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TDMS Study 92013-05 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Southern Research Inst                                4-METHYLIMIDAZOLE                                   DATE: 12/06/04       
EXPERIMENT: 92013 TEST: 05                                                                                     TIME: 08:46:08       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85420                              ROUTE: DOSED FEED                                              NTP C#: 92013B       
PATHOLOGIST: FARNELL, DANIEL R.                                                                                CAS: 822-36-6        
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                                                           FINAL #1 RATS                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Southern Research Inst                                4-METHYLIMIDAZOLE                                   DATE: 12/06/04       
EXPERIMENT: 92013 TEST: 05                                                                                     TIME: 08:46:08       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85420                              ROUTE: DOSED FEED                                              NTP C#: 92013B       
PATHOLOGIST: FARNELL, DANIEL R.                                                                                CAS: 822-36-6        
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                   4-METHYLIMIDAZOLE                                                                              
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Adrenal Medulla                        Hyperplasia Focal                                                                            
Eye: Retina                            Degeneration                                                                                 
Kidney                                 Infarct                                                                                      
                                       Nephropathy                                                                                  
Liver                                  Congestion                                                                                   
                                       Eosinophilic Focus                                                                           
                                       Histiocytosis                                                                                
                                       Infiltration Cellular Mixed Cell                                                             
                                       Inflammation Chronic                                                                         
                                       Mixed Cell Focus                                                                             
Liver: Bile Duct                       Hyperplasia                                                                                  
Liver: Hepatocyte                      Fatty Change Focal                                                                           
Lung                                   Congestion                                                                                   
                                       Hemorrhage Focal                                                                             
Lymph Node: Mediastinal                Hyperplasia                                                                                  
Mammary Gland                          Dilatation                                                                                   
Nose: Nasolacrimal Duct                Inflammation                                                                                 
Pituitary Gland: Pars Distalis         Hemorrhage Focal                                                                             
                                       Hypertrophy Focal                                                                            
Preputial Gland                        Hyperplasia Cystic                                                                           
                                       Inflammation Chronic                                                                         
Prostate                               Inflammation Chronic                                                                         
Prostate: Epithelium                   Hyperplasia Focal                                                                            
Spleen                                 Atrophy                                                                                      
Stomach, Forestomach                   Edema                                                                                        
Stomach, Glandular                     Edema                                                                                        
                                       Erosion                                                                                      
Testes: Interstitial Cell              Hyperplasia Focal                                                                            
Thymus                                 Hemorrhage                                                                                   
Thyroid Gland: C-Cell                  Hyperplasia                                                                                  
Thyroid Gland: Follicle                Cyst                                                                                         
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Cortex                         Accessory Adrenal Cortical Nodule                                                            
Bone Marrow                            Atrophy                                                                                      
                                       Hyperplasia Focal Histiocytic                                                                
Brain                                  Compression Focal                                                                            
Clitoral Gland                         Hyperplasia Cystic                                                                           
Eye                                    Atrophy                                                                                      
Heart                                  Cardiomyopathy                                                                               
                                       Thrombosis                                                                                   
Kidney                                 Nephropathy                                                                                  
Kidney: Renal Tubule                   Pigmentation                                                                                 
Liver                                  Basophilic Focus                                                                             
                                       Clear Cell Focus                                                                             
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Southern Research Inst                                4-METHYLIMIDAZOLE                                   DATE: 12/06/04       
EXPERIMENT: 92013 TEST: 05                                                                                     TIME: 08:46:08       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85420                              ROUTE: DOSED FEED                                              NTP C#: 92013B       
PATHOLOGIST: FARNELL, DANIEL R.                                                                                CAS: 822-36-6        
                                       Eosinophilic Focus                                                                           
                                       Hepatodiaphragmatic Nodule                                                                   
                                       Histiocytosis                                                                                
                                       Hyperplasia Focal Histiocytic                                                                
                                       Infiltration Cellular Mixed Cell                                                             
                                       Inflammation Chronic                                                                         
                                       Mixed Cell Focus                                                                             
Liver: Bile Duct                       Hyperplasia                                                                                  
Liver: Hepatocyte                      Fatty Change Focal                                                                           
                                       Vacuolization Cytoplasmic                                                                    
Lung                                   Inflammation Chronic Focal                                                                   
Lymph Node, Mesenteric                 Hyperplasia                                                                                  
Lymph Node: Deep Cervical              Hemorrhage                                                                                   
Lymph Node: Mediastinal                Ectasia                                                                                      
Mammary Gland                          Dilatation                                                                                   
                                       Hyperplasia                                                                                  
Mesentery: Fat                         Necrosis Focal                                                                               
Ovary                                  Angiectasis                                                                                  
                                       Cyst                                                                                         
Pancreas: Acinus                       Atrophy Focal                                                                                
Pancreas: Duct                         Cyst Focal                                                                                   
Pituitary Gland                        Cyst                                                                                         
Pituitary Gland: Pars Distalis         Degeneration Cystic Focal                                                                    
                                       Hypertrophy Focal                                                                            
Spinal Cord                            Hemorrhage Focal                                                                             
Spleen                                 Hematopoietic Cell Proliferation                                                             
                                       Inflammation Granulomatous                                                                   
Stomach, Forestomach: Epithelium       Hyperplasia                                                                                  
Thymus                                 Cyst                                                                                         
Thyroid Gland: C-Cell                  Hyperplasia                                                                                  
Thyroid Gland: Follicle                Mineralization                                                                               
===============================================================                                                                     
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Accessory Adrenal Cortical Nodule                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     9/50 (18%)   6/50 (12%)   5/50 (10%)   9/50 (18%)  |8/49 (16%)   6/50 (12%)   3/50 (6%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     9/45.67      6/43.74      5/44.41      9/43.64     |8/45.90      6/46.30      3/43.76      2/44.39      | 
|POLY-3 PERCENT (g) |     19.7%        13.7%        11.3%        20.6%       |17.4%        13.0%        6.9%         4.5%         | 
|TERMINAL (d)       |     7/31 (23%)   4/34 (12%)   5/33 (15%)   9/32 (28%)  |7/43 (16%)   4/39 (10%)   3/34 (9%)    2/35 (6%)    | 
|FIRST INCIDENCE    |     653          567          729 (T)      729 (T)     |667          636          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.482      P=0.253N     P=0.169N     P=0.593N    |P=0.049N*    P=0.454N     P=0.189N     P=0.091N     | 
|POLY 3             |     P=0.463      P=0.318N     P=0.207N     P=0.562     |P=0.025N*    P=0.380N     P=0.114N     P=0.051N     | 
|POLY 1.5           |     P=0.475      P=0.312N     P=0.202N     P=0.578     |P=0.023N*    P=0.369N     P=0.103N     P=0.045N*    | 
|POLY 6             |     P=0.443      P=0.316N     P=0.214N     P=0.539     |P=0.029N*    P=0.392N     P=0.132N     P=0.059N     | 
|LOGISTIC REGRESSION|     P=0.445      P=0.317N     P=0.203N     P=0.538     |P=0.026N*    P=0.374N     P=0.132N     P=0.058N     | 
|COCH-ARM / FISHERS |     P=0.486      P=0.288N     P=0.194N     P=0.602N    |P=0.021N*    P=0.371N     P=0.094N     P=0.043N*    | 
|ORDER RESTRICTED   |     P=0.370      (e)          (e)          (e)         |P=0.030N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |4/49 (8%)    2/50 (4%)    7/50 (14%)   4/50 (8%)    | 
|POLY-3 RATE (b)    |     0/45.22      1/43.15      0/44.41      0/43.64     |4/46.67      2/46.50      7/43.88      4/44.39      | 
|POLY-3 PERCENT (g) |     0.0%         2.3%         0.0%         0.0%        |8.6%         4.3%         16.0%        9.0%         | 
|TERMINAL (d)       |     0/31 (0%)    1/34 (3%)    0/33 (0%)    0/32 (0%)   |3/43 (7%)    1/39 (3%)    5/34 (15%)   4/35 (11%)   | 
|FIRST INCIDENCE    |     ---          729 (T)      ---          ---         |16           421          700          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.567N     P=0.518      (e)          (e)         |P=0.309      P=0.366N     P=0.163      P=0.541      | 
|POLY 3             |     P=0.575N     P=0.491      (e)          (e)         |P=0.375      P=0.339N     P=0.227      P=0.615      | 
|POLY 1.5           |     P=0.573N     P=0.493      (e)          (e)         |P=0.395      P=0.333N     P=0.244      P=0.632      | 
|POLY 6             |     P=0.575N     P=0.491      (e)          (e)         |P=0.350      P=0.347N     P=0.203      P=0.593      | 
|LOGISTIC REGRESSION|     (e)          P=0.518      (e)          (e)         |P=0.429      P=0.417N     P=0.282      P=0.645      | 
|COCH-ARM / FISHERS |     P=0.567N     P=0.500      (e)          (e)         |P=0.425      P=0.329N     P=0.274      P=0.631N     | 
|ORDER RESTRICTED   |     P=0.379N     (e)          (e)          (e)         |P=0.256      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Cytoplasmic Alteration Focal                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    2/50 (4%)    1/50 (2%)    2/50 (4%)   |1/49 (2%)    2/50 (4%)    2/50 (4%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     3/45.71      2/43.15      1/44.41      2/44.01     |1/45.67      2/45.69      2/43.76      2/44.98      | 
|POLY-3 PERCENT (g) |     6.6%         4.6%         2.3%         4.5%        |2.2%         4.4%         4.6%         4.5%         | 
|TERMINAL (d)       |     2/31 (7%)    2/34 (6%)    1/33 (3%)    1/32 (3%)   |1/43 (2%)    2/39 (5%)    2/34 (6%)    1/35 (3%)    | 
|FIRST INCIDENCE    |     582          729 (T)      729 (T)      628         |729 (T)      729 (T)      729 (T)      541          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.400N     P=0.476N     P=0.294N     P=0.493N    |P=0.355      P=0.466      P=0.418      P=0.452      | 
|POLY 3             |     P=0.408N     P=0.526N     P=0.316N     P=0.517N    |P=0.412      P=0.500      P=0.485      P=0.495      | 
|POLY 1.5           |     P=0.406N     P=0.520N     P=0.312N     P=0.511N    |P=0.423      P=0.506      P=0.496      P=0.503      | 
|POLY 6             |     P=0.413N     P=0.529N     P=0.319N     P=0.525N    |P=0.397      P=0.492      P=0.469      P=0.483      | 
|LOGISTIC REGRESSION|     P=0.406N     P=0.511N     P=0.301N     P=0.480N    |P=0.424      P=0.466      P=0.418      P=0.505      | 
|COCH-ARM / FISHERS |     P=0.404N     P=0.500N     P=0.309N     P=0.500N    |P=0.429      P=0.508      P=0.508      P=0.508      | 
|ORDER RESTRICTED   |     P=0.373N     (e)          (e)          (e)         |P=0.450      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hemorrhage Focal                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/49 (0%)    0/50 (0%)    2/50 (4%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     1/45.71      0/43.15      0/44.41      0/43.64     |0/45.67      0/45.69      2/44.26      1/44.44      | 
|POLY-3 PERCENT (g) |     2.2%         0.0%         0.0%         0.0%        |0.0%         0.0%         4.5%         2.3%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |0/43 (0%)    0/39 (0%)    1/34 (3%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     582          ---          ---          ---         |---          ---          581          717          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.305N     P=0.522N     P=0.508N     P=0.500N    |P=0.220      (e)          P=0.210      P=0.465      | 
|POLY 3             |     P=0.297N     P=0.512N     P=0.506N     P=0.509N    |P=0.234      (e)          P=0.230      P=0.495      | 
|POLY 1.5           |     P=0.300N     P=0.509N     P=0.503N     P=0.506N    |P=0.242      (e)          P=0.236      P=0.500      | 
|POLY 6             |     P=0.295N     P=0.513N     P=0.508N     P=0.514N    |P=0.223      (e)          P=0.222      P=0.487      | 
|LOGISTIC REGRESSION|     P=0.297N     P=0.405N     P=0.463N     P=0.410N    |P=0.250      (e)          P=0.245      P=0.494      | 
|COCH-ARM / FISHERS |     P=0.306N     P=0.500N     P=0.500N     P=0.500N    |P=0.249      (e)          P=0.253      P=0.505      | 
|ORDER RESTRICTED   |     P=0.129N     (e)          (e)          (e)         |P=0.162      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Vacuolization Cytoplasmic Focal                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/50 (12%)   5/50 (10%)   13/50 (26%)  7/50 (14%)  |8/49 (16%)   9/50 (18%)   13/50 (26%)  12/50 (24%)  | 
|POLY-3 RATE (b)    |     6/45.39      5/43.15      13/46.97     7/44.16     |8/46.35      9/45.96      13/44.26     12/45.33     | 
|POLY-3 PERCENT (g) |     13.2%        11.6%        27.7%        15.9%       |17.3%        19.6%        29.4%        26.5%        | 
|TERMINAL (d)       |     5/31 (16%)   5/34 (15%)   7/33 (21%)   5/32 (16%)  |7/43 (16%)   7/39 (18%)   12/34 (35%)  8/35 (23%)   | 
|FIRST INCIDENCE    |     685          729 (T)      493          650         |498          677          581          628          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.310      P=0.444N     P=0.084      P=0.499     |P=0.072      P=0.422      P=0.061      P=0.128      | 
|POLY 3             |     P=0.296      P=0.536N     P=0.070      P=0.479     |P=0.138      P=0.492      P=0.131      P=0.208      | 
|POLY 1.5           |     P=0.302      P=0.527N     P=0.066      P=0.486     |P=0.154      P=0.511      P=0.152      P=0.227      | 
|POLY 6             |     P=0.288      P=0.538N     P=0.076      P=0.472     |P=0.121      P=0.473      P=0.106      P=0.188      | 
|LOGISTIC REGRESSION|     P=0.305      P=0.511N     P=0.068      P=0.461     |P=0.144      P=0.516      P=0.150      P=0.233      | 
|COCH-ARM / FISHERS |     P=0.310      P=0.500N     P=0.062      P=0.500     |P=0.170      P=0.518      P=0.176      P=0.242      | 
|ORDER RESTRICTED   |     P=0.178      (e)          (e)          (e)         |P=0.173      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/50 (14%)   1/50 (2%)    3/50 (6%)    0/50 (0%)   |2/48 (4%)    0/50 (0%)    2/50 (4%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     7/45.32      1/43.15      3/44.73      0/43.64     |2/44.67      0/45.69      2/43.76      0/44.39      | 
|POLY-3 PERCENT (g) |     15.5%        2.3%         6.7%         0.0%        |4.5%         0.0%         4.6%         0.0%         | 
|TERMINAL (d)       |     5/31 (16%)   1/34 (3%)    2/33 (6%)    0/32 (0%)   |2/42 (5%)    0/39 (0%)    2/34 (6%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     712          729 (T)      642          ---         |729 (T)      ---          729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.009N**   P=0.026N*    P=0.147N     P=0.010N*   |P=0.294N     P=0.255N     P=0.617      P=0.279N     | 
|POLY 3             |     P=0.008N**   P=0.035N*    P=0.162N     P=0.009N**  |P=0.247N     P=0.232N     P=0.687      P=0.239N     | 
|POLY 1.5           |     P=0.008N**   P=0.034N*    P=0.161N     P=0.008N**  |P=0.243N     P=0.228N     P=0.690N     P=0.232N     | 
|POLY 6             |     P=0.008N**   P=0.035N*    P=0.161N     P=0.009N**  |P=0.253N     P=0.237N     P=0.670      P=0.247N     | 
|LOGISTIC REGRESSION|     P=0.010N*    P=0.031N*    P=0.166N     P=0.011N*   |P=0.294N     (e)          P=0.617      (e)          | 
|COCH-ARM / FISHERS |     P=0.009N**   P=0.030N*    P=0.159N     P=0.006N**  |P=0.239N     P=0.237N     P=0.676N     P=0.237N     | 
|ORDER RESTRICTED   |     P<0.001N**   (e)          (e)          (e)         |P=0.116N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/47 (2%)    0/50 (0%)    0/48 (0%)    0/50 (0%)   |0/50 (0%)    0/48 (0%)    0/49 (0%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |     1/43.95      0/43.15      0/42.86      0/43.64     |0/46.53      0/44.39      0/43.76      2/42.90      | 
|POLY-3 PERCENT (g) |     2.3%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         4.7%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |0/43 (0%)    0/39 (0%)    0/34 (0%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     642          ---          ---          ---         |---          ---          ---          654          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.312N     P=0.523N     P=0.509N     P=0.514N    |P=0.043 *    (e)          (e)          P=0.217      | 
|POLY 3             |     P=0.288N     P=0.504N     P=0.505N     P=0.501N    |P=0.042 *    (e)          (e)          P=0.219      | 
|POLY 1.5           |     P=0.292N     P=0.499N     P=0.501N     P=0.496N    |P=0.043 *    (e)          (e)          P=0.225      | 
|POLY 6             |     P=0.284N     P=0.508N     P=0.509N     P=0.509N    |P=0.041 *    (e)          (e)          P=0.213      | 
|LOGISTIC REGRESSION|     P=0.291N     P=0.441N     P=0.457N     P=0.437N    |P=0.045 *    (e)          (e)          P=0.226      | 
|COCH-ARM / FISHERS |     P=0.300N     P=0.485N     P=0.495N     P=0.485N    |P=0.045 *    (e)          (e)          P=0.237      | 
|ORDER RESTRICTED   |     P=0.122N     (e)          (e)          (e)         |P=0.024 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/47 (4%)    3/50 (6%)    2/48 (4%)    4/50 (8%)   |3/50 (6%)    2/48 (4%)    1/49 (2%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |     2/44.04      3/44.21      2/43.60      4/43.89     |3/46.53      2/44.51      1/43.88      2/42.39      | 
|POLY-3 PERCENT (g) |     4.5%         6.8%         4.6%         9.1%        |6.5%         4.5%         2.3%         4.7%         | 
|TERMINAL (d)       |     0/31 (0%)    1/34 (3%)    0/33 (0%)    3/32 (9%)   |3/43 (7%)    1/39 (3%)    0/34 (0%)    2/33 (6%)    | 
|FIRST INCIDENCE    |     667          275          538          663         |729 (T)      700          700          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.258      P=0.490      P=0.675      P=0.313     |P=0.505N     P=0.540N     P=0.387N     P=0.620N     | 
