b)    |     4/44.47      8/46.21      1/47.40      2/46.24     |                                                    | 
|POLY-3 PERCENT (g) |     9.0%         17.3%        2.1%         4.3%        |                                                    | 
|TERMINAL (d)       |     1/30 (3%)    4/32 (13%)   1/35 (3%)    1/34 (3%)   |                                                    | 
|FIRST INCIDENCE    |     589          692          726 (T)      397         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.073N     P=0.244      P=0.145N     P=0.308N    |                                                    | 
|POLY 3             |     P=0.079N     P=0.195      P=0.160N     P=0.319N    |                                                    | 
|POLY 1.5           |     P=0.084N     P=0.187      P=0.168N     P=0.327N    |                                                    | 
|POLY 6             |     P=0.074N     P=0.209      P=0.150N     P=0.309N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.106N     P=0.175      P=0.261N     P=0.365N    |                                                    | 
|COCH-ARM / FISHERS |     P=0.094N     P=0.178      P=0.181N     P=0.339N    |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Prostate                                                                                                                         | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    3/50 (6%)    0/50 (0%)   |                                                    | 
|POLY-3 RATE (b)    |     2/43.44      0/45.85      3/47.40      0/45.40     |                                                    | 
|POLY-3 PERCENT (g) |     4.6%         0.0%         6.3%         0.0%        |                                                    | 
|TERMINAL (d)       |     2/30 (7%)    0/32 (0%)    3/35 (9%)    0/34 (0%)   |                                                    | 
|FIRST INCIDENCE    |     726 (T)      ---          726 (T)      ---         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.260N     P=0.224N     P=0.571      P=0.211N    |                                                    | 
|POLY 3             |     P=0.291N     P=0.225N     P=0.540      P=0.227N    |                                                    | 
|POLY 1.5           |     P=0.293N     P=0.231N     P=0.523      P=0.232N    |                                                    | 
|POLY 6             |     P=0.287N     P=0.217N     P=0.563      P=0.220N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.260N     (e)          P=0.571      (e)         |                                                    | 
|COCH-ARM / FISHERS |     P=0.296N     P=0.247N     P=0.500      P=0.247N    |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 39      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Prostate                                                                                                                         | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    1/50 (2%)    2/50 (4%)   |                                                    | 
|POLY-3 RATE (b)    |     0/43.44      0/45.85      1/47.42      2/45.41     |                                                    | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.1%         4.4%        |                                                    | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/35 (0%)    1/34 (3%)   |                                                    | 
|FIRST INCIDENCE    |     ---          ---          723          723         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.082      (e)          P=0.536      P=0.271     |                                                    | 
|POLY 3             |     P=0.073      (e)          P=0.517      P=0.247     |                                                    | 
|POLY 1.5           |     P=0.071      (e)          P=0.510      P=0.242     |                                                    | 
|POLY 6             |     P=0.075      (e)          P=0.528      P=0.255     |                                                    | 
|LOGISTIC REGRESSION|     P=0.078      (e)          P=0.547      P=0.274     |                                                    | 
|COCH-ARM / FISHERS |     P=0.070      (e)          P=0.500      P=0.247     |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Prostate                                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     22/50 (44%)  30/50 (60%)  28/50 (56%)  22/50 (44%) |                                                    | 
|POLY-3 RATE (b)    |     22/46.93     30/48.08     28/49.01     22/47.29    |                                                    | 
|POLY-3 PERCENT (g) |     46.9%        62.4%        57.1%        46.5%       |                                                    | 
|TERMINAL (d)       |     14/30 (47%)  21/32 (66%)  20/35 (57%)  17/34 (50%) |                                                    | 
