Skip to Main Navigation
Skip to Page Content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Share This:
https://ntp.niehs.nih.gov/go/18915

TDMS Study 92013-06 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Southern Research Inst                                4-METHYLIMIDAZOLE                                   DATE: 01/12/04       
EXPERIMENT: 92013 TEST: 06                                                                                     TIME: 14:42:31       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85420                              ROUTE: DOSED FEED                                              NTP C#: 92013B       
PATHOLOGIST: HEATH, JAMES                                                                                      CAS: 822-36-6        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                           FINAL #1 MICE                                                            
                                                                                                                                    
                                                                                                                                    
               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: 01/12/04       
EXPERIMENT: 92013 TEST: 06                                                                                     TIME: 14:42:31       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85420                              ROUTE: DOSED FEED                                              NTP C#: 92013B       
PATHOLOGIST: HEATH, JAMES                                                                                      CAS: 822-36-6        
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                   4-METHYLIMIDAZOLE                                                                              
===============================================================                                                                     
Male Mice                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Adrenal Cortex                         Accessory Adrenal Cortical Nodule                                                            
Adrenal Cortex: Capsule                Hyperplasia                                                                                  
Islets, Pancreatic                     Hyperplasia                                                                                  
Liver                                  Eosinophilic Focus                                                                           
                                       Mixed Cell Focus                                                                             
Liver: Hepatocyte                      Vacuolization Cytoplasmic                                                                    
Lung                                   Infiltration Cellular Histiocyte                                                             
Lung: Alveolar Epithelium              Hyperplasia                                                                                  
Lymph Node, Mesenteric                 Hemorrhage                                                                                   
Preputial Gland                        Cyst                                                                                         
Spleen: Lymphoid Follicle              Hyperplasia                                                                                  
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Heart                                  Mineralization                                                                               
Intestine Small, Jejunum               Hyperplasia Lymphoid                                                                         
Liver                                  Cyst                                                                                         
                                       Hematopoietic Cell Proliferation                                                             
Lung                                   Infiltration Cellular Histiocyte                                                             
Lung: Alveolar Epithelium              Hyperplasia                                                                                  
Lymph Node, Mandibular                 Hemorrhage                                                                                   
                                       Hyperplasia Lymphoid                                                                         
Lymph Node, Mesenteric                 Hyperplasia Lymphoid                                                                         
Mammary Gland                          Hyperplasia                                                                                  
Pancreas                               Cyst                                                                                         
Parathyroid Gland                      Cyst                                                                                         
Salivary Glands                        Atrophy                                                                                      
Stomach, Forestomach                   Diverticulum                                                                                 
Thyroid Gland: Follicle                Cyst                                                                                         
===============================================================                                                                     
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 1       
                     Statistical Analysis of Non-neoplastic Lesions in        Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Accessory Adrenal Cortical Nodule                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    4/50 (8%)    6/50 (12%)   8/50 (16%)  |9/50 (18%)   9/50 (18%)   9/50 (18%)   5/50 (10%)   | 
|POLY-3 RATE (b)    |     2/48.24      4/48.80      6/46.57      8/47.85     |9/47.07      9/47.90      9/48.22      5/46.05      | 
|POLY-3 PERCENT (g) |     4.2%         8.2%         12.9%        16.7%       |19.1%        18.8%        18.7%        10.9%        | 
|TERMINAL (d)       |     2/45 (4%)    3/44 (7%)    5/42 (12%)   8/46 (17%)  |8/43 (19%)   8/40 (20%)   7/43 (16%)   5/40 (13%)   | 
|FIRST INCIDENCE    |     729 (T)      335          348          729 (T)     |593          702          684          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.033 *    P=0.330      P=0.118      P=0.052     |P=0.177N     P=0.545      P=0.595N     P=0.233N     | 
|POLY 3             |     P=0.026 *    P=0.343      P=0.122      P=0.044 *   |P=0.162N     P=0.587N     P=0.581N     P=0.205N     | 
|POLY 1.5           |     P=0.026 *    P=0.342      P=0.127      P=0.045 *   |P=0.155N     P=0.585N     P=0.583N     P=0.197N     | 
|POLY 6             |     P=0.025 *    P=0.343      P=0.117      P=0.044 *   |P=0.172N     P=0.595N     P=0.581N     P=0.216N     | 
|LOGISTIC REGRESSION|     P=0.029 *    P=0.366      P=0.166      P=0.052     |P=0.158N     P=0.582N     P=0.583N     P=0.200N     | 
|COCH-ARM / FISHERS |     P=0.028 *    P=0.339      P=0.134      P=0.046 *   |P=0.148N     P=0.602N     P=0.602N     P=0.194N     | 
|ORDER RESTRICTED   |     P=0.029 *    (e)          (e)          (e)         |P=0.233N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    2/50 (4%)    1/50 (2%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     3/48.24      2/47.90      1/45.68      1/47.85     |0/46.61      0/47.80      1/48.01      2/46.05      | 
|POLY-3 PERCENT (g) |     6.2%         4.2%         2.2%         2.1%        |0.0%         0.0%         2.1%         4.3%         | 
|TERMINAL (d)       |     3/45 (7%)    2/44 (5%)    1/42 (2%)    1/46 (2%)   |0/43 (0%)    0/40 (0%)    1/43 (2%)    2/40 (5%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      729 (T)     |---          ---          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.196N     P=0.510N     P=0.330N     P=0.298N    |P=0.065      (e)          P=0.500      P=0.223      | 
|POLY 3             |     P=0.204N     P=0.503N     P=0.325N     P=0.308N    |P=0.068      (e)          P=0.506      P=0.235      | 
|POLY 1.5           |     P=0.203N     P=0.502N     P=0.318N     P=0.308N    |P=0.069      (e)          P=0.505      P=0.237      | 
|POLY 6             |     P=0.205N     P=0.504N     P=0.333N     P=0.309N    |P=0.066      (e)          P=0.506      P=0.231      | 
|LOGISTIC REGRESSION|     P=0.196N     P=0.510N     P=0.330N     P=0.298N    |(e)          (e)          P=0.500      P=0.223      | 
|COCH-ARM / FISHERS |     P=0.199N     P=0.500N     P=0.309N     P=0.309N    |P=0.070      (e)          P=0.500      P=0.247      | 
|ORDER RESTRICTED   |     P=0.223N     (e)          (e)          (e)         |P=0.073      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 2       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     17/50 (34%)  11/50 (22%)  10/50 (20%)  14/50 (28%) |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     17/48.24     11/48.10     10/45.68     14/48.73    |0/46.61      0/47.80      0/48.01      0/46.05      | 
|POLY-3 PERCENT (g) |     35.2%        22.9%        21.9%        28.7%       |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     17/45 (38%)  10/44 (23%)  10/42 (24%)  13/46 (28%) |0/43 (0%)    0/40 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      676          729 (T)      355         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.348N     P=0.147N     P=0.121N     P=0.307N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.368N     P=0.132N     P=0.114N     P=0.320N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.368N     P=0.133N     P=0.103N     P=0.324N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.370N     P=0.131N     P=0.126N     P=0.318N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.384N     P=0.139N     P=0.121N     P=0.334N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.372N     P=0.133N     P=0.088N     P=0.333N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.181N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex: Capsule                                                                                                          | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    2/50 (4%)    5/50 (10%)  |0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/48.24      1/47.90      2/45.68      5/47.85     |0/46.61      2/47.80      0/48.01      0/46.05      | 
|POLY-3 PERCENT (g) |     2.1%         2.1%         4.4%         10.5%       |0.0%         4.2%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/45 (2%)    1/44 (2%)    2/42 (5%)    5/46 (11%)  |0/43 (0%)    2/40 (5%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      729 (T)     |---          729 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.032 *    P=0.757      P=0.476      P=0.109     |P=0.414N     P=0.223      (e)          (e)          | 
|POLY 3             |     P=0.027 *    P=0.759      P=0.481      P=0.100     |P=0.400N     P=0.243      (e)          (e)          | 
|POLY 1.5           |     P=0.027 *    P=0.759      P=0.488      P=0.101     |P=0.399N     P=0.243      (e)          (e)          | 
|POLY 6             |     P=0.027 *    P=0.758      P=0.474      P=0.100     |P=0.403N     P=0.242      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.032 *    P=0.757      P=0.476      P=0.109     |(e)          P=0.223      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.029 *    P=0.753N     P=0.500      P=0.102     |P=0.405N     P=0.247      (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.035 *    (e)          (e)          (e)         |P=0.254N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 3       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/48.24      0/47.90      0/45.68      0/47.85     |0/46.61      0/47.80      1/48.01      2/46.22      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         2.1%         4.3%         | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    0/42 (0%)    0/46 (0%)   |0/43 (0%)    0/40 (0%)    1/43 (2%)    1/40 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          729 (T)      685          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.066      (e)          P=0.500      P=0.227      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.068      (e)          P=0.506      P=0.235      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.069      (e)          P=0.505      P=0.237      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.067      (e)          P=0.506      P=0.233      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.069      (e)          P=0.500      P=0.238      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.070      (e)          P=0.500      P=0.247      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.073      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone                                                                                                                             | 
|     Hyperostosis                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |10/50 (20%)  12/50 (24%)  10/50 (20%)  6/50 (12%)   | 
|POLY-3 RATE (b)    |     0/48.24      0/47.90      0/45.68      0/47.85     |10/46.61     12/48.15     10/48.01     6/46.05      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |21.5%        24.9%        20.8%        13.0%        | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    0/42 (0%)    0/46 (0%)   |10/43 (23%)  10/40 (25%)  10/43 (23%)  6/40 (15%)   | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |729 (T)      668          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.148N     P=0.341      P=0.600      P=0.251N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.132N     P=0.438      P=0.570N     P=0.213N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.126N     P=0.433      P=0.574N     P=0.207N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.140N     P=0.440      P=0.569N     P=0.221N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.142N     P=0.423      P=0.600      P=0.251N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.123N     P=0.405      P=0.598N     P=0.207N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.175N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 4       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     13/50 (26%)  15/50 (30%)  14/50 (28%)  15/50 (30%) |13/50 (26%)  13/50 (26%)  10/50 (20%)  17/50 (34%)  | 
|POLY-3 RATE (b)    |     13/48.95     15/49.04     14/49.40     15/48.52    |13/47.98     13/49.63     10/48.60     17/46.46     | 
|POLY-3 PERCENT (g) |     26.6%        30.6%        28.3%        30.9%       |27.1%        26.2%        20.6%        36.6%        | 
|TERMINAL (d)       |     11/45 (24%)  11/44 (25%)  7/42 (17%)   13/46 (28%) |9/43 (21%)   6/40 (15%)   9/43 (21%)   15/40 (38%)  | 
|FIRST INCIDENCE    |     513          586          348          628         |539          525          539          665          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.430      P=0.397      P=0.432      P=0.437     |P=0.188      P=0.539      P=0.321N     P=0.203      | 
|POLY 3             |     P=0.395      P=0.415      P=0.511      P=0.401     |P=0.181      P=0.551N     P=0.305N     P=0.221      | 
|POLY 1.5           |     P=0.398      P=0.411      P=0.507      P=0.403     |P=0.198      P=0.558N     P=0.303N     P=0.240      | 
|POLY 6             |     P=0.396      P=0.422      P=0.516      P=0.404     |P=0.163      P=0.546N     P=0.312N     P=0.199      | 
|LOGISTIC REGRESSION|     P=0.430      P=0.420      P=0.504N     P=0.414     |P=0.217      P=0.535      P=0.336N     P=0.255      | 
