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TDMS Study 56348-03 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                           CITRAL                                        DATE: 07/05/01       
EXPERIMENT: 56348 TEST: 03                                                                                     TIME: 13:17:14       
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       
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               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 PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                           CITRAL                                        DATE: 07/05/01       
EXPERIMENT: 56348 TEST: 03                                                                                     TIME: 13:17:14       
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       
Rats(FISCHER 344)                                                                                                                   
-----------------------------                                                                                                       
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE                                                                   
BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES                                                                 
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Adrenal Cortex                                                                     
                                                 Adrenal Medulla                                                                    
                                                 Clitoral/Preputial Gland                                                           
                                                 Heart                                                                              
                                                 Islets, Pancreatic                                                                 
                                                 Kidney                                                                             
                                                 Lung                                                                               
                                                 Nose                                                                               
                                                 Pancreas                                                                           
                                                 Parathyroid Gland                                                                  
                                                 Pituitary Gland                                                                    
                                                 Testes                                                                             
                                                 Thyroid Gland                                                                      
                                                 Urinary Bladder                                                                    
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                           CITRAL                                        DATE: 07/05/01       
EXPERIMENT: 56348 TEST: 03                                                                                     TIME: 13:17:14       
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                                                                                    
-----                                 ----------                                                                                    
Mammary Gland                          Fibroma, Fibroadenoma or Adenoma                                                             
                                       Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                 
Testes                                 Adenoma                                                                                      
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Clitoral/Preputial Gland               Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
Mammary Gland                          Fibroadenoma                                                                                 
                                       Fibroma, Fibroadenoma or Adenoma                                                             
                                       Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                 
Skin                                   Keratoacanthoma                                                                              
                                       Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma               
                                       Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                       
All Organs                             Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                           
                                       Malignant Tumors                                                                             
===============================================================                                                                     
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 1       
                     Statistical Analysis of Primary Tumors 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 Medulla                                                                                                                  | 
|     Pheochromocytoma Benign                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/50 (12%)   3/50 (6%)    3/50 (6%)    8/50 (16%)  |2/49 (4%)    1/50 (2%)    2/50 (4%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     6/44.21      3/45.97      3/47.40      8/45.40     |2/44.20      1/45.60      2/45.17      1/44.18      | 
|POLY-3 PERCENT (g) |     13.6%        6.5%         6.3%         17.6%       |4.5%         2.2%         4.4%         2.3%         | 
|TERMINAL (d)       |     3/30 (10%)   2/32 (6%)    3/35 (9%)    8/34 (24%)  |2/34 (6%)    1/36 (3%)    2/36 (6%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     639          695          726 (T)      726 (T)     |732 (T)      732 (T)      732 (T)      732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.274      P=0.201N     P=0.177N     P=0.478     |P=0.428N     P=0.480N     P=0.675N     P=0.480N     | 
|POLY 3             |     P=0.217      P=0.222N     P=0.209N     P=0.407     |P=0.448N     P=0.489N     P=0.686N     P=0.500N     | 
|POLY 1.5           |     P=0.215      P=0.232N     P=0.223N     P=0.397     |P=0.446N     P=0.491N     P=0.687N     P=0.499N     | 
|POLY 6             |     P=0.220      P=0.210N     P=0.191N     P=0.422     |P=0.446N     P=0.486N     P=0.682N     P=0.498N     | 
|LOGISTIC REGRESSION|     P=0.240      P=0.230N     P=0.221N     P=0.442     |P=0.428N     P=0.480N     P=0.675N     P=0.480N     | 
|COCH-ARM / FISHERS |     P=0.213      P=0.243N     P=0.243N     P=0.387     |P=0.438N     P=0.492N     P=0.684N     P=0.492N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/50 (14%)   3/50 (6%)    3/50 (6%)    9/50 (18%)  |2/49 (4%)    1/50 (2%)    2/50 (4%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     7/44.21      3/45.97      3/47.40      9/45.67     |2/44.20      1/45.60      2/45.17      1/44.18      | 
|POLY-3 PERCENT (g) |     15.8%        6.5%         6.3%         19.7%       |4.5%         2.2%         4.4%         2.3%         | 
|TERMINAL (d)       |     4/30 (13%)   2/32 (6%)    3/35 (9%)    8/34 (24%)  |2/34 (6%)    1/36 (3%)    2/36 (6%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     639          695          726 (T)      655         |732 (T)      732 (T)      732 (T)      732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.262      P=0.128N     P=0.108N     P=0.492     |P=0.428N     P=0.480N     P=0.675N     P=0.480N     | 
|POLY 3             |     P=0.205      P=0.141N     P=0.130N     P=0.419     |P=0.448N     P=0.489N     P=0.686N     P=0.500N     | 
|POLY 1.5           |     P=0.202      P=0.149N     P=0.142N     P=0.406     |P=0.446N     P=0.491N     P=0.687N     P=0.499N     | 
|POLY 6             |     P=0.209      P=0.131N     P=0.116N     P=0.440     |P=0.446N     P=0.486N     P=0.682N     P=0.498N     | 
|LOGISTIC REGRESSION|     P=0.222      P=0.143N     P=0.132N     P=0.441     |P=0.428N     P=0.480N     P=0.675N     P=0.480N     | 
|COCH-ARM / FISHERS |     P=0.200      P=0.159N     P=0.159N     P=0.393     |P=0.438N     P=0.492N     P=0.684N     P=0.492N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 2       
                     Statistical Analysis of Primary Tumors 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/Preputial Gland                                                                                                         | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    5/49 (10%)   4/50 (8%)    3/50 (6%)   |9/49 (18%)   3/49 (6%)    4/50 (8%)    1/49 (2%)    | 
|POLY-3 RATE (b)    |     4/43.69      5/46.39      4/47.47      3/45.98     |9/44.60      3/44.60      4/45.34      1/43.18      | 
|POLY-3 PERCENT (g) |     9.2%         10.8%        8.4%         6.5%        |20.2%        6.7%         8.8%         2.3%         | 
|TERMINAL (d)       |     3/30 (10%)   0/32 (0%)    3/35 (9%)    2/34 (6%)   |8/35 (23%)   3/35 (9%)    3/36 (8%)    1/35 (3%)    | 
