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TDMS Study 92012-05 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                2-METHYLIMIDAZOLE                                   DATE: 02/24/03       
EXPERIMENT: 92012 TEST: 05                                                                                     TIME: 14:27:17       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85420                              ROUTE: DOSED FEED                                              NTP C#: 92012B       
PATHOLOGIST: FARNELL, DANIEL R.                                                                                CAS: 693-98-1        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                           FINAL #1/RATS                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                2-METHYLIMIDAZOLE                                   DATE: 02/24/03       
EXPERIMENT: 92012 TEST: 05                                                                                     TIME: 14:27:17       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85420                              ROUTE: DOSED FEED                                              NTP C#: 92012B       
PATHOLOGIST: FARNELL, DANIEL R.                                                                                CAS: 693-98-1        
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                                                                    
                                                 Brain                                                                              
                                                 Clitoral/Preputial Gland                                                           
                                                 Islets, Pancreatic                                                                 
                                                 Kidney                                                                             
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Nose                                                                               
                                                 Ovary                                                                              
                                                 Pancreas                                                                           
                                                 Pituitary Gland                                                                    
                                                 Testes                                                                             
                                                 Thymus                                                                             
                                                 Thyroid Gland                                                                      
                                                 Urinary Bladder                                                                    
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                2-METHYLIMIDAZOLE                                   DATE: 02/24/03       
EXPERIMENT: 92012 TEST: 05                                                                                     TIME: 14:27:17       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85420                              ROUTE: DOSED FEED                                              NTP C#: 92012B       
PATHOLOGIST: FARNELL, DANIEL R.                                                                                CAS: 693-98-1        
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                   2-METHYLIMIDAZOLE                                                                              
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Bone                                   Osteoma                                                                                      
                                       Osteosarcoma                                                                                 
Clitoral/Preputial Gland               Carcinoma or Adenoma                                                                         
Islets, Pancreatic                     Adenoma                                                                                      
Mammary Gland                          Fibroadenoma                                                                                 
                                       Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                 
Skin                                   Basal Cell Carcinoma                                                                         
Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthom
a, Trichoepitheliom                                                                                                                 
Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous Tumor (malignant or NOS), or Carcinoma                                  
Testes                                 Adenoma                                                                                      
Thyroid Gland: C-Cell                  Carcinoma                                                                                    
Thyroid Gland: Follicular Cell         Carcinoma or Adenoma                                                                         
All Organs                             Osteoma                                                                                      
                                       Osteosarcoma                                                                                 
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Cortex                         Adenoma                                                                                      
Clitoral/Preputial Gland               Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
Islets, Pancreatic                     Carcinoma                                                                                    
Liver                                  Hepatocellular Adenoma                                                                       
                                       Hepatocellular Carcinoma or Hepatocellular Adenoma                                           
                                       Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                          
Mammary Gland                          Fibroadenoma                                                                                 
                                       Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                 
Pituitary Gland: Pars Distalis or Unspecified Site                                                                                  
                                       Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
Skin                                                                                                                                
Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, malignant or NOS), or Trichoepithelioma                       
Thyroid Gland: C-Cell                  Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
Thyroid Gland: Follicular Cell         Adenoma                                                                                      
                                       Carcinoma                                                                                    
                                       Carcinoma or Adenoma                                                                         
All Organs                             Benign Tumors                                                                                
                                       Malignant Tumors                                                                             
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 1       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)        -                    2-METHYLIMIDAZOLE      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |5/50 (10%)   0/49 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/46.13      1/45.93      0/44.49      0/43.91     |5/46.87      0/44.59      0/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         0.0%         0.0%        |10.7%        0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/35 (0%)    1/40 (3%)    0/36 (0%)    0/35 (0%)   |3/40 (8%)    0/39 (0%)    0/28 (0%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     ---          729 (T)      ---          ---         |588          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.586N     P=0.527      (e)          (e)         |P=0.015N*    P=0.039N*    P=0.065N     P=0.031N*    | 
|POLY 3             |     P=0.579N     P=0.499      (e)          (e)         |P=0.010N*    P=0.035N*    P=0.044N*    P=0.029N*    | 
|POLY 1.5           |     P=0.578N     P=0.500      (e)          (e)         |P=0.010N*    P=0.034N*    P=0.038N*    P=0.029N*    | 
|POLY 6             |     P=0.579N     P=0.499      (e)          (e)         |P=0.010N*    P=0.036N*    P=0.053N     P=0.028N*    | 
|LOGISTIC REGRESSION|     (e)          P=0.527      (e)          (e)         |P=0.011N*    P=0.033N*    P=0.028N*    P=0.040N*    | 
|COCH-ARM / FISHERS |     P=0.576N     P=0.500      (e)          (e)         |P=0.012N*    P=0.030N*    P=0.028N*    P=0.028N*    | 
|ORDER RESTRICTED   |     P=0.389N     (e)          (e)          (e)         |P<0.001N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Benign                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/50 (16%)   3/50 (6%)    6/50 (12%)   6/50 (12%)  |0/49 (0%)    2/49 (4%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     8/46.55      3/45.93      6/44.98      6/44.15     |0/45.00      2/44.59      0/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     17.2%        6.5%         13.3%        13.6%       |0.0%         4.5%         0.0%         0.0%         | 
|TERMINAL (d)       |     5/35 (14%)   3/40 (8%)    5/36 (14%)   4/35 (11%)  |0/39 (0%)    2/39 (5%)    0/28 (0%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     689          729 (T)      583          689         |---          729 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.515      P=0.079N     P=0.382N     P=0.407N    |P=0.351N     P=0.238      (e)          (e)          | 
|POLY 3             |     P=0.526      P=0.102N     P=0.413N     P=0.428N    |P=0.350N     P=0.235      (e)          (e)          | 
|POLY 1.5           |     P=0.537      P=0.101N     P=0.403N     P=0.414N    |P=0.350N     P=0.236      (e)          (e)          | 
|POLY 6             |     P=0.517      P=0.104N     P=0.421N     P=0.441N    |P=0.349N     P=0.235      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.522      P=0.101N     P=0.407N     P=0.430N    |(e)          P=0.238      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.562      P=0.100N     P=0.387N     P=0.387N    |P=0.348N     P=0.247      (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.304N     (e)          (e)          (e)         |P=0.233N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 2       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Malignant                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    3/50 (6%)    1/50 (2%)   |0/49 (0%)    0/49 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/46.13      1/45.93      3/44.49      1/43.91     |0/45.00      0/44.59      1/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         6.7%         2.3%        |0.0%         0.0%         2.5%         0.0%         | 