|POLY 3             |     P=0.279      P=0.502      P=0.690      P=0.335     |P=0.433N     P=0.520N     P=0.327N     P=0.542N     | 
|POLY 1.5           |     P=0.289      P=0.511      P=0.693N     P=0.348     |P=0.424N     P=0.516N     P=0.316N     P=0.529N     | 
|POLY 6             |     P=0.265      P=0.494      P=0.686      P=0.319     |P=0.446N     P=0.525N     P=0.342N     P=0.560N     | 
|LOGISTIC REGRESSION|     P=0.321      P=0.689N     P=0.622N     P=0.360     |P=0.459N     P=0.526N     P=0.342N     P=0.620N     | 
|COCH-ARM / FISHERS |     P=0.302      P=0.530      P=0.684N     P=0.369     |P=0.416N     P=0.520N     P=0.316N     P=0.520N     | 
|ORDER RESTRICTED   |     P=0.299      (e)          (e)          (e)         |P=0.399N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia Focal Histiocytic                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/47 (0%)    0/50 (0%)    0/48 (0%)    0/50 (0%)   |0/50 (0%)    1/48 (2%)    2/49 (4%)    3/48 (6%)    | 
|POLY-3 RATE (b)    |     0/43.63      0/43.15      0/42.86      0/43.64     |0/46.53      1/44.39      2/43.76      3/42.39      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         2.3%         4.6%         7.1%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |0/43 (0%)    1/39 (3%)    2/34 (6%)    3/33 (9%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          729 (T)      729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.035 *    P=0.481      P=0.188      P=0.079      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.051      P=0.491      P=0.224      P=0.103      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.055      P=0.493      P=0.230      P=0.108      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.046 *    P=0.488      P=0.214      P=0.096      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          P=0.481      P=0.188      P=0.079      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.058      P=0.490      P=0.242      P=0.114      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.046 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain                                                                                                                            | 
|     Compression Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    6/50 (12%)   1/50 (2%)    1/50 (2%)   |13/50 (26%)  8/50 (16%)   8/50 (16%)   2/50 (4%)    | 
|POLY-3 RATE (b)    |     4/46.10      6/44.37      1/44.41      1/43.64     |13/47.02     8/46.34      8/43.76      2/44.44      | 
|POLY-3 PERCENT (g) |     8.7%         13.5%        2.3%         2.3%        |27.7%        17.3%        18.3%        4.5%         | 
|TERMINAL (d)       |     1/31 (3%)    4/34 (12%)   1/33 (3%)    1/32 (3%)   |10/43 (23%)  5/39 (13%)   8/34 (24%)   1/35 (3%)    | 
|FIRST INCIDENCE    |     464          477          729 (T)      729 (T)     |667          653          729 (T)      717          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.057N     P=0.392      P=0.179N     P=0.195N    |P=0.010N*    P=0.233N     P=0.345N     P=0.010N*    | 
|POLY 3             |     P=0.059N     P=0.345      P=0.190N     P=0.196N    |P=0.003N**   P=0.170N     P=0.209N     P=0.002N**   | 
|POLY 1.5           |     P=0.057N     P=0.350      P=0.186N     P=0.190N    |P=0.003N**   P=0.161N     P=0.185N     P=0.002N**   | 
|POLY 6             |     P=0.063N     P=0.348      P=0.194N     P=0.203N    |P=0.004N**   P=0.181N     P=0.251N     P=0.003N**   | 
|LOGISTIC REGRESSION|     P=0.050N     P=0.437      P=0.162N     P=0.154N    |P=0.004N**   P=0.166N     P=0.244N     P=0.003N**   | 
|COCH-ARM / FISHERS |     P=0.054N     P=0.370      P=0.181N     P=0.181N    |P=0.002N**   P=0.163N     P=0.163N     P=0.002N**   | 
|ORDER RESTRICTED   |     P=0.069N     (e)          (e)          (e)         |P<0.001N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain                                                                                                                            | 
|     Hemorrhage Focal                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    4/50 (8%)    3/50 (6%)    3/50 (6%)   |1/50 (2%)    2/50 (4%)    4/50 (8%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     1/45.31      4/44.51      3/46.10      3/44.56     |1/46.53      2/47.23      4/44.32      2/45.86      | 
|POLY-3 PERCENT (g) |     2.2%         9.0%         6.5%         6.7%        |2.2%         4.2%         9.0%         4.4%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |1/43 (2%)    0/39 (0%)    1/34 (3%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     705          567          493          607         |729 (T)      434          635          368          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.340      P=0.170      P=0.306      P=0.286     |P=0.353      P=0.491      P=0.136      P=0.481      | 
|POLY 3             |     P=0.349      P=0.173      P=0.311      P=0.299     |P=0.375      P=0.505      P=0.164      P=0.495      | 
|POLY 1.5           |     P=0.351      P=0.172      P=0.309      P=0.301     |P=0.385      P=0.507      P=0.172      P=0.501      | 
|POLY 6             |     P=0.346      P=0.178      P=0.315      P=0.298     |P=0.359      P=0.501      P=0.154      P=0.486      | 
|LOGISTIC REGRESSION|     P=0.371      P=0.222      P=0.374      P=0.341     |P=0.359      P=0.393      P=0.176      P=0.437      | 
|COCH-ARM / FISHERS |     P=0.357      P=0.181      P=0.309      P=0.309     |P=0.387      P=0.500      P=0.181      P=0.500      | 
|ORDER RESTRICTED   |     P=0.242      (e)          (e)          (e)         |P=0.250      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |4/50 (8%)    0/50 (0%)    5/50 (10%)   3/50 (6%)    | 
|POLY-3 RATE (b)    |                                                        |4/46.53      0/45.69      5/43.88      3/44.46      | 
|POLY-3 PERCENT (g) |                                                        |8.6%         0.0%         11.4%        6.8%         | 
|TERMINAL (d)       |                                                        |4/43 (9%)    0/39 (0%)    4/34 (12%)   2/35 (6%)    | 
|FIRST INCIDENCE    |                                                        |729 (T)      ---          700          712          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.396      P=0.076N     P=0.360      P=0.606N     | 
|POLY 3             |                                                        |P=0.477      P=0.063N     P=0.463      P=0.525N     | 
|POLY 1.5           |                                                        |P=0.488      P=0.061N     P=0.482      P=0.510N     | 
|POLY 6             |                                                        |P=0.461      P=0.065N     P=0.437      P=0.544N     | 
|LOGISTIC REGRESSION|                                                        |P=0.434      (e)          P=0.402      P=0.575N     | 
|COCH-ARM / FISHERS |                                                        |P=0.500      P=0.059N     P=0.500      P=0.500N     | 
|ORDER RESTRICTED   |                                                        |P=0.288      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |7/50 (14%)   4/50 (8%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |                                                        |7/46.53      4/45.96      1/44.10      1/44.39      | 
|POLY-3 PERCENT (g) |                                                        |15.0%        8.7%         2.3%         2.3%         | 
|TERMINAL (d)       |                                                        |7/43 (16%)   3/39 (8%)    0/34 (0%)    1/35 (3%)    | 
|FIRST INCIDENCE    |                                                        |729 (T)      657          635          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.023N*    P=0.318N     P=0.063N     P=0.060N     | 
|POLY 3             |                                                        |P=0.012N*    P=0.268N     P=0.036N*    P=0.035N*    | 
|POLY 1.5           |                                                        |P=0.011N*    P=0.260N     P=0.033N*    P=0.032N*    | 
|POLY 6             |                                                        |P=0.013N*    P=0.277N     P=0.041N*    P=0.040N*    | 
|LOGISTIC REGRESSION|                                                        |P=0.013N*    P=0.278N     P=0.039N*    P=0.060N     | 
|COCH-ARM / FISHERS |                                                        |P=0.011N*    P=0.262N     P=0.030N*    P=0.030N*    | 
|ORDER RESTRICTED   |                                                        |P=0.011N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |2/50 (4%)    2/50 (4%)    0/50 (0%)    3/50 (6%)    | 
|POLY-3 RATE (b)    |                                                        |2/46.53      2/45.69      0/43.76      3/44.39      | 
|POLY-3 PERCENT (g) |                                                        |4.3%         4.4%         0.0%         6.8%         | 
|TERMINAL (d)       |                                                        |2/43 (5%)    2/39 (5%)    0/34 (0%)    3/35 (9%)    | 
|FIRST INCIDENCE    |                                                        |729 (T)      729 (T)      ---          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.343      P=0.659      P=0.291N     P=0.406      | 
|POLY 3             |                                                        |P=0.407      P=0.687      P=0.251N     P=0.479      | 
|POLY 1.5           |                                                        |P=0.415      P=0.693      P=0.244N     P=0.491      | 
|POLY 6             |                                                        |P=0.395      P=0.680      P=0.261N     P=0.462      | 
|LOGISTIC REGRESSION|                                                        |P=0.343      P=0.659      (e)          P=0.406      | 
|COCH-ARM / FISHERS |                                                        |P=0.423      P=0.691N     P=0.247N     P=0.500      | 
|ORDER RESTRICTED   |                                                        |P=0.274      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye                                                                                                                              | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    0/48 (0%)    0/45 (0%)   |0/48 (0%)    0/45 (0%)    3/40 (8%)    4/45 (9%)    | 
|POLY-3 RATE (b)    |     0/43.79      0/41.81      0/42.89      0/40.07     |0/45.04      0/42.88      3/38.47      4/39.76      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         7.8%         10.1%        | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |0/43 (0%)    0/39 (0%)    3/34 (9%)    4/33 (12%)   | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.005 **   (e)          P=0.083      P=0.035 *    | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.007 **   (e)          P=0.091      P=0.045 *    | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.008 **   (e)          P=0.092      P=0.049 *    | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.006 **   (e)          P=0.089      P=0.041 *    | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          P=0.083      P=0.035 *    | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.010 *    (e)          P=0.090      P=0.051      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.012 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye                                                                                                                              | 
|     Cataract                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    1/47 (2%)    0/48 (0%)    2/45 (4%)   |4/48 (8%)    0/45 (0%)    1/40 (3%)    1/45 (2%)    | 
|POLY-3 RATE (b)    |     2/44.24      1/42.75      0/42.89      2/40.36     |4/45.04      0/42.88      1/38.47      1/39.76      | 
|POLY-3 PERCENT (g) |     4.5%         2.3%         0.0%         5.0%        |8.9%         0.0%         2.6%         2.5%         | 
|TERMINAL (d)       |     1/31 (3%)    0/34 (0%)    0/33 (0%)    1/32 (3%)   |4/43 (9%)    0/39 (0%)    1/34 (3%)    1/33 (3%)    | 
|FIRST INCIDENCE    |     597          275          ---          650         |729 (T)      ---          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.591      P=0.502N     P=0.235N     P=0.691N    |P=0.228N     P=0.076N     P=0.256N     P=0.267N     | 
|POLY 3             |     P=0.566      P=0.512N     P=0.244N     P=0.661     |P=0.189N     P=0.066N     P=0.229N     P=0.218N     | 
|POLY 1.5           |     P=0.568      P=0.511N     P=0.241N     P=0.663     |P=0.186N     P=0.066N     P=0.228N     P=0.207N     | 
|POLY 6             |     P=0.564      P=0.511N     P=0.246N     P=0.660     |P=0.191N     P=0.068N     P=0.234N     P=0.233N     | 
|LOGISTIC REGRESSION|     P=0.622N     P=0.280N     P=0.219N     P=0.696     |P=0.228N     (e)          P=0.256N     P=0.267N     | 
|COCH-ARM / FISHERS |     P=0.572      P=0.508N     P=0.247N     P=0.667     |P=0.182N     P=0.067N     P=0.242N     P=0.201N     | 
|ORDER RESTRICTED   |     P=0.378      (e)          (e)          (e)         |P=0.051N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye                                                                                                                              | 
|     Synechia                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    0/48 (0%)    0/45 (0%)   |1/48 (2%)    0/45 (0%)    0/40 (0%)    2/45 (4%)    | 
|POLY-3 RATE (b)    |     0/43.79      0/41.81      0/42.89      0/40.07     |1/45.04      0/42.88      0/38.47      2/39.76      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |2.2%         0.0%         0.0%         5.0%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |1/43 (2%)    0/39 (0%)    0/34 (0%)    2/33 (6%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |729 (T)      ---          ---          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.193      P=0.519N     P=0.547N     P=0.408      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.228      P=0.510N     P=0.531N     P=0.457      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.231      P=0.509N     P=0.531N     P=0.468      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.224      P=0.512N     P=0.534N     P=0.442      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.193      (e)          (e)          P=0.408      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.236      P=0.516N     P=0.545N     P=0.476      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.107      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Anterior Chamber                                                                                                            | 
|     Exudate                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    1/47 (2%)    0/48 (0%)    2/45 (4%)   |0/48 (0%)    1/45 (2%)    0/40 (0%)    1/45 (2%)    | 
|POLY-3 RATE (b)    |     0/43.79      1/41.81      0/42.89      2/41.23     |0/45.04      1/42.88      0/38.47      1/39.76      | 
|POLY-3 PERCENT (g) |     0.0%         2.4%         0.0%         4.9%        |0.0%         2.3%         0.0%         2.5%         | 
|TERMINAL (d)       |     0/31 (0%)    1/34 (3%)    0/33 (0%)    0/32 (0%)   |0/43 (0%)    1/39 (3%)    0/34 (0%)    1/33 (3%)    | 
|FIRST INCIDENCE    |     ---          729 (T)      ---          369         |---          729 (T)      ---          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.140      P=0.518      (e)          P=0.232     |P=0.351      P=0.481      (e)          P=0.447      | 
|POLY 3             |     P=0.129      P=0.491      (e)          P=0.224     |P=0.378      P=0.490      (e)          P=0.475      | 
|POLY 1.5           |     P=0.129      P=0.492      (e)          P=0.223     |P=0.387      P=0.491      (e)          P=0.482      | 
|POLY 6             |     P=0.130      P=0.492      (e)          P=0.225     |P=0.367      P=0.488      (e)          P=0.467      | 
|LOGISTIC REGRESSION|     P=0.147      P=0.518      (e)          P=0.388     |(e)          P=0.481      (e)          P=0.447      | 
|COCH-ARM / FISHERS |     P=0.129      P=0.495      (e)          P=0.231     |P=0.393      P=0.484      (e)          P=0.484      | 
|ORDER RESTRICTED   |     P=0.066      (e)          (e)          (e)         |P=0.227      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Cornea                                                                                                                      | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    0/48 (0%)    0/45 (0%)   |0/48 (0%)    1/45 (2%)    1/40 (3%)    2/45 (4%)    | 
|POLY-3 RATE (b)    |     0/43.79      0/41.81      0/42.89      0/40.07     |0/45.04      1/42.88      1/38.47      2/39.76      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         2.3%         2.6%         5.0%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |0/43 (0%)    1/39 (3%)    1/34 (3%)    2/33 (6%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          729 (T)      729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.108      P=0.481      P=0.453      P=0.182      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.132      P=0.490      P=0.468      P=0.210      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.139      P=0.491      P=0.469      P=0.217      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.124      P=0.488      P=0.466      P=0.201      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          P=0.481      P=0.453      P=0.182      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.145      P=0.484      P=0.455      P=0.231      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.099      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Retina                                                                                                                      | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    0/47 (0%)    0/48 (0%)    0/45 (0%)   |4/48 (8%)    1/45 (2%)    0/40 (0%)    3/45 (7%)    | 
|POLY-3 RATE (b)    |     2/44.24      0/41.81      0/42.89      0/40.07     |4/45.04      1/42.88      0/38.47      3/39.76      | 
|POLY-3 PERCENT (g) |     4.5%         0.0%         0.0%         0.0%        |8.9%         2.3%         0.0%         7.6%         | 
|TERMINAL (d)       |     1/31 (3%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |4/43 (9%)    1/39 (3%)    0/34 (0%)    3/33 (9%)    | 
|FIRST INCIDENCE    |     597          ---          ---          ---         |729 (T)      729 (T)      ---          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.113N     P=0.239N     P=0.235N     P=0.234N    |P=0.582      P=0.210N     P=0.097N     P=0.643N     | 
|POLY 3             |     P=0.115N     P=0.250N     P=0.244N     P=0.259N    |P=0.534N     P=0.194N     P=0.081N     P=0.568N     | 
|POLY 1.5           |     P=0.115N     P=0.248N     P=0.241N     P=0.257N    |P=0.532N     P=0.192N     P=0.081N     P=0.550N     | 
|POLY 6             |     P=0.115N     P=0.250N     P=0.246N     P=0.261N    |P=0.537N     P=0.197N     P=0.084N     P=0.590N     | 
|LOGISTIC REGRESSION|     P=0.113N     P=0.215N     P=0.219N     P=0.224N    |P=0.582      P=0.210N     (e)          P=0.643N     | 
|COCH-ARM / FISHERS |     P=0.119N     P=0.253N     P=0.247N     P=0.264N    |P=0.528N     P=0.201N     P=0.083N     P=0.536N     | 
|ORDER RESTRICTED   |     P=0.037N*    (e)          (e)          (e)         |P=0.175N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Hyperplasia Focal Histiocytic                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    4/50 (8%)    5/50 (10%)   0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/45.22      0/43.15      0/44.41      0/43.64     |1/46.53      4/45.69      5/43.76      0/44.39      | 
|POLY-3 PERCENT (g) |     2.2%         0.0%         0.0%         0.0%        |2.2%         8.8%         11.4%        0.0%         | 
|TERMINAL (d)       |     1/31 (3%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |1/43 (2%)    4/39 (10%)   5/34 (15%)   0/35 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      ---          ---          ---         |729 (T)      729 (T)      729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.303N     P=0.482N     P=0.488N     P=0.494N    |P=0.382N     P=0.151      P=0.058      P=0.541N     | 
|POLY 3             |     P=0.299N     P=0.509N     P=0.504N     P=0.507N    |P=0.320N     P=0.173      P=0.088      P=0.509N     | 
|POLY 1.5           |     P=0.301N     P=0.507N     P=0.502N     P=0.505N    |P=0.303N     P=0.179      P=0.095      P=0.504N     | 
|POLY 6             |     P=0.298N     P=0.509N     P=0.505N     P=0.510N    |P=0.345N     P=0.167      P=0.079      P=0.517N     | 
|LOGISTIC REGRESSION|     P=0.303N     (e)          (e)          (e)         |P=0.382N     P=0.151      P=0.058      (e)          | 
|COCH-ARM / FISHERS |     P=0.306N     P=0.500N     P=0.500N     P=0.500N    |P=0.292N     P=0.181      P=0.102      P=0.500N     | 
|ORDER RESTRICTED   |     P=0.127N     (e)          (e)          (e)         |P=0.092N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)   |1/50 (2%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/45.22      0/43.15      2/44.52      0/43.64     |1/46.53      1/45.69      0/43.76      0/44.39      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         4.5%         0.0%        |2.2%         2.2%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    1/33 (3%)    0/32 (0%)   |1/43 (2%)    1/39 (3%)    0/34 (0%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          700          ---         |729 (T)      729 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.581      (e)          P=0.244      (e)         |P=0.271N     P=0.740      P=0.547N     P=0.541N     | 
|POLY 3             |     P=0.583      (e)          P=0.234      (e)         |P=0.242N     P=0.756      P=0.512N     P=0.509N     | 
|POLY 1.5           |     P=0.588      (e)          P=0.235      (e)         |P=0.239N     P=0.760      P=0.506N     P=0.504N     | 
|POLY 6             |     P=0.573      (e)          P=0.233      (e)         |P=0.246N     P=0.752      P=0.521N     P=0.517N     | 
|LOGISTIC REGRESSION|     P=0.588      (e)          P=0.233      (e)         |P=0.271N     P=0.740      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.595      (e)          P=0.247      (e)         |P=0.236N     P=0.753N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.244      (e)          (e)          (e)         |P=0.257N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     40/50 (80%)  38/50 (76%)  36/50 (72%)  39/50 (78%) |30/50 (60%)  43/50 (86%)  38/48 (79%)  44/50 (88%)  | 
|POLY-3 RATE (b)    |     40/48.09     38/44.61     36/46.50     39/48.66    |30/47.88     43/48.40     38/43.65     44/47.67     | 
|POLY-3 PERCENT (g) |     83.2%        85.2%        77.4%        80.2%       |62.7%        88.9%        87.1%        92.3%        | 
|TERMINAL (d)       |     29/31 (94%)  32/34 (94%)  27/33 (82%)  27/32 (84%) |27/43 (63%)  35/39 (90%)  32/33 (97%)  34/35 (97%)  | 
|FIRST INCIDENCE    |     582          547          538          369         |16           421          552          323          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.497N     P=0.234N     P=0.195N     P=0.485N    |P<0.001 **   P=0.002 **   P<0.001 **   P<0.001 **   | 
|POLY 3             |     P=0.320N     P=0.509      P=0.319N     P=0.450N    |P<0.001 **   P=0.002 **   P=0.005 **   P<0.001 **   | 
|POLY 1.5           |     P=0.365N     P=0.607      P=0.281N     P=0.465N    |P<0.001 **   P=0.002 **   P=0.010 *    P<0.001 **   | 
|POLY 6             |     P=0.290N     P=0.408      P=0.374N     P=0.449N    |P<0.001 **   P=0.002 **   P=0.002 **   P<0.001 **   | 
|LOGISTIC REGRESSION|     P=0.516N     P=0.573      P=0.293N     P=0.533N    |P=0.002 **   P=0.004 **   P=0.018 *    P<0.001 **   | 
|COCH-ARM / FISHERS |     P=0.466N     P=0.405N     P=0.241N     P=0.500N    |P=0.004 **   P=0.003 **   P=0.032 *    P<0.001 **   | 
|ORDER RESTRICTED   |     P=0.371N     (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Thrombosis                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    3/50 (6%)    1/50 (2%)    4/50 (8%)   |0/50 (0%)    0/50 (0%)    2/48 (4%)    5/50 (10%)   | 