|COCH-ARM / FISHERS |     P=0.406      P=0.412      P=0.500      P=0.412     |P=0.216      P=0.590N     P=0.318N     P=0.257      | 
|ORDER RESTRICTED   |     P=0.503      (e)          (e)          (e)         |P=0.152      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain                                                                                                                            | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    2/50 (4%)    1/50 (2%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     1/48.89      0/47.90      0/45.68      0/47.85     |0/46.61      2/48.27      1/48.01      2/46.42      | 
|POLY-3 PERCENT (g) |     2.1%         0.0%         0.0%         0.0%        |0.0%         4.1%         2.1%         4.3%         | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    0/42 (0%)    0/46 (0%)   |0/43 (0%)    0/40 (0%)    1/43 (2%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     513          ---          ---          ---         |---          632          729 (T)      647          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.307N     P=0.500N     P=0.504N     P=0.500N    |P=0.237      P=0.247      P=0.500      P=0.235      | 
|POLY 3             |     P=0.306N     P=0.504N     P=0.514N     P=0.504N    |P=0.245      P=0.245      P=0.506      P=0.236      | 
|POLY 1.5           |     P=0.306N     P=0.503N     P=0.509N     P=0.503N    |P=0.247      P=0.244      P=0.505      P=0.238      | 
|POLY 6             |     P=0.306N     P=0.506N     P=0.519N     P=0.506N    |P=0.242      P=0.246      P=0.506      P=0.234      | 
|LOGISTIC REGRESSION|     P=0.244N     P=0.375N     P=0.312N     P=0.377N    |P=0.240      P=0.199      P=0.500      P=0.232      | 
|COCH-ARM / FISHERS |     P=0.306N     P=0.500N     P=0.500N     P=0.500N    |P=0.246      P=0.247      P=0.500      P=0.247      | 
|ORDER RESTRICTED   |     P=0.124N     (e)          (e)          (e)         |P=0.155      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 5       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |1/50 (2%)    3/49 (6%)    5/50 (10%)   3/50 (6%)    | 
|POLY-3 RATE (b)    |                                                        |1/46.61      3/46.84      5/48.52      3/46.05      | 
|POLY-3 PERCENT (g) |                                                        |2.2%         6.4%         10.3%        6.5%         | 
|TERMINAL (d)       |                                                        |1/43 (2%)    2/40 (5%)    3/43 (7%)    3/40 (8%)    | 
|FIRST INCIDENCE    |                                                        |729 (T)      721          635          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.255      P=0.284      P=0.112      P=0.280      | 
|POLY 3             |                                                        |P=0.266      P=0.307      P=0.111      P=0.301      | 
|POLY 1.5           |                                                        |P=0.273      P=0.307      P=0.109      P=0.305      | 
|POLY 6             |                                                        |P=0.257      P=0.305      P=0.114      P=0.296      | 
|LOGISTIC REGRESSION|                                                        |P=0.272      P=0.296      P=0.099      P=0.280      | 
|COCH-ARM / FISHERS |                                                        |P=0.276      P=0.301      P=0.102      P=0.309      | 
|ORDER RESTRICTED   |                                                        |P=0.168      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye                                                                                                                              | 
|     Cataract                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    2/50 (4%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     1/48.29      0/47.90      0/45.68      2/47.85     |0/46.61      0/47.80      2/48.01      1/46.05      | 
|POLY-3 PERCENT (g) |     2.1%         0.0%         0.0%         4.2%        |0.0%         0.0%         4.2%         2.2%         | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    0/42 (0%)    2/46 (4%)   |0/43 (0%)    0/40 (0%)    2/43 (5%)    1/40 (3%)    | 
|FIRST INCIDENCE    |     715          ---          ---          729 (T)     |---          ---          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.252      P=0.500N     P=0.518N     P=0.505     |P=0.235      (e)          P=0.238      P=0.486      | 
|POLY 3             |     P=0.244      P=0.502N     P=0.511N     P=0.497     |P=0.237      (e)          P=0.244      P=0.498      | 
|POLY 1.5           |     P=0.244      P=0.501N     P=0.507N     P=0.498     |P=0.241      (e)          P=0.243      P=0.500      | 
|POLY 6             |     P=0.243      P=0.502N     P=0.515N     P=0.496     |P=0.231      (e)          P=0.244      P=0.495      | 
|LOGISTIC REGRESSION|     P=0.244      P=0.500N     P=0.506N     P=0.497     |(e)          (e)          P=0.238      P=0.486      | 
|COCH-ARM / FISHERS |     P=0.246      P=0.500N     P=0.500N     P=0.500     |P=0.246      (e)          P=0.247      P=0.500      | 
|ORDER RESTRICTED   |     P=0.131      (e)          (e)          (e)         |P=0.173      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 6       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    1/50 (2%)    3/50 (6%)   |2/50 (4%)    3/50 (6%)    2/50 (4%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/48.24      1/47.90      1/45.68      3/48.21     |2/46.61      3/47.80      2/48.01      0/46.05      | 
|POLY-3 PERCENT (g) |     2.1%         2.1%         2.2%         6.2%        |4.3%         6.3%         4.2%         0.0%         | 
|TERMINAL (d)       |     1/45 (2%)    1/44 (2%)    1/42 (2%)    2/46 (4%)   |2/43 (5%)    3/40 (8%)    2/43 (5%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      628         |729 (T)      729 (T)      729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.172      P=0.757      P=0.746      P=0.313     |P=0.144N     P=0.467      P=0.695      P=0.254N     | 
|POLY 3             |     P=0.163      P=0.759      P=0.748      P=0.305     |P=0.138N     P=0.511      P=0.683N     P=0.240N     | 
|POLY 1.5           |     P=0.163      P=0.759      P=0.753      P=0.305     |P=0.135N     P=0.511      P=0.685N     P=0.238N     | 
|POLY 6             |     P=0.164      P=0.758      P=0.744      P=0.307     |P=0.141N     P=0.509      P=0.683N     P=0.243N     | 
|LOGISTIC REGRESSION|     P=0.163      P=0.757      P=0.746      P=0.310     |P=0.144N     P=0.467      P=0.695      (e)          | 
|COCH-ARM / FISHERS |     P=0.163      P=0.753N     P=0.753N     P=0.309     |P=0.134N     P=0.500      P=0.691N     P=0.247N     | 
|ORDER RESTRICTED   |     P=0.189      (e)          (e)          (e)         |P=0.141N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    2/50 (4%)    1/50 (2%)   |1/50 (2%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/48.24      0/47.90      2/45.68      1/47.85     |1/46.61      0/47.80      1/48.01      0/46.05      | 
|POLY-3 PERCENT (g) |     4.2%         0.0%         4.4%         2.1%        |2.2%         0.0%         2.1%         0.0%         | 
|TERMINAL (d)       |     2/45 (4%)    0/44 (0%)    2/42 (5%)    1/46 (2%)   |1/43 (2%)    0/40 (0%)    1/43 (2%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      ---          729 (T)      729 (T)     |729 (T)      ---          729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.523N     P=0.243N     P=0.670      P=0.492N    |P=0.415N     P=0.514N     P=0.762      P=0.514N     | 
|POLY 3             |     P=0.533N     P=0.239N     P=0.674      P=0.503N    |P=0.410N     P=0.495N     P=0.754N     P=0.502N     | 
|POLY 1.5           |     P=0.532N     P=0.239N     P=0.681      P=0.502N    |P=0.409N     P=0.495N     P=0.755N     P=0.500N     | 
|POLY 6             |     P=0.533N     P=0.239N     P=0.667      P=0.503N    |P=0.412N     P=0.496N     P=0.754N     P=0.505N     | 
|LOGISTIC REGRESSION|     P=0.523N     (e)          P=0.670      P=0.492N    |P=0.415N     (e)          P=0.762      (e)          | 
|COCH-ARM / FISHERS |     P=0.531N     P=0.247N     P=0.691N     P=0.500N    |P=0.405N     P=0.500N     P=0.753N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.418N     (e)          (e)          (e)         |P=0.254N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 7       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    4/50 (8%)    | 
|POLY-3 RATE (b)    |     0/48.24      0/47.90      2/46.66      0/47.85     |0/46.61      0/47.80      0/48.01      4/47.24      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         4.3%         0.0%        |0.0%         0.0%         0.0%         8.5%         | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    0/42 (0%)    0/46 (0%)   |0/43 (0%)    0/40 (0%)    0/43 (0%)    1/40 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          522          ---         |---          ---          ---          409          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.593      (e)          P=0.230      (e)         |P=0.003 **   (e)          (e)          P=0.064      | 
|POLY 3             |     P=0.594      (e)          P=0.230      (e)         |P=0.003 **   (e)          (e)          P=0.062      | 
|POLY 1.5           |     P=0.594      (e)          P=0.232      (e)         |P=0.003 **   (e)          (e)          P=0.062      | 
|POLY 6             |     P=0.594      (e)          P=0.228      (e)         |P=0.003 **   (e)          (e)          P=0.061      | 
|LOGISTIC REGRESSION|     P=0.643      (e)          P=0.350      (e)         |P=0.002 **   (e)          (e)          P=0.045 *    | 
|COCH-ARM / FISHERS |     P=0.595      (e)          P=0.247      (e)         |P=0.003 **   (e)          (e)          P=0.059      | 
|ORDER RESTRICTED   |     P=0.241      (e)          (e)          (e)         |P=0.002 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Cecum                                                                                                           | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    1/49 (2%)    3/47 (6%)    4/50 (8%)   |3/49 (6%)    4/48 (8%)    2/46 (4%)    2/46 (4%)    | 
|POLY-3 RATE (b)    |     3/48.24      1/47.38      3/43.85      4/47.85     |3/46.61      4/46.78      2/44.63      2/42.28      | 
|POLY-3 PERCENT (g) |     6.2%         2.1%         6.8%         8.4%        |6.4%         8.6%         4.5%         4.7%         | 
|TERMINAL (d)       |     3/45 (7%)    1/44 (2%)    3/42 (7%)    4/46 (9%)   |3/43 (7%)    3/40 (8%)    2/41 (5%)    2/38 (5%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      729 (T)     |729 (T)      525          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.294      P=0.314N     P=0.631      P=0.512     |P=0.364N     P=0.468      P=0.522N     P=0.556N     | 
|POLY 3             |     P=0.279      P=0.312N     P=0.617      P=0.496     |P=0.363N     P=0.502      P=0.520N     P=0.544N     | 
|POLY 1.5           |     P=0.281      P=0.313N     P=0.622      P=0.497     |P=0.359N     P=0.497      P=0.523N     P=0.539N     | 
|POLY 6             |     P=0.278      P=0.311N     P=0.614      P=0.495     |P=0.368N     P=0.505      P=0.517N     P=0.550N     | 
|LOGISTIC REGRESSION|     P=0.294      P=0.314N     P=0.631      P=0.512     |P=0.339N     P=0.462      P=0.522N     P=0.556N     | 
|COCH-ARM / FISHERS |     P=0.284      P=0.316N     P=0.631      P=0.500     |P=0.348N     P=0.488      P=0.530N     P=0.530N     | 
|ORDER RESTRICTED   |     P=0.301      (e)          (e)          (e)         |P=0.455N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 8       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Jejunum                                                                                                         | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    2/47 (4%)    3/48 (6%)    1/50 (2%)   |4/50 (8%)    2/48 (4%)    2/47 (4%)    0/47 (0%)    | 
|POLY-3 RATE (b)    |     2/46.29      2/46.49      3/44.48      1/47.85     |4/46.61      2/45.93      2/45.13      0/43.28      | 
|POLY-3 PERCENT (g) |     4.3%         4.3%         6.8%         2.1%        |8.6%         4.4%         4.4%         0.0%         | 
|TERMINAL (d)       |     2/44 (5%)    2/44 (5%)    3/42 (7%)    1/46 (2%)   |4/43 (9%)    2/40 (5%)    2/42 (5%)    0/39 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      729 (T)     |729 (T)      729 (T)      729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.388N     P=0.695      P=0.479      P=0.484N    |P=0.051N     P=0.371N     P=0.348N     P=0.076N     | 
|POLY 3             |     P=0.393N     P=0.692N     P=0.482      P=0.489N    |P=0.051N     P=0.344N     P=0.352N     P=0.070N     | 
|POLY 1.5           |     P=0.391N     P=0.692      P=0.488      P=0.488N    |P=0.051N     P=0.345N     P=0.355N     P=0.069N     | 
|POLY 6             |     P=0.396N     P=0.690N     P=0.476      P=0.489N    |P=0.052N     P=0.346N     P=0.351N     P=0.072N     | 
|LOGISTIC REGRESSION|     P=0.388N     P=0.695      P=0.479      P=0.484N    |P=0.051N     P=0.371N     P=0.348N     (e)          | 
|COCH-ARM / FISHERS |     P=0.384N     P=0.684      P=0.500      P=0.485N    |P=0.050N     P=0.359N     P=0.369N     P=0.066N     | 
|ORDER RESTRICTED   |     P=0.374N     (e)          (e)          (e)         |P=0.033N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/49 (8%)    2/49 (4%)    0/50 (0%)    1/50 (2%)   |1/49 (2%)    0/48 (0%)    0/47 (0%)    2/49 (4%)    | 
|POLY-3 RATE (b)    |     4/47.37      2/47.38      0/45.68      1/47.85     |1/46.61      0/46.15      0/45.13      2/45.05      | 
|POLY-3 PERCENT (g) |     8.4%         4.2%         0.0%         2.1%        |2.2%         0.0%         0.0%         4.4%         | 
|TERMINAL (d)       |     4/45 (9%)    2/44 (5%)    0/42 (0%)    1/46 (2%)   |1/43 (2%)    0/40 (0%)    0/42 (0%)    2/39 (5%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      ---          729 (T)     |729 (T)      ---          ---          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.085N     P=0.348N     P=0.072N     P=0.174N    |P=0.229      P=0.514N     P=0.505N     P=0.466      | 
|POLY 3             |     P=0.084N     P=0.337N     P=0.065N     P=0.176N    |P=0.242      P=0.502N     P=0.506N     P=0.488      | 
|POLY 1.5           |     P=0.083N     P=0.338N     P=0.062N     P=0.175N    |P=0.244      P=0.503N     P=0.507N     P=0.493      | 
|POLY 6             |     P=0.086N     P=0.337N     P=0.068N     P=0.177N    |P=0.241      P=0.502N     P=0.506N     P=0.483      | 
|LOGISTIC REGRESSION|     P=0.085N     P=0.348N     (e)          P=0.174N    |P=0.229      (e)          (e)          P=0.466      | 
|COCH-ARM / FISHERS |     P=0.083N     P=0.339N     P=0.056N     P=0.175N    |P=0.247      P=0.505N     P=0.510N     P=0.500      | 
|ORDER RESTRICTED   |     P=0.038N*    (e)          (e)          (e)         |P=0.124      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 9       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     13/50 (26%)  12/50 (24%)  12/50 (24%)  7/50 (14%)  |1/49 (2%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     13/48.24     12/48.10     12/45.84     7/47.85     |1/46.61      1/47.80      0/48.01      0/46.05      | 
|POLY-3 PERCENT (g) |     27.0%        25.0%        26.2%        14.6%       |2.2%         2.1%         0.0%         0.0%         | 
|TERMINAL (d)       |     13/45 (29%)  11/44 (25%)  11/42 (26%)  7/46 (15%)  |1/43 (2%)    1/40 (3%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      676          686          729 (T)     |729 (T)      729 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.077N     P=0.526N     P=0.580N     P=0.094N    |P=0.243N     P=0.746      P=0.500N     P=0.514N     | 
|POLY 3             |     P=0.087N     P=0.503N     P=0.559N     P=0.107N    |P=0.234N     P=0.755N     P=0.494N     P=0.502N     | 