|TERMINAL (d)       |     0/35 (0%)    1/40 (3%)    3/36 (8%)    1/35 (3%)   |0/39 (0%)    0/39 (0%)    1/28 (4%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     ---          729 (T)      729 (T)      729 (T)     |---          ---          729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.491      P=0.527      P=0.126      P=0.500     |P=0.677      (e)          P=0.434      (e)          | 
|POLY 3             |     P=0.483      P=0.499      P=0.112      P=0.490     |P=0.709      (e)          P=0.480      (e)          | 
|POLY 1.5           |     P=0.492      P=0.500      P=0.115      P=0.493     |P=0.699      (e)          P=0.490      (e)          | 
|POLY 6             |     P=0.475      P=0.499      P=0.111      P=0.487     |P=0.720      (e)          P=0.469      (e)          | 
|LOGISTIC REGRESSION|     (e)          P=0.527      P=0.126      P=0.500     |(e)          (e)          P=0.434      (e)          | 
|COCH-ARM / FISHERS |     P=0.512      P=0.500      P=0.121      P=0.500     |P=0.682      (e)          P=0.505      (e)          | 
|ORDER RESTRICTED   |     P=0.148      (e)          (e)          (e)         |P=0.364      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/50 (16%)   4/50 (8%)    9/50 (18%)   7/50 (14%)  |0/49 (0%)    2/49 (4%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     8/46.55      4/45.93      9/44.98      7/44.15     |0/45.00      2/44.59      1/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     17.2%        8.7%         20.0%        15.9%       |0.0%         4.5%         2.5%         0.0%         | 
|TERMINAL (d)       |     5/35 (14%)   4/40 (10%)   8/36 (22%)   5/35 (14%)  |0/39 (0%)    2/39 (5%)    1/28 (4%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     689          729 (T)      583          689         |---          729 (T)      729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.440      P=0.140N     P=0.512      P=0.517N    |P=0.416N     P=0.238      P=0.434      (e)          | 
|POLY 3             |     P=0.448      P=0.183N     P=0.469      P=0.544N    |P=0.408N     P=0.235      P=0.480      (e)          | 
|POLY 1.5           |     P=0.462      P=0.180N     P=0.481      P=0.529N    |P=0.412N     P=0.236      P=0.490      (e)          | 
|POLY 6             |     P=0.435      P=0.186N     P=0.459      P=0.558N    |P=0.402N     P=0.235      P=0.469      (e)          | 
|LOGISTIC REGRESSION|     P=0.442      P=0.178N     P=0.469      P=0.549N    |(e)          P=0.238      P=0.434      (e)          | 
|COCH-ARM / FISHERS |     P=0.493      P=0.178N     P=0.500      P=0.500N    |P=0.418N     P=0.247      P=0.505      (e)          | 
|ORDER RESTRICTED   |     P=0.405      (e)          (e)          (e)         |P=0.299N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 3       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone                                                                                                                             | 
|     Osteoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/46.14      0/45.93      0/44.49      0/43.91     |0/46.00      0/44.99      0/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     4.3%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/35 (3%)    0/40 (0%)    0/36 (0%)    0/35 (0%)   |0/40 (0%)    0/39 (0%)    0/28 (0%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     726          ---          ---          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.252N     P=0.214N     P=0.237N     P=0.243N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.241N     P=0.238N     P=0.245N     P=0.248N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.241N     P=0.238N     P=0.242N     P=0.245N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.242N     P=0.238N     P=0.247N     P=0.251N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.253N     P=0.226N     P=0.241N     P=0.248N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.242N     P=0.247N     P=0.247N     P=0.247N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.033N*    (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone                                                                                                                             | 
|     Osteosarcoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/46.13      0/45.93      0/44.49      2/44.60     |0/46.00      0/44.99      0/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         4.5%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/35 (0%)    0/40 (0%)    0/36 (0%)    1/35 (3%)   |0/40 (0%)    0/39 (0%)    0/28 (0%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          491         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.039 *    (e)          (e)          P=0.237     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.039 *    (e)          (e)          P=0.230     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.040 *    (e)          (e)          P=0.232     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.039 *    (e)          (e)          P=0.228     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.061      (e)          (e)          P=0.277     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.042 *    (e)          (e)          P=0.247     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.027 *    (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 4       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone                                                                                                                             | 
|     Osteosarcoma or Osteoma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/46.14      0/45.93      0/44.49      2/44.60     |0/46.00      0/44.99      0/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     4.3%         0.0%         0.0%         4.5%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/35 (3%)    0/40 (0%)    0/36 (0%)    1/35 (3%)   |0/40 (0%)    0/39 (0%)    0/28 (0%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     726          ---          ---          491         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.364      P=0.214N     P=0.237N     P=0.688     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.375      P=0.238N     P=0.245N     P=0.682     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.376      P=0.238N     P=0.242N     P=0.685     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.373      P=0.238N     P=0.247N     P=0.679     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.410      P=0.226N     P=0.241N     P=0.673N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.381      P=0.247N     P=0.247N     P=0.691N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.259      (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    3/50 (6%)    0/50 (0%)   |5/50 (10%)   4/49 (8%)    6/50 (12%)   0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/46.13      1/45.93      3/44.75      0/43.91     |5/46.10      4/43.99      6/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         6.7%         0.0%        |10.9%        9.1%         14.7%        0.0%         | 
|TERMINAL (d)       |     0/35 (0%)    1/40 (3%)    1/36 (3%)    0/35 (0%)   |4/40 (10%)   4/38 (11%)   6/28 (21%)   0/42 (0%)    | 
|FIRST INCIDENCE    |     ---          729 (T)      673          ---         |703          729 (T)      729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.520N     P=0.527      P=0.123      (e)         |P=0.051N     P=0.532N     P=0.263      P=0.030N*    | 
|POLY 3             |     P=0.524N     P=0.499      P=0.113      (e)         |P=0.037N*    P=0.529N     P=0.414      P=0.027N*    | 
|POLY 1.5           |     P=0.516N     P=0.500      P=0.115      (e)         |P=0.041N*    P=0.523N     P=0.448      P=0.029N*    | 
|POLY 6             |     P=0.531N     P=0.499      P=0.113      (e)         |P=0.033N*    P=0.535N     P=0.372      P=0.026N*    | 
|LOGISTIC REGRESSION|     P=0.513N     P=0.527      P=0.117      (e)         |P=0.043N*    P=0.530N     P=0.304      P=0.027N*    | 
|COCH-ARM / FISHERS |     P=0.500N     P=0.500      P=0.121      (e)         |P=0.048N*    P=0.513N     P=0.500      P=0.028N*    | 
|ORDER RESTRICTED   |     P=0.214      (e)          (e)          (e)         |P=0.025N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 5       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    2/50 (4%)    3/50 (6%)   |3/50 (6%)    2/49 (4%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/46.13      2/46.50      2/44.63      3/44.07     |3/46.00      2/44.59      1/40.77      1/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         4.3%         4.5%         6.8%        |6.5%         4.5%         2.5%         2.1%         | 
|TERMINAL (d)       |     0/35 (0%)    1/40 (3%)    1/36 (3%)    2/35 (6%)   |3/40 (8%)    1/38 (3%)    1/28 (4%)    1/42 (2%)    | 
|FIRST INCIDENCE    |     ---          548          694          687         |729 (T)      538          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.143      P=0.252      P=0.240      P=0.122     |P=0.203N     P=0.522N     P=0.439N     P=0.288N     | 
|POLY 3             |     P=0.142      P=0.239      P=0.230      P=0.111     |P=0.194N     P=0.514N     P=0.350N     P=0.290N     | 
|POLY 1.5           |     P=0.146      P=0.239      P=0.233      P=0.113     |P=0.197N     P=0.512N     P=0.332N     P=0.296N     | 
|POLY 6             |     P=0.138      P=0.240      P=0.229      P=0.109     |P=0.191N     P=0.514N     P=0.373N     P=0.283N     | 
|LOGISTIC REGRESSION|     P=0.159      P=0.209      P=0.231      P=0.111     |P=0.196N     P=0.504N     P=0.439N     P=0.288N     | 
|COCH-ARM / FISHERS |     P=0.156      P=0.247      P=0.247      P=0.121     |P=0.198N     P=0.510N     P=0.309N     P=0.309N     | 
|ORDER RESTRICTED   |     P=0.070      (e)          (e)          (e)         |P=0.202N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    3/50 (6%)    5/50 (10%)   3/50 (6%)   |8/50 (16%)   6/49 (12%)   7/50 (14%)   1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/46.13      3/46.50      5/44.89      3/44.07     |8/46.10      6/44.59      7/40.77      1/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         6.5%         11.1%        6.8%        |17.4%        13.5%        17.2%        2.1%         | 
|TERMINAL (d)       |     0/35 (0%)    2/40 (5%)    2/36 (6%)    2/35 (6%)   |7/40 (18%)   5/38 (13%)   7/28 (25%)   1/42 (2%)    | 
|FIRST INCIDENCE    |     ---          548          673          687         |703          538          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.267      P=0.138      P=0.036 *    P=0.122     |P=0.022N*    P=0.427N     P=0.426      P=0.015N*    | 
|POLY 3             |     P=0.259      P=0.120      P=0.028 *    P=0.111     |P=0.015N*    P=0.412N     P=0.603N     P=0.013N*    | 
|POLY 1.5           |     P=0.269      P=0.120      P=0.029 *    P=0.113     |P=0.017N*    P=0.409N     P=0.562N     P=0.014N*    | 