|POLY-3 RATE (b)    |     1/45.54      3/44.32      1/44.73      4/44.47     |0/46.53      0/45.69      2/42.77      5/44.55      | 
|POLY-3 PERCENT (g) |     2.2%         6.8%         2.2%         9.0%        |0.0%         0.0%         4.7%         11.2%        | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    1/32 (3%)   |0/43 (0%)    0/39 (0%)    0/33 (0%)    4/35 (11%)   | 
|FIRST INCIDENCE    |     642          593          642          584         |---          ---          635          688          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.164      P=0.278      P=0.751      P=0.171     |P=0.002 **   (e)          P=0.220      P=0.020 *    | 
|POLY 3             |     P=0.157      P=0.296      P=0.757      P=0.171     |P=0.002 **   (e)          P=0.219      P=0.027 *    | 
|POLY 1.5           |     P=0.160      P=0.296      P=0.758      P=0.174     |P=0.002 **   (e)          P=0.223      P=0.029 *    | 
|POLY 6             |     P=0.154      P=0.300      P=0.756      P=0.169     |P=0.002 **   (e)          P=0.212      P=0.024 *    | 
|LOGISTIC REGRESSION|     P=0.167      P=0.392      P=0.744N     P=0.203     |P=0.003 **   (e)          P=0.231      P=0.026 *    | 
|COCH-ARM / FISHERS |     P=0.164      P=0.309      P=0.753N     P=0.181     |P=0.003 **   (e)          P=0.237      P=0.028 *    | 
|ORDER RESTRICTED   |     P=0.105      (e)          (e)          (e)         |P=0.003 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 13      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    1/49 (2%)    0/48 (0%)    0/50 (0%)   |0/48 (0%)    0/48 (0%)    2/43 (5%)    0/43 (0%)    | 
|POLY-3 RATE (b)    |     2/44.18      1/42.48      0/42.84      0/43.64     |0/44.67      0/44.39      2/40.28      0/38.77      | 
|POLY-3 PERCENT (g) |     4.5%         2.4%         0.0%         0.0%        |0.0%         0.0%         5.0%         0.0%         | 
|TERMINAL (d)       |     2/31 (7%)    1/34 (3%)    0/33 (0%)    0/32 (0%)   |0/42 (0%)    0/39 (0%)    2/34 (6%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      ---          ---         |---          ---          729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.097N     P=0.468N     P=0.224N     P=0.231N    |P=0.544      (e)          P=0.193      (e)          | 
|POLY 3             |     P=0.098N     P=0.514N     P=0.244N     P=0.240N    |P=0.551      (e)          P=0.214      (e)          | 
|POLY 1.5           |     P=0.097N     P=0.508N     P=0.241N     P=0.235N    |P=0.563      (e)          P=0.216      (e)          | 
|POLY 6             |     P=0.098N     P=0.516N     P=0.246N     P=0.246N    |P=0.534      (e)          P=0.211      (e)          | 
|LOGISTIC REGRESSION|     P=0.097N     P=0.468N     (e)          (e)         |(e)          (e)          P=0.193      (e)          | 
|COCH-ARM / FISHERS |     P=0.098N     P=0.492N     P=0.247N     P=0.237N    |P=0.570      (e)          P=0.221      (e)          | 
|ORDER RESTRICTED   |     P=0.076N     (e)          (e)          (e)         |P=0.228      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Infarct                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    2/49 (4%)    1/48 (2%)    4/50 (8%)   |1/48 (2%)    1/48 (2%)    1/43 (2%)    2/43 (5%)    | 
|POLY-3 RATE (b)    |     0/44.18      2/42.94      1/43.13      4/44.50     |1/44.67      1/44.59      1/40.28      2/38.77      | 
|POLY-3 PERCENT (g) |     0.0%         4.7%         2.3%         9.0%        |2.2%         2.2%         2.5%         5.2%         | 
|TERMINAL (d)       |     0/31 (0%)    1/34 (3%)    0/33 (0%)    0/32 (0%)   |1/42 (2%)    0/39 (0%)    1/34 (3%)    2/33 (6%)    | 
|FIRST INCIDENCE    |     ---          593          650          622         |729 (T)      677          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.039 *    P=0.242      P=0.486      P=0.056     |P=0.281      P=0.747      P=0.714      P=0.416      | 
|POLY 3             |     P=0.040 *    P=0.231      P=0.495      P=0.061     |P=0.303      P=0.760      P=0.738      P=0.451      | 
|POLY 1.5           |     P=0.041 *    P=0.233      P=0.497      P=0.063     |P=0.310      P=0.759N     P=0.739      P=0.459      | 
|POLY 6             |     P=0.039 *    P=0.231      P=0.494      P=0.059     |P=0.294      P=0.758      P=0.734      P=0.439      | 
|LOGISTIC REGRESSION|     P=0.045 *    P=0.263      P=0.528      P=0.078     |P=0.301      P=0.762N     P=0.714      P=0.416      | 
|COCH-ARM / FISHERS |     P=0.043 *    P=0.253      P=0.500      P=0.064     |P=0.312      P=0.753N     P=0.725      P=0.458      | 
|ORDER RESTRICTED   |     P=0.019 *    (e)          (e)          (e)         |P=0.351      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 14      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     47/48 (98%)  43/49 (88%)  47/48 (98%)  46/50 (92%) |45/48 (94%)  37/48 (77%)  36/43 (84%)  38/43 (88%)  | 
|POLY-3 RATE (b)    |     47/47.26     43/47.55     47/47.86     46/48.73    |45/45.70     37/45.83     36/41.42     38/40.42     | 
|POLY-3 PERCENT (g) |     99.5%        90.4%        98.2%        94.4%       |98.5%        80.7%        86.9%        94.0%        | 
|TERMINAL (d)       |     31/31 (100%) 32/34 (94%)  33/33 (100%) 32/32 (100%)|42/42 (100%) 33/39 (85%)  31/34 (91%)  33/33 (100%) | 
|FIRST INCIDENCE    |     547          275          493          369         |498          434          581          541          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.468      P=0.159N     P=0.458N     P=0.518N    |P=0.183      P=0.125N     P=0.525N     P=0.322      | 
|POLY 3             |     P=0.356N     P=0.043N*    P=0.672N     P=0.154N    |P=0.551N     P=0.004N**   P=0.033N*    P=0.248N     | 
|POLY 1.5           |     P=0.341N     P=0.044N*    P=0.709N     P=0.157N    |P=0.479N     P=0.004N**   P=0.036N*    P=0.189N     | 
|POLY 6             |     P=0.434N     P=0.054N     P=0.669N     P=0.205N    |P=0.510      P=0.004N**   P=0.033N*    P=0.422N     | 
|LOGISTIC REGRESSION|     P=0.386N     P=0.102N     P=0.706      P=0.302N    |P=0.561N     P=0.009N**   P=0.040N*    P=0.318N     | 
|COCH-ARM / FISHERS |     P=0.361N     P=0.059N     P=0.753N     P=0.194N    |P=0.484N     P=0.020N*    P=0.117N     P=0.297N     | 
|ORDER RESTRICTED   |     P=0.129N     (e)          (e)          (e)         |P=0.036N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Accumulation, Hyaline Droplet                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    3/49 (6%)    2/48 (4%)    2/50 (4%)   |3/48 (6%)    0/48 (0%)    2/43 (5%)    1/43 (2%)    | 
|POLY-3 RATE (b)    |     1/44.28      3/42.48      2/43.51      2/43.98     |3/45.35      0/44.39      2/40.56      1/38.77      | 
|POLY-3 PERCENT (g) |     2.3%         7.1%         4.6%         4.6%        |6.6%         0.0%         4.9%         2.6%         | 
|TERMINAL (d)       |     0/31 (0%)    3/34 (9%)    0/33 (0%)    0/32 (0%)   |2/42 (5%)    0/39 (0%)    1/34 (3%)    1/33 (3%)    | 
|FIRST INCIDENCE    |     705          729 (T)      538          666         |498          ---          653          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.480      P=0.329      P=0.495      P=0.459     |P=0.400N     P=0.135N     P=0.569N     P=0.373N     | 
|POLY 3             |     P=0.492      P=0.290      P=0.494      P=0.498     |P=0.387N     P=0.123N     P=0.551N     P=0.363N     | 
|POLY 1.5           |     P=0.501      P=0.296      P=0.496      P=0.504     |P=0.383N     P=0.119N     P=0.546N     P=0.352N     | 
|POLY 6             |     P=0.481      P=0.287      P=0.492      P=0.490     |P=0.393N     P=0.126N     P=0.558N     P=0.378N     | 
|LOGISTIC REGRESSION|     P=0.518      P=0.292      P=0.549      P=0.522     |P=0.389N     P=0.129N     P=0.579N     P=0.351N     | 
|COCH-ARM / FISHERS |     P=0.515      P=0.316      P=0.500      P=0.515     |P=0.379N     P=0.121N     P=0.553N     P=0.351N     | 
|ORDER RESTRICTED   |     P=0.383      (e)          (e)          (e)         |P=0.241N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 15      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    1/49 (2%)    2/48 (4%)    0/50 (0%)   |0/48 (0%)    0/48 (0%)    0/43 (0%)    2/43 (5%)    | 
|POLY-3 RATE (b)    |     1/44.30      1/42.48      2/43.45      0/43.64     |0/44.67      0/44.39      0/40.28      2/39.16      | 
|POLY-3 PERCENT (g) |     2.3%         2.4%         4.6%         0.0%        |0.0%         0.0%         0.0%         5.1%         | 
|TERMINAL (d)       |     0/31 (0%)    1/34 (3%)    0/33 (0%)    0/32 (0%)   |0/42 (0%)    0/39 (0%)    0/34 (0%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     700          729 (T)      642          ---         |---          ---          ---          642          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.382N     P=0.756N     P=0.484      P=0.533N    |P=0.042 *    (e)          (e)          P=0.216      | 
|POLY 3             |     P=0.372N     P=0.751      P=0.493      P=0.503N    |P=0.038 *    (e)          (e)          P=0.208      | 
|POLY 1.5           |     P=0.365N     P=0.755      P=0.496      P=0.499N    |P=0.038 *    (e)          (e)          P=0.212      | 
|POLY 6             |     P=0.381N     P=0.750      P=0.493      P=0.509N    |P=0.037 *    (e)          (e)          P=0.203      | 
|LOGISTIC REGRESSION|     P=0.352N     P=0.754      P=0.537      P=0.494N    |P=0.038 *    (e)          (e)          P=0.210      | 
|COCH-ARM / FISHERS |     P=0.357N     P=0.747N     P=0.500      P=0.490N    |P=0.039 *    (e)          (e)          P=0.221      | 
|ORDER RESTRICTED   |     P=0.267N     (e)          (e)          (e)         |P=0.021 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     31/50 (62%)  26/50 (52%)  30/50 (60%)  36/50 (72%) |46/50 (92%)  43/50 (86%)  31/48 (65%)  25/50 (50%)  | 
|POLY-3 RATE (b)    |     31/46.54     26/43.76     30/46.16     36/46.55    |46/47.95     43/47.57     31/45.14     25/45.95     | 
|POLY-3 PERCENT (g) |     66.6%        59.4%        65.0%        77.3%       |95.9%        90.4%        68.7%        54.4%        | 
|TERMINAL (d)       |     27/31 (87%)  24/34 (71%)  26/33 (79%)  30/32 (94%) |42/43 (98%)  37/39 (95%)  27/34 (79%)  20/35 (57%)  | 
|FIRST INCIDENCE    |     464          577          531          369         |302          421          552          538          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.055      P=0.068N     P=0.358N     P=0.183     |P<0.001N**   P=0.499      P=0.078N     P=0.002N**   | 
|POLY 3             |     P=0.084      P=0.305N     P=0.522N     P=0.163     |P<0.001N**   P=0.230N     P<0.001N**   P<0.001N**   | 
|POLY 1.5           |     P=0.090      P=0.280N     P=0.515N     P=0.181     |P<0.001N**   P=0.201N     P<0.001N**   P<0.001N**   | 
|POLY 6             |     P=0.068      P=0.310N     P=0.524N     P=0.132     |P<0.001N**   P=0.265N     P<0.001N**   P<0.001N**   | 
|LOGISTIC REGRESSION|     P=0.057      P=0.291N     P=0.564N     P=0.135     |P<0.001N**   P=0.218N     P<0.001N**   P<0.001N**   | 
|COCH-ARM / FISHERS |     P=0.088      P=0.210N     P=0.500N     P=0.198     |P<0.001N**   P=0.262N     P<0.001N**   P<0.001N**   | 
|ORDER RESTRICTED   |     P=0.091      (e)          (e)          (e)         |P<0.001N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 16      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Clear Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     31/50 (62%)  28/50 (56%)  29/50 (58%)  31/50 (62%) |20/50 (40%)  32/50 (64%)  23/48 (48%)  27/50 (54%)  | 
|POLY-3 RATE (b)    |     31/46.03     28/43.26     29/44.52     31/43.93    |20/46.53     32/45.98     23/43.62     27/45.66     | 
|POLY-3 PERCENT (g) |     67.4%        64.7%        65.1%        70.6%       |43.0%        69.6%        52.7%        59.1%        | 
|TERMINAL (d)       |     27/31 (87%)  27/34 (79%)  28/33 (85%)  30/32 (94%) |20/43 (47%)  31/39 (80%)  23/34 (68%)  25/35 (71%)  | 
|FIRST INCIDENCE    |     667          700          700          653         |729 (T)      653          729 (T)      323          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.450      P=0.126N     P=0.237N     P=0.560N    |P=0.024 *    P<0.001 **   P=0.053      P=0.010 *    | 
|POLY 3             |     P=0.379      P=0.484N     P=0.500N     P=0.457     |P=0.206      P=0.007 **   P=0.235      P=0.085      | 
|POLY 1.5           |     P=0.426      P=0.440N     P=0.462N     P=0.511     |P=0.246      P=0.009 **   P=0.274      P=0.106      | 
|POLY 6             |     P=0.294      P=0.520N     P=0.555N     P=0.367     |P=0.149      P=0.004 **   P=0.175      P=0.061      | 
|LOGISTIC REGRESSION|     P=0.176      P=0.380N     P=0.458N     P=0.275     |P=0.107      P=0.003 **   P=0.053      P=0.069      | 
|COCH-ARM / FISHERS |     P=0.471      P=0.342N     P=0.419N     P=0.582N    |P=0.259      P=0.014 *    P=0.279      P=0.115      | 
|ORDER RESTRICTED   |     P=0.477      (e)          (e)          (e)         |P=0.053      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Congestion                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |2/50 (4%)    2/50 (4%)    0/48 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     2/45.22      0/43.15      0/44.41      0/43.64     |2/47.53      2/45.89      0/43.62      1/44.55      | 
|POLY-3 PERCENT (g) |     4.4%         0.0%         0.0%         0.0%        |4.2%         4.4%         0.0%         2.2%         | 
|TERMINAL (d)       |     2/31 (7%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |1/43 (2%)    1/39 (3%)    0/34 (0%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      ---          ---          ---         |16           677          ---          688          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.112N     P=0.218N     P=0.224N     P=0.231N    |P=0.339N     P=0.671      P=0.268N     P=0.540N     | 
|POLY 3             |     P=0.109N     P=0.248N     P=0.241N     P=0.245N    |P=0.310N     P=0.681      P=0.257N     P=0.523N     | 
|POLY 1.5           |     P=0.110N     P=0.246N     P=0.240N     P=0.242N    |P=0.305N     P=0.686      P=0.251N     P=0.513N     | 
|POLY 6             |     P=0.109N     P=0.247N     P=0.242N     P=0.248N    |P=0.318N     P=0.675      P=0.267N     P=0.534N     | 
|LOGISTIC REGRESSION|     P=0.112N     (e)          (e)          (e)         |P=0.360N     P=0.599      P=0.479N     P=0.608N     | 
|COCH-ARM / FISHERS |     P=0.115N     P=0.247N     P=0.247N     P=0.247N    |P=0.298N     P=0.691N     P=0.258N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.032N*    (e)          (e)          (e)         |P=0.282N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 17      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Degeneration Cystic Focal                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    3/50 (6%)    1/50 (2%)    7/50 (14%)  |1/50 (2%)    0/50 (0%)    1/48 (2%)    3/50 (6%)    | 
|POLY-3 RATE (b)    |     4/45.22      3/43.33      1/44.41      7/45.23     |1/46.53      0/45.69      1/43.62      3/44.55      | 
|POLY-3 PERCENT (g) |     8.9%         6.9%         2.3%         15.5%       |2.2%         0.0%         2.3%         6.7%         | 
|TERMINAL (d)       |     4/31 (13%)   1/34 (3%)    1/33 (3%)    4/32 (13%)  |1/43 (2%)    0/39 (0%)    1/34 (3%)    2/35 (6%)    | 
|FIRST INCIDENCE    |     729 (T)      700          729 (T)      384         |729 (T)      ---          729 (T)      688          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.147      P=0.466N     P=0.159N     P=0.275     |P=0.073      P=0.519N     P=0.709      P=0.242      | 
|POLY 3             |     P=0.150      P=0.523N     P=0.184N     P=0.260     |P=0.092      P=0.504N     P=0.746      P=0.290      | 
|POLY 1.5           |     P=0.150      P=0.519N     P=0.182N     P=0.261     |P=0.095      P=0.500N     P=0.752      P=0.299      | 
|POLY 6             |     P=0.148      P=0.521N     P=0.185N     P=0.260     |P=0.089      P=0.508N     P=0.737      P=0.278      | 
|LOGISTIC REGRESSION|     P=0.149      P=0.517N     P=0.159N     P=0.285     |P=0.085      (e)          P=0.709      P=0.283      | 
|COCH-ARM / FISHERS |     P=0.148      P=0.500N     P=0.181N     P=0.262     |P=0.097      P=0.500N     P=0.742      P=0.309      | 
|ORDER RESTRICTED   |     P=0.075      (e)          (e)          (e)         |P=0.074      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    3/50 (6%)    7/50 (14%)   12/50 (24%) |1/50 (2%)    2/50 (4%)    5/48 (10%)   11/50 (22%)  | 
|POLY-3 RATE (b)    |     4/45.39      3/43.15      7/44.41      12/43.64    |1/46.53      2/46.03      5/43.62      11/45.81     | 
|POLY-3 PERCENT (g) |     8.8%         7.0%         15.8%        27.5%       |2.2%         4.3%         11.5%        24.0%        | 
|TERMINAL (d)       |     3/31 (10%)   3/34 (9%)    7/33 (21%)   12/32 (38%) |1/43 (2%)    1/39 (3%)    5/34 (15%)   8/35 (23%)   | 
|FIRST INCIDENCE    |     685          729 (T)      729 (T)      729 (T)     |729 (T)      636          729 (T)      538          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.003 **   P=0.461N     P=0.290      P=0.027 *   |P<0.001 **   P=0.477      P=0.058      P<0.001 **   | 
|POLY 3             |     P=0.003 **   P=0.528N     P=0.248      P=0.019 *   |P<0.001 **   P=0.496      P=0.087      P=0.002 **   | 
|POLY 1.5           |     P=0.003 **   P=0.521N     P=0.254      P=0.022 *   |P<0.001 **   P=0.501      P=0.092      P=0.002 **   | 
|POLY 6             |     P=0.002 **   P=0.529N     P=0.242      P=0.016 *   |P<0.001 **   P=0.491      P=0.078      P<0.001 **   | 
|LOGISTIC REGRESSION|     P=0.002 **   P=0.517N     P=0.252      P=0.016 *   |P<0.001 **   P=0.500      P=0.058      P=0.003 **   | 
|COCH-ARM / FISHERS |     P=0.004 **   P=0.500N     P=0.262      P=0.027 *   |P<0.001 **   P=0.500      P=0.093      P=0.002 **   | 
|ORDER RESTRICTED   |     P=0.005 **   (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 18      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatodiaphragmatic Nodule                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/50 (10%)   2/50 (4%)    5/50 (10%)   4/50 (8%)   |5/50 (10%)   4/50 (8%)    6/48 (13%)   11/50 (22%)  | 
|POLY-3 RATE (b)    |     5/47.01      2/43.87      5/45.69      4/43.64     |5/46.53      4/46.23      6/44.57      11/46.66     | 
|POLY-3 PERCENT (g) |     10.6%        4.6%         10.9%        9.2%        |10.8%        8.7%         13.5%        23.6%        | 
|TERMINAL (d)       |     2/31 (7%)    1/34 (3%)    1/33 (3%)    4/32 (13%)  |5/43 (12%)   2/39 (5%)    3/34 (9%)    5/35 (14%)   | 
|FIRST INCIDENCE    |     464          477          531          729 (T)     |729 (T)      636          578          368          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.563      P=0.220N     P=0.620N     P=0.491N    |P=0.016 *    P=0.550N     P=0.368      P=0.052      | 
|POLY 3             |     P=0.540      P=0.245N     P=0.612      P=0.546N    |P=0.027 *    P=0.504N     P=0.470      P=0.084      | 
|POLY 1.5           |     P=0.554      P=0.237N     P=0.618      P=0.529N    |P=0.028 *    P=0.497N     P=0.480      P=0.088      | 
|POLY 6             |     P=0.521      P=0.250N     P=0.609      P=0.567N    |P=0.025 *    P=0.511N     P=0.451      P=0.080      | 
|LOGISTIC REGRESSION|     P=0.555N     P=0.099N     P=0.552N     P=0.443N    |P=0.028 *    P=0.503N     P=0.473      P=0.087      | 
|COCH-ARM / FISHERS |     P=0.570      P=0.218N     P=0.630N     P=0.500N    |P=0.027 *    P=0.500N     P=0.471      P=0.086      | 
|ORDER RESTRICTED   |     P=0.542N     (e)          (e)          (e)         |P=0.035 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Histiocytosis                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     38/50 (76%)  45/50 (90%)  50/50 (100%) 50/50 (100%)|40/50 (80%)  50/50 (100%) 48/48 (100%) 50/50 (100%) | 
|POLY-3 RATE (b)    |     38/48.44     45/48.87     50/50.00     50/50.00    |40/48.18     50/50.00     48/48.00     50/50.00     | 
|POLY-3 PERCENT (g) |     78.5%        92.1%        100.0%       100.0%      |83.0%        100.0%       100.0%       100.0%       | 
|TERMINAL (d)       |     26/31 (84%)  32/34 (94%)  33/33 (100%) 32/32 (100%)|36/43 (84%)  39/39 (100%) 34/34 (100%) 35/35 (100%) | 
|FIRST INCIDENCE    |     547          275          493          369         |302          421          552          323          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.019 *    P=0.238      P=0.050      P=0.029 *   |P<0.001 **   P=0.003 **   P<0.001 **   P<0.001 **   | 
|POLY 3             |     P<0.001 **   P=0.044 *    P<0.001 **   P<0.001 **  |P<0.001 **   P=0.002 **   P=0.003 **   P=0.002 **   | 
|POLY 1.5           |     P<0.001 **   P=0.048 *    P<0.001 **   P<0.001 **  |P<0.001 **   P=0.002 **   P=0.002 **   P=0.002 **   | 
|POLY 6             |     P<0.001 **   P=0.041 *    P<0.001 **   P<0.001 **  |P<0.001 **   P=0.003 **   P=0.004 **   P=0.003 **   | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.046 *    P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P=0.002 **   P<0.001 **   | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.054      P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 19      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hyperplasia Focal Histiocytic                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    1/50 (2%)    3/50 (6%)   |0/50 (0%)    0/50 (0%)    0/48 (0%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     1/45.22      0/43.15      1/44.41      3/43.93     |0/46.53      0/45.69      0/43.62      2/44.39      | 
|POLY-3 PERCENT (g) |     2.2%         0.0%         2.3%         6.8%        |0.0%         0.0%         0.0%         4.5%         | 
|TERMINAL (d)       |     1/31 (3%)    0/34 (0%)    1/33 (3%)    2/32 (6%)   |0/43 (0%)    0/39 (0%)    0/34 (0%)    2/35 (6%)    | 
|FIRST INCIDENCE    |     729 (T)      ---          729 (T)      653         |---          ---          ---          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.093      P=0.482N     P=0.748N     P=0.304     |P=0.037 *    (e)          (e)          P=0.194      | 
|POLY 3             |     P=0.096      P=0.509N     P=0.757      P=0.295     |P=0.044 *    (e)          (e)          P=0.227      | 
|POLY 1.5           |     P=0.097      P=0.507N     P=0.758      P=0.298     |P=0.045 *    (e)          (e)          P=0.233      | 
|POLY 6             |     P=0.094      P=0.509N     P=0.756      P=0.291     |P=0.043 *    (e)          (e)          P=0.219      | 
|LOGISTIC REGRESSION|     P=0.091      (e)          P=0.748N     P=0.291     |(e)          (e)          (e)          P=0.194      | 
|COCH-ARM / FISHERS |     P=0.097      P=0.500N     P=0.753N     P=0.309     |P=0.047 *    (e)          (e)          P=0.247      | 
|ORDER RESTRICTED   |     P=0.077      (e)          (e)          (e)         |P=0.026 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Infiltration Cellular Mixed Cell                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     15/50 (30%)  5/50 (10%)   5/50 (10%)   17/50 (34%) |5/50 (10%)   5/50 (10%)   0/48 (0%)    5/50 (10%)   | 
|POLY-3 RATE (b)    |     15/45.69     5/44.09      5/45.02      17/43.89    |5/46.53      5/45.69      0/43.62      5/44.75      | 
|POLY-3 PERCENT (g) |     32.8%        11.3%        11.1%        38.7%       |10.8%        10.9%        0.0%         11.2%        | 
|TERMINAL (d)       |     13/31 (42%)  4/34 (12%)   4/33 (12%)   16/32 (50%) |5/43 (12%)   5/39 (13%)   0/34 (0%)    4/35 (11%)   | 
|FIRST INCIDENCE    |     667          275          531          663         |729 (T)      729 (T)      ---          628          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.148      P=0.007N**   P=0.009N**   P=0.429     |P=0.546      P=0.568      P=0.057N     P=0.509      | 
|POLY 3             |     P=0.138      P=0.012N*    P=0.010N*    P=0.357     |P=0.498N     P=0.619      P=0.036N*    P=0.605      | 
|POLY 1.5           |     P=0.145      P=0.012N*    P=0.010N*    P=0.380     |P=0.489N     P=0.629      P=0.034N*    P=0.620      | 
|POLY 6             |     P=0.128      P=0.012N*    P=0.010N*    P=0.328     |P=0.513N     P=0.606      P=0.040N*    P=0.586      | 
|LOGISTIC REGRESSION|     P=0.143      P=0.014N*    P=0.013N*    P=0.304     |P=0.538N     P=0.568      (e)          P=0.595      | 
|COCH-ARM / FISHERS |     P=0.159      P=0.011N*    P=0.011N*    P=0.415     |P=0.485N     P=0.630N     P=0.031N*    P=0.630N     | 