|POLY 1.5           |     P=0.086N     P=0.504N     P=0.538N     P=0.107N    |P=0.234N     P=0.755N     P=0.495N     P=0.500N     | 
|POLY 6             |     P=0.088N     P=0.502N     P=0.578N     P=0.108N    |P=0.234N     P=0.756N     P=0.494N     P=0.505N     | 
|LOGISTIC REGRESSION|     P=0.090N     P=0.513N     P=0.585      P=0.094N    |P=0.243N     P=0.746      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.083N     P=0.500N     P=0.500N     P=0.105N    |P=0.233N     P=0.747N     P=0.495N     P=0.495N     | 
|ORDER RESTRICTED   |     P=0.114N     (e)          (e)          (e)         |P=0.254N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    2/50 (4%)    0/50 (0%)    2/50 (4%)   |1/49 (2%)    2/50 (4%)    6/50 (12%)   3/50 (6%)    | 
|POLY-3 RATE (b)    |     2/48.24      2/47.90      0/45.68      2/47.85     |1/46.61      2/47.80      6/48.01      3/46.46      | 
|POLY-3 PERCENT (g) |     4.2%         4.2%         0.0%         4.2%        |2.2%         4.2%         12.5%        6.5%         | 
|TERMINAL (d)       |     2/45 (4%)    2/44 (5%)    0/42 (0%)    2/46 (4%)   |1/43 (2%)    1/40 (3%)    6/43 (14%)   1/40 (3%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      ---          729 (T)     |729 (T)      727          729 (T)      665          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.546N     P=0.686      P=0.254N     P=0.687N    |P=0.194      P=0.478      P=0.058      P=0.289      | 
|POLY 3             |     P=0.561N     P=0.691      P=0.250N     P=0.691     |P=0.200      P=0.509      P=0.061      P=0.304      | 
|POLY 1.5           |     P=0.559N     P=0.692      P=0.245N     P=0.691     |P=0.205      P=0.509      P=0.061      P=0.307      | 
|POLY 6             |     P=0.563N     P=0.690      P=0.254N     P=0.690     |P=0.197      P=0.507      P=0.061      P=0.302      | 
|LOGISTIC REGRESSION|     P=0.546N     P=0.686      (e)          P=0.687N    |P=0.203      P=0.491      P=0.058      P=0.319      | 
|COCH-ARM / FISHERS |     P=0.556N     P=0.691N     P=0.247N     P=0.691N    |P=0.216      P=0.508      P=0.059      P=0.316      | 
|ORDER RESTRICTED   |     P=0.451N     (e)          (e)          (e)         |P=0.111      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 10      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Metaplasia Osseous                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    3/50 (6%)    0/50 (0%)    2/50 (4%)   |1/49 (2%)    1/50 (2%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     2/48.24      3/47.90      0/45.68      2/47.85     |1/46.61      1/47.80      0/48.01      1/46.05      | 
|POLY-3 PERCENT (g) |     4.2%         6.3%         0.0%         4.2%        |2.2%         2.1%         0.0%         2.2%         | 
|TERMINAL (d)       |     2/45 (4%)    3/44 (7%)    0/42 (0%)    2/46 (4%)   |1/43 (2%)    1/40 (3%)    0/43 (0%)    1/40 (3%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      ---          729 (T)     |729 (T)      729 (T)      ---          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.465N     P=0.490      P=0.254N     P=0.687N    |P=0.629N     P=0.746      P=0.500N     P=0.746      | 
|POLY 3             |     P=0.481N     P=0.497      P=0.250N     P=0.691     |P=0.613N     P=0.755N     P=0.494N     P=0.758      | 
|POLY 1.5           |     P=0.479N     P=0.498      P=0.245N     P=0.691     |P=0.612N     P=0.755N     P=0.495N     P=0.760      | 
|POLY 6             |     P=0.483N     P=0.496      P=0.254N     P=0.690     |P=0.613N     P=0.756N     P=0.494N     P=0.755      | 
|LOGISTIC REGRESSION|     P=0.465N     P=0.490      (e)          P=0.687N    |P=0.629N     P=0.746      (e)          P=0.746      | 
|COCH-ARM / FISHERS |     P=0.474N     P=0.500      P=0.247N     P=0.691N    |P=0.612N     P=0.747N     P=0.495N     P=0.747N     | 
|ORDER RESTRICTED   |     P=0.337N     (e)          (e)          (e)         |P=0.535N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)   |0/49 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/48.24      0/47.90      2/46.19      0/47.85     |0/46.61      0/47.80      0/48.01      0/46.05      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         4.3%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    0/42 (0%)    0/46 (0%)   |0/43 (0%)    0/40 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          632          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.588      (e)          P=0.221      (e)         |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.595      (e)          P=0.228      (e)         |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.595      (e)          P=0.231      (e)         |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.595      (e)          P=0.225      (e)         |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.611      (e)          P=0.276      (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.595      (e)          P=0.247      (e)         |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.239      (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 11      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     34/50 (68%)  40/50 (80%)  38/50 (76%)  35/50 (70%) |21/49 (43%)  20/50 (40%)  17/50 (34%)  25/50 (50%)  | 
|POLY-3 RATE (b)    |     34/49.05     40/49.06     38/47.00     35/48.21    |21/47.38     20/49.07     17/48.34     25/49.53     | 
|POLY-3 PERCENT (g) |     69.3%        81.5%        80.9%        72.6%       |44.3%        40.8%        35.2%        50.5%        | 
|TERMINAL (d)       |     32/45 (71%)  37/44 (84%)  35/42 (83%)  34/46 (74%) |18/43 (42%)  14/40 (35%)  16/43 (37%)  17/40 (43%)  | 
|FIRST INCIDENCE    |     459          335          441          628         |539          525          635          409          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.418N     P=0.101      P=0.114      P=0.562     |P=0.190      P=0.558      P=0.270N     P=0.217      | 
|POLY 3             |     P=0.518      P=0.117      P=0.137      P=0.447     |P=0.270      P=0.441N     P=0.240N     P=0.344      | 
|POLY 1.5           |     P=0.540      P=0.122      P=0.173      P=0.461     |P=0.261      P=0.450N     P=0.241N     P=0.329      | 
|POLY 6             |     P=0.507      P=0.111      P=0.109      P=0.441     |P=0.280      P=0.437N     P=0.242N     P=0.358      | 
|LOGISTIC REGRESSION|     P=0.524N     P=0.120      P=0.146      P=0.478     |P=0.286      P=0.469N     P=0.232N     P=0.351      | 
|COCH-ARM / FISHERS |     P=0.489N     P=0.127      P=0.252      P=0.500     |P=0.247      P=0.466N     P=0.242N     P=0.305      | 
|ORDER RESTRICTED   |     P=0.226      (e)          (e)          (e)         |P=0.238      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Accumulation, Hyaline Droplet                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |3/49 (6%)    2/50 (4%)    1/50 (2%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/48.24      0/47.90      0/45.68      0/47.85     |3/46.61      2/48.78      1/48.01      2/46.12      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |6.4%         4.1%         2.1%         4.3%         | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    0/42 (0%)    0/46 (0%)   |3/43 (7%)    0/40 (0%)    1/43 (2%)    1/40 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |729 (T)      525          729 (T)      711          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.420N     P=0.510N     P=0.305N     P=0.530N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.408N     P=0.479N     P=0.295N     P=0.505N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.404N     P=0.483N     P=0.296N     P=0.500N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.412N     P=0.477N     P=0.294N     P=0.511N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.343N     P=0.557N     P=0.305N     P=0.517N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.397N     P=0.490N     P=0.301N     P=0.490N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.354N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 12      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/48.24      0/47.90      0/45.68      0/47.85     |0/46.61      0/47.80      2/48.01      0/46.05      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         4.2%         0.0%         | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    0/42 (0%)    0/46 (0%)   |0/43 (0%)    0/40 (0%)    2/43 (5%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.585      (e)          P=0.238      (e)          | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.582      (e)          P=0.244      (e)          | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.589      (e)          P=0.243      (e)          | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.574      (e)          P=0.244      (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          P=0.238      (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.595      (e)          P=0.247      (e)          | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.254      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Clear Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    3/50 (6%)    2/50 (4%)    3/50 (6%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     3/48.24      3/47.90      2/45.68      3/47.85     |0/46.61      0/47.80      0/48.01      0/46.05      | 
|POLY-3 PERCENT (g) |     6.2%         6.3%         4.4%         6.3%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     3/45 (7%)    3/44 (7%)    2/42 (5%)    3/46 (7%)   |0/43 (0%)    0/40 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      729 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.550N     P=0.652      P=0.531N     P=0.653N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.569N     P=0.659      P=0.525N     P=0.658     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.567N     P=0.659      P=0.516N     P=0.659     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.571N     P=0.658      P=0.534N     P=0.658     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.550N     P=0.652      P=0.531N     P=0.653N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.562N     P=0.661N     P=0.500N     P=0.661N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.656N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 13      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    1/50 (2%)   |3/50 (6%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/48.24      1/47.90      0/45.68      1/47.85     |3/46.61      0/47.80      0/48.01      1/46.05      | 
|POLY-3 PERCENT (g) |     0.0%         2.1%         0.0%         2.1%        |6.4%         0.0%         0.0%         2.2%         | 
|TERMINAL (d)       |     0/45 (0%)    1/44 (2%)    0/42 (0%)    1/46 (2%)   |3/43 (7%)    0/40 (0%)    0/43 (0%)    1/40 (3%)    | 
|FIRST INCIDENCE    |     ---          729 (T)      ---          729 (T)     |729 (T)      ---          ---          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.411      P=0.496      (e)          P=0.504     |P=0.258N     P=0.134N     P=0.121N     P=0.331N     | 
|POLY 3             |     P=0.402      P=0.499      (e)          P=0.498     |P=0.248N     P=0.114N     P=0.114N     P=0.310N     | 
|POLY 1.5           |     P=0.403      P=0.499      (e)          P=0.499     |P=0.249N     P=0.115N     P=0.115N     P=0.306N     | 
|POLY 6             |     P=0.401      P=0.498      (e)          P=0.498     |P=0.247N     P=0.115N     P=0.113N     P=0.315N     | 
|LOGISTIC REGRESSION|     (e)          P=0.496      (e)          P=0.504     |P=0.258N     (e)          (e)          P=0.331N     | 
|COCH-ARM / FISHERS |     P=0.405      P=0.500      (e)          P=0.500     |P=0.248N     P=0.121N     P=0.121N     P=0.309N     | 
|ORDER RESTRICTED   |     P=0.250      (e)          (e)          (e)         |P=0.038N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/50 (10%)   2/50 (4%)    1/50 (2%)    1/50 (2%)   |1/50 (2%)    2/50 (4%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     5/48.24      2/48.10      1/45.68      1/47.85     |1/46.61      2/47.80      1/48.18      0/46.05      | 
|POLY-3 PERCENT (g) |     10.4%        4.2%         2.2%         2.1%        |2.2%         4.2%         2.1%         0.0%         | 
|TERMINAL (d)       |     5/45 (11%)   1/44 (2%)    1/42 (2%)    1/46 (2%)   |1/43 (2%)    2/40 (5%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      676          729 (T)      729 (T)     |729 (T)      729 (T)      685          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.061N     P=0.228N     P=0.120N     P=0.099N    |P=0.258N     P=0.475      P=0.758N     P=0.514N     | 
|POLY 3             |     P=0.061N     P=0.218N     P=0.115N     P=0.104N    |P=0.250N     P=0.509      P=0.753N     P=0.502N     | 
|POLY 1.5           |     P=0.060N     P=0.218N     P=0.110N     P=0.103N    |P=0.248N     P=0.508      P=0.754N     P=0.500N     | 
|POLY 6             |     P=0.062N     P=0.217N     P=0.120N     P=0.104N    |P=0.253N     P=0.507      P=0.752N     P=0.505N     | 
|LOGISTIC REGRESSION|     P=0.063N     P=0.218N     P=0.120N     P=0.099N    |P=0.248N     P=0.475      P=0.762      (e)          | 
|COCH-ARM / FISHERS |     P=0.060N     P=0.218N     P=0.102N     P=0.102N    |P=0.247N     P=0.500      P=0.753N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.037N*    (e)          (e)          (e)         |P=0.234N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 14      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |6/50 (12%)   0/50 (0%)    5/50 (10%)   3/50 (6%)    | 
|POLY-3 RATE (b)    |     0/48.24      0/47.90      0/45.68      0/47.85     |6/47.21      0/47.80      5/48.60      3/46.22      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |12.7%        0.0%         10.3%        6.5%         | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    0/42 (0%)    0/46 (0%)   |5/43 (12%)   0/40 (0%)    4/43 (9%)    2/40 (5%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |539          ---          539          685          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.415N     P=0.022N*    P=0.497N     P=0.278N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.403N     P=0.015N*    P=0.480N     P=0.253N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.397N     P=0.015N*    P=0.483N     P=0.246N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.407N     P=0.015N*    P=0.479N     P=0.261N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.392N     P=0.018N*    P=0.531N     P=0.242N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.390N     P=0.013N*    P=0.500N     P=0.243N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.147N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)   |2/50 (4%)    3/50 (6%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/48.24      0/47.90      0/45.68      1/47.85     |2/46.61      3/47.80      1/48.01      0/46.05      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         2.1%        |4.3%         6.3%         2.1%         0.0%         | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    0/42 (0%)    1/46 (2%)   |2/43 (5%)    3/40 (8%)    1/43 (2%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          729 (T)     |729 (T)      729 (T)      729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.205      (e)          (e)          P=0.504     |P=0.111N     P=0.467      P=0.500N     P=0.254N     | 
|POLY 3             |     P=0.198      (e)          (e)          P=0.498     |P=0.105N     P=0.511      P=0.490N     P=0.240N     | 
|POLY 1.5           |     P=0.198      (e)          (e)          P=0.499     |P=0.103N     P=0.511      P=0.491N     P=0.238N     | 
|POLY 6             |     P=0.198      (e)          (e)          P=0.498     |P=0.107N     P=0.509      P=0.489N     P=0.243N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.504     |P=0.111N     P=0.467      P=0.500N     (e)          | 