|POLY 6             |     P=0.252      P=0.121      P=0.028 *    P=0.109     |P=0.013N*    P=0.413N     P=0.569      P=0.012N*    | 
|LOGISTIC REGRESSION|     P=0.287      P=0.112      P=0.031 *    P=0.111     |P=0.017N*    P=0.418N     P=0.478      P=0.013N*    | 
|COCH-ARM / FISHERS |     P=0.291      P=0.121      P=0.028 *    P=0.121     |P=0.020N*    P=0.403N     P=0.500N     P=0.015N*    | 
|ORDER RESTRICTED   |     P=0.052      (e)          (e)          (e)         |P=0.012N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 6       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/49 (0%)    1/50 (2%)    3/50 (6%)   |0/50 (0%)    0/49 (0%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/46.13      0/45.35      1/44.49      3/43.91     |0/46.00      0/44.59      1/40.77      1/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.3%         6.8%        |0.0%         0.0%         2.5%         2.1%         | 
|TERMINAL (d)       |     0/35 (0%)    0/40 (0%)    1/36 (3%)    3/35 (9%)   |0/40 (0%)    0/39 (0%)    1/28 (4%)    1/42 (2%)    | 
|FIRST INCIDENCE    |     ---          ---          729 (T)      729 (T)     |---          ---          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.018 *    (e)          P=0.506      P=0.121     |P=0.240      (e)          P=0.429      P=0.510      | 
|POLY 3             |     P=0.019 *    (e)          P=0.493      P=0.110     |P=0.244      (e)          P=0.476      P=0.509      | 
|POLY 1.5           |     P=0.019 *    (e)          P=0.495      P=0.113     |P=0.238      (e)          P=0.485      P=0.505      | 
|POLY 6             |     P=0.018 *    (e)          P=0.491      P=0.108     |P=0.252      (e)          P=0.464      P=0.513      | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.506      P=0.121     |(e)          (e)          P=0.429      P=0.510      | 
|COCH-ARM / FISHERS |     P=0.022 *    (e)          P=0.500      P=0.121     |P=0.227      (e)          P=0.500      P=0.500      | 
|ORDER RESTRICTED   |     P=0.018 *    (e)          (e)          (e)         |P=0.229      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    3/49 (6%)    0/50 (0%)    0/50 (0%)   |2/50 (4%)    0/49 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/46.13      3/45.35      0/44.49      0/43.91     |2/46.22      0/44.59      0/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         6.6%         0.0%         0.0%        |4.3%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/35 (0%)    3/40 (8%)    0/36 (0%)    0/35 (0%)   |1/40 (3%)    0/39 (0%)    0/28 (0%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     ---          729 (T)      ---          ---         |671          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.265N     P=0.146      (e)          (e)         |P=0.134N     P=0.243N     P=0.307N     P=0.222N     | 
|POLY 3             |     P=0.257N     P=0.116      (e)          (e)         |P=0.130N     P=0.245N     P=0.266N     P=0.229N     | 
|POLY 1.5           |     P=0.255N     P=0.116      (e)          (e)         |P=0.129N     P=0.244N     P=0.254N     P=0.232N     | 
|POLY 6             |     P=0.259N     P=0.116      (e)          (e)         |P=0.131N     P=0.246N     P=0.282N     P=0.225N     | 
|LOGISTIC REGRESSION|     (e)          P=0.146      (e)          (e)         |P=0.128N     P=0.242N     P=0.250N     P=0.244N     | 
|COCH-ARM / FISHERS |     P=0.253N     P=0.117      (e)          (e)         |P=0.128N     P=0.253N     P=0.247N     P=0.247N     | 
|ORDER RESTRICTED   |     P=0.169N     (e)          (e)          (e)         |P=0.027N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 7       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    3/49 (6%)    1/50 (2%)    3/50 (6%)   |2/50 (4%)    0/49 (0%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/46.13      3/45.35      1/44.49      3/43.91     |2/46.22      0/44.59      1/40.77      1/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         6.6%         2.3%         6.8%        |4.3%         0.0%         2.5%         2.1%         | 
|TERMINAL (d)       |     0/35 (0%)    3/40 (8%)    1/36 (3%)    3/35 (9%)   |1/40 (3%)    0/39 (0%)    1/28 (4%)    1/42 (2%)    | 
|FIRST INCIDENCE    |     ---          729 (T)      729 (T)      729 (T)     |671          ---          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.195      P=0.146      P=0.506      P=0.121     |P=0.514N     P=0.243N     P=0.609N     P=0.476N     | 
|POLY 3             |     P=0.203      P=0.116      P=0.493      P=0.110     |P=0.519N     P=0.245N     P=0.544N     P=0.487N     | 
|POLY 1.5           |     P=0.209      P=0.116      P=0.495      P=0.113     |P=0.522N     P=0.244N     P=0.526N     P=0.492N     | 
|POLY 6             |     P=0.199      P=0.116      P=0.491      P=0.108     |P=0.517N     P=0.246N     P=0.565N     P=0.481N     | 
|LOGISTIC REGRESSION|     (e)          P=0.146      P=0.506      P=0.121     |P=0.513N     P=0.242N     P=0.547N     P=0.501N     | 
|COCH-ARM / FISHERS |     P=0.220      P=0.117      P=0.500      P=0.121     |P=0.524N     P=0.253N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.069      (e)          (e)          (e)         |P=0.272N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Cholangiocarcinoma                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    2/50 (4%)    1/50 (2%)   |1/50 (2%)    0/49 (0%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     1/46.13      2/45.93      2/44.49      1/43.91     |1/46.00      0/44.59      0/40.77      1/48.02      | 
|POLY-3 PERCENT (g) |     2.2%         4.4%         4.5%         2.3%        |2.2%         0.0%         0.0%         2.1%         | 
|TERMINAL (d)       |     1/35 (3%)    2/40 (5%)    2/36 (6%)    1/35 (3%)   |1/40 (3%)    0/39 (0%)    0/28 (0%)    1/42 (2%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      729 (T)     |729 (T)      ---          ---          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.545N     P=0.547      P=0.510      P=0.762     |P=0.576      P=0.505N     P=0.571N     P=0.751N     | 
|POLY 3             |     P=0.541N     P=0.498      P=0.487      P=0.750     |P=0.583      P=0.506N     P=0.524N     P=0.751N     | 
|POLY 1.5           |     P=0.534N     P=0.500      P=0.492      P=0.753     |P=0.580      P=0.505N     P=0.515N     P=0.755N     | 
|POLY 6             |     P=0.546N     P=0.499      P=0.485      P=0.747     |P=0.586      P=0.506N     P=0.536N     P=0.746N     | 
|LOGISTIC REGRESSION|     P=0.545N     P=0.547      P=0.510      P=0.762     |P=0.576      (e)          (e)          P=0.751N     | 
|COCH-ARM / FISHERS |     P=0.521N     P=0.500      P=0.500      P=0.753N    |P=0.576      P=0.505N     P=0.500N     P=0.753N     | 
|ORDER RESTRICTED   |     P=0.536      (e)          (e)          (e)         |P=0.399N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 8       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Cholangioma                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/49 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/46.13      2/45.93      0/44.49      0/43.91     |0/46.00      0/44.59      0/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         4.4%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/35 (0%)    2/40 (5%)    0/36 (0%)    0/35 (0%)   |0/40 (0%)    0/39 (0%)    0/28 (0%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     ---          729 (T)      ---          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.380N     P=0.268      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.375N     P=0.236      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.373N     P=0.237      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.377N     P=0.236      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          P=0.268      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.369N     P=0.247      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.256N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Adenoma                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    3/50 (6%)    2/50 (4%)   |1/50 (2%)    0/49 (0%)    2/50 (4%)    4/50 (8%)    | 
|POLY-3 RATE (b)    |     0/46.13      1/45.93      3/44.62      2/44.01     |1/46.00      0/44.59      2/40.77      4/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         6.7%         4.5%        |2.2%         0.0%         4.9%         8.3%         | 
|TERMINAL (d)       |     0/35 (0%)    1/40 (3%)    2/36 (6%)    1/35 (3%)   |1/40 (3%)    0/39 (0%)    2/28 (7%)    4/42 (10%)   | 
|FIRST INCIDENCE    |     ---          729 (T)      696          702         |729 (T)      ---          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.237      P=0.527      P=0.126      P=0.237     |P=0.043 *    P=0.505N     P=0.376      P=0.194      | 
|POLY 3             |     P=0.235      P=0.499      P=0.113      P=0.227     |P=0.039 *    P=0.506N     P=0.458      P=0.192      | 
|POLY 1.5           |     P=0.241      P=0.500      P=0.115      P=0.230     |P=0.037 *    P=0.505N     P=0.475      P=0.187      | 
|POLY 6             |     P=0.229      P=0.499      P=0.112      P=0.224     |P=0.041 *    P=0.506N     P=0.437      P=0.199      | 
|LOGISTIC REGRESSION|     P=0.236      P=0.527      P=0.113      P=0.226     |P=0.043 *    (e)          P=0.376      P=0.194      | 
|COCH-ARM / FISHERS |     P=0.256      P=0.500      P=0.121      P=0.247     |P=0.036 *    P=0.505N     P=0.500      P=0.181      | 
|ORDER RESTRICTED   |     P=0.103      (e)          (e)          (e)         |P=0.044 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 9       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    1/50 (2%)    2/50 (4%)   |0/50 (0%)    0/49 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/46.13      0/45.93      1/44.49      2/43.91     |0/46.00      0/44.59      0/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.3%         4.6%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/35 (0%)    0/40 (0%)    1/36 (3%)    2/35 (6%)   |0/40 (0%)    0/39 (0%)    0/28 (0%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          729 (T)      729 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.075      (e)          P=0.506      P=0.238     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.077      (e)          P=0.493      P=0.226     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.079      (e)          P=0.495      P=0.230     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.075      (e)          P=0.491      P=0.223     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.506      P=0.238     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.084      (e)          P=0.500      P=0.247     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.067      (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    3/50 (6%)    3/50 (6%)   |1/50 (2%)    0/49 (0%)    2/50 (4%)    4/50 (8%)    | 
|POLY-3 RATE (b)    |     0/46.13      1/45.93      3/44.62      3/44.01     |1/46.00      0/44.59      2/40.77      4/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         6.7%         6.8%        |2.2%         0.0%         4.9%         8.3%         | 
|TERMINAL (d)       |     0/35 (0%)    1/40 (3%)    2/36 (6%)    2/35 (6%)   |1/40 (3%)    0/39 (0%)    2/28 (7%)    4/42 (10%)   | 