|ORDER RESTRICTED   |     P=0.012 *    (e)          (e)          (e)         |P=0.290N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 20      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     18/50 (36%)  32/50 (64%)  31/50 (62%)  36/50 (72%) |17/50 (34%)  28/50 (56%)  34/48 (71%)  35/50 (70%)  | 
|POLY-3 RATE (b)    |     18/45.97     32/46.65     31/46.19     36/46.64    |17/46.88     28/46.16     34/44.85     35/46.23     | 
|POLY-3 PERCENT (g) |     39.2%        68.6%        67.1%        77.2%       |36.3%        60.7%        75.8%        75.7%        | 
|TERMINAL (d)       |     16/31 (52%)  26/34 (77%)  27/33 (82%)  29/32 (91%) |15/43 (35%)  25/39 (64%)  31/34 (91%)  30/35 (86%)  | 
|FIRST INCIDENCE    |     547          275          531          369         |667          653          552          323          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.010 *    P=0.009 **   P<0.001 **  |P<0.001 **   P=0.009 **   P<0.001 **   P<0.001 **   | 
|POLY 3             |     P<0.001 **   P=0.003 **   P=0.004 **   P<0.001 **  |P<0.001 **   P=0.014 *    P<0.001 **   P<0.001 **   | 
|POLY 1.5           |     P<0.001 **   P=0.003 **   P=0.005 **   P<0.001 **  |P<0.001 **   P=0.017 *    P<0.001 **   P<0.001 **   | 
|POLY 6             |     P<0.001 **   P=0.003 **   P=0.003 **   P<0.001 **  |P<0.001 **   P=0.010 *    P<0.001 **   P<0.001 **   | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.003 **   P=0.005 **   P<0.001 **  |P<0.001 **   P=0.012 *    P<0.001 **   P<0.001 **   | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.004 **   P=0.008 **   P<0.001 **  |P<0.001 **   P=0.022 *    P<0.001 **   P<0.001 **   | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/50 (10%)   7/50 (14%)   11/50 (22%)  27/50 (54%) |10/50 (20%)  7/50 (14%)   6/48 (13%)   18/50 (36%)  | 
|POLY-3 RATE (b)    |     5/45.39      7/43.15      11/45.62     27/44.01    |10/46.88     7/46.03      6/43.62      18/45.06     | 
|POLY-3 PERCENT (g) |     11.0%        16.2%        24.1%        61.4%       |21.3%        15.2%        13.8%        39.9%        | 
|TERMINAL (d)       |     4/31 (13%)   7/34 (21%)   9/33 (27%)   26/32 (81%) |8/43 (19%)   6/39 (15%)   6/34 (18%)   16/35 (46%)  | 
|FIRST INCIDENCE    |     685          729 (T)      531          628         |667          636          729 (T)      628          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.436      P=0.103      P<0.001 **  |P=0.004 **   P=0.371N     P=0.372N     P=0.017 *    | 
|POLY 3             |     P<0.001 **   P=0.343      P=0.084      P<0.001 **  |P=0.010 *    P=0.311N     P=0.253N     P=0.041 *    | 
|POLY 1.5           |     P<0.001 **   P=0.352      P=0.084      P<0.001 **  |P=0.012 *    P=0.298N     P=0.234N     P=0.050      | 
|POLY 6             |     P<0.001 **   P=0.340      P=0.084      P<0.001 **  |P=0.008 **   P=0.328N     P=0.287N     P=0.032 *    | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.368      P=0.084      P<0.001 **  |P=0.008 **   P=0.308N     P=0.286N     P=0.038 *    | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.380      P=0.086      P<0.001 **  |P=0.015 *    P=0.298N     P=0.233N     P=0.059      | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |P=0.004 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 21      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Dilatation Focal                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    2/50 (4%)    2/50 (4%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    2/48 (4%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     2/45.22      2/43.15      2/44.41      2/43.64     |0/46.53      0/45.69      2/43.62      1/44.39      | 
|POLY-3 PERCENT (g) |     4.4%         4.6%         4.5%         4.6%        |0.0%         0.0%         4.6%         2.3%         | 
|TERMINAL (d)       |     2/31 (7%)    2/34 (6%)    2/33 (6%)    2/32 (6%)   |0/43 (0%)    0/39 (0%)    2/34 (6%)    1/35 (3%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      729 (T)     |---          ---          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.595N     P=0.662N     P=0.673N     P=0.684N    |P=0.206      (e)          P=0.188      P=0.459      | 
|POLY 3             |     P=0.585      P=0.677      P=0.688      P=0.681     |P=0.230      (e)          P=0.223      P=0.491      | 
|POLY 1.5           |     P=0.590      P=0.680      P=0.690      P=0.686     |P=0.238      (e)          P=0.228      P=0.496      | 
|POLY 6             |     P=0.577      P=0.678      P=0.686      P=0.676     |P=0.219      (e)          P=0.214      P=0.483      | 
|LOGISTIC REGRESSION|     P=0.595N     P=0.662N     P=0.673N     P=0.684N    |(e)          (e)          P=0.188      P=0.459      | 
|COCH-ARM / FISHERS |     P=0.596      P=0.691N     P=0.691N     P=0.691N    |P=0.246      (e)          P=0.237      P=0.500      | 
|ORDER RESTRICTED   |     P=0.732      (e)          (e)          (e)         |P=0.156      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     48/50 (96%)  48/50 (96%)  49/50 (98%)  42/50 (84%) |31/50 (62%)  38/50 (76%)  43/48 (90%)  35/50 (70%)  | 
|POLY-3 RATE (b)    |     48/49.26     48/48.11     49/49.32     42/47.28    |31/47.70     38/47.85     43/46.49     35/45.98     | 
|POLY-3 PERCENT (g) |     97.5%        99.8%        99.4%        88.8%       |65.0%        79.4%        92.5%        76.1%        | 
|TERMINAL (d)       |     30/31 (97%)  34/34 (100%) 33/33 (100%) 29/32 (91%) |27/43 (63%)  31/39 (80%)  32/34 (94%)  28/35 (80%)  | 
|FIRST INCIDENCE    |     547          477          493          584         |498          434          578          541          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.182N     P=0.420N     P=0.532N     P=0.214N    |P=0.029 *    P=0.044 *    P<0.001 **   P=0.039 *    | 
|POLY 3             |     P=0.005N**   P=0.448      P=0.522      P=0.081N    |P=0.119      P=0.085      P<0.001 **   P=0.166      | 
|POLY 1.5           |     P=0.003N**   P=0.492      P=0.518      P=0.061N    |P=0.179      P=0.100      P<0.001 **   P=0.216      | 
|POLY 6             |     P=0.011N*    P=0.480      P=0.514      P=0.118N    |P=0.068      P=0.071      P<0.001 **   P=0.117      | 
|LOGISTIC REGRESSION|     P=0.004N**   P=0.228      P=0.401      P=0.068N    |P=0.174      P=0.091      P<0.001 **   P=0.175      | 
|COCH-ARM / FISHERS |     P=0.009N**   P=0.691N     P=0.500      P=0.046N*   |P=0.252      P=0.097      P<0.001 **   P=0.263      | 
|ORDER RESTRICTED   |     P<0.001N**   (e)          (e)          (e)         |P=0.011 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 22      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Fatty Change Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     21/50 (42%)  24/50 (48%)  37/50 (74%)  33/50 (66%) |16/50 (32%)  29/50 (58%)  29/48 (60%)  32/50 (64%)  | 
|POLY-3 RATE (b)    |     21/46.34     24/44.48     37/47.38     33/44.41    |16/47.02     29/46.59     29/44.57     32/46.13     | 
|POLY-3 PERCENT (g) |     45.3%        54.0%        78.1%        74.3%       |34.0%        62.2%        65.1%        69.4%        | 
|TERMINAL (d)       |     17/31 (55%)  21/34 (62%)  29/33 (88%)  31/32 (97%) |13/43 (30%)  25/39 (64%)  25/34 (74%)  26/35 (74%)  | 
|FIRST INCIDENCE    |     547          477          531          584         |667          636          578          323          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.002 **   P=0.465      P=0.003 **   P=0.006 **  |P<0.001 **   P=0.004 **   P<0.001 **   P<0.001 **   | 
|POLY 3             |     P<0.001 **   P=0.267      P<0.001 **   P=0.003 **  |P<0.001 **   P=0.004 **   P=0.002 **   P<0.001 **   | 
|POLY 1.5           |     P<0.001 **   P=0.285      P<0.001 **   P=0.005 **  |P=0.002 **   P=0.006 **   P=0.003 **   P<0.001 **   | 
|POLY 6             |     P<0.001 **   P=0.259      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.003 **   P<0.001 **   P<0.001 **   | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.260      P<0.001 **   P=0.002 **  |P<0.001 **   P=0.005 **   P=0.002 **   P<0.001 **   | 
|COCH-ARM / FISHERS |     P=0.004 **   P=0.344      P<0.001 **   P=0.013 *   |P=0.003 **   P=0.008 **   P=0.004 **   P<0.001 **   | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    1/50 (2%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    0/48 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/45.22      2/43.87      1/44.87      0/43.64     |1/46.53      0/45.69      0/43.62      1/44.66      | 
|POLY-3 PERCENT (g) |     0.0%         4.6%         2.2%         0.0%        |2.2%         0.0%         0.0%         2.2%         | 
|TERMINAL (d)       |     0/31 (0%)    1/34 (3%)    0/33 (0%)    0/32 (0%)   |1/43 (2%)    0/39 (0%)    0/34 (0%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     ---          477          594          ---         |729 (T)      ---          ---          654          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.457N     P=0.248      P=0.500      (e)         |P=0.563      P=0.519N     P=0.547N     P=0.727      | 
|POLY 3             |     P=0.474N     P=0.230      P=0.498      (e)         |P=0.589      P=0.504N     P=0.513N     P=0.751      | 
|POLY 1.5           |     P=0.470N     P=0.231      P=0.499      (e)         |P=0.591      P=0.500N     P=0.508N     P=0.757      | 
|POLY 6             |     P=0.479N     P=0.232      P=0.499      (e)         |P=0.585      P=0.508N     P=0.521N     P=0.744      | 
|LOGISTIC REGRESSION|     P=0.453N     P=0.302      P=0.534      (e)         |P=0.594      (e)          (e)          P=0.762N     | 
|COCH-ARM / FISHERS |     P=0.461N     P=0.247      P=0.500      (e)         |P=0.594      P=0.500N     P=0.510N     P=0.753N     | 
|ORDER RESTRICTED   |     P=0.322      (e)          (e)          (e)         |P=0.392      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 23      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     11/50 (22%)  14/50 (28%)  12/50 (24%)  18/50 (36%) |6/50 (12%)   12/50 (24%)  17/48 (35%)  11/50 (22%)  | 
|POLY-3 RATE (b)    |     11/47.28     14/45.41     12/47.92     18/49.09    |6/48.46      12/49.35     17/45.92     11/46.90     | 
|POLY-3 PERCENT (g) |     23.3%        30.8%        25.0%        36.7%       |12.4%        24.3%        37.0%        23.5%        | 
|TERMINAL (d)       |     1/31 (3%)    6/34 (18%)   2/33 (6%)    3/32 (9%)   |4/43 (9%)    4/39 (10%)   8/34 (24%)   4/35 (11%)   | 
|FIRST INCIDENCE    |     464          567          493          369         |16           421          581          538          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.095      P=0.333      P=0.488      P=0.098     |P=0.114      P=0.095      P=0.005 **   P=0.107      | 
|POLY 3             |     P=0.112      P=0.279      P=0.515      P=0.112     |P=0.127      P=0.103      P=0.004 **   P=0.126      | 
|POLY 1.5           |     P=0.102      P=0.286      P=0.508      P=0.103     |P=0.136      P=0.100      P=0.005 **   P=0.130      | 
|POLY 6             |     P=0.126      P=0.284      P=0.524      P=0.125     |P=0.121      P=0.106      P=0.004 **   P=0.123      | 
|LOGISTIC REGRESSION|     P=0.095      P=0.359      P=0.591      P=0.135     |P=0.208      P=0.096      P=0.004 **   P=0.144      | 
|COCH-ARM / FISHERS |     P=0.086      P=0.322      P=0.500      P=0.093     |P=0.165      P=0.096      P=0.006 **   P=0.143      | 
|ORDER RESTRICTED   |     P=0.108      (e)          (e)          (e)         |P=0.027 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte, Centrilobular                                                                                                 | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |2/50 (4%)    0/50 (0%)    1/48 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/45.22      0/43.15      0/44.41      0/43.64     |2/47.53      0/45.69      1/43.95      1/44.39      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |4.2%         0.0%         2.3%         2.3%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |1/43 (2%)    0/39 (0%)    0/34 (0%)    1/35 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |16           ---          638          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.535N     P=0.250N     P=0.543N     P=0.548N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.506N     P=0.246N     P=0.527N     P=0.524N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.504N     P=0.242N     P=0.520N     P=0.514N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.510N     P=0.251N     P=0.540N     P=0.537N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.601N     P=0.403N     P=0.763N     P=0.599N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.501N     P=0.247N     P=0.515N     P=0.500N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.297N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 24      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Oval Cell                                                                                                                 | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    0/48 (0%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/45.22      0/43.15      0/44.41      0/43.64     |1/46.53      0/45.69      0/43.62      2/44.39      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |2.2%         0.0%         0.0%         4.5%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |1/43 (2%)    0/39 (0%)    0/34 (0%)    2/35 (6%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |729 (T)      ---          ---          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.206      P=0.519N     P=0.547N     P=0.428      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.241      P=0.504N     P=0.513N     P=0.484      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.243      P=0.500N     P=0.508N     P=0.493      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.237      P=0.508N     P=0.521N     P=0.471      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.206      (e)          (e)          P=0.428      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.246      P=0.500N     P=0.510N     P=0.500      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.122      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Congestion                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    1/50 (2%)    0/50 (0%)    2/50 (4%)   |1/50 (2%)    5/50 (10%)   3/50 (6%)    5/50 (10%)   | 
|POLY-3 RATE (b)    |     4/46.19      1/43.15      0/44.41      2/44.09     |1/46.53      5/46.93      3/45.74      5/45.79      | 
|POLY-3 PERCENT (g) |     8.7%         2.3%         0.0%         4.5%        |2.2%         10.7%        6.6%         10.9%        | 
|TERMINAL (d)       |     2/31 (7%)    1/34 (3%)    0/33 (0%)    0/32 (0%)   |1/43 (2%)    2/39 (5%)    0/34 (0%)    1/35 (3%)    | 
|FIRST INCIDENCE    |     464          729 (T)      ---          651         |729 (T)      421          383          323          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.297N     P=0.175N     P=0.065N     P=0.368N    |P=0.126      P=0.098      P=0.292      P=0.082      | 
|POLY 3             |     P=0.274N     P=0.200N     P=0.065N     P=0.359N    |P=0.143      P=0.104      P=0.299      P=0.098      | 
|POLY 1.5           |     P=0.274N     P=0.194N     P=0.064N     P=0.352N    |P=0.151      P=0.105      P=0.304      P=0.102      | 
|POLY 6             |     P=0.275N     P=0.203N     P=0.067N     P=0.366N    |P=0.133      P=0.101      P=0.289      P=0.092      | 
|LOGISTIC REGRESSION|     P=0.272N     P=0.147N     P=0.049N*    P=0.278N    |P=0.138      P=0.091      P=0.296      P=0.095      | 
|COCH-ARM / FISHERS |     P=0.279N     P=0.181N     P=0.059N     P=0.339N    |P=0.151      P=0.102      P=0.309      P=0.102      | 
|ORDER RESTRICTED   |     P=0.086N     (e)          (e)          (e)         |P=0.084      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 25      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hemorrhage Focal                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    1/50 (2%)    3/50 (6%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    2/50 (4%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     4/46.45      1/43.53      3/45.52      0/43.64     |1/47.21      0/45.69      2/45.18      2/45.90      | 
|POLY-3 PERCENT (g) |     8.6%         2.3%         6.6%         0.0%        |2.1%         0.0%         4.4%         4.4%         | 
|TERMINAL (d)       |     2/31 (7%)    0/34 (0%)    1/33 (3%)    0/32 (0%)   |0/43 (0%)    0/39 (0%)    0/34 (0%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     464          621          498          ---         |498          ---          383          323          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.073N     P=0.187N     P=0.489N     P=0.065N    |P=0.249      P=0.504N     P=0.502      P=0.507      | 
|POLY 3             |     P=0.074N     P=0.199N     P=0.511N     P=0.069N    |P=0.242      P=0.507N     P=0.485      P=0.490      | 
|POLY 1.5           |     P=0.072N     P=0.194N     P=0.507N     P=0.066N    |P=0.246      P=0.502N     P=0.493      P=0.498      | 
|POLY 6             |     P=0.078N     P=0.200N     P=0.513N     P=0.072N    |P=0.234      P=0.511N     P=0.471      P=0.479      | 
|LOGISTIC REGRESSION|     P=0.061N     P=0.103N     P=0.410N     P=0.032N*   |P=0.160      P=0.595N     P=0.482      P=0.376      | 
|COCH-ARM / FISHERS |     P=0.072N     P=0.181N     P=0.500N     P=0.059N    |P=0.245      P=0.500N     P=0.500      P=0.500      | 
|ORDER RESTRICTED   |     P=0.032N*    (e)          (e)          (e)         |P=0.257      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hyperplasia Focal Histiocytic                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/45.22      0/43.15      0/44.41      0/43.64     |0/46.53      1/45.69      0/43.76      2/44.46      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         2.2%         0.0%         4.5%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |0/43 (0%)    1/39 (3%)    0/34 (0%)    1/35 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          729 (T)      ---          712          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.116      P=0.481      (e)          P=0.202      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.132      P=0.496      (e)          P=0.227      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.136      P=0.500      (e)          P=0.233      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.127      P=0.492      (e)          P=0.220      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.125      P=0.481      (e)          P=0.221      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.140      P=0.500      (e)          P=0.247      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.068      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 26      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Mixed Cell                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    0/50 (0%)    1/50 (2%)    2/50 (4%)   |3/50 (6%)    1/50 (2%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     3/45.45      0/43.15      1/45.02      2/45.37     |3/46.53      1/46.50      0/43.76      1/45.30      | 
|POLY-3 PERCENT (g) |     6.6%         0.0%         2.2%         4.4%        |6.5%         2.2%         0.0%         2.2%         | 
|TERMINAL (d)       |     2/31 (7%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |3/43 (7%)    0/39 (0%)    0/34 (0%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     667          ---          531          369         |729 (T)      421          ---          323          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.564N     P=0.118N     P=0.307N     P=0.512N    |P=0.232N     P=0.329N     P=0.166N     P=0.359N     | 
|POLY 3             |     P=0.544N     P=0.128N     P=0.309N     P=0.501N    |P=0.205N     P=0.306N     P=0.130N     P=0.315N     | 
|POLY 1.5           |     P=0.546N     P=0.126N     P=0.307N     P=0.499N    |P=0.203N     P=0.302N     P=0.124N     P=0.307N     | 
|POLY 6             |     P=0.545N     P=0.129N     P=0.309N     P=0.506N    |P=0.209N     P=0.311N     P=0.139N     P=0.327N     | 
|LOGISTIC REGRESSION|     P=0.542N     P=0.127N     P=0.282N     P=0.318N    |P=0.213N     P=0.323N     (e)          P=0.318N     | 
|COCH-ARM / FISHERS |     P=0.556N     P=0.121N     P=0.309N     P=0.500N    |P=0.200N     P=0.309N     P=0.121N     P=0.309N     | 
|ORDER RESTRICTED   |     P=0.191N     (e)          (e)          (e)         |P=0.089N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Chronic Focal                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    3/50 (6%)    4/50 (8%)    2/50 (4%)   |25/50 (50%)  40/50 (80%)  39/50 (78%)  43/50 (86%)  | 
|POLY-3 RATE (b)    |     3/45.22      3/43.68      4/45.09      2/43.93     |25/46.78     40/47.33     39/46.64     43/46.98     | 
|POLY-3 PERCENT (g) |     6.6%         6.9%         8.9%         4.6%        |53.4%        84.5%        83.6%        91.5%        | 
|TERMINAL (d)       |     3/31 (10%)   2/34 (6%)    3/33 (9%)    1/32 (3%)   |23/43 (54%)  34/39 (87%)  30/34 (88%)  33/35 (94%)  | 
|FIRST INCIDENCE    |     729 (T)      567          498          651         |694          421          555          541          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.420N     P=0.632N     P=0.529      P=0.497N    |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|POLY 3             |     P=0.431N     P=0.646      P=0.498      P=0.513N    |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|POLY 1.5           |     P=0.426N     P=0.648      P=0.499      P=0.509N    |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|POLY 6             |     P=0.438N     P=0.650      P=0.499      P=0.518N    |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|LOGISTIC REGRESSION|     P=0.419N     P=0.650      P=0.502      P=0.521N    |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|COCH-ARM / FISHERS |     P=0.420N     P=0.661N     P=0.500      P=0.500N    |P<0.001 **   P=0.002 **   P=0.003 **   P<0.001 **   | 
|ORDER RESTRICTED   |     P=0.462N     (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 27      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    4/50 (8%)    3/50 (6%)    0/50 (0%)   |4/50 (8%)    3/50 (6%)    0/50 (0%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     2/45.22      4/43.72      3/44.41      0/43.64     |4/46.53      3/45.69      0/43.76      2/44.39      | 
|POLY-3 PERCENT (g) |     4.4%         9.2%         6.8%         0.0%        |8.6%         6.6%         0.0%         4.5%         | 
|TERMINAL (d)       |     2/31 (7%)    3/34 (9%)    3/33 (9%)    0/32 (0%)   |4/43 (9%)    3/39 (8%)    0/34 (0%)    2/35 (6%)    | 
|FIRST INCIDENCE    |     729 (T)      547          729 (T)      ---         |729 (T)      729 (T)      ---          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.133N     P=0.368      P=0.529      P=0.231N    |P=0.264N     P=0.553N     P=0.097N     P=0.435N     | 
|POLY 3             |     P=0.146N     P=0.322      P=0.492      P=0.245N    |P=0.204N     P=0.510N     P=0.068N     P=0.359N     | 
|POLY 1.5           |     P=0.142N     P=0.324      P=0.495      P=0.242N    |P=0.198N     P=0.501N     P=0.064N     P=0.346N     | 
|POLY 6             |     P=0.151N     P=0.324      P=0.489      P=0.248N    |P=0.212N     P=0.521N     P=0.075N     P=0.376N     | 
|LOGISTIC REGRESSION|     P=0.142N     P=0.327      P=0.529      (e)         |P=0.264N     P=0.553N     (e)          P=0.435N     | 
|COCH-ARM / FISHERS |     P=0.137N     P=0.339      P=0.500      P=0.247N    |P=0.194N     P=0.500N     P=0.059N     P=0.339N     | 
|ORDER RESTRICTED   |     P=0.111N     (e)          (e)          (e)         |P=0.127N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    1/48 (2%)    0/48 (0%)    0/49 (0%)   |0/49 (0%)    0/49 (0%)    2/49 (4%)    0/47 (0%)    | 
|POLY-3 RATE (b)    |     1/45.67      1/42.81      0/43.18      0/43.07     |0/45.67      0/45.30      2/43.76      0/41.44      | 
|POLY-3 PERCENT (g) |     2.2%         2.3%         0.0%         0.0%        |0.0%         0.0%         4.6%         0.0%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |0/43 (0%)    0/39 (0%)    2/34 (6%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     597          275          ---          ---         |---          ---          729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.236N     P=0.748      P=0.509N     P=0.500N    |P=0.540      (e)          P=0.188      (e)          | 