|FIRST INCIDENCE    |     660          505          709          544         |719          732 (T)      690          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.309N     P=0.564      P=0.544N     P=0.446N    |P=0.009N**   P=0.062N     P=0.108N     P=0.010N*    | 
|POLY 3             |     P=0.337N     P=0.538      P=0.597N     P=0.472N    |P=0.009N**   P=0.058N     P=0.108N     P=0.009N**   | 
|POLY 1.5           |     P=0.347N     P=0.515      P=0.617N     P=0.485N    |P=0.009N**   P=0.059N     P=0.109N     P=0.009N**   | 
|POLY 6             |     P=0.323N     P=0.571      P=0.569N     P=0.452N    |P=0.009N**   P=0.057N     P=0.104N     P=0.009N**   | 
|LOGISTIC REGRESSION|     P=0.379N     P=0.440      P=0.558N     P=0.503N    |P=0.009N**   P=0.062N     P=0.104N     P=0.010N*    | 
|COCH-ARM / FISHERS |     P=0.358N     P=0.487      P=0.643N     P=0.500N    |P=0.009N**   P=0.060N     P=0.109N     P=0.008N**   | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/50 (10%)   5/49 (10%)   5/50 (10%)   4/50 (8%)   |9/49 (18%)   3/49 (6%)    4/50 (8%)    1/49 (2%)    | 
|POLY-3 RATE (b)    |     5/44.08      5/46.39      5/47.67      4/46.05     |9/44.60      3/44.60      4/45.34      1/43.18      | 
|POLY-3 PERCENT (g) |     11.3%        10.8%        10.5%        8.7%        |20.2%        6.7%         8.8%         2.3%         | 
|TERMINAL (d)       |     3/30 (10%)   0/32 (0%)    3/35 (9%)    2/34 (6%)   |8/35 (23%)   3/35 (9%)    3/36 (8%)    1/35 (3%)    | 
|FIRST INCIDENCE    |     617          505          674          544         |719          732 (T)      690          732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.357N     P=0.560N     P=0.520N     P=0.435N    |P=0.009N**   P=0.062N     P=0.108N     P=0.010N*    | 
|POLY 3             |     P=0.397N     P=0.598N     P=0.580N     P=0.473N    |P=0.009N**   P=0.058N     P=0.108N     P=0.009N**   | 
|POLY 1.5           |     P=0.405N     P=0.618N     P=0.601N     P=0.485N    |P=0.009N**   P=0.059N     P=0.109N     P=0.009N**   | 
|POLY 6             |     P=0.385N     P=0.568N     P=0.551N     P=0.453N    |P=0.009N**   P=0.057N     P=0.104N     P=0.009N**   | 
|LOGISTIC REGRESSION|     P=0.441N     P=0.560      P=0.622N     P=0.512N    |P=0.009N**   P=0.062N     P=0.104N     P=0.010N*    | 
|COCH-ARM / FISHERS |     P=0.415N     P=0.617      P=0.630N     P=0.500N    |P=0.009N**   P=0.060N     P=0.109N     P=0.008N**   | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 3       
                     Statistical Analysis of Primary Tumors 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                                                                                                                            | 
|     Schwannoma Malignant                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    1/50 (2%)    0/50 (0%)   |1/50 (2%)    1/50 (2%)    2/50 (4%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/43.44      2/46.51      1/47.40      0/45.40     |1/45.25      1/45.60      2/45.40      1/44.35      | 
|POLY-3 PERCENT (g) |     0.0%         4.3%         2.1%         0.0%        |2.2%         2.2%         4.4%         2.3%         | 
|TERMINAL (d)       |     0/30 (0%)    1/32 (3%)    1/35 (3%)    0/34 (0%)   |0/35 (0%)    1/36 (3%)    1/36 (3%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     ---          505          726 (T)      ---         |719          732 (T)      673          687          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.440N     P=0.247      P=0.531      (e)         |P=0.597      P=0.755      P=0.509      P=0.758N     | 
|POLY 3             |     P=0.439N     P=0.253      P=0.517      (e)         |P=0.579      P=0.759N     P=0.501      P=0.756      | 
|POLY 1.5           |     P=0.449N     P=0.246      P=0.510      (e)         |P=0.581      P=0.760N     P=0.499      P=0.757      | 
|POLY 6             |     P=0.424N     P=0.263      P=0.528      (e)         |P=0.583      P=0.757N     P=0.506      P=0.758      | 
|LOGISTIC REGRESSION|     P=0.471N     P=0.191      P=0.531      (e)         |P=0.586      P=0.758N     P=0.499      P=0.761      | 
|COCH-ARM / FISHERS |     P=0.461N     P=0.247      P=0.500      (e)         |P=0.591      P=0.753N     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                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/49 (2%)    2/50 (4%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    2/50 (4%)    1/49 (2%)    | 
|POLY-3 RATE (b)    |     1/42.89      2/45.85      1/47.47      0/45.40     |0/45.20      0/45.60      2/45.17      1/43.98      | 
|POLY-3 PERCENT (g) |     2.3%         4.4%         2.1%         0.0%        |0.0%         0.0%         4.4%         2.3%         | 
|TERMINAL (d)       |     0/30 (0%)    2/32 (6%)    0/35 (0%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    2/36 (6%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     674          726 (T)      709          ---         |---          ---          732 (T)      732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.217N     P=0.532      P=0.704N     P=0.475N    |P=0.250      (e)          P=0.244      P=0.506      | 
|POLY 3             |     P=0.233N     P=0.523      P=0.738N     P=0.489N    |P=0.237      (e)          P=0.237      P=0.495      | 
|POLY 1.5           |     P=0.238N     P=0.516      P=0.745N     P=0.492N    |P=0.237      (e)          P=0.236      P=0.494      | 
|POLY 6             |     P=0.226N     P=0.534      P=0.727N     P=0.483N    |P=0.239      (e)          P=0.239      P=0.496      | 
|LOGISTIC REGRESSION|     P=0.234N     P=0.529      P=0.759      P=0.502N    |(e)          (e)          P=0.244      P=0.506      | 
|COCH-ARM / FISHERS |     P=0.243N     P=0.508      P=0.747N     P=0.495N    |P=0.241      (e)          P=0.247      P=0.495      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 4       
                     Statistical Analysis of Primary Tumors 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                                                                                                                             | 
|     Alveolar/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    2/50 (4%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    2/50 (4%)    2/50 (4%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     2/43.56      2/45.85      0/47.40      0/45.40     |1/45.20      2/46.07      2/45.17      1/44.18      | 
|POLY-3 PERCENT (g) |     4.6%         4.4%         0.0%         0.0%        |2.2%         4.3%         4.4%         2.3%         | 
|TERMINAL (d)       |     1/30 (3%)    2/32 (6%)    0/35 (0%)    0/34 (0%)   |1/35 (3%)    1/36 (3%)    2/36 (6%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     695          726 (T)      ---          ---         |732 (T)      594          732 (T)      732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.070N     P=0.658N     P=0.192N     P=0.205N    |P=0.553N     P=0.507      P=0.510      P=0.756N     | 
|POLY 3             |     P=0.081N     P=0.676N     P=0.219N     P=0.228N    |P=0.566N     P=0.507      P=0.500      P=0.756      | 
|POLY 1.5           |     P=0.083N     P=0.684N     P=0.227N     P=0.232N    |P=0.564N     P=0.503      P=0.499      P=0.756      | 
|POLY 6             |     P=0.079N     P=0.663N     P=0.209N     P=0.221N    |P=0.564N     P=0.512      P=0.504      P=0.757      | 
|LOGISTIC REGRESSION|     P=0.072N     P=0.649N     P=0.211N     P=0.221N    |P=0.562N     P=0.501      P=0.510      P=0.756N     | 
|COCH-ARM / FISHERS |     P=0.086N     P=0.691N     P=0.247N     P=0.247N    |P=0.556N     P=0.500      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                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    3/50 (6%)    1/50 (2%)    0/50 (0%)   |1/50 (2%)    2/50 (4%)    2/50 (4%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     2/43.56      3/45.91      1/47.40      0/45.40     |1/45.20      2/46.07      2/45.17      1/44.18      | 
|POLY-3 PERCENT (g) |     4.6%         6.5%         2.1%         0.0%        |2.2%         4.3%         4.4%         2.3%         | 
|TERMINAL (d)       |     1/30 (3%)    2/32 (6%)    1/35 (3%)    0/34 (0%)   |1/35 (3%)    1/36 (3%)    2/36 (6%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     695          709          726 (T)      ---         |732 (T)      594          732 (T)      732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.082N     P=0.551      P=0.430N     P=0.205N    |P=0.553N     P=0.507      P=0.510      P=0.756N     | 
|POLY 3             |     P=0.096N     P=0.524      P=0.471N     P=0.228N    |P=0.566N     P=0.507      P=0.500      P=0.756      | 
|POLY 1.5           |     P=0.099N     P=0.513      P=0.483N     P=0.232N    |P=0.564N     P=0.503      P=0.499      P=0.756      | 
|POLY 6             |     P=0.091N     P=0.540      P=0.453N     P=0.221N    |P=0.564N     P=0.512      P=0.504      P=0.757      | 
|LOGISTIC REGRESSION|     P=0.086N     P=0.553      P=0.445N     P=0.221N    |P=0.562N     P=0.501      P=0.510      P=0.756N     | 
|COCH-ARM / FISHERS |     P=0.104N     P=0.500      P=0.500N     P=0.247N    |P=0.556N     P=0.500      P=0.500      P=0.753N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 5       