|FIRST INCIDENCE    |     450          505          573          397         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.206N     P=0.187      P=0.413      P=0.407N    |                                                    | 
|POLY 3             |     P=0.351N     P=0.090      P=0.209      P=0.569N    |                                                    | 
|POLY 1.5           |     P=0.360N     P=0.084      P=0.185      P=0.575N    |                                                    | 
|POLY 6             |     P=0.332N     P=0.102      P=0.250      P=0.553N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.374N     P=0.074      P=0.113      P=0.558     |                                                    | 
|COCH-ARM / FISHERS |     P=0.369N     P=0.080      P=0.159      P=0.580N    |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 40      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    0/50 (0%)    1/50 (2%)   |2/50 (4%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     1/43.44      2/46.16      0/47.40      1/45.40     |2/45.68      0/45.60      0/45.17      1/44.18      | 
|POLY-3 PERCENT (g) |     2.3%         4.3%         0.0%         2.2%        |4.4%         0.0%         0.0%         2.3%         | 
|TERMINAL (d)       |     1/30 (3%)    1/32 (3%)    0/35 (0%)    1/34 (3%)   |1/35 (3%)    0/36 (0%)    0/36 (0%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     726 (T)      639          ---          726 (T)     |588          ---          ---          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.471N     P=0.528      P=0.469N     P=0.734N    |P=0.463N     P=0.239N     P=0.241N     P=0.501N     | 
|POLY 3             |     P=0.486N     P=0.521      P=0.483N     P=0.751N    |P=0.461N     P=0.238N     P=0.240N     P=0.512N     | 
|POLY 1.5           |     P=0.492N     P=0.511      P=0.490N     P=0.756N    |P=0.461N     P=0.238N     P=0.239N     P=0.509N     | 
|POLY 6             |     P=0.478N     P=0.536      P=0.472N     P=0.743N    |P=0.461N     P=0.237N     P=0.239N     P=0.512N     | 
|LOGISTIC REGRESSION|     P=0.495N     P=0.504      (e)          P=0.734N    |P=0.449N     P=0.226N     P=0.217N     P=0.488N     | 
|COCH-ARM / FISHERS |     P=0.500N     P=0.500      P=0.500N     P=0.753N    |P=0.461N     P=0.247N     P=0.247N     P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Hyperkeratosis                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    3/50 (6%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/43.44      0/45.85      3/47.40      0/45.40     |1/45.20      0/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         6.3%         0.0%        |2.2%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    3/35 (9%)    0/34 (0%)   |1/35 (3%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          726 (T)      ---         |732 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.570      (e)          P=0.149      (e)         |P=0.303N     P=0.494N     P=0.494N     P=0.494N     | 
|POLY 3             |     P=0.553      (e)          P=0.135      (e)         |P=0.305N     P=0.498N     P=0.500N     P=0.505N     | 
|POLY 1.5           |     P=0.546      (e)          P=0.128      (e)         |P=0.305N     P=0.499N     P=0.501N     P=0.504N     | 
|POLY 6             |     P=0.567      (e)          P=0.146      (e)         |P=0.305N     P=0.497N     P=0.498N     P=0.503N     | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.149      (e)         |P=0.303N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.539      (e)          P=0.121      (e)         |P=0.306N     P=0.500N     P=0.500N     P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 41      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    4/50 (8%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/43.44      1/45.89      4/47.40      0/45.40     |1/45.20      0/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         8.4%         0.0%        |2.2%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    4/35 (11%)   0/34 (0%)   |1/35 (3%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     ---          716          726 (T)      ---         |732 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.609N     P=0.531      P=0.083      (e)         |P=0.303N     P=0.494N     P=0.494N     P=0.494N     | 
|POLY 3             |     P=0.612      P=0.511      P=0.072      (e)         |P=0.305N     P=0.498N     P=0.500N     P=0.505N     | 
|POLY 1.5           |     P=0.602      P=0.506      P=0.067      (e)         |P=0.305N     P=0.499N     P=0.501N     P=0.504N     | 
|POLY 6             |     P=0.618N     P=0.518      P=0.080      (e)         |P=0.305N     P=0.497N     P=0.498N     P=0.503N     | 