|POLY 3             |     P=0.242N     P=0.746      P=0.511N     P=0.512N    |P=0.560      (e)          P=0.228      (e)          | 
|POLY 1.5           |     P=0.241N     P=0.747      P=0.510N     P=0.509N    |P=0.574      (e)          P=0.235      (e)          | 
|POLY 6             |     P=0.242N     P=0.748      P=0.512N     P=0.515N    |P=0.542      (e)          P=0.218      (e)          | 
|LOGISTIC REGRESSION|     P=0.211N     P=0.476N     P=0.480N     P=0.431N    |(e)          (e)          P=0.188      (e)          | 
|COCH-ARM / FISHERS |     P=0.239N     P=0.742      P=0.510N     P=0.505N    |P=0.587      (e)          P=0.247      (e)          | 
|ORDER RESTRICTED   |     P=0.250N     (e)          (e)          (e)         |P=0.240      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 28      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    1/48 (2%)    0/48 (0%)    2/49 (4%)   |7/49 (14%)   0/49 (0%)    1/49 (2%)    2/47 (4%)    | 
|POLY-3 RATE (b)    |     2/45.77      1/41.98      0/43.18      2/43.43     |7/46.35      0/45.30      1/43.76      2/41.44      | 
|POLY-3 PERCENT (g) |     4.4%         2.4%         0.0%         4.6%        |15.1%        0.0%         2.3%         4.8%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    1/32 (3%)   |6/43 (14%)   0/39 (0%)    1/34 (3%)    2/33 (6%)    | 
|FIRST INCIDENCE    |     642          700          ---          628         |498          ---          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.568      P=0.531N     P=0.256N     P=0.670     |P=0.125N     P=0.014N*    P=0.062N     P=0.151N     | 
|POLY 3             |     P=0.584      P=0.530N     P=0.250N     P=0.675     |P=0.081N     P=0.008N**   P=0.036N*    P=0.108N     | 
|POLY 1.5           |     P=0.586      P=0.527N     P=0.249N     P=0.679     |P=0.080N     P=0.008N**   P=0.032N*    P=0.098N     | 
|POLY 6             |     P=0.580      P=0.529N     P=0.251N     P=0.670     |P=0.083N     P=0.009N**   P=0.043N*    P=0.123N     | 
|LOGISTIC REGRESSION|     P=0.591      P=0.490N     P=0.232N     P=0.676N    |P=0.085N     P=0.009N**   P=0.033N*    P=0.093N     | 
|COCH-ARM / FISHERS |     P=0.587      P=0.515N     P=0.258N     P=0.684     |P=0.083N     P=0.006N**   P=0.030N*    P=0.090N     | 
|ORDER RESTRICTED   |     P=0.403      (e)          (e)          (e)         |P=0.005N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Deep Cervical                                                                                                        | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/19 (0%)    0/18 (0%)    0/26 (0%)    0/27 (0%)   |3/24 (13%)   0/11 (0%)    0/24 (0%)    0/35 (0%)    | 
|POLY-3 RATE (b)    |     0/15.75      0/14.68      0/21.00      0/22.83     |3/21.83      0/8.51       0/20.74      0/30.55      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |13.7%        0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/4 (0%)     0/8 (0%)     0/12 (0%)    0/13 (0%)   |3/20 (15%)   0/4 (0%)     0/12 (0%)    0/23 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |729 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.041N*    P=0.500N     P=0.220N     P=0.095N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.020N*    P=0.329N     P=0.121N     P=0.061N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.021N*    P=0.305N     P=0.113N     P=0.057N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.019N*    P=0.362N     P=0.137N     P=0.066N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.041N*    (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.026N*    P=0.309N     P=0.117N     P=0.062N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.002N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 29      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/19 (11%)   2/18 (11%)   0/26 (0%)    3/27 (11%)  |3/24 (13%)   1/11 (9%)    0/24 (0%)    1/35 (3%)    | 
|POLY-3 RATE (b)    |     2/16.37      2/15.25      0/21.00      3/22.83     |3/21.83      1/8.51       0/20.74      1/30.55      | 
|POLY-3 PERCENT (g) |     12.2%        13.1%        0.0%         13.1%       |13.7%        11.8%        0.0%         3.3%         | 
|TERMINAL (d)       |     0/4 (0%)     1/8 (13%)    0/12 (0%)    3/13 (23%)  |3/20 (15%)   1/4 (25%)    0/12 (0%)    1/23 (4%)    | 
|FIRST INCIDENCE    |     597          547          ---          729 (T)     |729 (T)      729 (T)      ---          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.577N     P=0.652N     P=0.248N     P=0.596N    |P=0.132N     P=0.595      P=0.220N     P=0.253N     | 
|POLY 3             |     P=0.583      P=0.674      P=0.176N     P=0.654     |P=0.094N     P=0.665N     P=0.121N     P=0.188N     | 
|POLY 1.5           |     P=0.587      P=0.670      P=0.173N     P=0.657     |P=0.094N     P=0.636N     P=0.113N     P=0.179N     | 
|POLY 6             |     P=0.575      P=0.686      P=0.179N     P=0.648     |P=0.097N     P=0.700N     P=0.137N     P=0.202N     | 
|LOGISTIC REGRESSION|     P=0.589      P=0.690N     P=0.139N     P=0.671     |P=0.132N     P=0.595      (e)          P=0.253N     | 
|COCH-ARM / FISHERS |     P=0.588      P=0.677      P=0.173N     P=0.698N    |P=0.096N     P=0.628N     P=0.117N     P=0.179N     | 
|ORDER RESTRICTED   |     P=0.426N     (e)          (e)          (e)         |P=0.035N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/19 (16%)   2/18 (11%)   2/26 (8%)    3/27 (11%)  |5/24 (21%)   3/11 (27%)   5/24 (21%)   3/35 (9%)    | 
|POLY-3 RATE (b)    |     3/16.67      2/14.68      2/21.07      3/23.12     |5/22.95      3/8.79       5/21.00      3/30.60      | 
|POLY-3 PERCENT (g) |     18.0%        13.6%        9.5%         13.0%       |21.8%        34.1%        23.8%        9.8%         | 
|TERMINAL (d)       |     0/4 (0%)     2/8 (25%)    1/12 (8%)    2/13 (15%)  |3/20 (15%)   2/4 (50%)    3/12 (25%)   2/23 (9%)    | 
|FIRST INCIDENCE    |     547          729 (T)      712          651         |16           653          693          717          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.423N     P=0.392N     P=0.421N     P=0.527N    |P=0.237N     P=0.438      P=0.400      P=0.332N     | 
|POLY 3             |     P=0.429N     P=0.560N     P=0.389N     P=0.505N    |P=0.114N     P=0.403      P=0.578      P=0.202N     | 
|POLY 1.5           |     P=0.428N     P=0.552N     P=0.377N     P=0.499N    |P=0.103N     P=0.443      P=0.607      P=0.187N     | 
|POLY 6             |     P=0.436N     P=0.564N     P=0.399N     P=0.515N    |P=0.131N     P=0.356      P=0.527      P=0.224N     | 
|LOGISTIC REGRESSION|     P=0.420N     P=0.528N     P=0.350N     P=0.510N    |P=0.094N     P=0.537      P=0.611      P=0.185N     | 
|COCH-ARM / FISHERS |     P=0.431N     P=0.527N     P=0.350N     P=0.484N    |P=0.091N     P=0.492      P=0.638N     P=0.167N     | 
|ORDER RESTRICTED   |     P=0.429N     (e)          (e)          (e)         |P=0.086N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 30      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/19 (32%)   3/18 (17%)   4/26 (15%)   4/27 (15%)  |4/24 (17%)   1/11 (9%)    2/24 (8%)    6/35 (17%)   | 
|POLY-3 RATE (b)    |     6/16.88      3/15.74      4/21.43      4/22.83     |4/21.83      1/8.78       2/21.23      6/30.92      | 
|POLY-3 PERCENT (g) |     35.6%        19.1%        18.7%        17.5%       |18.3%        11.4%        9.4%         19.4%        | 
|TERMINAL (d)       |     3/4 (75%)    1/8 (13%)    3/12 (25%)   4/13 (31%)  |4/20 (20%)   0/4 (0%)     1/12 (8%)    5/23 (22%)   | 
|FIRST INCIDENCE    |     547          275          605          729 (T)     |729 (T)      657          581          628          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.087N     P=0.125N     P=0.070N     P=0.032N*   |P=0.328      P=0.656N     P=0.548N     P=0.447      | 
|POLY 3             |     P=0.167N     P=0.253N     P=0.205N     P=0.173N    |P=0.467      P=0.527N     P=0.345N     P=0.601      | 
|POLY 1.5           |     P=0.161N     P=0.255N     P=0.195N     P=0.167N    |P=0.474      P=0.498N     P=0.328N     P=0.619      | 
|POLY 6             |     P=0.178N     P=0.245N     P=0.210N     P=0.185N    |P=0.455      P=0.561N     P=0.376N     P=0.576      | 
|LOGISTIC REGRESSION|     P=0.158N     P=0.197N     P=0.184N     P=0.148N    |P=0.462      P=0.560N     P=0.337N     P=0.568      | 
|COCH-ARM / FISHERS |     P=0.156N     P=0.252N     P=0.177N     P=0.160N    |P=0.465      P=0.491N     P=0.333N     P=0.650N     | 
|ORDER RESTRICTED   |     P=0.136N     (e)          (e)          (e)         |P=0.416      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Pancreatic                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/19 (0%)    1/18 (6%)    3/26 (12%)   1/27 (4%)   |1/24 (4%)    0/11 (0%)    2/24 (8%)    2/35 (6%)    | 
|POLY-3 RATE (b)    |     0/15.75      1/15.14      3/21.36      1/22.83     |1/22.83      0/8.51       2/20.74      2/30.55      | 
|POLY-3 PERCENT (g) |     0.0%         6.6%         14.1%        4.4%        |4.4%         0.0%         9.6%         6.6%         | 
|TERMINAL (d)       |     0/4 (0%)     0/8 (0%)     1/12 (8%)    1/13 (8%)   |0/20 (0%)    0/4 (0%)     2/12 (17%)   2/23 (9%)    | 
|FIRST INCIDENCE    |     ---          593          650          729 (T)     |16           ---          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.471      P=0.487      P=0.179      P=0.734     |P=0.380      P=0.496N     P=0.383      P=0.532      | 
|POLY 3             |     P=0.497      P=0.492      P=0.170      P=0.574     |P=0.436      P=0.687N     P=0.466      P=0.602      | 
|POLY 1.5           |     P=0.494      P=0.487      P=0.171      P=0.572     |P=0.445      P=0.674N     P=0.483      P=0.614      | 
|POLY 6             |     P=0.498      P=0.504      P=0.176      P=0.577     |P=0.423      P=0.702N     P=0.437      P=0.586      | 
|LOGISTIC REGRESSION|     P=0.490      P=0.555      P=0.172      P=0.734     |P=0.354      (e)          P=0.324      P=0.495      | 
|COCH-ARM / FISHERS |     P=0.486      P=0.486      P=0.183      P=0.587     |P=0.453      P=0.686N     P=0.500      P=0.641      | 
|ORDER RESTRICTED   |     P=0.217      (e)          (e)          (e)         |P=0.351      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 31      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Pancreatic                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/19 (11%)   0/18 (0%)    1/26 (4%)    4/27 (15%)  |7/24 (29%)   1/11 (9%)    7/24 (29%)   7/35 (20%)   | 
|POLY-3 RATE (b)    |     2/16.15      0/14.68      1/21.61      4/22.83     |7/21.83      1/8.62       7/21.56      7/31.19      | 
|POLY-3 PERCENT (g) |     12.4%        0.0%         4.6%         17.5%       |32.1%        11.6%        32.5%        22.4%        | 
|TERMINAL (d)       |     0/4 (0%)     0/8 (0%)     0/12 (0%)    4/13 (31%)  |7/20 (35%)   0/4 (0%)     5/12 (42%)   5/23 (22%)   | 
|FIRST INCIDENCE    |     667          ---          531          729 (T)     |729 (T)      700          581          628          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.223      P=0.253N     P=0.517N     P=0.678     |P=0.551N     P=0.437N     P=0.247      P=0.527N     | 
|POLY 3             |     P=0.206      P=0.254N     P=0.397N     P=0.505     |P=0.329N     P=0.249N     P=0.616      P=0.321N     | 
|POLY 1.5           |     P=0.208      P=0.253N     P=0.395N     P=0.507     |P=0.327N     P=0.216N     P=0.611N     P=0.304N     | 
|POLY 6             |     P=0.199      P=0.249N     P=0.394N     P=0.498     |P=0.333N     P=0.295N     P=0.570      P=0.344N     | 
|LOGISTIC REGRESSION|     P=0.209      P=0.246N     P=0.318N     P=0.540     |P=0.361N     P=0.393N     P=0.574      P=0.351N     | 
|COCH-ARM / FISHERS |     P=0.204      P=0.257N     P=0.382N     P=0.516     |P=0.349N     P=0.193N     P=0.624N     P=0.306N     | 
|ORDER RESTRICTED   |     P=0.165      (e)          (e)          (e)         |P=0.309N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     12/47 (26%)  7/46 (15%)   1/41 (2%)    2/45 (4%)   |37/50 (74%)  16/49 (33%)  8/50 (16%)   1/50 (2%)    | 
|POLY-3 RATE (b)    |     12/44.09     7/41.81      1/36.55      2/39.96     |37/47.39     16/46.48     8/44.35      1/44.44      | 
|POLY-3 PERCENT (g) |     27.2%        16.7%        2.7%         5.0%        |78.1%        34.4%        18.0%        2.3%         | 
|TERMINAL (d)       |     6/30 (20%)   4/32 (13%)   1/27 (4%)    1/30 (3%)   |33/43 (77%)  11/39 (28%)  5/34 (15%)   0/35 (0%)    | 
|FIRST INCIDENCE    |     464          477          729 (T)      663         |624          636          638          717          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.002N**   P=0.159N     P=0.003N**   P=0.009N**  |P<0.001N**   P<0.001N**   P<0.001N**   P<0.001N**   | 
|POLY 3             |     P<0.001N**   P=0.181N     P=0.003N**   P=0.006N**  |P<0.001N**   P<0.001N**   P<0.001N**   P<0.001N**   | 
|POLY 1.5           |     P<0.001N**   P=0.178N     P=0.002N**   P=0.005N**  |P<0.001N**   P<0.001N**   P<0.001N**   P<0.001N**   | 
|POLY 6             |     P<0.001N**   P=0.181N     P=0.003N**   P=0.006N**  |P<0.001N**   P<0.001N**   P<0.001N**   P<0.001N**   | 
|LOGISTIC REGRESSION|     P<0.001N**   P=0.145N     P=0.003N**   P=0.006N**  |P<0.001N**   P<0.001N**   P<0.001N**   P<0.001N**   | 
|COCH-ARM / FISHERS |     P<0.001N**   P=0.165N     P=0.002N**   P=0.005N**  |P<0.001N**   P<0.001N**   P<0.001N**   P<0.001N**   | 
|ORDER RESTRICTED   |     P<0.001N**   (e)          (e)          (e)         |P<0.001N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 32      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/47 (0%)    0/46 (0%)    0/41 (0%)    0/45 (0%)   |6/50 (12%)   3/49 (6%)    3/50 (6%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/42.88      0/40.47      0/36.55      0/39.72     |6/46.67      3/45.30      3/44.15      1/44.70      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |12.9%        6.6%         6.8%         2.2%         | 
|TERMINAL (d)       |     0/30 (0%)    0/32 (0%)    0/27 (0%)    0/30 (0%)   |5/43 (12%)   3/39 (8%)    2/34 (6%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |694          729 (T)      619          642          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.076N     P=0.292N     P=0.358N     P=0.095N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.049N*    P=0.257N     P=0.270N     P=0.063N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.046N*    P=0.251N     P=0.256N     P=0.059N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.053N     P=0.266N     P=0.292N     P=0.069N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.048N*    P=0.264N     P=0.263N     P=0.062N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.044N*    P=0.254N     P=0.243N     P=0.056N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.033N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Fat                                                                                                                   | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     9/13 (69%)   4/10 (40%)   6/11 (55%)   5/10 (50%)  |8/9 (89%)    3/7 (43%)    0/11 (0%)    1/8 (13%)    | 
|POLY-3 RATE (b)    |     9/12.86      4/8.81       6/9.38       5/8.70      |8/8.32       3/5.27       0/9.00       1/5.29       | 
|POLY-3 PERCENT (g) |     70.0%        45.4%        64.0%        57.5%       |96.2%        57.0%        0.0%         18.9%        | 
|TERMINAL (d)       |     5/7 (71%)    3/5 (60%)    3/3 (100%)   4/5 (80%)   |6/6 (100%)   3/4 (75%)    0/4 (0%)     1/2 (50%)    | 
|FIRST INCIDENCE    |     582          477          653          670         |694          729 (T)      ---          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.380N     P=0.186N     P=0.597      P=0.321N    |P=0.010N*    P=0.108N     P=0.004N**   P=0.078N     | 
|POLY 3             |     P=0.423N     P=0.241N     P=0.563N     P=0.445N    |P<0.001N**   P=0.096N     P<0.001N**   P<0.001N**   | 
|POLY 1.5           |     P=0.371N     P=0.204N     P=0.480N     P=0.378N    |P<0.001N**   P=0.073N     P<0.001N**   P<0.001N**   | 
|POLY 6             |     P=0.525N     P=0.301N     P=0.676N     P=0.563N    |P<0.001N**   P=0.143N     P<0.001N**   P<0.001N**   | 
|LOGISTIC REGRESSION|     P=0.352N     P=0.145N     P=0.476N     P=0.347N    |P=0.003N**   P=0.140N     P<0.001N**   P=0.030N*    | 
|COCH-ARM / FISHERS |     P=0.321N     P=0.164N     P=0.375N     P=0.306N    |P<0.001N**   P=0.077N     P<0.001N**   P=0.003N**   | 
|ORDER RESTRICTED   |     P=0.393N     (e)          (e)          (e)         |P<0.001N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 33      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Foreign Body                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/49 (2%)    0/50 (0%)    1/50 (2%)    1/50 (2%)   |0/49 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/45.19      0/43.15      1/44.87      1/43.64     |0/45.90      2/45.69      0/43.76      0/44.39      | 
|POLY-3 PERCENT (g) |     2.2%         0.0%         2.2%         2.3%        |0.0%         4.4%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    1/32 (3%)   |0/43 (0%)    2/39 (5%)    0/34 (0%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     464          ---          594          729 (T)     |---          729 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.542      P=0.508N     P=0.760      P=0.759     |P=0.448N     P=0.217      (e)          (e)          | 
|POLY 3             |     P=0.536      P=0.509N     P=0.759      P=0.753     |P=0.418N     P=0.236      (e)          (e)          | 
|POLY 1.5           |     P=0.540      P=0.506N     P=0.760N     P=0.757     |P=0.408N     P=0.241      (e)          (e)          | 
|POLY 6             |     P=0.530      P=0.511N     P=0.758      P=0.748     |P=0.432N     P=0.231      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.552      P=0.251N     P=0.728N     P=0.689N    |(e)          P=0.217      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.543      P=0.495N     P=0.747N     P=0.747N    |P=0.402N     P=0.253      (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.529      (e)          (e)          (e)         |P=0.253N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/49 (4%)    1/50 (2%)    4/50 (8%)    2/50 (4%)   |0/49 (0%)    3/50 (6%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/45.51      1/43.15      4/45.01      2/43.64     |0/45.90      3/45.79      1/43.76      0/44.39      | 
|POLY-3 PERCENT (g) |     4.4%         2.3%         8.9%         4.6%        |0.0%         6.6%         2.3%         0.0%         | 
|TERMINAL (d)       |     0/31 (0%)    1/34 (3%)    2/33 (6%)    2/32 (6%)   |0/43 (0%)    2/39 (5%)    1/34 (3%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     464          729 (T)      594          729 (T)     |---          705          729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.470      P=0.508N     P=0.347      P=0.688     |P=0.422N     P=0.109      P=0.453      (e)          | 
|POLY 3             |     P=0.462      P=0.519N     P=0.332      P=0.679     |P=0.386N     P=0.118      P=0.490      (e)          | 
|POLY 1.5           |     P=0.472      P=0.511N     P=0.338      P=0.687     |P=0.371N     P=0.122      P=0.497      (e)          | 
|POLY 6             |     P=0.446      P=0.523N     P=0.327      P=0.668     |P=0.406N     P=0.114      P=0.481      (e)          | 
|LOGISTIC REGRESSION|     P=0.491      P=0.382N     P=0.392      P=0.629N    |P=0.393N     P=0.118      P=0.453      (e)          | 
|COCH-ARM / FISHERS |     P=0.484      P=0.492N     P=0.349      P=0.684N    |P=0.362N     P=0.125      P=0.505      (e)          | 
|ORDER RESTRICTED   |     P=0.371      (e)          (e)          (e)         |P=0.227N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 34      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Nasolacrimal Duct                                                                                                          | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/49 (0%)    0/50 (0%)    0/50 (0%)    4/50 (8%)   |2/49 (4%)    5/50 (10%)   4/50 (8%)    5/50 (10%)   | 
|POLY-3 RATE (b)    |     0/44.45      0/43.15      0/44.41      4/43.89     |2/45.90      5/45.69      4/43.76      5/44.39      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         9.1%        |4.4%         10.9%        9.1%         11.3%        | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    3/32 (9%)   |2/43 (5%)    5/39 (13%)   4/34 (12%)   5/35 (14%)   | 
|FIRST INCIDENCE    |     ---          ---          ---          663         |729 (T)      729 (T)      729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.003 **   (e)          (e)          P=0.063     |P=0.150      P=0.179      P=0.235      P=0.141      | 
|POLY 3             |     P=0.003 **   (e)          (e)          P=0.058     |P=0.217      P=0.214      P=0.315      P=0.203      | 
|POLY 1.5           |     P=0.003 **   (e)          (e)          P=0.060     |P=0.234      P=0.223      P=0.331      P=0.215      | 
|POLY 6             |     P=0.003 **   (e)          (e)          P=0.056     |P=0.195      P=0.204      P=0.293      P=0.187      | 
|LOGISTIC REGRESSION|     P=0.003 **   (e)          (e)          P=0.059     |P=0.150      P=0.179      P=0.235      P=0.141      | 
|COCH-ARM / FISHERS |     P=0.003 **   (e)          (e)          P=0.061     |P=0.248      P=0.226      P=0.349      P=0.226      | 
|ORDER RESTRICTED   |     P=0.002 **   (e)          (e)          (e)         |P=0.195      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |0/50 (0%)    0/50 (0%)    0/48 (0%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |                                                        |0/46.53      0/45.69      0/43.10      2/44.70      | 
|POLY-3 PERCENT (g) |                                                        |0.0%         0.0%         0.0%         4.5%         | 
|TERMINAL (d)       |                                                        |0/43 (0%)    0/39 (0%)    0/34 (0%)    1/35 (3%)    | 
|FIRST INCIDENCE    |                                                        |---          ---          ---          642          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.042 *    (e)          (e)          P=0.213      | 
|POLY 3             |                                                        |P=0.044 *    (e)          (e)          P=0.228      | 
|POLY 1.5           |                                                        |P=0.045 *    (e)          (e)          P=0.234      | 
|POLY 6             |                                                        |P=0.043 *    (e)          (e)          P=0.222      | 
|LOGISTIC REGRESSION|                                                        |P=0.047 *    (e)          (e)          P=0.238      | 
|COCH-ARM / FISHERS |                                                        |P=0.047 *    (e)          (e)          P=0.247      | 
|ORDER RESTRICTED   |                                                        |P=0.026 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 35      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |7/50 (14%)   3/50 (6%)    5/48 (10%)   0/50 (0%)    | 
|POLY-3 RATE (b)    |                                                        |7/46.53      3/45.69      5/43.21      0/44.39      | 
|POLY-3 PERCENT (g) |                                                        |15.0%        6.6%         11.6%        0.0%         | 
|TERMINAL (d)       |                                                        |7/43 (16%)   3/39 (8%)    4/34 (12%)   0/35 (0%)    | 
|FIRST INCIDENCE    |                                                        |729 (T)      729 (T)      700          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.027N*    P=0.199N     P=0.546N     P=0.018N*    | 
|POLY 3             |                                                        |P=0.015N*    P=0.165N     P=0.432N     P=0.009N**   | 
|POLY 1.5           |                                                        |P=0.014N*    P=0.158N     P=0.414N     P=0.008N**   | 
|POLY 6             |                                                        |P=0.017N*    P=0.173N     P=0.459N     P=0.010N*    | 