|COCH-ARM / FISHERS |     P=0.198      (e)          (e)          P=0.500     |P=0.104N     P=0.500      P=0.500N     P=0.247N     | 
|ORDER RESTRICTED   |     P=0.119      (e)          (e)          (e)         |P=0.114N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 15      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Infiltration Cellular Mixed Cell                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    3/50 (6%)    1/50 (2%)   |1/50 (2%)    3/50 (6%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/48.24      0/47.90      3/45.68      1/47.85     |1/46.61      3/47.80      1/48.01      1/46.05      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         6.6%         2.1%        |2.2%         6.3%         2.1%         2.2%         | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    3/42 (7%)    1/46 (2%)   |1/43 (2%)    3/40 (8%)    1/43 (2%)    1/40 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          729 (T)      729 (T)     |729 (T)      729 (T)      729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.256      (e)          P=0.109      P=0.504     |P=0.462N     P=0.280      P=0.762      P=0.746      | 
|POLY 3             |     P=0.245      (e)          P=0.109      P=0.498     |P=0.446N     P=0.315      P=0.754N     P=0.758      | 
|POLY 1.5           |     P=0.245      (e)          P=0.113      P=0.499     |P=0.443N     P=0.314      P=0.755N     P=0.760      | 
|POLY 6             |     P=0.245      (e)          P=0.106      P=0.498     |P=0.451N     P=0.313      P=0.754N     P=0.755      | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.109      P=0.504     |P=0.462N     P=0.280      P=0.762      P=0.746      | 
|COCH-ARM / FISHERS |     P=0.247      (e)          P=0.121      P=0.500     |P=0.444N     P=0.309      P=0.753N     P=0.753N     | 
|ORDER RESTRICTED   |     P=0.106      (e)          (e)          (e)         |P=0.449N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    7/50 (14%)   2/50 (4%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     3/48.24      7/47.90      2/45.68      0/47.85     |1/46.61      0/47.80      1/48.01      0/46.05      | 
|POLY-3 PERCENT (g) |     6.2%         14.6%        4.4%         0.0%        |2.2%         0.0%         2.1%         0.0%         | 
|TERMINAL (d)       |     3/45 (7%)    7/44 (16%)   2/42 (5%)    0/46 (0%)   |1/43 (2%)    0/40 (0%)    1/43 (2%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      ---         |729 (T)      ---          729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.034N*    P=0.149      P=0.531N     P=0.118N    |P=0.415N     P=0.514N     P=0.762      P=0.514N     | 
|POLY 3             |     P=0.035N*    P=0.155      P=0.525N     P=0.120N    |P=0.410N     P=0.495N     P=0.754N     P=0.502N     | 
|POLY 1.5           |     P=0.034N*    P=0.156      P=0.516N     P=0.120N    |P=0.409N     P=0.495N     P=0.755N     P=0.500N     | 
|POLY 6             |     P=0.035N*    P=0.154      P=0.534N     P=0.121N    |P=0.412N     P=0.496N     P=0.754N     P=0.505N     | 
|LOGISTIC REGRESSION|     P=0.034N*    P=0.149      P=0.531N     (e)         |P=0.415N     (e)          P=0.762      (e)          | 
|COCH-ARM / FISHERS |     P=0.035N*    P=0.159      P=0.500N     P=0.121N    |P=0.405N     P=0.500N     P=0.753N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.022N*    (e)          (e)          (e)         |P=0.254N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 16      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    3/50 (6%)    2/50 (4%)    0/50 (0%)   |4/50 (8%)    3/50 (6%)    2/50 (4%)    6/50 (12%)   | 
|POLY-3 RATE (b)    |     2/49.12      3/47.90      2/45.68      0/47.85     |4/46.70      3/48.42      2/48.01      6/46.74      | 
|POLY-3 PERCENT (g) |     4.1%         6.3%         4.4%         0.0%        |8.6%         6.2%         4.2%         12.8%        | 
|TERMINAL (d)       |     0/45 (0%)    3/44 (7%)    2/42 (5%)    0/46 (0%)   |3/43 (7%)    2/40 (5%)    2/43 (5%)    3/40 (8%)    | 
|FIRST INCIDENCE    |     459          729 (T)      729 (T)      ---         |707          525          729 (T)      640          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.137N     P=0.490      P=0.666      P=0.244N    |P=0.232      P=0.530N     P=0.337N     P=0.342      | 
|POLY 3             |     P=0.142N     P=0.489      P=0.667      P=0.243N    |P=0.244      P=0.480N     P=0.325N     P=0.370      | 
|POLY 1.5           |     P=0.140N     P=0.492      P=0.677      P=0.241N    |P=0.247      P=0.484N     P=0.327N     P=0.373      | 
|POLY 6             |     P=0.145N     P=0.484      P=0.657      P=0.245N    |P=0.242      P=0.481N     P=0.325N     P=0.367      | 
|LOGISTIC REGRESSION|     P=0.124N     P=0.533      P=0.618N     P=0.156N    |P=0.248      P=0.520N     P=0.323N     P=0.369      | 
|COCH-ARM / FISHERS |     P=0.134N     P=0.500      P=0.691N     P=0.247N    |P=0.248      P=0.500N     P=0.339N     P=0.370      | 
|ORDER RESTRICTED   |     P=0.135N     (e)          (e)          (e)         |P=0.191      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    5/50 (10%)   2/50 (4%)    0/50 (0%)   |1/50 (2%)    1/50 (2%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     4/48.24      5/47.90      2/45.68      0/47.85     |1/46.70      1/47.90      1/48.18      1/46.87      | 
|POLY-3 PERCENT (g) |     8.3%         10.4%        4.4%         0.0%        |2.1%         2.1%         2.1%         2.1%         | 
|TERMINAL (d)       |     4/45 (9%)    5/44 (11%)   2/42 (5%)    0/46 (0%)   |0/43 (0%)    0/40 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      ---         |707          702          684          409          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.026N*    P=0.486      P=0.369N     P=0.061N    |P=0.622      P=0.753      P=0.753N     P=0.755      | 
|POLY 3             |     P=0.027N*    P=0.496      P=0.363N     P=0.062N    |P=0.632      P=0.755N     P=0.753N     P=0.760N     | 
|POLY 1.5           |     P=0.026N*    P=0.497      P=0.354N     P=0.061N    |P=0.631N     P=0.755N     P=0.755N     P=0.758N     | 
|POLY 6             |     P=0.027N*    P=0.494      P=0.373N     P=0.062N    |P=0.628      P=0.756N     P=0.753N     P=0.759      | 
|LOGISTIC REGRESSION|     P=0.026N*    P=0.486      P=0.369N     (e)         |P=0.581      P=0.761      P=0.756      P=0.713      | 
|COCH-ARM / FISHERS |     P=0.026N*    P=0.500      P=0.339N     P=0.059N    |P=0.634      P=0.753N     P=0.753N     P=0.753N     | 
|ORDER RESTRICTED   |     P=0.032N*    (e)          (e)          (e)         |P=0.741N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 17      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Kupffer Cell                                                                                                              | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    1/50 (2%)    2/50 (4%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/48.24      0/47.90      0/45.68      0/47.85     |1/47.17      1/47.83      2/48.34      0/46.05      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |2.1%         2.1%         4.1%         0.0%         | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    0/42 (0%)    0/46 (0%)   |0/43 (0%)    0/40 (0%)    1/43 (2%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |555          721          635          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.375N     P=0.758N     P=0.510      P=0.500N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.377N     P=0.757N     P=0.509      P=0.505N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.371N     P=0.757N     P=0.508      P=0.502N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.383N     P=0.760N     P=0.509      P=0.509N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.392N     P=0.721      P=0.419      P=0.564N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.366N     P=0.753N     P=0.500      P=0.500N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.281N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    2/50 (4%)    1/50 (2%)    5/50 (10%)  |1/50 (2%)    2/50 (4%)    3/50 (6%)    4/50 (8%)    | 
|POLY-3 RATE (b)    |     3/48.24      2/47.90      1/45.68      5/47.85     |1/46.61      2/47.80      3/48.01      4/47.36      | 
|POLY-3 PERCENT (g) |     6.2%         4.2%         2.2%         10.5%       |2.2%         4.2%         6.3%         8.5%         | 
|TERMINAL (d)       |     3/45 (7%)    2/44 (5%)    1/42 (2%)    5/46 (11%)  |1/43 (2%)    2/40 (5%)    3/43 (7%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      729 (T)     |729 (T)      729 (T)      729 (T)      447          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.227      P=0.510N     P=0.330N     P=0.369     |P=0.107      P=0.475      P=0.305      P=0.176      | 
|POLY 3             |     P=0.211      P=0.503N     P=0.325N     P=0.352     |P=0.117      P=0.509      P=0.316      P=0.184      | 
|POLY 1.5           |     P=0.213      P=0.502N     P=0.318N     P=0.354     |P=0.117      P=0.508      P=0.315      P=0.184      | 
|POLY 6             |     P=0.210      P=0.504N     P=0.333N     P=0.352     |P=0.118      P=0.507      P=0.317      P=0.184      | 
|LOGISTIC REGRESSION|     P=0.227      P=0.510N     P=0.330N     P=0.369     |P=0.111      P=0.475      P=0.305      P=0.153      | 
|COCH-ARM / FISHERS |     P=0.216      P=0.500N     P=0.309N     P=0.357     |P=0.114      P=0.500      P=0.309      P=0.181      | 
|ORDER RESTRICTED   |     P=0.147      (e)          (e)          (e)         |P=0.136      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 18      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    2/50 (4%)    6/50 (12%)   2/50 (4%)   |6/50 (12%)   6/50 (12%)   8/50 (16%)   8/50 (16%)   | 
|POLY-3 RATE (b)    |     3/48.24      2/47.90      6/45.68      2/47.85     |6/46.61      6/47.80      8/48.01      8/46.05      | 
|POLY-3 PERCENT (g) |     6.2%         4.2%         13.1%        4.2%        |12.9%        12.6%        16.7%        17.4%        | 
|TERMINAL (d)       |     3/45 (7%)    2/44 (5%)    6/42 (14%)   2/46 (4%)   |6/43 (14%)   6/40 (15%)   8/43 (19%)   8/40 (20%)   | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      729 (T)     |729 (T)      729 (T)      729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.507N     P=0.510N     P=0.209      P=0.490N    |P=0.252      P=0.570      P=0.386      P=0.330      | 
|POLY 3             |     P=0.524N     P=0.503N     P=0.216      P=0.504N    |P=0.277      P=0.603N     P=0.410      P=0.377      | 
|POLY 1.5           |     P=0.523N     P=0.502N     P=0.226      P=0.503N    |P=0.286      P=0.604N     P=0.406      P=0.386      | 
|POLY 6             |     P=0.525N     P=0.504N     P=0.207      P=0.504N    |P=0.267      P=0.606N     P=0.411      P=0.366      | 
|LOGISTIC REGRESSION|     P=0.507N     P=0.510N     P=0.209      P=0.490N    |P=0.252      P=0.570      P=0.386      P=0.330      | 
|COCH-ARM / FISHERS |     P=0.519N     P=0.500N     P=0.243      P=0.500N    |P=0.291      P=0.620N     P=0.387      P=0.387      | 
|ORDER RESTRICTED   |     P=0.385N     (e)          (e)          (e)         |P=0.422      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/50 (10%)   6/50 (12%)   5/50 (10%)   11/50 (22%) |1/50 (2%)    5/50 (10%)   1/50 (2%)    8/50 (16%)   | 
|POLY-3 RATE (b)    |     5/48.89      6/48.36      5/45.68      11/48.45    |1/46.61      5/47.92      1/48.01      8/46.91      | 
|POLY-3 PERCENT (g) |     10.2%        12.4%        11.0%        22.7%       |2.2%         10.4%        2.1%         17.1%        | 
|TERMINAL (d)       |     4/45 (9%)    4/44 (9%)    5/42 (12%)   10/46 (22%) |1/43 (2%)    4/40 (10%)   1/43 (2%)    4/40 (10%)   | 
|FIRST INCIDENCE    |     513          613          729 (T)      537         |729 (T)      697          729 (T)      640          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.060      P=0.489      P=0.589      P=0.098     |P=0.015 *    P=0.092      P=0.762      P=0.018 *    | 
|POLY 3             |     P=0.046 *    P=0.492      P=0.587      P=0.082     |P=0.015 *    P=0.108      P=0.754N     P=0.016 *    | 
|POLY 1.5           |     P=0.047 *    P=0.494      P=0.602      P=0.083     |P=0.015 *    P=0.108      P=0.755N     P=0.016 *    | 
|POLY 6             |     P=0.045 *    P=0.492      P=0.570      P=0.081     |P=0.015 *    P=0.107      P=0.754N     P=0.016 *    | 
|LOGISTIC REGRESSION|     P=0.050      P=0.516      P=0.629N     P=0.090     |P=0.016 *    P=0.107      P=0.762      P=0.018 *    | 
|COCH-ARM / FISHERS |     P=0.050      P=0.500      P=0.630N     P=0.086     |P=0.016 *    P=0.102      P=0.753N     P=0.015 *    | 
|ORDER RESTRICTED   |     P=0.052      (e)          (e)          (e)         |P=0.004 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 19      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/50 (14%)   3/50 (6%)    1/50 (2%)    9/50 (18%)  |3/50 (6%)    2/50 (4%)    3/50 (6%)    11/50 (22%)  | 
|POLY-3 RATE (b)    |     7/48.37      3/47.90      1/46.28      9/48.21     |3/46.79      2/47.80      3/48.01      11/46.05     | 
|POLY-3 PERCENT (g) |     14.5%        6.3%         2.2%         18.7%       |6.4%         4.2%         6.3%         23.9%        | 
|TERMINAL (d)       |     6/45 (13%)   3/44 (7%)    0/42 (0%)    8/46 (17%)  |1/43 (2%)    2/40 (5%)    3/43 (7%)    11/40 (28%)  | 
|FIRST INCIDENCE    |     695          729 (T)      535          628         |706          729 (T)      729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.228      P=0.170N     P=0.044N*    P=0.409     |P<0.001 **   P=0.530N     P=0.659N     P=0.016 *    | 
|POLY 3             |     P=0.206      P=0.162N     P=0.035N*    P=0.390     |P<0.001 **   P=0.490N     P=0.650N     P=0.018 *    | 
|POLY 1.5           |     P=0.207      P=0.161N     P=0.034N*    P=0.390     |P<0.001 **   P=0.490N     P=0.651N     P=0.019 *    | 
|POLY 6             |     P=0.206      P=0.164N     P=0.037N*    P=0.391     |P<0.001 **   P=0.494N     P=0.651N     P=0.016 *    | 
|LOGISTIC REGRESSION|     P=0.212      P=0.162N     P=0.028N*    P=0.388     |P<0.001 **   P=0.490N     P=0.651N     P=0.017 *    | 
|COCH-ARM / FISHERS |     P=0.213      P=0.159N     P=0.030N*    P=0.393     |P=0.002 **   P=0.500N     P=0.661N     P=0.020 *    | 
|ORDER RESTRICTED   |     P=0.052      (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    2/50 (4%)    0/48 (0%)    1/45 (2%)   |1/47 (2%)    0/47 (0%)    2/48 (4%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/46.24      2/47.90      0/43.68      1/43.21     |1/43.70      0/45.20      2/46.34      0/44.35      | 
|POLY-3 PERCENT (g) |     0.0%         4.2%         0.0%         2.3%        |2.3%         0.0%         4.3%         0.0%         | 
|TERMINAL (d)       |     0/43 (0%)    2/44 (5%)    0/40 (0%)    1/42 (2%)   |1/41 (2%)    0/40 (0%)    1/41 (2%)    0/39 (0%)    | 
|FIRST INCIDENCE    |     ---          729 (T)      ---          729 (T)     |729 (T)      ---          635          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.529      P=0.244      (e)          P=0.495     |P=0.467N     P=0.505N     P=0.507      P=0.510N     | 
|POLY 3             |     P=0.516      P=0.245      (e)          P=0.486     |P=0.463N     P=0.493N     P=0.520      P=0.497N     | 
|POLY 1.5           |     P=0.516      P=0.245      (e)          P=0.486     |P=0.459N     P=0.494N     P=0.518      P=0.495N     | 
|POLY 6             |     P=0.516      P=0.245      (e)          P=0.487     |P=0.467N     P=0.493N     P=0.522      P=0.499N     | 
|LOGISTIC REGRESSION|     (e)          P=0.244      (e)          P=0.495     |P=0.457N     (e)          P=0.496      (e)          | 
|COCH-ARM / FISHERS |     P=0.519      P=0.258      (e)          P=0.484     |P=0.455N     P=0.500N     P=0.508      P=0.495N     | 