|LOGISTIC REGRESSION|     P=0.608N     P=0.523      P=0.083      (e)         |P=0.303N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.591      P=0.500      P=0.059      (e)         |P=0.306N     P=0.500N     P=0.500N     P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/43.44      0/45.85      2/47.40      0/45.40     |0/45.20      0/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         4.2%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    2/35 (6%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          726 (T)      ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.620      (e)          P=0.273      (e)         |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.607      (e)          P=0.257      (e)         |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.601      (e)          P=0.249      (e)         |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.618      (e)          P=0.270      (e)         |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.273      (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.595      (e)          P=0.247      (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 42      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Epidermis                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/43.71      0/45.85      0/47.40      0/45.40     |0/45.20      0/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     4.6%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/30 (3%)    0/32 (0%)    0/35 (0%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     653          ---          ---          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.105N     P=0.220N     P=0.208N     P=0.218N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.116N     P=0.227N     P=0.220N     P=0.229N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.115N     P=0.231N     P=0.227N     P=0.233N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.119N     P=0.220N     P=0.210N     P=0.222N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.119N     P=0.240N     P=0.249N     P=0.239N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.115N     P=0.247N     P=0.247N     P=0.247N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    2/50 (4%)    2/50 (4%)    1/49 (2%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/43.44      2/45.97      2/47.40      1/44.40     |1/45.50      0/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     4.6%         4.4%         4.2%         2.3%        |2.2%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/30 (7%)    1/32 (3%)    2/35 (6%)    1/33 (3%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     726 (T)      695          726 (T)      726 (T)     |650          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.333N     P=0.658N     P=0.639N     P=0.467N    |P=0.304N     P=0.486N     P=0.490N     P=0.495N     | 
|POLY 3             |     P=0.368N     P=0.674N     P=0.662N     P=0.492N    |P=0.304N     P=0.500N     P=0.501N     P=0.506N     | 
|POLY 1.5           |     P=0.374N     P=0.683N     P=0.676N     P=0.500N    |P=0.304N     P=0.500N     P=0.501N     P=0.504N     | 
|POLY 6             |     P=0.359N     P=0.659N     P=0.643N     P=0.481N    |P=0.304N     P=0.499N     P=0.500N     P=0.506N     | 
|LOGISTIC REGRESSION|     P=0.336N     P=0.649N     P=0.639N     P=0.467N    |P=0.282N     P=0.487N     P=0.477N     P=0.468N     | 
|COCH-ARM / FISHERS |     P=0.380N     P=0.691N     P=0.691N     P=0.508N    |P=0.306N     P=0.500N     P=0.500N     P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 43      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    2/50 (4%)    4/50 (8%)    5/49 (10%)  |11/50 (22%)  8/50 (16%)   5/50 (10%)   5/50 (10%)   | 
|POLY-3 RATE (b)    |     3/43.85      2/45.97      4/48.48      5/46.05     |11/46.03     8/45.78      5/47.00      5/44.18      | 
|POLY-3 PERCENT (g) |     6.8%         4.4%         8.3%         10.9%       |23.9%        17.5%        10.6%        11.3%        | 
|TERMINAL (d)       |     2/30 (7%)    1/32 (3%)    1/35 (3%)    1/33 (3%)   |7/35 (20%)   6/36 (17%)   1/36 (3%)    5/36 (14%)   | 
|FIRST INCIDENCE    |     610          695          573          397         |609          708          445          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.237      P=0.461N     P=0.569      P=0.407     |P=0.060N     P=0.302N     P=0.094N     P=0.087N     | 
|POLY 3             |     P=0.215      P=0.478N     P=0.554      P=0.384     |P=0.060N     P=0.308N     P=0.076N     P=0.097N     | 
|POLY 1.5           |     P=0.205      P=0.488N     P=0.531      P=0.367     |P=0.059N     P=0.308N     P=0.080N     P=0.094N     | 
|POLY 6             |     P=0.228      P=0.463N     P=0.586      P=0.407     |P=0.060N     P=0.308N     P=0.071N     P=0.099N     | 
|LOGISTIC REGRESSION|     P=0.166      P=0.496N     P=0.330      P=0.304     |P=0.055N     P=0.294N     P=0.075N     P=0.092N     | 