|LOGISTIC REGRESSION|                                                        |P=0.022N*    P=0.199N     P=0.501N     (e)          | 
|COCH-ARM / FISHERS |                                                        |P=0.014N*    P=0.159N     P=0.409N     P=0.006N**   | 
|ORDER RESTRICTED   |                                                        |P=0.005N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Atrophy Focal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     23/50 (46%)  24/48 (50%)  24/48 (50%)  25/49 (51%) |13/49 (27%)  22/49 (45%)  26/47 (55%)  30/47 (64%)  | 
|POLY-3 RATE (b)    |     23/48.15     24/42.54     24/44.70     25/45.06    |13/45.90     22/45.51     26/44.81     30/45.28     | 
|POLY-3 PERCENT (g) |     47.8%        56.4%        53.7%        55.5%       |28.3%        48.3%        58.0%        66.3%        | 
|TERMINAL (d)       |     13/31 (42%)  19/34 (56%)  19/33 (58%)  19/32 (59%) |13/43 (30%)  20/39 (51%)  18/34 (53%)  21/33 (64%)  | 
|FIRST INCIDENCE    |     547          665          498          384         |729 (T)      700          555          368          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.367      P=0.567N     P=0.556      P=0.421     |P<0.001 **   P=0.020 *    P<0.001 **   P<0.001 **   | 
|POLY 3             |     P=0.302      P=0.268      P=0.357      P=0.294     |P<0.001 **   P=0.037 *    P=0.003 **   P<0.001 **   | 
|POLY 1.5           |     P=0.334      P=0.313      P=0.385      P=0.330     |P<0.001 **   P=0.043 *    P=0.003 **   P<0.001 **   | 
|POLY 6             |     P=0.252      P=0.238      P=0.326      P=0.245     |P<0.001 **   P=0.032 *    P=0.003 **   P<0.001 **   | 
|LOGISTIC REGRESSION|     P=0.340      P=0.360      P=0.421      P=0.375     |P<0.001 **   P=0.023 *    P=0.003 **   P<0.001 **   | 
|COCH-ARM / FISHERS |     P=0.364      P=0.423      P=0.423      P=0.383     |P<0.001 **   P=0.046 *    P=0.004 **   P<0.001 **   | 
|ORDER RESTRICTED   |     P=0.353      (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 36      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Duct                                                                                                                   | 
|     Cyst Focal                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     15/50 (30%)  12/48 (25%)  16/48 (33%)  10/49 (20%) |10/49 (20%)  18/49 (37%)  11/47 (23%)  9/47 (19%)   | 
|POLY-3 RATE (b)    |     15/46.05     12/42.69     16/43.96     10/43.30    |10/45.90     18/45.30     11/42.80     9/42.58      | 
|POLY-3 PERCENT (g) |     32.6%        28.1%        36.4%        23.1%       |21.8%        39.7%        25.7%        21.1%        | 
|TERMINAL (d)       |     12/31 (39%)  9/34 (27%)   12/33 (36%)  9/32 (28%)  |10/43 (23%)  18/39 (46%)  9/34 (27%)   5/33 (15%)   | 
|FIRST INCIDENCE    |     642          547          642          666         |729 (T)      729 (T)      693          628          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.214N     P=0.271N     P=0.549      P=0.170N    |P=0.477N     P=0.026 *    P=0.277      P=0.487      | 
|POLY 3             |     P=0.237N     P=0.411N     P=0.436      P=0.222N    |P=0.291N     P=0.049 *    P=0.427      P=0.573N     | 
|POLY 1.5           |     P=0.224N     P=0.406N     P=0.438      P=0.211N    |P=0.269N     P=0.056      P=0.452      P=0.553N     | 
|POLY 6             |     P=0.259N     P=0.400N     P=0.442      P=0.237N    |P=0.318N     P=0.042 *    P=0.392      P=0.595N     | 
|LOGISTIC REGRESSION|     P=0.231N     P=0.410N     P=0.438      P=0.224N    |P=0.354N     P=0.026 *    P=0.338      P=0.579N     | 
|COCH-ARM / FISHERS |     P=0.211N     P=0.372N     P=0.445      P=0.193N    |P=0.258N     P=0.058      P=0.457      P=0.541N     | 
|ORDER RESTRICTED   |     P=0.256N     (e)          (e)          (e)         |P=0.243N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Parathyroid Gland                                                                                                                | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    0/50 (0%)    0/48 (0%)    2/50 (4%)   |0/50 (0%)    0/49 (0%)    0/48 (0%)    1/49 (2%)    | 
|POLY-3 RATE (b)    |     1/43.54      0/43.15      0/42.41      2/43.64     |0/46.53      0/44.69      0/42.76      1/43.55      | 
|POLY-3 PERCENT (g) |     2.3%         0.0%         0.0%         4.6%        |0.0%         0.0%         0.0%         2.3%         | 
|TERMINAL (d)       |     0/29 (0%)    0/34 (0%)    0/31 (0%)    2/32 (6%)   |0/43 (0%)    0/38 (0%)    0/33 (0%)    1/35 (3%)    | 
|FIRST INCIDENCE    |     642          ---          ---          729 (T)     |---          ---          ---          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.250      P=0.523N     P=0.509N     P=0.515     |P=0.180      (e)          (e)          P=0.459      | 
|POLY 3             |     P=0.252      P=0.502N     P=0.505N     P=0.501     |P=0.193      (e)          (e)          P=0.487      | 
|POLY 1.5           |     P=0.253      P=0.500N     P=0.503N     P=0.506     |P=0.195      (e)          (e)          P=0.492      | 
|POLY 6             |     P=0.250      P=0.502N     P=0.507N     P=0.494     |P=0.189      (e)          (e)          P=0.480      | 
|LOGISTIC REGRESSION|     P=0.250      P=0.457N     P=0.481N     P=0.510     |(e)          (e)          (e)          P=0.459      | 
|COCH-ARM / FISHERS |     P=0.252      P=0.490N     P=0.500N     P=0.515     |P=0.197      (e)          (e)          P=0.495      | 
|ORDER RESTRICTED   |     P=0.132      (e)          (e)          (e)         |P=0.108      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 37      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/49 (2%)    0/49 (0%)    4/48 (8%)    1/48 (2%)   |6/48 (13%)   4/50 (8%)    3/50 (6%)    4/50 (8%)    | 
|POLY-3 RATE (b)    |     1/44.45      0/42.15      4/43.07      1/42.61     |6/46.21      4/45.69      3/44.27      4/44.39      | 
|POLY-3 PERCENT (g) |     2.3%         0.0%         9.3%         2.4%        |13.0%        8.8%         6.8%         9.0%         | 
|TERMINAL (d)       |     1/31 (3%)    0/33 (0%)    2/32 (6%)    1/32 (3%)   |5/42 (12%)   4/39 (10%)   1/34 (3%)    4/35 (11%)   | 
|FIRST INCIDENCE    |     729 (T)      ---          700          729 (T)     |498          729 (T)      619          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.425      P=0.488N     P=0.185      P=0.755N    |P=0.419N     P=0.414N     P=0.334N     P=0.476N     | 
|POLY 3             |     P=0.434      P=0.511N     P=0.169      P=0.751     |P=0.334N     P=0.377N     P=0.264N     P=0.395N     | 
|POLY 1.5           |     P=0.437      P=0.508N     P=0.170      P=0.753     |P=0.320N     P=0.363N     P=0.248N     P=0.374N     | 
|POLY 6             |     P=0.424      P=0.511N     P=0.168      P=0.748     |P=0.352N     P=0.392N     P=0.285N     P=0.422N     | 
|LOGISTIC REGRESSION|     P=0.424      (e)          P=0.167      P=0.755N    |P=0.317N     P=0.344N     P=0.207N     P=0.353N     | 
|COCH-ARM / FISHERS |     P=0.436      P=0.500N     P=0.175      P=0.747     |P=0.300N     P=0.344N     P=0.223N     P=0.344N     | 
|ORDER RESTRICTED   |     P=0.177      (e)          (e)          (e)         |P=0.324N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/49 (8%)    2/49 (4%)    6/48 (13%)   1/48 (2%)   |0/48 (0%)    4/50 (8%)    2/50 (4%)    5/50 (10%)   | 
|POLY-3 RATE (b)    |     4/44.57      2/42.15      6/42.93      1/42.61     |0/45.53      4/45.81      2/43.76      5/45.30      | 
|POLY-3 PERCENT (g) |     9.0%         4.8%         14.0%        2.4%        |0.0%         8.7%         4.6%         11.0%        | 
|TERMINAL (d)       |     3/31 (10%)   2/33 (6%)    5/32 (16%)   1/32 (3%)   |0/42 (0%)    3/39 (8%)    2/34 (6%)    3/35 (9%)    | 
|FIRST INCIDENCE    |     700          729 (T)      706          729 (T)     |---          700          729 (T)      538          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.235N     P=0.318N     P=0.386      P=0.185N    |P=0.036 *    P=0.057      P=0.193      P=0.026 *    | 
|POLY 3             |     P=0.243N     P=0.363N     P=0.346      P=0.192N    |P=0.047 *    P=0.061      P=0.228      P=0.030 *    | 
|POLY 1.5           |     P=0.240N     P=0.357N     P=0.350      P=0.189N    |P=0.050      P=0.063      P=0.235      P=0.032 *    | 
|POLY 6             |     P=0.252N     P=0.366N     P=0.342      P=0.197N    |P=0.043 *    P=0.059      P=0.219      P=0.028 *    | 
|LOGISTIC REGRESSION|     P=0.263N     P=0.355N     P=0.344      P=0.202N    |P=0.054      P=0.061      P=0.193      P=0.042 *    | 
|COCH-ARM / FISHERS |     P=0.243N     P=0.339N     P=0.357      P=0.187N    |P=0.056      P=0.064      P=0.258      P=0.031 *    | 
|ORDER RESTRICTED   |     P=0.168N     (e)          (e)          (e)         |P=0.017 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 38      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/49 (0%)    0/49 (0%)    0/48 (0%)    0/48 (0%)   |1/48 (2%)    2/50 (4%)    3/50 (6%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/44.45      0/42.15      0/42.84      0/42.61     |1/45.53      2/45.69      3/43.76      0/44.39      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |2.2%         4.4%         6.9%         0.0%         | 
|TERMINAL (d)       |     0/31 (0%)    0/33 (0%)    0/32 (0%)    0/32 (0%)   |1/42 (2%)    2/39 (5%)    3/34 (9%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |729 (T)      729 (T)      729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.402N     P=0.474      P=0.233      P=0.536N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.356N     P=0.501      P=0.291      P=0.505N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.343N     P=0.507      P=0.302      P=0.500N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.373N     P=0.494      P=0.276      P=0.512N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.402N     P=0.474      P=0.233      (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.326N     P=0.515      P=0.324      P=0.490N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.187N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Cytoplasmic Alteration Focal                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/49 (0%)    0/49 (0%)    2/48 (4%)    0/48 (0%)   |0/48 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/44.45      0/42.15      2/42.84      0/42.61     |0/45.53      0/45.69      0/43.76      0/44.39      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         4.7%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/31 (0%)    0/33 (0%)    2/32 (6%)    0/32 (0%)   |0/42 (0%)    0/39 (0%)    0/34 (0%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          729 (T)      ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.598      (e)          P=0.245      (e)         |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.587      (e)          P=0.229      (e)         |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.590      (e)          P=0.230      (e)         |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.579      (e)          P=0.228      (e)         |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.245      (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.590      (e)          P=0.242      (e)         |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.240      (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 39      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Degeneration Cystic Focal                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/49 (0%)    1/49 (2%)    0/48 (0%)    0/48 (0%)   |9/48 (19%)   6/50 (12%)   5/50 (10%)   3/50 (6%)    | 
|POLY-3 RATE (b)    |     0/44.45      1/42.26      0/42.84      0/42.61     |9/45.53      6/45.69      5/43.88      3/44.39      | 
|POLY-3 PERCENT (g) |     0.0%         2.4%         0.0%         0.0%        |19.8%        13.1%        11.4%        6.8%         | 
|TERMINAL (d)       |     0/31 (0%)    0/33 (0%)    0/32 (0%)    0/32 (0%)   |9/42 (21%)   6/39 (15%)   4/34 (12%)   3/35 (9%)    | 
|FIRST INCIDENCE    |     ---          700          ---          ---         |729 (T)      729 (T)      700          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.596N     P=0.489      (e)          (e)         |P=0.089N     P=0.341N     P=0.326N     P=0.110N     | 
|POLY 3             |     P=0.578N     P=0.490      (e)          (e)         |P=0.049N*    P=0.284N     P=0.213N     P=0.065N     | 
|POLY 1.5           |     P=0.576N     P=0.492      (e)          (e)         |P=0.045N*    P=0.273N     P=0.197N     P=0.059N     | 
|POLY 6             |     P=0.579N     P=0.490      (e)          (e)         |P=0.055N     P=0.298N     P=0.237N     P=0.073N     | 
|LOGISTIC REGRESSION|     P=0.571N     P=0.495      (e)          (e)         |P=0.075N     P=0.341N     P=0.282N     P=0.110N     | 
|COCH-ARM / FISHERS |     P=0.571N     P=0.500      (e)          (e)         |P=0.040N*    P=0.259N     P=0.172N     P=0.052N     | 
|ORDER RESTRICTED   |     P=0.379N     (e)          (e)          (e)         |P=0.045N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hemorrhage Focal                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/49 (4%)    0/49 (0%)    0/48 (0%)    0/48 (0%)   |0/48 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/44.45      0/42.15      0/42.84      0/42.61     |0/45.53      0/45.69      1/43.76      0/44.39      | 
|POLY-3 PERCENT (g) |     4.5%         0.0%         0.0%         0.0%        |0.0%         0.0%         2.3%         0.0%         | 
|TERMINAL (d)       |     2/31 (7%)    0/33 (0%)    0/32 (0%)    0/32 (0%)   |0/42 (0%)    0/39 (0%)    1/34 (3%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      ---          ---          ---         |---          ---          729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.113N     P=0.224N     P=0.231N     P=0.231N    |P=0.669      (e)          P=0.458      (e)          | 
|POLY 3             |     P=0.111N     P=0.249N     P=0.245N     P=0.246N    |P=0.679      (e)          P=0.492      (e)          | 
|POLY 1.5           |     P=0.112N     P=0.246N     P=0.244N     P=0.245N    |P=0.687      (e)          P=0.498      (e)          | 
|POLY 6             |     P=0.111N     P=0.250N     P=0.246N     P=0.250N    |P=0.669      (e)          P=0.483      (e)          | 
|LOGISTIC REGRESSION|     P=0.113N     (e)          (e)          (e)         |(e)          (e)          P=0.458      (e)          | 
|COCH-ARM / FISHERS |     P=0.117N     P=0.247N     P=0.253N     P=0.253N    |P=0.699      (e)          P=0.510      (e)          | 
|ORDER RESTRICTED   |     P=0.033N*    (e)          (e)          (e)         |P=0.373      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 40      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/49 (6%)    1/49 (2%)    1/48 (2%)    1/48 (2%)   |4/48 (8%)    4/50 (8%)    5/50 (10%)   4/50 (8%)    | 
|POLY-3 RATE (b)    |     3/44.45      1/42.15      1/42.84      1/42.61     |4/45.53      4/45.69      5/43.76      4/44.39      | 
|POLY-3 PERCENT (g) |     6.8%         2.4%         2.3%         2.4%        |8.8%         8.8%         11.4%        9.0%         | 
|TERMINAL (d)       |     3/31 (10%)   1/33 (3%)    1/32 (3%)    1/32 (3%)   |4/42 (10%)   4/39 (10%)   5/34 (15%)   4/35 (11%)   | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      729 (T)     |729 (T)      729 (T)      729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.236N     P=0.282N     P=0.293N     P=0.293N    |P=0.431      P=0.603      P=0.368      P=0.540      | 
|POLY 3             |     P=0.246N     P=0.324N     P=0.318N     P=0.320N    |P=0.528      P=0.641N     P=0.475      P=0.629      | 
|POLY 1.5           |     P=0.246N     P=0.320N     P=0.316N     P=0.317N    |P=0.546      P=0.632N     P=0.494      P=0.642N     | 
|POLY 6             |     P=0.248N     P=0.326N     P=0.320N     P=0.326N    |P=0.503      P=0.635      P=0.448      P=0.609      | 
|LOGISTIC REGRESSION|     P=0.236N     P=0.282N     P=0.293N     P=0.293N    |P=0.431      P=0.603      P=0.368      P=0.540      | 
|COCH-ARM / FISHERS |     P=0.248N     P=0.309N     P=0.316N     P=0.316N    |P=0.565N     P=0.619N     P=0.526      P=0.619N     | 
|ORDER RESTRICTED   |     P=0.205N     (e)          (e)          (e)         |P=0.634      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hypertrophy Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/49 (16%)   9/49 (18%)   20/48 (42%)  22/48 (46%) |1/48 (2%)    0/50 (0%)    1/50 (2%)    4/50 (8%)    | 
|POLY-3 RATE (b)    |     8/45.12      9/44.13      20/46.38     22/44.97    |1/45.53      0/45.69      1/43.76      4/44.98      | 
|POLY-3 PERCENT (g) |     17.7%        20.4%        43.1%        48.9%       |2.2%         0.0%         2.3%         8.9%         | 
|TERMINAL (d)       |     5/31 (16%)   6/33 (18%)   12/32 (38%)  16/32 (50%) |1/42 (2%)    0/39 (0%)    1/34 (3%)    2/35 (6%)    | 
|FIRST INCIDENCE    |     547          275          493          384         |729 (T)      ---          729 (T)      642          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.530      P=0.013 *    P=0.004 **  |P=0.026 *    P=0.515N     P=0.714      P=0.145      | 
|POLY 3             |     P<0.001 **   P=0.480      P=0.006 **   P<0.001 **  |P=0.033 *    P=0.499N     P=0.752      P=0.175      | 
|POLY 1.5           |     P<0.001 **   P=0.483      P=0.005 **   P<0.001 **  |P=0.034 *    P=0.496N     P=0.758      P=0.182      | 
|POLY 6             |     P<0.001 **   P=0.483      P=0.007 **   P<0.001 **  |P=0.032 *    P=0.503N     P=0.742      P=0.167      | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.558      P=0.006 **   P=0.002 **  |P=0.035 *    (e)          P=0.714      P=0.194      | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.500      P=0.005 **   P=0.002 **  |P=0.036 *    P=0.490N     P=0.742N     P=0.194      | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |P=0.025 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 41      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/50 (10%)   3/50 (6%)    2/50 (4%)    3/49 (6%)   |                                                    | 
|POLY-3 RATE (b)    |     5/45.75      3/43.87      2/44.41      3/44.21     |                                                    | 
|POLY-3 PERCENT (g) |     10.9%        6.8%         4.5%         6.8%        |                                                    | 
|TERMINAL (d)       |     2/31 (7%)    2/34 (6%)    2/33 (6%)    1/32 (3%)   |                                                    | 
|FIRST INCIDENCE    |     653          477          729 (T)      384         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.309N     P=0.347N     P=0.216N     P=0.379N    |                                                    | 
|POLY 3             |     P=0.306N     P=0.380N     P=0.228N     P=0.375N    |                                                    | 
|POLY 1.5           |     P=0.305N     P=0.375N     P=0.223N     P=0.372N    |                                                    | 
|POLY 6             |     P=0.311N     P=0.381N     P=0.234N     P=0.381N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.295N     P=0.336N     P=0.222N     P=0.292N    |                                                    | 
|COCH-ARM / FISHERS |     P=0.306N     P=0.357N     P=0.218N     P=0.369N    |                                                    | 
|ORDER RESTRICTED   |     P=0.266N     (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    1/50 (2%)    0/50 (0%)    0/49 (0%)   |                                                    | 
|POLY-3 RATE (b)    |     3/45.45      1/43.26      0/44.41      0/42.87     |                                                    | 
|POLY-3 PERCENT (g) |     6.6%         2.3%         0.0%         0.0%        |                                                    | 
|TERMINAL (d)       |     2/31 (7%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |                                                    | 
|FIRST INCIDENCE    |     667          700          ---          ---         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.049N*    P=0.305N     P=0.121N     P=0.131N    |                                                    | 
|POLY 3             |     P=0.043N*    P=0.323N     P=0.123N     P=0.129N    |                                                    | 
|POLY 1.5           |     P=0.043N*    P=0.319N     P=0.121N     P=0.127N    |                                                    | 
|POLY 6             |     P=0.043N*    P=0.323N     P=0.124N     P=0.132N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.046N*    P=0.318N     P=0.123N     P=0.129N    |                                                    | 
|COCH-ARM / FISHERS |     P=0.045N*    P=0.309N     P=0.121N     P=0.125N    |                                                    | 
|ORDER RESTRICTED   |     P=0.024N*    (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 42      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     30/50 (60%)  28/50 (56%)  21/50 (42%)  23/49 (47%) |                                                    | 
|POLY-3 RATE (b)    |     30/47.22     28/45.01     21/45.67     23/45.91    |                                                    | 
|POLY-3 PERCENT (g) |     63.5%        62.2%        46.0%        50.1%       |                                                    | 
|TERMINAL (d)       |     25/31 (81%)  20/34 (59%)  16/33 (49%)  12/32 (38%) |                                                    | 
|FIRST INCIDENCE    |     464          577          498          607         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.102N     P=0.300N     P=0.034N*    P=0.145N    |                                                    | 
|POLY 3             |     P=0.067N     P=0.534N     P=0.062N     P=0.131N    |                                                    | 
|POLY 1.5           |     P=0.075N     P=0.513N     P=0.059N     P=0.140N    |                                                    | 
|POLY 6             |     P=0.054N     P=0.515N     P=0.062N     P=0.106N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.092N     P=0.531N     P=0.062N     P=0.152N    |                                                    | 
|COCH-ARM / FISHERS |     P=0.084N     P=0.420N     P=0.055N     P=0.135N    |                                                    | 
|ORDER RESTRICTED   |     P=0.092N     (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Prostate                                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     27/50 (54%)  24/50 (48%)  28/50 (56%)  36/49 (73%) |                                                    | 
|POLY-3 RATE (b)    |     27/48.10     24/46.04     28/47.60     36/46.40    |                                                    | 
|POLY-3 PERCENT (g) |     56.1%        52.1%        58.8%        77.6%       |                                                    | 
|TERMINAL (d)       |     15/31 (48%)  16/34 (47%)  19/33 (58%)  26/32 (81%) |                                                    | 
|FIRST INCIDENCE    |     464          477          493          384         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.033 *    P=0.309N     P=0.553      P=0.086     |                                                    | 
|POLY 3             |     P=0.008 **   P=0.427N     P=0.476      P=0.019 *   |                                                    | 
|POLY 1.5           |     P=0.009 **   P=0.410N     P=0.485      P=0.023 *   |                                                    | 
|POLY 6             |     P=0.006 **   P=0.428N     P=0.470      P=0.015 *   |                                                    | 
|LOGISTIC REGRESSION|     P=0.012 *    P=0.364N     P=0.509      P=0.032 *   |                                                    | 
|COCH-ARM / FISHERS |     P=0.012 *    P=0.345N     P=0.500      P=0.035 *   |                                                    | 
|ORDER RESTRICTED   |     P=0.010 *    (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 43      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Prostate: Epithelium                                                                                                             | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    6/50 (12%)   5/50 (10%)   0/49 (0%)   |                                                    | 