                     Statistical Analysis of Primary Tumors 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                                                                                                                    | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    1/50 (2%)    3/50 (6%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/43.44      0/45.85      0/47.40      0/45.40     |0/45.20      1/45.92      3/45.94      0/44.18      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         2.2%         6.5%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/35 (0%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    2/36 (6%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          645          453          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.633N     P=0.519      P=0.125      (e)          | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.617      P=0.503      P=0.122      (e)          | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.621      P=0.501      P=0.120      (e)          | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.619      P=0.506      P=0.124      (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.570N     P=0.516      P=0.139      (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.634      P=0.500      P=0.121      (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    1/50 (2%)    3/50 (6%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/43.59      0/45.85      0/47.40      0/45.40     |0/45.20      1/45.92      3/45.94      0/44.18      | 
|POLY-3 PERCENT (g) |     2.3%         0.0%         0.0%         0.0%        |0.0%         2.2%         6.5%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/35 (0%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    2/36 (6%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     688          ---          ---          ---         |---          645          453          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.289N     P=0.458N     P=0.449N     P=0.473N    |P=0.633N     P=0.519      P=0.125      (e)          | 
|POLY 3             |     P=0.311N     P=0.490N     P=0.483N     P=0.492N    |P=0.617      P=0.503      P=0.122      (e)          | 
|POLY 1.5           |     P=0.308N     P=0.494N     P=0.490N     P=0.496N    |P=0.621      P=0.501      P=0.120      (e)          | 
|POLY 6             |     P=0.316N     P=0.483N     P=0.474N     P=0.486N    |P=0.619      P=0.506      P=0.124      (e)          | 
|LOGISTIC REGRESSION|     P=0.310N     P=0.505N     P=0.521N     P=0.502N    |P=0.570N     P=0.516      P=0.139      (e)          | 
|COCH-ARM / FISHERS |     P=0.306N     P=0.500N     P=0.500N     P=0.500N    |P=0.634      P=0.500      P=0.121      (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 6       
                     Statistical Analysis of Primary Tumors 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                                                                                                                    | 
|     Fibroadenoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    0/50 (0%)    3/50 (6%)    2/50 (4%)   |26/50 (52%)  22/50 (44%)  18/50 (36%)  16/50 (32%)  | 
|POLY-3 RATE (b)    |     3/43.44      0/45.85      3/47.55      2/45.40     |26/45.82     22/46.19     18/45.59     16/45.45     | 
|POLY-3 PERCENT (g) |     6.9%         0.0%         6.3%         4.4%        |56.7%        47.6%        39.5%        35.2%        | 
|TERMINAL (d)       |     3/30 (10%)   0/32 (0%)    2/35 (6%)    2/34 (6%)   |21/35 (60%)  20/36 (56%)  15/36 (42%)  13/36 (36%)  | 
|FIRST INCIDENCE    |     726 (T)      ---          688          726 (T)     |609          582          673          491          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.548N     P=0.109N     P=0.581N     P=0.442N    |P=0.020N*    P=0.242N     P=0.069N     P=0.033N*    | 
|POLY 3             |     P=0.593N     P=0.109N     P=0.620N     P=0.480N    |P=0.020N*    P=0.248N     P=0.070N     P=0.028N*    | 
|POLY 1.5           |     P=0.595N     P=0.114N     P=0.638N     P=0.490N    |P=0.022N*    P=0.262N     P=0.075N     P=0.031N*    | 
|POLY 6             |     P=0.590N     P=0.103N     P=0.593N     P=0.464N    |P=0.016N*    P=0.232N     P=0.060N     P=0.022N*    | 
|LOGISTIC REGRESSION|     P=0.552N     (e)          P=0.570N     P=0.442N    |P=0.025N*    P=0.221N     P=0.055N     P=0.037N*    | 
|COCH-ARM / FISHERS |     P=0.596      P=0.121N     P=0.661N     P=0.500N    |P=0.023N*    P=0.274N     P=0.079N     P=0.034N*    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma or Adenoma                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    0/50 (0%)    3/50 (6%)    2/50 (4%)   |26/50 (52%)  22/50 (44%)  18/50 (36%)  16/50 (32%)  | 
|POLY-3 RATE (b)    |     4/43.59      0/45.85      3/47.55      2/45.40     |26/45.82     22/46.19     18/45.59     16/45.45     | 
|POLY-3 PERCENT (g) |     9.2%         0.0%         6.3%         4.4%        |56.7%        47.6%        39.5%        35.2%        | 
|TERMINAL (d)       |     3/30 (10%)   0/32 (0%)    2/35 (6%)    2/34 (6%)   |21/35 (60%)  20/36 (56%)  15/36 (42%)  13/36 (36%)  | 
|FIRST INCIDENCE    |     688          ---          688          726 (T)     |609          582          673          491          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.380N     P=0.052N     P=0.401N     P=0.281N    |P=0.020N*    P=0.242N     P=0.069N     P=0.033N*    | 
|POLY 3             |     P=0.429N     P=0.054N     P=0.453N     P=0.318N    |P=0.020N*    P=0.248N     P=0.070N     P=0.028N*    | 
|POLY 1.5           |     P=0.430N     P=0.057N     P=0.473N     P=0.328N    |P=0.022N*    P=0.262N     P=0.075N     P=0.031N*    | 
|POLY 6             |     P=0.427N     P=0.050N     P=0.425N     P=0.304N    |P=0.016N*    P=0.232N     P=0.060N     P=0.022N*    | 
|LOGISTIC REGRESSION|     P=0.394N     P=0.048N*    P=0.418N     P=0.278N    |P=0.025N*    P=0.221N     P=0.055N     P=0.037N*    | 
|COCH-ARM / FISHERS |     P=0.432N     P=0.059N     P=0.500N     P=0.339N    |P=0.023N*    P=0.274N     P=0.079N     P=0.034N*    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 7       
                     Statistical Analysis of Primary Tumors 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                                                                                                                    | 
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    0/50 (0%)    3/50 (6%)    2/50 (4%)   |26/50 (52%)  23/50 (46%)  20/50 (40%)  16/50 (32%)  | 
|POLY-3 RATE (b)    |     4/43.59      0/45.85      3/47.55      2/45.40     |26/45.82     23/46.51     20/46.35     16/45.45     | 
|POLY-3 PERCENT (g) |     9.2%         0.0%         6.3%         4.4%        |56.7%        49.5%        43.2%        35.2%        | 
|TERMINAL (d)       |     3/30 (10%)   0/32 (0%)    2/35 (6%)    2/34 (6%)   |21/35 (60%)  20/36 (56%)  16/36 (44%)  13/36 (36%)  | 
|FIRST INCIDENCE    |     688          ---          688          726 (T)     |609          582          453          491          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.380N     P=0.052N     P=0.401N     P=0.281N    |P=0.021N*    P=0.309N     P=0.143N     P=0.033N*    | 
|POLY 3             |     P=0.429N     P=0.054N     P=0.453N     P=0.318N    |P=0.020N*    P=0.308N     P=0.131N     P=0.028N*    | 
|POLY 1.5           |     P=0.430N     P=0.057N     P=0.473N     P=0.328N    |P=0.022N*    P=0.327N     P=0.144N     P=0.031N*    | 
|POLY 6             |     P=0.427N     P=0.050N     P=0.425N     P=0.304N    |P=0.016N*    P=0.282N     P=0.113N     P=0.022N*    | 
|LOGISTIC REGRESSION|     P=0.394N     P=0.048N*    P=0.418N     P=0.278N    |P=0.026N*    P=0.295N     P=0.144N     P=0.037N*    | 
|COCH-ARM / FISHERS |     P=0.432N     P=0.059N     P=0.500N     P=0.339N    |P=0.022N*    P=0.345N     P=0.158N     P=0.034N*    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       | 
|     Papilloma Squamous or Papilloma                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/43.69      2/45.85      1/47.40      0/45.40     |0/45.20      1/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     2.3%         4.4%         2.1%         0.0%        |0.0%         2.2%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    2/32 (6%)    1/35 (3%)    0/34 (0%)   |0/35 (0%)    1/36 (3%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     660          726 (T)      726 (T)      ---         |---          732 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.223N     P=0.531      P=0.725N     P=0.485N    |P=0.564N     P=0.506      (e)          (e)          | 
|POLY 3             |     P=0.237N     P=0.517      P=0.742N     P=0.492N    |P=0.567N     P=0.502      (e)          (e)          | 
|POLY 1.5           |     P=0.242N     P=0.509      P=0.750N     P=0.496N    |P=0.567N     P=0.501      (e)          (e)          | 
|POLY 6             |     P=0.229N     P=0.528      P=0.731N     P=0.486N    |P=0.565N     P=0.503      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.236N     P=0.515      P=0.757      P=0.509N    |(e)          P=0.506      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.247N     P=0.500      P=0.753N     P=0.500N    |P=0.567N     P=0.500      (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 8       
                     Statistical Analysis of Primary Tumors 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                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       | 
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    3/50 (6%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     1/43.69      3/45.85      1/47.40      0/45.40     |0/45.20      1/45.60      0/45.17      1/44.33      | 
|POLY-3 PERCENT (g) |     2.3%         6.5%         2.1%         0.0%        |0.0%         2.2%         0.0%         2.3%         | 
|TERMINAL (d)       |     0/30 (0%)    2/32 (6%)    1/35 (3%)    0/34 (0%)   |0/35 (0%)    1/36 (3%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     660          725          726 (T)      ---         |---          732 (T)      ---          694          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.176N     P=0.341      P=0.725N     P=0.485N    |P=0.406      P=0.506      (e)          P=0.500      | 