|FIRST INCIDENCE    |     ---          729 (T)      696          702         |729 (T)      ---          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.095      P=0.527      P=0.126      P=0.121     |P=0.043 *    P=0.505N     P=0.376      P=0.194      | 
|POLY 3             |     P=0.095      P=0.499      P=0.113      P=0.110     |P=0.039 *    P=0.506N     P=0.458      P=0.192      | 
|POLY 1.5           |     P=0.098      P=0.500      P=0.115      P=0.113     |P=0.037 *    P=0.505N     P=0.475      P=0.187      | 
|POLY 6             |     P=0.092      P=0.499      P=0.112      P=0.108     |P=0.041 *    P=0.506N     P=0.437      P=0.199      | 
|LOGISTIC REGRESSION|     P=0.093      P=0.527      P=0.113      P=0.109     |P=0.043 *    (e)          P=0.376      P=0.194      | 
|COCH-ARM / FISHERS |     P=0.107      P=0.500      P=0.121      P=0.121     |P=0.036 *    P=0.505N     P=0.500      P=0.181      | 
|ORDER RESTRICTED   |     P=0.069      (e)          (e)          (e)         |P=0.044 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 10      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma, Hepatocellular Adenoma,                                                                           | 
|     or Hepatoblastoma                                                                                                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    3/50 (6%)    3/50 (6%)   |1/50 (2%)    0/49 (0%)    2/50 (4%)    4/50 (8%)    | 
|POLY-3 RATE (b)    |     0/46.13      1/45.93      3/44.62      3/44.01     |1/46.00      0/44.59      2/40.77      4/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         6.7%         6.8%        |2.2%         0.0%         4.9%         8.3%         | 
|TERMINAL (d)       |     0/35 (0%)    1/40 (3%)    2/36 (6%)    2/35 (6%)   |1/40 (3%)    0/39 (0%)    2/28 (7%)    4/42 (10%)   | 
|FIRST INCIDENCE    |     ---          729 (T)      696          702         |729 (T)      ---          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.095      P=0.527      P=0.126      P=0.121     |P=0.043 *    P=0.505N     P=0.376      P=0.194      | 
|POLY 3             |     P=0.095      P=0.499      P=0.113      P=0.110     |P=0.039 *    P=0.506N     P=0.458      P=0.192      | 
|POLY 1.5           |     P=0.098      P=0.500      P=0.115      P=0.113     |P=0.037 *    P=0.505N     P=0.475      P=0.187      | 
|POLY 6             |     P=0.092      P=0.499      P=0.112      P=0.108     |P=0.041 *    P=0.506N     P=0.437      P=0.199      | 
|LOGISTIC REGRESSION|     P=0.093      P=0.527      P=0.113      P=0.109     |P=0.043 *    (e)          P=0.376      P=0.194      | 
|COCH-ARM / FISHERS |     P=0.107      P=0.500      P=0.121      P=0.121     |P=0.036 *    P=0.505N     P=0.500      P=0.181      | 
|ORDER RESTRICTED   |     P=0.069      (e)          (e)          (e)         |P=0.044 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    2/50 (4%)    2/50 (4%)    1/50 (2%)   |0/50 (0%)    1/49 (2%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     2/46.13      2/46.44      2/44.49      1/43.91     |0/46.00      1/44.59      1/40.77      1/48.05      | 
|POLY-3 PERCENT (g) |     4.3%         4.3%         4.5%         2.3%        |0.0%         2.2%         2.5%         2.1%         | 
|TERMINAL (d)       |     2/35 (6%)    1/40 (3%)    2/36 (6%)    1/35 (3%)   |0/40 (0%)    1/39 (3%)    1/28 (4%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      572          729 (T)      729 (T)     |---          729 (T)      729 (T)      722          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.403N     P=0.661N     P=0.685N     P=0.500N    |P=0.409      P=0.495      P=0.429      P=0.519      | 
|POLY 3             |     P=0.402N     P=0.691N     P=0.681      P=0.517N    |P=0.415      P=0.494      P=0.476      P=0.509      | 
|POLY 1.5           |     P=0.395N     P=0.692N     P=0.685      P=0.511N    |P=0.407      P=0.495      P=0.485      P=0.505      | 
|POLY 6             |     P=0.408N     P=0.689N     P=0.678      P=0.522N    |P=0.424      P=0.494      P=0.464      P=0.513      | 
|LOGISTIC REGRESSION|     P=0.391N     P=0.693      P=0.685N     P=0.500N    |P=0.415      P=0.495      P=0.429      P=0.512      | 
|COCH-ARM / FISHERS |     P=0.380N     P=0.691N     P=0.691N     P=0.500N    |P=0.396      P=0.495      P=0.500      P=0.500      | 
|ORDER RESTRICTED   |     P=0.480N     (e)          (e)          (e)         |P=0.306      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 11      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    3/50 (6%)    0/50 (0%)   |0/50 (0%)    0/49 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/46.13      1/45.93      3/45.22      0/43.91     |0/46.00      0/44.59      0/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     4.3%         2.2%         6.6%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/35 (6%)    1/40 (3%)    2/36 (6%)    0/35 (0%)   |0/40 (0%)    0/39 (0%)    0/28 (0%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      471          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.237N     P=0.453N     P=0.508      P=0.238N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.240N     P=0.502N     P=0.491      P=0.248N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.234N     P=0.500N     P=0.494      P=0.245N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.244N     P=0.501N     P=0.490      P=0.251N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.212N     P=0.453N     P=0.519      (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.223N     P=0.500N     P=0.500      P=0.247N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.193N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    3/50 (6%)    5/50 (10%)   1/50 (2%)   |0/50 (0%)    1/49 (2%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     4/46.13      3/46.44      5/45.22      1/43.91     |0/46.00      1/44.59      1/40.77      1/48.05      | 
|POLY-3 PERCENT (g) |     8.7%         6.5%         11.1%        2.3%        |0.0%         2.2%         2.5%         2.1%         | 
|TERMINAL (d)       |     4/35 (11%)   2/40 (5%)    4/36 (11%)   1/35 (3%)   |0/40 (0%)    1/39 (3%)    1/28 (4%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      572          471          729 (T)     |---          729 (T)      729 (T)      722          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.177N     P=0.441N     P=0.514      P=0.178N    |P=0.409      P=0.495      P=0.429      P=0.519      | 
|POLY 3             |     P=0.180N     P=0.496N     P=0.488      P=0.194N    |P=0.415      P=0.494      P=0.476      P=0.509      | 
|POLY 1.5           |     P=0.173N     P=0.497N     P=0.492      P=0.189N    |P=0.407      P=0.495      P=0.485      P=0.505      | 
|POLY 6             |     P=0.187N     P=0.493N     P=0.486      P=0.198N    |P=0.424      P=0.494      P=0.464      P=0.513      | 
|LOGISTIC REGRESSION|     P=0.158N     P=0.500N     P=0.498      P=0.178N    |P=0.415      P=0.495      P=0.429      P=0.512      | 
|COCH-ARM / FISHERS |     P=0.159N     P=0.500N     P=0.500      P=0.181N    |P=0.396      P=0.495      P=0.500      P=0.500      | 
|ORDER RESTRICTED   |     P=0.186N     (e)          (e)          (e)         |P=0.306      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 12      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |4/50 (8%)    1/50 (2%)    3/50 (6%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/46.13      0/45.93      0/44.49      0/43.91     |4/46.42      1/44.99      3/41.98      1/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |8.6%         2.2%         7.2%         2.1%         | 
|TERMINAL (d)       |     0/35 (0%)    0/40 (0%)    0/36 (0%)    0/35 (0%)   |3/40 (8%)    1/39 (3%)    1/28 (4%)    1/42 (2%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |605          729 (T)      332          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.216N     P=0.191N     P=0.633N     P=0.167N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.198N     P=0.188N     P=0.555N     P=0.169N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.205N     P=0.185N     P=0.532N     P=0.173N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.192N     P=0.191N     P=0.584N     P=0.164N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.224N     P=0.181N     P=0.404N     P=0.184N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.214N     P=0.181N     P=0.500N     P=0.181N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.103N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroadenoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)   |26/50 (52%)  23/50 (46%)  24/50 (48%)  6/50 (12%)   | 
|POLY-3 RATE (b)    |     0/46.13      0/45.93      0/44.49      2/43.91     |26/47.63     23/47.19     24/42.36     6/48.05      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         4.6%        |54.6%        48.7%        56.7%        12.5%        | 
|TERMINAL (d)       |     0/35 (0%)    0/40 (0%)    0/36 (0%)    2/35 (6%)   |21/40 (53%)  19/39 (49%)  16/28 (57%)  5/42 (12%)   | 
|FIRST INCIDENCE    |     ---          ---          ---          729 (T)     |602          483          598          722          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.037 *    (e)          (e)          P=0.238     |P<0.001N**   P=0.399N     P=0.181      P<0.001N**   | 
|POLY 3             |     P=0.038 *    (e)          (e)          P=0.226     |P<0.001N**   P=0.357N     P=0.506      P<0.001N**   | 
|POLY 1.5           |     P=0.039 *    (e)          (e)          P=0.230     |P<0.001N**   P=0.349N     P=0.568N     P<0.001N**   | 
|POLY 6             |     P=0.038 *    (e)          (e)          P=0.223     |P<0.001N**   P=0.370N     P=0.396      P<0.001N**   | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.238     |P<0.001N**   P=0.357N     P=0.463      P<0.001N**   | 
|COCH-ARM / FISHERS |     P=0.042 *    (e)          (e)          P=0.247     |P<0.001N**   P=0.345N     P=0.421N     P<0.001N**   | 
|ORDER RESTRICTED   |     P=0.026 *    (e)          (e)          (e)         |P<0.001N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 13      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)   |28/50 (56%)  24/50 (48%)  26/50 (52%)  6/50 (12%)   | 
|POLY-3 RATE (b)    |     0/46.13      0/45.93      0/44.49      2/43.91     |28/47.63     24/47.19     26/43.57     6/48.05      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         4.6%        |58.8%        50.9%        59.7%        12.5%        | 
|TERMINAL (d)       |     0/35 (0%)    0/40 (0%)    0/36 (0%)    2/35 (6%)   |23/40 (58%)  20/39 (51%)  16/28 (57%)  5/42 (12%)   | 
|FIRST INCIDENCE    |     ---          ---          ---          729 (T)     |602          483          332          722          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.037 *    (e)          (e)          P=0.238     |P<0.001N**   P=0.331N     P=0.167      P<0.001N**   | 
|POLY 3             |     P=0.038 *    (e)          (e)          P=0.226     |P<0.001N**   P=0.283N     P=0.551      P<0.001N**   | 
|POLY 1.5           |     P=0.039 *    (e)          (e)          P=0.230     |P<0.001N**   P=0.276N     P=0.538N     P<0.001N**   | 
|POLY 6             |     P=0.038 *    (e)          (e)          P=0.223     |P<0.001N**   P=0.295N     P=0.454      P<0.001N**   | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.238     |P<0.001N**   P=0.289N     P=0.549      P<0.001N**   | 