|COCH-ARM / FISHERS |     P=0.190      P=0.500N     P=0.500      P=0.346     |P=0.055N     P=0.306N     P=0.086N     P=0.086N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Infarct                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    1/50 (2%)    2/49 (4%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/43.88      0/45.85      1/47.42      2/45.20     |1/45.50      0/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     4.6%         0.0%         2.1%         4.4%        |2.2%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/30 (3%)    0/32 (0%)    0/35 (0%)    0/33 (0%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     600          ---          723          596         |650          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.491      P=0.230N     P=0.454N     P=0.673N    |P=0.304N     P=0.486N     P=0.490N     P=0.495N     | 
|POLY 3             |     P=0.469      P=0.227N     P=0.473N     P=0.683N    |P=0.304N     P=0.500N     P=0.501N     P=0.506N     | 
|POLY 1.5           |     P=0.466      P=0.232N     P=0.485N     P=0.692N    |P=0.304N     P=0.500N     P=0.501N     P=0.504N     | 
|POLY 6             |     P=0.474      P=0.221N     P=0.457N     P=0.669N    |P=0.304N     P=0.499N     P=0.500N     P=0.506N     | 
|LOGISTIC REGRESSION|     P=0.451      P=0.257N     P=0.554N     P=0.673     |P=0.282N     P=0.487N     P=0.477N     P=0.468N     | 
|COCH-ARM / FISHERS |     P=0.462      P=0.247N     P=0.500N     P=0.684     |P=0.306N     P=0.500N     P=0.500N     P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 44      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    1/50 (2%)    1/49 (2%)   |1/50 (2%)    1/50 (2%)    3/50 (6%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/43.44      2/46.60      1/47.91      1/45.24     |1/45.20      1/46.02      3/45.37      0/44.18      | 
|POLY-3 PERCENT (g) |     0.0%         4.3%         2.1%         2.2%        |2.2%         2.2%         6.6%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/35 (0%)    0/33 (0%)   |1/35 (3%)    0/36 (0%)    1/36 (3%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     ---          526          573          397         |732 (T)      612          694          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.510      P=0.264      P=0.512      P=0.500     |P=0.409N     P=0.755N     P=0.320      P=0.494N     | 
|POLY 3             |     P=0.523      P=0.253      P=0.519      P=0.508     |P=0.423N     P=0.757N     P=0.306      P=0.505N     | 
|POLY 1.5           |     P=0.511      P=0.246      P=0.511      P=0.503     |P=0.419N     P=0.759N     P=0.305      P=0.504N     | 
|POLY 6             |     P=0.541      P=0.264      P=0.531      P=0.516     |P=0.422N     P=0.753N     P=0.312      P=0.503N     | 
|LOGISTIC REGRESSION|     P=0.516      P=0.188      P=0.231      (e)         |P=0.407N     P=0.759N     P=0.307      (e)          | 
|COCH-ARM / FISHERS |     P=0.494      P=0.247      P=0.500      P=0.495     |P=0.409N     P=0.753N     P=0.309      P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Red Pulp                                                                                                                 | 
|     Depletion Cellular                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    0/50 (0%)    0/49 (0%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/43.44      2/45.85      0/47.40      0/44.40     |1/45.59      0/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     0.0%         4.4%         0.0%         0.0%        |2.2%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    2/32 (6%)    0/35 (0%)    0/33 (0%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     ---          726 (T)      ---          ---         |622          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.385N     P=0.252      (e)          (e)         |P=0.313N     P=0.500N     P=0.500N     P=0.514N     | 
|POLY 3             |     P=0.388N     P=0.249      (e)          (e)         |P=0.303N     P=0.500N     P=0.502N     P=0.506N     | 
|POLY 1.5           |     P=0.397N     P=0.244      (e)          (e)         |P=0.304N     P=0.500N     P=0.502N     P=0.505N     | 
|POLY 6             |     P=0.375N     P=0.258      (e)          (e)         |P=0.303N     P=0.499N     P=0.501N     P=0.506N     | 
|LOGISTIC REGRESSION|     (e)          P=0.252      (e)          (e)         |P=0.264N     P=0.470N     P=0.455N     P=0.440N     | 
|COCH-ARM / FISHERS |     P=0.409N     P=0.247      (e)          (e)         |P=0.306N     P=0.500N     P=0.500N     P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 45      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    2/50 (4%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/43.64      1/46.06      2/47.65      0/45.40     |1/45.59      0/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     2.3%         2.2%         4.2%         0.0%        |2.2%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    1/35 (3%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     674          671          660          ---         |622          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.341N     P=0.724N     P=0.559      P=0.475N    |P=0.313N     P=0.500N     P=0.500N     P=0.514N     | 