|POLY-3 RATE (b)    |     4/46.45      6/45.09      5/46.24      0/42.80     |                                                    | 
|POLY-3 PERCENT (g) |     8.6%         13.3%        10.8%        0.0%        |                                                    | 
|TERMINAL (d)       |     2/31 (7%)    3/34 (9%)    2/33 (6%)    0/32 (0%)   |                                                    | 
|FIRST INCIDENCE    |     464          477          493          ---         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.050N     P=0.385      P=0.515      P=0.065N    |                                                    | 
|POLY 3             |     P=0.059N     P=0.351      P=0.497      P=0.071N    |                                                    | 
|POLY 1.5           |     P=0.055N     P=0.353      P=0.498      P=0.068N    |                                                    | 
|POLY 6             |     P=0.064N     P=0.355      P=0.498      P=0.075N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.035N*    P=0.526      P=0.615      P=0.034N*   |                                                    | 
|COCH-ARM / FISHERS |     P=0.049N*    P=0.370      P=0.500      P=0.061N    |                                                    | 
|ORDER RESTRICTED   |     P=0.043N*    (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Atrophy Focal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/45.39      0/43.15      0/44.41      0/43.64     |0/46.53      0/45.69      2/43.76      0/44.39      | 
|POLY-3 PERCENT (g) |     2.2%         0.0%         0.0%         0.0%        |0.0%         0.0%         4.6%         0.0%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |0/43 (0%)    0/39 (0%)    2/34 (6%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     685          ---          ---          ---         |---          ---          729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.323N     P=0.510N     P=0.510N     P=0.532N    |P=0.552      (e)          P=0.188      (e)          | 
|POLY 3             |     P=0.298N     P=0.510N     P=0.504N     P=0.508N    |P=0.576      (e)          P=0.224      (e)          | 
|POLY 1.5           |     P=0.300N     P=0.508N     P=0.503N     P=0.505N    |P=0.587      (e)          P=0.230      (e)          | 
|POLY 6             |     P=0.297N     P=0.511N     P=0.506N     P=0.512N    |P=0.561      (e)          P=0.214      (e)          | 
|LOGISTIC REGRESSION|     P=0.305N     P=0.496N     P=0.496N     P=0.494N    |(e)          (e)          P=0.188      (e)          | 
|COCH-ARM / FISHERS |     P=0.306N     P=0.500N     P=0.500N     P=0.500N    |P=0.595      (e)          P=0.247      (e)          | 
|ORDER RESTRICTED   |     P=0.128N     (e)          (e)          (e)         |P=0.236      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 44      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Cyst Epithelial Inclusion                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    2/50 (4%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/45.67      1/43.15      2/45.34      1/43.64     |0/46.53      0/45.69      0/43.76      0/44.39      | 
|POLY-3 PERCENT (g) |     2.2%         2.3%         4.4%         2.3%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/31 (0%)    1/34 (3%)    0/33 (0%)    1/32 (3%)   |0/43 (0%)    0/39 (0%)    0/34 (0%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     597          729 (T)      531          729 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.591      P=0.760N     P=0.490      P=0.754N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.576      P=0.748      P=0.497      P=0.751     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.582      P=0.751      P=0.498      P=0.754     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.566      P=0.747      P=0.498      P=0.746     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.600      P=0.747N     P=0.573      P=0.744N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.591      P=0.753N     P=0.500      P=0.753N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.577      (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Epidermis                                                                                                                  | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/45.22      1/43.21      1/44.41      0/43.64     |0/46.53      0/45.69      1/43.76      2/44.83      | 
|POLY-3 PERCENT (g) |     0.0%         2.3%         2.3%         0.0%        |0.0%         0.0%         2.3%         4.5%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    1/33 (3%)    0/32 (0%)   |0/43 (0%)    0/39 (0%)    1/34 (3%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     ---          712          729 (T)      ---         |---          ---          729 (T)      654          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.602N     P=0.506      P=0.512      (e)         |P=0.061      (e)          P=0.453      P=0.217      | 
|POLY 3             |     P=0.605N     P=0.491      P=0.496      (e)         |P=0.067      (e)          P=0.488      P=0.229      | 
|POLY 1.5           |     P=0.601N     P=0.493      P=0.498      (e)         |P=0.068      (e)          P=0.494      P=0.234      | 
|POLY 6             |     P=0.609N     P=0.491      P=0.495      (e)         |P=0.064      (e)          P=0.479      P=0.223      | 
|LOGISTIC REGRESSION|     P=0.606N     P=0.491      P=0.512      (e)         |P=0.070      (e)          P=0.453      P=0.236      | 
|COCH-ARM / FISHERS |     P=0.595N     P=0.500      P=0.500      (e)         |P=0.070      (e)          P=0.500      P=0.247      | 
|ORDER RESTRICTED   |     P=0.395      (e)          (e)          (e)         |P=0.069      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 45      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spinal Cord                                                                                                                      | 
|     Hemorrhage Focal                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/2 (0%)     1/3 (33%)    0/2 (0%)     1/3 (33%)   |0/7 (0%)     0/3 (0%)     0/24 (0%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/1.38       1/1.85       0/1.71       1/1.86      |0/5.32       0/2.72       0/20.93      2/45.35      | 
|POLY-3 PERCENT (g) |     0.0%         54.0%        0.0%         53.9%       |0.0%         0.0%         0.0%         4.4%         | 
|TERMINAL (d)       |     0/0 (0%)     0/0 (0%)     0/1 (0%)     0/0 (0%)    |0/5 (0%)     0/2 (0%)     0/17 (0%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     ---          567          ---          689         |---          ---          ---          368          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.411      P=0.487      (e)          P=0.512     |P=0.045 *    (e)          (e)          P=0.228      | 
|POLY 3             |     P=0.429      P=0.568      (e)          P=0.567     |P=0.315      (e)          (e)          P=0.735      | 
|POLY 1.5           |     P=0.432      P=0.569      (e)          P=0.563     |P=0.312      (e)          (e)          P=0.734      | 
|POLY 6             |     P=0.465      P=0.592      (e)          P=0.610     |P=0.317      (e)          (e)          P=0.734      | 
|LOGISTIC REGRESSION|     P=0.449      P=0.823      (e)          (e)         |P=0.149      (e)          (e)          P=0.488      | 
|COCH-ARM / FISHERS |     P=0.458      P=0.600      (e)          P=0.600     |P=0.291      (e)          (e)          P=0.768      | 
|ORDER RESTRICTED   |     P=0.264      (e)          (e)          (e)         |P=0.579      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Accessory Spleen                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    0/48 (0%)    1/48 (2%)    3/49 (6%)   |3/50 (6%)    0/48 (0%)    1/47 (2%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     3/45.31      0/42.47      1/43.18      3/42.93     |3/46.65      0/43.79      1/43.00      1/42.39      | 
|POLY-3 PERCENT (g) |     6.6%         0.0%         2.3%         7.0%        |6.4%         0.0%         2.3%         2.4%         | 
|TERMINAL (d)       |     2/31 (7%)    0/34 (0%)    1/33 (3%)    3/32 (9%)   |2/43 (5%)    0/38 (0%)    0/34 (0%)    1/33 (3%)    | 
|FIRST INCIDENCE    |     705          ---          729 (T)      729 (T)     |700          ---          700          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.418      P=0.114N     P=0.290N     P=0.660N    |P=0.362N     P=0.141N     P=0.382N     P=0.393N     | 
|POLY 3             |     P=0.414      P=0.130N     P=0.323N     P=0.637     |P=0.311N     P=0.130N     P=0.335N     P=0.340N     | 
|POLY 1.5           |     P=0.417      P=0.130N     P=0.322N     P=0.643     |P=0.309N     P=0.127N     P=0.327N     P=0.329N     | 
|POLY 6             |     P=0.410      P=0.129N     P=0.321N     P=0.631     |P=0.314N     P=0.135N     P=0.347N     P=0.356N     | 
|LOGISTIC REGRESSION|     P=0.393      P=0.127N     P=0.313N     P=0.630     |P=0.323N     P=0.131N     P=0.330N     P=0.350N     | 
|COCH-ARM / FISHERS |     P=0.418      P=0.129N     P=0.324N     P=0.651     |P=0.307N     P=0.129N     P=0.332N     P=0.324N     | 
|ORDER RESTRICTED   |     P=0.273      (e)          (e)          (e)         |P=0.127N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 46      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    0/48 (0%)    0/48 (0%)    0/49 (0%)   |0/50 (0%)    0/48 (0%)    2/47 (4%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     3/46.09      0/42.47      0/43.18      0/42.93     |0/46.53      0/43.79      2/43.36      0/42.39      | 
|POLY-3 PERCENT (g) |     6.5%         0.0%         0.0%         0.0%        |0.0%         0.0%         4.6%         0.0%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |0/43 (0%)    0/38 (0%)    0/34 (0%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     589          ---          ---          ---         |---          ---          638          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.051N     P=0.137N     P=0.128N     P=0.134N    |P=0.572      (e)          P=0.209      (e)          | 
|POLY 3             |     P=0.045N*    P=0.134N     P=0.131N     P=0.132N    |P=0.560      (e)          P=0.222      (e)          | 
|POLY 1.5           |     P=0.045N*    P=0.132N     P=0.129N     P=0.128N    |P=0.574      (e)          P=0.225      (e)          | 
|POLY 6             |     P=0.044N*    P=0.135N     P=0.132N     P=0.136N    |P=0.541      (e)          P=0.216      (e)          | 
|LOGISTIC REGRESSION|     P=0.044N*    P=0.096N     P=0.112N     P=0.093N    |P=0.585      (e)          P=0.211      (e)          | 
|COCH-ARM / FISHERS |     P=0.049N*    P=0.129N     P=0.129N     P=0.125N    |P=0.587      (e)          P=0.232      (e)          | 
|ORDER RESTRICTED   |     P=0.010N*    (e)          (e)          (e)         |P=0.235      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Fibrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    2/48 (4%)    2/48 (4%)    0/49 (0%)   |1/50 (2%)    0/48 (0%)    1/47 (2%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     2/45.25      2/42.59      2/43.46      0/42.93     |1/46.53      0/43.79      1/43.38      1/42.39      | 
|POLY-3 PERCENT (g) |     4.4%         4.7%         4.6%         0.0%        |2.2%         0.0%         2.3%         2.4%         | 
|TERMINAL (d)       |     1/31 (3%)    1/34 (3%)    1/33 (3%)    0/32 (0%)   |1/43 (2%)    0/38 (0%)    0/34 (0%)    1/33 (3%)    | 
|FIRST INCIDENCE    |     722          700          653          ---         |729 (T)      ---          581          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.174N     P=0.678N     P=0.690N     P=0.240N    |P=0.491      P=0.525N     P=0.729      P=0.702      | 
|POLY 3             |     P=0.175N     P=0.672      P=0.679      P=0.249N    |P=0.516      P=0.512N     P=0.745      P=0.740      | 
|POLY 1.5           |     P=0.172N     P=0.673      P=0.679      P=0.247N    |P=0.523      P=0.509N     P=0.748      P=0.746      | 
|POLY 6             |     P=0.178N     P=0.676      P=0.683      P=0.252N    |P=0.506      P=0.516N     P=0.739      P=0.730      | 
|LOGISTIC REGRESSION|     P=0.172N     P=0.679      P=0.679      P=0.253N    |P=0.530      (e)          P=0.737      P=0.702      | 
|COCH-ARM / FISHERS |     P=0.167N     P=0.676      P=0.676      P=0.253N    |P=0.530      P=0.510N     P=0.737      P=0.742      | 
|ORDER RESTRICTED   |     P=0.186N     (e)          (e)          (e)         |P=0.511      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 47      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    1/48 (2%)    1/48 (2%)    1/49 (2%)   |6/50 (12%)   2/48 (4%)    0/47 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     1/45.45      1/42.59      1/43.77      1/42.93     |6/48.14      2/43.79      0/42.89      0/42.39      | 
|POLY-3 PERCENT (g) |     2.2%         2.4%         2.3%         2.3%        |12.5%        4.6%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    1/32 (3%)   |4/43 (9%)    2/38 (5%)    0/34 (0%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     667          700          538          729 (T)     |302          729 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.611      P=0.744      P=0.745      P=0.744     |P=0.007N**   P=0.170N     P=0.030N*    P=0.031N*    | 
|POLY 3             |     P=0.618      P=0.746      P=0.752      P=0.748     |P=0.004N**   P=0.166N     P=0.022N*    P=0.023N*    | 
|POLY 1.5           |     P=0.622      P=0.747      P=0.752      P=0.751     |P=0.004N**   P=0.156N     P=0.020N*    P=0.021N*    | 
|POLY 6             |     P=0.612      P=0.747      P=0.754      P=0.744     |P=0.004N**   P=0.176N     P=0.025N*    P=0.027N*    | 
|LOGISTIC REGRESSION|     P=0.621N     P=0.762      P=0.749N     P=0.757     |P=0.005N**   P=0.162N     P=0.026N*    P=0.020N*    | 
|COCH-ARM / FISHERS |     P=0.630      P=0.742      P=0.742      P=0.747     |P=0.004N**   P=0.148N     P=0.016N*    P=0.015N*    | 
|ORDER RESTRICTED   |     P=0.729      (e)          (e)          (e)         |P=0.002N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Infarct                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/48 (2%)    0/48 (0%)    2/49 (4%)   |0/50 (0%)    0/48 (0%)    0/47 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/45.22      1/42.59      0/43.18      2/43.52     |0/46.53      0/43.79      0/42.89      0/42.39      | 
|POLY-3 PERCENT (g) |     0.0%         2.4%         0.0%         4.6%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |0/43 (0%)    0/38 (0%)    0/34 (0%)    0/33 (0%)    | 
|FIRST INCIDENCE    |     ---          700          ---          632         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.126      P=0.489      (e)          P=0.218     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.137      P=0.488      (e)          P=0.229     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.137      P=0.488      (e)          P=0.230     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.136      P=0.490      (e)          P=0.228     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.145      P=0.490      (e)          P=0.260     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.139      P=0.490      (e)          P=0.242     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.069      (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 48      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    2/48 (4%)    1/48 (2%)    2/49 (4%)   |0/50 (0%)    3/48 (6%)    10/47 (21%)  3/48 (6%)    | 
|POLY-3 RATE (b)    |     0/45.22      2/42.59      1/43.77      2/42.93     |0/46.53      3/43.91      10/42.89     3/42.39      | 
|POLY-3 PERCENT (g) |     0.0%         4.7%         2.3%         4.7%        |0.0%         6.8%         23.3%        7.1%         | 
|TERMINAL (d)       |     0/31 (0%)    1/34 (3%)    0/33 (0%)    2/32 (6%)   |0/43 (0%)    2/38 (5%)    10/34 (29%)  3/33 (9%)    | 
|FIRST INCIDENCE    |     ---          700          538          729 (T)     |---          700          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.238      P=0.244      P=0.492      P=0.245     |P=0.072      P=0.106      P<0.001 **   P=0.079      | 
|POLY 3             |     P=0.234      P=0.224      P=0.494      P=0.226     |P=0.098      P=0.108      P<0.001 **   P=0.103      | 
|POLY 1.5           |     P=0.237      P=0.224      P=0.493      P=0.228     |P=0.112      P=0.111      P<0.001 **   P=0.108      | 
|POLY 6             |     P=0.230      P=0.226      P=0.496      P=0.223     |P=0.081      P=0.106      P<0.001 **   P=0.096      | 
|LOGISTIC REGRESSION|     P=0.247      P=0.225      P=0.534      P=0.245     |P=0.084      P=0.109      P<0.001 **   P=0.079      | 
|COCH-ARM / FISHERS |     P=0.243      P=0.237      P=0.490      P=0.242     |P=0.134      P=0.114      P<0.001 **   P=0.114      | 
|ORDER RESTRICTED   |     P=0.147      (e)          (e)          (e)         |P=0.006 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Capsule                                                                                                                  | 
|     Infiltration Cellular Focal Mixed Cell                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/48 (0%)    0/48 (0%)    0/49 (0%)   |0/50 (0%)    0/48 (0%)    2/47 (4%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     0/45.22      0/42.47      0/43.18      0/42.93     |0/46.53      0/43.79      2/42.89      1/42.39      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         4.7%         2.4%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |0/43 (0%)    0/38 (0%)    2/34 (6%)    1/33 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.195      (e)          P=0.188      P=0.447      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.222      (e)          P=0.219      P=0.481      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.231      (e)          P=0.224      P=0.487      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.210      (e)          P=0.212      P=0.474      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          P=0.188      P=0.447      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.239      (e)          P=0.232      P=0.490      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.153      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 49      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    0/50 (0%)    0/50 (0%)    0/49 (0%)   |1/50 (2%)    1/50 (2%)    2/49 (4%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     3/45.66      0/43.15      0/44.41      0/43.07     |1/46.53      1/45.69      2/44.40      1/44.70      | 
|POLY-3 PERCENT (g) |     6.6%         0.0%         0.0%         0.0%        |2.2%         2.2%         4.5%         2.2%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |1/43 (2%)    1/39 (3%)    0/34 (0%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     642          ---          ---          ---         |729 (T)      729 (T)      581          642          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.052N     P=0.131N     P=0.127N     P=0.137N    |P=0.545      P=0.740      P=0.449      P=0.733      | 
|POLY 3             |     P=0.043N*    P=0.129N     P=0.124N     P=0.129N    |P=0.572      P=0.756      P=0.484      P=0.752      | 
|POLY 1.5           |     P=0.044N*    P=0.126N     P=0.122N     P=0.127N    |P=0.582      P=0.760      P=0.492      P=0.757      | 
|POLY 6             |     P=0.043N*    P=0.130N     P=0.126N     P=0.133N    |P=0.560      P=0.752      P=0.472      P=0.745      | 
|LOGISTIC REGRESSION|     P=0.048N*    P=0.118N     P=0.118N     P=0.120N    |P=0.589      P=0.740      P=0.484      P=0.762N     | 
|COCH-ARM / FISHERS |     P=0.048N*    P=0.121N     P=0.121N     P=0.125N    |P=0.590      P=0.753N     P=0.492      P=0.753N     | 
|ORDER RESTRICTED   |     P=0.010N*    (e)          (e)          (e)         |P=0.566      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    1/50 (2%)    3/49 (6%)   |0/50 (0%)    0/50 (0%)    2/49 (4%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/45.39      0/43.15      1/45.10      3/43.60     |0/46.53      0/45.69      2/44.58      0/44.39      | 
|POLY-3 PERCENT (g) |     2.2%         0.0%         2.2%         6.9%        |0.0%         0.0%         4.5%         0.0%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    1/32 (3%)   |0/43 (0%)    0/39 (0%)    0/34 (0%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     685          ---          493          651         |---          ---          581          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.089      P=0.510N     P=0.757      P=0.279     |P=0.585      (e)          P=0.222      (e)          | 
|POLY 3             |     P=0.094      P=0.510N     P=0.759      P=0.291     |P=0.572      (e)          P=0.228      (e)          | 
|POLY 1.5           |     P=0.094      P=0.508N     P=0.760      P=0.293     |P=0.584      (e)          P=0.232      (e)          | 
|POLY 6             |     P=0.093      P=0.511N     P=0.759      P=0.289     |P=0.556      (e)          P=0.221      (e)          | 
|LOGISTIC REGRESSION|     P=0.092      P=0.496N     P=0.731N     P=0.309     |P=0.569      (e)          P=0.195      (e)          | 
|COCH-ARM / FISHERS |     P=0.093      P=0.500N     P=0.753N     P=0.301     |P=0.594      (e)          P=0.242      (e)          | 
|ORDER RESTRICTED   |     P=0.075      (e)          (e)          (e)         |P=0.239      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 50      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/50 (10%)   2/50 (4%)    2/50 (4%)    3/49 (6%)   |1/50 (2%)    1/50 (2%)    3/49 (6%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     5/46.03      2/43.39      2/45.04      3/43.88     |1/47.21      1/45.96      3/44.73      2/44.86      | 
|POLY-3 PERCENT (g) |     10.9%        4.6%         4.4%         6.8%        |2.1%         2.2%         6.7%         4.5%         | 
|TERMINAL (d)       |     0/31 (0%)    1/34 (3%)    0/33 (0%)    0/32 (0%)   |0/43 (0%)    0/39 (0%)    0/34 (0%)    0/35 (0%)    | 
|FIRST INCIDENCE    |     642          665          642          632         |498          657          581          642          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.391N     P=0.241N     P=0.237N     P=0.430N    |P=0.299      P=0.753      P=0.284      P=0.478      | 
|POLY 3             |     P=0.351N     P=0.241N     P=0.225N     P=0.383N    |P=0.303      P=0.755      P=0.286      P=0.482      | 
|POLY 1.5           |     P=0.351N     P=0.234N     P=0.222N     P=0.378N    |P=0.314      P=0.759      P=0.295      P=0.492      | 
|POLY 6             |     P=0.353N     P=0.245N     P=0.228N     P=0.389N    |P=0.290      P=0.750      P=0.275      P=0.471      | 
|LOGISTIC REGRESSION|     P=0.348N     P=0.213N     P=0.198N     P=0.336N    |P=0.301      P=0.724      P=0.239      P=0.475      | 
|COCH-ARM / FISHERS |     P=0.353N     P=0.218N     P=0.218N     P=0.369N    |P=0.324      P=0.753N     P=0.301      P=0.500      | 
|ORDER RESTRICTED   |     P=0.230N     (e)          (e)          (e)         |P=0.306      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    3/50 (6%)    2/50 (4%)    4/49 (8%)   |0/50 (0%)    1/50 (2%)    6/49 (12%)   1/50 (2%)    | 
|POLY-3 RATE (b)    |     4/45.63      3/43.77      2/45.42      4/43.68     |0/46.53      1/45.79      6/44.40      1/44.70      | 
|POLY-3 PERCENT (g) |     8.8%         6.9%         4.4%         9.2%        |0.0%         2.2%         13.5%        2.2%         | 
|TERMINAL (d)       |     0/31 (0%)    1/34 (3%)    0/33 (0%)    2/32 (6%)   |0/43 (0%)    0/39 (0%)    4/34 (12%)   0/35 (0%)    | 
|FIRST INCIDENCE    |     685          621          493          622         |---          705          581          642          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.530      P=0.511N     P=0.349N     P=0.602     |P=0.260      P=0.490      P=0.010 *    P=0.491      | 
|POLY 3             |     P=0.543      P=0.523N     P=0.339N     P=0.619     |P=0.281      P=0.497      P=0.013 *    P=0.492      | 
|POLY 1.5           |     P=0.545      P=0.518N     P=0.339N     P=0.623     |P=0.296      P=0.500      P=0.014 *    P=0.497      | 