|COCH-ARM / FISHERS |     P=0.042 *    (e)          (e)          P=0.247     |P<0.001N**   P=0.274N     P=0.421N     P<0.001N**   | 
|ORDER RESTRICTED   |     P=0.026 *    (e)          (e)          (e)         |P<0.001N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     9/50 (18%)   6/50 (12%)   8/50 (16%)   9/50 (18%)  |23/50 (46%)  24/48 (50%)  21/50 (42%)  13/50 (26%)  | 
|POLY-3 RATE (b)    |     9/46.40      6/45.93      8/46.05      9/44.06     |23/46.48     24/46.25     21/44.42     13/48.36     | 
|POLY-3 PERCENT (g) |     19.4%        13.1%        17.4%        20.4%       |49.5%        51.9%        47.3%        26.9%        | 
|TERMINAL (d)       |     7/35 (20%)   6/40 (15%)   5/36 (14%)   8/35 (23%)  |21/40 (53%)  18/39 (46%)  10/28 (36%)  11/42 (26%)  | 
|FIRST INCIDENCE    |     694          729 (T)      392          689         |658          425          532          644          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.354      P=0.214N     P=0.489N     P=0.589     |P=0.017N*    P=0.458      P=0.252      P=0.020N*    | 
|POLY 3             |     P=0.363      P=0.294N     P=0.507N     P=0.556     |P=0.006N**   P=0.490      P=0.500N     P=0.018N*    | 
|POLY 1.5           |     P=0.378      P=0.291N     P=0.504N     P=0.572     |P=0.007N**   P=0.463      P=0.477N     P=0.021N*    | 
|POLY 6             |     P=0.351      P=0.297N     P=0.508N     P=0.541     |P=0.004N**   P=0.532      P=0.515N     P=0.014N*    | 
|LOGISTIC REGRESSION|     P=0.378      P=0.279N     P=0.488N     P=0.544     |P=0.009N**   P=0.413      P=0.565N     P=0.015N*    | 
|COCH-ARM / FISHERS |     P=0.409      P=0.288N     P=0.500N     P=0.602N    |P=0.010N*    P=0.423      P=0.420N     P=0.030N*    | 
|ORDER RESTRICTED   |     P=0.476      (e)          (e)          (e)         |P=0.010N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 14      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |2/50 (4%)    1/48 (2%)    3/50 (6%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/46.13      0/45.93      0/44.49      0/43.91     |2/46.71      1/43.78      3/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |4.3%         2.3%         7.4%         0.0%         | 
|TERMINAL (d)       |     0/35 (0%)    0/40 (0%)    0/36 (0%)    0/35 (0%)   |0/40 (0%)    1/39 (3%)    3/28 (11%)   0/42 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |602          729 (T)      729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.256N     P=0.516N     P=0.371      P=0.228N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.236N     P=0.523N     P=0.438      P=0.231N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.242N     P=0.519N     P=0.463      P=0.233N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.231N     P=0.525N     P=0.407      P=0.229N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.251N     P=0.509N     P=0.493      P=0.292N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.250N     P=0.515N     P=0.500      P=0.247N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.157N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     9/50 (18%)   6/50 (12%)   8/50 (16%)   9/50 (18%)  |25/50 (50%)  25/48 (52%)  24/50 (48%)  13/50 (26%)  | 
|POLY-3 RATE (b)    |     9/46.40      6/45.93      8/46.05      9/44.06     |25/47.20     25/46.25     24/44.42     13/48.36     | 
|POLY-3 PERCENT (g) |     19.4%        13.1%        17.4%        20.4%       |53.0%        54.1%        54.0%        26.9%        | 
|TERMINAL (d)       |     7/35 (20%)   6/40 (15%)   5/36 (14%)   8/35 (23%)  |21/40 (53%)  19/39 (49%)  13/28 (46%)  11/42 (26%)  | 
|FIRST INCIDENCE    |     694          729 (T)      392          689         |602          425          532          644          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.354      P=0.214N     P=0.489N     P=0.589     |P=0.009N**   P=0.527      P=0.170      P=0.009N**   | 
|POLY 3             |     P=0.363      P=0.294N     P=0.507N     P=0.556     |P=0.002N**   P=0.541      P=0.543      P=0.007N**   | 
|POLY 1.5           |     P=0.378      P=0.291N     P=0.504N     P=0.572     |P=0.003N**   P=0.525      P=0.582      P=0.008N**   | 
|POLY 6             |     P=0.351      P=0.297N     P=0.508N     P=0.541     |P=0.002N**   P=0.564      P=0.506      P=0.006N**   | 
|LOGISTIC REGRESSION|     P=0.378      P=0.279N     P=0.488N     P=0.544     |P=0.004N**   P=0.492      P=0.517      P=0.008N**   | 
|COCH-ARM / FISHERS |     P=0.409      P=0.288N     P=0.500N     P=0.602N    |P=0.004N**   P=0.498      P=0.500N     P=0.011N*    | 
|ORDER RESTRICTED   |     P=0.476      (e)          (e)          (e)         |P=0.004N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 15      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Basal Cell Carcinoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/46.13      0/45.93      0/44.49      2/43.91     |1/46.22      0/44.99      0/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         4.6%        |2.2%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/35 (0%)    0/40 (0%)    0/36 (0%)    2/35 (6%)   |0/40 (0%)    0/39 (0%)    0/28 (0%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          729 (T)     |671          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.037 *    (e)          (e)          P=0.238     |P=0.316N     P=0.500N     P=0.548N     P=0.478N     | 
|POLY 3             |     P=0.038 *    (e)          (e)          P=0.226     |P=0.328N     P=0.505N     P=0.525N     P=0.492N     | 
|POLY 1.5           |     P=0.039 *    (e)          (e)          P=0.230     |P=0.326N     P=0.503N     P=0.515N     P=0.495N     | 
|POLY 6             |     P=0.038 *    (e)          (e)          P=0.223     |P=0.330N     P=0.507N     P=0.538N     P=0.489N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.238     |P=0.321N     P=0.494N     P=0.487N     P=0.528N     | 
|COCH-ARM / FISHERS |     P=0.042 *    (e)          (e)          P=0.247     |P=0.321N     P=0.500N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.026 *    (e)          (e)          (e)         |P=0.113N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous                                                                      | 
|     Tumor (benign, malignant or NOS), or Trichoepithelioma                                                                      | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    1/50 (2%)    3/50 (6%)   |2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/46.13      0/45.93      1/44.80      3/43.91     |2/46.22      0/44.99      0/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     2.2%         0.0%         2.2%         6.8%        |4.3%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/35 (3%)    0/40 (0%)    0/36 (0%)    3/35 (9%)   |1/40 (3%)    0/39 (0%)    0/28 (0%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      ---          644          729 (T)     |671          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.070      P=0.473N     P=0.758      P=0.305     |P=0.134N     P=0.243N     P=0.307N     P=0.222N     | 
|POLY 3             |     P=0.073      P=0.501N     P=0.754      P=0.288     |P=0.129N     P=0.243N     P=0.266N     P=0.229N     | 
|POLY 1.5           |     P=0.075      P=0.500N     P=0.756      P=0.294     |P=0.129N     P=0.241N     P=0.254N     P=0.232N     | 
|POLY 6             |     P=0.072      P=0.501N     P=0.754      P=0.283     |P=0.130N     P=0.245N     P=0.282N     P=0.225N     | 
|LOGISTIC REGRESSION|     P=0.073      (e)          P=0.758N     P=0.305     |P=0.129N     P=0.237N     P=0.250N     P=0.244N     | 
|COCH-ARM / FISHERS |     P=0.080      P=0.500N     P=0.753N     P=0.309     |P=0.129N     P=0.247N     P=0.247N     P=0.247N     | 
|ORDER RESTRICTED   |     P=0.073      (e)          (e)          (e)         |P=0.027N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 16      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|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)        |     2/50 (4%)    2/50 (4%)    2/50 (4%)    7/50 (14%)  |2/50 (4%)    0/50 (0%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     2/46.13      2/45.93      2/44.80      7/44.67     |2/46.22      0/44.99      1/41.26      1/48.02      | 
|POLY-3 PERCENT (g) |     4.3%         4.4%         4.5%         15.7%       |4.3%         0.0%         2.4%         2.1%         | 
|TERMINAL (d)       |     2/35 (6%)    2/40 (5%)    1/36 (3%)    4/35 (11%)  |1/40 (3%)    0/39 (0%)    0/28 (0%)    1/42 (2%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      644          598         |671          ---          580          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.014 *    P=0.646N     P=0.690N     P=0.082     |P=0.514N     P=0.243N     P=0.586N     P=0.476N     | 
|POLY 3             |     P=0.015 *    P=0.692      P=0.683      P=0.071     |P=0.518N     P=0.243N     P=0.539N     P=0.487N     | 
|POLY 1.5           |     P=0.015 *    P=0.693      P=0.687      P=0.073     |P=0.522N     P=0.241N     P=0.524N     P=0.492N     | 
|POLY 6             |     P=0.014 *    P=0.693      P=0.683      P=0.070     |P=0.514N     P=0.245N     P=0.559N     P=0.481N     | 
|LOGISTIC REGRESSION|     P=0.015 *    P=0.646N     P=0.688      P=0.074     |P=0.537N     P=0.237N     P=0.462N     P=0.501N     | 
|COCH-ARM / FISHERS |     P=0.017 *    P=0.691N     P=0.691N     P=0.080     |P=0.527N     P=0.247N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.023 *    (e)          (e)          (e)         |P=0.271N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    4/50 (8%)    0/50 (0%)    2/50 (4%)   |1/50 (2%)    0/50 (0%)    2/50 (4%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     2/46.36      4/45.93      0/44.49      2/43.91     |1/46.00      0/44.99      2/41.11      2/48.35      | 
|POLY-3 PERCENT (g) |     4.3%         8.7%         0.0%         4.6%        |2.2%         0.0%         4.9%         4.1%         | 
|TERMINAL (d)       |     1/35 (3%)    4/40 (10%)   0/36 (0%)    2/35 (6%)   |1/40 (3%)    0/39 (0%)    0/28 (0%)    1/42 (2%)    | 
|FIRST INCIDENCE    |     668          729 (T)      ---          729 (T)     |729 (T)      ---          668          638          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.477N     P=0.388      P=0.242N     P=0.687     |P=0.253      P=0.505N     P=0.403      P=0.524      | 
|POLY 3             |     P=0.467N     P=0.333      P=0.246N     P=0.674     |P=0.249      P=0.504N     P=0.461      P=0.517      | 
|POLY 1.5           |     P=0.461N     P=0.336      P=0.243N     P=0.681     |P=0.240      P=0.503N     P=0.476      P=0.510      | 
|POLY 6             |     P=0.472N     P=0.331      P=0.249N     P=0.668     |P=0.260      P=0.505N     P=0.443      P=0.526      | 
|LOGISTIC REGRESSION|     P=0.480N     P=0.335      P=0.237N     P=0.678     |P=0.224      (e)          P=0.475      P=0.485      | 
|COCH-ARM / FISHERS |     P=0.451N     P=0.339      P=0.247N     P=0.691N    |P=0.226      P=0.500N     P=0.500      P=0.500      | 
|ORDER RESTRICTED   |     P=0.259N     (e)          (e)          (e)         |P=0.245      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 17      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        | 