|ORDER RESTRICTED   |     P=0.313      (e)          (e)          (e)         |P=0.322N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 20      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/50 (0%)    0/48 (0%)    0/45 (0%)   |0/47 (0%)    0/47 (0%)    1/48 (2%)    3/48 (6%)    | 
|POLY-3 RATE (b)    |     0/46.24      0/47.90      0/43.68      0/43.21     |0/43.70      0/45.20      1/46.18      3/44.35      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         2.2%         6.8%         | 
|TERMINAL (d)       |     0/43 (0%)    0/44 (0%)    0/40 (0%)    0/42 (0%)   |0/41 (0%)    0/40 (0%)    0/41 (0%)    3/39 (8%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          684          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.019 *    (e)          P=0.509      P=0.112      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.020 *    (e)          P=0.511      P=0.121      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.020 *    (e)          P=0.510      P=0.123      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.019 *    (e)          P=0.512      P=0.119      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.020 *    (e)          P=0.489      P=0.112      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.021 *    (e)          P=0.505      P=0.125      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.021 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     10/48 (21%)  8/50 (16%)   9/48 (19%)   12/45 (27%) |6/47 (13%)   8/47 (17%)   7/48 (15%)   13/48 (27%)  | 
|POLY-3 RATE (b)    |     10/46.24     8/47.90      9/45.09      12/43.21    |6/44.30      8/45.90      7/46.01      13/44.52     | 
|POLY-3 PERCENT (g) |     21.6%        16.7%        20.0%        27.8%       |13.5%        17.4%        15.2%        29.2%        | 
|TERMINAL (d)       |     10/43 (23%)  8/44 (18%)   7/40 (18%)   12/42 (29%) |5/41 (12%)   5/40 (13%)   7/41 (17%)   12/39 (31%)  | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      441          729 (T)     |539          632          729 (T)      685          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.250      P=0.375N     P=0.563N     P=0.378     |P=0.035 *    P=0.382      P=0.501      P=0.051      | 
|POLY 3             |     P=0.210      P=0.366N     P=0.524N     P=0.335     |P=0.041 *    P=0.414      P=0.529      P=0.060      | 
|POLY 1.5           |     P=0.211      P=0.365N     P=0.515N     P=0.335     |P=0.044 *    P=0.409      P=0.530      P=0.064      | 
|POLY 6             |     P=0.211      P=0.367N     P=0.535N     P=0.338     |P=0.037 *    P=0.418      P=0.525      P=0.055      | 
|LOGISTIC REGRESSION|     P=0.211      P=0.375N     P=0.481N     P=0.378     |P=0.045 *    P=0.366      P=0.528      P=0.067      | 
|COCH-ARM / FISHERS |     P=0.214      P=0.361N     P=0.500N     P=0.338     |P=0.048 *    P=0.387      P=0.517      P=0.068      | 
|ORDER RESTRICTED   |     P=0.258      (e)          (e)          (e)         |P=0.042 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 21      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     10/48 (21%)  5/50 (10%)   7/48 (15%)   12/45 (27%) |12/47 (26%)  19/47 (40%)  18/48 (38%)  19/48 (40%)  | 
|POLY-3 RATE (b)    |     10/46.54     5/48.58      7/44.97      12/44.40    |12/43.70     19/46.16     18/46.22     19/45.11     | 
|POLY-3 PERCENT (g) |     21.5%        10.3%        15.6%        27.0%       |27.5%        41.2%        39.0%        42.1%        | 
|TERMINAL (d)       |     8/43 (19%)   3/44 (7%)    4/40 (10%)   10/42 (24%) |12/41 (29%)  16/40 (40%)  16/41 (39%)  16/39 (41%)  | 
|FIRST INCIDENCE    |     685          586          441          355         |729 (T)      525          684          569          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.190      P=0.134N     P=0.365N     P=0.385     |P=0.103      P=0.086      P=0.137      P=0.072      | 
|POLY 3             |     P=0.153      P=0.111N     P=0.324N     P=0.356     |P=0.146      P=0.125      P=0.175      P=0.108      | 
|POLY 1.5           |     P=0.152      P=0.112N     P=0.314N     P=0.350     |P=0.152      P=0.117      P=0.171      P=0.110      | 
|POLY 6             |     P=0.154      P=0.111N     P=0.335N     P=0.361     |P=0.142      P=0.132      P=0.178      P=0.107      | 
|LOGISTIC REGRESSION|     P=0.157      P=0.111N     P=0.267N     P=0.347     |P=0.135      P=0.110      P=0.166      P=0.097      | 
|COCH-ARM / FISHERS |     P=0.150      P=0.113N     P=0.297N     P=0.338     |P=0.151      P=0.094      P=0.151      P=0.107      | 
|ORDER RESTRICTED   |     P=0.128      (e)          (e)          (e)         |P=0.120      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/49 (0%)    0/48 (0%)    0/48 (0%)    0/50 (0%)   |0/49 (0%)    2/47 (4%)    0/49 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/47.29      0/47.28      0/44.48      0/47.85     |0/46.61      2/46.24      0/47.01      0/46.05      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         4.3%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    0/42 (0%)    0/46 (0%)   |0/43 (0%)    0/40 (0%)    0/42 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          525          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.416N     P=0.239      (e)          (e)          | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.397N     P=0.235      (e)          (e)          | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.397N     P=0.233      (e)          (e)          | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.398N     P=0.238      (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.248N     P=0.115      (e)          (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.398N     P=0.237      (e)          (e)          | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.248N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 22      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/49 (0%)    0/48 (0%)    0/48 (0%)    1/50 (2%)   |2/49 (4%)    1/47 (2%)    2/49 (4%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/47.29      0/47.28      0/44.48      1/47.85     |2/47.20      1/45.51      2/47.01      0/46.05      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         2.1%        |4.2%         2.2%         4.3%         0.0%         | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    0/42 (0%)    1/46 (2%)   |1/43 (2%)    1/40 (3%)    2/42 (5%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          729 (T)     |539          729 (T)      729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.205      (e)          (e)          P=0.504     |P=0.211N     P=0.517N     P=0.689      P=0.250N     | 
|POLY 3             |     P=0.201      (e)          (e)          P=0.502     |P=0.206N     P=0.513N     P=0.692      P=0.243N     | 
|POLY 1.5           |     P=0.202      (e)          (e)          P=0.503     |P=0.202N     P=0.513N     P=0.693      P=0.239N     | 
|POLY 6             |     P=0.201      (e)          (e)          P=0.502     |P=0.211N     P=0.513N     P=0.691      P=0.247N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.504     |P=0.165N     P=0.594N     P=0.674      P=0.160N     | 
|COCH-ARM / FISHERS |     P=0.203      (e)          (e)          P=0.505     |P=0.193N     P=0.516N     P=0.691N     P=0.242N     | 
|ORDER RESTRICTED   |     P=0.122      (e)          (e)          (e)         |P=0.160N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/49 (8%)    7/48 (15%)   4/48 (8%)    14/50 (28%) |0/49 (0%)    0/47 (0%)    0/49 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     4/47.43      7/47.28      4/44.48      14/48.15    |0/46.61      0/45.51      0/47.01      0/46.05      | 
|POLY-3 PERCENT (g) |     8.4%         14.8%        9.0%         29.1%       |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     3/45 (7%)    7/44 (16%)   4/42 (10%)   13/46 (28%) |0/43 (0%)    0/40 (0%)    0/42 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     695          729 (T)      729 (T)      645         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.006 **   P=0.251      P=0.601      P=0.012 *   |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.004 **   P=0.260      P=0.607      P=0.009 **  |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.004 **   P=0.257      P=0.616      P=0.009 **  |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.004 **   P=0.260      P=0.598      P=0.009 **  |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.005 **   P=0.261      P=0.605      P=0.010 *   |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.005 **   P=0.250      P=0.631      P=0.010 *   |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.002 **   (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 23      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/49 (14%)   4/48 (8%)    4/48 (8%)    7/50 (14%)  |3/49 (6%)    8/47 (17%)   9/49 (18%)   10/50 (20%)  | 
|POLY-3 RATE (b)    |     7/47.47      4/47.28      4/45.37      7/47.85     |3/46.61      8/45.51      9/47.01      10/46.46     | 
|POLY-3 PERCENT (g) |     14.8%        8.5%         8.8%         14.6%       |6.4%         17.6%        19.2%        21.5%        | 
|TERMINAL (d)       |     6/45 (13%)   4/44 (9%)    3/42 (7%)    7/46 (15%)  |3/43 (7%)    8/40 (20%)   9/42 (21%)   8/40 (20%)   | 
|FIRST INCIDENCE    |     685          729 (T)      348          729 (T)     |729 (T)      729 (T)      729 (T)      665          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.484      P=0.277N     P=0.305N     P=0.599N    |P=0.036 *    P=0.078      P=0.056      P=0.030 *    | 
|POLY 3             |     P=0.473      P=0.264N     P=0.288N     P=0.607N    |P=0.047 *    P=0.091      P=0.061      P=0.034 *    | 
|POLY 1.5           |     P=0.478      P=0.267N     P=0.282N     P=0.603N    |P=0.050      P=0.089      P=0.061      P=0.035 *    | 
|POLY 6             |     P=0.468      P=0.263N     P=0.296N     P=0.611N    |P=0.045 *    P=0.092      P=0.061      P=0.032 *    | 
|LOGISTIC REGRESSION|     P=0.498      P=0.262N     P=0.231N     P=0.606N    |P=0.040 *    P=0.078      P=0.056      P=0.034 *    | 
|COCH-ARM / FISHERS |     P=0.488      P=0.274N     P=0.274N     P=0.597N    |P=0.056      P=0.087      P=0.060      P=0.039 *    | 
|ORDER RESTRICTED   |     P=0.424N     (e)          (e)          (e)         |P=0.032 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Iliac                                                                                                                | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/2 (0%)     0/2 (0%)     0/1 (0%)     0/2 (0%)    |0/3 (0%)     2/9 (22%)    1/12 (8%)    1/7 (14%)    | 
|POLY-3 RATE (b)    |     0/1.83       0/1.95       0/1.00       0/2.00      |0/3.00       2/7.79       1/11.40      1/4.78       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         25.7%        8.8%         20.9%        | 
|TERMINAL (d)       |     0/1 (0%)     0/1 (0%)     0/1 (0%)     0/2 (0%)    |0/3 (0%)     0/3 (0%)     1/9 (11%)    1/3 (33%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          632          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.521      P=0.242      P=0.718      P=0.500      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.529      P=0.461      P=0.762      P=0.598      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.571      P=0.479      P=0.764      P=0.626      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.494      P=0.436      P=0.757      P=0.563      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.583      P=0.544      P=0.718      P=0.500      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.645      P=0.545      P=0.800      P=0.700      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.452      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 24      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Inguinal                                                                                                             | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/2 (0%)     0/2 (0%)     0/1 (0%)     1/2 (50%)   |0/3 (0%)     2/9 (22%)    1/12 (8%)    0/7 (0%)     | 
|POLY-3 RATE (b)    |     0/1.83       0/1.95       0/1.00       1/2.00      |0/3.00       2/7.79       1/11.40      0/4.78       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         50.0%       |0.0%         25.7%        8.8%         0.0%         | 
|TERMINAL (d)       |     0/1 (0%)     0/1 (0%)     0/1 (0%)     1/2 (50%)   |0/3 (0%)     1/3 (33%)    1/9 (11%)    0/3 (0%)     | 
|FIRST INCIDENCE    |     ---          ---          ---          729 (T)     |---          632          729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.308      (e)          (e)          P=0.638     |P=0.424N     P=0.247      P=0.718      (e)          | 
|POLY 3             |     P=0.236      (e)          (e)          P=0.518     |P=0.407N     P=0.461      P=0.762      (e)          | 
|POLY 1.5           |     P=0.231      (e)          (e)          P=0.509     |P=0.380N     P=0.479      P=0.764      (e)          | 
|POLY 6             |     P=0.246      (e)          (e)          P=0.533     |P=0.451N     P=0.435      P=0.757      (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.638     |P=0.357N     P=0.540      P=0.718      (e)          | 
|COCH-ARM / FISHERS |     P=0.189      (e)          (e)          P=0.500     |P=0.331N     P=0.545      P=0.800      (e)          | 
|ORDER RESTRICTED   |     P=0.141      (e)          (e)          (e)         |P=0.449N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/2 (0%)     0/2 (0%)     0/1 (0%)     0/2 (0%)    |0/3 (0%)     2/9 (22%)    0/12 (0%)    0/7 (0%)     | 
|POLY-3 RATE (b)    |     0/1.83       0/1.95       0/1.00       0/2.00      |0/3.00       2/7.91       0/11.40      0/4.78       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         25.3%        0.0%         0.0%         | 
|TERMINAL (d)       |     0/1 (0%)     0/1 (0%)     0/1 (0%)     0/2 (0%)    |0/3 (0%)     0/3 (0%)     0/9 (0%)     0/3 (0%)     | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          632          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.412N     P=0.244      (e)          (e)          | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.312N     P=0.466      (e)          (e)          | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.305N     P=0.481      (e)          (e)          | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.332N     P=0.445      (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.234N     P=0.603      (e)          (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.293N     P=0.545      (e)          (e)          | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.382N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 25      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |16/50 (32%)  10/50 (20%)  14/49 (29%)  24/49 (49%)  | 
|POLY-3 RATE (b)    |     0/48.24      0/47.90      0/45.68      0/47.85     |16/47.77     10/49.04     14/47.94     24/48.29     | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |33.5%        20.4%        29.2%        49.7%        | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    0/42 (0%)    0/46 (0%)   |14/43 (33%)  6/40 (15%)   12/42 (29%)  18/40 (45%)  | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |539          525          539          409          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.014 *    P=0.173N     P=0.436N     P=0.061      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.013 *    P=0.110N     P=0.409N     P=0.079      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.013 *    P=0.112N     P=0.412N     P=0.076      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.013 *    P=0.109N     P=0.408N     P=0.079      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.013 *    P=0.140N     P=0.446N     P=0.063      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.012 *    P=0.127N     P=0.440N     P=0.064      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.010 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Fat                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/4 (75%)    3/7 (43%)    2/2 (100%)   2/3 (67%)   |3/3 (100%)   3/7 (43%)    3/7 (43%)    3/4 (75%)    | 