|POLY 3             |     P=0.186N     P=0.323      P=0.742N     P=0.492N    |P=0.401      P=0.502      (e)          P=0.496      | 
|POLY 1.5           |     P=0.192N     P=0.315      P=0.750N     P=0.496N    |P=0.401      P=0.501      (e)          P=0.497      | 
|POLY 6             |     P=0.177N     P=0.334      P=0.731N     P=0.486N    |P=0.403      P=0.503      (e)          P=0.498      | 
|LOGISTIC REGRESSION|     P=0.185N     P=0.329      P=0.757      P=0.509N    |P=0.401      P=0.506      (e)          P=0.502      | 
|COCH-ARM / FISHERS |     P=0.200N     P=0.309      P=0.753N     P=0.500N    |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                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Parathyroid Gland                                                                                                                | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    0/45 (0%)    0/45 (0%)   |2/43 (5%)    0/40 (0%)    0/43 (0%)    0/47 (0%)    | 
|POLY-3 RATE (b)    |     0/42.01      0/43.06      0/42.40      0/41.20     |2/38.24      0/35.97      0/39.01      0/41.18      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |5.2%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/29 (0%)    0/31 (0%)    0/30 (0%)    0/31 (0%)   |2/29 (7%)    0/28 (0%)    0/31 (0%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |732 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.103N     P=0.246N     P=0.223N     P=0.210N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.106N     P=0.250N     P=0.232N     P=0.220N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.106N     P=0.252N     P=0.235N     P=0.220N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.107N     P=0.247N     P=0.228N     P=0.217N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.103N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.108N     P=0.265N     P=0.247N     P=0.225N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 9       
                     Statistical Analysis of Primary Tumors 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 or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/50 (16%)   7/50 (14%)   9/50 (18%)   6/49 (12%)  |12/50 (24%)  11/50 (22%)  17/50 (34%)  13/49 (27%)  | 
|POLY-3 RATE (b)    |     8/43.59      7/45.98      9/48.21      6/45.36     |12/45.77     11/46.43     17/46.88     13/43.58     | 
|POLY-3 PERCENT (g) |     18.4%        15.2%        18.7%        13.2%       |26.2%        23.7%        36.3%        29.8%        | 
|TERMINAL (d)       |     7/30 (23%)   6/32 (19%)   5/35 (14%)   5/34 (15%)  |8/35 (23%)   8/36 (22%)   11/36 (31%)  12/35 (34%)  | 
|FIRST INCIDENCE    |     688          692          573          636         |609          612          445          617          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.278N     P=0.429N     P=0.556N     P=0.295N    |P=0.356      P=0.481N     P=0.224      P=0.492      | 
|POLY 3             |     P=0.342N     P=0.455N     P=0.590      P=0.355N    |P=0.294      P=0.484N     P=0.206      P=0.443      | 
|POLY 1.5           |     P=0.362N     P=0.476N     P=0.551      P=0.377N    |P=0.306      P=0.493N     P=0.196      P=0.451      | 
|POLY 6             |     P=0.314N     P=0.424N     P=0.568N     P=0.323N    |P=0.291      P=0.471N     P=0.224      P=0.444      | 
|LOGISTIC REGRESSION|     P=0.329N     P=0.376N     P=0.592      P=0.306N    |P=0.310      P=0.491N     P=0.187      P=0.451      | 
|COCH-ARM / FISHERS |     P=0.386N     P=0.500N     P=0.500      P=0.403N    |P=0.338      P=0.500N     P=0.189      P=0.477      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/50 (16%)   7/50 (14%)   9/50 (18%)   6/49 (12%)  |12/50 (24%)  11/50 (22%)  18/50 (36%)  13/49 (27%)  | 
|POLY-3 RATE (b)    |     8/43.59      7/45.98      9/48.21      6/45.36     |12/45.77     11/46.43     18/47.03     13/43.58     | 
|POLY-3 PERCENT (g) |     18.4%        15.2%        18.7%        13.2%       |26.2%        23.7%        38.3%        29.8%        | 
|TERMINAL (d)       |     7/30 (23%)   6/32 (19%)   5/35 (14%)   5/34 (15%)  |8/35 (23%)   8/36 (22%)   11/36 (31%)  12/35 (34%)  | 
|FIRST INCIDENCE    |     688          692          573          636         |609          612          445          617          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.278N     P=0.429N     P=0.556N     P=0.295N    |P=0.347      P=0.481N     P=0.174      P=0.492      | 
|POLY 3             |     P=0.342N     P=0.455N     P=0.590      P=0.355N    |P=0.283      P=0.484N     P=0.152      P=0.443      | 
|POLY 1.5           |     P=0.362N     P=0.476N     P=0.551      P=0.377N    |P=0.295      P=0.493N     P=0.144      P=0.451      | 
|POLY 6             |     P=0.314N     P=0.424N     P=0.568N     P=0.323N    |P=0.281      P=0.471N     P=0.170      P=0.444      | 
|LOGISTIC REGRESSION|     P=0.329N     P=0.376N     P=0.592      P=0.306N    |P=0.301      P=0.491N     P=0.136      P=0.451      | 
|COCH-ARM / FISHERS |     P=0.386N     P=0.500N     P=0.500      P=0.403N    |P=0.328      P=0.500N     P=0.138      P=0.477      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 10      
                     Statistical Analysis of Primary Tumors 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 Intermedia                                                                                                 | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    0/50 (0%)    2/49 (4%)   |1/50 (2%)    1/50 (2%)    1/50 (2%)    0/49 (0%)    | 
|POLY-3 RATE (b)    |     1/43.76      1/45.85      0/47.40      2/45.05     |1/45.20      1/45.77      1/45.17      0/43.18      | 
|POLY-3 PERCENT (g) |     2.3%         2.2%         0.0%         4.4%        |2.2%         2.2%         2.2%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    1/32 (3%)    0/35 (0%)    1/34 (3%)   |1/35 (3%)    0/36 (0%)    1/36 (3%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     639          726 (T)      ---          723         |732 (T)      687          732 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.395      P=0.741N     P=0.478N     P=0.537     |P=0.308N     P=0.749N     P=0.756N     P=0.500N     | 
|POLY 3             |     P=0.371      P=0.750N     P=0.484N     P=0.510     |P=0.323N     P=0.758N     P=0.760      P=0.509N     | 
|POLY 1.5           |     P=0.366      P=0.755N     P=0.491N     P=0.502     |P=0.322N     P=0.759N     P=0.760      P=0.508N     | 
|POLY 6             |     P=0.377      P=0.743N     P=0.475N     P=0.522     |P=0.322N     P=0.755N     P=0.759N     P=0.508N     | 
|LOGISTIC REGRESSION|     P=0.363      P=0.755      P=0.617N     P=0.495     |P=0.321N     P=0.762N     P=0.756N     (e)          | 
|COCH-ARM / FISHERS |     P=0.360      P=0.753N     P=0.500N     P=0.492     |P=0.316N     P=0.753N     P=0.753N     P=0.505N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Basal Cell Adenoma                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/43.44      2/45.85      1/47.40      0/45.40     |0/45.20      0/45.60      1/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     0.0%         4.4%         2.1%         0.0%        |0.0%         0.0%         2.2%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    2/32 (6%)    1/35 (3%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    1/36 (3%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     ---          726 (T)      726 (T)      ---         |---          ---          732 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.429N     P=0.252      P=0.531      (e)         |P=0.697      (e)          P=0.506      (e)          | 
|POLY 3             |     P=0.440N     P=0.249      P=0.517      (e)         |P=0.683      (e)          P=0.500      (e)          | 
|POLY 1.5           |     P=0.450N     P=0.244      P=0.510      (e)         |P=0.686      (e)          P=0.499      (e)          | 
|POLY 6             |     P=0.425N     P=0.258      P=0.528      (e)         |P=0.684      (e)          P=0.502      (e)          | 
|LOGISTIC REGRESSION|     (e)          P=0.252      P=0.531      (e)         |(e)          (e)          P=0.506      (e)          | 
|COCH-ARM / FISHERS |     P=0.461N     P=0.247      P=0.500      (e)         |P=0.694      (e)          P=0.500      (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 11      
                     Statistical Analysis of Primary Tumors 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                                                                                                                             | 
|     Basal Cell Adenoma, Basosquamous Tumor Benign, or                                                                           | 
|     Trichoepithelioma                                                                                                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    3/50 (6%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/43.44      3/45.85      1/47.40      0/45.40     |0/45.20      0/45.60      1/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     2.3%         6.5%         2.1%         0.0%        |0.0%         0.0%         2.2%         0.0%         | 
|TERMINAL (d)       |     1/30 (3%)    3/32 (9%)    1/35 (3%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    1/36 (3%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     726 (T)      726 (T)      726 (T)      ---         |---          ---          732 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.170N     P=0.327      P=0.727N     P=0.475N    |P=0.697      (e)          P=0.506      (e)          | 
|POLY 3             |     P=0.184N     P=0.325      P=0.741N     P=0.491N    |P=0.683      (e)          P=0.500      (e)          | 