|     or Fibrous Histiocytoma                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    4/50 (8%)    1/50 (2%)    3/50 (6%)   |1/50 (2%)    0/50 (0%)    2/50 (4%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     2/46.36      4/45.93      1/44.49      3/43.91     |1/46.00      0/44.99      2/41.11      2/48.35      | 
|POLY-3 PERCENT (g) |     4.3%         8.7%         2.3%         6.8%        |2.2%         0.0%         4.9%         4.1%         | 
|TERMINAL (d)       |     1/35 (3%)    4/40 (10%)   1/36 (3%)    3/35 (9%)   |1/40 (3%)    0/39 (0%)    0/28 (0%)    1/42 (2%)    | 
|FIRST INCIDENCE    |     668          729 (T)      729 (T)      729 (T)     |729 (T)      ---          668          638          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.531      P=0.388      P=0.499N     P=0.494     |P=0.253      P=0.505N     P=0.403      P=0.524      | 
|POLY 3             |     P=0.536      P=0.333      P=0.514N     P=0.475     |P=0.249      P=0.504N     P=0.461      P=0.517      | 
|POLY 1.5           |     P=0.544      P=0.336      P=0.509N     P=0.484     |P=0.240      P=0.503N     P=0.476      P=0.510      | 
|POLY 6             |     P=0.528      P=0.331      P=0.519N     P=0.467     |P=0.260      P=0.505N     P=0.443      P=0.526      | 
|LOGISTIC REGRESSION|     P=0.527      P=0.335      P=0.508N     P=0.474     |P=0.224      (e)          P=0.475      P=0.485      | 
|COCH-ARM / FISHERS |     P=0.561      P=0.339      P=0.500N     P=0.500     |P=0.226      P=0.500N     P=0.500      P=0.500      | 
|ORDER RESTRICTED   |     P=0.475      (e)          (e)          (e)         |P=0.245      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Keratoacanthoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    1/50 (2%)    4/50 (8%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     1/46.13      2/45.93      1/44.49      4/44.67     |0/46.00      0/44.99      0/40.77      1/48.02      | 
|POLY-3 PERCENT (g) |     2.2%         4.4%         2.3%         9.0%        |0.0%         0.0%         0.0%         2.1%         | 
|TERMINAL (d)       |     1/35 (3%)    2/40 (5%)    1/36 (3%)    1/35 (3%)   |0/40 (0%)    0/39 (0%)    0/28 (0%)    1/42 (2%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      598         |---          ---          ---          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.099      P=0.547      P=0.756N     P=0.177     |P=0.208      (e)          (e)          P=0.510      | 
|POLY 3             |     P=0.102      P=0.498      P=0.753      P=0.169     |P=0.202      (e)          (e)          P=0.509      | 
|POLY 1.5           |     P=0.104      P=0.500      P=0.755      P=0.172     |P=0.199      (e)          (e)          P=0.505      | 
|POLY 6             |     P=0.102      P=0.499      P=0.751      P=0.169     |P=0.205      (e)          (e)          P=0.513      | 
|LOGISTIC REGRESSION|     P=0.104      P=0.547      P=0.756N     P=0.185     |(e)          (e)          (e)          P=0.510      | 
|COCH-ARM / FISHERS |     P=0.108      P=0.500      P=0.753N     P=0.181     |P=0.194      (e)          (e)          P=0.500      | 
|ORDER RESTRICTED   |     P=0.087      (e)          (e)          (e)         |P=0.129      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 18      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous                                                                 | 
|     Tumor (malignant or NOS), or Carcinoma                                                                                      | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)   |1/50 (2%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/46.13      0/45.93      0/44.49      2/43.91     |1/46.22      0/44.99      1/41.26      0/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         4.6%        |2.2%         0.0%         2.4%         0.0%         | 
|TERMINAL (d)       |     0/35 (0%)    0/40 (0%)    0/36 (0%)    2/35 (6%)   |0/40 (0%)    0/39 (0%)    0/28 (0%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          729 (T)     |671          ---          580          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.037 *    (e)          (e)          P=0.238     |P=0.417N     P=0.500N     P=0.716      P=0.478N     | 
|POLY 3             |     P=0.038 *    (e)          (e)          P=0.226     |P=0.416N     P=0.505N     P=0.735      P=0.492N     | 
|POLY 1.5           |     P=0.039 *    (e)          (e)          P=0.230     |P=0.420N     P=0.503N     P=0.745      P=0.495N     | 
|POLY 6             |     P=0.038 *    (e)          (e)          P=0.223     |P=0.412N     P=0.507N     P=0.721      P=0.489N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.238     |P=0.440N     P=0.494N     P=0.718N     P=0.528N     | 
|COCH-ARM / FISHERS |     P=0.042 *    (e)          (e)          P=0.247     |P=0.425N     P=0.500N     P=0.753N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.026 *    (e)          (e)          (e)         |P=0.243N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma, Papilloma, Squamous Cell                                                                           | 
|     Carcinoma or Keratoacanthoma                                                                                                | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    1/50 (2%)    4/50 (8%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     1/46.13      2/45.93      1/44.49      4/44.67     |0/46.00      0/44.99      1/41.26      1/48.02      | 
|POLY-3 PERCENT (g) |     2.2%         4.4%         2.3%         9.0%        |0.0%         0.0%         2.4%         2.1%         | 
|TERMINAL (d)       |     1/35 (3%)    2/40 (5%)    1/36 (3%)    1/35 (3%)   |0/40 (0%)    0/39 (0%)    0/28 (0%)    1/42 (2%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      598         |---          ---          580          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.099      P=0.547      P=0.756N     P=0.177     |P=0.237      (e)          P=0.469      P=0.510      | 
|POLY 3             |     P=0.102      P=0.498      P=0.753      P=0.169     |P=0.243      (e)          P=0.478      P=0.509      | 
|POLY 1.5           |     P=0.104      P=0.500      P=0.755      P=0.172     |P=0.237      (e)          P=0.487      P=0.505      | 
|POLY 6             |     P=0.102      P=0.499      P=0.751      P=0.169     |P=0.251      (e)          P=0.468      P=0.513      | 
|LOGISTIC REGRESSION|     P=0.104      P=0.547      P=0.756N     P=0.185     |P=0.205      (e)          P=0.579      P=0.510      | 
|COCH-ARM / FISHERS |     P=0.108      P=0.500      P=0.753N     P=0.181     |P=0.225      (e)          P=0.500      P=0.500      | 
|ORDER RESTRICTED   |     P=0.087      (e)          (e)          (e)         |P=0.231      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 19      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     48/50 (96%)  45/50 (90%)  42/50 (84%)  43/50 (86%) |                                                    | 
|POLY-3 RATE (b)    |     48/48.94     45/48.27     42/46.44     43/47.50    |                                                    | 
|POLY-3 PERCENT (g) |     98.1%        93.2%        90.4%        90.5%       |                                                    | 
|TERMINAL (d)       |     35/35 (100%) 38/40 (95%)  34/36 (94%)  31/35 (89%) |                                                    | 
|FIRST INCIDENCE    |     572          548          538          562         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.453N     P=0.075N     P=0.123N     P=0.277N    |                                                    | 
|POLY 3             |     P=0.144N     P=0.225N     P=0.090N     P=0.109N    |                                                    | 
|POLY 1.5           |     P=0.146N     P=0.193N     P=0.055N     P=0.091N    |                                                    | 
|POLY 6             |     P=0.124N     P=0.298N     P=0.163N     P=0.119N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.300N     P=0.235N     P=0.111N     P=0.153N    |                                                    | 
|COCH-ARM / FISHERS |     P=0.129N     P=0.218N     P=0.046N*    P=0.080N    |                                                    | 
|ORDER RESTRICTED   |     P=0.078N     (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     9/48 (19%)   5/46 (11%)   9/43 (21%)   7/50 (14%)  |9/49 (18%)   9/48 (19%)   8/42 (19%)   3/48 (6%)    | 
|POLY-3 RATE (b)    |     9/45.06      5/43.50      9/40.29      7/44.17     |9/45.71      9/44.22      8/36.31      3/46.81      | 
|POLY-3 PERCENT (g) |     20.0%        11.5%        22.3%        15.9%       |19.7%        20.4%        22.0%        6.4%         | 
|TERMINAL (d)       |     9/35 (26%)   5/39 (13%)   9/35 (26%)   5/35 (14%)  |8/40 (20%)   7/39 (18%)   5/28 (18%)   3/41 (7%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      689         |602          638          638          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.562N     P=0.134N     P=0.607      P=0.396N    |P=0.047N*    P=0.577      P=0.429      P=0.057N     | 
|POLY 3             |     P=0.521N     P=0.211N     P=0.499      P=0.409N    |P=0.036N*    P=0.573      P=0.505      P=0.054N     | 
|POLY 1.5           |     P=0.501N     P=0.215N     P=0.498      P=0.395N    |P=0.040N*    P=0.576      P=0.528      P=0.058N     | 
|POLY 6             |     P=0.538N     P=0.202N     P=0.510      P=0.415N    |P=0.033N*    P=0.574      P=0.483      P=0.051N     | 
|LOGISTIC REGRESSION|     P=0.562N     P=0.134N     P=0.607      P=0.424N    |P=0.042N*    P=0.574      P=0.508      P=0.056N     | 
|COCH-ARM / FISHERS |     P=0.455N     P=0.218N     P=0.500      P=0.359N    |P=0.049N*    P=0.584      P=0.572      P=0.065N     | 
|ORDER RESTRICTED   |     P=0.474N     (e)          (e)          (e)         |P=0.039N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 20      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    0/46 (0%)    0/43 (0%)    3/50 (6%)   |0/49 (0%)    1/48 (2%)    0/42 (0%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     1/45.06      0/43.50      0/40.29      3/44.06     |0/45.28      1/44.11      0/35.57      1/46.81      | 
|POLY-3 PERCENT (g) |     2.2%         0.0%         0.0%         6.8%        |0.0%         2.3%         0.0%         2.1%         | 
|TERMINAL (d)       |     1/35 (3%)    0/39 (0%)    0/35 (0%)    2/35 (6%)   |0/40 (0%)    0/39 (0%)    0/28 (0%)    1/41 (2%)    | 
|FIRST INCIDENCE    |     729 (T)      ---          ---          689         |---          638          ---          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.051      P=0.478N     P=0.500N     P=0.302     |P=0.438      P=0.500      (e)          P=0.505      | 
|POLY 3             |     P=0.059      P=0.507N     P=0.522N     P=0.297     |P=0.433      P=0.495      (e)          P=0.507      | 
|POLY 1.5           |     P=0.061      P=0.508N     P=0.523N     P=0.304     |P=0.428      P=0.495      (e)          P=0.503      | 
|POLY 6             |     P=0.057      P=0.504N     P=0.520N     P=0.293     |P=0.439      P=0.496      (e)          P=0.511      | 
|LOGISTIC REGRESSION|     P=0.054      (e)          (e)          P=0.291     |P=0.407      P=0.498      (e)          P=0.505      | 
|COCH-ARM / FISHERS |     P=0.066      P=0.511N     P=0.527N     P=0.324     |P=0.420      P=0.495      (e)          P=0.495      | 