|POLY-3 RATE (b)    |     3/4.00       3/6.74       2/2.00       2/3.00      |3/3.00       3/6.15       3/6.74       3/4.00       | 
|POLY-3 PERCENT (g) |     75.0%        44.5%        100.0%       66.7%       |100.0%       48.8%        44.5%        75.0%        | 
|TERMINAL (d)       |     3/4 (75%)    3/5 (60%)    2/2 (100%)   2/3 (67%)   |3/3 (100%)   3/4 (75%)    2/4 (50%)    3/4 (75%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      729 (T)     |729 (T)      729 (T)      720          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.653      P=0.588N     P=0.638      P=0.712N    |P=0.465N     P=0.557N     P=0.567N     P=0.557N     | 
|POLY 3             |     P=0.568      P=0.372N     P=0.631      P=0.696N    |P=0.566N     P=0.188N     P=0.156N     P=0.556N     | 
|POLY 1.5           |     P=0.561      P=0.362N     P=0.631      P=0.696N    |P=0.587N     P=0.167N     P=0.152N     P=0.556N     | 
|POLY 6             |     P=0.580      P=0.392N     P=0.631      P=0.696N    |P=0.539N     P=0.224N     P=0.165N     P=0.556N     | 
|LOGISTIC REGRESSION|     P=0.653      P=0.588N     P=0.638      P=0.712N    |P=0.437N     P=0.557N     P=0.347N     P=0.557N     | 
|COCH-ARM / FISHERS |     P=0.556      P=0.348N     P=0.667      P=0.714N    |P=0.617N     P=0.167N     P=0.167N     P=0.571N     | 
|ORDER RESTRICTED   |     P=0.435      (e)          (e)          (e)         |P=0.239N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 26      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    2/50 (4%)    0/50 (0%)   |1/50 (2%)    0/49 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/48.89      0/47.90      2/45.84      0/47.85     |1/47.21      0/46.80      0/48.01      0/46.05      | 
|POLY-3 PERCENT (g) |     2.1%         0.0%         4.4%         0.0%        |2.1%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    1/42 (2%)    0/46 (0%)   |0/43 (0%)    0/39 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     513          ---          686          ---         |539          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.462N     P=0.500N     P=0.479      P=0.500N    |P=0.308N     P=0.500N     P=0.496N     P=0.504N     | 
|POLY 3             |     P=0.464N     P=0.504N     P=0.478      P=0.504N    |P=0.303N     P=0.502N     P=0.497N     P=0.505N     | 
|POLY 1.5           |     P=0.463N     P=0.503N     P=0.486      P=0.503N    |P=0.305N     P=0.501N     P=0.497N     P=0.502N     | 
|POLY 6             |     P=0.465N     P=0.506N     P=0.470      P=0.506N    |P=0.300N     P=0.504N     P=0.497N     P=0.509N     | 
|LOGISTIC REGRESSION|     P=0.436N     P=0.375N     P=0.596      P=0.377N    |P=0.378N     P=0.632N     P=0.628N     P=0.574N     | 
|COCH-ARM / FISHERS |     P=0.461N     P=0.500N     P=0.500      P=0.500N    |P=0.305N     P=0.505N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.319N     (e)          (e)          (e)         |P=0.125N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |9/48 (19%)   9/49 (18%)   7/49 (14%)   6/50 (12%)   | 
|POLY-3 RATE (b)    |                                                        |9/44.70      9/47.65      7/47.01      6/46.05      | 
|POLY-3 PERCENT (g) |                                                        |20.1%        18.9%        14.9%        13.0%        | 
|TERMINAL (d)       |                                                        |8/41 (20%)   7/39 (18%)   7/42 (17%)   6/40 (15%)   | 
|FIRST INCIDENCE    |                                                        |706          525          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.210N     P=0.562      P=0.374N     P=0.309N     | 
|POLY 3             |                                                        |P=0.195N     P=0.544N     P=0.351N     P=0.266N     | 
|POLY 1.5           |                                                        |P=0.187N     P=0.552N     P=0.354N     P=0.259N     | 
|POLY 6             |                                                        |P=0.204N     P=0.541N     P=0.350N     P=0.276N     | 
|LOGISTIC REGRESSION|                                                        |P=0.188N     P=0.574N     P=0.351N     P=0.290N     | 
|COCH-ARM / FISHERS |                                                        |P=0.182N     P=0.584N     P=0.375N     P=0.259N     | 
|ORDER RESTRICTED   |                                                        |P=0.295N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 27      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |16/48 (33%)  20/49 (41%)  14/49 (29%)  19/50 (38%)  | 
|POLY-3 RATE (b)    |                                                        |16/45.70     20/47.52     14/47.01     19/46.22     | 
|POLY-3 PERCENT (g) |                                                        |35.0%        42.1%        29.8%        41.1%        | 
|TERMINAL (d)       |                                                        |14/41 (34%)  18/39 (46%)  14/42 (33%)  18/40 (45%)  | 
|FIRST INCIDENCE    |                                                        |114          525          729 (T)      685          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.397      P=0.213      P=0.385N     P=0.302      | 
|POLY 3             |                                                        |P=0.415      P=0.313      P=0.376N     P=0.349      | 
|POLY 1.5           |                                                        |P=0.433      P=0.306      P=0.380N     P=0.365      | 
|POLY 6             |                                                        |P=0.395      P=0.312      P=0.376N     P=0.330      | 
|LOGISTIC REGRESSION|                                                        |P=0.458      P=0.276      P=0.391N     P=0.394      | 
|COCH-ARM / FISHERS |                                                        |P=0.466      P=0.290      P=0.387N     P=0.393      | 
|ORDER RESTRICTED   |                                                        |P=0.432      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/49 (0%)    0/49 (0%)    1/50 (2%)    0/50 (0%)   |3/49 (6%)    1/48 (2%)    0/48 (0%)    0/49 (0%)    | 
|POLY-3 RATE (b)    |     0/47.37      0/47.38      1/45.68      0/47.85     |3/46.61      1/46.15      0/46.09      0/45.05      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.2%         0.0%        |6.4%         2.2%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    1/42 (2%)    0/46 (0%)   |3/43 (7%)    1/40 (3%)    0/42 (0%)    0/39 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          729 (T)      ---         |729 (T)      729 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.694      (e)          P=0.486      (e)         |P=0.049N*    P=0.331N     P=0.125N     P=0.139N     | 
|POLY 3             |     P=0.696      (e)          P=0.493      (e)         |P=0.044N*    P=0.309N     P=0.121N     P=0.125N     | 
|POLY 1.5           |     P=0.696      (e)          P=0.497      (e)         |P=0.044N*    P=0.310N     P=0.121N     P=0.123N     | 
|POLY 6             |     P=0.696      (e)          P=0.488      (e)         |P=0.044N*    P=0.309N     P=0.120N     P=0.128N     | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.486      (e)         |P=0.049N*    P=0.331N     (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.697      (e)          P=0.505      (e)         |P=0.044N*    P=0.316N     P=0.125N     P=0.121N     | 
|ORDER RESTRICTED   |     P=0.374      (e)          (e)          (e)         |P=0.023N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 28      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Parathyroid Gland                                                                                                                | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/47 (2%)    0/49 (0%)    1/49 (2%)    1/49 (2%)   |0/49 (0%)    1/49 (2%)    5/48 (10%)   2/47 (4%)    | 
|POLY-3 RATE (b)    |     1/45.29      0/47.10      1/44.68      1/47.45     |0/46.21      1/46.90      5/46.26      2/43.35      | 
|POLY-3 PERCENT (g) |     2.2%         0.0%         2.2%         2.1%        |0.0%         2.1%         10.8%        4.6%         | 
|TERMINAL (d)       |     1/43 (2%)    0/44 (0%)    1/41 (2%)    1/46 (2%)   |0/43 (0%)    0/40 (0%)    5/43 (12%)   2/38 (5%)    | 
|FIRST INCIDENCE    |     729 (T)      ---          729 (T)      729 (T)     |---          705          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.553      P=0.495N     P=0.751      P=0.747N    |P=0.138      P=0.491      P=0.033 *    P=0.212      | 
|POLY 3             |     P=0.549      P=0.492N     P=0.757      P=0.750N    |P=0.137      P=0.503      P=0.031 *    P=0.223      | 
|POLY 1.5           |     P=0.548      P=0.492N     P=0.759N     P=0.751N    |P=0.143      P=0.503      P=0.031 *    P=0.226      | 
|POLY 6             |     P=0.550      P=0.492N     P=0.753      P=0.749N    |P=0.131      P=0.501      P=0.031 *    P=0.219      | 
|LOGISTIC REGRESSION|     P=0.553      (e)          P=0.751      P=0.747N    |P=0.138      P=0.497      P=0.033 *    P=0.212      | 
|COCH-ARM / FISHERS |     P=0.548      P=0.490N     P=0.742N     P=0.742N    |P=0.152      P=0.500      P=0.027 *    P=0.237      | 
|ORDER RESTRICTED   |     P=0.533      (e)          (e)          (e)         |P=0.051      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/49 (2%)    3/48 (6%)    3/49 (6%)    2/50 (4%)   |1/49 (2%)    3/46 (7%)    4/49 (8%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/47.37      3/46.38      3/44.68      2/47.85     |1/45.61      3/44.25      4/47.04      0/46.05      | 
|POLY-3 PERCENT (g) |     2.1%         6.5%         6.7%         4.2%        |2.2%         6.8%         8.5%         0.0%         | 
|TERMINAL (d)       |     1/45 (2%)    3/43 (7%)    3/41 (7%)    2/46 (4%)   |1/42 (2%)    3/38 (8%)    4/43 (9%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      729 (T)     |729 (T)      729 (T)      729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.490      P=0.289      P=0.273      P=0.508     |P=0.317N     P=0.270      P=0.187      P=0.510N     | 
|POLY 3             |     P=0.482      P=0.298      P=0.285      P=0.503     |P=0.306N     P=0.294      P=0.188      P=0.498N     | 
|POLY 1.5           |     P=0.485      P=0.298      P=0.292      P=0.505     |P=0.299N     P=0.293      P=0.187      P=0.496N     | 
|POLY 6             |     P=0.480      P=0.298      P=0.277      P=0.502     |P=0.314N     P=0.295      P=0.189      P=0.501N     | 
|LOGISTIC REGRESSION|     P=0.490      P=0.289      P=0.273      P=0.508     |P=0.317N     P=0.270      P=0.187      (e)          | 
|COCH-ARM / FISHERS |     P=0.490      P=0.301      P=0.309      P=0.508     |P=0.298N     P=0.285      P=0.181      P=0.495N     | 
|ORDER RESTRICTED   |     P=0.320      (e)          (e)          (e)         |P=0.131N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 29      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/49 (0%)    0/48 (0%)    0/49 (0%)    0/50 (0%)   |2/49 (4%)    4/46 (9%)    1/49 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/47.37      0/46.38      0/44.68      0/47.85     |2/45.61      4/44.26      1/47.04      0/46.05      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |4.4%         9.0%         2.1%         0.0%         | 
|TERMINAL (d)       |     0/45 (0%)    0/43 (0%)    0/41 (0%)    0/46 (0%)   |2/42 (5%)    3/38 (8%)    1/43 (2%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |729 (T)      727          729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.089N     P=0.297      P=0.492N     P=0.249N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.081N     P=0.323      P=0.489N     P=0.235N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.079N     P=0.321      P=0.491N     P=0.233N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.082N     P=0.324      P=0.488N     P=0.238N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.088N     P=0.307      P=0.492N     (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.081N     P=0.309      P=0.500N     P=0.242N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.069N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     29/50 (58%)  27/50 (54%)  31/50 (62%)  36/50 (72%) |                                                    | 
|POLY-3 RATE (b)    |     29/49.12     27/48.43     31/47.00     36/48.81    |                                                    | 
|POLY-3 PERCENT (g) |     59.0%        55.8%        66.0%        73.8%       |                                                    | 
|TERMINAL (d)       |     26/45 (58%)  25/44 (57%)  28/42 (67%)  34/46 (74%) |                                                    | 
|FIRST INCIDENCE    |     513          586          441          537         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.076      P=0.468N     P=0.277      P=0.145     |                                                    | 
|POLY 3             |     P=0.040 *    P=0.451N     P=0.312      P=0.090     |                                                    | 
|POLY 1.5           |     P=0.042 *    P=0.442N     P=0.350      P=0.093     |                                                    | 
|POLY 6             |     P=0.038 *    P=0.462N     P=0.274      P=0.089     |                                                    | 
|LOGISTIC REGRESSION|     P=0.042 *    P=0.431N     P=0.333      P=0.097     |                                                    | 
|COCH-ARM / FISHERS |     P=0.050      P=0.420N     P=0.419      P=0.104     |                                                    | 
|ORDER RESTRICTED   |     P=0.064      (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 30      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     17/50 (34%)  19/50 (38%)  24/50 (48%)  23/50 (46%) |                                                    | 
|POLY-3 RATE (b)    |     17/48.95     19/47.95     24/48.25     23/48.45    |                                                    | 
|POLY-3 PERCENT (g) |     34.7%        39.6%        49.7%        47.5%       |                                                    | 
|TERMINAL (d)       |     15/45 (33%)  18/44 (41%)  20/42 (48%)  22/46 (48%) |                                                    | 
|FIRST INCIDENCE    |     513          716          348          537         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.136      P=0.390      P=0.080      P=0.181     |                                                    | 
|POLY 3             |     P=0.100      P=0.387      P=0.097      P=0.141     |                                                    | 
|POLY 1.5           |     P=0.103      P=0.397      P=0.103      P=0.145     |                                                    | 
|POLY 6             |     P=0.099      P=0.376      P=0.090      P=0.139     |                                                    | 
|LOGISTIC REGRESSION|     P=0.107      P=0.409      P=0.135      P=0.150     |                                                    | 
|COCH-ARM / FISHERS |     P=0.108      P=0.418      P=0.111      P=0.154     |                                                    | 
|ORDER RESTRICTED   |     P=0.127      (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/48 (0%)    0/50 (0%)    2/49 (4%)    | 