|POLY 1.5           |     P=0.191N     P=0.316      P=0.749N     P=0.495N    |P=0.686      (e)          P=0.499      (e)          | 
|POLY 6             |     P=0.174N     P=0.338      P=0.729N     P=0.484N    |P=0.684      (e)          P=0.502      (e)          | 
|LOGISTIC REGRESSION|     P=0.170N     P=0.327      P=0.727N     (e)         |(e)          (e)          P=0.506      (e)          | 
|COCH-ARM / FISHERS |     P=0.200N     P=0.309      P=0.753N     P=0.500N    |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                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous                                                                      | 
|     Tumor (benign, malignant or NOS), or Trichoepithelioma                                                                      | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    4/50 (8%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/43.44      4/45.89      1/47.40      0/45.40     |0/45.20      0/45.60      1/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     2.3%         8.7%         2.1%         0.0%        |0.0%         0.0%         2.2%         0.0%         | 
|TERMINAL (d)       |     1/30 (3%)    3/32 (9%)    1/35 (3%)    0/34 (0%)   |0/35 (0%)    0/36 (0%)    1/36 (3%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     726 (T)      716          726 (T)      ---         |---          ---          732 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.135N     P=0.206      P=0.727N     P=0.475N    |P=0.697      (e)          P=0.506      (e)          | 
|POLY 3             |     P=0.145N     P=0.195      P=0.741N     P=0.491N    |P=0.683      (e)          P=0.500      (e)          | 
|POLY 1.5           |     P=0.153N     P=0.188      P=0.749N     P=0.495N    |P=0.686      (e)          P=0.499      (e)          | 
|POLY 6             |     P=0.135N     P=0.207      P=0.729N     P=0.484N    |P=0.684      (e)          P=0.502      (e)          | 
|LOGISTIC REGRESSION|     P=0.128N     P=0.224      P=0.727N     (e)         |(e)          (e)          P=0.506      (e)          | 
|COCH-ARM / FISHERS |     P=0.163N     P=0.181      P=0.753N     P=0.500N    |P=0.694      (e)          P=0.500      (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 12      
                     Statistical Analysis of Primary Tumors 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                                                                                                                             | 
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor                                                                       | 
|     (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/50 (14%)   7/50 (14%)   7/50 (14%)   4/50 (8%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     7/44.42      7/45.89      7/47.62      4/45.53     |0/45.20      0/45.60      1/45.17      2/44.35      | 
|POLY-3 PERCENT (g) |     15.8%        15.3%        14.7%        8.8%        |0.0%         0.0%         2.2%         4.5%         | 
|TERMINAL (d)       |     5/30 (17%)   6/32 (19%)   5/35 (14%)   3/34 (9%)   |0/35 (0%)    0/36 (0%)    1/36 (3%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     505          716          688          695         |---          ---          732 (T)      687          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.145N     P=0.558N     P=0.487N     P=0.204N    |P=0.074      (e)          P=0.506      P=0.251      | 
|POLY 3             |     P=0.190N     P=0.589N     P=0.559N     P=0.246N    |P=0.067      (e)          P=0.500      P=0.233      | 
|POLY 1.5           |     P=0.197N     P=0.600N     P=0.583N     P=0.255N    |P=0.068      (e)          P=0.499      P=0.233      | 
|POLY 6             |     P=0.177N     P=0.569N     P=0.524N     P=0.231N    |P=0.068      (e)          P=0.502      P=0.235      | 
|LOGISTIC REGRESSION|     P=0.180N     P=0.584N     P=0.613N     P=0.257N    |P=0.067      (e)          P=0.506      P=0.234      | 
|COCH-ARM / FISHERS |     P=0.203N     P=0.613N     P=0.613N     P=0.262N    |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                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    3/50 (6%)    2/50 (4%)    2/50 (4%)   |0/50 (0%)    1/50 (2%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     1/43.85      3/45.87      2/47.40      2/45.53     |0/45.20      1/45.60      1/45.17      1/44.18      | 
|POLY-3 PERCENT (g) |     2.3%         6.5%         4.2%         4.4%        |0.0%         2.2%         2.2%         2.3%         | 
|TERMINAL (d)       |     0/30 (0%)    2/32 (6%)    2/35 (6%)    1/34 (3%)   |0/35 (0%)    1/36 (3%)    1/36 (3%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     610          720          726 (T)      695         |---          732 (T)      732 (T)      732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.551      P=0.334      P=0.543      P=0.540     |P=0.389      P=0.506      P=0.506      P=0.506      | 
|POLY 3             |     P=0.520      P=0.321      P=0.527      P=0.513     |P=0.375      P=0.502      P=0.500      P=0.495      | 
|POLY 1.5           |     P=0.510      P=0.314      P=0.516      P=0.507     |P=0.377      P=0.501      P=0.499      P=0.496      | 
|POLY 6             |     P=0.535      P=0.333      P=0.543      P=0.524     |P=0.377      P=0.503      P=0.502      P=0.497      | 
|LOGISTIC REGRESSION|     P=0.511      P=0.305      P=0.460      P=0.489     |(e)          P=0.506      P=0.506      P=0.506      | 
|COCH-ARM / FISHERS |     P=0.500      P=0.309      P=0.500      P=0.500     |P=0.384      P=0.500      P=0.500      P=0.500      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 13      
                     Statistical Analysis of Primary Tumors 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                                                                                                                             | 
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        | 
|     or Fibrous Histiocytoma                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    6/50 (12%)   3/50 (6%)    4/50 (8%)   |0/50 (0%)    1/50 (2%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     4/44.05      6/46.09      3/47.43      4/46.16     |0/45.20      1/45.60      1/45.17      1/44.18      | 
|POLY-3 PERCENT (g) |     9.1%         13.0%        6.3%         8.7%        |0.0%         2.2%         2.2%         2.3%         | 
|TERMINAL (d)       |     2/30 (7%)    3/32 (9%)    2/35 (6%)    2/34 (6%)   |0/35 (0%)    1/36 (3%)    1/36 (3%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     610          688          720          520         |---          732 (T)      732 (T)      732 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.378N     P=0.438      P=0.414N     P=0.581N    |P=0.389      P=0.506      P=0.506      P=0.506      | 
|POLY 3             |     P=0.421N     P=0.398      P=0.460N     P=0.617N    |P=0.375      P=0.502      P=0.500      P=0.495      | 
|POLY 1.5           |     P=0.434N     P=0.385      P=0.477N     P=0.629N    |P=0.377      P=0.501      P=0.499      P=0.496      | 
|POLY 6             |     P=0.404N     P=0.418      P=0.437N     P=0.599N    |P=0.377      P=0.503      P=0.502      P=0.497      | 
|LOGISTIC REGRESSION|     P=0.451N     P=0.393      P=0.492N     P=0.626     |(e)          P=0.506      P=0.506      P=0.506      | 
|COCH-ARM / FISHERS |     P=0.449N     P=0.370      P=0.500N     P=0.643N    |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                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibrosarcoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    1/50 (2%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/43.44      1/45.91      1/47.43      1/45.40     |0/45.20      0/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     4.6%         2.2%         2.1%         2.2%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/30 (7%)    0/32 (0%)    0/35 (0%)    1/34 (3%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     726 (T)      709          720          726 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.364N     P=0.465N     P=0.434N     P=0.456N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.404N     P=0.481N     P=0.469N     P=0.485N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.406N     P=0.490N     P=0.483N     P=0.492N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.400N     P=0.467N     P=0.451N     P=0.472N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.371N     P=0.451N     P=0.415N     P=0.456N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.409N     P=0.500N     P=0.500N     P=0.500N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 14      
                     Statistical Analysis of Primary Tumors 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                                                                                                                             | 
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    3/50 (6%)    1/50 (2%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     3/43.64      3/46.06      1/47.43      2/46.04     |0/45.20      0/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     6.9%         6.5%         2.1%         4.3%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/30 (7%)    1/32 (3%)    0/35 (0%)    1/34 (3%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     674          688          720          520         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.297N     P=0.603N     P=0.243N     P=0.453N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.328N     P=0.637N     P=0.276N     P=0.476N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.335N     P=0.649N     P=0.289N     P=0.487N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.319N     P=0.620N     P=0.260N     P=0.459N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.353N     P=0.634N     P=0.262N     P=0.516N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.343N     P=0.661N     P=0.309N     P=0.500N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Keratoacanthoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/50 (10%)   3/50 (6%)    5/50 (10%)   4/50 (8%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     5/44.42      3/45.85      5/47.62      4/45.53     |0/45.20      0/45.60      0/45.17      2/44.35      | 