|POLY 6             |     P=0.539      P=0.521N     P=0.340N     P=0.615     |P=0.263      P=0.493      P=0.011 *    P=0.486      | 
|LOGISTIC REGRESSION|     P=0.553      P=0.498N     P=0.301N     P=0.635     |P=0.313      P=0.500      P=0.016 *    P=0.494      | 
|COCH-ARM / FISHERS |     P=0.547      P=0.500N     P=0.339N     P=0.631     |P=0.312      P=0.500      P=0.012 *    P=0.500      | 
|ORDER RESTRICTED   |     P=0.514      (e)          (e)          (e)         |P=0.043 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 51      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/49 (0%)    0/49 (0%)   |0/50 (0%)    0/50 (0%)    0/49 (0%)    0/49 (0%)    | 
|POLY-3 RATE (b)    |     2/45.43      0/43.15      0/43.75      0/43.07     |0/46.53      0/45.69      0/43.76      0/43.39      | 
|POLY-3 PERCENT (g) |     4.4%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |0/43 (0%)    0/39 (0%)    0/34 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     700          ---          ---          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.125N     P=0.249N     P=0.243N     P=0.272N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.111N     P=0.249N     P=0.246N     P=0.249N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.112N     P=0.246N     P=0.244N     P=0.247N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.110N     P=0.250N     P=0.247N     P=0.252N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.118N     P=0.244N     P=0.243N     P=0.245N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.117N     P=0.247N     P=0.253N     P=0.253N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.034N*    (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Erosion                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    1/50 (2%)    1/49 (2%)    6/49 (12%)  |2/50 (4%)    1/50 (2%)    1/49 (2%)    4/49 (8%)    | 
|POLY-3 RATE (b)    |     3/45.69      1/43.39      1/43.89      6/44.21     |2/46.53      1/46.48      1/44.15      4/44.84      | 
|POLY-3 PERCENT (g) |     6.6%         2.3%         2.3%         13.6%       |4.3%         2.2%         2.3%         8.9%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |2/43 (5%)    0/39 (0%)    0/34 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     653          665          694          651         |729 (T)      434          619          368          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.062      P=0.328N     P=0.319N     P=0.198     |P=0.144      P=0.520N     P=0.562N     P=0.288      | 
|POLY 3             |     P=0.074      P=0.324N     P=0.320N     P=0.225     |P=0.154      P=0.500N     P=0.518N     P=0.320      | 
|POLY 1.5           |     P=0.074      P=0.320N     P=0.317N     P=0.227     |P=0.157      P=0.497N     P=0.509N     P=0.328      | 
|POLY 6             |     P=0.074      P=0.325N     P=0.322N     P=0.226     |P=0.149      P=0.506N     P=0.532N     P=0.310      | 
|LOGISTIC REGRESSION|     P=0.075      P=0.293N     P=0.307N     P=0.248     |P=0.137      P=0.535N     P=0.507N     P=0.317      | 
|COCH-ARM / FISHERS |     P=0.074      P=0.309N     P=0.316N     P=0.233     |P=0.158      P=0.500N     P=0.508N     P=0.329      | 
|ORDER RESTRICTED   |     P=0.035 *    (e)          (e)          (e)         |P=0.124      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 52      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    2/49 (4%)    0/49 (0%)   |0/50 (0%)    1/50 (2%)    0/49 (0%)    0/49 (0%)    | 
|POLY-3 RATE (b)    |     1/45.33      1/43.61      2/44.55      0/43.07     |0/46.53      1/45.79      0/43.76      0/43.39      | 
|POLY-3 PERCENT (g) |     2.2%         2.3%         4.5%         0.0%        |0.0%         2.2%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |0/43 (0%)    0/39 (0%)    0/34 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     700          593          493          ---         |---          705          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.385N     P=0.747      P=0.496      P=0.533N    |P=0.586N     P=0.490      (e)          (e)          | 
|POLY 3             |     P=0.380N     P=0.752      P=0.494      P=0.510N    |P=0.577N     P=0.497      (e)          (e)          | 
|POLY 1.5           |     P=0.377N     P=0.753      P=0.493      P=0.508N    |P=0.572N     P=0.500      (e)          (e)          | 
|POLY 6             |     P=0.385N     P=0.753      P=0.496      P=0.513N    |P=0.584N     P=0.493      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.364N     P=0.735N     P=0.532      P=0.506N    |P=0.573N     P=0.500      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.373N     P=0.753N     P=0.492      P=0.505N    |P=0.571N     P=0.500      (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.274N     (e)          (e)          (e)         |P=0.391N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     15/50 (30%)  10/50 (20%)  8/50 (16%)   10/50 (20%) |                                                    | 
|POLY-3 RATE (b)    |     15/46.51     10/43.35     8/45.36      10/44.51    |                                                    | 
|POLY-3 PERCENT (g) |     32.3%        23.1%        17.6%        22.5%       |                                                    | 
|TERMINAL (d)       |     10/31 (32%)  8/34 (24%)   4/33 (12%)   8/32 (25%)  |                                                    | 
|FIRST INCIDENCE    |     589          694          594          584         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.185N     P=0.150N     P=0.080N     P=0.183N    |                                                    | 
|POLY 3             |     P=0.174N     P=0.230N     P=0.082N     P=0.208N    |                                                    | 
|POLY 1.5           |     P=0.170N     P=0.214N     P=0.080N     P=0.196N    |                                                    | 
|POLY 6             |     P=0.184N     P=0.243N     P=0.085N     P=0.226N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.181N     P=0.212N     P=0.079N     P=0.195N    |                                                    | 
|COCH-ARM / FISHERS |     P=0.169N     P=0.178N     P=0.077N     P=0.178N    |                                                    | 
|ORDER RESTRICTED   |     P=0.129N     (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 53      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Interstitial Cell                                                                                                        | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    0/50 (0%)    6/50 (12%)   7/50 (14%)  |                                                    | 
|POLY-3 RATE (b)    |     4/46.23      0/43.15      6/45.80      7/45.95     |                                                    | 
|POLY-3 PERCENT (g) |     8.7%         0.0%         13.1%        15.2%       |                                                    | 
|TERMINAL (d)       |     1/31 (3%)    0/34 (0%)    2/33 (6%)    2/32 (6%)   |                                                    | 
|FIRST INCIDENCE    |     547          ---          493          384         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.060      P=0.071N     P=0.376      P=0.261     |                                                    | 
|POLY 3             |     P=0.060      P=0.069N     P=0.364      P=0.257     |                                                    | 
|POLY 1.5           |     P=0.059      P=0.067N     P=0.366      P=0.259     |                                                    | 
|POLY 6             |     P=0.060      P=0.071N     P=0.363      P=0.255     |                                                    | 
|LOGISTIC REGRESSION|     P=0.058      P=0.043N*    P=0.415      P=0.354     |                                                    | 
|COCH-ARM / FISHERS |     P=0.056      P=0.059N     P=0.370      P=0.262     |                                                    | 
|ORDER RESTRICTED   |     P=0.050      (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/49 (0%)    0/46 (0%)    0/45 (0%)   |2/47 (4%)    0/50 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/43.45      0/43.09      0/40.87      0/40.12     |2/43.67      0/45.69      0/43.10      0/42.55      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |4.6%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    0/34 (0%)    0/30 (0%)    0/31 (0%)   |2/41 (5%)    0/39 (0%)    0/34 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |729 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.135N     P=0.249N     P=0.280N     P=0.280N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.110N     P=0.227N     P=0.240N     P=0.243N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.112N     P=0.223N     P=0.234N     P=0.237N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.109N     P=0.232N     P=0.249N     P=0.251N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.135N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.113N     P=0.232N     P=0.242N     P=0.242N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.031N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 54      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    0/49 (0%)    0/46 (0%)    0/45 (0%)   |0/47 (0%)    1/50 (2%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     2/44.22      0/43.09      0/40.87      0/40.12     |0/43.67      1/46.50      0/43.10      0/42.55      | 
|POLY-3 PERCENT (g) |     4.5%         0.0%         0.0%         0.0%        |0.0%         2.2%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/30 (0%)    0/34 (0%)    0/30 (0%)    0/31 (0%)   |0/41 (0%)    0/39 (0%)    0/34 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     582          ---          ---          ---         |---          421          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.123N     P=0.263N     P=0.255N     P=0.258N    |P=0.569N     P=0.508      (e)          (e)          | 
|POLY 3             |     P=0.116N     P=0.243N     P=0.255N     P=0.259N    |P=0.571N     P=0.513      (e)          (e)          | 
|POLY 1.5           |     P=0.117N     P=0.240N     P=0.251N     P=0.257N    |P=0.567N     P=0.515      (e)          (e)          | 
|POLY 6             |     P=0.116N     P=0.245N     P=0.259N     P=0.262N    |P=0.578N     P=0.509      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.108N     P=0.167N     P=0.211N     P=0.189N    |P=0.695N     P=0.357      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.121N     P=0.242N     P=0.258N     P=0.264N    |P=0.567N     P=0.515      (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.037N*    (e)          (e)          (e)         |P=0.396N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     41/47 (87%)  28/46 (61%)  26/48 (54%)  29/44 (66%) |45/47 (96%)  42/44 (95%)  36/40 (90%)  35/45 (78%)  | 
|POLY-3 RATE (b)    |     41/45.75     28/43.27     26/45.54     29/41.58    |45/47.00     42/43.93     36/39.50     35/44.27     | 
|POLY-3 PERCENT (g) |     89.6%        64.7%        57.1%        69.7%       |95.7%        95.6%        91.1%        79.1%        | 
|TERMINAL (d)       |     29/31 (94%)  24/34 (71%)  20/33 (61%)  24/32 (75%) |40/42 (95%)  37/38 (97%)  31/34 (91%)  27/34 (79%)  | 
|FIRST INCIDENCE    |     547          275          493          384         |16           434          581          368          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.034N*    P=0.003N**   P=0.002N**   P=0.015N*   |P=0.282N     P=0.502      P=0.500N     P=0.362N     | 
|POLY 3             |     P=0.036N*    P=0.003N**   P<0.001N**   P=0.014N*   |P=0.002N**   P=0.685N     P=0.331N     P=0.014N*    | 
|POLY 1.5           |     P=0.037N*    P=0.003N**   P<0.001N**   P=0.014N*   |P=0.002N**   P=0.677N     P=0.301N     P=0.012N*    | 
|POLY 6             |     P=0.036N*    P=0.003N**   P<0.001N**   P=0.014N*   |P=0.003N**   P=0.699N     P=0.371N     P=0.018N*    | 
|LOGISTIC REGRESSION|     P=0.048N*    P=0.006N**   P<0.001N**   P=0.023N*   |P=0.002N**   P=0.678N     P=0.260N     P=0.011N*    | 
|COCH-ARM / FISHERS |     P=0.042N*    P=0.003N**   P<0.001N**   P=0.015N*   |P=0.002N**   P=0.666N     P=0.264N     P=0.011N*    | 
|ORDER RESTRICTED   |     P=0.002N**   (e)          (e)          (e)         |P=0.002N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 55      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicle                                                                                                          | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/47 (0%)    3/46 (7%)    1/48 (2%)    5/44 (11%)  |0/47 (0%)    1/44 (2%)    0/40 (0%)    0/45 (0%)    | 
|POLY-3 RATE (b)    |     0/43.51      3/41.52      1/43.18      5/39.55     |0/44.04      1/42.14      0/38.35      0/40.67      | 
|POLY-3 PERCENT (g) |     0.0%         7.2%         2.3%         12.6%       |0.0%         2.4%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/31 (0%)    2/34 (6%)    1/33 (3%)    5/32 (16%)  |0/42 (0%)    1/38 (3%)    0/34 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          547          729 (T)      729 (T)     |---          729 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.028 *    P=0.130      P=0.512      P=0.035 *   |P=0.598N     P=0.480      (e)          (e)          | 
|POLY 3             |     P=0.020 *    P=0.110      P=0.498      P=0.023 *   |P=0.569N     P=0.491      (e)          (e)          | 
|POLY 1.5           |     P=0.020 *    P=0.111      P=0.500      P=0.023 *   |P=0.568N     P=0.492      (e)          (e)          | 
|POLY 6             |     P=0.019 *    P=0.111      P=0.497      P=0.022 *   |P=0.573N     P=0.489      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.022 *    P=0.132      P=0.512      P=0.035 *   |(e)          P=0.480      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.023 *    P=0.117      P=0.505      P=0.023 *   |P=0.572N     P=0.484      (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.006 **   (e)          (e)          (e)         |P=0.388N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicle                                                                                                          | 
|     Degeneration Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/47 (13%)   4/46 (9%)    8/48 (17%)   4/44 (9%)   |0/47 (0%)    0/44 (0%)    1/40 (3%)    1/45 (2%)    | 
|POLY-3 RATE (b)    |     6/43.51      4/41.08      8/43.49      4/40.17     |0/44.04      0/42.14      1/38.35      1/40.67      | 
|POLY-3 PERCENT (g) |     13.8%        9.7%         18.4%        10.0%       |0.0%         0.0%         2.6%         2.5%         | 
|TERMINAL (d)       |     6/31 (19%)   3/34 (9%)    7/33 (21%)   2/32 (6%)   |0/42 (0%)    0/38 (0%)    1/34 (3%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     729 (T)      694          642          622         |---          ---          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.414N     P=0.319N     P=0.428      P=0.362N    |P=0.203      (e)          P=0.458      P=0.458      | 
|POLY 3             |     P=0.451N     P=0.406N     P=0.385      P=0.420N    |P=0.221      (e)          P=0.472      P=0.484      | 
|POLY 1.5           |     P=0.453N     P=0.401N     P=0.391      P=0.421N    |P=0.228      (e)          P=0.473      P=0.490      | 
|POLY 6             |     P=0.444N     P=0.401N     P=0.385      P=0.413N    |P=0.211      (e)          P=0.470      P=0.477      | 
|LOGISTIC REGRESSION|     P=0.465N     P=0.377N     P=0.379      P=0.427N    |(e)          (e)          P=0.458      P=0.458      | 
|COCH-ARM / FISHERS |     P=0.450N     P=0.384N     P=0.403      P=0.413N    |P=0.233      (e)          P=0.460      P=0.489      | 
|ORDER RESTRICTED   |     P=0.458N     (e)          (e)          (e)         |P=0.223      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 56      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicle                                                                                                          | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/47 (6%)    3/46 (7%)    5/48 (10%)   6/44 (14%)  |2/47 (4%)    7/44 (16%)   6/40 (15%)   19/45 (42%)  | 
|POLY-3 RATE (b)    |     3/43.51      3/41.44      5/43.18      6/40.31     |2/44.04      7/42.14      6/38.35      19/41.06     | 
|POLY-3 PERCENT (g) |     6.9%         7.2%         11.6%        14.9%       |4.5%         16.6%        15.6%        46.3%        | 
|TERMINAL (d)       |     3/31 (10%)   2/34 (6%)    5/33 (15%)   4/32 (13%)  |2/42 (5%)    7/38 (18%)   6/34 (18%)   17/34 (50%)  | 
|FIRST INCIDENCE    |     729 (T)      577          729 (T)      622         |729 (T)      729 (T)      729 (T)      642          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.146      P=0.633N     P=0.389      P=0.258     |P<0.001 **   P=0.059      P=0.076      P<0.001 **   | 
|POLY 3             |     P=0.117      P=0.640      P=0.352      P=0.204     |P<0.001 **   P=0.068      P=0.091      P<0.001 **   | 
|POLY 1.5           |     P=0.117      P=0.641      P=0.358      P=0.204     |P<0.001 **   P=0.069      P=0.093      P<0.001 **   | 
|POLY 6             |     P=0.119      P=0.645      P=0.348      P=0.209     |P<0.001 **   P=0.065      P=0.087      P<0.001 **   | 
|LOGISTIC REGRESSION|     P=0.115      P=0.648      P=0.389      P=0.205     |P<0.001 **   P=0.059      P=0.076      P<0.001 **   | 
|COCH-ARM / FISHERS |     P=0.119      P=0.651      P=0.369      P=0.210     |P<0.001 **   P=0.064      P=0.087      P<0.001 **   | 
|ORDER RESTRICTED   |     P=0.176      (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/47 (2%)    1/46 (2%)    1/48 (2%)    0/44 (0%)   |1/47 (2%)    1/44 (2%)    1/40 (3%)    2/45 (4%)    | 
|POLY-3 RATE (b)    |     1/43.51      1/41.59      1/43.87      0/39.55     |1/44.04      1/42.14      1/38.35      2/40.67      | 
|POLY-3 PERCENT (g) |     2.3%         2.4%         2.3%         0.0%        |2.3%         2.4%         2.6%         4.9%         | 
|TERMINAL (d)       |     1/31 (3%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |1/42 (2%)    1/38 (3%)    1/34 (3%)    2/34 (6%)    | 
|FIRST INCIDENCE    |     729 (T)      516          493          ---         |729 (T)      729 (T)      729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.313N     P=0.755N     P=0.751N     P=0.494N    |P=0.288      P=0.739      P=0.714      P=0.426      | 
|POLY 3             |     P=0.329N     P=0.751      P=0.759N     P=0.519N    |P=0.328      P=0.751      P=0.730      P=0.472      | 
|POLY 1.5           |     P=0.328N     P=0.751      P=0.758N     P=0.518N    |P=0.337      P=0.752      P=0.731      P=0.482      | 
|POLY 6             |     P=0.330N     P=0.753      P=0.759N     P=0.519N    |P=0.316      P=0.749      P=0.726      P=0.459      | 
|LOGISTIC REGRESSION|     P=0.256N     P=0.700N     P=0.642N     (e)         |P=0.288      P=0.739      P=0.714      P=0.426      | 
|COCH-ARM / FISHERS |     P=0.323N     P=0.747      P=0.747N     P=0.516N    |P=0.341      P=0.736      P=0.711      P=0.484      | 
|ORDER RESTRICTED   |     P=0.338N     (e)          (e)          (e)         |P=0.378      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 57      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth                                                                                                                            | 
|     Malformation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/1 (0%)     0/1 (0%)     0/0 (0%)     0/0 (0%)    |0/1 (0%)     1/1 (100%)   2/2 (100%)   0/0 (0%)     | 
|POLY-3 RATE (b)    |     0/0.42       0/1.00       0/0.00       0/0.00      |0/1.00       1/1.00       2/2.00       0/0.00       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         100.0%       100.0%       0.0%         | 
|TERMINAL (d)       |     0/0 (0%)     0/1 (0%)     0/0 (0%)     0/0 (0%)    |0/1 (0%)     1/1 (100%)   0/0 (0%)     0/0 (0%)     | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          729 (T)      383          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.464      P=0.500      P=0.202      (e)          | 
|POLY 3             |     (e)          (e)          (e)          (e)         |(e)          P=1.000N     P=0.333      (e)          | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |(e)          P=1.000N     P=0.333      (e)          | 
|POLY 6             |     (e)          (e)          (e)          (e)         |(e)          P=1.000N     P=0.333      (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          P=0.250      (e)          (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.364      P=0.500      P=0.333      (e)          | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder                                                                                                                  | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/49 (2%)    1/50 (2%)    0/50 (0%)    1/50 (2%)   |0/49 (0%)    0/50 (0%)    1/49 (2%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |     1/44.48      1/43.39      0/44.41      1/43.93     |0/45.67      0/45.69      1/43.76      2/43.52      | 
|POLY-3 PERCENT (g) |     2.3%         2.3%         0.0%         2.3%        |0.0%         0.0%         2.3%         4.6%         | 
|TERMINAL (d)       |     0/31 (0%)    0/34 (0%)    0/33 (0%)    0/32 (0%)   |0/43 (0%)    0/39 (0%)    1/34 (3%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     705          665          ---          651         |---          ---          729 (T)      368          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.642N     P=0.749      P=0.500N     P=0.737     |P=0.062      (e)          P=0.453      P=0.228      | 
|POLY 3             |     P=0.613N     P=0.755      P=0.500N     P=0.758     |P=0.064      (e)          P=0.491      P=0.226      | 
|POLY 1.5           |     P=0.612N     P=0.757      P=0.499N     P=0.760     |P=0.066      (e)          P=0.498      P=0.231      | 
|POLY 6             |     P=0.615N     P=0.756      P=0.502N     P=0.755     |P=0.062      (e)          P=0.482      P=0.220      | 
|LOGISTIC REGRESSION|     P=0.609N     P=0.756N     P=0.498N     P=0.749N    |P=0.055      (e)          P=0.453      P=0.179      | 
|COCH-ARM / FISHERS |     P=0.612N     P=0.747N     P=0.495N     P=0.747N    |P=0.067      (e)          P=0.500      P=0.242      | 
|ORDER RESTRICTED   |     P=0.533N     (e)          (e)          (e)         |P=0.067      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/06/04                           EXPERIMENT: 92013 TEST: 05                                            Page 58      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                    4-METHYLIMIDAZOLE                   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        625 PPM      1250 PPM     2500 PPM    |0 PPM        1250 PPM     2500 PPM     5000 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |25/50 (50%)  26/50 (52%)  18/48 (38%)  26/50 (52%)  | 
|POLY-3 RATE (b)    |                                                        |25/46.88     26/46.48     18/44.64     26/46.05     | 
|POLY-3 PERCENT (g) |                                                        |53.3%        55.9%        40.3%        56.5%        | 
|TERMINAL (d)       |                                                        |23/43 (54%)  25/39 (64%)  14/34 (41%)  21/35 (60%)  | 
|FIRST INCIDENCE    |                                                        |667          434          383          541          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.199      P=0.310      P=0.395N     P=0.173      | 
|POLY 3             |                                                        |P=0.508      P=0.482      P=0.147N     P=0.462      | 
|POLY 1.5           |                                                        |P=0.532      P=0.513      P=0.132N     P=0.493      | 
|POLY 6             |                                                        |P=0.476      P=0.435      P=0.181N     P=0.424      | 
|LOGISTIC REGRESSION|                                                        |P=0.468      P=0.451      P=0.163N     P=0.406      | 
|COCH-ARM / FISHERS |                                                        |P=0.538N     P=0.500      P=0.148N     P=0.500      | 
|ORDER RESTRICTED   |                                                        |P=0.415      (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).