|ORDER RESTRICTED   |     P=0.036 *    (e)          (e)          (e)         |P=0.258      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     10/48 (21%)  5/46 (11%)   9/43 (21%)   10/50 (20%) |9/49 (18%)   10/48 (21%)  8/42 (19%)   3/48 (6%)    | 
|POLY-3 RATE (b)    |     10/45.06     5/43.50      9/40.29      10/44.33    |9/45.71      10/44.55     8/36.31      3/46.81      | 
|POLY-3 PERCENT (g) |     22.2%        11.5%        22.3%        22.6%       |19.7%        22.5%        22.0%        6.4%         | 
|TERMINAL (d)       |     10/35 (29%)  5/39 (13%)   9/35 (26%)   7/35 (20%)  |8/40 (20%)   7/39 (18%)   5/28 (18%)   3/41 (7%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      689         |602          638          638          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.273      P=0.083N     P=0.500N     P=0.593     |P=0.039N*    P=0.477      P=0.429      P=0.057N     | 
|POLY 3             |     P=0.318      P=0.144N     P=0.596      P=0.584     |P=0.030N*    P=0.475      P=0.505      P=0.054N     | 
|POLY 1.5           |     P=0.337      P=0.148N     P=0.594      P=0.598     |P=0.033N*    P=0.476      P=0.528      P=0.058N     | 
|POLY 6             |     P=0.304      P=0.136N     P=0.599N     P=0.579     |P=0.027N*    P=0.481      P=0.483      P=0.051N     | 
|LOGISTIC REGRESSION|     P=0.274      P=0.083N     P=0.500N     P=0.559     |P=0.035N*    P=0.472      P=0.508      P=0.056N     | 
|COCH-ARM / FISHERS |     P=0.382      P=0.150N     P=0.596      P=0.558N    |P=0.040N*    P=0.480      P=0.572      P=0.065N     | 
|ORDER RESTRICTED   |     P=0.394      (e)          (e)          (e)         |P=0.033N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 21      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    0/46 (0%)    1/43 (2%)    3/50 (6%)   |0/49 (0%)    0/48 (0%)    0/42 (0%)    5/48 (10%)   | 
|POLY-3 RATE (b)    |     1/45.06      0/43.50      1/40.29      3/43.91     |0/45.28      0/43.78      0/35.57      5/47.14      | 
|POLY-3 PERCENT (g) |     2.2%         0.0%         2.5%         6.8%        |0.0%         0.0%         0.0%         10.6%        | 
|TERMINAL (d)       |     1/35 (3%)    0/39 (0%)    1/35 (3%)    3/35 (9%)   |0/40 (0%)    0/39 (0%)    0/28 (0%)    4/41 (10%)   | 
|FIRST INCIDENCE    |     729 (T)      ---          729 (T)      729 (T)     |---          ---          ---          638          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.072      P=0.478N     P=0.762      P=0.305     |P<0.001 **   (e)          (e)          P=0.038 *    | 
|POLY 3             |     P=0.083      P=0.507N     P=0.736      P=0.296     |P<0.001 **   (e)          (e)          P=0.034 *    | 
|POLY 1.5           |     P=0.087      P=0.508N     P=0.735      P=0.303     |P<0.001 **   (e)          (e)          P=0.032 *    | 
|POLY 6             |     P=0.080      P=0.504N     P=0.738      P=0.291     |P<0.001 **   (e)          (e)          P=0.036 *    | 
|LOGISTIC REGRESSION|     P=0.072      (e)          P=0.762      P=0.305     |P<0.001 **   (e)          (e)          P=0.028 *    | 
|COCH-ARM / FISHERS |     P=0.095      P=0.511N     P=0.725      P=0.324     |P<0.001 **   (e)          (e)          P=0.027 *    | 
|ORDER RESTRICTED   |     P=0.077      (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    2/46 (4%)    0/43 (0%)    2/50 (4%)   |1/49 (2%)    1/48 (2%)    1/42 (2%)    7/48 (15%)   | 
|POLY-3 RATE (b)    |     0/45.06      2/43.64      0/40.29      2/44.75     |1/45.77      1/44.38      1/35.57      7/46.84      | 
|POLY-3 PERCENT (g) |     0.0%         4.6%         0.0%         4.5%        |2.2%         2.3%         2.8%         14.9%        | 
|TERMINAL (d)       |     0/35 (0%)    1/39 (3%)    0/35 (0%)    1/35 (3%)   |0/40 (0%)    0/39 (0%)    1/28 (4%)    6/41 (15%)   | 
|FIRST INCIDENCE    |     ---          693          ---          395         |583          538          729 (T)      722          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.273      P=0.252      (e)          P=0.240     |P=0.005 **   P=0.744      P=0.700      P=0.039 *    | 
|POLY 3             |     P=0.296      P=0.230      (e)          P=0.236     |P=0.003 **   P=0.754      P=0.703      P=0.033 *    | 
|POLY 1.5           |     P=0.300      P=0.229      (e)          P=0.239     |P=0.003 **   P=0.754      P=0.711      P=0.031 *    | 
|POLY 6             |     P=0.293      P=0.234      (e)          P=0.233     |P=0.003 **   P=0.754      P=0.692      P=0.034 *    | 
|LOGISTIC REGRESSION|     P=0.473      P=0.228      (e)          P=0.403     |P=0.002 **   P=0.767      P=0.761      P=0.026 *    | 
|COCH-ARM / FISHERS |     P=0.310      P=0.237      (e)          P=0.258     |P=0.003 **   P=0.747      P=0.713      P=0.028 *    | 
|ORDER RESTRICTED   |     P=0.115      (e)          (e)          (e)         |P=0.003 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 22      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    2/46 (4%)    1/43 (2%)    5/50 (10%)  |1/49 (2%)    1/48 (2%)    1/42 (2%)    11/48 (23%)  | 
|POLY-3 RATE (b)    |     1/45.06      2/43.64      1/40.29      5/44.75     |1/45.77      1/44.38      1/35.57      11/47.17     | 
|POLY-3 PERCENT (g) |     2.2%         4.6%         2.5%         11.2%       |2.2%         2.3%         2.8%         23.3%        | 
|TERMINAL (d)       |     1/35 (3%)    1/39 (3%)    1/35 (3%)    4/35 (11%)  |0/40 (0%)    0/39 (0%)    1/28 (4%)    9/41 (22%)   | 
|FIRST INCIDENCE    |     729 (T)      693          729 (T)      395         |583          538          729 (T)      638          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.037 *    P=0.525      P=0.762      P=0.105     |P<0.001 **   P=0.744      P=0.700      P=0.004 **   | 
|POLY 3             |     P=0.046 *    P=0.489      P=0.736      P=0.099     |P<0.001 **   P=0.754      P=0.703      P=0.002 **   | 
|POLY 1.5           |     P=0.049 *    P=0.486      P=0.735      P=0.103     |P<0.001 **   P=0.754      P=0.711      P=0.002 **   | 
|POLY 6             |     P=0.044 *    P=0.495      P=0.738      P=0.097     |P<0.001 **   P=0.754      P=0.692      P=0.003 **   | 
|LOGISTIC REGRESSION|     P=0.069      P=0.487      P=0.762      P=0.136     |P<0.001 **   P=0.767      P=0.761      P=0.002 **   | 
|COCH-ARM / FISHERS |     P=0.054      P=0.484      P=0.725      P=0.112     |P<0.001 **   P=0.747      P=0.713      P=0.002 **   | 
|ORDER RESTRICTED   |     P=0.035 *    (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Polyp Stromal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |8/50 (16%)   6/50 (12%)   7/50 (14%)   3/50 (6%)    | 
|POLY-3 RATE (b)    |                                                        |8/46.00      6/45.70      7/41.86      3/48.02      | 
|POLY-3 PERCENT (g) |                                                        |17.4%        13.1%        16.7%        6.3%         | 
|TERMINAL (d)       |                                                        |8/40 (20%)   5/39 (13%)   5/28 (18%)   3/42 (7%)    | 
|FIRST INCIDENCE    |                                                        |729 (T)      483          332          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.099N     P=0.405N     P=0.454      P=0.085N     | 
|POLY 3             |                                                        |P=0.082N     P=0.391N     P=0.579N     P=0.086N     | 
|POLY 1.5           |                                                        |P=0.088N     P=0.390N     P=0.546N     P=0.091N     | 
|POLY 6             |                                                        |P=0.075N     P=0.390N     P=0.602      P=0.079N     | 
|LOGISTIC REGRESSION|                                                        |P=0.095N     P=0.399N     P=0.559N     P=0.085N     | 
|COCH-ARM / FISHERS |                                                        |P=0.097N     P=0.387N     P=0.500N     P=0.100N     | 
|ORDER RESTRICTED   |                                                        |P=0.078N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 23      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Zymbal's Gland                                                                                                                   | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    2/50 (4%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/46.13      1/46.59      2/44.70      0/43.91     |0/46.00      0/44.99      0/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         2.2%         4.5%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/35 (0%)    0/40 (0%)    1/36 (3%)    0/35 (0%)   |0/40 (0%)    0/39 (0%)    0/28 (0%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     ---          507          673          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.528N     P=0.504      P=0.238      (e)         |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.535N     P=0.502      P=0.230      (e)         |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.528N     P=0.502      P=0.233      (e)         |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.541N     P=0.503      P=0.229      (e)         |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.456N     P=0.357      P=0.236      (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.515N     P=0.500      P=0.247      (e)         |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.319      (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or                                                                           | 
|     Undifferentiated                                                                                                            | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     15/50 (30%)  14/50 (28%)  21/50 (42%)  10/50 (20%) |6/50 (12%)   4/50 (8%)    9/50 (18%)   10/50 (20%)  | 
|POLY-3 RATE (b)    |     15/48.70     14/48.08     21/47.64     10/45.67    |6/47.21      4/45.63      9/42.95      10/49.18     | 
|POLY-3 PERCENT (g) |     30.8%        29.1%        44.1%        21.9%       |12.7%        8.8%         21.0%        20.3%        | 
|TERMINAL (d)       |     4/35 (11%)   8/40 (20%)   11/36 (31%)  4/35 (11%)  |2/40 (5%)    2/39 (5%)    3/28 (11%)   6/42 (14%)   | 
|FIRST INCIDENCE    |     572          521          439          574         |583          598          548          434          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.222N     P=0.449N     P=0.182      P=0.245N    |P=0.111      P=0.392N     P=0.157      P=0.261      | 
|POLY 3             |     P=0.193N     P=0.516N     P=0.127      P=0.228N    |P=0.090      P=0.391N     P=0.222      P=0.233      | 
|POLY 1.5           |     P=0.172N     P=0.506N     P=0.136      P=0.209N    |P=0.083      P=0.383N     P=0.246      P=0.224      | 
|POLY 6             |     P=0.217N     P=0.530N     P=0.120      P=0.251N    |P=0.097      P=0.399N     P=0.196      P=0.242      | 
|LOGISTIC REGRESSION|     P=0.099N     P=0.485N     P=0.179      P=0.146N    |P=0.058      P=0.351N     P=0.354      P=0.144      | 
|COCH-ARM / FISHERS |     P=0.137N     P=0.500N     P=0.149      P=0.178N    |P=0.073      P=0.370N     P=0.288      P=0.207      | 