|POLY-3 RATE (b)    |     0/48.24      0/47.90      0/45.68      0/47.85     |0/46.61      0/46.16      0/48.01      2/45.35      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         4.4%         | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    0/42 (0%)    0/46 (0%)   |0/43 (0%)    0/40 (0%)    0/43 (0%)    2/40 (5%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          ---          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.043 *    (e)          (e)          P=0.223      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.044 *    (e)          (e)          P=0.231      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.045 *    (e)          (e)          P=0.233      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.044 *    (e)          (e)          P=0.229      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          P=0.223      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.046 *    (e)          (e)          P=0.242      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.027 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 31      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |3/50 (6%)    4/48 (8%)    3/50 (6%)    3/49 (6%)    | 
|POLY-3 RATE (b)    |     0/48.24      0/47.90      0/45.68      0/47.85     |3/46.61      4/46.20      3/48.01      3/45.35      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |6.4%         8.7%         6.3%         6.6%         | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    0/42 (0%)    0/46 (0%)   |3/43 (7%)    3/40 (8%)    3/43 (7%)    3/40 (8%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |729 (T)      721          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.547N     P=0.463      P=0.663      P=0.629      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.529N     P=0.495      P=0.648N     P=0.649      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.524N     P=0.492      P=0.650N     P=0.653      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.534N     P=0.495      P=0.648N     P=0.645      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.549N     P=0.480      P=0.663      P=0.629      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.523N     P=0.477      P=0.661N     P=0.651      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.646N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    0/50 (0%)    0/49 (0%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/48.24      2/49.28      0/45.68      0/46.85     |0/46.61      0/47.80      1/48.18      1/46.12      | 
|POLY-3 PERCENT (g) |     0.0%         4.1%         0.0%         0.0%        |0.0%         0.0%         2.1%         2.2%         | 
|TERMINAL (d)       |     0/45 (0%)    0/44 (0%)    0/42 (0%)    0/45 (0%)   |0/43 (0%)    0/40 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          335          ---          ---         |---          ---          685          711          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.407N     P=0.242      (e)          (e)         |P=0.228      (e)          P=0.504      P=0.490      | 
|POLY 3             |     P=0.411N     P=0.242      (e)          (e)         |P=0.230      (e)          P=0.507      P=0.498      | 
|POLY 1.5           |     P=0.410N     P=0.241      (e)          (e)         |P=0.234      (e)          P=0.505      P=0.500      | 
|POLY 6             |     P=0.412N     P=0.243      (e)          (e)         |P=0.227      (e)          P=0.507      P=0.495      | 
|LOGISTIC REGRESSION|     P=0.290N     P=0.236      (e)          (e)         |P=0.236      (e)          P=0.485      P=0.500      | 
|COCH-ARM / FISHERS |     P=0.409N     P=0.247      (e)          (e)         |P=0.235      (e)          P=0.500      P=0.500      | 
|ORDER RESTRICTED   |     P=0.257N     (e)          (e)          (e)         |P=0.249      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 32      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Epidermis                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    2/50 (4%)    0/49 (0%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/48.24      0/47.90      2/45.68      0/46.85     |0/46.61      1/47.80      0/48.01      0/46.05      | 
|POLY-3 PERCENT (g) |     4.2%         0.0%         4.4%         0.0%        |0.0%         2.1%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/45 (4%)    0/44 (0%)    2/42 (5%)    0/45 (0%)   |0/43 (0%)    1/40 (3%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      ---          729 (T)      ---         |---          729 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.250N     P=0.243N     P=0.670      P=0.239N    |P=0.574N     P=0.486      (e)          (e)          | 
|POLY 3             |     P=0.253N     P=0.239N     P=0.674      P=0.244N    |P=0.562N     P=0.505      (e)          (e)          | 
|POLY 1.5           |     P=0.253N     P=0.239N     P=0.681      P=0.243N    |P=0.563N     P=0.505      (e)          (e)          | 
|POLY 6             |     P=0.253N     P=0.239N     P=0.667      P=0.244N    |P=0.563N     P=0.504      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.250N     (e)          P=0.670      (e)         |(e)          P=0.486      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.252N     P=0.247N     P=0.691N     P=0.253N    |P=0.567N     P=0.500      (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.122N     (e)          (e)          (e)         |P=0.388N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     10/49 (20%)  14/49 (29%)  9/50 (18%)   12/50 (24%) |15/49 (31%)  16/49 (33%)  13/49 (27%)  11/49 (22%)  | 
|POLY-3 RATE (b)    |     10/48.83     14/48.04     9/47.70      12/48.76    |15/47.38     16/48.53     13/48.15     11/45.92     | 
|POLY-3 PERCENT (g) |     20.5%        29.1%        18.9%        24.6%       |31.7%        33.0%        27.0%        24.0%        | 
|TERMINAL (d)       |     6/44 (14%)   11/44 (25%)  5/42 (12%)   10/46 (22%) |12/43 (28%)  12/40 (30%)  10/43 (23%)  8/40 (20%)   | 
|FIRST INCIDENCE    |     459          613          441          537         |539          525          539          665          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.516      P=0.253      P=0.547N     P=0.440     |P=0.212N     P=0.431      P=0.410N     P=0.323N     | 
|POLY 3             |     P=0.488      P=0.227      P=0.522N     P=0.403     |P=0.190N     P=0.532      P=0.392N     P=0.275N     | 
|POLY 1.5           |     P=0.496      P=0.230      P=0.509N     P=0.410     |P=0.180N     P=0.520      P=0.400N     P=0.266N     | 
|POLY 6             |     P=0.482      P=0.227      P=0.534N     P=0.399     |P=0.198N     P=0.542      P=0.385N     P=0.284N     | 
|LOGISTIC REGRESSION|     P=0.543      P=0.234      P=0.320N     P=0.447     |P=0.142N     P=0.472      P=0.425N     P=0.258N     | 
|COCH-ARM / FISHERS |     P=0.515      P=0.241      P=0.480N     P=0.426     |P=0.160N     P=0.500      P=0.412N     P=0.246N     | 
|ORDER RESTRICTED   |     P=0.496      (e)          (e)          (e)         |P=0.300N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 33      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/49 (2%)    1/49 (2%)    2/50 (4%)    2/50 (4%)   |8/49 (16%)   11/49 (22%)  8/49 (16%)   11/49 (22%)  | 
|POLY-3 RATE (b)    |     1/47.24      1/47.38      2/45.68      2/47.85     |8/46.61      11/47.15     8/47.04      11/45.52     | 
|POLY-3 PERCENT (g) |     2.1%         2.1%         4.4%         4.2%        |17.2%        23.3%        17.0%        24.2%        | 
|TERMINAL (d)       |     1/44 (2%)    1/44 (2%)    2/42 (5%)    2/46 (4%)   |8/43 (19%)   11/40 (28%)  8/43 (19%)   10/40 (25%)  | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      729 (T)     |729 (T)      729 (T)      729 (T)      685          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.353      P=0.762      P=0.484      P=0.516     |P=0.287      P=0.243      P=0.609      P=0.247      | 
|POLY 3             |     P=0.342      P=0.760N     P=0.488      P=0.504     |P=0.311      P=0.314      P=0.600N     P=0.284      | 
|POLY 1.5           |     P=0.343      P=0.760N     P=0.495      P=0.505     |P=0.319      P=0.312      P=0.602N     P=0.291      | 
|POLY 6             |     P=0.341      P=0.759N     P=0.481      P=0.504     |P=0.304      P=0.313      P=0.598N     P=0.278      | 
|LOGISTIC REGRESSION|     P=0.353      P=0.762      P=0.484      P=0.516     |P=0.278      P=0.243      P=0.609      P=0.262      | 
|COCH-ARM / FISHERS |     P=0.345      P=0.753N     P=0.508      P=0.508     |P=0.335      P=0.305      P=0.607N     P=0.305      | 
|ORDER RESTRICTED   |     P=0.435      (e)          (e)          (e)         |P=0.324      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     10/49 (20%)  8/49 (16%)   2/50 (4%)    7/50 (14%)  |14/49 (29%)  12/49 (24%)  12/49 (24%)  13/49 (27%)  | 
|POLY-3 RATE (b)    |     10/47.24     8/47.38      2/45.68      7/47.85     |14/46.61     12/47.42     12/47.04     13/46.15     | 
|POLY-3 PERCENT (g) |     21.2%        16.9%        4.4%         14.6%       |30.0%        25.3%        25.5%        28.2%        | 
|TERMINAL (d)       |     10/44 (23%)  8/44 (18%)   2/42 (5%)    7/46 (15%)  |14/43 (33%)  11/40 (28%)  12/43 (28%)  11/40 (28%)  | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      729 (T)     |729 (T)      656          729 (T)      552          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.170N     P=0.396N     P=0.019N*    P=0.262N    |P=0.541      P=0.489N     P=0.408N     P=0.581N     | 
|POLY 3             |     P=0.185N     P=0.395N     P=0.016N*    P=0.287N    |P=0.507N     P=0.389N     P=0.398N     P=0.512N     | 
|POLY 1.5           |     P=0.182N     P=0.397N     P=0.014N*    P=0.286N    |P=0.502N     P=0.397N     P=0.403N     P=0.510N     | 
|POLY 6             |     P=0.188N     P=0.392N     P=0.017N*    P=0.288N    |P=0.509N     P=0.384N     P=0.396N     P=0.512N     | 
|LOGISTIC REGRESSION|     P=0.170N     P=0.396N     P=0.019N*    P=0.262N    |P=0.533N     P=0.401N     P=0.408N     P=0.533N     | 
|COCH-ARM / FISHERS |     P=0.178N     P=0.397N     P=0.013N*    P=0.282N    |P=0.489N     P=0.410N     P=0.410N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.078N     (e)          (e)          (e)         |P=0.541N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 34      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Diverticulum                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/49 (0%)    2/50 (4%)    1/50 (2%)    1/50 (2%)   |2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/47.24      2/47.90      1/45.68      1/47.85     |2/46.61      0/47.80      0/48.01      0/46.05      | 
|POLY-3 PERCENT (g) |     0.0%         4.2%         2.2%         2.1%        |4.3%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/44 (0%)    2/44 (5%)    1/42 (2%)    1/46 (2%)   |2/43 (5%)    0/40 (0%)    0/43 (0%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          729 (T)      729 (T)      729 (T)     |729 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.512      P=0.238      P=0.491      P=0.509     |P=0.119N     P=0.254N     P=0.238N     P=0.254N     | 
|POLY 3             |     P=0.501      P=0.240      P=0.493      P=0.503     |P=0.114N     P=0.232N     P=0.231N     P=0.240N     | 
|POLY 1.5           |     P=0.502      P=0.241      P=0.497      P=0.503     |P=0.115N     P=0.232N     P=0.232N     P=0.238N     | 
|POLY 6             |     P=0.500      P=0.240      P=0.489      P=0.502     |P=0.113N     P=0.233N     P=0.230N     P=0.243N     | 
|LOGISTIC REGRESSION|     (e)          P=0.238      P=0.491      P=0.509     |P=0.119N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.505      P=0.253      P=0.505      P=0.505     |P=0.115N     P=0.247N     P=0.247N     P=0.247N     | 
|ORDER RESTRICTED   |     P=0.269      (e)          (e)          (e)         |P=0.030N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/49 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/47.24      0/47.90      2/45.68      0/47.85     |0/46.61      0/47.80      1/48.01      1/46.12      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         4.4%         0.0%        |0.0%         0.0%         2.1%         2.2%         | 
|TERMINAL (d)       |     0/44 (0%)    0/44 (0%)    2/42 (5%)    0/46 (0%)   |0/43 (0%)    0/40 (0%)    1/43 (2%)    0/40 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          729 (T)      ---         |---          ---          729 (T)      711          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.602      (e)          P=0.228      (e)         |P=0.228      (e)          P=0.500      P=0.490      | 
|POLY 3             |     P=0.599      (e)          P=0.230      (e)         |P=0.230      (e)          P=0.506      P=0.498      | 
|POLY 1.5           |     P=0.599      (e)          P=0.234      (e)         |P=0.234      (e)          P=0.505      P=0.500      | 
|POLY 6             |     P=0.600      (e)          P=0.226      (e)         |P=0.227      (e)          P=0.506      P=0.495      | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.228      (e)         |P=0.231      (e)          P=0.500      P=0.500      | 
|COCH-ARM / FISHERS |     P=0.598      (e)          P=0.253      (e)         |P=0.235      (e)          P=0.500      P=0.500      | 
|ORDER RESTRICTED   |     P=0.241      (e)          (e)          (e)         |P=0.249      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 35      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/49 (6%)    2/50 (4%)    4/50 (8%)    0/50 (0%)   |3/50 (6%)    5/50 (10%)   2/50 (4%)    5/50 (10%)   | 
|POLY-3 RATE (b)    |     3/47.29      2/48.10      4/46.57      0/47.85     |3/47.17      5/47.90      2/48.01      5/47.71      | 
|POLY-3 PERCENT (g) |     6.3%         4.2%         8.6%         0.0%        |6.4%         10.4%        4.2%         10.5%        | 
|TERMINAL (d)       |     2/44 (5%)    1/44 (2%)    3/42 (7%)    0/46 (0%)   |2/43 (5%)    4/40 (10%)   2/43 (5%)    2/40 (5%)    | 
|FIRST INCIDENCE    |     715          676          348          ---         |555          702          729 (T)      409          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.137N     P=0.502N     P=0.475      P=0.118N    |P=0.354      P=0.331      P=0.498N     P=0.340      | 
|POLY 3             |     P=0.135N     P=0.492N     P=0.492      P=0.117N    |P=0.381      P=0.365      P=0.492N     P=0.363      | 
|POLY 1.5           |     P=0.134N     P=0.492N     P=0.500      P=0.116N    |P=0.383      P=0.366      P=0.492N     P=0.365      | 
|POLY 6             |     P=0.135N     P=0.492N     P=0.482      P=0.117N    |P=0.377      P=0.360      P=0.494N     P=0.357      | 
|LOGISTIC REGRESSION|     P=0.119N     P=0.491N     P=0.589      P=0.118N    |P=0.360      P=0.347      P=0.521N     P=0.312      | 
|COCH-ARM / FISHERS |     P=0.132N     P=0.490N     P=0.511      P=0.117N    |P=0.376      P=0.357      P=0.500N     P=0.357      | 
|ORDER RESTRICTED   |     P=0.109N     (e)          (e)          (e)         |P=0.364      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Erosion                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/49 (4%)    0/50 (0%)    1/49 (2%)    1/50 (2%)   |0/49 (0%)    0/49 (0%)    2/50 (4%)    1/49 (2%)    | 
|POLY-3 RATE (b)    |     2/47.41      0/47.90      1/45.19      1/48.21     |0/46.61      0/46.80      2/48.27      1/45.57      | 
|POLY-3 PERCENT (g) |     4.2%         0.0%         2.2%         2.1%        |0.0%         0.0%         4.1%         2.2%         | 
|TERMINAL (d)       |     1/44 (2%)    0/44 (0%)    0/42 (0%)    0/46 (0%)   |0/43 (0%)    0/40 (0%)    0/43 (0%)    0/39 (0%)    | 
|FIRST INCIDENCE    |     685          ---          632          628         |---          ---          684          569          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.502N     P=0.244N     P=0.531N     P=0.500N    |P=0.239      (e)          P=0.247      P=0.504      | 
|POLY 3             |     P=0.497N     P=0.235N     P=0.517N     P=0.494N    |P=0.236      (e)          P=0.245      P=0.496      | 
|POLY 1.5           |     P=0.497N     P=0.234N     P=0.511N     P=0.494N    |P=0.239      (e)          P=0.244      P=0.497      | 
|POLY 6             |     P=0.496N     P=0.236N     P=0.522N     P=0.494N    |P=0.232      (e)          P=0.247      P=0.494      | 
|LOGISTIC REGRESSION|     P=0.481N     P=0.231N     P=0.463N     P=0.474N    |P=0.333      (e)          P=0.232      P=0.645      | 