|POLY 3             |     P=0.357N     P=0.749N     P=0.531      P=0.492N    |P=0.303N     P=0.500N     P=0.502N     P=0.506N     | 
|POLY 1.5           |     P=0.362N     P=0.754N     P=0.517      P=0.496N    |P=0.304N     P=0.500N     P=0.502N     P=0.505N     | 
|POLY 6             |     P=0.350N     P=0.740N     P=0.549      P=0.486N    |P=0.303N     P=0.499N     P=0.501N     P=0.506N     | 
|LOGISTIC REGRESSION|     P=0.377N     P=0.748      P=0.458      P=0.507N    |P=0.264N     P=0.470N     P=0.455N     P=0.440N     | 
|COCH-ARM / FISHERS |     P=0.366N     P=0.753N     P=0.500      P=0.500N    |P=0.306N     P=0.500N     P=0.500N     P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    3/50 (6%)    1/50 (2%)    2/50 (4%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/43.44      3/46.37      1/47.91      2/46.69     |0/45.20      1/46.02      0/45.17      1/44.66      | 
|POLY-3 PERCENT (g) |     0.0%         6.5%         2.1%         4.3%        |0.0%         2.2%         0.0%         2.2%         | 
|TERMINAL (d)       |     0/30 (0%)    1/32 (3%)    0/35 (0%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     ---          639          573          397         |---          612          ---          588          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.353      P=0.146      P=0.512      P=0.242     |P=0.396      P=0.504      (e)          P=0.487      | 
|POLY 3             |     P=0.373      P=0.131      P=0.519      P=0.254     |P=0.403      P=0.504      (e)          P=0.498      | 
|POLY 1.5           |     P=0.358      P=0.125      P=0.511      P=0.246     |P=0.402      P=0.502      (e)          P=0.497      | 
|POLY 6             |     P=0.395      P=0.140      P=0.531      P=0.264     |P=0.406      P=0.507      (e)          P=0.500      | 
|LOGISTIC REGRESSION|     P=0.322      P=0.109      P=0.231      P=0.226     |P=0.495      P=0.537      (e)          P=0.602      | 
|COCH-ARM / FISHERS |     P=0.337      P=0.121      P=0.500      P=0.247     |P=0.405      P=0.500      (e)          P=0.500      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 46      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    3/50 (6%)    3/50 (6%)   |2/50 (4%)    2/50 (4%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     1/43.56      2/46.37      3/48.22      3/46.69     |2/46.16      2/46.16      0/45.17      1/44.66      | 
|POLY-3 PERCENT (g) |     2.3%         4.3%         6.2%         6.4%        |4.3%         4.3%         0.0%         2.2%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/35 (0%)    1/34 (3%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     695          639          573          397         |508          612          ---          588          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.252      P=0.556      P=0.379      P=0.339     |P=0.308N     P=0.681N     P=0.241N     P=0.514N     | 
|POLY 3             |     P=0.253      P=0.522      P=0.343      P=0.330     |P=0.303N     P=0.694      P=0.242N     P=0.512N     | 
|POLY 1.5           |     P=0.243      P=0.512      P=0.327      P=0.320     |P=0.301N     P=0.693      P=0.241N     P=0.509N     | 
|POLY 6             |     P=0.268      P=0.537      P=0.366      P=0.346     |P=0.303N     P=0.692N     P=0.242N     P=0.511N     | 
|LOGISTIC REGRESSION|     P=0.203      P=0.470      P=0.174      P=0.275     |P=0.192N     P=0.665N     P=0.134N     P=0.319N     | 
|COCH-ARM / FISHERS |     P=0.227      P=0.500      P=0.309      P=0.309     |P=0.296N     P=0.691N     P=0.247N     P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    7/50 (14%)   8/50 (16%)   3/50 (6%)   |6/50 (12%)   4/50 (8%)    3/50 (6%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     1/43.64      7/47.36      8/48.56      3/45.86     |6/47.69      4/46.99      3/45.22      1/44.66      | 
|POLY-3 PERCENT (g) |     2.3%         14.8%        16.5%        6.5%        |12.6%        8.5%         6.6%         2.2%         | 
|TERMINAL (d)       |     0/30 (0%)    1/32 (3%)    3/35 (9%)    1/34 (3%)   |0/35 (0%)    0/36 (0%)    2/36 (6%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     674          526          573          596         |508          515          721          588          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.515      P=0.056      P=0.037 *    P=0.347     |P=0.045N*    P=0.360N     P=0.246N     P=0.073N     | 
|POLY 3             |     P=0.494      P=0.040 *    P=0.024 *    P=0.323     |P=0.045N*    P=0.379N     P=0.269N     P=0.067N     | 
|POLY 1.5           |     P=0.474      P=0.035 *    P=0.020 *    P=0.315     |P=0.042N*    P=0.376N     P=0.259N     P=0.063N     | 
|POLY 6             |     P=0.526      P=0.047 *    P=0.031 *    P=0.337     |P=0.047N*    P=0.383N     P=0.280N     P=0.071N     | 
|LOGISTIC REGRESSION|     P=0.422      P=0.022 *    P=0.008 **   P=0.295     |P=0.015N*    P=0.366N     P=0.190N     P=0.013N*    | 