|POLY-3 PERCENT (g) |     11.3%        6.5%         10.5%        8.8%        |0.0%         0.0%         0.0%         4.5%         | 
|TERMINAL (d)       |     3/30 (10%)   3/32 (9%)    3/35 (9%)    3/34 (9%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     505          726 (T)      688          695         |---          ---          ---          687          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.446N     P=0.324N     P=0.525N     P=0.432N    |P=0.049 *    (e)          (e)          P=0.251      | 
|POLY 3             |     P=0.506N     P=0.339N     P=0.586N     P=0.485N    |P=0.044 *    (e)          (e)          P=0.233      | 
|POLY 1.5           |     P=0.512N     P=0.348N     P=0.605N     P=0.493N    |P=0.045 *    (e)          (e)          P=0.233      | 
|POLY 6             |     P=0.496N     P=0.325N     P=0.558N     P=0.469N    |P=0.045 *    (e)          (e)          P=0.235      | 
|LOGISTIC REGRESSION|     P=0.511N     P=0.369N     P=0.577      P=0.507N    |P=0.045 *    (e)          (e)          P=0.234      | 
|COCH-ARM / FISHERS |     P=0.517N     P=0.357N     P=0.630N     P=0.500N    |P=0.046 *    (e)          (e)          P=0.247      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 15      
                     Statistical Analysis of Primary Tumors 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                                                                                                                             | 
|     Lipoma                                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/43.44      1/45.85      0/47.40      0/45.40     |2/45.68      0/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         0.0%         0.0%        |4.4%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    1/32 (3%)    0/35 (0%)    0/34 (0%)   |1/35 (3%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     ---          726 (T)      ---          ---         |588          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.549N     P=0.513      (e)          (e)         |P=0.118N     P=0.239N     P=0.241N     P=0.244N     | 
|POLY 3             |     P=0.554N     P=0.511      (e)          (e)         |P=0.113N     P=0.238N     P=0.240N     P=0.245N     | 
|POLY 1.5           |     P=0.560N     P=0.506      (e)          (e)         |P=0.113N     P=0.238N     P=0.239N     P=0.243N     | 
|POLY 6             |     P=0.546N     P=0.518      (e)          (e)         |P=0.113N     P=0.237N     P=0.239N     P=0.245N     | 
|LOGISTIC REGRESSION|     (e)          P=0.513      (e)          (e)         |P=0.101N     P=0.226N     P=0.217N     P=0.207N     | 
|COCH-ARM / FISHERS |     P=0.567N     P=0.500      (e)          (e)         |P=0.115N     P=0.247N     P=0.247N     P=0.247N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma, Papilloma, Squamous Cell                                                                           | 
|     Carcinoma or Keratoacanthoma                                                                                                | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/50 (12%)   3/50 (6%)    6/50 (12%)   4/50 (8%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     6/44.42      3/45.85      6/47.62      4/45.53     |0/45.20      0/45.60      0/45.17      2/44.35      | 
|POLY-3 PERCENT (g) |     13.5%        6.5%         12.6%        8.8%        |0.0%         0.0%         0.0%         4.5%         | 
|TERMINAL (d)       |     4/30 (13%)   3/32 (9%)    4/35 (11%)   3/34 (9%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     505          726 (T)      688          695         |---          ---          ---          687          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.347N     P=0.214N     P=0.505N     P=0.305N    |P=0.049 *    (e)          (e)          P=0.251      | 
|POLY 3             |     P=0.409N     P=0.226N     P=0.571N     P=0.354N    |P=0.044 *    (e)          (e)          P=0.233      | 
|POLY 1.5           |     P=0.415N     P=0.234N     P=0.593N     P=0.363N    |P=0.045 *    (e)          (e)          P=0.233      | 
|POLY 6             |     P=0.398N     P=0.213N     P=0.539N     P=0.338N    |P=0.045 *    (e)          (e)          P=0.235      | 
|LOGISTIC REGRESSION|     P=0.407N     P=0.246N     P=0.600      P=0.370N    |P=0.045 *    (e)          (e)          P=0.234      | 
|COCH-ARM / FISHERS |     P=0.419N     P=0.243N     P=0.620N     P=0.370N    |P=0.046 *    (e)          (e)          P=0.247      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 16      
                     Statistical Analysis of Primary Tumors 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                                                                                                                             | 
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/50 (12%)   3/50 (6%)    6/50 (12%)   4/50 (8%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     6/44.42      3/45.85      6/47.62      4/45.53     |0/45.20      0/45.60      0/45.17      2/44.35      | 
|POLY-3 PERCENT (g) |     13.5%        6.5%         12.6%        8.8%        |0.0%         0.0%         0.0%         4.5%         | 
|TERMINAL (d)       |     4/30 (13%)   3/32 (9%)    4/35 (11%)   3/34 (9%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    1/36 (3%)    | 
|FIRST INCIDENCE    |     505          726 (T)      688          695         |---          ---          ---          687          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.347N     P=0.214N     P=0.505N     P=0.305N    |P=0.049 *    (e)          (e)          P=0.251      | 
|POLY 3             |     P=0.409N     P=0.226N     P=0.571N     P=0.354N    |P=0.044 *    (e)          (e)          P=0.233      | 
|POLY 1.5           |     P=0.415N     P=0.234N     P=0.593N     P=0.363N    |P=0.045 *    (e)          (e)          P=0.233      | 
|POLY 6             |     P=0.398N     P=0.213N     P=0.539N     P=0.338N    |P=0.045 *    (e)          (e)          P=0.235      | 
|LOGISTIC REGRESSION|     P=0.407N     P=0.246N     P=0.600      P=0.370N    |P=0.045 *    (e)          (e)          P=0.234      | 
|COCH-ARM / FISHERS |     P=0.419N     P=0.243N     P=0.620N     P=0.370N    |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                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     49/50 (98%)  49/50 (98%)  45/50 (90%)  47/50 (94%) |                                                    | 
|POLY-3 RATE (b)    |     49/49.24     49/49.68     45/49.09     47/48.99    |                                                    | 
|POLY-3 PERCENT (g) |     99.5%        98.6%        91.7%        95.9%       |                                                    | 
|TERMINAL (d)       |     30/30 (100%) 32/32 (100%) 34/35 (97%)  34/34 (100%)|                                                    | 
|FIRST INCIDENCE    |     505          478          600          520         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.078N     P=0.297N     P=0.028N*    P=0.126N    |                                                    | 
|POLY 3             |     P=0.149N     P=0.779N     P=0.060N     P=0.283N    |                                                    | 
|POLY 1.5           |     P=0.154N     P=0.755N     P=0.069N     P=0.287N    |                                                    | 
|POLY 6             |     P=0.144N     P=0.896N     P=0.068N     P=0.293N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.135N     P=0.723N     P=0.013N*    P=0.260N    |                                                    | 
|COCH-ARM / FISHERS |     P=0.162N     P=0.753N     P=0.102N     P=0.309N    |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 17      
                     Statistical Analysis of Primary Tumors 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: C-Cell                                                                                                            | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/50 (14%)   9/50 (18%)   10/50 (20%)  10/50 (20%) |8/50 (16%)   9/50 (18%)   9/50 (18%)   11/50 (22%)  | 
|POLY-3 RATE (b)    |     7/43.44      9/45.91      10/48.40     10/45.95    |8/45.25      9/46.05      9/45.51      11/44.77     | 
|POLY-3 PERCENT (g) |     16.1%        19.6%        20.7%        21.8%       |17.7%        19.6%        19.8%        24.6%        | 
|TERMINAL (d)       |     7/30 (23%)   8/32 (25%)   4/35 (11%)   6/34 (18%)  |7/35 (20%)   6/36 (17%)   8/36 (22%)   7/36 (19%)   | 
|FIRST INCIDENCE    |     726 (T)      709          573          636         |719          659          638          687          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.377      P=0.452      P=0.444      P=0.410     |P=0.277      P=0.518      P=0.526      P=0.331      | 
|POLY 3             |     P=0.310      P=0.439      P=0.386      P=0.341     |P=0.244      P=0.516      P=0.505      P=0.294      | 
|POLY 1.5           |     P=0.290      P=0.418      P=0.347      P=0.319     |P=0.246      P=0.507      P=0.500      P=0.293      | 