|COCH-ARM / FISHERS |     P=0.496N     P=0.242N     P=0.500N     P=0.492N    |P=0.245      (e)          P=0.253      P=0.500      | 
|ORDER RESTRICTED   |     P=0.271N     (e)          (e)          (e)         |P=0.174      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 36      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Germinal Epithelium                                                                                                      | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    3/50 (6%)    1/50 (2%)    3/50 (6%)   |                                                    | 
|POLY-3 RATE (b)    |     0/48.24      3/47.90      1/45.68      3/48.15     |                                                    | 
|POLY-3 PERCENT (g) |     0.0%         6.3%         2.2%         6.2%        |                                                    | 
|TERMINAL (d)       |     0/45 (0%)    3/44 (7%)    1/42 (2%)    2/46 (4%)   |                                                    | 
|FIRST INCIDENCE    |     ---          729 (T)      729 (T)      645         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.173      P=0.117      P=0.486      P=0.125     |                                                    | 
|POLY 3             |     P=0.162      P=0.118      P=0.489      P=0.119     |                                                    | 
|POLY 1.5           |     P=0.163      P=0.118      P=0.493      P=0.119     |                                                    | 
|POLY 6             |     P=0.163      P=0.117      P=0.485      P=0.119     |                                                    | 
|LOGISTIC REGRESSION|     P=0.164      P=0.117      P=0.486      P=0.123     |                                                    | 
|COCH-ARM / FISHERS |     P=0.165      P=0.121      P=0.500      P=0.121     |                                                    | 
|ORDER RESTRICTED   |     P=0.076      (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/48 (15%)   7/49 (14%)   5/45 (11%)   8/45 (18%)  |3/49 (6%)    6/49 (12%)   2/50 (4%)    5/48 (10%)   | 
|POLY-3 RATE (b)    |     7/48.00      7/48.54      5/44.40      8/44.12     |3/47.26      6/48.01      2/48.52      5/44.94      | 
|POLY-3 PERCENT (g) |     14.6%        14.4%        11.3%        18.1%       |6.4%         12.5%        4.1%         11.1%        | 
|TERMINAL (d)       |     3/44 (7%)    4/44 (9%)    1/40 (3%)    5/41 (12%)  |0/42 (0%)    0/39 (0%)    0/43 (0%)    2/38 (5%)    | 
|FIRST INCIDENCE    |     459          335          348          537         |114          525          635          569          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.424      P=0.603      P=0.437N     P=0.467     |P=0.408      P=0.250      P=0.486N     P=0.342      | 
|POLY 3             |     P=0.379      P=0.604N     P=0.435N     P=0.430     |P=0.401      P=0.251      P=0.488N     P=0.329      | 
|POLY 1.5           |     P=0.382      P=0.601N     P=0.431N     P=0.434     |P=0.407      P=0.248      P=0.489N     P=0.335      | 
|POLY 6             |     P=0.378      P=0.609N     P=0.439N     P=0.428     |P=0.395      P=0.252      P=0.487N     P=0.324      | 
|LOGISTIC REGRESSION|     P=0.542      P=0.521N     P=0.094N     P=0.546     |P=0.455      P=0.073      P=0.659      P=0.301      | 
|COCH-ARM / FISHERS |     P=0.392      P=0.597N     P=0.426N     P=0.445     |P=0.418      P=0.243      P=0.490N     P=0.346      | 
|ORDER RESTRICTED   |     P=0.421      (e)          (e)          (e)         |P=0.330      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 37      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/49 (0%)    0/45 (0%)    0/45 (0%)   |3/49 (6%)    1/49 (2%)    2/50 (4%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/46.89      0/47.38      0/41.85      0/42.85     |3/45.61      1/46.80      2/48.01      0/44.05      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |6.6%         2.1%         4.2%         0.0%         | 
|TERMINAL (d)       |     0/44 (0%)    0/44 (0%)    0/40 (0%)    0/41 (0%)   |3/42 (7%)    1/39 (3%)    2/43 (5%)    0/38 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |729 (T)      729 (T)      729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.113N     P=0.332N     P=0.489N     P=0.139N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.109N     P=0.296N     P=0.477N     P=0.125N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.108N     P=0.297N     P=0.479N     P=0.123N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.111N     P=0.298N     P=0.476N     P=0.128N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.113N     P=0.332N     P=0.489N     (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.105N     P=0.309N     P=0.490N     P=0.125N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.061N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicle                                                                                                          | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     13/50 (26%)  13/50 (26%)  13/50 (26%)  14/50 (28%) |20/50 (40%)  22/49 (45%)  29/50 (58%)  30/48 (63%)  | 
|POLY-3 RATE (b)    |     13/48.41     13/48.31     13/46.83     14/48.52    |20/47.17     22/48.14     29/49.28     30/45.68     | 
|POLY-3 PERCENT (g) |     26.9%        26.9%        27.8%        28.9%       |42.4%        45.7%        58.8%        65.7%        | 
|TERMINAL (d)       |     12/45 (27%)  12/44 (27%)  11/42 (26%)  12/46 (26%) |18/43 (42%)  17/40 (43%)  25/43 (58%)  26/39 (67%)  | 
|FIRST INCIDENCE    |     685          613          441          628         |593          525          539          447          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.471      P=0.563      P=0.510      P=0.520     |P=0.009 **   P=0.333      P=0.067      P=0.015 *    | 
|POLY 3             |     P=0.445      P=0.588      P=0.552      P=0.503     |P=0.008 **   P=0.453      P=0.077      P=0.018 *    | 
|POLY 1.5           |     P=0.444      P=0.587      P=0.566      P=0.500     |P=0.009 **   P=0.439      P=0.071      P=0.020 *    | 
|POLY 6             |     P=0.451      P=0.587      P=0.536      P=0.509     |P=0.007 **   P=0.461      P=0.084      P=0.016 *    | 
|LOGISTIC REGRESSION|     P=0.441      P=0.583      P=0.573      P=0.494     |P=0.009 **   P=0.414      P=0.066      P=0.019 *    | 
|COCH-ARM / FISHERS |     P=0.446      P=0.590N     P=0.590N     P=0.500     |P=0.010 *    P=0.386      P=0.055      P=0.021 *    | 
|ORDER RESTRICTED   |     P=0.640      (e)          (e)          (e)         |P=0.016 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 38      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth                                                                                                                            | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/4 (75%)    0/0 (0%)     0/0 (0%)     2/3 (67%)   |0/0 (0%)     0/1 (0%)     0/0 (0%)     0/1 (0%)     | 
|POLY-3 RATE (b)    |     3/4.00       0/0.00       0/0.00       2/3.00      |0/0.00       0/0.99       0/0.00       0/1.00       | 
|POLY-3 PERCENT (g) |     75.0%        0.0%         0.0%         66.7%       |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     3/4 (75%)    0/0 (0%)     0/0 (0%)     2/3 (67%)   |0/0 (0%)     0/0 (0%)     0/0 (0%)     0/1 (0%)     | 
|FIRST INCIDENCE    |     729 (T)      ---          ---          729 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.567N     P=1.000      P=1.000N     P=0.712N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     (e)          (e)          (e)          P=0.696N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     (e)          (e)          (e)          P=0.696N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     (e)          (e)          (e)          P=0.696N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.567N     (e)          (e)          P=0.712N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.572N     P=1.000      P=1.000      P=0.714N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder                                                                                                                  | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/49 (0%)    0/49 (0%)    0/50 (0%)   |1/50 (2%)    3/50 (6%)    4/50 (8%)    3/50 (6%)    | 
|POLY-3 RATE (b)    |     0/48.24      0/46.90      0/44.68      0/47.85     |1/46.61      3/47.80      4/48.78      3/46.05      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |2.2%         6.3%         8.2%         6.5%         | 
|TERMINAL (d)       |     0/45 (0%)    0/43 (0%)    0/41 (0%)    0/46 (0%)   |1/43 (2%)    3/40 (8%)    2/43 (5%)    3/40 (8%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |729 (T)      729 (T)      539          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.263      P=0.280      P=0.188      P=0.280      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.274      P=0.315      P=0.193      P=0.301      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.280      P=0.314      P=0.190      P=0.305      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.266      P=0.313      P=0.196      P=0.296      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.283      P=0.280      P=0.150      P=0.280      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.282      P=0.309      P=0.181      P=0.309      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.228      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 39      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |0/50 (0%)    3/50 (6%)    0/50 (0%)    3/50 (6%)    | 
|POLY-3 RATE (b)    |                                                        |0/46.61      3/47.80      0/48.01      3/46.05      | 
|POLY-3 PERCENT (g) |                                                        |0.0%         6.3%         0.0%         6.5%         | 
|TERMINAL (d)       |                                                        |0/43 (0%)    3/40 (8%)    0/43 (0%)    3/40 (8%)    | 
|FIRST INCIDENCE    |                                                        |---          729 (T)      ---          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.151      P=0.109      (e)          P=0.109      | 
|POLY 3             |                                                        |P=0.161      P=0.123      (e)          P=0.117      | 
|POLY 1.5           |                                                        |P=0.163      P=0.123      (e)          P=0.119      | 
|POLY 6             |                                                        |P=0.158      P=0.122      (e)          P=0.114      | 
|LOGISTIC REGRESSION|                                                        |(e)          P=0.109      (e)          P=0.109      | 
|COCH-ARM / FISHERS |                                                        |P=0.164      P=0.121      (e)          P=0.121      | 
|ORDER RESTRICTED   |                                                        |P=0.053      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |45/50 (90%)  47/50 (94%)  46/50 (92%)  47/50 (94%)  | 
|POLY-3 RATE (b)    |                                                        |45/48.32     47/49.99     46/48.98     47/48.41     | 
|POLY-3 PERCENT (g) |                                                        |93.1%        94.0%        93.9%        97.1%        | 
|TERMINAL (d)       |                                                        |41/43 (95%)  38/40 (95%)  42/43 (98%)  39/40 (98%)  | 
|FIRST INCIDENCE    |                                                        |539          525          539          552          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.193      P=0.179      P=0.512      P=0.150      | 
|POLY 3             |                                                        |P=0.245      P=0.593      P=0.607      P=0.322      | 
|POLY 1.5           |                                                        |P=0.300      P=0.541      P=0.612      P=0.360      | 
|POLY 6             |                                                        |P=0.214      P=0.645      P=0.578      P=0.315      | 
|LOGISTIC REGRESSION|                                                        |P=0.266      P=0.508      P=0.599N     P=0.311      | 
|COCH-ARM / FISHERS |                                                        |P=0.342      P=0.357      P=0.500      P=0.357      | 
|ORDER RESTRICTED   |                                                        |P=0.294      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/12/04                           EXPERIMENT: 92013 TEST: 06                                            Page 40      
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                    4-METHYLIMIDAZOLE   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |1/50 (2%)    1/50 (2%)    1/50 (2%)    3/50 (6%)    | 
|POLY-3 RATE (b)    |                                                        |1/46.61      1/47.80      1/48.01      3/46.87      | 
|POLY-3 PERCENT (g) |                                                        |2.2%         2.1%         2.1%         6.4%         | 
|TERMINAL (d)       |                                                        |1/43 (2%)    1/40 (3%)    1/43 (2%)    2/40 (5%)    | 
|FIRST INCIDENCE    |                                                        |729 (T)      729 (T)      729 (T)      409          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.155      P=0.746      P=0.762      P=0.290      | 
|POLY 3             |                                                        |P=0.164      P=0.755N     P=0.754N     P=0.307      | 
|POLY 1.5           |                                                        |P=0.165      P=0.755N     P=0.755N     P=0.309      | 
|POLY 6             |                                                        |P=0.162      P=0.756N     P=0.754N     P=0.303      | 
|LOGISTIC REGRESSION|                                                        |P=0.155      P=0.746      P=0.762      P=0.278      | 
|COCH-ARM / FISHERS |                                                        |P=0.163      P=0.753N     P=0.753N     P=0.309      | 
|ORDER RESTRICTED   |                                                        |P=0.187      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        312 PPM      625 PPM      1250 PPM    |0 PPM        312 PPM      625 PPM      1250 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |2/50 (4%)    3/50 (6%)    1/50 (2%)    5/50 (10%)   | 
|POLY-3 RATE (b)    |                                                        |2/46.61      3/47.80      1/48.01      5/46.05      | 
|POLY-3 PERCENT (g) |                                                        |4.3%         6.3%         2.1%         10.9%        | 
|TERMINAL (d)       |                                                        |2/43 (5%)    3/40 (8%)    1/43 (2%)    5/40 (13%)   | 
|FIRST INCIDENCE    |                                                        |729 (T)      729 (T)      729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.143      P=0.467      P=0.500N     P=0.188      | 
|POLY 3             |                                                        |P=0.156      P=0.511      P=0.490N     P=0.211      | 
|POLY 1.5           |                                                        |P=0.159      P=0.511      P=0.491N     P=0.216      | 
|POLY 6             |                                                        |P=0.153      P=0.509      P=0.489N     P=0.205      | 
|LOGISTIC REGRESSION|                                                        |P=0.143      P=0.467      P=0.500N     P=0.188      | 
|COCH-ARM / FISHERS |                                                        |P=0.160      P=0.500      P=0.500N     P=0.218      | 
|ORDER RESTRICTED   |                                                        |P=0.136      (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).