|COCH-ARM / FISHERS |     P=0.452      P=0.030 *    P=0.015 *    P=0.309     |P=0.038N*    P=0.370N     P=0.243N     P=0.056N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 47      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Erosion                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    3/50 (6%)    2/50 (4%)    2/50 (4%)   |2/50 (4%)    1/50 (2%)    4/50 (8%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     2/43.70      3/45.87      2/47.67      2/45.92     |2/45.96      1/45.68      4/46.41      2/44.84      | 
|POLY-3 PERCENT (g) |     4.6%         6.5%         4.2%         4.4%        |4.4%         2.2%         8.6%         4.5%         | 
|TERMINAL (d)       |     0/30 (0%)    2/32 (6%)    0/35 (0%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     674          720          660          628         |622          712          510          588          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.472N     P=0.547      P=0.619N     P=0.644N    |P=0.468      P=0.503N     P=0.353      P=0.682      | 
|POLY 3             |     P=0.501N     P=0.522      P=0.662N     P=0.676N    |P=0.463      P=0.502N     P=0.342      P=0.685      | 
|POLY 1.5           |     P=0.511N     P=0.512      P=0.676N     P=0.685N    |P=0.466      P=0.502N     P=0.339      P=0.687      | 
|POLY 6             |     P=0.486N     P=0.537      P=0.643N     P=0.662N    |P=0.466      P=0.503N     P=0.348      P=0.687      | 
|LOGISTIC REGRESSION|     P=0.528N     P=0.539      P=0.677      P=0.683     |P=0.571      P=0.483N     P=0.400      P=0.614N     | 
|COCH-ARM / FISHERS |     P=0.523N     P=0.500      P=0.691N     P=0.691N    |P=0.477      P=0.500N     P=0.339      P=0.691N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    2/50 (4%)    5/50 (10%)   1/50 (2%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     3/43.97      2/46.17      5/47.46      1/45.98     |0/45.20      0/45.60      1/45.23      0/44.18      | 
|POLY-3 PERCENT (g) |     6.8%         4.3%         10.5%        2.2%        |0.0%         0.0%         2.2%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    2/35 (6%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     653          674          720          544         |---          ---          719          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.271N     P=0.422N     P=0.476      P=0.271N    |P=0.690      (e)          P=0.495      (e)          | 
|POLY 3             |     P=0.302N     P=0.478N     P=0.399      P=0.289N    |P=0.683      (e)          P=0.500      (e)          | 
|POLY 1.5           |     P=0.310N     P=0.488N     P=0.381      P=0.297N    |P=0.686      (e)          P=0.499      (e)          | 
|POLY 6             |     P=0.292N     P=0.463N     P=0.423      P=0.279N    |P=0.684      (e)          P=0.502      (e)          | 
|LOGISTIC REGRESSION|     P=0.331N     P=0.521N     P=0.394      P=0.322N    |P=0.692      (e)          P=0.501      (e)          | 
|COCH-ARM / FISHERS |     P=0.319N     P=0.500N     P=0.357      P=0.309N    |P=0.694      (e)          P=0.500      (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 48      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    3/50 (6%)    1/50 (2%)   |                                                    | 
|POLY-3 RATE (b)    |     2/43.69      0/45.85      3/47.74      1/45.57     |                                                    | 
|POLY-3 PERCENT (g) |     4.6%         0.0%         6.3%         2.2%        |                                                    | 
|TERMINAL (d)       |     1/30 (3%)    0/32 (0%)    1/35 (3%)    0/34 (0%)   |                                                    | 
|FIRST INCIDENCE    |     660          ---          639          684         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.521N     P=0.217N     P=0.571      P=0.458N    |                                                    | 
|POLY 3             |     P=0.550N     P=0.226N     P=0.540      P=0.485N    |                                                    | 
|POLY 1.5           |     P=0.553N     P=0.231N     P=0.523      P=0.492N    |                                                    | 
|POLY 6             |     P=0.545N     P=0.219N     P=0.564      P=0.474N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.562N     P=0.237N     P=0.479      P=0.502N    |                                                    | 
|COCH-ARM / FISHERS |     P=0.556N     P=0.247N     P=0.500      P=0.500N    |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Interstitial Cell                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    4/50 (8%)    9/50 (18%)   5/50 (10%)  |                                                    | 
|POLY-3 RATE (b)    |     4/45.43      4/47.61      9/48.52      5/47.21     |                                                    | 
|POLY-3 PERCENT (g) |     8.8%         8.4%         18.6%        10.6%       |                                                    | 