|POLY 6             |     P=0.345      P=0.473      P=0.445      P=0.379     |P=0.254      P=0.531      P=0.519      P=0.307      | 
|LOGISTIC REGRESSION|     P=0.310      P=0.515      P=0.369      P=0.386     |P=0.238      P=0.519      P=0.517      P=0.291      | 
|COCH-ARM / FISHERS |     P=0.267      P=0.393      P=0.298      P=0.298     |P=0.259      P=0.500      P=0.500      P=0.306      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    2/50 (4%)    1/50 (2%)   |0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/43.44      0/45.85      2/47.40      1/45.40     |0/45.20      2/45.70      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     4.6%         0.0%         4.2%         2.2%        |0.0%         4.4%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/30 (7%)    0/32 (0%)    2/35 (6%)    1/34 (3%)   |0/35 (0%)    1/36 (3%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     726 (T)      ---          726 (T)      726 (T)     |---          708          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.490N     P=0.224N     P=0.639N     P=0.456N    |P=0.406N     P=0.246      (e)          (e)          | 
|POLY 3             |     P=0.528N     P=0.225N     P=0.662N     P=0.485N    |P=0.406N     P=0.240      (e)          (e)          | 
|POLY 1.5           |     P=0.529N     P=0.231N     P=0.676N     P=0.492N    |P=0.407N     P=0.238      (e)          (e)          | 
|POLY 6             |     P=0.526N     P=0.217N     P=0.643N     P=0.472N    |P=0.403N     P=0.242      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.490N     (e)          P=0.639N     P=0.456N    |P=0.409N     P=0.241      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.531N     P=0.247N     P=0.691N     P=0.500N    |P=0.405N     P=0.247      (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 18      
                     Statistical Analysis of Primary Tumors 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: C-Cell                                                                                                            | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     9/50 (18%)   9/50 (18%)   12/50 (24%)  11/50 (22%) |8/50 (16%)   11/50 (22%)  9/50 (18%)   11/50 (22%)  | 
|POLY-3 RATE (b)    |     9/43.44      9/45.91      12/48.40     11/45.95    |8/45.25      11/46.14     9/45.51      11/44.77     | 
|POLY-3 PERCENT (g) |     20.7%        19.6%        24.8%        23.9%       |17.7%        23.8%        19.8%        24.6%        | 
|TERMINAL (d)       |     9/30 (30%)   8/32 (25%)   6/35 (17%)   7/34 (21%)  |7/35 (20%)   7/36 (19%)   8/36 (22%)   7/36 (19%)   | 
|FIRST INCIDENCE    |     726 (T)      709          573          636         |719          659          638          687          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.431      P=0.539N     P=0.478      P=0.532     |P=0.344      P=0.329      P=0.526      P=0.331      | 
|POLY 3             |     P=0.354      P=0.553N     P=0.415      P=0.456     |P=0.309      P=0.320      P=0.505      P=0.294      | 
|POLY 1.5           |     P=0.331      P=0.576N     P=0.369      P=0.429     |P=0.310      P=0.312      P=0.500      P=0.293      | 
|POLY 6             |     P=0.391      P=0.516N     P=0.483      P=0.501     |P=0.321      P=0.335      P=0.519      P=0.307      | 
|LOGISTIC REGRESSION|     P=0.366      P=0.472N     P=0.428      P=0.521     |P=0.302      P=0.320      P=0.517      P=0.291      | 
|COCH-ARM / FISHERS |     P=0.307      P=0.602N     P=0.312      P=0.402     |P=0.326      P=0.306      P=0.500      P=0.306      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    0/50 (0%)    2/50 (4%)    0/50 (0%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     3/44.26      0/45.85      2/47.40      0/45.40     |0/45.20      1/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     6.8%         0.0%         4.2%         0.0%        |0.0%         2.2%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/30 (3%)    0/32 (0%)    2/35 (6%)    0/34 (0%)   |0/35 (0%)    1/36 (3%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     450          ---          726 (T)      ---         |---          732 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.110N     P=0.113N     P=0.436N     P=0.109N    |P=0.564N     P=0.506      (e)          (e)          | 
|POLY 3             |     P=0.124N     P=0.112N     P=0.469N     P=0.114N    |P=0.567N     P=0.502      (e)          (e)          | 
|POLY 1.5           |     P=0.125N     P=0.116N     P=0.483N     P=0.117N    |P=0.567N     P=0.501      (e)          (e)          | 
|POLY 6             |     P=0.124N     P=0.107N     P=0.448N     P=0.109N    |P=0.565N     P=0.503      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.138N     P=0.146N     P=0.633N     P=0.125N    |(e)          P=0.506      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.126N     P=0.121N     P=0.500N     P=0.121N    |P=0.567N     P=0.500      (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 19      
                     Statistical Analysis of Primary Tumors 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                                                                                                   | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/43.83      0/45.85      0/47.40      2/45.40     |0/45.20      0/45.60      1/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     2.3%         0.0%         0.0%         4.4%        |0.0%         0.0%         2.2%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/35 (0%)    2/34 (6%)   |0/35 (0%)    0/36 (0%)    1/36 (3%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     617          ---          ---          726 (T)     |---          ---          732 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.265      P=0.482N     P=0.478N     P=0.537     |P=0.697      (e)          P=0.506      (e)          | 
|POLY 3             |     P=0.246      P=0.491N     P=0.484N     P=0.512     |P=0.683      (e)          P=0.500      (e)          | 
|POLY 1.5           |     P=0.246      P=0.495N     P=0.491N     P=0.506     |P=0.686      (e)          P=0.499      (e)          | 
|POLY 6             |     P=0.247      P=0.485N     P=0.475N     P=0.522     |P=0.684      (e)          P=0.502      (e)          | 
|LOGISTIC REGRESSION|     P=0.243      P=0.538N     P=0.664N     P=0.497     |(e)          (e)          P=0.506      (e)          | 
|COCH-ARM / FISHERS |     P=0.246      P=0.500N     P=0.500N     P=0.500     |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                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    0/50 (0%)    2/50 (4%)    2/50 (4%)   |0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     4/44.65      0/45.85      2/47.40      2/45.40     |0/45.20      1/45.60      1/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     9.0%         0.0%         4.2%         4.4%        |0.0%         2.2%         2.2%         0.0%         | 
|TERMINAL (d)       |     1/30 (3%)    0/32 (0%)    2/35 (6%)    2/34 (6%)   |0/35 (0%)    1/36 (3%)    1/36 (3%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     450          ---          726 (T)      726 (T)     |---          732 (T)      732 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.365N     P=0.058N     P=0.280N     P=0.298N    |P=0.590N     P=0.506      P=0.506      (e)          | 
|POLY 3             |     P=0.404N     P=0.057N     P=0.310N     P=0.329N    |P=0.600N     P=0.502      P=0.500      (e)          | 
|POLY 1.5           |     P=0.404N     P=0.059N     P=0.322N     P=0.334N    |P=0.599N     P=0.501      P=0.499      (e)          | 
|POLY 6             |     P=0.403N     P=0.054N     P=0.293N     P=0.319N    |P=0.598N     P=0.503      P=0.502      (e)          | 
|LOGISTIC REGRESSION|     P=0.421N     P=0.080N     P=0.508N     P=0.359N    |(e)          P=0.506      P=0.506      (e)          | 
|COCH-ARM / FISHERS |     P=0.404N     P=0.059N     P=0.339N     P=0.339N    |P=0.595N     P=0.500      P=0.500      (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 20      
                     Statistical Analysis of Primary Tumors 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                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Polyp Stromal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |14/50 (28%)  8/50 (16%)   8/50 (16%)   10/50 (20%)  | 
|POLY-3 RATE (b)    |                                                        |14/45.92     8/46.10      8/45.48      10/44.89     | 
|POLY-3 PERCENT (g) |                                                        |30.5%        17.4%        17.6%        22.3%        | 
|TERMINAL (d)       |                                                        |12/35 (34%)  6/36 (17%)   7/36 (19%)   7/36 (19%)   | 
|FIRST INCIDENCE    |                                                        |508          612          649          588          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.267N     P=0.108N     P=0.102N     P=0.233N     | 
|POLY 3             |                                                        |P=0.292N     P=0.107N     P=0.114N     P=0.258N     | 
|POLY 1.5           |                                                        |P=0.289N     P=0.111N     P=0.116N     P=0.257N     | 
|POLY 6             |                                                        |P=0.285N     P=0.100N     P=0.107N     P=0.246N     | 
|LOGISTIC REGRESSION|                                                        |P=0.294N     P=0.109N     P=0.111N     P=0.258N     | 
|COCH-ARM / FISHERS |                                                        |P=0.275N     P=0.114N     P=0.114N     P=0.241N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or                                                                           | 