|ORDER RESTRICTED   |     P=0.141N     (e)          (e)          (e)         |P=0.135      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 24      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Mesothelioma: Benign, Malignant, NOS                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    4/50 (8%)    2/50 (4%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/46.44      4/46.60      2/44.49      0/43.91     |0/46.00      0/44.99      0/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     4.3%         8.6%         4.5%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/35 (3%)    2/40 (5%)    2/36 (6%)    0/35 (0%)   |0/40 (0%)    0/39 (0%)    0/28 (0%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     643          608          729 (T)      ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.100N     P=0.364      P=0.692N     P=0.252N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.097N     P=0.339      P=0.678      P=0.250N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.094N     P=0.339      P=0.684      P=0.245N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.101N     P=0.341      P=0.674      P=0.254N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.085N     P=0.330      P=0.689      P=0.230N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.087N     P=0.339      P=0.691N     P=0.247N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.103N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Mesothelioma: Malignant                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    4/50 (8%)    2/50 (4%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/46.44      4/46.60      2/44.49      0/43.91     |0/46.00      0/44.99      0/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     4.3%         8.6%         4.5%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/35 (3%)    2/40 (5%)    2/36 (6%)    0/35 (0%)   |0/40 (0%)    0/39 (0%)    0/28 (0%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     643          608          729 (T)      ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.100N     P=0.364      P=0.692N     P=0.252N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.097N     P=0.339      P=0.678      P=0.250N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.094N     P=0.339      P=0.684      P=0.245N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.101N     P=0.341      P=0.674      P=0.254N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.085N     P=0.330      P=0.689      P=0.230N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.087N     P=0.339      P=0.691N     P=0.247N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.103N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 25      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Osteoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/46.14      0/45.93      0/44.49      0/43.91     |0/46.00      0/44.99      0/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     4.3%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/35 (3%)    0/40 (0%)    0/36 (0%)    0/35 (0%)   |0/40 (0%)    0/39 (0%)    0/28 (0%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     726          ---          ---          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.252N     P=0.214N     P=0.237N     P=0.243N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.241N     P=0.238N     P=0.245N     P=0.248N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.241N     P=0.238N     P=0.242N     P=0.245N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.242N     P=0.238N     P=0.247N     P=0.251N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.253N     P=0.226N     P=0.241N     P=0.248N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.242N     P=0.247N     P=0.247N     P=0.247N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.033N*    (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Osteosarcoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/46.13      0/45.93      0/44.49      2/44.60     |0/46.00      0/44.99      0/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         4.5%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/35 (0%)    0/40 (0%)    0/36 (0%)    1/35 (3%)   |0/40 (0%)    0/39 (0%)    0/28 (0%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          491         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.039 *    (e)          (e)          P=0.237     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.039 *    (e)          (e)          P=0.230     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.040 *    (e)          (e)          P=0.232     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.039 *    (e)          (e)          P=0.228     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.061      (e)          (e)          P=0.277     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.042 *    (e)          (e)          P=0.247     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.027 *    (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 26      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Osteosarcoma or Osteoma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/46.14      0/45.93      0/44.49      2/44.60     |0/46.00      0/44.99      0/40.77      0/48.02      | 
|POLY-3 PERCENT (g) |     4.3%         0.0%         0.0%         4.5%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/35 (3%)    0/40 (0%)    0/36 (0%)    1/35 (3%)   |0/40 (0%)    0/39 (0%)    0/28 (0%)    0/42 (0%)    | 
|FIRST INCIDENCE    |     726          ---          ---          491         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.364      P=0.214N     P=0.237N     P=0.688     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.375      P=0.238N     P=0.245N     P=0.682     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.376      P=0.238N     P=0.242N     P=0.685     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.373      P=0.238N     P=0.247N     P=0.679     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.410      P=0.226N     P=0.241N     P=0.673N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.381      P=0.247N     P=0.247N     P=0.691N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.259      (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     49/50 (98%)  46/50 (92%)  47/50 (94%)  45/50 (90%) |43/50 (86%)  43/50 (86%)  40/50 (80%)  27/50 (54%)  | 
|POLY-3 RATE (b)    |     49/49.08     46/48.27     47/48.49     45/47.50    |43/48.60     43/49.21     40/45.84     27/48.69     | 
|POLY-3 PERCENT (g) |     99.8%        95.3%        96.9%        94.7%       |88.5%        87.4%        87.3%        55.5%        | 
|TERMINAL (d)       |     35/35 (100%) 39/40 (98%)  35/36 (97%)  33/35 (94%) |35/40 (88%)  34/39 (87%)  25/28 (89%)  24/42 (57%)  | 
|FIRST INCIDENCE    |     572          548          392          562         |588          425          332          638          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.545N     P=0.073N     P=0.387N     P=0.344N    |P<0.001N**   P=0.495      P=0.055      P<0.001N**   | 
|POLY 3             |     P=0.220N     P=0.165N     P=0.347N     P=0.154N    |P<0.001N**   P=0.558N     P=0.557N     P<0.001N**   | 
|POLY 1.5           |     P=0.201N     P=0.135N     P=0.284N     P=0.113N    |P<0.001N**   P=0.567N     P=0.441N     P<0.001N**   | 
|POLY 6             |     P=0.215N     P=0.289N     P=0.451N     P=0.205N    |P<0.001N**   P=0.566N     P=0.579      P<0.001N**   | 
|LOGISTIC REGRESSION|     P=0.361N     P=0.193N     P=0.458N     P=0.205N    |P<0.001N**   P=0.588      P=0.591N     P<0.001N**   | 
|COCH-ARM / FISHERS |     P=0.150N     P=0.181N     P=0.309N     P=0.102N    |P<0.001N**   P=0.613N     P=0.298N     P<0.001N**   | 
|ORDER RESTRICTED   |     P=0.082N     (e)          (e)          (e)         |P<0.001N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/24/03                           EXPERIMENT: 92012 TEST: 05                                            Page 27      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                    2-METHYLIMIDAZOLE       
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     22/50 (44%)  26/50 (52%)  30/50 (60%)  25/50 (50%) |19/50 (38%)  10/50 (20%)  21/50 (42%)  20/50 (40%)  | 
|POLY-3 RATE (b)    |     22/49.63     26/50.00     30/48.58     25/47.52    |19/49.74     10/46.66     21/46.62     20/49.18     | 
|POLY-3 PERCENT (g) |     44.3%        52.0%        61.8%        52.6%       |38.2%        21.4%        45.0%        40.7%        | 
|TERMINAL (d)       |     9/35 (26%)   16/40 (40%)  18/36 (50%)  15/35 (43%) |10/40 (25%)  5/39 (13%)   10/28 (36%)  16/42 (38%)  | 
|FIRST INCIDENCE    |     315          507          439          395         |328          538          244          434          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.354      P=0.410      P=0.137      P=0.334     |P=0.236      P=0.070N     P=0.153      P=0.569N     | 
|POLY 3             |     P=0.335      P=0.287      P=0.062      P=0.270     |P=0.172      P=0.056N     P=0.318      P=0.482      | 
|POLY 1.5           |     P=0.371      P=0.281      P=0.066      P=0.293     |P=0.170      P=0.049N*    P=0.362      P=0.490      | 
|POLY 6             |     P=0.300      P=0.296      P=0.060      P=0.248     |P=0.168      P=0.065N     P=0.259      P=0.469      | 
|LOGISTIC REGRESSION|     P=0.548      P=0.196      P=0.108      P=0.419     |P=0.106      P=0.023N*    P=0.401N     P=0.308      | 
|COCH-ARM / FISHERS |     P=0.448      P=0.274      P=0.080      P=0.344     |P=0.163      P=0.038N*    P=0.419      P=0.500      | 
|ORDER RESTRICTED   |     P=0.157      (e)          (e)          (e)         |P=0.137      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0PPM         300 PPM      1000 PPM     3000 PPM    |0PPM         1000 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     50/50 (100%) 49/50 (98%)  49/50 (98%)  48/50 (96%) |45/50 (90%)  44/50 (88%)  48/50 (96%)  38/50 (76%)  | 
|POLY-3 RATE (b)    |     50/50.00     49/50.00     49/50.00     48/49.04    |45/50.00     44/49.40     48/49.76     38/49.82     | 
|POLY-3 PERCENT (g) |     100.0%       98.0%        98.0%        97.9%       |90.0%        89.1%        96.5%        76.3%        | 
|TERMINAL (d)       |     35/35 (100%) 39/40 (98%)  35/36 (97%)  34/35 (97%) |35/40 (88%)  34/39 (87%)  27/28 (96%)  32/42 (76%)  | 
|FIRST INCIDENCE    |     315          507          392          395         |328          425          244          434          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.440      P=0.173N     P=0.465N     P=0.493N    |P=0.096N     P=0.567      P=0.005 **   P=0.062N     | 
|POLY 3             |     P=0.463N     P=0.500N     P=0.500N     P=0.480N    |P=0.024N*    P=0.570N     P=0.185      P=0.057N     | 
|POLY 1.5           |     P=0.405N     P=0.500N     P=0.500N     P=0.419N    |P=0.025N*    P=0.542N     P=0.200      P=0.055N     | 
|POLY 6             |     P=0.477N     P=0.500N     P=0.500N     P=0.495N    |P=0.024N*    P=0.598N     P=0.163      P=0.060N     | 
|LOGISTIC REGRESSION|     P=0.269N     (e)          (e)          P=0.325N    |P=0.040N*    P=0.489N     P=0.305      P=0.077N     | 
|COCH-ARM / FISHERS |     P=0.194N     P=0.500N     P=0.500N     P=0.247N    |P=0.030N*    P=0.500N     P=0.218      P=0.054N     | 
|ORDER RESTRICTED   |     P=0.310N     (e)          (e)          (e)         |P=0.009N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
(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).