|TERMINAL (d)       |     1/30 (3%)    0/32 (0%)    4/35 (11%)   1/34 (3%)   |                                                    | 
|FIRST INCIDENCE    |     450          478          573          397         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.404      P=0.615N     P=0.188      P=0.530     |                                                    | 
|POLY 3             |     P=0.373      P=0.617N     P=0.142      P=0.524     |                                                    | 
|POLY 1.5           |     P=0.363      P=0.629N     P=0.130      P=0.512     |                                                    | 
|POLY 6             |     P=0.391      P=0.598N     P=0.164      P=0.543     |                                                    | 
|LOGISTIC REGRESSION|     P=0.223      P=0.483      P=0.011 *    P=0.365     |                                                    | 
|COCH-ARM / FISHERS |     P=0.351      P=0.643N     P=0.117      P=0.500     |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 49      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     45/50 (90%)  47/49 (96%)  44/47 (94%)  45/49 (92%) |45/49 (92%)  45/49 (92%)  44/48 (92%)  46/49 (94%)  | 
|POLY-3 RATE (b)    |     45/48.21     47/48.84     44/46.92     45/48.65    |45/47.00     45/47.89     44/47.07     46/48.15     | 
|POLY-3 PERCENT (g) |     93.3%        96.2%        93.8%        92.5%       |95.7%        94.0%        93.5%        95.5%        | 
|TERMINAL (d)       |     30/30 (100%) 32/32 (100%) 31/32 (97%)  30/33 (91%) |35/35 (100%) 34/35 (97%)  34/35 (97%)  34/35 (97%)  | 
|FIRST INCIDENCE    |     450          478          573          397         |588          400          445          386          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.217N     P=0.445N     P=0.208N     P=0.283N    |P=0.441      P=0.572N     P=0.493N     P=0.485      | 
|POLY 3             |     P=0.418N     P=0.417      P=0.640      P=0.601N    |P=0.580      P=0.535N     P=0.486N     P=0.698N     | 
|POLY 1.5           |     P=0.501N     P=0.315      P=0.521      P=0.629     |P=0.487      P=0.585N     P=0.552N     P=0.616      | 
|POLY 6             |     P=0.299N     P=0.610      P=0.567N     P=0.467N    |P=0.482N     P=0.468N     P=0.405N     P=0.560N     | 
|LOGISTIC REGRESSION|     P=0.569      P=0.278      P=0.591      P=0.546     |P=0.255      P=0.629      P=0.551      P=0.276      | 
|COCH-ARM / FISHERS |     P=0.549      P=0.226      P=0.393      P=0.513     |P=0.412      P=0.643N     P=0.631N     P=0.500      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     32/50 (64%)  41/50 (82%)  41/50 (82%)  34/50 (68%) |45/50 (90%)  39/50 (78%)  43/50 (86%)  36/50 (72%)  | 
|POLY-3 RATE (b)    |     32/47.86     41/48.66     41/48.52     34/47.38    |45/48.81     39/47.19     43/47.26     36/46.12     | 
|POLY-3 PERCENT (g) |     66.9%        84.3%        84.5%        71.8%       |92.2%        82.7%        91.0%        78.1%        | 
|TERMINAL (d)       |     19/30 (63%)  28/32 (88%)  32/35 (91%)  26/34 (77%) |33/35 (94%)  32/36 (89%)  34/36 (94%)  31/36 (86%)  | 
|FIRST INCIDENCE    |     450          478          639          397         |519          582          453          432          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.244N     P=0.208      P=0.350      P=0.452N    |P=0.046N*    P=0.112N     P=0.339N     P=0.036N*    | 
|POLY 3             |     P=0.490      P=0.033 *    P=0.030 *    P=0.380     |P=0.049N*    P=0.118N     P=0.567N     P=0.037N*    | 
|POLY 1.5           |     P=0.513      P=0.033 *    P=0.032 *    P=0.395     |P=0.039N*    P=0.102N     P=0.488N     P=0.028N*    | 
|POLY 6             |     P=0.461      P=0.035 *    P=0.031 *    P=0.363     |P=0.060N     P=0.141N     P=0.642N     P=0.049N*    | 
|LOGISTIC REGRESSION|     P=0.493N     P=0.040 *    P=0.061      P=0.441     |P=0.052N     P=0.062N     P=0.452N     P=0.031N*    | 
|COCH-ARM / FISHERS |     P=0.543N     P=0.035 *    P=0.035 *    P=0.417     |P=0.030N*    P=0.086N     P=0.380N     P=0.020N*    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 50      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    4/50 (8%)    3/50 (6%)   |0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/43.44      1/45.85      4/47.85      3/45.43     |0/45.20      2/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     2.3%         2.2%         8.4%         6.6%        |0.0%         4.4%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/30 (3%)    1/32 (3%)    2/35 (6%)    2/34 (6%)   |0/35 (0%)    2/36 (6%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     726 (T)      726 (T)      600          720         |---          732 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.199      P=0.748N     P=0.228      P=0.357     |P=0.400N     P=0.244      (e)          (e)          | 
|POLY 3             |     P=0.174      P=0.749N     P=0.210      P=0.321     |P=0.406N     P=0.239      (e)          (e)          | 