|     Undifferentiated                                                                                                            | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     33/50 (66%)  39/50 (78%)  32/50 (64%)  29/50 (58%) |14/50 (28%)  22/50 (44%)  14/50 (28%)  15/50 (30%)  | 
|POLY-3 RATE (b)    |     33/48.54     39/49.03     32/48.86     29/47.51    |14/48.56     22/48.95     14/47.07     15/47.23     | 
|POLY-3 PERCENT (g) |     68.0%        79.5%        65.5%        61.0%       |28.8%        45.0%        29.7%        31.8%        | 
|TERMINAL (d)       |     16/30 (53%)  26/32 (81%)  21/35 (60%)  18/34 (53%) |5/35 (14%)   13/36 (36%)  8/36 (22%)   7/36 (19%)   | 
|FIRST INCIDENCE    |     450          478          600          596         |508          400          504          386          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.060N     P=0.390      P=0.210N     P=0.162N    |P=0.399N     P=0.122      P=0.556N     P=0.506      | 
|POLY 3             |     P=0.121N     P=0.139      P=0.482N     P=0.308N    |P=0.438N     P=0.073      P=0.550      P=0.464      | 
|POLY 1.5           |     P=0.113N     P=0.136      P=0.487N     P=0.295N    |P=0.419N     P=0.073      P=0.562      P=0.478      | 
|POLY 6             |     P=0.128N     P=0.140      P=0.482N     P=0.318N    |P=0.454N     P=0.074      P=0.542      P=0.452      | 
|LOGISTIC REGRESSION|     P=0.095N     P=0.116      P=0.561N     P=0.266N    |P=0.305N     P=0.043 *    P=0.569N     P=0.591N     | 
|COCH-ARM / FISHERS |     P=0.098N     P=0.133      P=0.500N     P=0.268N    |P=0.389N     P=0.072      P=0.588N     P=0.500      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 21      
                     Statistical Analysis of Primary Tumors 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                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Mesothelioma: Benign, Malignant, NOS                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    4/50 (8%)    4/50 (8%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/43.91      4/46.05      4/47.53      2/45.57     |0/45.20      0/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     4.6%         8.7%         8.4%         4.4%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    3/32 (9%)    2/35 (6%)    1/34 (3%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     610          674          709          684         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.439N     P=0.379      P=0.433      P=0.650N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.479N     P=0.359      P=0.375      P=0.681N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.489N     P=0.349      P=0.359      P=0.687N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.462N     P=0.375      P=0.397      P=0.670N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.491N     P=0.338      P=0.331      P=0.688     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.500N     P=0.339      P=0.339      P=0.691N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Mesothelioma: Malignant                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    4/50 (8%)    4/50 (8%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/43.91      4/46.05      4/47.53      2/45.57     |0/45.20      0/45.60      0/45.17      0/44.18      | 
|POLY-3 PERCENT (g) |     4.6%         8.7%         8.4%         4.4%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    3/32 (9%)    2/35 (6%)    1/34 (3%)   |0/35 (0%)    0/36 (0%)    0/36 (0%)    0/36 (0%)    | 
|FIRST INCIDENCE    |     610          674          709          684         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.439N     P=0.379      P=0.433      P=0.650N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.479N     P=0.359      P=0.375      P=0.681N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.489N     P=0.349      P=0.359      P=0.687N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.462N     P=0.375      P=0.397      P=0.670N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.491N     P=0.338      P=0.331      P=0.688     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.500N     P=0.339      P=0.339      P=0.691N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 22      
                     Statistical Analysis of Primary Tumors 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                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     50/50 (100%) 50/50 (100%) 48/50 (96%)  48/50 (96%) |37/50 (74%)  39/50 (78%)  37/50 (74%)  38/50 (76%)  | 
|POLY-3 RATE (b)    |     50/50.00     50/50.00     48/49.98     48/49.00    |37/46.97     39/48.01     37/47.68     38/46.98     | 
|POLY-3 PERCENT (g) |     100.0%       100.0%       96.0%        98.0%       |78.8%        81.2%        77.6%        80.9%        | 
|TERMINAL (d)       |     30/30 (100%) 32/32 (100%) 34/35 (97%)  34/34 (100%)|30/35 (86%)  30/36 (83%)  28/36 (78%)  28/36 (78%)  | 
|FIRST INCIDENCE    |     450          478          573          520         |508          582          445          491          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.092N     (e)          P=0.068N     P=0.131N    |P=0.525N     P=0.488      P=0.509N     P=0.548      | 
|POLY 3             |     P=0.226N     (e)          P=0.239N     P=0.495N    |P=0.490      P=0.482      P=0.546N     P=0.501      | 
|POLY 1.5           |     P=0.161N     (e)          P=0.238N     P=0.371N    |P=0.475      P=0.436      P=0.578N     P=0.475      | 
|POLY 6             |     P=0.299N     (e)          P=0.241N     P=0.647N    |P=0.538N     P=0.576      P=0.464N     P=0.597      | 
|LOGISTIC REGRESSION|     P=0.089N     (e)          P=0.292N     P=0.229N    |P=0.392      P=0.432      P=0.571      P=0.389      | 
|COCH-ARM / FISHERS |     P=0.086N     (e)          P=0.247N     P=0.247N    |P=0.511      P=0.408      P=0.590N     P=0.500      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     UNTREAT      1000 PPM     2000 PPM     4000 PPM    |UNTREAT      1000 PPM     2000 PPM     4000 PPM     | 
|                   |     CONTROL                                            |CONTROL                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     35/50 (70%)  41/50 (82%)  37/50 (74%)  33/50 (66%) |15/50 (30%)  26/50 (52%)  22/50 (44%)  17/50 (34%)  | 
|POLY-3 RATE (b)    |     35/48.93     41/49.10     37/49.42     33/48.98    |15/48.95     26/49.41     22/49.81     17/47.37     | 
|POLY-3 PERCENT (g) |     71.5%        83.5%        74.9%        67.4%       |30.6%        52.6%        44.2%        35.9%        | 
|TERMINAL (d)       |     17/30 (57%)  27/32 (84%)  24/35 (69%)  20/34 (59%) |5/35 (14%)   15/36 (42%)  10/36 (28%)  8/36 (22%)   | 
|FIRST INCIDENCE    |     450          478          600          397         |508          400          445          386          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.118N     P=0.403      P=0.337N     P=0.242N    |P=0.467N     P=0.057      P=0.166      P=0.431      | 
|POLY 3             |     P=0.198N     P=0.115      P=0.442      P=0.410N    |P=0.524N     P=0.020 *    P=0.118      P=0.371      | 
|POLY 1.5           |     P=0.201N     P=0.118      P=0.431      P=0.410N    |P=0.500N     P=0.020 *    P=0.113      P=0.388      | 
|POLY 6             |     P=0.199N     P=0.111      P=0.452      P=0.415N    |P=0.530      P=0.021 *    P=0.125      P=0.355      | 
|LOGISTIC REGRESSION|     P=0.227N     P=0.105      P=0.318      P=0.475N    |P=0.383N     P=0.008 **   P=0.048 *    P=0.496      | 
|COCH-ARM / FISHERS |     P=0.209N     P=0.121      P=0.412      P=0.415N    |P=0.461N     P=0.021 *    P=0.107      P=0.415      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  07/05/01                           EXPERIMENT: 56348 TEST: 03                                            Page 23      
                     Statistical Analysis of Primary Tumors 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                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     50/50 (100%) 50/50 (100%) 49/50 (98%)  50/50 (100%)|47/50 (94%)  47/50 (94%)  46/50 (92%)  43/50 (86%)  | 
|POLY-3 RATE (b)    |     50/50.00     50/50.00     49/50.00     50/50.00    |47/50.00     47/50.00     46/50.00     43/49.36     | 
|POLY-3 PERCENT (g) |     100.0%       100.0%       98.0%        100.0%      |94.0%        94.0%        92.0%        87.1%        | 
|TERMINAL (d)       |     30/30 (100%) 32/32 (100%) 34/35 (97%)  34/34 (100%)|32/35 (91%)  33/36 (92%)  32/36 (89%)  30/36 (83%)  | 
|FIRST INCIDENCE    |     450          478          573          397         |508          400          445          386          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.180N     (e)          P=0.093N     (e)         |P=0.230N     P=0.493N     P=0.432N     P=0.276N     | 
|POLY 3             |     P=0.694N     (e)          P=0.500N     (e)         |P=0.113N     P=0.662      P=0.500N     P=0.201N     | 
|POLY 1.5           |     P=0.694N     (e)          P=0.500N     (e)         |P=0.099N     P=0.662      P=0.500N     P=0.183N     | 
|POLY 6             |     P=0.694N     (e)          P=0.500N     (e)         |P=0.129N     P=0.662      P=0.500N     P=0.221N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.072N     (e)          (e)          P=0.151N     | 
|COCH-ARM / FISHERS |     P=0.694N     (e)          P=0.500N     (e)         |P=0.079N     P=0.661N     P=0.500N     P=0.159N     | 
|=================================================================================================================================| 
(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).