|POLY 1.5           |     P=0.169      P=0.754N     P=0.196      P=0.314     |P=0.407N     P=0.238      (e)          (e)          | 
|POLY 6             |     P=0.183      P=0.740N     P=0.229      P=0.334     |P=0.404N     P=0.241      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.173      P=0.748N     P=0.175      P=0.364     |(e)          P=0.244      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.163      P=0.753N     P=0.181      P=0.309     |P=0.405N     P=0.247      (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth                                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/1 (0%)     0/1 (0%)     0/0 (0%)     0/0 (0%)    |0/0 (0%)     0/1 (0%)     2/2 (100%)   1/2 (50%)    | 
|POLY-3 RATE (b)    |     0/0.75       0/1.00       0/0.00       0/0.00      |0/0.00       0/1.00       2/2.00       1/1.83       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         100.0%       54.7%        | 
|TERMINAL (d)       |     0/0 (0%)     0/1 (0%)     0/0 (0%)     0/0 (0%)    |0/0 (0%)     0/1 (0%)     1/1 (100%)   1/1 (100%)   | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          719          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.384      (e)          (e)          P=1.000N     | 
|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)         |P=0.506      (e)          (e)          P=1.000N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.728      (e)          (e)          P=1.000      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 51      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                       CITRAL      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Trachea                                                                                                                          | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    3/50 (6%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     1/43.44      0/45.85      0/47.40      0/45.40     |1/45.20      3/45.60      1/45.17      1/44.18      | 
|POLY-3 PERCENT (g) |     2.3%         0.0%         0.0%         0.0%        |2.2%         6.6%         2.2%         2.3%         | 
|TERMINAL (d)       |     1/30 (3%)    0/32 (0%)    0/35 (0%)    0/34 (0%)   |1/35 (3%)    3/36 (8%)    1/36 (3%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     726 (T)      ---          ---          ---         |732 (T)      732 (T)      732 (T)      732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.290N     P=0.487N     P=0.469N     P=0.475N    |P=0.436N     P=0.315      P=0.756N     P=0.756N     | 
|POLY 3             |     P=0.312N     P=0.489N     P=0.483N     P=0.491N    |P=0.452N     P=0.308      P=0.760      P=0.756      | 
|POLY 1.5           |     P=0.309N     P=0.494N     P=0.490N     P=0.495N    |P=0.451N     P=0.307      P=0.760      P=0.756      | 
|POLY 6             |     P=0.317N     P=0.482N     P=0.472N     P=0.484N    |P=0.449N     P=0.311      P=0.759N     P=0.757      | 
|LOGISTIC REGRESSION|     P=0.290N     (e)          (e)          (e)         |P=0.436N     P=0.315      P=0.756N     P=0.756N     | 
|COCH-ARM / FISHERS |     P=0.306N     P=0.500N     P=0.500N     P=0.500N    |P=0.444N     P=0.309      P=0.753N     P=0.753N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |9/50 (18%)   15/50 (30%)  9/50 (18%)   14/50 (28%)  | 
|POLY-3 RATE (b)    |                                                        |9/46.26      15/46.65     9/46.15      14/44.50     | 
|POLY-3 PERCENT (g) |                                                        |19.5%        32.2%        19.5%        31.5%        | 
|TERMINAL (d)       |                                                        |5/35 (14%)   12/36 (33%)  7/36 (19%)   12/36 (33%)  | 
|FIRST INCIDENCE    |                                                        |595          515          504          687          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.275      P=0.144      P=0.579N     P=0.193      | 
|POLY 3             |                                                        |P=0.217      P=0.121      P=0.601      P=0.140      | 
|POLY 1.5           |                                                        |P=0.229      P=0.120      P=0.599      P=0.149      | 
|POLY 6             |                                                        |P=0.212      P=0.122      P=0.602N     P=0.136      | 
|LOGISTIC REGRESSION|                                                        |P=0.240      P=0.121      P=0.600N     P=0.155      | 
|COCH-ARM / FISHERS |                                                        |P=0.259      P=0.121      P=0.602N     P=0.171      | 
|=================================================================================================================================| 
(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).                                                    

--multipart-boundary
Content-type: text/plain
Range: bytes 431427-431427/431427


--multipart-boundary--